Malaysia Health 2005

foreword
The Ministry of Health, as the lead agency in healthcare

provision, and authority on health in Malaysia, leads the
way in directing the development of healthcare services
in the country. We are proud to present Malaysia’s Health
2005 which provides the latest developments in the Ministry
of Health, population health, health system management
as well as research and development in the health sector
in Malaysia.
The 2005 report covers several current issues, among

them the National Influenza Pandemic Preparedness
Plan; Harm Reduction in the Prevention and Control of
HIV/AIDs; and plans for the Development of Regulations
on Medical Devices. Topics on Control of Unregistered
Drugs; Malaysia’s approach to Suicide Prevention and
New Generation Hospitals provide interesting reading on
health sector development in Malaysia.
We will continue to strive towards further improvements

to this technical report series and make it an important
source of information on health sector development in the
country. We hope this report will enlighten our readers on
the evolving health scenario in Malaysia, especially for
those who are directly involved in the healthcare sector.
TAN SRI DATUK DR. MOHAMAD ISMAIL MERICAN

DIRECTOR-GENERAL OF HEALTH, MALAYSIA
vision
FOR HEALTH
Malaysia is to be a nation of healthy individuals, families
and communities, through a health system that is
equitable, affordable, efficient, technologically appropriate,
environmentally-adaptable and consumer-friendly, with
emphasis on quality, innovation, health promotion and
respect of human dignity and which promotes individual
responsibility and community participation towards an
enhanced quality of life.
mission
OF THE MINISTRY OF HEALTH
The mission of the Ministry of Health is to build
partnership for health to facilitate and support the
people to :
• Attain fully their potential in health.

• Motivate them to appreciate health as valuable
asset.
• Take positive action to improve further and sustain their
health status to enjoy a better quality of life.
contentsForeward
Vision for Health
Mission
PART 1
CHAPTER 1 - HEALTHCARE SERVICE
11 Emergency Medical and Trauma Care Service in Malaysia

20 Rehabilitative Services in Malaysia
30 Specialisation and subspecialisation in the ministry of Health
52 Hospital Infection Control
62 Optimising Intensive Care Service in Malaysia
78 Chronic Pain Management Service
87 Advances in Oral Healthcare in Malaysia
104 Challenges for Generic Drugs
CHAPTER 2 - POPULATION HEALTH
129 Dengue Control in Malaysia

139 Prevention and Control of Zoonotic Diseases
148 National Influenza Pandemic Preparedness Plan
156 Harm Reduction in the Prevention and Control of HIV/AIDS
160 Suicide Prevention in Malaysia
contentsCHAPTER 3 - HEALTH SYSTEM MANAGEMENT
177 New Generation Hospital - IT Hospitals

187 Control of Unregistered Drugs and Healthcare Products in Malaysia
195 Information versus Advertising
201 Health Technology Assessment in Malaysia
210 Development and Implementation of Medical Devices Regulation in
Malaysia
CHAPTER 4 - RESEARCH AND DEVELOPMENT
227 Meeting Outpatient Expectations at Public Hospital Specialist Clinics in

Peninsular Malaysia
239 Job Satisfaction Among Staff in Selayang Hospital
252 National Laboratory Biosafety
PART 2
261 EDITORIAL COMMITTEE

262 CONTRIBUTORS
264 ACKNOWLEDGEMENT
1
part
CHAPTER 1 HEALTHCARE SERVICE
CHAPTER 2 POPULATION HEALTH
CHAPTER 3 HEALTH SYSTEM MANAGEMENT
CHAPTER 4 RESEARCH AND DEVELOPMENT
part one
EMERGENCY MEDICAL AND TRAUMA CARE SERVICE IN
MALAYSIA
SUMMARY
Emergency medical and trauma care service (EMTS) is a major and important
component of hospital care service in the country. The development of the Emergency
Medicine as a specialty and the commencement of local Masters Programme in the
training of Emergency Physicians in 1998 have helped to improve and upgrade
the provision of EMTS in the country. However, much more needs to be done to
enhance the quality and level of EMTS in the country, among them, improvements
to pre-hospital care service; adequate staffing; enhancing skills and competence of
emergency department personnel. Improvements to structure, equipment and work
processes as well as adoption of quality standards would further help to upgrade
EMTS provided to the public.
Introduction
E
Emergency medical and trauma care service (EMTS) is a crucial ED, critical first
component of any hospital service, providing 24 hour non-stop point of contact
service throughout the year. It is a critical ‘first point of contact’ with patients
between healthcare providers and the acutely ill and trauma
patients where early and appropriate intervention could greatly
influence morbidity and mortality of cases coming to the hospital.
Therefore, a high level of skill is required for emergency medical
personnel to ensure prompt, effective and high quality service is
delivered to improve patient outcome.
EMTS has seen some new developments over the last 5-10 years, New ED
especially with the emergence of our locally trained emergency leadership
medicine specialists. The first batch of such specialists graduated in
2003 and since then, almost all state capital hospitals have emergency
physicians heading the Emergency Departments. These emergency
physicians have provided the leadership for the further development
of emergency care service in the country.
Healthcare Service 13
A total of 4.409 million attendances at the emergency departments/ ED attendance
units were recorded in 2005 of which about 3.5 million were recorded
in hospitals in Peninsular Malaysia, 0.5 million in Sabah and another
400,000 attendances in Sarawak. However, a large proportion of the
patients seen were not real emergencies but rather, non-emergency
acute illnesses.
Mission
To provide initial, comprehensive and holistic emergency medical

and trauma care services in the hospital and pre-hospital settings
which include resuscitation, stabilisation and definitive treatment to
all patients in need so as to lessen morbidity and reduce mortality in
such patients.
Objectives
The objectives of emergency medical and trauma care service are as

follows :
i) Providing holistic emergency care with emphasis on technical

aspects and corporate culture of professionalism, teamwork and
caring service
ii) Providing emergency care through skilful emergency medical
personnel who meet professional standards.
iii) Developing an organisation that emphasis on research and
continual professional development
Scope and service system
The scope of service and the service system offered by the Emergency ED before and
Department (ED) were unclear for many years. Emergency now
Departments, therefore, became a dumping ground for patients where
diagnosis were unclear, as well as for medical officers who have no
career plan. This was due to the lack of ‘senior cover’ or specialist
overseeing the running of the department.
However over the years, this has changed. Emergency service is now
recognised as the most important front line service in a hospital, and
emergency medicine has gain more respect with its emergence as a
specialty. The current scope of service in the Emergency Department
are as follows :
14 MALAYSIA’S HEALTH 2005

i) Pre-hospital care service ( Ambulance ) service
This is a first responder service provided by all Ministry of Pre-hospital

Health (MOH) hospitals except Hospital Kuala Lumpur where the care
service is provided by the St. John’s Ambulance, the Red Crescent
Society and the Civil Defence.
ii) Emergency medicine
This service is the back bone of the EMTS which comprise of holistic Emergency care
and comprehensive approach to diagnostic, therapeutic and definitive
treatment provided to patients in the emergency department.
iii) Emergency medicine specialist service
This is provided by emergency physicians who are stationed at the ED. Emergency
ED specialist service was started at HKL in 1993 and is now provided specialist care
at all state capital MOH hospitals. It will eventually be extended to all
the district hospitals with specialist services.
iv) Medical observation
Providing temporary on-bed monitoring of patients pending decision Observation

on admission. These observation bays with beds are only available in
the state capital and bigger district hospitals.
v) Medical standby
Medical cover for special events which are mainly government Medical cover
functions involving the Head of State or Government. From time to
time, it covers international events hosted by the Government and
attended by Heads of States from foreign countries. Some of the major
events that had been covered are as follows :
• Commonwealth Games (SUKOM ) in 1998

• South East Asia (SEA) Games, 2001
• Non-Aligned Nation Members (NAM) Meeting, 2003
• Organisation of Islamic Countries (OIC) Meeting, 2003
• Association of South East Asian Nations(ASEAN) Summit, 2005
vi) Disaster management
This is one of the ‘core business’ of EMTS. Emergency departments Disaster

have been directly involved in the management of disasters in this management
country, acting as the main focal point for emergency response to
disasters. This include major catastrophes like building collapse, the
most famous of which was the Highland Towers incident in 1993;
natural disaster like the Tsunami in 2004; and standby for other
disasters, in particular airport disasters. The emergency departments
must always be vigilant on other possible emerging disasters like
bioterrorism and nuclear accidents.
vii) One Stop Crisis Centre (OSCC)
This centre has been operational since 1993 at the Kuala Lumpur One-stop crisis
Hospital. It has since been extended to all hospitals in the country. management
OSCC aims to provide a one-stop service and care for cases of violence
against women and children, sexual assault and rape victims. OSCC
is one of the essential services in EMTS. It has become a model used
by the WHO to provide similar service in other countries such as
Bangladesh, India, Philippines, Indonesia and Thailand.
Human resource and training
The Ministry of Health is going towards the training of a skilled group

of staff that would be working in the Emergency Department. The staff
would be trained towards pre-hospital care, disaster management
and will also now be looking towards being trained in the handling
of Hyperbaric Chamber.
i) Short training courses
Training is one of the most important aspects of human resource Short-training

development and it has been greater emphasis in the 9th Malaysia courses
Plan. Short in-service training courses are conducted locally by the
respective hospitals or nationally from time to time, among them are
as follows :
• Basic Life Support (BLS)

• Advance Life Support (ALS)
• Major incident management
• Patient triaging

• Managing patients in crisis ( domestic violence, sexual assault,
child abuse, and others )
• Wound management
A new course on handling of casualties of weapons of mass destruction

(Hospital-based mass casualty) is being introduced in collaboration
with the American Embassy.
ii) Post-basic Emergency Medicine
This is a 6 months post-basic training opened to medical assistants and Post-basic

staff nurses aimed at improving the level of competence of emergency training course
department personnel. The first post-basic emergency course was
started in May 1989 at the Medical Assistants Training College in
Seremban. Currently, the programme is provided at two other training
colleges in Ipoh and Kuching.
iii) Emergency medicine specialist training
This is a four year Masters programme which was started by Universiti Local Masters
Sains Malaysia (USM) in 1998. Since then, the programme is now programme
available at two other universities, namely, the National University of
Malaysia (Universiti Kebangsaan Malaysia, UKM ) and the University
of Malaya where the latter has just started in 2005. Upon graduation,
these officers undergo a six-month pre-gazetment training in one of
the accreditated hospitals before final gazetment as an emergency
medicine specialist (emergency physician). Currently there are 21
gazetted emergency physicians working in the Ministry of Health
hospitals and another 7 working in the university/Ministry of Defence
hospitals (Table 1).
Table 1 : Distribution Of Emergency Medicine Specialist in Malaysia, 2005
Hospital Number
Hospital Kuala Lumpur 6

Hospital Selayang 1
Hospital Serdang 1
All other state hospitals 13
USM Hospital, Kubang Krian 3
UKM Hospital, Cheras 2
Ministry of Defence 2
Total : 28
EMTS New Initiatives
i) Ambulance control and dispatch control centre
This was a pilot project that was carried out in mid 2004 to the end
of 2004. Following the Tsunami disaster in December 2004, this pilot
project was extended to 7 sites after it was noted to be successful in
Penang. The sites include Hospital Pulau Pinang, Hospital Kangar,
Hospital Ipoh, Hospital Melaka, HTAR Klang, Hospital Temerloh
and Hospital Batu Pahat..
ii) Motorcycle squad
This squad moves on a motorcycle and acts as a First Responder to

an emergency call. It is particularly useful in crowded urban areas
like the Klang Valley where the traditional ambulance may not be
able to respond to emergency calls speedily due to heavy traffic. The
motorcycle squad manned by trained paramedic will be dispatched
as a first responder to emergency calls, while awaiting the arrival of
the ambulance. This project would be piloted in the Klang Valley in
the late 2006.
iii) Pre-hospital care project
The pilot project involving the establishment of ‘Pre-hospital Care Unit’

at the Emergency Departments has been planned for the Klang Valley
and Penang Island and is expected to take off in early 2007.
iv) Hyperbaric chamber service
The first hyperbaric chamber service providing mainly decompression

therapy to deep sea compression sickness incidents, will be first
established at the Emergency Department in Hospital Kuala
Terengganu as several islands in the state are popular destinations for
divers. Two other centres will also be established in Hospital Sungai
Buloh and Hospital Kota Kinabalu.
Issues and challenges
i) Career development
The current policy of ‘promote & transfer’ is no longer suitable because Review
it prevents skill expansion of emergency medical personnel. A clearer ‘’promote &

career path must be set up in emergency medicine to encourage transfer’’ policy
more personnel to further their studies up to the tertiary levels.
First degree courses for the support staff should be recognized and
encouraged. Furthermore, extended roles for the paramedics should
be considered.
Attractive career path in Emergency Medicine should be established

for the medical officer waiting in the Emergency Department.
ii) Norms
Norms for the EMTS personnel at all levels must be revised and Staffing norm
separate from outpatient department norms to reflect a totally different for ED
scope of service provided in the emergency department. Besides the
usual workload norm in terms of number of patients managed per
day, staffing norms for EMTS personnel must take into consideration
special factors such as :
• Condition of patients – whether critical and semi critical

• Average time spent on critical patients
• Actual core services provided (first responder, EMS, medical
standby, inter-facility transfer and others)
iii) Training
Opportunities for short courses and long term courses must be Further training
expanded and extended. Under the 9th Malaysia Plan, local and opportunities
overseas training courses have been introduced to give more exposure
to the staff on disaster management, pre-hospital care and also in
hyperbaric medicine.
iv) Pre-hospital care
The Ambulance service in the country has to be upgraded and Upgrading of

improved, including water ambulance service though air ambulance pre-hospital
would be costly to be provided under the Ministry of Health. Inter- care service
hospital networking among all the hospitals in the state must be further
enhanced to provide a more efficient pre-hospital care service.
vi) Service standards
Work processes development including clinical guidelines and critical Introduction

pathways must be emphasized in order to sustain high standard of of service
EMTS care. Service standards and professional standards need to be standards
addressed. Proposals for the indicators of standards of care are as
follows :
• Preventable trauma death

• Triaging error
• Waiting time in non critical zone
• Door to needle time in thrombolytic therapy for acute myocardial
infarction
• Rate of miss fractures in the Emergency Department
vi) Structure and layout
Modern emergency department designs incorporate features that cater Proper physical
for the many different categories of patients being managed at the ED structure and
while structural layout provides ease of patient flow and support new design of ED
concepts in patient care. Structural layout since 1994 has been based
on dedicated zones according to physical condition of the patient.
Treatment zones are colour coded to ensure efficient execution of the
emergency care from the time of arrival of the patient at the ED to
exit for the ward, home or mortuary. Components of the ED by zone
should include the followings :
• Triage zone
• Critical Zone
• Semi-critical zone
• Non-critical zone
• Asthma zone
• One Stop Crisis centre ( OSCC )
• Observation ward
• Procedural zone
• Decontamination zone
• Emergency operation zone
vii) Inappropriate use of ED
EDs are increasingly being used as a primary care centre for acute Inappropriate
but non-emergency conditions. This is particularly so in urban use of ED
areas where hospitals, in particular EDs, are readily accessible and
where health clinics do not provide after office on-call service. The
problem could be related to socio-economic factors. A large segment
of the urban population are working during office hours and often
sought treatment for themselves or family members after work. The

large number of non-emergency patients create congestion and long
waiting for patients, resulting in complaints at times. The problem is
compounded by the fee structure which encourages use of ED facility
as the payment of RM1 is a token, compared to the much higher fees
charged by the private clinics.
To overcome the problem, out-of office hour primary care service Review fee
under the “hospital-locum” service system was introduced in October structure in ED
2002. Currently, it is being provided by the bigger hospitals. It is
perhaps time to consider revising fee structure for ED to promote a
more appropriate use of ED as a centre for emergency service.
Conclusion
Emergency medical and trauma care service in this country has evolved
significantly over the last ten years. However, much more can be
done in terms of human resource, facility, service and organisational
developments to ensure this crucial first point of contact with the
hospital under emergency conditions truly reflect the level and
standard of service provided by the hospital. An efficient, effective
and high quality EMT service can make a difference to the outcome of
patients in reducing morbidity and mortality associated with medical
emergencies and trauma.
In line with the theme of the 9th Malaysian Plan to “Achieve Greater
Health through Consolidation” and the goals of Enhancing Healthcare
Delivery and Reducing Disease Burdens, it is hoped that sufficient
resources would be provided to develop EMTS further towards better
health for all Malaysians.
REHABILITATIVE SERVICES IN MALAYSIA
SUMMARY
Rehabilitation medicine involves the prevention and reduction of disability and

handicap arising from impairments, and the management of disabilities from a
physical, psychosocial and vocational perspective. Rehabilitation medicine as a
specialty only started in 1996 with the posting and establishment of the Rehabilitation
Medicine department in Hospital Kuala Lumpur. The development of rehabilitation
medicine is still slow with only seventeen rehab physicians in the country, of which
half are in the Ministry of Health hospitals. The main bulk of rehabilitation service is
still being delivered by the physiotherapists and occupational therapists where the
focus is mainly on physical rehabilitation of mobility and Activities of Daily Living.
Training programmes for various categories of rehabilitation professionals have been
started in the local universities in recent years. However, the number is still limited
and the acute shortage of rehabilitation professionals will hamper the development
of rehabilitation service in the country.
Introduction
R
ehabilitation medicine refers to the care provided in returning an Defining
individual to his or her maximum possible functional capability rehabilitation
following the loss of function and/or ability. In a broader sense, medicine
Rehabilitation medicine is the branch of medicine concerned with
the prevention as well as reduction of disability and handicap arising
from impairment and the management of disabilities from a physical,
psychosocial and vocational perspective. It emphasizes maximal
restoration of the physical, psychological, social and vocational
function of the person, the maintenance of health and the prevention
of secondary complications of disabilities.
The demand for rehabilitation services is growing world-wide. The

World Health Organization (WHO) estimates the number of people
who require rehabilitation services at any point in time to be 1.5% of
the total population of any particular country.
The Second National Health Morbidity Survey (1997), revealed that Second National
the proportion of our population with overt disabilities (including Health and
stroke, spinal cord injury, cerebral palsy etc.) is about 6.5%. Factors Morbidity
associated with the increase in this demand for rehabilitative services Survey

in Malaysia include better perinatal care; change in the demographic
structure of the population and changes in pattern of disease from
acute infectious diseases to chronic life-style related diseases. These,
respectively have resulted in increased survival rates for children with
disabilities; a higher proportion of the elderly as a result in increase life
expectancy and an increase in the number of persons with disabilities.
The Malaysian Burden of Disease and Injury Study (2001) indicated
that ischaemic heart disease, cerebro-vascular accidents and motor
vehicle accidents are high among the top 10 disease burdens in the
country.
Industrial accidents have also resulted in premature deaths and Injuries due
disabilities. A study conducted by the Social Security Organization to industrial
revealed that from 1998 to 2002, a total of 50,992 insured persons were accidents
permanently disabled while another 91,896 insured persons were
found to be invalid. The number of insured persons suffering each
year from permanent disability has stabilized to less than 12,000 per
year recently. The number of insured person suffering from invalidity
however, increased significantly from 13,316 persons in 1998 to 23,449
persons in 2002. Such a trend reflects increasing wastage of valuable
human resources especially for a nation such as Malaysia which
faces a labour shortage. Thus, this demonstrates the importance of
Rehabilitation Medicine.
Scope of rehabilitation medicine service
Rehabilitation medicine requires a holistic or integrated approach and

is best achieved through the combined and coordinated use of the
skills of medical and allied health professionals. This addresses not
only the physical but also vocational, social, home and psychological
rehabilitation of persons with loss of ability.
In Malaysia, rehabilitation medicine encompasses the following

services :
• Consultation services for assessment, therapeutic and rehabilitative
care
• Nursing care
• Physiotherapy
• Occupational therapy
• Medical Social services
• Speech therapy
• Orthotic and Prosthetic services
The main clients of rehabilitation consultation are amputees; Main clients of
neuromedical and neurosurgical patients; patients with spinal cord rehabilitation
injuries; persons requiring orthotic services; paediatric patients with medicine service
physical handicap such as cerebral palsy and spina bifida as well
as cardio-respiratory patients. Other clients require assessments
for their driving licenses; assessments for wheelchair requirements
or specialized wheelchair seating needs; home modification and
vocational placement. Patients are normally referred from other
departments of the hospital as well as from primary health centers for
this service. Currently the services are provided in 19 primary health
care facilities as well as all secondary and tertiary hospitals.
Current status of rehabilitation medicine services in Malaysia
Rehabilitation medicine specialist service was first started in Development of

Hospital Kuala Lumpur in June 1996. Currently, there are seventeen rehabilitation
rehabilitation medicine specialists in the country. Out of the seventeen, medicine
only nine are with the Ministry of Health. However, this service specialist service
is only available in three MOH hospitals namely, Hospital Kuala
Lumpur, Hospital Putrajaya and Hospital Seremban. Non-specialist
rehabilitation services provided by the allied health professionals are
available in most large hospitals throughout the country, including
some larger health clinics. These include physiotherapy, occupational
therapy and speech therapy services.
Hospital Putrajaya also serves the Bangi Vocational Rehabilitation Physiothera-

center which is a training centre for the physically handicapped under pists,
the Ministry of Women and Family Development. The University of occupational
Malaya Medical Center has the most comprehensive Rehabilitation therapists, the
Medicine service. However, it is constantly challenged with the main providers
problem of brain drain of its trained personnel, increasing demand of rehabilitation
for its services as well as the lack of financial support to expand its service
services
Currently, most of the rehabilitation services are managed by individual Rehabilita-

clinical disciplines, supported by physiotherapists, occupational tion physicians
therapists, speech therapists and medical social workers. Rehabilitation needed for more
services delivered by physiotherapists and occupational therapists are complex
focused mainly on physical rehabilitation of mobility and “Activities disabilities
of Daily Living” (ADL). These have been in existence in Malaysian
hospitals for decades, and still form the backbone of rehabilitation
services for the majority of government hospitals nationwide.

However with increasing complexity of disabilities, Rehabilitation
Physician forms the essential bridge to address the complex needs of
these patients. With increasing acute care workload and increasing
number of patients needing long term rehabilitative care, the future
will see additional emphasis being given to developing Rehabilitation
Medicine as a specialty and organized as a department, for close liaison
and continuity of care of patients.
Rehabilitation services provided by health clinics and other

agencies
From 1996, under the expanded scope of activities, rehabilitative Rehabilitation

services were introduced to selected health centres. Currently there service in health
are 115 health centres providing rehabilitative services for children clinics
with special needs, 229 for geriatric patients and 23 centres providing
psychosocial rehabilitative services for the stable mental patient.
These services are being provided by trained paramedics such as
public health nurses and medical assistants. Case management plans
of the clients receive input from the physiotherapist and occupational
therapist in hospitals and clients are followed up at the health centres
under the supervision of the therapist in nearby hospitals.
Rehabilitation services are also provided by other government Rehabilitation

agencies and non-government organizations (NGOs). The Department service by other
of Social Welfare provides rehabilitation services through its 313 agencies and
Community-based Rehabilitation (CBR) centers that focus mainly on NGOs.
social, educational and vocational rehabilitation and which caters to all
ages. The National Stroke Association of Malaysia (NASAM) conducts
rehab sessions which include physiotherapy, occupational therapy and
speech therapy for stroke survivors through its 6 centres in Petaling
Jaya, Ampang, Penang, Perak, Malacca and Sabah.
Rehabilitation medical services are provided by many different Categories of

healthcare professionals who look after different aspects of rehabilitation
rehabilitation. They include: medicine
professionals
HC Professional Role
Rehabilitation Consultants / specialists in rehabilitation medicine supervise

physician rehabilitation programs for complex cases and assess and
manage the care of patients requiring multidisciplinary
rehabilitation services
Nursing/ Rehabilitation nurses and medical assistants in wards provide
Medical comprehensive care and assist patients to become more
assistants independent as their condition improves
Physiothera- Physiotherapists design individual programs for patients and

pists assist them in physical rehabilitation
Occupational Occupational therapists identifies individual treatment plans and

therapists assist patients to return to their former activities, which include
personal care, domestic tasks, work, driving and home/work
adaptations
Speech Speech Therapists assess and rehabilitate those with speech and
therapists swallowing problems
Medical social Medical Social Workers offer supportive assistance which

workers includes financial, prosthetic aids, vocational placement,
networking with relevant agencies, and community placement
in preparation for the patients to return to the community.
Clinical Psychologists assess and assist in rehabilitating those with

psychologists behavioural problems that interfere with a person capacity to
be rehabilitated, especially head injury cases, cerebrovascular
accidents
Counselors Counselors provide moral support, guidance and counseling

for those who need mental support while adjusting to their
disabilities, including the carers
Rehabilitation Orthotic and prosthetic devices for disabled persons are

technicians manufactured and provided by rehabilitation technicians
Human resource
Currently, there are 17 rehabilitation physicians in the country with only Distribution of
9 working in the Ministry of Health, 5 in University Hospitals and 3 in rehabilitation
the private sector. Malaysia has a need of between 150 rehabilitation physicians
physicians based on the planning norm of 1:150,000 (Medical
Development Division, Ministry of Health) to 300 based on the Royal
College of Physician, London (RCPSC)’s norm of 1: 85,500 population.

As for the physiotherapists, there are currently 405 physiotherapists Physiotherapists
in the Ministry of Health and 218 in private practice while the number and
for occupational therapist is 364, most of them are in the public sector occupational
(270 in MOH hospitals, 10 in health clinics, 16 in university hospitals therapists
and 5 in Social Welfare Centers) while 16 are in the private sector and
8 are with non-government organisations.
The number of speech therapists in the country is very limited, Speech

totaling 83 with most of them in the universities (38); 25 in MOH therapists
hospitals and another 20 are in private facilities. The distribution of
the physiotherapist, occupational therapist and speech therapist in the
Ministry of Health by state are as shown in the table below.
Table 1: The distribution of the physiotherapist, occupational therapist and speech

therapist in the Ministry of Health by state, 2005
States Physio- Occupational Speech

therapist therapist therapist

Perlis 6 5 1
Kedah 19 12 2
Pulau Pinang 31 19 1
Perak 40 35 3
Selangor 38 32 3
Negeri Sembilan 13 15 1
Melaka 11 7 1
Johor 31 29 4
Pahang 19 13 0
Terengganu 16 7 1
Kelantan 22 11 1
Sabah 52 21 1
Sarawak 50 38 2
WP K. Lumpur 46 26 4
Total 405 270 25
Training in rehabilitation medicine
The training of rehabilitation physician is presently available only at Training of

the University of Malaya as a postgraduate Masters Programme. This rehab physicians
is a four year post-graduate programme was started in 1997. It is a
closed system program where trainees spend their full four years in
the university. The programme attracts only a handful of candidates
each year, except in 2002/2003 session which attracted 9 candidates.
Previously, trainees spent a 6 month elective period at the Melbourne
Extended Care and Rehabilitation Services, Australia. However, this
was stopped in 2004 due to the cost involved.
It is envisaged that the Open Masters program will be adopted, Open masters
with candidates spending at least one to two years in an accredited programme
government hospital and rehabilitation consultant physicians of these preferred
hospitals will become honorary lectures of the academic institutions to
facilitate the training, monitoring and enhancement of competency of
the trainees in meeting service needs upon their graduation.
Speech therapists are presently trained at the National University of Training

Malaysia (UKM). This is the only training centre for speech therapists of speech
at the moment. This four years training programme was started in therapists
1995.
Physiotherapist training programme started in 1976 at the College Training of

of Physiotherapy in Hospital Kuala Lumpur while the College of physiotherapists
Occupational Therapist commenced its training programme in 1984. and
Both these are a three year diploma programme under the Ministry of occupational
Health. These training colleges moved to the Allied Health Sciences
College in Sungai Buloh in 2004 but practical training is still based at
the Kuala Lumpur Hospital.
Since the past five years, UKM has offered a degree program for Degree
physiotherapy students while the degree programme for occupational programme
therapy started this year (2005). In the same year, MARA University of in physio and
Technology (UiTM) also initiated a degree program for physiotherapy occupational
and occupational therapy. therapy
There is no special training in rehabilitation medicine for nurses and Post-basic

medical assistants. However, it is important to establish a post-basic rehab training
programme for rehabilitation nursing in the future. The delivery programme for
of acute and long term rehabilitation care is inherently dependent paramedics
on competent nursing support, and presently, this is lacking in needed

Malaysia. The post-basic program would facilitate the development
of this needed trained manpower, and provide a career incentive for
personnel to venture and commit to the development of this service.
Future development of rehabilitation medicine
Medical Rehabilitation was identified as one of the seven major Rehabilitation

activities of the Medical Program since the 7th Malaysia Plan (1996 medicine
– 2000) and again under the ‘Extended Medical Care’ activity of the identified for
8th Malaysia Plan (2001-2005). The plan included the building of a development
special Rehabilitation Hospital to provide a comprehensive range since the 7th
of rehabilitation services. This centre would have provided the Malaysia Plan
impetus for the development of rehabilitation service in the country.
However, this plan had to be delayed and brought forward to the
9th Malaysia Plan (2006-2010). In addition, the rehabilitative services
that were initially slated for all MOH hospitals and health clinics had
to be deferred or reduced in scope and size due to human resource
constraints.
For planning and development of rehabilitation medicine services in Levels of

the Ministry of Health hospitals and health clinics, six levels of services rehabilitation
have been identified as follows: medicine service
Level Description
1 Limited range of medical rehabilitation services provided by

non-specialised staff (nurses/medical assistants) and by visiting
physiotherapists
2 As in level 1 plus physical and vocational rehabilitation provided

by professional staff for assessing and rehabilitating physical
disabilities. Counseling services provided. Have access to
specialized care. Day care services provided. Non in-patient
rehabilitation wards. (+ physiotherapist, occupational therapist,
counselors)
3 As in level 2 plus social rehabilitation services provided by

professional staff. No formal rehabilitation wards. May have
visiting medical rehabilitation specialist services. Quality
assurance activities undertaken. (+ medical social worker)
4 As in level 3 plus full range of medical rehabilitation services
(including speech and psychological rehabilitation) provided
by professional teams appropriate to other services provided
within the hospital. Inpatient rehabilitation wards provided
for medical rehabilitation. Full time medical rehabilitation
specialists available for consultation and participation in
wards rounds. Consultation available from other specialists.
Formal QA program. (+ speech therapist, psychologist, medical
rehabilitation consultations)
5 As in level 4 plus professional staff may have subspecialty

interest/skills relevant to the needs of the designated population
such as stroke rehab, head injury rehab, cardiac rehab, pain
rehab. Artificial aids and prosthesis fabricated. Rehabilitation
technology services provided. Regular basic and undergraduate
training undertaken. (+ trainers, subspecialists, therapist, with
advanced skills)
6 As in level 5 plus regular postbasic and postgraduate training

for a range of professional disciplines. Conducts formal research
projects.
Various specialties of rehabilitation services would be developed in Specialties in

phases. These include neuro rehabilitation, cardiac and pulmonary rehabilitation
rehabilitation, spinal rehabilitation and paediatric rehabilitation with medicine
cardiac and neuro rehabilitation to be developed first. A Stroke Day
Care centre was established in December 2003 in Hospital Kuala
Lumpur. This centre is headed by a neurologist and the cases are
jointly managed by multidisciplinary team comprises of rehabilitation
physician, physiotherapist, occupational therapist, speech therapist
and the rehabilitation nurse.
Conclusion
Rehabilitation medicine is an important component of medical care

service in the country as the burden of disease moves towards more
chronic debilitating disorders. One of the biggest challenges in the
development of rehabilitation medicine service is the acute shortage
of all categories of rehabilitation healthcare professionals, in particular
rehabilitation physicians. However, with the local universities starting
training programmes for the rehabilitation therapists, the situation

will improve a little. Training for rehabilitation physicians need to be
increased while post-basic rehabilitation nursing need to be considered
to hasten the development of rehabilitation medicine service to meet
future needs of the country. There is also a need to work with other
agencies and NGOs involved in rehabilitation service to increase
accessibility of rehabilitation service to those who need them
References:
1. Institute for Public Health, Ministry of Health Malaysia. Malaysian Burden of Disease
and Injury Study, Health Prioritization: Burden of Disease Approach, 2004.
2. Medical Development Division, Ministry of Health Malaysia. Rehabilitation Medicine

– scope and levels of service in MOH facilities; paper presented at the Director General’s
Meeting No. 6/97, 1997.
3. Family Health Division, Ministry of Health Malaysia. Community Rehabilitative

Services – Integrating the partnership concept. Paper presented at the Pre-Conference
Workshop of the Directors’ Conference, Ministry of Health, 1999.
4. Medical Development Division, Ministry of Health Malaysia. Proposal paper on

“Halatuju perkhidmatan dan perkembangan kerjaya kepakaran dan anggota kesihatan
bersekutu dalam perkhidmatan perubatan rehabilitasi Kementerian Kesihatan Malaysia
Menjelang RMK9, 2005.
5. Stroke Association of Malaysia (NASAM) web page http://www.nasam.org/about-

activities.php ( 22 May 2006).
SPECIALISATION AND SUBSPECIALISATION
IN THE MINISTRY OF HEALTH
SUMMARY
As the practice of medicine has grown more complex, coupled with public
expectations, there has been a need for doctors to specialise and subspecialise.
Specialisation and subspecialisation have enabled the Ministry of Health in its
medical care programme to provide specialist medical services in 61 (55 hospitals
and 6 institution) of its 131 hospitals and medical institutions. Specialisation and
subspecialisation training programmes can be pursued both locally and abroad. The
MOH recognizes some 100 basic specialty degrees and 117 subspecialties in 16 broad
clinical disciplines. For the year-end 2005, 2014 specialists. (inclusive of 220 contract
specialists) served in the Ministry of Health hospitals representing 43.6% of the total
specialist workforce in the country. This includes 419 formally gazetted subspecialist
or specialists who have undergone training in subspecialty area of interest. With
specialisation and subspecialisation programmes, the MOH is currently providing
resident tertiary care specialist services on a regional basis (5 regions), secondary care
specialist services in all state hospitals and varying scopes of secondary care specialist
services in specific district hospitals. The training programmes for specialists and
subspecialists are monitored objectively by formalised specialty and subspecialty
training committees. Specialist attrition to the private sector is a perennial issue that
needs to be addressed.
Introduction
R
apid advancements in science and technology have continually
added new dimensions and knowledge to the practice of medicine
and making it more complex. Thus, it has become increasingly
difficult for physicians to keep pace with advancements in all
areas of medicine and be an expert in all. The need to keep abreast with
latest development becomes even more relevant as doctors grapple
with an increasingly knowledgeable public, thanks to advancements
in information technology where medical knowledge is no longer
confined to those in the medical fraternity. This has lead to greater
demand for specialist services in the country and all over.

Specialisation and subspecialisation
Knowledge and sound evidence-based clinical judgments are the

competencies that justify the physician’s status as a professional.
Physicians have a duty to maintain and add to their knowledge new
developments in medicine throughout their professional careers.
Hence, specialization and subspecialisation have become more
essential than ever, in order to develop expertise in specific areas,
taking advantage on the vast knowledge available on each particular
area.
The term specialisation in medicine can be defined as medical practice Defining

limited to some special branch of medicine or surgery, especially by specialisation
one (specialist) whom, by virtue of advanced training, is certified by and
a specialty board as being qualified to so limit his of her practice. A subspecialisation
specialist is defined as one who possesses a postgraduate qualification
in a basic clinical specialty. The term subspecialisation refers to the
limited practice of a branch of medicine subordinate to a specialty. A
subspecialist is one who has further specialisation in a particular area
in that specialty.
The provision of specialist and subspecialist healthcare services is Specialist

delivered through two parallel healthcare systems that exist in this service delivery
country, i.e. those provided by the public or government health sector
and those by the private sector. In the public sector, the Ministry
of Health (MOH) is meeting this demand of the majority of the
population through its extensive network of healthcare facilities. Other
government sectors providing specialist and subspecialist healthcare
services though on a much smaller scale include the Ministry of Higher
Education (3 University Hospitals), and the Ministry of Defense (2
Armed Forces Hospitals).
The private health sector has responded concomitantly to demand for

specialist services, resulting in the growth of private healthcare sector,
in particular specialist clinics and medical centres, as well as private
hospitals which offer mainly specialist services.
Specialist services in the Ministry Of Health
The Ministry of Health is the main healthcare provider in the public Holistic service
sector, from primary healthcare in the health clinics and outpatient provision by
departments in hospitals; to basic inpatient, specialist and subspecialist the Ministry of
medical care services in the hospitals. Health
Development of specialist services and facilities have been well planned
in terms of geographical distribution and service types offered. They
are being continually upgraded through progressive development in
priority areas to enhance the quality of care provided. These include
basic specialist services in all state hospitals and identified district
hospitals as well as tertiary subspecialty services on a regional basis
and in centres of excellence for various disciplines at the national
referral centres.
Specialist services are sometimes defined by their levels, namely Levels of

secondary and tertiary specialist services. Secondary level specialties specialist service
are generally those that are acquired as a first level of specialization
after the basic medical degree. Tertiary level specialist services
are further subspecialty training in a particular area of the general
specialty. The terms secondary and tertiary are however, relative and
changes over time as the country develops. They were also defined for
the purpose of planning and development as illustrated in the way
secondary level specialist services were developed in consecutive 5-
year Malaysia Plans as follows :
6th Malaysia 7 basic secondary level specialist services

Plan • General medicine
(1991-1995) • General surgery
• Paediatrics
• Obstetrics and Gynaecology
• Anaesthesiology
• Pathology
• Radiology
7th Malaysia 15 secondary specialist services

Plan • 7 of the above
(1996-2000) • Orthopaedics
• ENT
• Ophthalmology
• Psychiatry
• Dermatology
• Emergency Medicine
• Rehabilitative Medicine
• Geriatrics
8th Malaysia Continuation of the above 15 specialty services

Plan (2001-2005)

At the conclusion of the 8th Malaysia Plan (2001-2005), there are a
total of 125 MOH government hospitals and 6 MOH special medical
institutions in the whole country. Of these, a total of 61 hospitals and
institutions, comprising of state level hospitals and the larger district
hospitals, provide specialist services varying in scope of disciplines.
In general, all state hospitals are to provide full secondary level Specialist
specialist services and designated tertiary care services by resident service provision
specialists. The district hospitals with specialists provide varying by government
scopes of specialist services by resident specialists and also visiting hospitals
specialists from the state hospitals while other district hospitals are
covered by visiting specialists from the state hospitals and district
hospitals with specialists. In addition specialist services are also
provided in hospitals by specialists from medical colleges utilising
government hospitals for their undergraduate training programmes,
and also by private doctors contracted on a sessional or honourarium
basis by some hospitals. The list of hospitals providing secondary and
tertiary level specialist services are shown in Appendix 1.
Specialist and subspecialist human resource
Traditionally the MOH uses the Canadian specialist-population norms Specialist norms
in projecting its specialist complement needs. In the 80’s the norms
used were 1/6 of the Canadian norms. Subsequently, it was revised
to 1/3 in the 90’s and currently, the Ministry adopts the full Canadian
norms for planning purposes. However there are no particular norms
for projecting the needs for subspecialists. The MOH has been guided
by both “service norms” of 1 department per 1 million population and
also by regional centre needs. (Appendix 2)
As of year-end 2005, the country has a total of 4,615 specialists (all Specialist and
sectors) compared to the need for 15,235 specialists in 32 major subspecialist
disciplines. complement
Of these, 2,013 (43.6%) serve in the Ministry of Health, including 231

contract specialists, constituting 27.2% of the total 7,393 doctors serving
in the MOH in 2005. Of the 2,013 MOH specialists, 1,285 (88.5%) are
specialists in various disciplines, including contract officers and those
undergoing pre-gazettement training (Table 1).
Table 1: Specialist and subspecialist manpower in the
Ministry of Health (including public health), Dec. 2005
Category Permanent Contract Total
Specialist 1579 206 1785

Subspecialist 203 25 228
Total : 1782 (88.5%) 231 (11.5%) 2013 (100.0%)
On record in the Ministry of Health, 227 (11.3%) had been gazetted

as subspecialists in various areas of specialties. Another 200 odd
specialists are undergoing various stages of subspecialty training.
This figure, however, does not portray the actual situation as many
subspecialists do not proceed to be gazetted as subspecialist as it does
not provide any difference to the scheme of service.
Specialist training
Before the 70’s, doctors who wished to specialize had to do so abroad Specialisation in
on their own, mainly in the United Kingdom or Australia. Beginning the early years
early 70’s, the University of Malaya began coordinating local training
programmes for foreign specialist degrees like the Membership of the
Royal College of Gynaecologists (MRCOG) and Membership of the
Royal College of Physicians (MRCP).
Realising the urgent need for more specialists for the country’s healthcare Local specialist
delivery system, the local universities introduced local master’s (Masters)
specialisation training programmes. This was initiated by University training
of Malaya in 1973 in the disciplines of pathology, medical psychology programmes
and community health, followed by the University Kebangsaan in 1981
in the disciplines of general surgery and orthopaedics and University
Sains Malaysia in 1988 in the discipline of internal medicine. Although
specialisation certification can be pursued locally, those who wish to
obtain foreign specialisation certification are free to do so.
The Master’s specialist training programme subsequently introduced Open Masters

the concept of “open” Master’s degree specialisation programme in July training
1996 where the training period is conducted in both accredited MOH programme
hospitals and the university hospitals, as opposed to the earlier “closed
system” where the full duration of training is conducted in the university
hospitals. Presently 1419 doctors are pursuing the Master’s training
programme in the three universities in 19 specialty courses (Table 2) and
26 MOH hospitals are accredited as training centres for the Master’s open

programme (Table 3). Some of the newer masters training programmes
offered include neurosurgery and plastic surgery in 2001 at Universiti
Sains Malaysia and clinical oncology in 2003 at University of Malaya.
Table 2: Number of Remaining Trainees in Local Masters Training

Programme (2002– 2005)
Clinical 2002/2003 2003/2004 2004/2005 2005/2006 Total

Discipline (Year 4) (Year 3) (Year 2) (Year 1)
Obstetric & Gynae 29 38 33 33 133

Anaestesiology 35 45 40 21 141
Paediatric 19 8 10 18 55
Internal Medicine 20 29 23 36 108
Psychiatry 7 8 11 25 51
Radiology 28 25 23 22 98
Surgery 34 37 25 42 138
Ophthalmology 22 20 18 30 90
Orthopaedic 18 25 34 34 111
Otorinolaryngology 16 17 21 17 71
Pathology 13 15 30 33 91
Family Medicine 21 20 18 25 84
Public Health 39 41 42 41 163
Sports Medicine 1 3 2 0 6
Rehab. Medicine 3 2 9 3 17
Emergency Med. 8 8 8 12 36
Plastic Surgery 2 3 1 1 7
Neurosurgery 2 0 4 5 11
Oncology 0 1 2 5 8
Total : 317 345 354 403 1419
Source: Training and Human Resource Planning Division, Ministry of Health
MOH doctors who are selected for the Master’s Programme are offered
scholarships by the Public Service Department (Hadiah Latihan
Perseketuan). An average of about 400 scholarships are offered each
year for MOH doctors to pursue the programme. For foreign specialist
certification, MOH doctors are either provided scholarships by the
Public Service Department in selected specialty disciplines where
there is no local programme. Many doctors pursue foreign specialist
certification in basic specialties on own their own (self-study and self-
financing) while undertaking the local master’s training programme.
The expansion of the local Master’s programme and overseas post-
graduate training for specialists has increased specialist output in
the basic specialties. Between 2000 and 2004, 1384 specialists had
graduated from the Master’s programme, with increasing numbers
yearly. A postgraduate training committee oversees the Master’s
specialist training programmes.
Table 3: MOH hospitals as training centres for open system masters training
programme (20 clinical disciplines)
State Hospital Total
Perlis Hospital Kangar 1
Kedah Hospital Alor Setar 1

Pulau Pinang Hospital Pulau Pinang 2
Hospital Seberang Jaya

Perak Hospital Ipoh 3
Hospital Taiping
Hospital Ulu Kinta
Selangor Hospital Tengku Ampuan Rahimah 2
Hospital Selayang
W.P. Kuala Lumpur / Hospital Kuala Lumpur 2
Putrajaya Hospital Putrajaya
Negeri Sembilan Hospital Seremban 1
Melaka Hospital Melaka 1
Johor Hospital Sultanah Aminah 3
Hospital Muar
Hospital Batu Pahat
Pahang Hospital Tengku Ampuan Afzan 2
Terengganu Hospital Kuala Terengganu 1
Kelantan Hospital Kota Bharu 1
Sarawak Hospital Umum Sarawak 1
Sabah Hospital Queen Elizabeth 2
Hospital Likas
Institusi Hospital Permai, Johor 3
Hospital Sentosa, Sarawak
Hospital Bukit Padang, Sabah
Total 26
Source: Medical Development Division, Ministry Of Health

Subspecialist training
A gazetted specialist wishing to further subspecialise in a particular Enrolment

field of a clinical discipline may apply to do so, and if selected has to
undergo a pre-determined training programme, which currently is
a minimum of 3 years duration, and spend a major part of his/her
practice in that subspecialty. There are also specialists with special
interests who have undergone a period of training in a particular
clinical field within their specialty, but not subspecialising. The
education and training for subspecialisation programmes is more
intensive and confined to a narrower area of medical practice.
In 2001, the Ministry of Health formalised the Fellowship Training Fellowship

Committee and Individual Fellowship Training Committees at Training
subspecialty level, responsible for the overall planning for fellowship Committee
training. Presently there are 117 subspecialties within 16 major
secondary specialist disciplines, and a further 20 subspecialties have
been proposed for the additional secondary specialist disciplines of
emergency medicine and rehabilitative medicine.
Subspecialty training programmes are being conducted in various

specialties at recognized training centres locally. Between 2001 and
2005, 329 trainees have were offered foreign subspecialty training
programmes in 14 broad disciplines (Table 4).
Generally, all state level hospitals are accredited local training centres
for subspecialty training programmes in specific areas of subspecialties
depending on the availability of trainer or mentor subspecialists. The
commoner subspecialties for example, nephrology and cardiology
are provided in more than one hospital while some are provided
exclusively in one particular hospital, for example, Hospital Selayang
is the only centre that provides subspecialty training in hand and
micro-surgery, hepatology and liver transplants while Hospital Kuala
Lumpur provides training in oncology and radiotherapy.
The training is of residency type and currently being planned towards

a formal exit examination certification. To facilitate the training, each
specialty has established its own specialty committee responsible
for the planning, organisation and supervision of the programme. A
specialist wishing to sub-specialise undergoes supervised training
under a consultant for a period of 2-3 years and often followed by
additional exposure in overseas centres.
For Fellowship Training Programmes currently not available in
the country, the specialist may pursue the training in accredited
centres abroad under a credentialed trainer. As with the local Master
Programme, the Public Service Department offers scholarships for
subspecialisation training abroad.
Table 4: Number of Trainees Offered Foreign Subspecialty Training Programmes

(2001 – 2005)
Year
No. Discipline Total
2001 2002 2003 2004 2005

1 Medical 9 11 11 7 20 58
2 Surgery 9 6 12 3 10 40
3 Paediatric 7 7 4 4 7 29
4 Obstetrics & Gynaecology 3 4 5 4 7 23
5 Anaestesiology 3 7 8 6 10 34
6 Orthopaedic 4 4 10 6 15 39
7 ENT 2 4 4 4 5 19
8 Ophthalmology 2 4 5 2 6 19
9 Psychiatry 5 2 5 0 2 14
10 Pathology 3 5 8 4 8 28
11 Radiology 4 5 6 1 2 16
12 Radiotherapy 2 2 0 0 1 5
13 Forensic Medicine 0 0 0 0 2 2
14 Palliative Medicine 0 0 0 0 1 1
Total 53 61 78 41 96 329
Source: Medical Development Division, Ministry of Health
System of recognition - specialist and subspecialist
A medical practitioner wishing to practice in Malaysia must register Recognition of

with the Malaysian Medical Council. However, this registration specialist status
does not differentiate a specialist from a general practitioner. Within
the MOH, there is a formal system of evaluation and gazettement
for specialist doctors after a specified period of working under
supervision.

In granting recognition to the various postgraduate qualifications Gazettement of
reference is made to the entry qualification, duration of course, specialist
structure of course and examination. MOH specialist recognition is
not obligatory for the private sector or in the universities. For MOH
medical specialist degree recognition, the current MOH circular lists
20 specialty disciplines consisting of some 100 degrees both from
recognized local and foreign institutions.
The granting of specialist status will identify practitioners who have Pre-gazettement
completed a residency and have expertise in a specific field of medicine. training
On completing a postgraduate training programme, doctors in the
MOH are required to undergo a period of assessment or validation
of their knowledge, skills and experience in their respective fields
of training. On satisfactory completion of the assessment period,
the practitioner is gazetted as a specialist. This process is useful for
assessing the clinical competence of a specialist. The gazettement
period for a specialist of the local Master’s programme is six months
and for overseas specialist degrees is 18 months. Specialists who have
been working overseas are also required to undergo a probationary
period to assess their clinical competence.
A specialist in turn will be gazetted as a subspecialist if he or she has Gazettement of

undergone a pre-determined training programme, which currently is subspecialist
a minimum of 3 years duration, and has spent a major part of his/her
practice in that subspecialty.
Specialists in the Ministry of Health are designated in three hierarchical Classification of

status - as clinical specialist, consultant and senior consultant based on specialists
the duration of specialist service after gazettement. A clinical specialist
refers to one with five (5) years or less of post-gazettement working
duration. A consultant is a specialist who has between five (5) to ten
(10) years of post-gazettement working duration. A senior consultant
is a specialist with ten (10) or more year’s post-gazettement working
duration and in the U54 service category or higher.
The Ministry of Health has also established and implemented a Credentialing

process of credentialing and privileging for specialists. It has begun and privileging
initially for specialised procedures outside the approved scope of core
procedural skills required of specialists in their respective clinical
fields. It is intended to eventually be implemented for all doctors and
allied health professionals.
Issues in specialization and subspecialisation
Unmet specialist human resource needs
Despite the fact that between 2000 and 2004, 1384 specialist had Specialist
graduated from the Master’s programme, there is still a shortage of shortages
specialists in the MOH. This shortage is due to rapid expansion of
specialist and subspecialist services in MOH hospitals, consumer
expectations and attrition to the private sector. Expansion of
subspecialty training has, to a certain extent, contributed to the
retention of specialists in state capital hospitals with subspecialty
services.
Between the years 2000 to 2005, the total number of Ministry of Health
specialists increased from 1371 to 2014, representing a 46.9% increase.
When comparing specialist numbers year-end 2005 to that of 2000, there
were 6% fewer plastic surgeons and 11% fewer urologists, the same
number of hand and micro-surgeons (2), and hardly any significant
increment in forensic medicine specialists (7.6%), cardiologists (8.6%),
radiotherapist and oncologist (11.1%) and paediatric surgeons (15%).
Most significant increases were rehabilitative specialists (160%),
otorhinolaryngologists (80%), obstetricians and gynaecologists (73%),
and ophthalmologists (64.6%). (Table 5).
Table 5: Number of specialists serving in the Ministry of Health by disciplines.

2000-2005
Discipline 2000 2001 2002 2003 2004 2005

Internal Medicine 154 154 169 181 221 235
General Surgery 133 136 154 161 183 190
Obstetrics & Gynaecology 133 136 154 161 183 190
Orthopaedic 108 132 135 138 160 171
Paediatric 143 158 168 180 219 216
Ophthalmology 79 82 96 108 128 130
ENT 45 45 54 56 70 81
Psychiatry 45 45 54 56 70 81
Rehabilitative Medicine 3 5 4 4 7 8
Emergency Medicine - - 6 10 18 22
Anaesthesiology 138 139 162 175 200 207
Radiology 89 80 82 94 106 113
Pathology: 99 119 123 107 107 123

Between the years 2000 and 2005 a total of 313 specialists resigned from Attrition of
government services. (Table 6) The attrition rate of specialists since 2000 specialist
showed an upward trend. The highest rate were from the disciplines
of rehabilitative medicine, otorhinolaryngology, orthopaedics and
radiology. The lowest attrition rate were the paediatricians.
Table 6 : Number of Ministry of Health specialists who resigned from services

(2000-2005)
Specialist Resignation Specialist rate

Year of
U41-U44 U48-U52 > U54 Total resignation

2000 27 13 1 41 2.9%
2001 14 12 2 28 1.9%
2002 4 12 3 19 1.9%
2003 33 27 4 64 3.7%
2004 26 45 0 71 3.7%
2005 38 16 9 90 4.5%
Total 142 125 19 313 2.35%

With recent introduction of specialist training programmes in the Opportunities

disciplines of emergency medicine, plastic surgery and neurosurgery, for
it is envisaged that the shortages of specialists in these disciplines specialisation
will be addressed. It is recommended that the specialist manpower
development plan be effectively implemented to ensure more doctors
are given opportunities to pursue postgraduate training by considering
flexible training programmes to meet the needs of those not able to
train full-time and to anticipate the increasing proportion of women
in the medical profession.
The continuing formal training of health personnel by the Ministry of Human resource
Health is a policy issue that needs to be addressed. Accurate human planning and
resource projections particularly with regards to doctors, dentists, development
pharmacists and other allied health personnel should be objectively
undertaken and resourcefulness is a challenge. There is always a
need to more effectively implement the long-term plan to develop the
specialist manpower needs for the country.
Apart from these measures the MOH should continue utilizing Outsourcing
specialists from the private sector on a sessional or honorarium basis specialist
to provide specialist services in government hospitals where the need services
arises.
Inequitable distribution of specialists manpower
There still remains the difficulty in expanding and sustaining specialists’ Specialist
services in district hospitals. Most specialists are concentrated in the posting
state capital hospitals especially tertiary care centres, and also in the to district
private sector in urban cities. hospitals
Mandatory posting of specialists to district hospitals for a time-specific Strategies to

period undertaken in a transparent manner is a strategy to address address equity
this issue. Apart from expanding the scope of specialist services to and access
more district hospitals, other strategies addressing equity and access
to specialist services include the well-established referral system,
specialist visitations to district hospitals without specialists, hospital-
networking and telemedicine.
To effectively reduce human resource maldistribution, between urban Reward system

and peripheral / rural sectors, by using combined approaches such as for specialist
providing financial incentives, accelerated promotions, time-limit on the to serve in the
assignment, granting of priority for further training and in-service training, periphery
adequate housing and means of communication and transport.
Credentialing specialists
Though there is a formal system of credentialing specialists in the Who is a

MOH, there is no formal system of certification in the private sector. specialist?
The implication is that there is at present no control as to who can call
themselves specialists and charge specialist rates.
A system of specialists register is presently being worked out between Strengthening

the Academy of Medicine and the MOH. The MOH being the credentialing
custodian of healthcare should ensure that a credentialing process for and privileging
specialists be effectively implemented by strengthening the National process
Credentialing Committee and by having user-friendly credentialing
guidelines with functioning Hospital Privileging Committees in place
to enable all healthcare providers to be credentialed.

General specialist versus subspecialists
The trend towards more specialisation is an integral part of

continued professional development of a specialist. With the
increase interest in subspecialties, the number of specialists
subspecialising in various disciplines has been increasing,
from 85 in 2001 to 339 in 2005. However the medical discipline
remains the most popular with the majority of trainees in the
disciplines of nephrology, cardiology, and gastroenterology.
Also the disciplines of infectious disease, nuclear medicine and
endocrinology have seen increases in subspecialists facilitated
by fast tract entry into the training programme. Applications for
subspecialty training in geriatrics and plastic surgery have not
been encouraging.
Distribution of specialists to regional centres and centres of excellence Regional centre

has been affected by the small number of subspecialists available to shortages
provide the services and the high workload of subspecialty services.
An effective subspecialty unit would require a minimum of 3 to 5
subspecialists, which the MOH finds difficulty in establishing such
units.
While there is a definite need for a subspecialist to provide the best Dwindling
possible care to the community, there are concerns over the dwindling numbers
numbers of general specialists, especially for general medicine and of general
general surgery. There is a formalized Fellowship Training Committee specialists
at the Ministry level and individual Fellowship Training Committees
at the subspecialty levels. Subspecialty training has been somewhat
affected due to shortages in specialists.
There should be an equitable emphasis on general specialties and Specialty

subspecialties to ensure an appropriate balance. The MOH will balance
need to define clearly doctors to specialists ratio norms to effect
objective human resource planning for general and specialist
services.
Loss to private sector
The country has seen a rapid development of the private healthcare Brain drain
sector. For the year-end 2005, there were 222 private hospitals, private
nursing homes and private maternity centres having a total of 10,794
hospital beds (24% of total hospital beds for the country). This has led
to a steady loss of government specialists, doctors and allied health
personnel to the private sector. Between the years 2000 and 2005, 313
specialists resigned from the MOH while in 2005 alone, 90 specialists
resigned from government service.
Poor retention of specialist within the public sector continues to be a Retention of

major drawback and must be addressed through objectively planned specialists
strategies to minimize this exodus. Consideration should be given
to improvements in working conditions, better career development
/ pathways, attractive remunerations and better opportunities for
continuing professional development.
There is evident dissatisfaction among the newly graduated Career

specialists, with regard to PTK (competency) examinations which development
they have to pass as a pre-requisite for promotion. Infrequent exams, bureaucracy
delayed examination results, bureaucratic delays and the addition
of intervening hierarchical grade levels have prompted many junior
specialists to leave government service for the private sector, with
the potential of affecting future provision of specialist services in the
MOH.
Retaining specialists in the MOH
The Government recently has provided incentives in various measure

to retain specialists in the public sector among which are:
• Increasing normal after office hours working allowances from

between 59% to 340% effective 1st June 2005.
• Tax exemption for after office hours working allowances and
specialists incentive allowance.
• Expediting the process for specialist promotions to Grade U48 pay
scale after post-gazettement.
• Proposal to appoint specialists without experience directly to
Grade U43 pay scale and specialists with experience directly to
Grade U47 pay scale
• Creating 298 extra promotional (Special Grade A, B, C) for
specialist years period 2005-2010
• Extending specialists services on contract basis up to the age of 65
after compulsory retirement.
• Improving facilities and working environment and providing
needed medical equipments for clinical practice.

Strengthening specialists and subspecialists training
Currently at the MOH, there exist two separate committees to oversee Separate
the Master’s specialist training programme and the subspecialty specialty and
training programme. For future plans to be effective, the Conjoint subspecialty
Board and these committees need to be linked. training
committees
Other issues and strategies related to specialists and subspecialists Strengthening

training included the effective implementation of the subspecialties Fellowship
development plan by strengthening the Fellowship training training
programmes by having more available training posts, formal programmes
assessment of training programmes with exit certification for all
trainees.
The possibility of optimizing the expertise and resources Utilizing the

available in the private sector and private universities in training private sector
programmes for specialists and subspecialists, in view of the lack for specialist
of available trainers and resources in the country could be further and subspecialty
explored. training
There is also the need to strengthen the basic training program for Strengthening
medical officers for a more comprehensive exposure before they basic training
embark on specialty programmes. programme for
medical officers
Conclusion
Specialisation and subspecialisation are natural progressions in

hospital medicine with continual advancements in medical science
and technologies, coupled with increasing patient expectations.
The MOH has to also define in clearer terms the direction in
which specialist and subspecialty services are to be developed.
This development must be in consonant with medical technology
advances, growth of the medical profession and the perceived needs
and demands of the population.
Doctors who wish to do specialisation and subspecialisation should

be guided and facilitated with options of career development plans
and pathways in an objective manner. This is a combined challenge
for the Medical Development Division, the Training Division and
the Human Resource Division of the MOH. Activities to develop
specialist services in the MOH have continued despite the many
constraints. Objective steps are being taken to further improve the
situation within the resources available to ensure equity in access and
quality of health care provided for all. Specialty balance across clinical
disciplines is a challenge and while we encourage specialisation and
subspecialisation to improve the quality of health care, one needs
also to take cognizance of the negative effects of extensive or over
specialisation.
References:
1. Egan E. Practical and Ethical Implications of Hospitals as Subspecialists. Virtual Mentor.

2006; 8:109-113.
2. Ministry of Health Malaysia (2005). Surat Pekeliling Pengarah Kesihatan Malaysia Bil
3/2002: Gelaran Rasmi Bagi Pakar-Pakar. 21 April 2002.
3. Ministry of Health Malaysia (2005). Pekeliling Ketua Pengarah Kesihatan Malaysia

Bil.2/2005. Senarai Ijazah-Ijazah Lanjutan Kepakaran Yang Diiktiraf Dalam Berbagai-Berbagai
Disiplin Perubatan Yang Telah Disemak Pada 1 Januari 2004. 10 February 2005.
4. Ministry of Health Malaysia (1995). Medical Development Division; Development of

specialist services. Proceedings of Specialist Conference, 12 December 1995
5. Ministry Of Health Malaysia (2001). Medical Development Services; Guidelines for

credentialing and privileging in the Ministry of Health. December 2001.
6. Ministry Of Health Malaysia. Ninth Malaysia Plan (2006-2010): The Way Forward.
Mesyuarat Khas Ketua Pengarah Kesihatan Dengan Pengarah Bahagian Dan Pengarah
Kesihatan Negeri. 18th October 2004.
7. Ministry of Health Malaysia (2005). Medical Development Division; Proposal for

development and distribution of subspecialty services in the Ministry of Health
Malaysia. 20 July 2005.
8. Ministry of Health Malaysia (2005). Ninth Malaysia Plan (2006 – 2010). Book II – The
Medical Programme. 2005

9. Suleiman AB. Working for Health: A collection of keynote addresses and working
papers presented by the Director-General of Health of Malaysia from 1990-1995.
Ministry of Health, 1996.
10. Suleiman AB, Jegathesan M. Health in Malaysia - Achievements and Challenges.

Ministry of Health, 2000.
Appendix 1
50
Distribution of Resident Secondary Care Specialist Services in MOH
Hospitals (As of December 2005)
MALAYSIA’S HEALTH 2005

STATE. HOSPITAL
Total
General Medicine
General Surgery
Paediatric
Orthopaedic
Anaesthesiology
Ophthalmology
Otorhilaryngology
Psychiatry
Pathology
Radiology
Rehab. Medicine
Emergency Med.
Dermatology
Geriatric
O&G
Perlis Hospital Kangar
Kedah Hospital Alor Setar
Hospital Sungai Petani
Hospital Kulim
Hospital Lang a i
P.Pinang Hospital Pulau Pinang
Hospital Seberang aya
Hospital u it
Merta am
Pera Hospital Ipoh
Hospital Taiping
Hospital Telu Intan
Hospital Seri Man ung
Hospital Slim Ri er
Selangor Hospital Klang
Hospital Selayang
STATE. HOSPITAL
Total
O G
General Medicine
General Surgery
Paediatric
Orthopaedic
Anaesthesiology
Ophthalmology
Otorhilaryngology
Psychiatry
Pathology
Radiology
Rehab. Medicine
Emergency Med.
Dermatology
Geriatric
Hospital Serdang
Hospital a ang
Hospital anting
Hospital uala Lumpur
P L.
Hospital Putra aya
Hospital Labuan
Hospital Seremban
Sembilan
Hospital uala Pilah
Hospital Port Dic son
Mela a Hospital Mela a
ohor Hospital Sult. Aminah
Hospital Muar
Hospital atu Pahat
Hospital luang
Hospital Segamat
Pahang Hospital uantan
Hospital Temerloh
uala Lipis
Terenganu Hospital uala
Healthcare Service
Trengganu
51
52
STATE. HOSPITAL
Total
MALAYSIA’S HEALTH 2005

O&G
General Medicine
General Surgery
Paediatric
Orthopaedic
Anaesthesiology
Ophthalmology
Otorhilaryngology
Psychiatry
Pathology
Radiology
Rehab. Medicine
Emergency Med.
Dermatology
Geriatric
Terengganu Hospital Kemaman

Kelantan Hospital Kota ahru
Hospital Kuala Krai
Sara a Hospital mm Kuching
Hospital Sibu
Hospital Miri
Hospital Sri Aman
Hospital intulu
Hospital Kapit
Hospital Sari ei
Sabah Hospital E
Hospital Li as
Hospital Sanda an
Hospital Ta au
Hospital Keningau
Hospital Lahad Datu
Source Medical De elopment Di ision Ministry o Health

Appendix 2
Norms (based Expected Present

Shortfall
No. Specialty on Canadian Number Stock
norm) 2005 Dis. 05 2005
1 Physician
1:16,000 1,646 457 -1189
2 Surgeon
1:23,000 1123 613 -510
3 Paediatrician
1:25,000 1045 608 -437
4 O&G Specialist
1:26,000 992 565 -427
5 Orthopaedic Spec.
1:46,000 575 230 -345
6 Anaesthesiologist 1:25,000 1045 464 -581
7 Ophthalmologist
1:50,000 523 375 -148
8 ENT Surgeon
1:76,000 340 202 -138
9 Radiologist
1:27,000 967 321 -646
10 Pathologist
1:43,000 601 217 -384
11 Rehab. Specialist
1:200,000 131 13 -118
12 Psychiatrist
1:15,000 1751 171 -1580
13 Emer. Med. Spec.
1:167,000 156 34 -122
14 Forensic Path.
1:200,000 131 20 -111
15 Family Med. Spec.
1:25,000 1045 215 -830
HOSPITAL INFECTION CONTROL
SUMMARY
Hospital acquired infections (HAIs) result in longer hospital stay and cost to the
patient and hospital. The national Hospital Infection Control Programme utilizing
point prevalence surveillance involving 17 major public hospitals in the country,
including 3 university hospitals, was started in 2002. This has brought about greater
awareness on the seriousness of nosocomial infection (NI) and a decline in the
prevalence of nosocomial infections in most participating hospitals. To strengthen
infection control in hospitals, a formal infection control training course is being
conducted by the Infection Control Association of Malaysia (ICAM) and the Ministry
of Health for various categories of healthcare professionals. The establishment of
dedicated hospital infection control nurse in hospitals has further strengthened the
programme in hospitals. The programme would be expanded to all hospitals in the
Ministry of Health and it is hoped private hospitals in the country would initiate
similar programme in their hospitals.
Introduction
H
ospital acquired infections (HAIs) or nosocomial infections
(NI) are on the increase, more so with greater use of invasive
procedures and more aggressive modalities of medical therapies
to treat disease. The infections are acquired as a result of
hospital treatment from which the patient was not suffering from
at the time of admission to the hospital. HAIs increase the length of
hospital stay, and incur costs in treating the infection acquired and
the complications that ensued.
HAIs remain a significant problem for the MOH hospitals. Evidence

based counter measures of known effectiveness are not being
implemented consistently or vigorously in many hospitals. Infection
control must be everyone’s responsibility from clinicians, cleaners
and ancillary workers to patients and relatives, but evidence that
this message has been adopted is scarce. Thus, efforts put into
strengthening the Hospital Infection Control Program will certainly
reap substantial benefits for the hospital.

The Ministry of Health (MOH) is committed to ensuring that infection MOH’s
control programme are actively and effectively implemented. Hospital commitment to
acquired infections have a much higher profile now then before. At Hospital
the central strategic level, it has been accorded a higher priority with Infection
the launch of a number of key requirements. Infection control is one Control
of the major criteria required to complement the clinical governance
initiatives and hospitals are required to self assess their performance
against hospital accreditation standards.
Organisation
In the 1980s, individual hospitals initiated their own infection Hospital

control activities. Since 2001, the programme has been reorganized Infection and
to fulfill a more effective and goal oriented role with the added Antibiotic
function of antibiotic control. Thus, the committee became known as Control
Infection and Antibiotic Control Committee operating at two levels.
At the national level, the National infection and Antibiotic Control
Committee (NIACC) is chaired by the Director General of Health
and the secretariat is at the Quality in Healthcare section of Medical
Development Division.
At the hospital level, the Hospital Infection and Antibiotic Committee

(HIACC) chaired by the Hospital Director, is responsible for the
implementation of hospital infection control programme in the
hospital. Members of the committee include heads of clinical
departments, senior clinicians, microbiologist, pharmacist, infection
control nurses and other co-opted members.
The State Infection Control Committee chaired by the State Director

of Health coordinates the functions and activities of all HIACCs in
the state.
Nosocomial infection surveillance
Surveillance which involves data collection, analysis and feedback

of results to clinicians, is central to detecting infection, dealing with
them and ultimately reducing infection rates. Lack of comparable data
on rates and trends of infections limited the MOH understanding of
the infection problem. Nevertheless, since the initiation of the Point
Surveillance Programme by the MOH in 2002, surveillance has been
collected. This provides very useful data on the state of NI in Malaysian
hospitals. However, this is limited to public sector hospitals only.
Point prevalence surveillance involves a one day survey to determine Point prevalence
the prevalence of hospital acquired infections in participating hospitals. surveillance
It is conducted twice a year in the months of March and September
in Hospital Kuala Lumpur, 13 state hospitals and three university
hospitals throughout the country. Figure 1 shows the NI rate for these
17 participating hospitals for the period 2003-2005. It is noted that there
is a declining rate from 7.4% at the beginning of the programme to
4.5% in September 2005.
Figure 1 : Nosocomial infection rates from 17 participating hospitals,

March 2003 – September 2005)
8.00% 7.40%
7.00% 6.40%
6.00% 5.43% 5.60% 5.49%
5.00%
4.50%
4.00%
3.00%
2.00%
1.00%
0.00%
Mar -03 Sept.-03 Mar -04 Sept.-04 Mar -05 Sept.-05
Period
Source: Medical Development Division, Ministry of Health Malaysia, 2005
Further analysis of these 17 hospitals indicate that 13 of the 17 hospitals

had a decreasing trend between their initial and the last cycle in
September 2005 while 4 showed an increase ( Table 1).
One tertiary care hospital (A4) and one regional hospital (B4) showed
NI rates that were higher than hospitals in their respective categories.
Generally, state hospitals had a lower NI rate except for two hospitals
(C5 and C6).

Table 1 : Nosocomial infection rates in 17 hospitals, March 2004 – September 2005
Hospital Mac 04 Sept. 04 Mac 05 Sept.05

A1 6.10% 6.40% 6.40% 2.90%
A2 9.83% 3.92% 3.85% 5.20%
A3 - - 7.10% 4.70%
A4 9.66% 12.23% 6.41% 11.10%
B1 2.22% 4.60% 3.74% 2.90%
B2 3.53% 3.00% 3.30% 2.80%
B3 4.72% 4.21% 5.25% 3.20%
B4 12.27% 11.62% 6.97% 8.40%
C1 6.53% 1.80% 3.93% 3.10%
C2 3.54% 4.10% 3.80% 2.90%
C3 4.94% 3.60% 3.90% 3.10%
C4 3.24% 1.61% 3.04% 2.20%
C5 6.39% 5.51% 4.30% 5.30%
C6 4.43% 2.90% 5.00% 7.40%
C7 1.82% 4.32% 4.40% 2.20%
C8 6.57% 5.02% 2.50% 4.00%
C9 3.62% 6.51% 1.75% 1.60%

Note : A1-A4 = HKL and 3 university hospitals, ; B1-B4 = 4 busy regional hospital (HSAJohor Baru,
Hospital P. Pinang, Hospital QE, Hosp. Umum Sarawak), C1-C9 = other state hospitals
Types of nosocomial infection
Pneumonia, blood stream infections (BSI) and surgical site infections

(SSI) are consistently the commonest types of nosocomial infections
encountered. Table 2 shows the types of NI reported between March
2004 and September 2005
Table 2 : Common types of nosocomial infection from point prevalence studies in
17 hospitals, March 2004 – September 2005
Type of Infection Mar 2004 Sept. 2004 Mar 2005 Sept. 2005
SSI 21.8% 20.1% 26.5% 24.0%

BSI 17.8% 17.8% 18.1% 17.2%
UTI 10.0% 9.9% 6.2% 8.2%
Pneumonia 26.7% 24.5% 24.4% 24.6%
Clinical sepsis 14.7% 13.1% 12.6% 17.2%
Others 9.0% 14.6% 12.2% 8.8%
Total : 100.0% 100.0% 100.0% 100.0%
SSI-Surgical site infection, BSI – blood stream infection; UTI-urinary tract infection
Ventilation associated pneumonia (VAP)
Ventilated associated pneumonia is a serious problem in critically ill VAP a serious

patients with a high fatality rate. Point Prevalence Surveillance carried problem in
out consistently showed that pneumonia is among the highest form critically ill
of NI in the hospitals. patients
The National Audit on Adult Intensive Care Units (NIACCU) 2003

reported that the incidence rate for ventilated associated pneumonia
was 26.9% per 1000 ventilator days where 79.0% of the VAP were
associated with gram-negative organisms notably Acinetobacter and
Pseudomonas.
A more in-depth study involving 14 MOH hospitals (Hospital Kuala Prevalence

Lumpur and 13 state hospitals) was carried out between June to of VAPs - a
August 2004 showed the prevalence of VAPs which ranges from 0 one day point
to 44.2 per 1000 ventilated days (Figure 2). Being a one-day point prevalence study
prevalence study, 4 hospitals had zero episodes of VAP during the
study period.

Fig 2: Ventilation associated Pneumonia (VAP) in 14 MOH hospitals
44.2 42.8
45 .0
VAP Rate (per 1000 ventilation days)
40 .0 36.5
35 .0
30 .0 27.7
23.4 25.6
25 .0
19.2
20 .0 16.2
15 .0 4.0
10 .0
11.7
5. 0
0. 0
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Ho s pita l
Source : Report of Task Force for the study of VAP, Jan 2005, Ministry of Health
Malaysia
Antibiotic resistance
Tracking resistance patterns of Methicillin Resistance Staphylococcus Surveillance

infections (MRSA) and Extended Spectrum Beta-Lactamases on common
producing organisms (ESBL) provide a rough estimate of growing antibiotic
magnitude of troublesome pathogens in the hospitals. Therefore resistance
continuous surveillance of antimicrobial prevalence of MRSA, ESBL
and Vancomysin Resistant Enterococci (VRE) to assess trend and
appropriate use of antimicrobial agent is imperative.
In order to minimize the morbidity and mortality due to antimicrobial

resistant infection have lead the policy makers to formulate guideline
to reduce unnecessary and inappropriate use of antimicrobial agents.
The Pharmaceutical Division, Ministry of Health issued the second
edition of Guidelines on the use of Antibiotics in 1994.
Figure 3 and 4 show the annual average percentage of MRSA and ESBL MRSA and
in 17 hospitals under the national NI surveillance programme. The ESBL on the
rates for MRSA and ESBL is on the decreasing trend between 2003 and decreasing trend
2005 for almost all hospitals except hospital C6 for MRSA and hospital
C4 for ESBL. This is a favourable sign that continual surveillance and
greater awareness of MRSA and ESBL has perhaps produced positive
changes in practices, resulting in the reduction of these rates.
Fig 3: Annual MRSA reported in 17 hospitals, 2003-2005
0.70
2003
0.60
2004
0.50 2005
M R SA reported (% )
0.40
0.30
0.20
0.10
0.00
A1 A2 A3 A4 B1 B2 B3 B4 C1 C2 C3 C4 C5 C6 C7 C8 C9
o p t
Fig 4: Annual ESBL reported in 17 hospitals, 2003-2005
1.40 2003
2004
1.20
2005
1.00
SB ( % )
0.80
0.60
0.40
0.20
0.00
A1 A2 A3 A4 B1 B2 B3 B4 C1 C2 C3 C4 C5 C6 C7 C8 C9
o p t
Human resource development
Trained infection control nursing personnel forms the backbone of Training of

the hospital infection control programme. Currently formal infection infection control
control training courses are conducted by the Asia Pacific Society personnel
of Infection Control (APSIC) which is recognized by the University
of New South Wales, Australia. Since 2003, the Infection Control

Association of Malaysia (ICAM) and Ministry of Health has been
conducting APSIC training once a year. A total of 440 personnel had
been trained under this programme between 2003 to 2005 (Table 3).
Table 3 : IPSIC Training Programme, 2003-2005
Number Trained
Year
Doctors Scientific Officers Nursing Personnel Others Total
2003 7 13 99 3 122
2004 2 4 115 2 123
2005 8 12 145 30 195
Total 17 29 359 35 440
Source : Medical Development Division, Ministry of Health Malaysia, 2005
Realising the importance of infection control nurses in achieving Posts of

success in the program, the MOH had created several posts for infection control
infection control sisters and nurses (ICN) in hospitals. Although nurse
not all these posts are filled, nevertheless, it is a move in the right
direction. The MOH has also adopted a planning staffing ratio of 1
ICN : 250 beds as an optimal target. However, this is still below the
US Joint Commission standards of 1.5:200 beds for the accreditation
of healthcare organizations. Currently, there are 153 infection control
nurses in the MOH hospitals. All except two MOH hospitals have
infection control nurse.
The MOH is also aware of the shortage of clinical microbiologists and

is looking into training of more such personnel in this area. At the
present, there are only 12 clinical microbiologists and 12 infectious
diseases specialists actively involved in infection control.
Besides formal training, substantial allocations have also been given Conferences and
for training of all categories of healthcare workers in recent years. This seminars
includes participation in infection control conferences and seminars.
In addition, regular updates are also conducted by various State level
Infection Control Committees.
Hospital design and facilities
Many of the MOH hospitals are operating at very high levels of bed
occupancy which can compromise good infection control practice. The
MOH has taken infection control as an integral part of bed management
policies. Thus, newly constructed hospitals should not encounter
problems of over crowding.
New hospitals are now designed to have appropriate ventilation Better hospital
systems in wards and proper isolation rooms. In the wake of recent design in new
new emerging infectious diseases like SARS and Nipah encephalitis, hospitals for
isolation rooms in designated hospitals are equipped with negative infection control
pressure and hepar filters to enhance safety of the hospital environment.
Allocations have also been provided to upgrade isolation wards in
more hospitals to include the above features.
Conclusion
Hospital infection control is a major concern for the MOH. The national Hospital infection
hospital infection control programme utilizing point prevalence control is a major
surveillance involving 17 major public hospitals in the country, concern
including university hospitals, has brought about greater awareness on
the seriousness of nosocomial infection in hospitals. The programme
has yielded some data concerning the status of nosocomial infection in
the country. Targeted surveillance surveys and observational behavior
studies will identify problem areas and remedial measures needed.
Continual surveillance, education and close attention to remedial
measures are needed to ensure HAIs are effectively controlled.
The programme needs to be expanded further to involve all hospitals in Need for
the country, while it is hoped that private hospitals would also initiate expansion of
such a programme as a continual effort towards quality improvements programme to
in patient care. More trained infection control personnel are needed to other hospitals
strengthen hospital infection control programme in the country.

References:
1. APR Wilson et al. Surgical wound infection as a performance indicator: agreement of

common definitions of wound infection in 4773 patients. BMJ; 2004: 329:720 (25 Sept.
2004).
2. Benner E.J., F.H. Kayser. Growing clinical significance of MRSA. Lancet, 1968:741-744.
3. Bonten MJM, BergmansCJJ, Ambergh AW et al. Risk factors for pneumonia and
colonization of respiratory tract and stomach in mechanically ventilated ICU. VMJ
Respir Critcare Med. 1996;154:13391346.
4. Boyce J.M. 2001. MRSA patients proven method to treat colonization and infections.
Hospital Infection Journal 48 (Suppl A), Jan. 2004:10(1).
5. Crinch CJ, Maki DG. The promise of novel technology for the prevention of
intravascular device related blood stream infections. Clin Infect Dis 2002; 34:1232-42.
6. Deva SR., Ling TL. A study of the national audit on adult intensive care unit, Ministry
of Health, 2005.
7. Garner JS, Jarris WR, Emori TG, Horan TC, Hughes JM. CDC Definitions for NI
In : Olmsted RN, ed. APIC Infection control and applied epidemiology: principles &
practice. St. Louis Mesby, 1996 :.A-1 to A-20.
8. Haley RW et al. The efficacy of infection surveillances and control program in

preventing NI in USA hospitals. AM J. Epidemiol 1985; 121:182-205.
9. Lynch P. Strengthening strategies in confronting infection control challenges, HUKM,

June 2005,
10. Pittet D, Wenzel RP. Nosocomial blood stream infections secular trends in rates,
mortality and contribution to total hospital deaths. Arch Intern Med 1995; 155:1177-
84.
11. Royal College of Pathology Service: Medical and scientific standard staffing in NHS
Pathology Departments. London: The College, 1999
12. Scott. K et al Antimicrobial resistance in intensive care units. Chest Medicine; 20 (2)
June 1999.
13. Weinstein R. A. 1998. Nosocomial Infection Update Emerging Infectious Diseases;

4(3), July – September 1998.
14. Wenzel RP The economic of nosocomial Infection: J Hosp. Infection 1996; 1:79-87
OPTIMISING INTENSIVE CARE SERVICE IN MALAYSIA
SUMMARY
Intensive Care Unit (ICU) in Malaysia was first started in University Hospital in 1965.
Currently (2005), there are 547 ICU beds in Malaysia representing 1.5% of hospital beds
in the country and a ratio of 2.4 beds to 100,000 population. This is low as compared
with developed countries. To achieve a ratio of 5 ICU beds per 100,000 population
for an estimated population of 26 million, Malaysia will require a total of 1,300 ICU
beds. Strategies to overcome the current shortage of ICU beds include expanding
ICU beds in current hospitals; opening up non-functioning ICU beds; networking
and optimizing use of current available beds through proper triaging and selection
of patients. Further development of intensive care service include development of
integrated multi-disciplinary ICUs; step-up in training of intensivists; improving on
nursing support and development of paediatric ICUs where case load is sufficiently
large.
Introduction
I
ntensive care units (ICUs) are specialized areas where critically ill Definition of
patients requiring advanced life support are managed by a team ICU
of specially trained doctors and nurses. The ICU is an integral
component of an acute care hospital, providing care for the critically
ill patients from medical diseases or following trauma or surgery.
Intensive care beds are defined as one with the capability for intensive
monitoring and mechanical ventilation.
ICUs were established in the 1960’s during the poliomyelitis epidemic Development
where patients were ventilated and managed in specialized units of ICU in
with increased nurse to patient ratio. The impetus for the specialty of Malaysia
intensive care came from advances in anaesthesia, coronary care and
resuscitation. Early intensive care units were generally the extensions
of the recovery rooms used for post-surgical patients.
The first ICU in Malaysia was established in University Hospital of the First ICU in
University of Malaya in 1965. Since then, such units have been set up 1965
in other government hospitals, mainly state hospitals. From the 1970s

to 1980s, many Ministry of Health hospitals converted the general
wards or the recovery rooms in the operation theatre to become the
general ICUs. These ‘makeshift’ ICUs were generally small with space
constraints. Purpose-built ICUs became available in new hospitals
built from the 6th Malaysia Plan (1991-1995) onwards. New generation
hospitals built in the 7th and 8th Malaysia Plans (1996-2000, 2001-2005)
such as Selayang, Serdang, Ampang and Sungai Buloh hospitals have
well designed ICUs with a higher ratio of intensive care beds.
Intensive care service in the Ministry of Health (MOH) hospitals ICU comes under
comes under the Department of Anaesthesia and Intensive Care. Care Department of
for these patients care is coordinated by the anaesthetists with input Anaesthesia
from the primary unit consultants. However, in the last few years,
ICUs are increasingly being managed by dedicated intensive care
teams directed by certified intensivists. Currently, these intensivists
are anaesthetists who have undergone a two year specialized training
in intensive care.
Distribution of intensive care beds
According to a national survey carried out in Jun 20051, there are a Current
total of 104 intensive care units providing 547 intensive care beds in Situation
Malaysia. Of these, the Ministry of Health (MOH) has a total of 48
ICUs (46.2%) and 268 beds (49%) in 39 hospitals (Table 1).
Table 1: Number of intensive care units and beds in Malaysia, 2005
Type of hospital No. of ICUs (%) No. of ICU beds (%)
MOH, state hospitals 26 (25.0) 173 (31.6)

MOH, district hospitals 22 (21.2) 95 (17.4)
Military hospitals 1 (1.0) 2 (0.4)
University hospitals 4 (3.8) 41 (7.5)
Private hospitals 51 (49.0) 236 (43.1)
Total 104 (100.0) 547 (100.0)
Source : National Audit of Adult Intensive Care Unit (NAICU) report 2005
Table 2: ICU beds in some selected countries
Country No. of ICU beds % of hospital beds ICU beds /100,000 pop.
Australia 1,595 3.0 7.5

France 22,000 3.2 38.4
Germany 23,000 2.7 28.5
Italy 5,480 1.2 9.4
Japan 14,670 2.7 11.8
Spain 5,800 3.0 14.8
UK 5,000 2.7 8.5
United States 77,600 6.3 30.5
Singapore 180 2.7 7.0
Malaysia 547 1.5 2.4
Source : NAICU report 2005
The 547 beds in Malaysia represent 1.5 % of total acute hospital beds in Unequal
the country, and gives the ratio of 2.4 ICU beds per 100,000 population. geographical
This is relatively low ratio when compared to some developed distribution
countries like France and United States with more than 30 beds per
100,000 population while UK, Australia and Singapore have between
7.0-8.5 beds per 100,000 population (Table 2).
As can be seen from Table 3, there is an unequal geographical

distribution of ICU beds in the country. States with the lowest bed
: population ratios are Terengganu, Pahang, Sabah and Negeri
Sembilan while Melaka, Penang and the Federal Territory (FT) of
Kuala Lumpur have the highest ratios. Almost half of the ICU beds,
both public and private combined, are concentrated in 3 states,
namely FT Kuala Lumpur, Penang and Selangor (272 beds or 49.7%).
A significant number of intensive care beds (43.1%) are in the private
sector, especially in Melaka, Penang and Selangor, which may not be
as readily accessible to the public due to financial constraints.

Table 3 : Distribution of ICU beds by state (Malaysia), 2005
State Government hospitals Private hospitals Total
Johor 28 15 43
Kedah 19 6 25
Kelantan 19 3 22
Melaka 8 26 34
N.Sembilan 8 2 10
Pahang 11 3 14
Penang 34 50 84
Perak 25 18 43
Perlis 4 0 4
Sabah 23 9 32
Sarawak 28 9 37
Selangor 22 43 65
Terengganu 7 0 7
WPK.Lumpur 71 52 123
W P.Labuan 4 0 4
Total 311 (56.9%) 236(43.1%) 547(100%)
It can also be seen from Table 4 that intensive beds constitute between
1.1% -1.2% of the total acute beds in the MOH hospitals compared to
3% in private hospitals.
Table 4: ICU beds as percentage of hospital beds, 2005
Type of hospital ICU beds /hospital beds
State hospitals, Govt. 1.1%

District hospitals, Govt. 1.2%
University hospitals (not available)
Private hospitals 3.0%
Total 1.5%
A study in Germany estimated that 6.1 % of total number of Norm for
hospital beds are required for intensive care bed2. In Malaysia, the intensive care
recommended minimum percentage of ICU beds are 3% for hospitals beds
without subspecialty services and 5% for hospitals with subspecialty
services.
The Malaysian ICUs are typically small with an average of 4 beds. The
average size of ICU in state hospitals is 6 beds as compared to 10 beds
in universities. It is recommended that the minimum size for ICU for
cost-effectiveness is 8 to 12 beds3.
Utilisation of intensive care beds
In 2005, approximately 30,000 patients in Malaysia were treated in Admissions to

ICU, of which about 13,000 patients were treated in MOH hospitals ICU
(43%). This constituted 1.9% of total MOH hospital admissions for the
year. The mean bed occupancy rates (BOR) in the government state
and university hospital ICUs are high (82.8% and 84.8% respectively)
while that for private hospitals are below 50%.
Table 5: Number of Trainees Offered Foreign Subspecialty Training Programmes

(2001 – 2005)
No. Hospital No. Of Admission Patients Days BOR

1 Sultanah Aminah, JB 1012 1133 113.0%
2 Kuala Lumpur 1,053 5,165 111.1%
3 Queen Elizabeth 563 3,079 105.4%
4 Umum Sarawak 570 1,938 101.1%
5 HTAR Klang 418 2,128 94.4%
6 Pulau Pinang 514 2,755 93.1%
7 Seremban 309 1,452 90.0%
8 Melaka 661 2,009 87.5%
9 Ipoh 466 2,303 87.0%
10 Kota Bharu 429 2,210 86.5%
11 HTAA Kuantan 463 2,375 85.5%
12 Selayang 672 6,586 82.3%
13 Kuala Terengganu 460 1,656 78.6%
14 Alor Setar 447 2,022 70.0%
15 Kangar 280 644 65.0%
16 Private Hospitals 14,870 NA 48.9%

The Scottish Intensive Care Society audit recommends a mean BOR in ICUs
occupancy rate of 70 to 75 % as a reasonable benchmark. Table 5 shows
the BOR of state level and tertiary level hospitals in the Ministry of
Health where all but the last three hospitals had BOR of more than
80%. It is to be noted that the BOR is calculated based on midnight
census and the actual BOR is higher as the data does not capture same
day discharges or deaths before 12 midnight.
Issues in intensive care service
1. Shortage of ICU beds
The shortage of ICU beds in Ministry of Health hospitals was first Shortage
highlighted in the reports of the Peri-operative Mortality Review in resulted in
the 1990s. The lack of post-operative intensive care was identified as a lack of post-
major contributing factor in post-surgical deaths. The National Audit operative care
of Intensive Care Units reported that close to 5,000 patients could not
be admitted to fourteen ICUs in MOH hospitals in 2003 due to the lack
of beds. Subsequent reports in 2004 and 20054,5 showed a worsening
situation (Figure 1).
Fig. 1 : Number of patients referred and number not admitted in 14 MOH ICUs,
2003-2005
Referred Not Admitted

12000
10000 9,833
9,272
8,615
Number of Patients
8000
6000 4,911 5,057 5,557
4000
2000
0 Year
2003 2004 2005
Currently Malaysia has 2.4 ICU beds per 100,000 population. This low Additional ICU
ratio is compounded by the fact that in Malaysia, government hospital beds needed
ICUs only contributed to 57% of total beds whereas in developed
countries like Australia, government hospitals contributed to 75% of
the nation’s ICU beds6. In order to achieve a ratio of 5 ICU beds per
100,000 population for an estimated population of 26 million, Malaysia
will require a total of 1300 ICU beds.
Assuming 65% of these beds are based in Ministry of Health, our Additional ICU
hospitals would require a total of 845 beds, that is, an additional beds in new
of 577 beds to the current 268 beds. This will partly be overcome hospitals
with additional ICU beds that will be made available in 5 new and
replacement hospitals which will be operational in the next 2 years
(2005/2006), namely Hospital Temerloh, Hospital Serdang, Hospital
Ampang, Hospital Sg. Buloh., Hospital Alor Star and Hospital Sg.
Petani. In addition, there are also plans to upgrade and expand
existing ICUs in hospitals that are already operating in full capacity,
for example, Hospital Kuala Lumpur, HTAR Klang and HSA Johor
Baru.
2. Non-functioning ICU beds
Not all available ICU beds in MOH hospitals are functioning due to
shortage of staff or essential equipment. Table 6 indicates the position
of 7 hospitals with non-functioning ICU beds.
Table 6 : Available but non-functioning ICU beds in MOH hospitals, 2005
Hospital Maximum bed No. of functional Remaining available

capacity beds beds (but non-
functioning)
Selayang 24 12 12
Kajang 6 4 2
Putrajaya 11 7 4
Port Dickson 4 0 4
Kota Bharu 12 7 5
Ipoh 22 16 6
Kangar 5 4 1
Total : 84 50 34

3. Integrated intensive care service
A comprehensive development plan is necessary to ensure that Comprehensive

intensive care is developed in tandem with advances made in other development
disciplines and their needs, the national health plan and the expectation plan needed
of the community. In the last decade, intensive care has undergone
rapid development and a shift in the organization of the service.
In UK, the Health department stated that existing division between

ICU and High dependency Unit (HDU) should be replaced by a
classification that focuses on the level of care that individual patients
need. Physical separation into ICU and HDU are not recommended7. In
the US, the Leapfrog group mandates that all ICUs should be directed
by intensivists and care must be delivered by a dedicated team of
trained doctors and nurses. Fragmentation of intensive care and the
establishment of organ specific ICUs are not encouraged.
4. Training of intensivists
The number of intensivists in Malaysia has increased steadily in the Number of

last five years and currently there are eight serving the various states intensivisits in
(Table 7). Each year under the MOH subspecialty training programme, Malaysia
one to two specialists are awarded scholarship or paid leave to pursue
intensive care training overseas.
There is an increasing interest and commitment among trainees to

seek certification by examination, for example, European Diploma in
Intensive Care (EDIC).
Table 7 : Distribution of Intensivists in Ministry of Health Hospitals, 2005
Hospital No. of Intensivist
Alor Setar 1
P. Pinang 1
Selayang 1
Kuala Lumpur 2
Klang 1
Melaka 1
Johor Baru 1
Kuantan 1 (seconded to IIU)
Total 9
To encourage local specialists to pursue EDIC programme, MOH and EDIC
the Intensive Care Section of the Malaysian Society of Anesthesiologists programme
have collaborated with the European Society of Intensive Care
Medicine (ESICM) to hold the part two examination in Malaysia. The
first of such examination was held last year (2004) at Hospital Selayang
and the coming examination for 2006 will be held in Hospital Kuala
Lumpur in August.
Five specialists are currently undergoing training and they have been Intensivist in
earmarked for hospitals in Kuala Terengganu, Kota Bharu, Putrajaya, every state by
Selayang and Ipoh. Thus it is hoped that by 2010, there will be at least 2010
one intensivist in every state. To ensure that the standards of training
in intensive care are maintained, a document on the requirements for
credentialing of an Intensivist was jointly prepared by the Intensive
Care Section of Malaysian Society of Anaesthesiologists and the
Anaesthetic Service of Ministry of Health in 2005.
5. Nursing support
The role of the nurses in the ICU setting cannot be over-emphasized. Shortages of
Good nursing care forms the cornerstone of intensive care. It is ICU trained
observed that in general, the quality of intensive care nursing in MOH nurses
ICUs has not been on par with the developed countries. This could be
due to the low percentage of trained nurses in the ICU. The NAICU
2003 report showed that only 37.5% of ICU nurses in the fourteen
state hospitals had post-basic intensive care nursing training. The
preliminary report of NAICU in 2005 showed that only 16% of ICUs
have more than 50% of the nurses trained in intensive care nursing.
This low percentage of trained nurses could be due to the low intake
of nurses for post-basic intensive care nursing and the high transfer
rate among nurses especially in hospitals in the West coast.
Recommendations
1. Strategies to overcome the shortage of beds
1.1. Expanding intensive care physical facilities
In hospitals where the ICU is functioning at its maximum capacity, for Expansion
example, Hospital Pulau Pinang, Hospital Umum Sarawak, Hospital in existing
QE Kota Kinabalu, Hospital Teluk Intan and Hospital Sri Manjong, hospitals
the plan is to build new ICUs or expand existing units. In hospitals
with multi-disciplinary high dependency units, it is recommended that

these units be upgraded to intensive care level, for example, Hospital
Kota Bharu and Seberang Jaya.
1.2. Utilise all designated but non-functioning ICU beds
More staff (nurses and medical officers) shouId be posted to hospitals Resolving
where ICUs are not functioning at maximum capacity, for example, issue of non-
Hospital Selayang, Kajang, Ipoh, Serdang, Kota Bharu and Taiping. functioning ICU
In hospitals where ICU beds cannot function due to the lack of certain beds
critical equipment e.g. ventilator, these equipment should be provided
for. This is to ensure all designated ICU beds are functional.
1.3 Networking of ICUs
In geographical regions within a reasonable traveling distance (less Networking

than 2 hrs by land), networking can be carried out to share ICU beds in of ICUs in the
order to reduce the effects of peak and low demands. This will ensure Klang Valey and
that all deserving patients will receive intensive care at the time of by zone
contact and improve outcomes. Networking has been established in
hospitals in the Klang Valley since 2004. This should be extended to
other regions:
• Northern network involving Hospital Penang, Seberang Jaya,

Sungai Petani and Alor Setar
• Southern network involving Hospital Johor Baru, Pandan, Muar,
Batu Pahat and Melaka
• Perak : Hospital Ipoh, Taiping, Teluk Intan and Sri Manjong
To ensure successful networking and the ability to track the number Tracking ICU
of beds available in a continuous manner and in real time, a software beds - ICU Bed-
called “ICU Bed-watcher’ has been developed. This was introduced watcher
to the Klang Valley network March 2005 and is now fully operational.
Authorized personnel from the 6 hospitals in Klang Valley (Hospital
Kuala Lumpur, Selayang, Klang, Kajang, Putrajaya and Serdang) are
able to view the ICU bed situation by accessing the website http://
www.icu.org.my and refer deserving cases appropriately.
1.4. Optimise utilization of beds
This includes training of doctors in triaging and selection of patients, Triaging and
use of management care plans and protocols and withdrawal and selection of
withholding of life support in non-survivors. In line with this, the patients
MOH in collaboration with the Intensive Care Section of the Malaysian
Society of Anesthesiologists will conduct a series of road shows to
increase awareness on withholding and withdrawal of therapy. A
national forum will also be planned where foreign experts and senior
clinicians from the various disciplines are invited to share their views
and come up with a consensus statement.
The National Audit on Intensive Care Units (NAICU) which was Extending ICU
established in 2002 should be extended to all ICUs in the Ministry of Audit to all
Health. The audit allows continuous monitoring of performance and ICUs in MOH
patient outcome and ensures accountability and better patient care.
It is proposed that eventually all ICUs in the country (public and
private) shall be mandated to participate in the audit as is the case in
the UK. NAICU should be made the pre-requisite for all ICUs seeking
accreditation or recognition as training centres.
2. Establish an integrated Intensive Care Service
It is recommended that intensive care services should be integrated Integrated ICU

and provided by a dedicated team of trained doctors and nurses.
The ICU should function as a closed unit and directed by a qualified
intensivist.
All ICUs (including organ specific ICUs, for example, neuro ICU,
nephro ICU, cardiothoracic ICU) and high dependency care units in
the hospitals should be integrated under one service. Historically high
dependency units (HDU) were introduced to provide a step between
intensive care and ward care in order to overcome the shortage of
intensive care beds. They provide monitoring and support to patient
at risk of developing organ system failure but not for managing
patients with multi-organ failure. The HDU is an area where patients
are managed post discharge from ICU before returning to the wards.
This involves multiple transfers and does not allow flexibility in
bed utilization and sharing of equipment and staff. It operates as
an independent unit physically separated from the ICU and may be
headed by separate medical and nursing team. Numerous papers have
shown that an integrated and dedicated intensive care team improves
patient outcome, reduces hospitalization cost and ensures optimal
utilization of resources.
Integrated intensive care/high dependency units are common in Step-down care

Australia and the trend is for increased integration and flexibility in the within ICU
way that beds are used. Under this concept, patients who are weaned to minimize
off from mechanical ventilation remain in same the bed in the ICU patient

but with a ‘step-down’ in nursing ratio and other interventions. This movement
reduces the cost of hospital care without having to move the patient
from one unit to another thus minimising the risk of transportation.
More importantly, the patient remains under the care of the same
intensive care team. It also reduces the stress of patients and relatives
from another transfer and thus results in better patient outcome.
The current trend is towards establishing big multi disciplinary ICUs Multi-
catering for all disciplines including specialised surgical disciplines. For disciplinary
example, The Alfred Hospital in Australia in its upgrading exercise in ICUs
year 2000 amalgamated its three specialist ICUs that is cardiothoracic,
trauma and general intensive care units into a 35 bedded ICU which
incorporate both intensive care and high dependency patients.
3. Increase the critical mass of intensivists
This can be achieved by:
• increasing scholarship per year from 1-2 to 4 per year

• encouraging participation of non-anaesthetic specialists, for
example, physician, surgeons, emergency physicians to take up
intensive care as a subspecialty
• consolidating the link with European Society of Intensive Care
Medicine and to recognize the European Diploma in Intensive
Care (EDIC) as the ‘national examination’ for the purpose of
certification. Intensive care subspecialty training programme
should be standardized and based on the curriculum as outlined
in the Anaesthetic Subspecialty Training Programme for Intensive
Care.
• recognizing and gazetting intensivist as a sub-specialist based
on set criteria proposed by the Intensive Care Section, Malaysia
Society of Anaesthesiologists. (Appendix 1).
4. Improve nursing care by :
• ensuring that ICUs are appropriately staffed and that the nurse to
patient ratio remains constant during the three shifts
• increasing the intake for post-basic intensive care nursing.
• intensifying in-house training as part of the credentialing
process
• ensuring that nurses in ICU remain in the unit for a minimum
period of three years
Similarly, the University College London Hospital will soon be moving
into a new hospital complex which has an ICU with provision for up
to 35 critical care beds, making it the largest unit of its kind in London.
It is proposed that future ICUs should have bigger number of beds
to provide for ‘stepped down care’ thus allowing sharing of staff and
equipment and resulting in better patient and relatives’ satisfaction.
Intensive care services should be categorised according to the level of

acuity e.g. Level 1 to Level 3. This will help determine the appropriate
level of resources needed to provide care and help establish parameters
for the level of care that each hospital is reasonably expected to
provide.
• Level 1 ICU is equivalent to the HDU or acute care ward and Level 1 ICU
should be made available in all district hospitals without an
anaesthetist. The unit should have 4 to 6 beds and be capable of
providing intensive monitoring and basic intensive care such as
oxygen therapy and inotropic support but not invasive mechanical
ventilation. The nurse to patient ratio is 1 is to 2-3 patients.
• Level 2 ICU refers to one that is located in a district hospital with Level 2 ICU
anaesthetist capable of providing intensive care. The number of
beds should be 6 to 10 beds and capable of providing mechanical
ventilation. Nurse to patient ratio is 1 to 2 for non ventilated
patients and 1 to 1 for ventilated patients.
• Level 3 ICU refers to those that should be available at all state Level 3 ICU
hospitals with facilities for multiple organ support such as
mechanical ventilation and renal replacement. Nurse to patient
ratio is 1 to 1 or more and the unit shall operate as a closed unit
directed by an intensivist or an anaesthetist with special interest
in intensive care.
The number of beds required will range from 16 to 35 or approximately

3 to 5 % of hospital beds depending on services provided by the
hospitals.
5. Paediatric Intensive Care Units
Currently in MOH hospitals, pediatric patients are managed in the Intensive care
general ICUs except in hospitals where there are dedicated Pediatric for paediatric
ICUs, for example, HKL and Hospital Ipoh. Pediatric patients patients
comprised about 10% of the cases admitted to the general ICUs. In

addition, a number of critically ill children were also managed in the
neonatal ICU or the acute bays in pediatric wards.
The Joint Faculty of Intensive Care Medicine, Australia and New

Zealand in its Policy Document Review 2003 on Minimum Standards
for Intensive Care recommended that a pediatric ICU should have
a minimum of 300 admissions per year to ensure sufficient clinical
workload to maintain clinical expertise.
Based on the Australian model, we recommend that Pediatric ICUs

be established in KKM state hospitals where the case load exceeds
300 admissions per year. Pediatric ICUs in the state hospitals shall be
managed by the Pediatric Departments.
Conclusion
Optimal intensive care for Malaysian will be hopefully achieved once

issues highlighted in this paper are addressed. Ministry of Healthcare
addressing the issues mentioned in stages and it is hoped that Ministry
of Health Hospitals will have enough ICU beds for all the critically
ill admitted in our hospitals and at the same time delivering high
standard of care for these patients. Greater emphasis should be placed
on training for all categories of staff managing the ICU at all times.
References:
1. Australian and New Zealand Intensive Care Society; Descriptive analysis of intensive
care facilities in Australia and New Zealand, Intensive Care Registry Report (1998),
ANZICS, Melbourne.
2. Carson SS, Stocking C, Podsadecki T, et al. Effects of organizational change in the medical
intensive care unit of a teaching hospital: a comparison of “open” and “closed” formats.
JAMA 1996; 276: 322-28.
3. Department of Health, UK, 2000. Comprehensive critical care. Report of an expert

group.
4. Ferdinande P. Recommendations on minimal requirements for intensive care

departments. Intensive Care Med 1997;23:226-32).
5. Multz AS, Chaflin DB, Samson IM et al. A “closed” medical intensive care unit (micu)
improves resource utilization when compared with an “open” MICU. Am J Respir Crit
Care Med 1998; 157: 1468-73.
6. Pronovost PJ, Angus DC, Dorman T, et.al. Physician staffing patterns and clinical
outcomes in critically ill patients: a systematic review. JAMA 2002; 288: 2151-2162
7. Ministry of Health Malaysia (2005). Special Report on “A national survey on intensive

care resources in malaysia” and national audit on adult intensive care units, 2005.
8. Sinuff T et al. Rationing critical care beds: a systematic review. Critical Care Medicine
2004; 32: 1588-1597

Appendix 1
Requirements for the credentialing of an Intensivist
An intensivist must fulfill all the following:
1. Have a recognised degree in Anesthesiology, Internal Medicine, Surgery or other

related disciplines.
2. Have completed 24 months training in intensive care. These 24 months must be spent
full-time in intensive care in recognised centres, which could be :

a.) Unrestricted recognised training
Refers to Level 3 ICUs in major tertiary/ referral hospitals with at least 2 consultant
intensivists, who have at minimum a 50% involvement in the unit. Total admissions
of at least 750 per year with a diverse case mix, normally including five of the following
six specialties: trauma, general medicine, general surgery, acute cardiology, burns and
neurosurgery.
b) 6 months recognised training

Refers to Level 3 ICUs in major tertiary/ referral hospitals with at least one consultant
intensivist, who has at minimum a 50% involvement in the unit. Total admissions of at
least 500 per year with a diverse case mix, normally including general medicine, general
surgery and trauma.

The unit should also meet the following criteria:
• Perform research, regular medical audits and quality improvement programmes.

• Has continuous medical educational programmes including bedside teachings, journal
clubs and grand rounds.
• Has adequate educational facilities, which include medical library facilities and computerised
search system.
3. Have obtained certification after completion of training from one of the following:
(from year 2006 onwards)
a) EDIC (European Diploma in Intensive Care)

b) FFICANZCA (Fellow of Faculty of Intensive Care, Australian New Zealand College
of Anaesthetists)
c) FRACP (Int Care) Fellow of the Royal Australian College of
d) Physicians, endorsed in Intensive Care
e) ABCCM (American Boards, Critical Care Medicine)
CHRONIC PAIN MANAGEMENT SERVICE
SUMMARY
Pain management service encompasses the management of acute pain, cancer pain
and chronic pain. While Acute Pain Services were set up in the Ministry of Health
(MOH) in the early 1990s, chronic pain services only started in 2000 with the setting
up of the Pain Clinic at Hospital Selayang. Currently there are only 4 trained pain
specialists and 7 pain clinics in the MOH. Selayang Hospital is the main center, and
clinics have also been started in Penang, Kota Bharu, Ipoh, Batu Pahat, Johore Bahru
and Melaka. The Hospital Ipoh pain clinic also offers acupuncture as a modality of
treatment as the pain specialist there has been trained in this. Pain medicine is a
relatively new field and needs to be developed much more, especially chronic cancer
and non-cancer pain. Although anaesthesiologists are the main specialists involved
in pain medicine, all doctors need to have a better knowledge and understanding of
acute, chronic and cancer pain to ensure more effective management of the different
types of pain in patients.
Introduction
T
he core business of the chronic pain management services in the Holistic
Ministry of Health is to ensure that all patients with chronic cancer multidisciplinary
and non-cancer pain have access to good pain management. approach in pain
This is done using a holistic multidisciplinary approach, management
which recognizes that pain is not just uni-dimensional but is better
approached using a bio-psycho-social perspective. Effective pain
management includes the use of appropriate analgesic medications and
techniques delivered by an appropriate method, appropriate exercise
and mobilization, and the incorporation of a psychological approach
into the overall management of the patient.
Pain medicine is still a very young specialty in Malaysia, and in the Pain medicine,
MOH specialized pain management services were only started in a very young
1993 with the establishment of Anaesthesiology-based Acute Pain specialty in
Services (APS). The next development was in 2000 with the setting Malaysia
up of chronic pain clinics in Hospital Selayang, followed by clinics in
6 other hospitals over the next few years. These pain clinics currently
form the core of the pain management services in the MOH and are
not only involved in the management of patients with pain but also

in teaching and training of other doctors and health care providers
in order to improve the overall management of acute, chronic and
cancer pain.
Chronic pain
Chronic pain is different from acute pain and has to be approached Chronic pain is
differently. In acute pain, short-term analgesic techniques using strong different from
opioids and regional nerve blocks are very effective, as the pain goes acute pain
away after the tissues heal and there is no need for long-term analgesia.
In patients with chronic pain, however, the pain persists for more than
3 months, and continues after tissues have healed.
Chronic pain is now recognised as a disease in its own right, a disease Chronic pain as
of the nervous system which has to be treated aggressively, separately a disease
from the underlying condition which may have contributed to or
brought about the chronic pain in the first place. Although pain relief
is usually what patients seek, worldwide experience has shown that
this is not possible in most chronic pain conditions. More importantly
though, studies have shown that pain relief alone is not enough to bring
about improvements in mood and function of patients with chronic
pain, and, conversely, that patients with chronic pain can increase their
function and improve their mood despite continuing pain.
Cancer pain
Pain is a symptom in over 70% of patients with advanced cancer. Pain in patients
According to WHO, the majority (over 90%) of cancer pain can be with advanced
controlled by easy means, the main one being the appropriate use cancer
of oral morphine. The role of pain specialists and pain clinics in the
management of cancer pain is to apply more advanced and invasive
techniques for the control of pain in the 5-10% of patients where oral
analgesics and simple parenteral analgesics is not enough.
Pain clinics
Pain clinics aim at providing accurate diagnosis, and formulating a

rational plan of management for patients with chronic pain, in order
to relieve suffering, to improve patients’ ability to cope with pain, and
to return patients to productive living.
The first chronic pain clinic in MOH was established at the Hospital Pain
Selayang in 2000. This was a multidisciplinary pain clinic, run by a management
consultant anesthesiologist trained in pain medicine, with support from team and
a physiotherapist, consultant psychiatrist and clinical psychologist. As training
there are no specific posts for clinical psychologists in this setting, a
clincial psychologist was recruited on a “voluntary” basis from one
of the local universities. A lecturer from the College of Physiotherapy
in HKL was also recruited to be the pioneering physiotherapists as
she had had some training in pain management. Later other local
physiotherapists were also trained and have subsequently joined the
multidisciplinary team. The workload has increased since, especially
over the last 2 years (Table 1).
Table 1 : No. of patients in Hospital Selayang Pain Clinic 2000 – 2005
Year New Cases Follow-up Total
2000 19 32 51
2001 36 121 157
2002 57 203 260
2003 115 245 360
2004 119 441 560
2005 136 545 681
Total 482 1587 2069
Subsequently 3 other specialists have been trained in pain medicine Other pain
and have started pain clinics in their respective hospitals, one each clinics
in Hospital Kota Bharu, Hospital Batu Pahat and HSI Johore Bahru,
and Hospital Ipoh. In order to increase the number of pain clinics
available in the Ministry of Health, pain clinics were also started in
Hospital Pulau Pinang and Hospital Melaka, with the pain specialist
from Selayang hospital providing the consultant service to run these
clinics. To date, therefore, there are 7 Pain clinics in MOH hospitals. All
Pain clinics are administratively under the Department of Anaesthesia;
most clinics are run once a week, except for that in Hospital Selayang
which is run two days a week. Due to logistic reasons, the clinic in
Hospital Pulau Pinang is currently not active.
All the pain clinics in the MOH take a multidisciplinary approach Pain and
to pain, and function in cooperation with the departments of psychosocial
Physiotherapy and Psychiatry. In patients with chronic pain, factors
psychosocial factors usually play a much bigger role and these
factors have to be addressed in order to achieve good outcomes. In

addition, many patients with chronic pain have developed secondary
deconditioning and are physically inactive, thus active physiotherapy
plays a critical role in their management.
There is an increasing trend in the number of patients referred to

and seen in the Pain clinics, especially Hospital Ipoh (Table 2), the
limiting factor being the staffing The clinic in Melaka Hospital is very
new and is only run once a month with a visiting consultant from
Selayang hospital
Table 2: No. of patients in Hospital Ipoh Pain Clinic 2003 – 2005
Year New Cases Follow-up Total
2003 40 44 84
2004 36 157 193
2005 31 234 265
Total 107 435 542
Characteristics of patients seen pain clinics
Pain clinics see both non-cancer and cancer patients but the majority
of patients treated are those with non-malignant pain. Patients with
cancer pain are mostly managed by Palliative Care Units in the MOH
hospitals. The majority of patients were aged between 40-49, but
patients of all age groups were seen (Figure 1). Patients were also about
evenly distributed between all the three ethnic groups (Figure 2).
Fig. 1: Age of patients, Hospital Selayang Pain Clinic, 2000-2004
80
80
70 70
60 54
50
40 37
30 29
25
20
10 5 6
0
0
9
9
80
9
9
-2
-3
-5
-6
<2
-4
-7
>=
30
50
60
20
40
70
Age (years)
Fig 2: Ethnic group of patients, Hospital Selayang Pain Clinic, 2000-2004.
Ot hers
3%
Ma lay
Ma lay
33% Chi nese
Indi an
Indi an
Others
36%
Chi nese
28%
The main source of referral was from government hospitals, with a

large number from the orthopaedic surgeons; however, patients were
also referred by oral surgeons, general surgeons, neurologists and
a number of other specialists (Figure3). Types of pain include both
nociceptive (musculoskeletal and visceral) pain and neuropathic pain,
again in almost equal distribution, and site of pain included all parts,
from the face to the back and legs (Tables 3 and 4).
Fig 3: Source of Referral of patients, Hospital Selayang Pain Clinic, 2000-2004
GP 17
Misc 29
Anaes/ Pain 4
Surgical 20
Neuro 17
Medical 13
Oral S 33
HMS 12
Ortho 46
0 10 20 30 40 50

Table 3 : Type of pain of patients, Hospital Selayang Pain Clinic, 2000-2004
Type of pain No. of patients %
Cancer 28 12.7
Musculoskeletal 70 31.8
Neuropathic 85 38.6
Visceral 24 10.9
Mixed 13 5.9
Total 220 100
Table 4 : Site of pain of patients, Hospital Selayang Pain Clinic, 2000-2004
Site of pain No. of patients %
Cancer 28 12.7
Musculoskeletal 70 31.8
Head / face 38 19.8
Upper Limb 36 18.8
Neck and Upper Limb 13 6.8
Back 26 13.5
Lower limbs 25 13.0
Back and lower limbs 14 7.3
Abdomen 24 12.5
Chest / abdominal wall 10 5.2
Multiple sites 6 3.1
Total 192 100
Management modalities in chronic pain
A multidisciplinary approach to management of chronic pain is Pain

taken for all patients. The management begins with a thorough assessement
assessment where patients are seen separately by a pain specialist, a before
physiotherapist and a clinical psychologist or psychiatrist. All patients commencement
are also assessed using self-administered questionnaires which assess of treatment
the level of disability, self confidence, anxiety, depression and stress,
and “catastrophising” (a term used by psychologists to refer to
thoughts like “The pain is killing me”) as well as active coping. After
the assessment, the team meets to discuss the best management plan
for the patient and then each of the members of the team carries out
his/her part of the management plan.
Management includes the use of analgesic drugs, including Multi-treatment
“traditional” analgesics like NSAIDs and opioids and antineuropathic approaches
drugs, nerve blocks, physiotherapy and psychological modalities. In the
Ipoh hospital clinic, acupuncture is also offered as the specialist there
was trained in this modality of treatment. Psychological approaches
include a clear explanation of the pain and what it means, so that the
patient has a good understanding of his/her pain, and teaching the
patient self-management skills like relaxation and pacing. Treatment
with drugs alone are less suitable in patients with chronic non-
cancer pain as they will either develop long term side effects or their
dose requirements will escalate over time. Therefore, a multimodal
approach that includes self-management techniques is very important
in patients with non-cancer pain. Patients are treated on an individual
basis initially, but those who do not do well or those who have high
levels of distress and disability are treated in a group program using
a cognitive behavioural approach, described in the next section.
Patients with difficult cancer pain are managed mainly with the use
of invasive techniques like the insertion of intrathecal catheters for
spinal administration of morphine and local anaesthetics, neurolytic
blocks like celiac plexus blocks for pain from pancreatic carcinoma,
and combinations of drugs like lignocaine, ketamine and morphine.
However these patients constitute only a small proportion of the
patients seen in a pain clinic.
The MENANG Pain Management Programme (Program MENANGani

Kesakitan)
Systematic reviews and meta-analyses have provided evidence of the The MENANG
effectiveness of pain self-management based on cognitive-behavioural pain
principles. These interventions aim to equip patients with the management
necessary skills to improve their social, occupational and psychological programme
functioning and decrease reliance on passive modalities, such as taking
unnecessary medication and undergoing repeated procedures.
In November 2001, a team of 4 people comprising a pain specialist, Training in

physiotherapist, psychiatrist and nurse were sent by the Ministry of Sydney Hospital
Health to observe a 3-week program Pain Management & Research
Centre (PMRC) at the Royal North Shore Hospital in Sydney, and
returned to start the Menang Programme in June 2002. The structure
and approach of the Menang Programme is essentially the same as the
Sydney program, but while the Sydney program runs for 3 weeks and
is an outpatient program, the Menang Programme runs for two weeks

and patients are admitted when necessary, for example outstation
patients.
As with the Sydney program, the Menang Programme emphasised Approach

re-formulation of the pain (as chronic but not sinister), goal setting, in Menang
education about pain, applied relaxation training, training in identifying Programme
and challenging unhelpful thoughts and beliefs, practising effective
problem-solving and pain management strategies like activity pacing,
daily planning; programmed exercise and systematic encouragement
of activities to limit avoidance behaviours and to regain confidence in
functioning despite pain. Pain medications are also gradually reduced
and eventually stopped over the two week period. Two programs are
run per year, and 7 groups have been completed by the end of 2005
(Table 5).
Results have been very encouraging, with significant improvements Encouraging

achieved by most participants on measures of daily function, results
mood, confidence, distressing beliefs, medication use, and physical
performance. Although not an intended outcome, there was also a
median reduction in usual pain scores despite substantially reduced
use of analgesic medication and increased activity levels. These
outcomes are consistent with those reported from similar programs
assessed in randomised controlled trials with different chronic pain
patient populations in the UK and Australia.
Table 5: Menang Programme, Hospital Selayang, 2002-2005
Year Group No. No. of participants (patients)

2002 1 10
2003 2 9
3 10
2004 4 10
5 8
2005 6 11
7 9
Total 67
A number of challenges exist for the future of the Menang Programme. Challenges
The concept that complete relief of pain is not always necessary for in pain
improvements in function, mood, and lifestyle is not easily accepted management
and is especially important for all to grasp, including health care
professionals, employers and relatives of sufferers of chronic pain,
and the community as a whole. There are implications for resource
allocation: this treatment can reduce the need for ongoing attendance
at hospital and multiple drug use, but it does require skilled staff and
time, especially in the more disabled and distressed patients. At the
moment there is no specific recognition of this type of self-management
approach to chronic pain as a treatment modality, and no specific staff
allocated to run such programs. We need to address this in the Ministry
of Health so that we can continue to offer pain management programs
as a treatment option to patients with chronic pain, so that they can
improve their function and their mood, despite continuing pain.
Conclusion
Pain medicine is a relatively young in Malaysia but has great potential

to make a big difference to the management of patients with chronic
pain. Furthermore, and perhaps more importantly, the application of
self-management techniques and encouragement to reduce reliance
on medication and doctors, has the potential to relieve the increasing
burden on health services posed by the growing population of patients
with chronic diseases, including chronic pain. The Ministry of Health
should definitely invest more resources into developing the field of
pain medicine.

ADVANCES IN ORAL HEALTHCARE IN MALAYSIA
SUMMARY
There has been remarkable progress in oral healthcare in Malaysia since its inception
as a school dental service. Expansion in scope to encompass all segments of the
population and evolution of care to include complex specialty care has brought
progress in care delivery and improvements in oral health status. Dental education
has seen a greater focus on higher standards while research includes forays into
more basic sciences and greater collaborative ventures. The contributory role of oral
health to general health is increasingly recognised. The electronic/digital revolution
has brought an explosion of information on disease causation, diagnostics, treatment
philosophies, treatment plans, and the increasing shift to evidence-based care with
technological and mechanistic advances charted in all dental disciplines. There is also
an increase in interdisciplinary approach to the management of complex medical and
dental conditions. Much, however, remains to be done for oral healthcare in Malaysia,
including quicker uptake of developments and trends to develop a competitive
edge.
Introduction
T
he oral health services of the Ministry of Health (MOH) started The past
off as a school dental service in 1946, and the Dental Division
was part of the Medical Department then1. In 1947, the dental
needs of the then Federation of Malaya were met by 50 private
practitioners and 400 registered dentists alongside only 20 government
dental officers serving in 26 dental clinics. Dentists then were trained
mainly in Singapore and care rendered was mostly basic outpatient
care confined to emergency dental treatment.
Oral healthcare in the country has since made great strides. By 31 The present
December 2004, the MOH oral health service is 8,015 strong; with
1,060 dental officers and 1,199 dental nurses, among other oral health
personnel in its fold2. The number of facilities has also burgeoned to
1,926, with 3,326 dental operating units/chairs3. There are now three
dental faculties, 1,439 private practitioners and 74 registered dentists
to a population estimated at 25.6 million4 in 2005. This gives a dentist
to population ratio of 1:10,032 population.
Care has also evolved to include specialty oral healthcare. The number Service delivery
of recognised specialties in the country has increased from two in the
1950s to seven currently, namely oral surgery, orthodontics, paediatric
dental surgery, periodontology, oral pathology/oral medicine,
restorative dentistry and forensic dentistry. There are now 242 dental
specialists providing specialty clinical oral healthcare in the country,
with 96 of them serving in the MOH.
Diagnosis forms the basis of all treatments and there is a move towards
more sophisticated diagnostics. Detection and treatment of oral and
systemic diseases affecting the maxillofacial complex contribute a
major area for research and innovative treatment. Globally, there is
increasing recognition of dental pain and dental radiology as fields
of specialty.
It is the aim of the MOH to provide access to oral healthcare to at least MOH
25% of the nation’s population, visit at least 90% of primary schools performance
and treat 90% of primary schoolchildren, visit at least 70% of secondary indicators
schools and treat at least 70% of secondary schoolchildren5.
The target for coverage of 25% of the population seems to be within

grasp, with more than 5.9 million patients (23.1% of the population)
rendered care in 2004. The target for primary schools has been
surpassed since 1998. Visits to primary schools have increased
gradually from 91.4% (1998) to 96.1% (2004) with coverage of 93.9% and
96.9% of primary schoolchildren respectively. For secondary schools,
76.2% of schools were visited with coverage of 63.9% of secondary
schoolchildren (targeted 70%).
The MOH oral health service has moving outcome targets of 30%, 60% Outcome
and 50% caries-free dentition for 6-, 12-, and 16-year-olds respectively. indicators
It has certainly made progress, albeit not as effectively as it had hoped.
Figures for caries-free dentitions in these age groups increased from
12.7%, 41.9% and 28.0% respectively in 1995 to 28.8%, 57.1% and 48.2%
in 2004.
There have been improvements in oral health status for all age
categories in many parameters of oral health. More teeth are retained
for longer periods and in better condition now than before (Table 1).
In the year 2000 epidemiological survey of adults aged 15 years and
above, the mean number of teeth present was 22.5 with more than
80.0% of the population having 20 teeth or more6.

Table 1 : Oral Health Status of Malaysians 15 Years and Above from Epidemiological Surveys of
1974/757 and 20006
Mean *DMFX Mean number of teeth Having

Age group Per Su present Pocket

1975 2000 1975 2000 1975
15-19 6.2 2.9 26.7 28.3 10.5

20-24 8.8 4.4 26.9 29.4 17.4
25-29 11.5 6.0 25.0 29.0 22.5
30-34 12.1 8.4 24.0 27.3 36.3
35-44 14.5 12.1 21.2 23.4 39.2
45-54 17.8 15.6 16.8 18.5 45.2
55-64 20.7 20.1 13.0 12.8 42.4
65+ 25.2 23.5 7.5 8.2 32.6
Overall 13.2 11.3 21.6 22.5 29.0
*DMFX – Teeth Decayed, Missing, Filled or indicated for extraction

Source: Oral Health Division, MOH
Current trends and developments
There is growing realisation of the inter-relationship between oral Oral health and
and general health. General health affects oral health and poor oral general health
health has detrimental impacts on general health - jeopardizing food
choices, intakes and nutrition status. The mouth has been termed the
‘mirror of the body’ as many general conditions manifest with oral
signs and symptoms.
Numerous factors, especially lifestyle, affect both general and oral Common risk
health leading to adoption of common risk approaches in managing approaches
these diseases. The medically-compromised and the infirmed may
present for dental treatment, necessitating sound medical knowledge
on the part of the dental professionals.
There is increasing number of older persons in the population. In Socio-

1990, the elderly aged 65+ years made up 3.7% of the country’s demographic
population8, increasing to 5.8% of the population in year 20006. This changes
affects healthcare provision, as special dental programmes need to
be developed in gerondontology to manage increasing edentulism,
root caries, malignancy, and medical conditions, as well as fiscal
challenges. Gerondontology is presently not a specialty. However,
an oral healthcare programme for the institutionalised elderly was
started in 1993 aimed at enhancing the quality of life of the elderly
through improving their oral health4. This programme was extended
to include those attending dental clinics of the MOH and community
day care centres.
Developments in dental education
There have been tremendous advances in dental education in the Dental

country1. The Faculty of Dentistry, University of Malaya (UM) was professional
the pioneer to offer a four-year local dental undergraduate degree programmes
programme with its first intake of 32 students in May 1972. Before
that, dentists were mainly trained in Singapore or abroad. There are
now three local dental degree programmes. The National University of
Malaysia (UKM) started in 1997 and the Science University of Malaysia
(USM) followed suit in 1999. Currently, all three programmes have
a total output of about 150 graduates annually. Presently, the Asian
Institute for Medical Sciences (AIMS) and a few others in the pipeline
are private entities providing dental degree programmes.
Dental education now covers a broader base to encompass critical Dental

thinking, research, science (and the scientific method), medicine, auxiliaries
behaviour, communication, patient and practice management. The training
dental curriculum of UM became a five-year programme in 19951. Post-
graduate studies were initiated in 1994 with the Master in Community
Dentistry (MCD) programme and this was further expanded in
2000 to include the Master in Clinical Dentistry (MClinDent) in Oral
Surgery, Periodontology, Paediatric Dentistry, and Oral Medicine/
Oral Pathology1. All undergraduate programmes are now five-year
programmes and post-graduate studies are now a common feature.
Parallel advances have been charted in dental auxiliary training. The

Dental Training School (now College) in Penang was established in
1949 to train ‘Dental Nurses’ based on a New Zealand curriculum.
Training for dental technologists, then known as dental mechanics,
was initiated prior to World War 2 in the King Edward VII College of
Medicine, Singapore. Formal training in the Penang Dental Training
School began in 1951.
In 1996, these certificate courses for dental nurses and technologists

were upgraded to diploma level. For the first time in 1998, post-basic
courses were introduced for both groups. To date 104 (63 dental nurses
and 41 dental technologists) have completed post basic training9.

On-the-job training for dental surgery assistants (DSAs) began in
1951. Formal training started in the Penang Dental Training School
in 1982. In 1993, the mode of training was changed to incorporate
distance learning.
Clearly, for all three categories of dental auxiliaries, as well as the

dental professionals, there has been a convergence towards higher
standards.
Information Technology (IT) and dentistry
Advances in information technology (IT) are have impact on direct Electronic

provision of oral healthcare and in other related fields such as patient records
management, research, and dental education.
The MOH started a computerisation programme for patient dental

care data in 1998. An electronic clinical dental record system was
introduced to support the following functions :
• core business of patient care

• services that facilitate this function
• clinical preventive activities, and
• generation of management decision reports.
The system comprises patient registration, appointment bookings, Scope of IT in

comprehensive and complete patient clinical records that include dentistry of the
case notes, charting and treatment planning, diagnosis, treatment MOH
procedures, prescription, referrals, billing, and follow-ups. Expanded
modules such as the oral maxillo-facial, orthodontic, periodontic
assessment and oral cancer screening are also part of this clinical
information system.
Pilot studies in selected dental clinics in Selangor were carried out in Pilot studies on
1999 and 2003. Future phased implementation in the country will be electronic dental
undertaken under the Ninth Malaysia Plan (2006-2010). records
The need for the dental researcher to be knowledgeable in biomedical

informatics is just beginning to be recognised. Advances in IT will
influence techniques of dental research and consequently the methods
and materials used to deliver oral healthcare.
Intra–oral cameras and digital radiography enable practitioners to Use of Digital

store and retrieve, manipulate and analyse visual patient information. Imaging
These are decision support tools in planning treatment that requires the
integration of many disciplines and many types of clinical information.
Radiovisionography (RVG) facilities have been provided to selected
dental clinics in state hospitals, and specialist dental clinics in the
capital of Kuala Lumpur.
The use of IT in dental education is continually increasing. There IT in dental

is application of IT to curriculum development, computer assisted education
learning (CAL), educational administration, dental practice
administration and clinical research. In some local universities,
multimedia teaching, electronic mail and conferencing are useful
tools applied in undergraduate teaching. The development of new
software and systems also allows many undergraduates in this country
to undertake their own electronic searches.
Dental libraries that have used computers for database searching

have made much contribution to the design and development of an
integrated system for dental education. Such facilities are available in
most universities. The MOH library can now be accessed online, thus
enabling personnel to have continuing education and professional
development. The newest development in the MOH is to encourage
continuous professional education among staff.
To strengthen and improve the smooth functioning of the for Malaysian

Malaysian Dental Council, the following functions can be processed Dental Council
electronically: IT
• processing and issue of Annual Practicing Certificates (APC)
• online registrations of dental practitioners.
The electronic processing and issue of APCs began a few years ago.
However, to improve the efficiency and effectiveness of the system,
there is a need to upgrade the existing system.
Registration of private dental clinics is compulsory under the Private Registration of

Healthcare Facilities and Services Act 1998. Computerisation of the private dental
various activities involved will improve the efficiency of the services clinics
provided. The proposed plan for implementation is to develop an
online registration system to establish the network linkages, thus
creating a database system for approval of applications.
A national committee was set up in 2004 to implement the forthcoming Regulating

national registration of dental devices for regulatory control to improve dental devices
safety on use of instruments /equipment/ materials/apparatus/

appliances. A National Medical/ Dental Device Registration and
Surveillance/Vigilance System will be developed soon.
Dental research
Closely intertwined with advances in dental education is dental Increasing

research. Evolution of the evidenced-based approach10 has increasingly research conduct
propelled dentistry as a medical science with additional demand for
technical expertise11 and dentists as learned professionals. There is
increasing need to cultivate an enquiring, curious, problem-analysing,
problem-solving dentists. This gave impetus to inclusion of research
in the profession resulting in growing interest and involvement with
increased output of dental scientific presentations and papers. The
research culture is certainly growing; the country has only recently
hosted the 27th Asian Pacific Dental Congress, which saw participation
of an international mix of speakers and delegates with presentations
of 41 free papers and 43 posters from local participants12.
The Oral Health Division has, since its inception, conducted 16 dental Types of
epidemiological surveys and various health systems research (HSR) research
projects. The Stomatology Unit of the Institute for Medical Research
(IMR) focuses on clinico-pathological research for oral cancer and
precancers13. Various state dental departments are involved in self-
identified and sometimes centrally identified HSR projects to provide
solutions to various problems related to oral healthcare delivery.
Recently, the scope of research has expanded to include collaborative

projects. These include a cost analysis study of various dental
procedures with University of Malaya, and an occupational health
study with the Environmental Health Research Centre(EHRC) of
the IMR to evaluate urinary mercury levels among dental personnel.
The fluoride content of toothpastes available locally has also been
investigated in a collaborative project between the Sarawak State
Dental and Chemistry Departments.
Globally, advances are seen in genomics, proteomics, stem cell, The future in
molecular biology, nanotechnology, and bioinformatics. Genomics oral health
and proteomic advances resulted in improved clinical (including research
salivary) diagnostics methods; and the increasing understanding of
bodily processes at molecular levels have led to better understanding
of disease causation, pathophysiology, natural history, and the
application of such knowledge for better disease diagnostics, treatment
planning, therapeutics and intervention.
Genetic testing will allow for pre-symptomatic identification of at-risk
individuals to permit the implementation of preventive intervention
strategies. Genes are reportedly etiologically important in chronic
periodontitis, childhood dental caries, cleft lip/cleft palate and oral
squamous cell carcinoma14. These and many other oral diseases,
however, are complex genetic diseases in which multiple different
genes increase an individuals’ susceptibility. Further, environmental,
nutritional and behavioural factors interacting with the gene and
gene products play a part in the risk of these dental diseases in an
individual. Genetic testing for oral diseases is currently limited but
will continue to evolve.
Local dental researchers are not yet in the forefront of research in these
fields. However, isolated works15 and many recent local post-graduate
research works have witnessed modest forays into more basic science,
molecular, oral biology and dental material researches. The premier
dental faculty of the nation has also recently won awards at the 33rd
International Exhibition of Inventions, New Techniques and Products
in Geneva. (Table 2).
Table 2: Awards Won in Geneva by the Dental Faculty of The University Of Malaya
1. OMX Probiotic Dentifrice for Oral Health

2. Skinplast for Ulcers and Wounds
3. ORTHOPROS - UM Novel Orthodontic Prosthesis
4. Computer Software for Repositioning the Jaw and the Face and for giving Qualitative
3D Impression of the Patient’s Face after a Cranio-maxillofacial Operation
5. TriAquora Rinse – Alcohol Free Plant-based Oral Healthcare Product
6. Computer Software for 3D Production of Models for Cranio-facial Reconstruction from
CT and MRI Images
7. Polyhydroxyalkanoates (PHA) as a Scaffolding Material for RigidFracture the
Maxillofacial Skeleton
UM has also recently spearheaded an ambitious Intensification of

research Priorities Areas (IRPA) funded project on oral cancer16 in
collaboration with Oral Surgeons/Pathologists of the Ministry of
Health, and the Cancer Research Initiative Foundation (CARIF)
involving highly advanced research technology including DNA micro-
array technology.
The local dental fraternity is nevertheless, privy to information from

cutting-edge research works on the world-wide-web. The impact of

these advances on dental care in Malaysia is the increasing onus on the
profession to keep abreast with innovations in products and services.
Competency requirements will indirectly impose a need for continuing
professional education, which is already underway for those in the
civil service. The increasingly knowledgeable clientele with equally
easy access to information are indirectly the impetus to ongoing self-
improvement, critical to ensuring a continued high standard of dental
care especially in the private sector.
The practice of dentistry should be evidence-based. The cornerstones Towards more

of evidence-based practice are clinical practice guidelines (CPG) and evidence-based
systematic reviews. The Oral Health Division has to date produced five practices
CPGs with three more in the pipeline. Additionally, 11 guidelines have
been produced on issues of infection control, occupational safety and
implementation of the various programmes for differing age groups
and categories of patients.
Advances in primary dental care
Dental caries is now increasingly managed as a preventable infectious Dental caries

disease caused by specific micro-organisms (MS) of which Strep. aetiology
mutans and Strep. sobriius are the main aetiological agents17.
Prevention of caries is by interfering with the transmission of MS,
eliminating established MS populations from the oral cavity, increasing
the acid resistance of the teeth and control of the consumption of
carbohydrate composition of the diet.
Although anti-mutans vaccines can be produced, the cost is prohibitive. Chemothera-

Use of antibiotics can cause resistance and opportunistic infections that peutics
are of far worse consequences than dental caries. Chemo prophylactic
agents for MS elimination include chlorhexidine and cetylpyridinium
chloride; plant derived compounds such as sanquinaria extract; metal
ions such as Zn and Cu , sodium dodecyl sulphate and triclosan. These
are normally delivered as mouth wash/rinses or toothpastes.
Efforts to increase the acid resistance of the teeth are achieved through Fluorides
application of fluorides (through toothpaste or mouthwash) or addition
of phosphates, both of which promotes remineralisation.
Elimination of MS from pits and fissures of primary and permanent Pit and fissure
molars are difficult. Treating teeth with pit and fissure sealants has sealants
been shown to prevent colonisation. The Oral Health Division started
a fissure sealant programme in 19994. This is a school-based clinical
preventive programme targeted at children at risk to occlusal caries.
In the years 2000-2003, a total of 431,758 teeth in 265,558 subjects were
fissure sealed, representing approximately 77% of subjects and teeth
considered at risk2.
Control of the carbohydrate composition of the diet can reduce the Sugar
level of MS. Xylitol, sorbitol, saccharin and aspartame are a few of the substitutes
common sugar substitutes used which are locally available. However,
current evidence still shows that fluoride is still the best anti-caries
chemical agent and owing to persistent efforts of the MOH, 62.4% of
the public water supply in Malaysia is fluoridated2.
Caries management was traditionally aimed at its removal and the Towards
restoration of the tooth. The current paradigm in the treatment of minimal cavity
caries is that of an ongoing dynamic process of demineralisation preparation
and remineralisation. Research has shown that the caries fronts
are relatively sterile and appropriate proprietary linings/cements
with antibacterial characteristics can render any remaining bacteria
quiescent. This has led to a shift in treatment philosophies, from one
of extension for prevention to minimal cavity preparation.
Restorations previously were dependent on physical design features Evolution

such as dovetails and undercuts for retention. Current nanotechnology of adhesive
has improved bonding systems of restorative materials to tooth, the dentistry
so-called adhesive dentistry. The use of amalgam as a restorative
is on the decline. Today, composites resins are frequently applied
to posterior teeth and are not limited to small restorations. Special
posterior composites for easier handling are available18.
Teeth are increasingly valued for their contribution to appearance and Aesthetic
social acceptability. Crown, bridges, veneers, and implants are now dentistry
available to restore loss of tooth or to improve aesthetics. Advances in
dental ceramic technology have made available restorative materials
with enhanced appearance that also meet functional and longevity
criteria. Bonded crowns have had exceptional clinical success but
have the disadvantage of poor harmonisation with adjacent natural
teeth. All-ceramic restorations are now available. In addition, use of
computer-aided design (CAD) and computer-aided manufacturing
(CAM) systems can provide dentists with ceramic and polymer options
for inlays, onlays, veneers and crowns.
With the current globalisation/liberalisation policy, there is eagerness CAD/CAM

to promote health tourism. For dental care, there is already an technology

entrepreneurial offer to set up a laboratory using CAD/CAM
technology to serve as a hub for the prosthetic needs of the ASEAN
region (Mode 3 delivery – Commercial Presence, for trade in services
under the General Agreement on Trade and Services or GATS).
Globally, tooth whitening, the process that makes teeth appear whiter Tooth whitening
with removal of extrinsic or intrinsic stains, is becoming popular as
a cosmetic procedure. Several bleaching systems for professional in-
clinic or dentist-supervised self/home application are now available.
These products are often available over-the-counter, but patients
are best advised to use products only after consultation/advice by
a dentist.
Advances in dental specialties
Use of digital cephalometry is available locally for better imaging, Advances in

patient education, diagnostics, treatment planning and documentation. Orthodontics
The orthodontists are involved in multi-disciplinary management of
cleft lip/cleft palate repair as well as treatment of obstructive sleep
apnoea (OSA), a potentially life-threatening breathing disorder due
to collapse of the airway during sleep. OSA is treated effectively
with mandibular advancement surgery and devices (functional type
appliance) in co-operation with maxillofacial surgeons, ENT surgeons
and chest physicians19.
Digital technology is now available for simulation of treatment results.

Lingual orthodontics with braces applied on the lingual rather than
the facial aspects, aesthetic brackets and coloured bands offer better
aesthetics during treatment20 for those willing to pay.
Use of inflammatory markers has not yet found its place in local Advances in
clinical practice for identification of the individual at risk. Many of the Periodontology
periodontists in the country have digital imaging technology, which
contribute to improved diagnostics and treatment planning.
Regenerative techniques have been available in the treatment of loss

of supporting structures surrounding teeth such as alveolar bone,
cementum and periodontal ligament. These techniques include
root conditioning, bone grafts, bone substitutes and guided tissue
regeneration. Autogenous bone is the most effective graft material
that promotes new bone formation. Decalcified and freeze-dried bone
allograft are commercially available but carries the risk of disease
transmission and as such are increasingly replaced with alloplasts
or synthetic substitutes such as synthetic hydroxy apatite, tricalcium
phosphate, and bioactive glass21.
The increasing interest and demand for aesthetics of the gums have
favoured the advances of periodontal plastic surgery to correct or
eliminate anatomic, developmental or traumatic deformities of the
gingival or alveolar mucosa. Recent advances include sub-epithelial
connective tissue grafting22.
Advances in paediatric dentistry have been charted especially in caries Advances in

management, pain control and behaviour management, restoration of Paediatric
teeth, and management of oro-dental trauma23. Fluoride remains the Dental Surgery
best method of caries prevention and it is now known that the topical
effects of fluoride on teeth are most effective. Water fluoridation is
still the most important method of delivery in this country. Several
alternative methods are topical use of fluoridated toothpastes and
applications of fluoride varnishes or gels. Novel techniques such as
fluoride slow-releasing glass devices are still not available locally at
this juncture.
Modern bonding materials now enable bonding of fractured Aesthetic tooth

permanent incisor crowns onto the tooth if the fractured portion is repair
available. Moderate fluorosis can be managed with micro-abrasion
technique or tooth whitening. Aesthetics of discoloured teeth with
intrinsic stains can be much improved with direct composite veneers
without any prior tooth preparation.
Greater emphasis is now placed on preservation of the pulp.

Formocresol used in pulpotomies is being replaced with ferric
sulphate. Resin-based bonding materials have also been advocated
as pulp capping material in place of calcium hydroxide (CaOH). The
literature reports apexogenesis (process of maturation of the root) as
opposed to apexification (apical closure) to enable traumatised anterior
young incisors to have continued growth development 23. Apical
closure through normal physiologic mechanisms with Mineral Trioxide
Aggregate (MTA) is increasingly preferred, although at high costs.
Local analgesia remains the main method of pain control in paediatric

dentistry but there is increased practice of in-office sedation in the
dental treatment of the apprehensive child or the special child by our
paediatric dental specialists.
In-situ-hybridisation and immuno-histochemistry has long been Advances in

applied in clinicopathological studies in the Stomatology Unit of Oral Pathology/
the IMR. Other tools emerging in diagnostic pathology include the Oral Medicine
polymerase chain reaction (PCR), complementary DNA (cDNA),
microarray, flowcytometry, laser microdissection and other state-of-
the-art technology are all available within the various units of the IMR,
local universities, as well as NGOs such as CARIF, for application in
oral diseases as well.
Traditional restorative philosophy was based on the concept of Advances in

maintaining a complete dentition of 28 functional teeth24. There Prosthetic
has, however, been a change in treatment philosophy based on the Dentistry
‘shortened dental arch (SDA)’ concept. Based on need for oral function
in its widest sense, many patients can function with ten (instead of 14)
occluding pairs of teeth. Every reasonable attempt should be made to
maintain a complete dentition but the SDA concept provides a rational
problem-oriented approach to ensure that the burden of attempting
to maintain a full dentition is not excessive.
There have been improvements in almost all materials used for

prostheses, their fabrication, as well as refinements in prosthodontic
techniques, the most profound being that of dental implants. These
provide a potentially permanent method of stabilising a fixed or
removable prosthesis. Implants are also gaining popularity in
orthodontics as anchorage supports. Sub-periosteal implants have
been developed which may be placed in the hard palate to provide
intra-oral anchorage, eliminating the need for patient compliance
with headgear.
Oral and Maxillofacial Surgery is the specialty of dentistry which Advances

deals with the diagnosis and surgical management of anomalies and in Oral and
pathological processes of the teeth and their supporting structures25. Maxillofacial
These specialists are involved in the surgical management of Surgery
pathologies, detractions, injuries of the oro-facial regions as well as
other procedures such as surgical removal of impacted third molar,
surgical endodontics, and orthognathic surgery. They are often also
the specialists to whom medically compromised patients are referred
for management.
Recent guidelines from the National Institute for Clinical Excellence Guidelines for
(NICE)26 recommended that routine prophylactic removal of pathology- antibiotic use
free impacted third molars should be discontinued. Indications for
third molar removal were pericoronitis, cyst formation, non-restorable
carious lesions, destruction of adjacent teeth or bone and tumours.

The role of prophylactic antibiotics in third molar surgery remains
controversial. Current literature shows little evidence for the use of
prophylactic antibiotics for the removal of impacted third molars
and that indiscriminate use of antibiotics can lead to development
of resistant strains, secondary infection, toxicity of antibiotics and
allergic reactions. Use is considered justified in the presence of an
active infection at the time of surgery where there is risk of sub-acute
bacterial endocarditis or when patient is immunocompromised.
Failed endodontics is most commonly due to inadequate removal of Changing

bacteria and their toxins within the root canal system. Re-root treatment techniques of
is thus considered the first line of treatment before considering root treatment
surgical intervention. Surgical endodontics is the recourse when the
skilled practitioner is certain that no better results can be achieved
by non-surgical treatment or if a biopsy is required. There have been
changes in the way surgical endodontics is carried out. The traditional
bevel cut at the root apex increase the cut dentinal tubules in a bucco-
lingual direction making the sealing of the canal system more difficult.
Perpendicular root resections, a more demanding technique especially
in inaccessible sites such as lower incisor and molar roots, are currently
recommended. The use of methylene blue greatly aids visibility in
inaccessible sites.
A number of substances have been used as root end filling material Newer
including traditionally amalgam, or zinc oxide eugenol. Amalgam root filling
has the disadvantage of staining mucosa, prone to scatter, mercury substances
contamination, corrosion, electrochemical reactions, need for undercut
preparation and moisture contamination. Recent materials to provide
a hermetic seal include immediate restorative materials (IRM), super
ethioxybenzoic acid and mineral trioxide aggregate (MTA). MTA has
shown better seals, and excellent tissue response with reduced peri-
radicular inflammation. DIAKAT is a new material similar to MTA
whose use is under investigation25.
For severe facial skeletal discrepancies, orthognathic surgery may be orthognathic

indicated26. The most common procedures are sagittal split mandibular surgery
osteotomy and Le Fort I maxillary osteotomy either individually or
combined. Other operations include intra-oral vertical subsignoid
osteotomy, high Le Fort II and III osteotomies. Orthognathic surgery
has not changed greatly but fixation is now nearly always achieved
internally using mini or microplates used with small self-tapping
monocortical screws.

The greatest innovation for treatment of facial deformity is distraction
osteogenesis. First used for leg lengthening this technique has been
adapted for treatment of maxillary and mandibular hypoplasia.
The jaw is fractured, the distractor applied and then after 3-4 days,
distraction of 1 mm per day is done until the desired length is achieved.
External distractors have given way to internal distractors. The close
consultation between the orthodontist and oral surgeon is critical for
the success of orthognathic operations27.
The rapidity of scientific and technological advances made in the

various medical and dental fields have made it increasingly difficult
to keep up to date in all associated fields, so that an interdisciplinary
approach has become essential to increase patient benefits especially
in the treatment of complex medical and dental conditions.
The number of dental specialists is increasing and it is timely that Upholding

a Dental Specialist Accreditation board be set up to determine standards
qualification and training programmes, and a great need for a
Dental Specialists’ Register to uphold the standard of dental care in
Malaysia.
Conclusion
There has been much progress in dental care in Malaysia in tandem

with global advances. However, much remains to be done to ensure
equitable access to care for the population. There is need for the dental
workforce to not only be aware of current developments and trends
but also to embrace these more quickly for a competitive edge.
While country developments have ensured that Malaysian dental

professionals are always at the forefront of knowledge, of more
importance is that these knowledge be translated into appropriate
and timely interventions for the client who should be the focus of all
concerns.

References:
1. Oral Health Division, Ministry of Health Malaysia. Through the dental mirror : history
of dentistry in Malaysia. 2nd Edition, 2003
2. Oral Health Division, Ministry of Health Malaysia. Facts and Figures. Oral Health
Division, December 2004
3. Information and Documentation System Unit, Ministry of Health. List of dental facilities
by states, Malaysia as on 31.12.2004, March 2005
4. Oral Health Division, Ministry of Health Malaysia. Oral healthcare in Malaysia, April
2005
5. Oral Health Division, Ministry of Health Malaysia. Key performance indicators, October
2005
6. Oral Health Division, Ministry of Health Malaysia. National oral health survey of
adults 2000 (NOHSA 2000), November 2004
7. Dental Division, Ministry of Health Malaysia. Dental epidemiological survey of adults

in Peninsula Malaysia, September 1974-April 1975. Kuala Lumpur, 1977
8. Dental Services Division, Ministry of Health Malaysia. Dental epidemiological survey

of adults in Malaysia 1990. Kuala Lumpur, 1993
9. Oral Health Division, Ministry of Health Malaysia. Penang Dental Training School.
Facts and Figures. 2nd Edition, 2005
10. Sutherland SE. The building block of evidence-based dentistry. J Can Dent Assoc 2000;
66:241-4
11. Razmus TF. Guest Editorial. J Dent Res September 1991;1309-10
12. Asia Pacific Dental Federation. Congress Programme. 27th Asia Pacific Dental Congress,
25-29 May 2005. Putra World Trade Centre, Kuala Lumpur p. 49-81
13. Institute for Medical Research. Stomatology Unit. Http://www.imr.gov.my/org/

stoma.htm (7 November 2005)
14. Hart TC, Ferrell RE. Genetic testing considerations for oral medicine. J Dent Educ 2002;
66(10):1185-1202.

15. Yadav M, Arivananthan M, Chandrashekran A, Tan BS, Hashim BY. Human
herpesvirus-6 (HHV-6) DNA and virus-encoded antigen in oral Lesions. J Oral Pathol
Med 1997;26(9):393-401
16. Dental Faculty, University of Malaya. Oral cancer and pre-cancer in malaysia – risk
factors, prognostic markers, gene expression and impact on quality of life (Project No.
06-02-03-0174 PR 0054/05-05)
17. Balakrishnan M, Simmonnds RS, Tagg JR. Dental caries is a preventable infectious
disease. Aust Dent J 2000; 54(4):235-45
18. Roeters JJM, Shortall ACC, Opdam. Can a single composite resin serve all purposes.
Brit Dent J 2005; 199(2):73-9
19. Cunningham SJ, Jones SP, Hodges SJ, Horrocks EN, Hunt NP, Moseley HC, Noar JH.
Advances in orthodontics. Primary Dental Care 2002; 9(1):5-8
20. Russell JS. Current products and practice aesthetics orthodontic brackets. J Orthod
2005; 32:146-63
21. King GN. New regenerative technologies: rationale and potential for periodontal
regeneration. In : New advances in established regenerative strategies. Dent Update
2001; 28:7-12
22. Fozum TF, Dini FM. Treatment of adjacent gingival recessions with sub epithelial
connective tissue grafts and the modified tunnel technique. Quintessence Int 2003;34:7-
13
23. Ashley PF, Roberts GJ. Advances in paediatric dentistry. Primary Dental Care 2002;
9(1):71-73
24. Hobkirk JA. Advances in prosthetic dentistry. Primary Dental Care 2002; 9(3):81-85)
25. Patel D, Manhem CG, Sindet-Petersen S. Advances in surgical dentistry. Primary

Dental Care 2001; 8(4):145-8
26. National Institute for Clinical Excellence. Guidance on the removal of wisdom teeth.
technology appraisals guidance No. 1. NICE, London, 2000
27. Sandy JR, Irvinne GH, Leach A. Update on orthognathic surgery. Dent Update 2001;
28:337-45

CHALLENGES FOR GENERIC DRUGS
SUMMARY
The increasing use of generic therapeutics has led generics to capture 14% of the global
healthcare market in 2004, with overall revenues of USD 58 billion. The imminent
patent expirations of many major drugs in major markets will provide a major growth
stimulus for the generic companies as they compete to capture market share from
multi-billion dollar drugs whose patents expire in this period. Cost containment
pressures on healthcare and issues on access and affordability of essential medicines,
will lead to increased adoption of generic substitution and prescribing practices by
governments of many countries. To maximize the generic industry’s capacity to
meet the challenges of rising demand, Malaysia needs to improve the current market
conditions for generic medicines and generate a stronger public awareness of their
benefits.
Introduction
H
ealth is a basic need and governments have a duty to their Medicine,
citizens to protect and promote public health. Medicines a major
constitute a major and important component in the provision component in
of healthcare service for the population, to reduce morbidity healthcare
and mortality associated with the illness. According to the World
Health Organization (WHO) in its Regional Strategy For Improving
Access to Essential Medicines in the Western Pacific Region for 2005-2010,
expenditure on medicines usually accounts for 25 to 50% of total public
and private health expenditures in developing countries.
Health is a basic need and governments have a duty to their citizens

to protect and promote public health. Medicines constitute a major
and important component in the provision of healthcare service for
the population, to reduce morbidity and mortality associated with
the illness.
According to the World Health Organization (WHO) in its Regional
Strategy For Improving Access to Essential Medicines in the Western
Pacific Region for 2005-2010, expenditure on medicines usually
accounts for 25 to 50% of total public and private health expenditures
in developing countries.

Ageing populations, increasing incidence of chronic diseases, dramatic
rise in prices for originator pharmaceuticals and the rapidly rising
treatment costs, are causing governments throughout the world to
review the sustainability of their health care provisions.
For the developing world, the challenge is in providing its populations

with an acceptable level of healthcare and ensuring patient access
to quality, safe and effective medicines while reducing the cost of
pharmaceutical care. In the developed countries the focus is on
containment of cost of medicines rather than on access to medicines.
Generic medicines provide the opportunity for major savings in the Generic, a
healthcare expenditure since they may be substantially lower in price cost saving
than the innovator brand. Hence the relative affordability of generic alternative
pharmaceuticals in comparison to their branded counterparts, further
enhanced by the increasing costs of healthcare, is seen as a cost effective
means of controlling the fastest growing budget item in healthcare:
pharmaceuticals.
Today, the use of generic drugs has been increasing steadily,

internationally.
This report will describe the role and significance of the generic drugs
in relation to healthcare and the issues and concerns pertaining to its
place in the industry.
The generics invasion
The World Health Organization (WHO) defined generics as

pharmaceutical products that contain the same active ingredient in
the same amounts as the original products on which they are based.
Marketed after the expiry of patent or other exclusivity rights, generics
are legally available from multiple sources and are intended to be
interchangeable with the original product.
Generics are approved for marketing by national authorities after they

are found to have the same quality, safety and efficacy as the original
product and are either under a non-propriety name (INN or other
approved name) or under brand names (‘branded generics’).
Depending on national legislation, the above elements may be Generic name

different in some countries. The term ‘multisource’ products has been versus Brand
introduced to encompass both branded and unbranded generics. name

A generic name is that of the active drug substance while a brand
name is the registered trademark under which the drug is sold.
Generics and brand names may contain different non active ingredients
(such as colouring, bulking agents) and hence may differ in terms of
characteristics like colour, flavour size and shape.
Malaysian healthcare sector overview
The Malaysian healthcare system which has traditionally been Malaysian

essentially government driven has grown rapidly since the 1980s Healthcare
particularly in the private sector. system
The healthcare sector encompasses a broad spectrum of goods and

services. Services include hospital based care and primary care while
goods include western medicines, traditional medicines, health/
dietary supplements and medical devices. The provision of adequate
and affordable healthcare is essential for the wellbeing of any citizen.
About 80 percent of the healthcare services is provided by the public
sector.
The Malaysian government considers the country’s healthcare industry

as one of the its top priorities and continuously strive to implement
new schemes to help boost the country’s healthcare sector.
The Malaysian healthcare sector has grown rapidly since the 1980s Healthcare
and the industry is growing at a rate of 6-8 % annually. It is currently expenditure
valued at around USD 1 billion. In 1990, healthcare expenditures were
close to RM1.8 billion (USD 426 million) and in 1997 almost doubled
to RM 3.4 billion (USD 805 million).
The Malaysian healthcare industry is heavily subsidized and spends

an enormous amount of money on medicinal drugs annually. In 2004,
the Malaysian government spent about RM 800 million subsidizing
97% of the drug costs in government hospitals and clinics as compared
to RM 288 million in 1996. The amount subsidized is increasing every
year by 10 to 15 %.
The costs of healthcare in Malaysia is on the rise. There is an increasing

concern over whether the government can continue to sustain this
level of subsidy in the years to come.

Malaysian pharmaceutical industry overview
The Malaysian pharmaceutical industry can be broadly categorized Product

as prescription, over-the-counter (OTC), traditional and health/food category
supplements. The prescription medicines comprise of patented and
generic drugs, the sale and transaction of which are confined to doctors
and pharmacists. The OTC, traditional medicines and health/food
supplements may be sold by non professional outlets and to the
public.
The domestic industry which comprises of local, foreign and joint Domestic
venture companies with factories in Malaysia, has evolved into a capability
modern, sophisticated sector of the Malaysian economy and capable
of producing a wide range of pharmaceuticals which include mostly
generic drugs such as antibiotics and painkillers. It has the capability
to produce almost all dosage forms including sterile preparations (eye
preparations, injections) soft gelatin capsules and powders.
The 36 members of the Malaysian Organization of Pharmaceutical

Industries (MOPI), collectively produces about 35% of Malaysian
medicine requirements. In terms of product range, MOPI members
have the capabilities to manufacture more than 80% of product
categories in the National Essential Drug List (NEDL).
The Malaysian pharmaceutical market in year 2004 was estimated Malaysian

at USD 665 million (RM 2527 million) exhibiting growth of around Pharmaceutical
10%. However, strong growth is anticipated in the market which Market Value
propels a Compound Annual Growth Rate from year 2001 to 2007 at
an estimated 12.5%.
Currently, approximately 70% of the local market is monopolized by

the multinational companies, while Malaysian companies comprise
about 20-30% of the market. With healthcare high on the list of
government priorities, the prospect of the pharmaceutical industry
appears favorable.
Global Generic Market
In year 2003, the global generic drug market was estimated to be

between USD 19 and USD 22 billion, with compound growth of 11-
12% annually. Currently, it is estimated at approximately 11% or USD
53.9 billion of the global pharmaceutical sales.

The European Union’s (EU-25) generic market today is worth around EU market
seven billion euros, compared to around 70 billion euros for the total
European pharmaceutical market value.
The size of the generic market differs widely in the various EU member
states, mainly as a consequence of the different policies followed.
Generics make up a relatively large part of the pharmaceutical
market in Germany (41%), Sweden (39%) and the United Kingdom,
UK (22%).
Licensed manufacturers/premises
In year 2005, a total of 1928 licenses were issued by the Drug Control Growth status
Authority (DCA). Of these, 292 were for licensed manufacturers, 658
licensed importers and 978 licensed wholesalers (Figure 1).
Figure 1 : Number of Licenses (Year 2001-2005)
774
2001 330
247
890
2002 326
214 Wholesale
875
Year
2003 316 Import

217
864 Manufacturing
2004 456
227
978
2005 658
292
0 200 400 600 800 1000 1200
No. of Premises
Geographical distribution of licensed premises for the year 2005 is Geographical

illustrated in Figure 2. Selangor remained as the state with the highest distribution
number of licensed premises, followed by Wilayah Persekutuan (Kuala of licensed
Lumpur) and Johor. premises

Figure 2 : Geographical Distribution of Licensed Premises (Year 2005)
Categories of licensed manufacturers for the year 2005 are as Categories

illustrated in Figure 3. A total of 87 manufacturers were licensed to of licensed
produce pharmaceuticals, 48 traditional medicines and 61 produce manufacturers
cosmetics.
Figure 3 : Categories of Licensed Manufacturers (Year 2005)

Products registered
As of 2005, a total of 117,466 products were registered by the DCA.

A total of 37,947 products were registered in year 2005 of which 327
(0.86%) were prescription products; 300 (0.79%) OTC products; 1,308
(3.45%) traditional medicines and 36,012 (94.9%) cosmetics. Breakdown
of products registered between 2001 and 2005 is shown in Table 1.
Table 1 : Total Number of Products Registered ( Year 2001-2005)
Year Prescription OTC Products Traditional Cosmetics Total

Drugs Medicines
2001 180 624 1,344 309 2,457

2002 342 235 864 159 1,600
2003 324 275 1,349 4,721 6,669
2004 353 226 970 40,762 42,311
2005 327 300 1,308 36,012 37,947
From the year 2001 to 2005, the total number of applications received New Drugs
for New Drugs (previously known as New Chemical Entity) was 408
(Figure 4). Of these, 330 (80.9%) were approved, 26 (6.4%), rejected
and 18 (4.4%) deferred for additional information. In year 2005, 43
products (58%) were registered and 1 (1.4%) deferred.
Figure 4 : Registration Status of New Drugs (Year 2001 - 2005)
120
100
80
60
40
20
0
Received
Approved
Rejected
Deferred

A total of 24 applications were received and 11 products were Biotechnology
registered. Examples of biological products are vaccines, serum for products
therapeutic use, antitoxin, blood components and its derivatives as
well as other products derived by biotechnology method such as
interferon and erythropoietin.
The number of locally manufactured products constitutes 26.2% Local and

(9,933) and the imported products 73.8% (28,014) of the total number imported
of products registered in the year 2005. The ratio between locally products
manufactured and imported products for prescription drugs is in the
order of 29:71; 50:50 for OTC products; 71:29 for traditional medicines;
and 24:76 for cosmetics as shown in (Table 2).
Table 2 : Number of Local and Imported Products Registered ( Year 2005 )
No DCA meeting in November 2005*

Based on the total number of locally manufactured products registered
(n = 9,933), 0.96% were prescription drugs, 1.5% OTC products, 9.3%
traditional medicines and 88.2% cosmetics. For imported products
(n = 28,014), 0.8% were prescription drugs, 1.5% OTC products, 1.4%
traditional medicines and 97.3% cosmetics.
The leading foreign sources of imported products include France, Sources of

United States of America, Italy, Japan, Germany, Thailand, China, imported
U.K, Australia, and Canada. Together they account for approximately products
22.2% (55,137) of our total imports (n = 71,457). Products imported
from ASEAN countries such as Indonesia, Thailand, Singapore and
Philippines constitute nearly 10.7% (7,621) (Figure 5).
Figure 5: Major Sources of Imported Products (Year 2005)

Generics: Relation to healthcare
WHO has long advocated the use of generics of known quality as a Global
cost effective means to ensure access to and availability of essential perspectives
medicines. WHO advocacy
In some EU member states (UK, Germany), generics are promoted European

and are seen as a tool to contain rising pharmaceutical costs. Generic countries
medicines play an increasingly equitable access to medicinal care in
the EU. The generic medicine is fast becoming the major supplier of
pharmaceuticals in the EU, providing more than 60% of medicines to
countries of Central and Eastern Europe, and up to 50% in Western
European countries such as the UK, Denmark and Germany. The
growing role of equivalent generic products is due in large part to their
reduced price. This works effectively to make medicinal treatment
affordable to a large number of patients throughout Europe.
Recognizing the budgetary importance of generic drugs coupled with

the increasing demands of healthcare provision and costs, the Ministry
of Health Malaysia, (MOH), as part of a cost containment measure,
has been promoting the use of quality, safe and efficacious generics
to substitute the equivalent originator drugs.
Potential benefits of generic drugs
Generics are products containing well established drugs whose safety Equivalent
and efficacy are well known and provided they are well made, generics versions of
are to all intents and purposes identical to the original products and originals
can thus be used interchangeably.
As with all pharmaceuticals, generic drugs must meet the established Assurance of
standards of quality, safety and efficacy as stipulated by the Drug quality, safety
Control Authority (DCA), Ministry of Health Malaysia, before they and efficacy
are registered and given market approval in the country.
The promulgation of the Control of Drugs and Cosmetics Regulations Regulatory

in June 1984 laid the groundwork necessary towards moulding a control
systematic pharmaceutical regulatory system in Malaysia
As the national drug regulatory agency, the National Pharmaceutical

Control Bureau (NPCB) and its executive arm, the DCA (established
in January 1985), employ global best drug regulatory practices. The
objective of drug regulation is to ensure that therapeutic substances

approved for the local market are safe, efficacious and of quality
and also to ensure that cosmetic products approved are safe and of
quality.
Drug regulation which was initiated in Malaysia in 1985 was

implemented in phases. Activities associated with drug regulation
include processing of applications prior to registration with emphasis
on evaluation of documents submitted, quality control assessment of
products, inspection , licensing and auditing of manufacturers, packers
and wholesalers of medicines to ensure their premises and practices
meet an acceptable international standard. Adverse drug reactions
monitoring and market surveillance are conducted both locally and
internationally, through collaboration and networking with other
national regulatory agencies and the WHO.
Generics are considerably less expensive than the innovator medicine Price
because their manufacturers do not incur the risks and costs associated competition
with the research and development of the latter which is costly, time
consuming and one that is not without risks or failures. The availability
of relatively lower priced generic drugs can bring down the price of
innovator drugs through market competition, producing savings
to both the consumer and the government. Some reports estimated
generic drugs reduce prescription costs by well over 50% without loss
of quality or safety.
With commercially available generic drugs, consumers will have the Consumer choice
opportunity to choose cheaper brands with savings to themselves as
individuals and taxpayers. Generics stimulate innovation through
competition and increased consumer choice, creating new sources
of enterprise and generating new employment and investment
opportunities
Documentation requirements
In the manufacture of generic drugs, the three concepts of quality, Bioequivalence

safety and efficacy apply in the same way as they do to the innovator (BE)
product. Since generic drugs contain established active ingredients, requirements
clinical studies are unnecessary although bioequivalence (BE) data will
be required. A BE study demonstrates therapeutic equivalence between
the test product and the originator product used as a reference
With the increasing availability of generic products in the domestic

market, the Ministry of Health Malaysia through the DCA, introduced

BE requirement as a mechanism to further ensure that generic products
available are therapeutically equivalent to the innovator product.
The move for BE requirement on oral immediate release products
was initiated in December 1999 for 3 selected active substances. As of
March 2004, the number of active substance listed for bioequivalence
study is 43.
For generic medicines, as with all pharmaceutical products, Quality control

scientifically controlled quality is of paramount importance. Quality
assurance of medicines is a feature of all procedures and processes
employed throughout the production chain. Quality has to be built in
at each critical stage of the production process, the end result of which
is the production of a medicinal product fit for its purpose and use. In
essence, the quality must be assured at the time of manufacture and
throughout the shelf life of the product.
Stability study is one of the most important parameters to be considered Stability study
because drugs with poor stability may not produce the desired
therapeutic effects. There is also a possible toxicity of the degradation
products which can be detrimental to peoples health. The objective
of a stability study is to determine the period of time during which
a pharmaceutical product is able to maintain its chemical, physical,
microbiological and biopharmaceutical properties when stored under
defined conditions.
As a member of the Pharmaceutical Inspection Convention and PIC/S

Pharmaceutical Inspection Co-operation Scheme (jointly referred to membership
as PIC/S) since January 2002, Malaysia’s standards for inspection
and licensing are at par with other members who are in this scheme,
including Europe, Australia and Canada.
The PIC/S, conceived by the European Free Trade Association

which upholds good manufacturing practices, are two international
instruments between countries and pharmaceutical inspection
authorities which provide together an active and constructive
cooperation in the field of Good Manufacturing Practice.The move is
expected to raise the standards of the local pharmaceutical industry.
The recognition has enabled Malaysian pharmaceutical companies to
export their products more easily to PIC/S members, mainly in the
European Union.

Generics: Potential/estimated savings
Innovator and generic drugs play separate, equally important roles

in healthcare. While innovator drugs are responsible for bringing
newer and better treatment to patients, generic drugs offer affordable
medicines and reduce the cost of healthcare to patients and the
government.
Generic drugs in the US account for about 40% of all prescribed Generics in US
medicines. A study based on data from a year 2000 National Medical
Expenditure Survey in the US concluded that switching to generic
drugs could save US adults up to USD 8.8 billion a year.
European governments are increasingly relying on generics to save Generics in EU

on healthcare costs. The prescribing of generic medicines in Britain is
increasing and is higher than in many other EU countries. About 76%
of all prescriptions are written generically.There is a potential increased
annual savings at nearly USD 9 billion, an 11% cost reduction, if generic
equivalents replaced brand name pharmaceuticals.
Industry perspectives
In recent years the issues driving the international generic industry Market drivers
include patent expirations of many major drugs, an estimated 42, in
the period between 2005 to 2009 in major markets. Also, the market
drivers include governmental curbs on healthcare spending in
developing countries and cost containment efforts in the US and other
international markets.
All these will provide a major growth stimulus for the generic
companies as they compete to capture market share from multi-billion
dollar drugs whose patents expire in this period. Furthermore, the
development of advanced manufacturing in developing markets has
created fresh opportunities for both the research based and generic
manufacturers.
Getting the right environment for generics
Recognizing the potential contribution of generics to healthcare,

there is thus an urgency to create the proper competitive and legal
environment for the industry to continue meeting the challenges of
providing high volumes of cost effective equivalents to the Malaysian
healthcare system.

According to the WHO, generics should have a prominent place in WHO
national medicines policy. The five principal areas for action that perspective
can contribute to ensuring this are supportive legislation, effective
regulation, systematic processes of generic selection, price and
financing incentives and professional and public acceptance.
Without laws and regulations to protect the local industry, the Supportive
companies have to compete with the more established multinational legislations
brands in its own country. National Policy on access to medicines, Laws and
patent law and patent law amendment are safeguard measures for regulations
generic production.
Currently, Malaysia is in the process of formalizing its National Drug National Drug
Policy which will provide clear direction and guidance for the nation Policy
to embark on future medicines related programmes to support the
healthcare needs of the country.
As a WHO collaborating Centre for Regulatory Control of WHO

Pharmaceuticals since 1996, the NPCB has and will continue to play Collaborating
important roles to fulfill the commitments and expectations as stated Centre
in its terms of reference.
The quality management system of NPCB based on MS ISO 9001 ISO

version 2000 is current and certified by the Standards and Industrial Certification
Research Institute of Malaysia (SIRIM). The scope of certification is
on Regulatory control of pharmaceuticals, traditional products and
cosmetics through registration, licensing and surveillance activities.
The ISO certification achieved by NPCB is testimony of its having

a good quality management system in place and reflects the total
commitment of the staff towards implementing its philosophy and
requirements. This has benefited the pharmaceutical industry in many
ways including transparency of the system, reduced bureaucracy and
creating a more clientele responsive approach.
Strong government promotions to consumers to encourage ‘Buy Encourage

Malaysian’ which was mooted by the 1997 Asian economic crises generic selection:
and fuelled by the adverse impact of the currency depreciation Buy local Policy
brought positive changes towards sustaining the viability of the local
pharmaceutical industry.
The National Essential Drug List (NEDL) launched in 1999, was a step National
towards the formulation of a National Drugs Policy. Based on the WHO Essential Drug

model List of Essential Drugs, the NEDL is intended to be used as a List (NEDL)
standard guideline for prescribing and is primarily aimed as a cost
containment measure for both the public and private healthcare sectors.
The adoption of the NEDL serves as an effort towards promotion of
rational drug use and improving accessibility to drugs.
The trend in most countries is to increase generic prescribing and Generic

dispensing whenever possible as a suggested means of lowering the prescribing
costs of healthcare. Recently, the government requested to review the
system of prescribing and dispensing medicines as the government
could not go on subsidizing the increasing costs. It was suggested
that government hospitals dispense more generic drugs as they were
cheaper, safe and of the same quality as patented drugs.
Health professionals and consumers have to be assured that the DCA Professional
approved generic drugs have met the same stringent standards as the and public
innovator drug. Health professionals, while ultimately responsible acceptance
for implementing best therapeutic options, have a vital role to play in
promoting quality use of medicine through good treatment choices
and good communication with consumers.
Medicine pricing issues have always been of great concern for Price controls
developed and developing countries due to high cost incurred in
pharmaceutical care. The high cost of medicine is recognized as one
of the major barriers to access to essential treatments for many in
developing countries. Research shows that huge differences exist for
the same medicine within a country and between countries.
Malaysia does not have laws to control drug prices. Instead, market
forces were allowed to stabilize prices and foster competition. Since
medicines are essential items there is a need for the government to
monitor prices.
A medicine price survey conducted in West Malaysia from October 2004 Medicine price
to January 2005, concluded that in general, prices of medicines were survey
high in the private sector. In private pharmacies, price of innovator
brands were 16 times higher than reference prices and generics were
6.6 times higher. In dispensing doctor’s clinics, the figures were 15
times higher for innovator brands and 7.5 for generics. Mark-ups were
high, especially those applied by dispensing doctors (innovator brands
50-70%, generics were up to 316%) . Retail pharmacy mark-ups were
also high (innovator brands 25-38%, generics 100-140%).

The Pharmaceutical Services Division, Ministry of Health Malaysia, has Medicine price
established a Medicines Price Monitoring Unit to collect information monitoring
on price of medicines in Malaysia as part of a requirement in the system
proposed National Medicines Policy. The policy shall be developed to
ensure fair, reasonable, affordable and stable prices of drugs, especially
essential drugs.
Issues and concerns with generics
The potential of the domestic pharmaceutical industry has been Pharmaceutical

recognized by the Malaysian government who has identified it as a industry, a
strategic industry which should be promoted. A strong and viable strategy sector
generic drug industry will not only reduce Malaysia’s dependence for national
on imports and reduce health care costs, but also ensure availability growth
of affordable medicines that are safe, efficacious and of quality to the
public and enhance export earnings.
Preferential government treatment for domestically manufactured

products will further foster local companies to enter this profitable
market, and expedite the growth of the Malaysian pharmaceutical
industry.
Though the generics market is largely risk free, the pharmaceutical

producers are urged to organize themselves better nationally, as well
as regionally and be able to meet not only intellectual property related
challenges but market challenges too.
The increasing globalization of commerce and trade and the merging Globalization
of pharmaceutical companies are internationalizing the pharmaceutical and
production. International norms and standards become more liberalization
important than before.
Globalization process has had an impact on healthcare with threats ASEAN Free
and opportunities in the generic pharmaceutical market. The Trade Area
implementation of the ASEAN Free Trade Area (AFTA) which is a
collective effort by ASEAN member countries to reduce/eliminate
tariffs on intra-ASEAN trade in the goods sector will provide enormous
potential for market expansion of Malaysian companies.
The flow of pharmaceutical products from neighbouring countries

is expected to increase, tightening competition and pushing local
manufacturers to create competitive advantages. Malaysia’s businesses
must strategize to tap the ASEAN market by establishing linkages

and strategic alliances, not only in other ASEAN countries but also
globally.
One of the major concerns raised by generic medicine manufacturers Data exclusivity
worldwide is over provisions that grant companies generating test data
(which is submitted to the government authorities) exclusive rights
over that data, commonly known as ‘data exclusivity’ provisions.
Data exclusivity (DE) would prevent the Drug Control Authority

(DCA) from relying on the originator’s clinical test data in order to
register the generic version until the data exclusivity period (between
5 to 11 years) has expired.
The Ministry of Health, Malaysia understands the concerns of

multinational companies regarding the need to set provisions for DE
in an effort to safeguard intellectual property rights. The final decision
by the Ministry of Health Malaysia for DE in pharmaceuticals will take
into account the views from all parties, whereby it must not jeopardize
the interests of both the domestic and multinational pharmaceutical
industry.
Malaysia is dependent on imports of raw materials(bulk actives, Import of raw

excipients, packaging materials).High cost of raw materials can lead to materials
intense domestic and price driven competition in the market place.
Despite the pharmaceutical industry’s insistence that drug prices in
Malaysia are relatively low, there is no denying that drug costs escalate
from time to time. Drug prices are especially affected in the events of
economic crises or currency crises.
Currently, there are 5 BE centres in the country with 4 based in the Recognition of
local universities (in Selangor, Kelantan, Penang and Kuala Lumpur) local BE studies:
and one owned by a private hospital in Penang. ASEAN member Strategies to
countries have adopted the harmonized ASEAN BE guideline for the strengthen and
conduct of BE studies. Malaysia needs to strengthen, upgrade and accreditate BE
increase existing capacity of its BE centres in terms of infrastructure, centres
laboratory, clinical facilities and together with a qualified and trained
workforce.
The accreditation of the BE centres will further enhance it’s credibility

and competence, which will result in the recognition and acceptance of
its BE studies internationally. In the advent of globalization and trade
liberalization, it is imperative that our local manufactured products
can be accepted with confidence globally.

To facilitate, encourage and expedite the full implementation of Incentives for
BE requirement on generic drugs will require the governments’ BE centres
participation and commitment. Proposals on incentives for the
BE centres include financial allocation for capacity building
through a National Capacity Building Fund, tax exemptions and
reimbursements.
Patent expirations of biopharmaceuticals are beckoning generic drug Biopharma-

companies but numerous hurdles remain to be a profitable business. ceuticals
Biotechnology products are expensive and the availability of generics
would spur competition and hopefully reduce prices.
The issue of the manufacture, approval and marketing has become

a major source of debate within the industry due to reasons of cost
containment and patent expiry. Generic biological products are harder
to characterize than small molecules drugs and thus harder to prove
equivalent entities.
Safety and other contentious scientific issues surrounding the

prescription biosimilars pharmaceutical market are staggering and
in some cases seemingly insurmountable compared with traditional
generic drug market.
Malaysia needs to address regulatory hurdles (technical issues like

bioequivalence), the political environment which affects development
(Malaysia’s Biotechnology Policy), and the commercial and competitive
costs of biosimilars.
The search for cheaper pharmaceutical products leads consumers Internet

directly to the doorsteps of internet peddlers and suppliers in other peddlers
countries advertising cheap and quality products.
These products may not have undergone the evaluation and testing
process that a registered product would have been subjected to.
Consumers are exposed to unnecessary risks because an unregistered
product is an unknown entity whose quality, safety and efficacy are
highly questionable
The existing legislation in Malaysia serves not only to control dietary

supplements, cosmetics, traditional medicines and pharmaceuticals
but also to protect the health of the public in general.

It is important for the industry to maintain and increase their capacity Research and
and develop long term strategies for sustainable future growth which Development
will help boost profitability, drive market share and enhance Research
and Development (R&D) productivity. In this context the local
pharmaceutical industries need to put more emphasis on R&D.
The government has taken steps to maintain an attractive environment

to support pharmaceutical R&D. The 8th Malaysia Plan (years 2001-
2005) has identified pharmaceuticals and nutraceutical biotechnology
to be explored and exploited by local manufacturers tapping on the
rich flora and fauna available in the country.
Enhancing access and availability
The NPCB has ongoing initiatives to improve timely registration Information

of safe, efficacious and quality pharmaceutical products. Initiatives technology
include upgrading Information Technology facilities, which is in line
with global trends, reviewing evaluation processes, procedures and
strengthening the workforce.
The current QUEST 2 Online system is a paperless web based Online

application accessible via internet connectivity. It was launched in registration
February 2002 for cosmetics and July 2003 for generic and OTC drug
applications. The format for generic drug application is based on the
ASEAN Common Technical Document/Requirement and aimed at
increasing efficiency, accessibility and convenience of applicants.
Efforts towards ASEAN Harmonization were initiated through the ASEAN

ASEAN Consultative Committee for Standards and Quality (ACCSQ) Harmonization
which was formed by the ASEAN Economic Ministers to facilitate and
complement the objectives of the ASEAN Free Trade Area (AFTA).
Hence the ACCSQ Pharmaceutical Product Working Group was

formed with the objective of developing harmonization schemes of
pharmaceutical regulations of the ASEAN member countries in order
to complement and facilitate the objective of AFTA, particularly, the
elimination of technical barriers to trade posed by regulations, without
compromising the quality, efficacy and safety of drugs.
The NPCB has ongoing activities with the pharmaceutical industry

to encourage and facilitate the harmonization process which will be
fully implemented in January 2009.

Conclusion
In recent years, the number of highly lucrative medicines coming

off patent has seen the role of the generic industry change, taking an
even more important role in the pharmaceutical sector. Generic drugs
provide the opportunity for major savings in healthcare expenditure
since they may be substantially lower in price than the innovator
brand.
The availability of relatively lower priced generic drugs can bring

down the price of the originator drugs through market competition,
producing savings to both the consumer and the government.
With healthcare high on the list of government priorities, coupled with

cost cutting initiatives of national healthcare systems, the prospect
of the pharmaceutical industry appears favorable. Creating the
proper legal and competitive environment through faster registration
procedures, less restrictive regulatory processes, increased promotion
of generics by doctors and pharmacists and better awareness of
generics by the consumers, are nevertheless essential for the industry
to continue meeting the challenges of providing high volumes of cost
effective generic equivalents to the Malaysian healthcare system.
References:
1. World Health Organization. Marketing authorization of pharmaceutical products with

special reference to multisource (generic ) products: regulatory support series. No 5:
Geneva 1999
2. World Health Organization (WHO): www.who.int/medicines/areas/policy/en/index.

htm1
3. Videau Jean-Yves, General policy issues: WHO drug information. Vol 14(2), 2000.
4. Healthcare in Malaysia, PHARMABIZ.com: Nov.2005 www.pharmabiz.com/article/
detnews.asp?articleid=20418&sectionid=50 .
5. S.Haas Jennifer et al, Potential savings from substituting generic drugs for Brand-name
Drugs:Medical Expenditure panel Survey, 1997-2000: Annals of Internal medicine. www.
annals.org/cgi/content/abstract/142/11/891:

6. Current and future generic prescription drugs: Global market analysis, Sept. 2003:www.
marketreaearch.com/researchindex/930812.html.
7. Malaysia Pharmaceutical Country Intelligence Report : Espicom Business Intelligence

Ltd, July 2004: www.researchandmarkets.com/reportinfo.asp?report_id45270&t=e&cat_
id=16:
8. Malaysia Pharmaceutical Country Intelligence Report : Espicom Business Intelligence

Ltd, July 30, 2004 : www.marketresearch.com/researchindex/1029928.html.
9. Centre for Drug Evaluation and Research(CDER): www.fda.gov/cder/ogd/ (12

November 2005)
10. Pharmaceutical Association of Malaysia (PhAMA): www.pharma.org.my/home.cfm

(12 November 2005)
11. Malaysian Organization of Pharmaceutical Industries (MOPI) www.mopi.org.my/main.

htm (28 November 2005)
12. Gross Ames et al , Drug, device and Cosmetic Regulations in Malaysia:2005 Update:
www.pacificbridgemedical.com/publications_Malaysia2.html (25 November 2005)
13. Current and future generic prescription drugs: Global Market Analysis:www.pjbompubs.
com/cms. (11 November 2005)
14. Frost and Sillivan., Growth for generic pharmaceuticals in Asia, 21 November 2002:
www.laboratorytalk.com/news/fro/fro144.htm1 (12 November 2005)
15. European Generic Medicines Association (EGA): www.egagenerics.com/gen-quality.

htm1 (9 November 2005)
16. EU News, Policy Positions & EU Actors online (EurActiv): www.euractiv.com/

Article?tcm:29-117497-16&type=LinksDossier (26 November 2005)
17. Health and Age.com: www.healthandage.com/htm1/res/healthpolicy/content/page6.

htm (26 November 2005)
18. The Association of British Pharmaceutical Industry (abpi): www.abpi.org.uk/

publications/publication_details/pharIdustryIssues/pii4.asp (26 November 2005)
19. Malaysian Industrial Development Authority (MIDA): www.mida.gov.my/beta/news/

view_news.php?id=450 (11 November 2005)

20. Hassali Azmi et al, Quality use of generic medicine: Australian Prescriber : www.
australianprescriber.com/index.php?content==/magazines/vol27no4/80_81_editori
.. (26 November 2005)
21. Babar Zaheer-Ud-Din et al, Medicine Prices: Health Action International : www.haiweb.
org/medicineprices/ (12 November 2005)
22. Pharmaceutical Services Division, Ministry Of Health Malaysia. National Medicines

Policy ( Draft 8), November 2005.
23. Pacific Bridge Medical: Business Development and regulatory Assistance for medical
companies: www.pacificbridgemedical.com/publications_malaysia2.html

DENGUE CONTROL IN MALAYSIA
SUMMARY
Dengue is a major public health problem in Malaysia and the incidence of dengue
in the country has been on an increasing trend. The incidence has been the highest
over the last two years with DEN 1 as the main circulating serotype. Selangor and the
Federal Territory of Kuala Lumpur are two States with the highest number of dengue
cases in the country, contributing to between 45- 48% of the total number of cases in
the country. Prevention and control of dengue is a multi-prong approach focusing
on the vector and the community at risk. Control of dengue is not dependent on the
health authority alone. Community involvement is crucial in combating the disease.
COMBI (Communication for Behavioural Impact) is increasingly being used to effect
positive behavioural changes in the community towards control of Aedes breeding.
Further strengthening of laboratory capabilities and research on dengue are needed
to curb the transmission and outbreaks of dengue in the country.
Introduction - global overview
D
engue is one of the most important mosquito borne diseases Global disease
in the world. Some 2.5 billion people, two fifths of the world’s burden
population, are at risk from Dengue1,2. The disease occurs in
two main forms, the commoner dengue fever (DF) and the more
serious dengue haemorrhagic fever (DHF). DF and DHF are primarily
diseases of tropical and sub tropical countries, with predominance in
the urban and sub-urban areas.
The World Health Organization (WHO) estimates that currently, there

are about 50 million cases of dengue infections worldwide every year.
The disease is now endemic in more than 100 countries in Africa, the
Americas, the Eastern Mediterranean, South-East Asia and the Western
Pacific regions. Countries in South-east Asia and the Western Pacific
are most seriously affected1,2.
The spread of dengue is attributed to expanding geographic Increasing

distribution of the four dengue viruses and of their mosquito vector, global trend
the most important of which is the predominantly urban species Aedes
aegypti. A rapid rise in urban populations is bringing ever greater
numbers of people into contact with this vector, especially in

areas that favour mosquito breeding, for example, where household
water storage is common and where solid waste disposal services are
inadequate.
Dengue situation in Malaysia
Dengue is endemic in Malaysia. With urbanization and increasing Incidence of

pace of development, the disease has been on the rising trend. Figure dengue in
1 indicates the incidence trend of dengue fever from 1973 in Malaysia. Malaysia
The incidence was less than 10 per 100,000 population in the 1970s
and 1980s, except for 1974 and 1982 where the incidence was 22.0
and 20.7 per 100,000 respectively. It was stable at about 30 per 100,000
population in the earlier part of 1990s until 1996 when it started rising
and reached a peak of 123.4 per 100,000 during the pandemic outbreak
in 19983.
After a decrease for two consecutive years, the incidence has been on Dengue trend in
the increasing trend again. The year 2005 recorded the highest incidence Malaysia
in the country, with an incidence of 150.6 per 100,000 population.
A total of 38,996 dengue cases were reported in 2005, compared to

33,895 cases in 2004. Ninety-five percent of the cases in 2005 were Selangor and FT
dengue fever with 108 deaths compared to 102 deaths in 2004. Kuala Lumpur
the most
affected states
The incidence of dengue is highest in Selangor and the Federal Territory
Fig. 1 : Incidence of Dengue in Malaysia, 1973- 2005
160
150.6
140 134.4
123.4 130.4
I.R/100,000 Population
120 124.6
100
89.7
80 68.7
67.3
60
36.4 44.67
40 32.8
27.5 29.5
22 20.7 31.99
20 29.5
7.5 8.5 8.8 8.5
4.5 12.4 15
15.2 5.9 16.1
0 8.1 7.3 7.7 4.55.3
95
97
99
01
03
05
73
75
77
79
81
83
85
87
89
91
93
19
19
19
19
19
19
19
19
19
19
20
20
20
19
19
19
19
Y E A R

of Kuala Lumpur, two of the most urbanized and densely populated
states in the country. These two states constitute 45% to 48% of the total
dengue cases in the country. In 2005, 12,729 of dengue were reported in
Selangor compared to 9,189 cases in 2004 (an increase of 38.5%) while
the corresponding figure for FT Kuala Lumpur were 5,515 and 6,288
cases respectively (an increase of 14%). Outbreak was also reported
on the Penang island in October 2005 where a total of 3,460 cases were
reported in 2005 compared to 1,761 cases in 2004 (an increase of 49.1%).
Aetiology
Dengue Fever (DF) and Dengue Haemorrhagic Fever (DHF) are caused
by the dengue virus of the Arbovirus family. There are four viral sero-
types, namely DEN 1, DEN 2, DEN 3 and DEN 4. Infection with one Dengue
serotype provides lifelong immunity to that particular serotype but serotypes
confers only transient and partial protection against infections by the
other serotypes. Hence, the exposed population can have more than
one dengue infection during their lifetime. There is evidence that
sequential infection with dengue increases the risk of more serious
disease resulting in dengue haemorrhagic fever4.
Sero-surveillance of the dengue serotypes indicates that DEN 1 as the

predominant serotype in the last two years ( 2004, 2005) with 73.4% and
58.6% respectively of the total.The last predominant DEN 1 infection Dengue serotype
was in 1997 where it made up 63.5% of the infections monitored (Fig.2). trend
Fig. 2 : Dengue Serotype Surveillance in Malaysia, 1991-2005
100 DEN 1
DEN 2
80 DEN 3
DEN 4
60
40
20
0
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
DEN 1 11.9 3.7 0 4.8 14.7 48.7 63.5 44.4 28.2 9.3 5.4 29.8 46.9 73.4 58.6
DEN 2 54.2 8.6 4.1 9.5 29.5 48.7 33.4 51.9 69.2 58.1 39.2 23.8 20.6 7.4 8.4
DEN 3 32.5 83.7 93.1 84.1 54.6 2.6 2.1 3.7 2.7 32.6 50 33.3 27.8 14.6 17.1
DEN 4 1.4 4 2.8 1.6 1.2 0 0 0 0 0 5.4 13.1 4.7 4.6 1.2

Transmission of dengue fever
The disease is transmitted by a vector; the Aedes mosquito of which Mosquito

two species, Aedes aegypti is the principal vector while Aedes albopictus vector
has also become increasingly involved in the transmission of the
disease. Humans are the main amplifying host of the dengue virus, Human reservoir
although studies have shown that in some parts of the world monkeys
may become infected and perhaps serve as possible reservoirs. There
is no environmental reservoir for this organism.
In Malaysia, Aedes aegypti breeds primarily in man-made containers Breeding places

like earthenware jars, metal drums and concrete cisterns used for
domestic water storage, as well as discarded plastic food containers,
used automobile tyres and other items that collect rainwater. It also
breeds extensively in natural habitats such as tree holes and leaf axils.
The dengue virus is transmitted to humans through the bites of Infected

infective female Aedes mosquitoes, a day biting mosquito. The Aedes mosquitoes
mosquito acquire the virus from feeding on the blood of an infected
person. The virus eventually enters the salivary gland and multiples
there. Thereafter, the mosquito becomes infective and continues to
harbour the virus for the rest of its life.
Infected female mosquitoes may also transmit the virus to their Transovarial
offspring by trans-ovarial (via the eggs) transmission, but the role of transmission
this in sustaining transmission of virus to humans has not yet been
clearly established5.
Clinical features
The incubation period of dengue ranges from 2 to 10 days, but generally, Spectrum of
it is between 5 to 7 days. Dengue has a wide spectrum of clinical illness clinical illness
ranging from asymptomatic, to mild sub-clinical infection, to dengue
fever with classical symptoms and the more serious potentially fatal
dengue haemorrhagic fever. Undifferentiated fever may be the most
common manifestation of dengue.
Dengue Fever (DF) generally is a self-limiting disease and seldom Dengue

cause death. The clinical features of dengue fever vary depending on Haemorrhagic
various factors. Infants and young children may have a non-specific Disease
febrile illness with rash. Older children and adults may have either a
mild febrile syndrome or the classical dengue fever with abrupt onset
and high fever, severe headache, pain behind the eyes, muscle and
joint pains, gastrointestinal symptoms, and rash.

Dengue Haemorrhagic Fever (DHF) is a potentially fatal entity that is Dengue Shock
characterized by high fever, haemorrhagic phenomena ranging from Syndrome
just bleeding under the skin (petechial rash) to bleeding into vital
organs and in severe cases, circulatory failure. The illness commonly
begins with a sudden rise in temperature accompanied by facial flush
and other non-specific constitutional symptoms of dengue fever. The
fever usually continues for two to seven days and can be as high as 40-
41°C, possibly with febrile convulsions and haemorrhagic phenomena.
In severe cases, the patient’s condition may suddenly deteriorate

after a few days of fever. The temperature drops, followed by signs
of circulatory collapse. The patient may rapidly go into a critical state
of shock and die within 12-24 hours, or quickly recover following
appropriate volume replacement therapy.
Diagnosis
For the purpose of instituting immediate prevention and control

measures, notification of dengue infection is made based on clinical Diagnosis by
presentation supported by presence of thrombocytopenia and evidence various methods
of haemoconcentration.5 Confirmatory diagnosis requires further
laboratory investigations which include :
• Dengue serology – IgG or IgM antibody titres to one or more

serotype virus
• Detection of dengue virus genomic sequences in serum, autopsy
tissue or cerebrospinal fluid samples by polymerase chain reaction
(PCR).
• Isolation of the dengue virus from serum or autopsy samples;
• Demonstration of dengue virus antigen in autopsy tissue, serum
or cerebrospinal fluids samples by immuno-histochemistry,
immunofluorescence or ELISA.
Factors influencing dengue outbreaks
Climatic factor
Climatic factors play an important role in the seasonal upsurge of

dengue disease. Dengue cases increase during the rainy season,
especially if the rainy days are interspersed with hot sunny days,
which is the ideal climate for Aedes breeding.

Urbanization
Malaysia has undergone rapid socioeconomic development over

the last 2 decades. This has resulted in major rural-urban migration
and rapid population growth in the urban areas. Rapid physical
development, created many man-made environment which facilitate
the breeding of Aedes mosquitoes. High population density in an
area with high index of Aedes breeding increase the chance of contact
between mosquito and man, and hence the risk of dengue outbreaks
in such areas.
Population movement
Population movements play a major role in the spread of dengue Population

infections. Persons with sub-clinical infections may carry the virus movement
from one place to another, and cause an outbreak in another locality
if the vector is present.
With a high number of people seeking employment in the urban areas,

holiday and festive seasons see massive movements of these people
back to their home towns and villages. The much improved road
network system in the country also facilitate movements of people
on all occasions throughout the country. Recent outbreaks of dengue
cases in FELDA (Federal Land Development Authority) land schemes
in Pahang was attributed to the return of workers and students from
the urban areas to their homes in the FELDA schemes during the
holiday season.
The vector too, may be transported from one locality to the next Vector
through the transport system and poses a threat to new virgin localities, movement
especially if they are infected mosquitoes.
Changing Serotype
Dengue outbreaks generally tend in a cyclic fashion depending on the Changing

type of circulating virus. Infection with one serotype provides lifelong serotype
immunity to that particular serotype but confers only transient and
partial protection against infections by the other serotypes4.
When a new serotype appears in a community, outbreaks occur due to

absence of low herd community. Infection by this serotype would abate
after sometime as the herd immunity increase, until the appearance
of another circulating serotype7.8.

The greatly increased number of dengue cases in 2004 and 2005 was Current
attributed to the changing circulating serotype where the DEN1 circulating
serotype virus became the dominant type after the last appearance in serotype
19973. Rapid movement of population and population growth resulted
in a new population composition with low herd immunity and hence
its vulnerability.
Prevention and control of dengue fever
The National Dengue Control Programme encompass a broad

approach with a combination of various strategies as follows :
• Disease surveillance through notification of all suspected cases

of dengue from hospitals and outpatient clinics. In urban areas,
this is channelled through the local authorities to the District and
State Health Departments.
• Vector surveillance from Aedes survey conducted regularly and
during case investigations. This is also a weekly report submitted
by the district health departments and local health authorities.
• Laboratory surveillance of circulating dengue serotypes to
the Institute for Medical Research, National Public Health
Laboratory in Sungai Buloh and University Malaya Medical
Centre.
• Vector control through source reduction of adult mosquitoes
and mosquito larva by chemical and biological means, as well
as environment management of rubbish disposal and public
education.
• Management of dengue cases in hospitals and clinics to prevent
deaths
• Law enforcement, which is provided under the Prevention
and Control of Infectious Diseases Act 1988 and Destruction of
Dangerous Disease Bearing Insect Act 1975 (Amendment 2000).
• Public Education in general and on targeted populations on
preventive measures and early identification of illness. This is
carried out through the mass media, exhibitions, health talks and
distribution of health information materials.
• Community involvement through community participation on
public education and environment cleaning campaigns.
• Research to better understand the bionomics of Aedes mosquitoes
and dengue transmission pattern for better management of dengue
outbreaks

In recent years, the Ministry of Health has come up with new Newer
approaches and strategies to combat Dengue. These include the approaches
following activities:
a) COMBI (Communication for Behavioural Impact approach to COMBI

inculcate positive behaviour change, centred mainly on reduction approach
of Aedes mosquito breeding. The activity was first started in Johor
Bahru in 2001 and since then, it has been extended to all States in
the country. COMBI utilizes a combination of behavioural science
approach and community participation from volunteers who are
mainly the youths, though not necessarily limited to them, to
inculcate positive behaviour changes such as regular inspection
of premises to get rid of Aedes mosquito breeding places.
b) COMFOG (Community Fogging) – empowering the community COMFOG

to control Aedes breeding through community fogging activity, approach
with supervision from the Health Personnel.
c) Using Ovitrap as surveillance tool to monitor the adult mosquito Ovitrap

density in a particular area to predict outbreaks. The results of
monitoring can also be used to determine whether a preventive
fogging is needed in the area.
d) Establishing Dengue Management Team in the districts to come Dengue

up with more effective ways in doing prevention and control Management
activities, and dengue management teams in hospitals to better Team
manage dengue patients during major outbreaks.
e) Using biological control (Bacillus thuringiensis israelensis) as Biological

larvicidal agent to control Aedes breeding in less accessible places. control
f) Strengthening the enforcement activities especially in places such

as construction sites, vacant lands / lots, abandoned projects and Law
factories. Enforcement
g) Using IEC Concept (Information, Education and Communication)

to educate the community and updating their knowledge on IEC approach
Dengue and its prevention.

Conclusion
Dengue infection is set to increase further with increasing urbanisation Control of

and population growth in such urban areas. Dengue is preventable dengue is
but requires concerted efforts from all relevant parties – the health a shared
departments, local authorities, and most important of all, the responsibility
community themselves. The community must take responsibility of
their environment - get rid of Aedes mosquito breeding places in their
premises and the surroundings.
The health department and local authrorities, on the other hand, have Continual
to continue to strengthen all preventive and control strategies to ensure improvements
they are being carried out effectively. Research and continual search needed
for better and more effective strategies would ensure this major public
References:
1. World Health Organisation. Dengue and dengue haemorrhagic fever Fact Sheet (WHO)
No. 117 Revised, April 2002.
2. World Health Organization. Global atlas of infectious disease. http://gamapserver.who.

int/GlobalAtlas/home.asp. (5 October 2005)
3. Ministry of Health Malaysia. Annual Report, 2002.
4. U.C. Chaturvedi, Richa Shrivastava & Rachna Nagar. Dengue Vaccines: Problems and
prospects. Indian J Med Res 121, May 2005; 121(5): 639-652.
5. World Health Organization. Clinical and laboratory guidelines for dengue fever and
dengue haemorrhagic fever / dengue shock syndrome for health care providers.
Produced by The Caribbean Epidemiology Center (CAREC), Pan American Health
Organization. www.carec.org/publications/DENGUIDE_lab.htm (5 October 2005)
6. Oon Chong Teik, A Guide to DHF/DSS Management – The Singapore Experience. Trop.
Med. & Inf. Dis., Mt. Elizabeth Hospital, Singapore. Singapore Dengue Bulletin Vol. 25
2001; 45-49.
7. Singapore sees dip in dengue cases – Experts. Reuters Health Information, Medline
Plus; 3 October 2005. http://www.nlm.nih.gov/medlineplus/news/fullstory_27240.
html. (7 October 2005)

8. Ministry of Health Singapore. Report of the Expert Panel on Dengue at http://www.
moh.gov.sg. (7 Oct 2005 )
9. Update from Expert Panel on Dengue, Singapore Government Media Release updated
information, 19 October 2005.
10. Annelies Wilder-Smith, M.D., Ph.D., and Eli Schwartz, M.D., Dengue in travellers. New
Eng J Med., Sept. 2005; 353(9): 924-932.

PREVENTION AND CONTROL OF ZOONOTIC DISEASES
SUMMARY
Many microbial pathogens and infectious diseases occurring primarily in wild and
domesticated animals may be transmitted to humans and is known as zoonoses. Even
though these occurrences are known to date back for centuries, it has increasingly
become important as 75% of newly emerging diseases are zoonoses. These diseases
cause negative impact on animal and human health and may affect commerce, travel,
socio-economy and even pose as a security threat to a country. They must thus be
prevented and controlled. The prevention and control of zoonotic diseases require
cooperation and collaboration between multi-disciplinary experts and multi-agencies.
The Nipah virus outbreak in Malaysia in September 1998 to May 1999 has proven
that cooperation and collaboration are key factors in ensuring successful prevention
and control of a zoonotic disease outbreak.
Introduction
A
nimals are a vital source of food, provide a means of transport, Definition
generate income through animal farming and also contribute as of zoonotic
a means of physical labour. In addition, domesticated animals diseases
are also kept as pets. However animals also harbour microbial
pathogens including parasites. These pathological agents may be
transmitted from animals to cause disease in man. Infectious diseases
occurring primarily in animals can be transmitted to man and is known
as zoonoses.
The World Health Organisation defines zoonoses as “…those diseases Transmission

and infections that are naturally transmitted between vertebrate
animals and man, with or without an arthropod intermediate.”
Infectious diseases can be transmitted from animal to man directly;
or indirectly through contact with faeces, urine, saliva blood or milk
of infected animals.
Zoonotic diseases are known to date back for many centuries. In early
times, it was recognised that ringworm in human was associated with First zoonotic
close contacts with cats and dogs. Other examples include the agents described

observation that glanders in horses and encephalitis in dogs may be
associated with similar disease in human. Among disease agents that
have been recognised early to cause zoonosis are as follows; cestodes
(1800), nematodes (1800s), ringworm, (1840s), trematodes (1870s), tick-
borne relapsing fever (1873) and bacillus anthracis (1877). Since its first
description, many other agents have been identified, some of which
were responsible for epidemics in human history.
The significance of zoonotic diseases is growing continuously, with Impact of

increasing commercialisation of animal trade and industry. The impact zoonotic
of these diseases on animal and human health and socio-economy diseases
are increasingly being felt by many countries especially developing
countries. Apart from causing human morbidity and mortality,
zoonotic diseases hamper agricultural production, decrease availability
of food and create barriers to international trade.
Emerging zoonotic diseases
Currently, it is estimated that there are 1,415 microbes which can infect
human. Of these, 868 (61%) are considered to be zoonotic. Zoonotic
pathogens are twice as likely to be associated with emerging diseases.
Emerging infections are defined as infection newly appeared in a
population or have existed but rapidly increasing in incidence.
Zoonotic diseases are on the increase and since 1973, more than 70% Occurrence
of newly recognized pathogens are zoonoses. Recent examples of of emerging
emerging zoonotic diseases are as follows; Lyme disease, Ebola viral zoonoses
hemorrhagic fever, Hantaan viral diseases, E. coli 0157:H7, Monkey
pox, West Nile virus, Cyclosporiasis, Australian bat Lyssa fever, Hendra
virus, Nipah virus and Highly Pathogenic Avian Influenza H5N1
(HPAI H5N1). Most of these emergent zoonotic diseases involved
the transmission of the etiologic agent to human from an ongoing
reservoir life cycle in animals, without the permanent establishment
of new life cycle in humans.
The factors influencing emergence of zoonotic diseases can be Factors

categorised as follows; influencing
emergence of
a) Ecological changes – deforestation, flood/drought, famine, climate zoonoses
changes;
b) Human demographic behaviour – migration, war / civil conflict,
sexual behaviour and changing animal husbandry practices.

c) International travel and commerce – increasing worldwide
movement of goods and air travel.
d) Technology and industry – changing techniques in food processing,
organ transplantation, inappropriate use of drugs causing
immuno-suppression and indiscriminate use of antibiotics.
e) Microbial adaptation and changes – mutation, natural selection
and evolution.
f) Breakdown in public health measures – reduction of prevention
programmes, inadequate sanitation, and inadequate vector control
measures.
Recent zoonotic outbreaks in Asia and Malaysia
Two well known recent zoonotic outbreaks that occurred in Asia and
Malaysia are the Highly Pathogenic Avian Influenza (HPAI) and Nipah
encephalitis, due to influenza virus H5N1 infection and Nipah virus
respectively.
Avian Influenza (AI)
Avian influenza is a viral disease of wild and domestic bird that Avian influenza
occasionally affects other animal species especially pigs. Human H5N1 outbreaks
infection due to avian influenza is rare. The first documented human in human
outbreak of avian influenza H5N1, occurred in Hong Kong in 1997.
The source of infection in all cases was traced to contact with diseased
birds in farms and in live poultry markets.
Currently, avian influenza H5N1 outbreaks occur in Asia. These Avian influenza
outbreaks began in late 2003. Since December 2003, nine countries H5N1 outbreaks
in Asia (Republic of Korea, Japan, and People’s Republic of China, among birds in
Vietnam, Thailand, Lao PDR, Cambodia, Indonesia and Malaysia) Asia
have confirmed outbreaks of avian influenza among birds / poultry
caused by the influenza virus H5N1 strain. More than 100 millions
birds have either died from the disease or have been culled in order
to prevent its further spread.
During these current outbreaks, humans also have been infected with Avian influenza
avian influenza H5N1. Since January 2004 till November 2005, a total H5N1 in humans
of 132 confirmed human avian influenza H5N1 cases with 68 deaths in Asia
have been reported to the World Health Organisation (WHO). These
cases occurred in Vietnam, Thailand, Cambodia, Indonesia and China.
Most cases have direct contact with diseased birds. Human-to-human
transmission, is rare .

Nipah virus encephalitis
Nipah virus was first discovered in Malaysia by a local researcher Emergence of

in 1999 and confirmed by CDC, Atlanta. Nipah virus caused disease Nipah virus
in pigs and encephalitis in humans. Scientific evidence showed that
certain species of fruit bats are the natural animal reservoir for Nipah
virus.
From September 1998-December 1999, Nipah virus was identified Nipah

as the cause of an encephalitis outbreak in states of Perak, Negeri encephalitis
Sembilan and Selangor. A total of 232 persons were laboratory outbreak
confirmed to be infected with this virus with 91 deaths. Most of the
victims were pig farmers or their family members or farms workers
that were in direct contact with infected pigs.
Impact due to zoonotic diseases
Zoonotic diseases cause negative impact on human and animal health

and may disrupt commerce, travel, socio-economic stability and even
pose as a security threat.
In the Nipah virus encephalitis outbreak in Malaysia in 1999, case Economic loss
fatality rate was high at 39.2%. The cases were highest among the
productive aged group who were bread winners in the family.
During the outbreak, 1.1 million pigs were culled and the calculated
monetary value of these pigs was estimated to be RM 221.5 million.
The government paid out RM 133 million compensations to the affected
pigs farmers while the farmers’ total financial loss was estimated to
be RM 471.2 million.
Zoonotic diseases have a negative impact on the socio-economy of

animal farmers and their families. As an example, the current avian
influenza outbreak leads to a stand-still in poultry production and
income loss. Poultry in farms around infected areas had to be culled.
Hard hit were small poultry farmers. Farmers are not the only people
that will lose financially, but other economic sectors and industries
are similarly affected. The Asian Development Bank estimated that
the impact of Severe Acute Respiratory Syndrome (SARS) epidemic
that occurred in 2003 which involved 26 countries in all continents
cost losses of about USD 18 billion in terms of GDP or USD 59 billion
in terms of business losses.

Zoonotic disease pathogens are often mentioned in context of Potential threat
bioterrorism and biological warfare. Among pathogens implicated as bioterrorism
are anthrax, brucellosis, viral equine encephalitis, ebola/marburg, agents
meliodosis, glanders, plague, psittacosis and tularemia. In this context,
zoonotic diseases can pose as a security threat to any country.
Zoonotic disease outbreaks may lead to other major health problems. Major health
Avian influenza outbreaks currently occurring in Asia may lead to problem
pandemic influenza if the influenza virus mutated with characteristics
that facilitate transmissibility from human-to-human. If this happens,
millions of people worldwide will be threatened.
The prevention and control of zoonotic diseases
Strategies for the prevention and control of zoonotic diseases are base Discovery-to-
on the principle of discovery-to-control continuum concept. Elements control conti-
of a discovery-to-control continuum of zoonotic diseases especially nuum concept
emerging zoonoses are as follows,
a) Discovery (recognition of zoonotic disease);

b) Epidemiologic field investigation;
c) Etiologic investigation;
d) Diagnostic development;
e) Focused research
f) Technology transfer;
g) Training of staff for control, elimination and eradication.
The disease must be recognised early in the initial phase of the Recognition of
discovery-to-control continuum. Local clinicians, pathologist the disease
(including medical examiners and forensic pathologist), veterinarians
and animal scientists, ecologist, wildlife scientists, as well as public
health officials should be trained to recognize zoonotic diseases early.
Currently, many of the zoonotic diseases are under-diagnosed, as the
diseases are not recognised. Initial investigation of zoonotic diseases
(especially newly emerging diseases) must focus on morbidity rate,
death rate, severity of disease, transmissibility, all of which are
important factors or predictors of epidemic potential and societal risk.
Primary diagnostic laboratories and the reference laboratory networks Diagnostic

play an important role in identifying and diagnosing agents of laboratory
zoonotic diseases. In this era, high technology molecular microbiology support
and virology are used to characterise the pathogens to complement
epidemiologic field investigation in identifying source of outbreak

and risk factors associated with the outbreak with precision so that
appropriate public health intervention could be undertaken.
In the intermediate phase in the discovery-to-control continuum, the Discovery-

continuum progresses to risk management. This phase may include to-control
elements as follow; continuum –
intermediate
a) Technology transfer – involving diagnostic development; phase elements
b) Drug and vaccine development;
c) Sanitation and vector control;
d) Medical and veterinary care activities;
e) Training and continuing education;
f) Public education
In the final phases of discovery-to-control continuum, public health Elements of

delivery systems play an important role. The elements of this phase final phases
will lead to control, elimination and eradication of zoonotic diseases. in discovery-
However, the elements of this final phase are more expensive and to-control
require specialized expertise and resources. The elements of final continuum
phase are as follows;
a) Rapid case reporting system;

b) Surveillance system;
c) Disease register and vital records;
d) Staffing and staff support;
e) Logistic support;
f) Legislation and regulation;
g) Special clinical systems – including isolation of cases, quarantine,
patient care;
h) Public infrastructure systems – including sanitation, sewerage,
safe food and water supplies; and
i) Reservoir host and vector control
Based on the discovery-to-control continuum concept, the control Multi-

of zoonotic diseases need cooperation and collaboration between disciplinary
multi-disciplinary expertise comprising of clinicians, public health expertise
physicians, public health officials, pathologists, veterinarians, cooperation
animal scientists, ecologist, wildlife scientist, ecologists, researchers,
public educators, communication experts, sanitation technicians,
administrators, politicians and the members of the community.
Other than cooperation and collaboration between multi-disciplinary Multi-agencies

expertises, the prevention and control of zoonotic diseases need cooperation and

cooperation and collaboration between multi agencies either collaboration
government or non-government agencies at local, national, regional
and international level. These include agencies involved with services
in public health, veterinary, laboratory, education and law and
enforcement.
Managing zoonotic disease outbreaks – Malaysia’s experience
Over a period from September 1998 to May 1999, clusters of viral Viral
encephalitis cases occurred in four localities in three states. A total of encephalitis
265 cases of viral encephalitis with 105 deaths due to this outbreak outbreak –
were reported to Ministry of Health, Malaysia. Most of the cases were September 1998
adult pig farmers. to May 1999.
In the outbreak, culling of pigs was proven to be effective in controlling Pig culling
the spread of the disease. Culling was carried in two phases and a total operation
of one million pigs were culled. Veterinary Services Department, army,
local authorities and non-government organizations were involved in
the culling operation. Farmers were compensated for the pigs culled.
Law enforcement agencies such as Malaysian Royal Police Force were
involved to ensure that no pigs were transported out from affected
areas.
Special protocols and guidelines were issued. These include: Nipah virus
managements of suspected cases of viral encephalitis; autopsy encephalitis case
examination for Nipah infection; transport and disposal of dead bodies management
due to Nipah infection; safety equipment for occupational exposure
to Nipah virus; and barrier prophylaxis for people exposed to Nipah
virus. All patients suspected of having Nipah virus were placed
in special isolation wards with close monitoring by special teams
consisting of medical specialists, medical officers, physiotherapist,
occupational therapist, counsellors and others.
Intensive health education for targeted groups (farm employers, Health

farm employees) was carried out through mass media and schools. education
Posters, pamphlets and other health education materials in various
languages were produced and distributed. Health education materials
for special groups such as farm workers, abattoir workers and those
involved in the trading and transport of pigs were also produced and
distributed. Advice was given on the need to wear personal protective
equipments (gloves, masks, goggles, boots and long sleeved shirts,
apron). Personal hygiene, especially hand washing with hand washing
was emphasised. .

Rapid case reporting system, enhanced surveillance of viral encephalitis Surveillance
cases and disease register were established and continued to this day. system
Organisational responses are an important component in the

management of disease outbreak. During the Nipah encephalitis Organisational
outbreak, several committees were established to coordinate control response
measures. These include: an Inter-Ministerial Committee for Control
of Zoonotic Diseases chaired by the Deputy Prime Minister himself;
a Technical Committee on the Control of Zoonotic Diseases; State
Outbreak Committee and District Outbreak Committee. Members
of these committees were from government and non-government
agencies.
As the Nipah virus was a newly recognised virus, Malaysia sought

assistance from WHO for experts to assist in the control and Experts
investigations of the outbreak. Twelve experts from CDC Atlanta, assistance
two from Commonwealth Scientific, Geelong and Industrial Research
Organisation (CSIRO), and one from Animal Research Institute,
Queensland arrived to provide expert assistance.
Based on experiences mentioned above, most of the elements of

discovery-to-control continuum were implemented. There has Key factors
been no repeat Nipah virus outbreak till now. . The cooperation and for successful
collaboration of multi-disciplinary experts and between multi agencies prevention and
at local, national and international are key success factors in the control control
and prevention of Nipah virus outbreak in the country.
Based on the experiences of the from the Nipah virus outbreak, similar
strategies and activities were also adopted in the control of the last Avian influenza
Avian Influenza outbreak in Kelantan in August 2004 which were outbreaks in
limited to poultry. No human case was detected. Kelantan
Conclusion
Zoonotic diseases or zoonoses are on the increase globally and locally.

The successful prevention and control of zoonotic disease requires
close cooperation and collaboration from multi-disciplinary experts
and between multi agencies, both government and non-government
sectors.

References:
1. Disease Control Division, Ministry of Health Malaysia. Report on JE / Nipah Outbreak

in Malaysia, 2001.
2. Morse SS. Factors in the emergence of infectious diseases. Emerging Infectious Diseases
Journal 1995; 1(1):7-14.
3. Murphy FA. Emerging zoonoses. Emerging 1998; 4(3).
4. Meslin FX. Global aspects of emerging and potential zoonoses: A WHO Perspective;
3(2):223-228.
5. Kruse H, Kirkemo AM, Handeland K. Wildlife as source of zoonotic infections. Emerging

Infectious Diseases Journal 2004; 10(12):2067-2072.
6. CDC. Compendium of measures to prevent disease associated with animals in various

settings, 2005. MMWR 2005; 54(RR04):1-12.
7. Chua KB, Corkill JE, Poh SH, Soo CH, Winstanley C, Hart CA. Isolation of Waddlia
malaysiensis, a novel intracellular bacterium, from fruit bat (Eonycteris spelaea). Emerging
Infectious Diseases Journal 2005; 11(2):271-2066.
8. Siemenis A. Zoonoses: a social and economic burden. Emerging Infectious Diseases Journal
1998; 4(2):220-222.
9. Jean-Pierre A, Castillo V, Castillo CN. Avian Flu: an economic assessment for selected
developing countries in Asia. Asian Developing Bank ERD Policy Brief No. 24 2004.

NATIONAL INFLUENZA PANDEMIC PREPAREDNESS
PLAN (NIPPP)
SUMMARY
The National Influenza Pandemic Preparedness Plan (NIPPP) provides guidance for
the preparedness and response needed in facing the threat of an influenza pandemic. It
contains specific advices and actions to be taken by the Ministry of Health at different
levels; spells out roles of various governmental departments and agencies as well as
non-governmental organisations to ensure resources are mobilised efficiently before,
during and after an influenza pandemic episode to reduce morbidity and mortality
in human. The document is also an advocacy tool,providing policy and strategic
framework for a multi-sectoral response, encouraging greater political commitment
and promotes public reassurance that the Ministry of Health is fully dedicated and
committed to protecting the Malaysian population from the threat of avian influenza
in the country.
Introduction
O
ver the last two years (2004-2005), outbreaks of the highly Influenza
pathogenic H5N1 avian influenza in poultry were reported in pandemic threat
some countries in Asia while isolated cases were also reported
in several countries in Europe. Occurrence of human cases
and the extremely high fatality rate among those infected gave rise to
concern on an impending avian influenza pandemic that would have
devastating consequences, both socially and economically.
Three pandemics had been recorded in the 20th century – the Spanish
Flu (1918 –1919), Asian Flu (1957–1958) and Hong Kong Flu (1968–1969)
which were caused by influenza virus originated from the avian
influenza virus. The pandemics resulted in millions of lives lost.
There is fear that the next global pandemic of a very virulent novel
influenza virus may reach our shores faster than we anticipate with
globalization, rapid human and animal traffic in the age of modern
transport system. Hence, there is a need for extra vigilance, less we
are caught unprepared if it happens.

Influenza virus
There are three main types of influenza viruses; viz. A, B and C. Influenza virus
Influenza C causes only mild disease and has not been associated with
widespread outbreaks. Influenza A viruses carry 15 antigenic subtypes
of haemaglutinin (HA) and nine antigenic subtypes of neuraminidase
(NA). They have been found in wild aquatic birds and poultry with
the current strains of H5, H7 and H9. Influenza viruses of the H1N1,
H2N2 and H3N2 subtypes have been associated with widespread
epidemics in human. Influenza B viruses are not divided into subtypes.
Influenza viruses have an ability to slightly change their structure from Antigenic drift
time to time. The process known as “antigenic drift” occurs frequently
over time. It results in the appearance of different strains of circulating
virus each year. The severity of the seasonal epidemic in any locality
may be related to a drift in the previously circulating virus.
The viruses could also change dramatically and unexpectedly through Antigenic shift
a process known as “antigenic shift” by acquiring a new H or H+N
surface proteins. This shift results in the appearance of a new or “novel”
influenza virus that has never previously infected human or has not
infected humans for a long time, for which the general population is
unlikely to have any immunity or antibodies to protect themselves
against the novel virus. The appearance of a novel virus is the first
step towards a pandemic.
Typical primary influenza illness lasts about a week and is characterized Signs and
by abrupt onset of fever, muscle aches, sore throat, and nonproductive symptoms
cough. In some persons, severe malaise and cough can persist for
several days or weeks. Influenza infection not only causes primary
illness but can also lead to severe secondary medical complications
such as influenza viral pneumonia and secondary bacterial pneumonia
or worsening of underlying medical conditions such as congestive
heart failure, asthma, or result in other complications such as otitis
media in children, and death from the illness itself.
The pandemic threat
A pandemic is a global disease outbreak. A pandemic influenza occurs

when a new influenza virus emerges. It will cause serious illness and
spread easily as there is little or no immunity in the human population.
The recent outbreaks of avian influenza among poultry due to influenza
virus H5N1 in Asia since the end of December 2003

has caused a lot of uneasiness among countries in the world. WHO
postulated that prolonged outbreaks of avian influenza in poultry
and human could trigger an influenza pandemic as influenza virus
can mutate easily.
National Influenza Pandemic Preparedness Plan (NIPPP)
The Ministry of Health has taken the lead in developing a workable

preparedness plan for influenza pandemic called the National Influenza
Pandemic Preparedness Plan (NIPPP). It is to facilitate an organised,
coordinated and effective national preparedness and response in the
event of an influenza pandemic.
The plan provides a framework for preparedness and response, with Roles and
specific advice and actions to be undertaken by the Ministry of Health responsibilities
at different levels. It also spells out roles of various governmental of different
departments and agencies, as well as non-governmental organizations. agencies
All these are to effect rapid, timely and coordinated inter-sectoral and
inter-agency actions to minimise morbidity and mortality of the illness,
as well as social and economic disruption.
In dealing with the influenza pandemic, an organizational response Organisational

is very critical - to provide policy direction, coordination and response in
implementation of an action plan. Under the NIPPP, 3 committees NIPPP
have been established. They are :
1. National Inter-ministerial Influenza Pandemic Committee (NIIPC)
This committee will provide policy, direction and coordination

of ministries, government departments and the relevant non-
governmental agencies for controlling pandemic in the country. The
Chairman of this committee is Minister of Health. The members are
Secretary General and Director General from multi ministries and
departments.
2. National Influenza Pandemic Planning Committee (NIPPC)
This is the technical and advisory committee for the Ministry of

Health and Inter-ministerial Influenza Pandemic Committee. It will
oversee the development and implementation of the outlined plan.
The Chairman of this committee is the Director General of Health and
the members are multi-disciplinary experts from Ministry of Health
and other agencies.

3. Influenza Pandemic Committee (NIPC)
This committee is established at the national, state and district levels

to ensure that the influenza pandemic plan is put into action. The
committee will be activated when an influenza pandemic is declared
by Ministry of Health.
The strategies and activities to be implemented in the preparedness

plan encompass 4 areas of response, namely - public health response;
medical response; laboratory response; and risk communication
response. The extent or degree of response are based on the level of
influenza pandemic alert. The alert levels are as follows :
Phase 1 Interpandemic Period
No new Influenza virus subtypes have been detected in humans.

An influenza virus subtype that has caused human infection may
be present in animals. If present in animals, the risk of human
infection or disease is considered to be low
Phase 2 No new influenza virus subtypes have been detected in humans.

However, a circulating animal influenza virus subtype poses a
substantial risk of human disease
Phase 3 Pandemic Alert period

Human infection(s) with a new subtype, but no human to human
spread, or at most rare instances of spread to a close contact
Phase 4 Small cluster(s) with limited human to human transmission but

spread is highly localised, suggesting that the virus is not well
adapted to humans.
Phase 5 Larger cluster(s) but human to human spread still localized,

suggesting that the virus is becoming increasingly better adapted
to humans, but may not yet be fully transmissible (substantial
pandemic risk).
Phase 6 Pandemic period

Pandemic phase: increased and sustained transmission in general
population.

Preparing for pandemic influenza
Preparations made during the inter-pandemic period are very Pre-pandemic

important in reducing morbidity and mortality associated with an period
influenza pandemic if it comes. Several steps have been taken by the
Ministry of Health as preparation for the pandemic as follows :
1. surveillance of influenza-like illness (ILI), a proxy of influenza Surveillance of

infection. It is carried out by weekly reports from sentinel clinics influenza-like
throughout the country, chosen based on certain criteria set. The illness (ILI)
influenza virus surveillance is carried out by selected government
and universities virology laboratories. Rumours surveillance
for any unusual events related to respiratory systems including
atypical pneumonia and acute respiratory syndrome are also
implemented to increase the sensitivity of the surveillance system.
The systems established are as an early warning for any influenza
epidemic and pandemic.
2. stockpiling of antiviral drugs Oseltamivir (Tamiflu). The World Stockpiling of

Health Organisation advised a stockpile of 25 % of the population. Oseltamivir
Malaysia has decided on a 10 % stockpile, with incremental
increase each year. It is to be noted that the shelf life of Oseltamivir
is only 4 years, and any overstocking would result in wastage as
the expired drugs will have to be disposed of.
3. vaccination for selected front-line healthcare workers (HCWs) Vaccination

and staff of the essential services such as the police, fire service, of front-line
transportation service and others. Even though the normal two- health-care
seasons influenza vaccines does not have a protective effect to workers
pandemic influenza, the vaccination policy will provide a logistic
mechanism in our country and also to the vaccine supplier if
pandemic were to occur.
4. stockpiling of the personal protective equipments (PPE) for HCWs. Stockpiling of

When a pandemic occurs, there will be increased PPE usage and PPE
there will be shortage of supply in the market, coupled with a
price increase.
5. upgrading of isolation facilities in hospitals. Even though the Upgrading

role of treating cases in hospitals during a massive pandemic of isolation
is debatable, isolating influenza cases in the early phase of the facilities in
pandemic is important to curb the spread of the virus. hospitals

6. risk communication to the public via the various channels Risk communi-
available in the countries. The multilingual and multicultural cation
factors are taken into consideration.
7. training of health staff in all disciplines, to reduce panic, to get Training

their commitment and to ensure continuity of services in all
departments.
8. research on influenza.
To implement all these preparedness need a support and commitment

from all agencies. A Cabinet Memorandum was presented in November
2005 and approved upon.
Activities during pandemic
When a pandemic influenza occurs, disease and viral surveillance will Enhanced
be enhanced and the medical response will be activated. Public health response
response will be initiated at places including ports of entry to prevent
the spread of disease. This might include closure of public functions
and gatherings, and closure of schools. Risk communication will be
intensified through media and hotlines.
The National Security Council will be alerted by the National Inter- NIPC alerted
ministerial Influenza Pandemic Committee (NIIPC) through the
Cabinet when the pandemic reaches a proportion outside the capability
and capacity of existing mechanism to handle pandemic.
This is expected to occur in phase 3 onward when the situation is Pandemic plan
considered a threat to the country’s security. The Council will then activated
be responsible for coordinating the overall incident management, as
well as non-medical support and response actions across all federal
departments and agencies at all levels. The Ministry of Health will
continue to play the lead agency role for public health and medical
emergency responses of the influenza pandemic.
Simulation exercise
Even though all strategies and activities for the prevention and control Testing the plan
of the influenza pandemic are well laid out in the NIPPP, it may not
work as planned. A simulation exercise will be carried out to ensure
the action plan works, and all weaknesses identified and rectified
accordingly.

Regional and international cooperation
Co-operation and collaboration between agencies at various levels are Inter-agency

very important to ensure effective measures are taken for preventing collaboration
and controlling the influenza pandemic. Regional cooperation has
been strengthened among the ASEAN countries through the ASEAN
+ 3 Emerging Infectious Disease (EID) Programme. There is also a
cooperation in this area in other regional forum such as APEC and
ASEM.
International partnerships in preparing for influenza pandemic

consist of capacity building i.e. training of human resources, anti-viral
stockpiling, upgrading of facilities and sharing laboratory facilities;
sharing information on important events and the progress and
educating the public. The partnership will ensure that all countries
are able to prevent and control the influenza pandemic effectively if
it were to occur.
Conclusion
The NIPPP document serves as a resource for influenza pandemic

preparedness; and stake-holders engagement and intensification of
the pre-existing core capacities to enable a quick response to pre-
empt the pandemic. It is aimed at minimising human morbidity and
mortality, social disruption and the economic consequences caused by
the pandemic. The plan is dynamic and would be continually updated
to reflect new knowledge and experiences gained; and advances made
by experts in the world. States and districts are required to have their
own detail plan of action using this document as guidance; and the
plan should be tested on the ground.
References:
1. CDC Atlanta, USA, August 2004. Pandemic Influenza Preparedness and Response Plan
(Draft).
2. Health Canada (2004). National Influenza Pandemic Preparedness Response.
3. PHLS , July 2001. The PHLS Plan for Pandemic Influenza.

4. WHO Geneva (1999). Influenza Pandemic Preparedness Plan:
Responding to Influenza Pandemic or Its Threat – Role of WHO
and Guidelines for National or Regional Planning. World Health
Organisation.
5. WHO, Geneva (2005). WHO Global Influenza Preparedness Plan

: The roles of WHO and recommendations for national measures
before and during the pandemics. World Health Organisation

HARM REDUCTION IN THE PREVENTION AND
CONTROL OF HIV/AIDS
SUMMARY
Harm Reduction Program should be viewed as a comprehensive community-based

package of measures, which include Need Syringe Exchange Programme, to prevent
HIV spread as well as to remedy the drug addiction situation among injection drug
users. The programme is particularly appropriate for Malaysia as its HIV epidemic is
mainly contributed through spread by sharing of contaminated needles while injection
drugs. Harm Reduction approach is consistent with the spirit embodied within United
Nation’s ‘Declaration of Commitment on HIV/AIDS which was adopted by United
Nation General Assembly Special Session on HIV/AIDS (UNGASS) in 2001
Introduction
S
haring of syringes and needles is associated with HIV transmission Drug use and
among injecting drug users (IDUs). It is estimated currently, that HIV/AIDS in
there are at least 5.5 million and possibly up to 10 million injecting Malaysia
drug users, across 128 countries globally. Malaysia is one of the
many countries whose HIV epidemic has been driven by IDUs.
Injection drug use contributes to the epidemic’s spread far beyond the
circle of IDVUs. People who have sex with an IDU are also at risk of
being infected with HIV, and children born to mothers who contracted
HIV through sharing of needles or having sex with an IDU may also
become infected. This disturbing trend appears to be continuing. HIV
infection is currently occurring at 18 new cases per day in the country.
As of December 2004, out of 64,439 cumulative individual reportedly

infected with HIV in the country, 48,369 (75.1%) were injecting drug
users. Heterosexual route of infection has increased from 4.8% in 1990
to 19.8% in 2004, while during the same period, HIV infection among
women jumped from 1.2% to 10.8%.

Studies conducted in relation to IDUs and HIV infection in Malaysia
A study conducted among 1,932 inmates from 26 Pusat Serenti (drug

rehabilitation centres) in 1998 revealed that; 64.6% of the respondents Multi-
were IDUs, of whom 77% admitted they injected drugs more than centre drug
3 times per day and shared needles with more than 5 others. Of the rehabilitation
1,139 (18%) drug users infected with HIV, 92.4% were IDUs, and 81% survey
shared needles. The risk of being infected with HIV among those
sharing needles is 7 times higher than among those who do not share
needles. 77.6% of HIV infected drug users were sexually active, while
only 18.7% of them used condom
A study conducted by the AIDS/STI Section of the Ministry of Health

(MOH ) in collaboration with Universiti Utara Malaysia (UUM) in 2003, Collaborative
estimated that there were 897,624 drug users in the country, of whom study between
117,955 were IDUs (13.15%). Knowing that the HIV prevalence among MOH and UUM
IDUs is about 20%, it is estimated that about 23,600 have already been
infected with HIV in 2003. However, only 4,792 IDUs were reported
as HIV positive for that year. This indicated that possibly, there were
about 18,800 IDUs infected with HIV virus that were not reported or
worst, they may not even realised that they had been infected with HIV.
Why Harm Reduction ?
Recognizing that it is the sharing of contaminated needles and unsafe

sex behaviour among the IDUs that continuously fuel the spread of
HIV in the country, and in response to ‘The Declaration of Commitment The United
on HIV/AIDS’ adopted by United Nation General Assembly Special Nation
Session on HIV/AIDS (UNGASS) in 2001, which specially indicated Declaration of
that by 2005, “a wide range of prevention programs including Harm Commitment on
Reduction efforts related to drug use would be made available by HIV/AIDS
all member states”. Thus, the plan by Malaysia to introduce Harm
Reduction as a strategic approach for reversing the HIV epidemic is in
accordance with UNGASS recommendation.
What is Harm Reduction?
Harm Reduction is about making dangerous behaviour less dangerous.

It is less dangerous to inject the drug with one’s own clean needle as
opposed to share needle with others. However, the concept of harm Concept of harm
reduction is not just exchanging clean needle and syringe with reduction

a dirty one. While Needle Syringe Exchange Program (SNEP) is an
important component of harm reduction activities, it is by no means
the only crucial activity. In fact, its major role is more on functioning
as a driving force towards a wider range of harm reduction related
activities, which include Information, Education and Communication
(IEC) on risk-reduction; HIV testing and counselling; Methadone
Substitution Therapy (MST); condom promotion; psycho-spiritual
support; live-skill counselling/training; and Anti-retroviral treatment
(ART). Therefore, Harm Reduction Program should be viewed as a
comprehensive package of measures that prevent the spread of HIV
infection as well as remedy to drug addiction among IDVUs, and thus
enhancing the quality of life of injecting drug users.
Needle Exchange Program (NEP)
The goals are firstly, to help the uninfected IDUs stay that way. Goals
Secondly, it is to help infected IDUs stay healthy and thirdly, to
help infected IDUs initiate and sustain behaviours that prevent HIV
transmission to others.
The NEP is a community-based ‘one-for-one exchange’ program, One-for-one

specifically targeted for: the hard-core IDUs who cannot or will not exchange
stop injecting drugs, and those who are not accessing to available program
health services. They are very vulnerable of being infected with HIV
as well as at very high risk of infecting others.
It is a program that reaches out at the IDUs through outreach points Program
and drop-in centres, which are characterised by peer education run structure
by authorised and trained NGOs. The program is guided by clear
operational policies, standard operating procedures, monitoring and
evaluation protocol, and security guidelines; This is fundamentally
accompanied by communication and bridges the participating drug
users to primary health care services, HIV testing and counselling,
STD / ART & other AIDS related treatment, Methadone Substitution
Therapy, and psycho-social services / support.
The basis of NEP service is to provide an avenue for drug users to

exchange dirty needles with clean one. For the programme to succeed,
it must have the support and full participation of the local community,
especially community leaders, the police, anti-drug agency and health
clinics. No single element of NEP activities will be effective if practiced
on its own.

Conclusion
The reality is that HIV still continues to attack our youth and; many
more remain to be detected with HIV as a result of sharing contaminated
needles and engaging in unprotected sex. The Australian government
invested Aus$130 million in their Needle Exchange Program during
1991-2000 to prevent 25,000 people from being infected with HIV, and
saved Aus$2.4 billion of treatment cost. If no to the Needle Exchange
Program, do we have a better alternative?
References:
1. Ministry of Health. Annual Report 2004, Ministry of Health Malaysia.
2. National Anti-Drug Agency. Annual Report, 2003/2004.
3. Ministry of Health Malaysia/World Health Organisation/Universiti Utara Malaya

(2003), Estimation of drug users and injection drug users in Malaysia.
4. World Health Organisation (2004). Evidence for action in HIV/AIDS and injecting drug
use. Policy brief – provision of sterile injecting equipment to reduce HIV transmission.

SUICIDE PREVENTION IN MALAYSIA
SUMMARY
In recent decades, suicide has emerged as a major public health problem, especially
among teenagers and young adults. It has been estimated that there is 30% under-
reporting of suicide in developed countries, and in Malaysia the magnitude of under-
reporting is substantially higher. It is estimated that more than 2,500 persons commit
suicide every year in Malaysia but this is probably an underestimate. Malaysia’s
annual crude suicide rate from 1990 to 2000 is estimated to range from 10.5 - 13.5
per 100,000 (for Peninsular Malaysia). Statistics on suicidal behaviour show that
the number of persons making non-fatal suicide attempts may be at least 15 times
higher than the number of suicides. Many of these are serious enough to require
medical attention, often resulting in irreversible physical or psychosocial disability.
For every person who commits or attempts suicide, about 20 other people are
emotionally affected. Some would be affected seriously enough to resort to suicidal
behaviour themselves. Suicide prevention remains a challenging and complex task,
which requires consistent, sustained and collaborative approaches across all levels
of government and the community.
Introduction
A
Among the wide range of mental health problems, the most Suicide and
tragic is perhaps suicide. It is not only a manifestation of a wilful suicidal
loss of life, it leaves in its wake feelings of grief, guilt and anger attempts - a
among the people known to the person. Suicidal behaviour, both major public
fatal and non-fatal, can have profound and lasting emotional effects health and
on family, friends and peers. social issue
The prevalence of non-fatal suicidal behaviour may be up to 15 times

higher than fatal suicidal behaviour. From the economic point of view,
suicidal behaviour places a considerable drain on the resources of
the healthcare system (Schmidtke, 1997). Hence, suicide and suicidal
attempts are now increasingly recognised as a major public health and
social issue, and suicide prevention has become an important concern
in many countries of the world.
Suicide prevention remains a challenging and complex task, which is

likely to benefit from a consistent, sustained and collaborative approach

across all levels of government and community. This paper reports on
the approach for suicide prevention helmed by the Ministry of Health
(MOH) in Malaysia.
Magnitude of the problem
Suicide is among the 10 leading causes of death for all ages in many Suicide rates
countries. In some countries, such as China, Hong Kong and the
European Region (Albania, Austria, Bulgaria, Finland, Germany, Spain
and United Kingdom), suicide is among the top three causes of death
for people aged 15 – 34 years (World Health Report 2001). Currently,
suicide is the leading cause of death among young adults for both males
and females, and the second leading cause of death among adolescents.
The World Health Organization (WHO) and the International

Association for Suicide Prevention estimate that close to 1 million people
commit suicide every year, that is, about 1 suicide every 40 seconds.
In 2000, the WHO (WHO 2001) reported a global estimate of mortality

due to suicide as 14.5 per 100 000 population. The suicide rate was 24.0
per 100 000 for males and 6.8 per 100 000 for females. Suicide rate of 53
countries reported to WHO shows that the highest suicides rates (more
than 13 deaths per 100,000 persons) are in the European Region and
Australia. In the Asian region, countries like Japan and Thailand show
suicide rate of less than 6.5 deaths per 100,000 population (Figure 1).
Nevertheless, countries like Hong Kong and Korea demonstrate
Figure 1 : Map of Suicide Rates (per 100,00 persons) from most recent available data
( March 2002)

increased suicide rate over the past two decades, of which Hong Kong
(9.6 to 16.6 deaths per 100,000 population from 1981 to 2003) was above
the global estimate, while Korea showed an increase in 6% from year
1983 to 2003.
At the global level, suicide mortality for males has increased by 7% Rising male
over the last four decades with rates at their highest point during the suicide rates
1980’s while in females, there has been a 27% decline in rates since
the 1960’s (Figure 2).
Figure 2 : Global Suicide Trends, 1960 – 1999
Males Trend Females Trend
20
15
Rate per 100,000
10
0
1960 1963 1966 1969 1972 1975 1978 1981 1984 1987 1990 1993 1996 1999
Year
Source:International Suicide Rates and Prevention Strategies 2004
Figures 3 and 4 show year 2001 suicide rates for males and females Global trends
from selected countries. While each country maintained relatively
consistent ranking for male and female suicide rates, four of the five
highest-ranking countries were in the Eastern European Region. Japan,
which had rates comparable to the Eastern European countries, has
shown a steady decline in suicide rates in the past decades (De Leo
& Evans,2004).

Figure 3 : Suicide Rates for Males from Selected Countries, 2001
LITHUANIA 16.1
JAPAN 14.1
HUNGARY 13
RUSSIAN FEDERATION 11. 9
LATVIA 11. 9
FINLAND 10.9
BELGIUM 10.7
SWITZERLAND 10
AUSTRIA 9.8
CHINA (HONG KONG SAR) 9.8
FRANCE 9.4
BULGARIA 9.1
REPUBLIC OF KOREA 8.3
DENMARK 8.1
SWEDEN 8
GERMANY 7.3
NEW ZEALAND 6.9
NORWAY 6.8
SINGAPORE 6. 4
NETHERLANDS 6.3
CANADA 5.1
AUSTRALIA 5.1
IRELAND 4.3
UNITED STATES OF AMERICA 4.1
SPAIN 4
ITALY 3.4
UNITED KONGDOM 3.3
PORTUGAL 2
GREECE 1.6
0 5 10 15 20
Rate (per 100 000 population)
Source: De Leo and Evans (2004)
Figure 4 : Suicide Rates for Females from Selected Countries, 2001
LITHUANIA 75.6
RUSSIAN FEDERATION 70.6
LATVIA 56.6
HUNGARY 47.1
JAPAN 36.5
FINLAND 34.6
BELGIUM 29.4
AUSTRIA 27 . 3
SWITZERLAND 26. 5
FRANCE 26. 1
BULGARIA 25.7
NEW ZEALAND 23.7
AUSTRALIA 21.2
DENMARK 20.9
GERMANY 20.2
SWEDEN 19.7
NORWAY 19.5
CANADA 19.5
REPUBLIC OF KOREA 18.8
IRELAND 18.4
UNITED STATES OF AMERICA 17.6
CHINA (HONG KONG SAR) 16.7
NETHERLANDS 13
SINGAPORE 12.5
SPAIN 12.4
UNITED KONGDOM 11.8
ITALY 11 .1
PORTUGAL 8.5
GREECE 5.7
Rate (per 100 000 population)

Source: De Leo and Evans (2004)

In Malaysia, the Ministry of Health (MOH) Report in 1999 showed National Trends
a suicide rate of 6.3 per 100,000 population. However, in 2004, the
suicide rate was later estimated to be between 9 - 12 per 100,000
population (Consensus meeting with International Association For
Suicide Prevention, IASP Consultant, 2003).
There is difficulty in obtaining correct statistics for suicidal mortality, Suicide

as there is no co-ordinating agency for data collection. Local research mortality
indicates substantial under-reporting of suicides. Estimates of the estimate for
corrected crude suicide rate for Peninsular Malaysia in the 1980s were Malaysia
between 8 to 13 per 100,000 population, while for the period 1990 to
2000 it was estimated at 10.5 to 13.5 per 100,000.
In 2002, it is estimated that about 7 suicides occurred everyday

amounting to more than 2,500 deaths per year. Therefore, about 30,000
family members and friends will be directly or indirectly affected by
suicide each year.
Generally, it is widely acknowledged that official mortality figures General under-

under-estimate the true extent of suicide mortality (Sainsbury & reporting
Jenkins, 1982) and Malaysia is no exception. This is attributed to
several reasons. One is the stigma attached to suicide as it may be
considered a religious contravention or a grave sin. Another important
contributing factor in Malaysia is the legal penalties for suicide and
attempted suicide being enforced by the legal system. Death by
suicide is considered a crime under the Malaysian Penal Code, and
attempting suicide is against the law and punishable by imprisonment.
Abetting suicide is a crime and punishable by imprisonment while
abetting suicide of a mentally ill person is punishable by death. Under
Malaysian law, all suicides are classified as “unnatural deaths” and
mandatory to be reported to the police.
There is no available co-ordinating body for compiling, analysing and Problems of

disseminating information on suicide in Malaysia. Suicide mortality establishing a
data are at three sources - the Ministry of Health (MOH), the Police database
Department and the Statistics Department. There is possibility of
overlap and duplication of data, but under-reporting is still the major
problem.
One local study indicates that there is a major problem in the reporting
of certified deaths as suicides because of poor certification procedures.
Underlying causes of deaths due to poisoning or drowning or fall from
heights are often not properly documented, resulting in many of these

deaths being clustered under the rubric of deaths due to undetermined
violence or other violence (Maniam, 1995).
This crucial issue needs immediate attention. There is a great need to MOH suicide
establish standard reporting of deaths and a centralized co-ordinating registry based
system to collect suicide statistics to facilitate planning and effective on autopsies
implementation of specific interventions and prevention programmes
for suicide. A database on suicide mortality based on autopsies from all
MOH hospitals was initiated recently in 2004. This suicide registry is
jointly undertaken by the Department of Public Health, MOH and the
Psychiatric Department of Kuala Lumpur Hospital and will be piloted
in three hospitals in Johor, Pahang and Kuala Lumpur.
Improving quality of data on suicide
To improve quality of suicide data, it is recommended that specialists Recommen-

supervise doctors reporting on causes of death to ensure full and dations
accurate reporting. Medical schools could place emphasis on teaching
students proper reporting procedures. Sometimes, family members
prevail upon the authorities to report suicides as accidental deaths to
avoid stigma or to avoid legal issues. A way to circumvent this may
be to develop a “Dual Reporting Method” for suicide mortality where
actual cause of death is only reported to the authorities, while the
family gets a death certificate stating medical causes.
A Suicide Surveillance System is the process of collecting information Establishing

about suicide mortality and morbidity resulting from suicidal a Suicide
behaviour. This includes information on suicide mortality, morbidity Surveillance
of suicidal behaviour, characteristics of victims, precipitating events, System
adequacy of social support and health services, and cost of injuries
related to suicidal behaviour. The MOH could be the main player with
experts from the Universities and the Police or other relevant agencies,
to establish a Suicide Surveillance System for the country.
Types of suicide mortality
In many countries, including Malaysia, the commonest method for Means and
suicide death is poisoning (ingestion of pesticides or other poisons methods
such as paracetamol). Other methods include hanging and jumping for suicidal
off heights, which is increasing in urban areas. There are also reports mortality
of carbon monoxide poisoning from exhaust gases of motor vehicles,
which appears to be an increasingly common method in recent years.
There is some evidence that sensational and detailed reporting of these

fatal methods influences the decisions of distressed people to take the
fatal step and their choice of method.
Availability of, and access to, the methods are major determining Limiting access
factors resulting in mortality. Limiting access to means is an approach to means
to suicide prevention that has the strongest evidence for efficacy in
suicide prevention (Gunnell and Frankel, 1994) and is a core component
of most National Suicide Prevention Strategies. Beneficial activities
include reducing the availability and accessibility of pesticides, as
well as lethal amounts of prescription and non-prescription drugs
over the counters.
Pesticides are responsible for about one third of suicides worldwide. Reducing
Sri Lanka has started a “Secure Access to Pesticides” Programme where availability and
all pesticides are required to be kept double-locked in a box with access accessibility to
only to two different members of the family, usually the father and the pesticides
mother. The programme which ensured that no one member of the
family has access to the poison in a fit of impulsive anger, sorrow or
grief, has shown encouraging preliminary results in reducing suicide.
This inexpensive preventive strategy, recently introduced as a national
programme is now being studied in detail.
In Malaysia, the most common methods are poisoning, with mainly Suicide methods
pesticides and other poisons including paracetamol, and hanging. in Malaysia
Paraquat, a lethal pesticide commonly used in plantation farms and
estates, is highly toxic and causes high fatality rate. Over the last 10
years (1987 to 1997), paraquat has been the source of 700 poisoning
cases in Malaysia and 3% of paraquat ingestion is suicidal cases.
Despite the announcement of a ban on paraquat in August 2002, there
were steps taken recently by the Ministry of Agriculture to review the
ban, and paraquat will still be available in the market up to November
2007.
Paracetamol has emerged as a major choice of deliberate overdosing.

Since it is harmful in higher doses, some countries have initiated steps
to restrict its availability by introducing by-laws to limit the number
of tablets in packaging.
Advocacy on suicide prevention
In tandem with the global advocacy on suicide prevention, the MOH Creating
in October 2003 began activities to increase awareness on suicide and awareness
prevention of suicide. A seminar and workshop was jointly organized among

by the Family Health Division of the Public Health Department, MOH healthcare
and the Department of Psychiatry, Faculty of Medicine, National providers
University of Malaysia (UKM) and held with the assistance of the
International Association for Suicide Prevention. The objectives
were to create awareness among healthcare providers on suicidality
and suicide prevention, and to establish national networking and
collaboration. About 80 participants from various agencies including
the MOH, the Ministry of Education, the Department of Social Welfare,
Universities, the media and “The Befrienders” (a non-government
organisation or NGO) attended the forum.
Since the theme for World Suicide Prevention 2004 was “Media Educating for
Advocacy in Suicide Prevention”, special exhibits highlighting responsible
newspaper cuttings on suicide reporting from local newspapers were media reporting
developed. The aim was to highlight the negative and sensational
media statements to educate on the need for responsible reporting.
A workshop on suicide prevention was also conducted for 60 Need to monitor

media representatives. A most useful part of this workshop was the Media reporting
preparation of media guidelines by representatives of the media, which
was launched in September 2005. What is needed now is a monitoring
body with representation from the media to assess how well reporting
conforms to these guidelines.
The MOH Community Mental Health Programme
The MOH Community Mental Health programme undertakes mental Strengthening

health promotion activities since its establishment in 1997. The efforts to
programme aims to reduce stigma and discrimination of people with destigmatise
mental illnesses. It is hoped that the campaigns will have an indirect mental problems
impact on suicide mortality and behaviour by increasing community
awareness, reducing the overall negative view on mental health
problems and illnesses, and increasing the likelihood and acceptability
of sufferers to seek help. Many mental health promotion activities,
such as health talks and advertorials through the media, public health
forums and talks, exhibitions, and press conferences have been held
during World Mental Health Month since 1997 and during the Suicide
Prevention Month since 2003 onwards.
These efforts to increase destigmatisation of mental illness have

included production and dissemination of Health Information,
Education and Communication (IEC) materials such as pamphlets,
posters, exhibits, info-kits, calendars and collaterals on mental health

and early treatment of mental illness such as depression, anxiety
bipolar disorders and schizophrenia.
Improving detection and treatment of depression
Detection and management of depression is another important Managing

component of suicide prevention. The Malaysian Psychiatric depression
Association has started training general practitioners to detect and
manage depression since 2001. The training has included Family
Medicine Specialists at primary healthcare level since 2003.
The psychiatric departments of MOH hospitals have conducted

ongoing training of health personnel to strengthen their knowledge
and skills in management of psychiatric disorders.
To address depression, anxiety and other emotional and behavioural Development of

disorders among children and adolescent, a training module on Child training modul
and Adolescent Mental Health for Specialists was developed in 2003.
The aim is to strengthen detection and early intervention. Training
using this module has been undertaken annually. Another module
on Child and Adolescent Mental Health for Primary Health Care
workers was developed in 2004. Training for healthcare providers,
school counsellors, teachers and lay counsellors from relevant NGOs
will be carried out in 2006 onwards using the same module.
Involvement of primary healthcare personnel, school counsellors, Capacity

social workers and the media is important to enhance public awareness building
and promote suicide prevention activities. They can play a major role
in providing emotional support to those experiencing depression and
anxiety as well as mental health problems. Training for journalists
and media personnel had already begun as early as 2003 by the
“Befrienders” and the MOH followed suit the two consecutive years.
Non-governmental organizations (NGOs) play an important role in

suicide prevention. However, there are not many NGOs providing Counselling
suicide prevention activities in Malaysia at present. The “Befrienders”, and Help Line
run by 80 trained volunteers, has been actively providing 24-hour services
counselling. Since it was established in 1970 it has been the only NGO,
which provides support in the form of counselling, help lines, public
forums and talks. The ‘Befrienders’ received a total of 6,201 calls in
2003 and 5,370 calls in 2004, of which 17.7% to 19.3% had suicidal
thought respectively (Figure 5)
Data from the ‘Befrienders’ also showed that there were more female

Figure 5 : Types of Callers to Befrienders” in 2003 and 2004
Percent Unknown
Non Suicidal
100.0% Suicidal
80.0% 53.1% 48.2%
60.0%
40.0% 29.2% 32.6%
20.0%
17.7% 19.3%
0.0%
2003 2004
Year
than male callers (Figure 6). Callers by

gender
Figure 6 : Distribution of Callers by Gender, 2003 and 2004
60.0% 55.8% 56.8%

Male
50.0% 43.8% Female
42.2%
Unknown
40.0%
Percent
30.0%
20.0%
10.0%
0.4% 1.0%
0.0%
2003 2004
Year

Chinese contributed to more than 50% of the calls for both years (Figure Callers by ethic
7). Although Indians had the highest number of suicidal mortality in group
2000-2004, not many of them sought help for their problems. Only an
average of 20% of callers was Indians. The majority of callers were in
the those aged between 21 – 30 years, contributing to an average of
Figure 7 : Distribution of Callers by Ethnic Group, 2003 and 2004
60.0%
50.0%
40.0% Malay
Chinese
Percent
30.0%
Indian
20.0% Others
10.0% Unknown
0.0%
2003 Year 2004
25% of the total callers, followed by those in the 31-40 year age group
which contribute to about 20% of the total (Figure 8).
Figure 8: Distribution of Callers by Age Group, 2003 – 2005 (Jan-Aug)
30.0%
25.0%
20.0%
2003
Percentage
15.0% 2004
2005 (Jan-Aug)
10.0%
5.0%
0.0%
0
0
0
wn
e
low
-5
-6
-3
-4
ov
o
41
51
21
31
ab
be
kn
Un
d
d
an
an
61
20

Among the callers, 14% were students, 11% were professionals
and executives while calls from the unemployed were about 8%
(Figure 9).
Figure 9: Distribution of Callers based on Occupation, 2004
4%
11% Professional & Executive Business
23% 8%
Non-Professional Skilled
2%
Unskilled Housewife
2% Student Unemployed
19% Pensioner & Retiree Others
14% 7%
2% 8%
Unknown
In response to growing concern over suicidal behaviour, in 1996, the Key elements
United Nations published guidelines to assist and stimulate countries to suicide
to develop national strategies aimed at reducing mortality, morbidity prevention
and other consequences of suicidal behaviour. The guidelines
emphasized the need for inter-sectoral collaboration, multi-disciplinary
approaches and continued evaluation and review.
Six key elements for effective suicide prevention strategies include:
• Support from government policy

• A conceptual framework
• Well-established aims and goals
• Measurable objectives
• Identification of organizations capable of implementing objectives
• Ongoing monitoring and evaluation
Suicide prevention strategies in Malaysia
While mental health problems are a core risk factor for suicide, suicide
prevention requires an integrated and multifaceted approach. Public health
approach

Recognising the interrelatedness of all risk and protective factors for
suicide, Malaysia’s approach to suicide prevention targets at a broader
public health perspective, both at individual and population levels.
The Malaysian National Suicide Prevention Strategy operates at three

levels - universal, selective level and indicative levels. The components
of the proposed strategies at various levels are as follows:
Universal level
Promotion of mental health awareness including encouragement of

help-seeking behaviour.
• Development of a mandatory supervised reporting system for

suicide
• Implementation of National Media Guidelines for Suicide
• Improvement of collaboration among different service providers
• Establishing networking with general practitioners
• Discourage the use of paraquat or alternatively ensure secure
access to such has been described in the case of Sri Lanka.
• Procurement of counsellors to be placed at the primary healthcare
facilities
Selective level
• Active outreach of individuals with the risk of suicide, for example

individual with depressive illness or psychosis
• Counselling and rehabilitation services
Indicative level
The following objectives have been adopted :
• To promote awareness on suicide through the schools, health

institutions and media with emphasis on recognition of mental
health disorders and suicidal behaviour
• To promote human resource development and training
• To enhance multi-sectoral collaboration in providing counselling
and help-line services
• To reduce the availability and accessibility of pesticides
• To reduce the availability of lethal amounts of prescription and
non-prescription drugs
A draft of the National Suicide Prevention Strategy has been developed

with the objectives mentioned above. A Technical Working Group A National
formulated this draft with the assistance of IASP experts and the Suicide
National University of Malaysia (UKM). This proposed action plan Prevention Plan
aims to promote positive emotional and spiritual well-being of Of Action
Malaysian society through continuous multi-sectoral collaboration.
Conclusion
Mental health problems represent a major, but rarely the only, precursor
to suicide and suicidal behaviour. While a majority of countries,
including Malaysia have enacted programmes to address mental
health, only some aspects of the mental health programmes may be
beneficial to suicide prevention and their limited usefulness does not
provide a sufficient response to suicide. Suicide needs to be addressed
thorough policies and strategies that acknowledge the interrelatedness
of all risk and protective factors for suicide, including socioeconomic,
cultural, and mental health problems.
Several countries have well-established national suicide prevention

strategies, and many others have either recently established one or are
in the process of doing so. Whatever the status may be, it is important
that the prevention strategies have a positive impact on the suicide
rate or trend.
As resources, in terms of manpower and funding are made available,

the MOH has in the pipeline, plans to implement suicide prevention
programme in the Ninth Malaysia Plan. The programme will include
the prevention strategies outlined above and will take a multi-sectorial,
holistic and comprehensive approach. A Suicide Prevention Policy
and Guidelines will need to be developed as blue print for suicide
prevention in Malaysia.
References:
1. World Health Report (2001). Country Report. Geneva: World Health Organisation.
2. Schmidtke, A. (1997). Perspective : Suicide in Europe. Suicide life threatening behaviour.

27:127-136.

3. De Leo D, Evans R. International suicide rates and prevention strategies, 2004. global
trends in suicide mortality 2:15-20.
4. Ministry of Health Malaysia. Malaysia ‘s Health 1999, Suicide and Parasuicide.
5. De Leo D, Heller T. Suicide in Queensland 1999-2001. Mortality rates and data; 2:23-28.
6. Department of Statistics, Malaysia. Population and Housing Census, 2000.
7. Maniam T. Suicides and undetermined violent deaths in Malaysia, 1966-1990: Evidence

for the misclassification of suicide statistics, 1995.
8. Law FYW. Suicide Prevention in Hong Kong. Paper presented at meeting on suicide
prevention in Western Pacific Region held in Manila, August 2005.
9. Graitcer J. Safety Res. 1987; 18:191-198, U.S Dept Health & Human Services, NSSP, 2001.
10. The Befrienders, Kuala Lumpur. Unpublished data of callers from 2003 – 2005 (January
- August).
11. United Nations. Prevention of Suicide : Guidelines for the formulation of national
strategies : New York, 1996.
12. Nam YY, Lee SH. Suicide Surveillance System. Paper presented at meeting on suicide
Gunnell , D. and Frankel, S. (1994) Prevention of suicide : aspirations and evidence.
British Medical Journal 308:1227-1233.
13. Sainsbury, P. and Jenkins, J.S. (1982) The accuracy of officially reported suicide statistics
for purposes of epidemiological research. Journal of Epidemiology and Community
Health 36:43-48.
14. Consensus meeting on formulating the national suicide prevention programme with
International Association for Suicide Prevention, IASP Consultant held in UKM,
Malaysia, Oct 2003.

THE NEW GENERATION HOSPITALS – IT HOSPITALS
SUMMARY
The Future Healthcare System is set to harness the power of information and
multimedia technologies to transform the delivery of healthcare services in the country
towards improving health and health outcomes in the population. Demands on the
healthcare system to provide safe, effective, efficient, seamless, timely and quality
health care service, through access to the right information at the right place and time,
has necessitated that health information be provided in an integrated and holistic
manner. The Electronic Medical Record (EMR) is the most important component for
information management in a computerized and Integrated Healthcare system. The
“rebirth” of hospitals in the 21st century into a new paradigm of healthcare delivery,
makes it imperative for this new generation of hospitals to adopt Hospital Information
System solutions to meet the above objectives.
Introduction
I
n line with the government’s Vision 2020 to achieve developed
country status by the year 2020, the Ministry of Health formulated
its Vision and Mission for Health, and identified eight health service
goals to ensure realization of the National Health Vision.
The attainment of the future healthcare system requires reshaping Future health
and transforming a system that has thus far largely focused on system
illness, facilities and healthcare providers, into one focused on
wellness, catering to future generation of informed persons and ICT
environment, as well as having the capacity to provided integrated
and seamless healthcare services across all sectors.
Through the various five year National Development Plans (Malaysia Earlier hospitals
Plan), hospitals have been built using templates of standard and one-
off plans, based on the traditional way of healthcare provision which
is provider focused. From the 7th Malaysia Plan period onwards,
there was a conscious effort to develop hospitals into the new ways
of working by leveraging on Information and Communication
Technology (ICT).

The new 21st century hospitals have to harness the strengths of New generation
information and multimedia technologies to enhance efficiency hospitals
in hospital management, improve patient care through better
documentation and record keeping, and bringing together all patient
information to support continuity of care. It is patient focused rather
than provider focused, providing coordinated continuous and seamless
care through a “network of care” concept . This is the “rebirth of
hospitals” into new ways of working and providing care using ICT to
generate, manage and retrieve health care information.
Hospital Information System (HIS)
Hospital Information system (HIS) refers to an electronic information Definition of

system that would support the core business of patient care and enable HIS
the hospital to run as a facility / organization . In the Malaysian context,
the HIS should have the minimum functionalities to meet the Eight
Health Services Goals (Table 1). The system should be able to improve
healthcare delivery so as to meet service requirement, ensure continuity
of care, improve efficiency and productivity, improve patient safety,
improve quality of care and health outcomes as well as empower
healthcare providers and consumers.
Table 1 : Eight Health Service Goals
Goals of Health Service Description of goals
1. Wellness focus Provide services that promote individual wellness

throughout life
2. Person focus Focus services on the person and ensure services are
available when and where required
3. Informed person Provide accurate and timely information and make

informed decisions
4. Self help Empower and enable individuals and families to manage

health through knowledge and skills transfer
5. Care provided at Provide services into rural and metropolitan homes, health
home or close to settings and community centres
home

6. Seamless Manage and integrate health care delivery across care
Continuous care settings, episodes of care and throughout life
7. Services tailored as Customise services to meet individual and group needs

much as possible and special circumstances
8. Effective, Efficient Provide enhanced access , integration and timely delivery

and affordable of high quality services at reasonable cost.
services
In addition, the Health Information System should also be able to Other benefits of
generate various health system reports for local management and HIS
planning, as well as contribute to the national population health
database from individual Lifetime Health Records (LHR). The LHR
repository will be the focal point for integration of all electronic health
records (hospital and clinic visit summaries) to ensure continuity of
care across the health sector.
The HIS should have the following minimum functionalities as

depicted in Table 2.
Table 2 : Minimum Functionalities in a Hospital Information System
• Person management Manage and integrate health care delivery across

• Patient Accounting care settings, episodes of care and throughout life
• Patient appointment/
scheduling Customise services to meet individual and group
• Order / report management needs and special circumstances
• Laboratory Management
• Pharmacy management Provide enhanced access , integration and timely
• Discharge Summary delivery of high quality services at reasonable
• Medical Records cost.
management & document
tracking
Source: Planning and Development Division, Ministry of Health Malaysia 2004: 9MP Technical
Working Group Paper: Transforming Healthcare Services through ICT: The Way Forward.

Health informatics
Health informatics, is a term used for healthcare information management, Health

originating in the systemic use of data to manage and provide health informatics, the
services. It contains elements of “acquisition, organization, analysis, basis for HIS
evaluation, synthesis, management, communication and dissemination
of information”.
With advances in computing and communications technology, it is Advancements

feasible to store, assemble and retrieve electronic patient records from in health
different systems, thus allowing clinicians to have an integrated view informatics
of a patient’s life-long health record at the point of care. The electronic
health record is the single most important component for information
management in computerized integrated healthcare systems.
The use of health informatics will help coordinate and manage patient
data more efficiently through electronic means. The development of
shared health information systems and technology infrastructures
in networking and patient databases will integrate the healthcare
enterprise and thus improve the quality of patient care. The new
generation hospitals with HIS systems have to be well versed with
health informatics.
The Malaysian experience in HIS
The use of information technology is not totally new in Malaysia. In SPPD / SPPL
the 1980’s, an in-patient administration system [Sistem Pengurusan
Pesakit Dalam (SPPD)] was implemented in 14 hospitals throughout
the country to manage in-patient billing and revenue collection.
Furthermore, an outpatient management system [Sistem Pengurusan
Pesakit Luar (SPPL)] was also introduced in two of the above hospitals
with similar financial objectives. Both these systems which were
developed in-house are independent stand-alone systems. In addition,
there are several other “stand-alone” systems which have been
implemented in the existing hospitals, by the end user clients, to meet
the functional requirements of the respective clinical disciplines.
In the 6th Malaysia Plan (6 MP, 1991-1995), it was proposed that all Selayang
hospitals (new and existing hospitals ) shall be equipped with electronic Hospital – the
Hospital Information Systems. Selayang Hospital was the test bed for first THIS
a hospital-wide IT solution called Total Hospital Information System hospital
(THIS) in 1998, followed by Putrajaya Hospital and Putrajaya Health
Clinic in 8th Malaysia Plan (2001-2005). However, these systems are

yet to be integrated across the health care enterprise, meaning between
institutions.
The implementation of a fully integrated facility information system

called Total Hospital Information System (THIS), encapsulates the
integration between clinical including imaging and critical care,
financial and administration systems. The challenge is in adopting
the best working method as well as innovations in forming electronic
work process in all aspects of patient flow to achieve the notion of
seamless and continuous patient care.
The years 2004 -2005 saw the implementation of two other IT hospital Basic and
models namely, the Basic Hospital Information System (BHIS) at Intermediate
Kepala Batas Hospital in Seberang Prai Utara district of Pulau Pinang, HIS
and the Intermediate Hospital Information System (IHIS) at Lahad
Datu Hospital in the state of Sabah. Figure 1 depicts the incremental
relationship between the various levels of the Hospital Information
systems that were hitherto outlined in 7th Malaysia Plan.
Figure 1 : Levels of Hospital Information Systems in 7 MP
evels o ICTIm lementation
Total
- IHIS+ Radiology + PACS
+ Administration +
Financial + Inventory +
Personnel Management +
DDS + Case Mix, etc
Intermediate
- integration o
HIS + a oratory
+ P armacy
asic
In ormation Systems
- Patient Management
System Clinical
In ormation System
F C MP IT
Figure 1 : Levels of Hospital Information Systems in 7 MP

The Basic Hospital Information System comprises of modules for person Various levels
management, computerized physician order entry and result reporting of Hospital
and a clinical discharge summary. The Intermediate level Hospital Information
Information System has in addition, a computerized Laboratory Systems
Information System and an electronic Pharmacy Information System.
Figure 2 depicts the scope of the Intermediate Hospital Information

System (IHIS) that was implemented in Lahad Datu Hospital, a 268
bedded replacement hospital in Sabah.
Figure 2 : Scope of the Intermediate Hospital Information

System (IHIS) in Lahad Datu Hospital
Patient Billing
Other Admin /
Finance System
Patient Management System
Clinical Documentation Paper Based ie ESPKB etc

(Hardcopy)
Order and Result Viewer Record Intermediate HS
Internet
Laboratory Information
System
Pharmacy Email
Information MAR
System
Medical Report &
Record Statistic
System Teleconsulta Office Automation
tion
Clinical Component
Clinical Component Non - Clinical Component
The scope of the Intermediate Hospital

Information System (IHIS) at Hospital Lahad Datu
Source: Lahad Datu Hospital 2005
Recognising the need for development of standardized data elements Standardizing

and customization of the application software to fulfill all information data sets
requirements for the provision of seamless patient care service, a central
“THIS Core Team” comprising of health care professionals was set up
in 2002 by the Ministry of Health. This was a multi disciplinary team
with a mix of personnel with varied expertise of HIS systems. This
team was also entrusted with the task of ensuring compliance and

consistency with other E government initiatives and guidelines. The
HIS implementation also took cognizance of the need to share data
and information where appropriate for the purpose of the delivery
of continuous and seamless care. The central THIS Core Team was
supported by the Telehealth Division of the Ministry of Health which
was responsible for the development of Health Informatics Standards.
Evaluation of HIS
End-user surveys and evaluation of the HIS System at Selayang

Hospital for the development of the Strategic Information System End-user surveys
Plan for Selayang Hospital, as well as surveys and evaluations of HIS
Systems in Putrajaya and Kepala Batas hospitals had been conducted.
The findings of these evaluations provided much needed evidence to
improve future implementations of HIS solutions.
In a case study report on Hospital Selayang in 2002, 3 years after it

started service, user satisfaction survey indicated widespread approval Selayang
of THIS, where 64% to 71% of the users rated the IT work processes as Hospital
being very good to excellent. More significantly, 93% of those surveyed experience
indicated they preferred working in a paperless environment versus
a traditional paper-based hospital3.
The same report also recorded results of a benefit study comparing

Selayang Hospital with Tengku Ampuan Rahimah Hospital in Comparison
Klang. Among others, it showed that comparatively, there was a with HTAR
11.3% reduction time in patient registration; 36.7% time reduction in Klang
admission procedures; 73% time reduction following portable x-ray
reporting; 80% reduction in time to view the patient’s medical records;
and 51.6% efficiency gain in scheduling patients.
In the Lahad Datu hospital experience there is concrete evidence of

tangible benefits primarily in the areas of patient safety, minimization Lahad Datu
of drug errors, elimination of transcription errors, improvements in Hospital
resource utilization and optimization, improvements in efficiency and experience
effectiveness, quantifiable reduction of financial losses resulting from
“expired drugs”, improvement in quality of care, and, turn around
times.
Intangible benefits have also been realized in the area of appropriate

bed allocations and minimization of non-clinical transfer of patients Intangible
between bed classes, in the online clinic scheduling feature, and in benefits

improved quality of patient care through appropriate and timely
interventions and seamless care across a continuum. Production of
real-time management reports as system outputs has produced an
unquantifiable benefit in terms of savings of man-hours spent to
produce the reports as well as the accuracy of data and information.
Future directions for the new generation HIS hospitals : the

challenges ahead
Implementation of HIS systems
Drawing from the experience of Selayang, Putrajaya and Lahad Leadership

Datu hospital, the critical success factors that contribute to successful
deployment of a HIS solution, among others, are good leadership,
strategic planning, user motivation and commitment, and, involvement
of the clinicians (clinician buy-in). A strong, well read and empowered
leadership with effective decision making skills (to resolve problems
as they arise) is crucial to project success.
In system deployment and roll out - there is no perfection, no tried and System
true method for implementation. It is a journey of “pilot and improve, deployment
rollout and improve”, and one should be prepared to make changes
as the need arises. It is critical to “fix the bugs” before further roll out.
One must also be aware that it is impossible to completely replicate the
production use of a system in a test environment – hence the end-user
will always a “beta tester”.
As with any innovative initiative in a socio-technical environment “Easy wins”

(healthcare), it is important to get customer feed back and use it. Problems,
especially those that affect patient safety should be resolved quickly.
Confidence can be enhanced by “looking for the opportunity and quick
wins” especially in fine tweaking of the system to get value and benefits.
It has been proven that the training never ends and implementation Training
never really ends. Clinician efficiency comes first - if a clinician is
saddled with many tasks at go live, the clinician may never learn the
system well enough to achieve a good level of comfort and efficiency.
The application software should be kept simple. Content should
support efficiency and it has to be managed and maintained.
Operations and maintenance
Sustenance of operations and continued maintenance of the system Data integrity

in terms of managing the system hardware, software, and the and security

enhancements, upgrades and content management are key challenge
areas in the deployment of HIS systems. Data volume, flexibility and
scalability of the system, data integrity and security are some of the
critical areas that have to be addressed.
In the Malaysian context, it is vital to allocate adequate budget to ensure Maintenance

continuity and efficient sustenance of the system operations. As a rule budget
of thumb based on the experience of deployment of HIS solutions
in the 3 hospitals, it would be prudent to allocate an operations and
maintenance budget equivalent to 15 – 20% of the capital expenditure.
There should be timely scheduling of the operations and maintenance
contracts so that there is a smooth transition from the project
completion phase into the operational phase. An added advantage
would be to ensure that the operations team is “on board” during
the project completion phase, as it will facilitate the Operations and
Maintenance (O&M) training of the personnel as well as the transfer of
technology (TOT). This O&M training and TOT are vital to ensuring
efficient and effective functioning of the hospital.
The Chief Information Officer (CIO)
The need for a new genre of specialized medical personnel, the Chief Need for Chief
Information Officer (CIO).has crystallized as we move into the era Information
where Health Information Technology is the core of every significant Officer (CIO
business process in a hospital and is a critical success factor for
innovation and enterprise success. The CIO has to be “one step ahead
of the curve” and become an irreplaceable part of their organisation’s
success.
Conclusion
Hospital Information System (HIS) provides the environment for Benefits of HIS
better patient care and safety. It has the potential to improve patient
outcome through better clinical governance and continuity of care.
Management of clinical data, medical records and hospital resources
can be made more efficient, contributing towards better control of
hospital cost in the long run. From the patient’s perspective, the HIS
will enable access to timely, appropriate and accurate information for
management of his health.
With the successful adoption of HIS in the first few Ministry of Health HIS set to be
hospitals, future generation hospitals are set to utilize more of HIS in utilized in future
the years to come. The experience gained from implementation generation

of different levels of Hospital IT systems ranging from basic to Total hospitals
Hospital Information System (THIS) has provided many useful insights
into the functional and operational requirements of an “IT hospital.”
These would be useful in helping the Ministry of Health in developing
the next generation “IT hospitals” in the future.
References:
1. Medical Development Division, Ministry of Health Malaysia. Future Hospitals, Future

Needs : Meeting the challenges. Report of proceedings of Hospital Management
Conference, June 2000.
2. Planning and Development Division, Ministry of Health Malaysia (2005). Health

Information System (HIS) Hospitals: Way Forward.
3. M A Zubir, Rosnah H.. The Implementation of a Total Hospital Information System

(THIS): A case study in Selayang Hospital, 2002.
4. S. Rasiah, A Jai Mohan et al. Harmony in reality : eastern tranquility vs. western
technology. Paper presented by S. Rasiah at HIMSS Annual Conference, San Diego,
USA. Feb. 2006

CONTROL OF UNREGISTERED DRUGS AND
HEALTHCARE PRODUCTS IN MALAYSIA
SUMMARY
Poor quality drugs and healthcare products can threaten the health of the public. The
Pharmaceutical Services Division plays an important role in protecting the health and
safety of the public through enforcement of pharmacy laws and regulations pertaining
to unregistered drugs and healthcare products. Activities such as registration of
products, licensing, adverse drug reaction monitoring, post-market surveillance,
raiding, investigation, prosecution, consumer education and hologram introduction
are imperative to ensure the safety, efficacy and quality of drugs and healthcare
products for the consumer.
Introduction
I
n Malaysia, the lucrative healthcare industry is considered one of Need for
government’s priorities and various schemes have been introduced regulation
to help boost the pharmaceutical and healthcare industry. The sector
is highly regulated by the Drug Control Authority (DCA), through
the Sales of Drugs Act 1952 (Revised 1989) and the Control of Drugs and
Cosmetics Regulations 1984. Recent fatalities due to consumption of
unregistered drugs have escalated activities within the Ministry of
Health (MOH) against illegal pharmaceutical drugs and healthcare
products.
The vision of the Pharmaceutical Services Division (PSD) of the MOH Regulating
is to provide the best pharmacy services for the health and well being bodies
of the nation so as to achieve definite outcomes and improve quality
of life. The National Pharmaceutical Control Bureau (NPCB) as the
secretariat and executive arm of the DCA ensures that pharmaceutical
and healthcare products produced locally or imported conform to
standards of quality, safety and efficacy before they are registered.
The NPCB also ensures that all manufacturers, importers and
wholesalers of these products comply with the required standards
until the products reach the public. The Pharmaceutical Enforcement
Branch (PEB) under the PSD has the responsibility to ensure that
the manufacture, importation, sale, supply, management and use of
pharmaceuticals and healthcare products are conducted according to
the existing acts and regulations.

Regulation of registered drugs and healthcare products
A registered drug is one that is approved by the DCA for sale and Registration of
use in Malaysia. The DCA requires the registration of any drug in products
a pharmaceutical dosage form, intended to be used, or capable or
purported or claimed to be capable of being used on humans or any
animals, whether internally or externally, for a medicinal purpose. The
registered drug must be evaluated for efficacy and safety. Registration
of products ensures medications and healthcare products are effective
and are not contaminated with lead, mercury, arsenic, steroids or any
scheduled poisons listed under the Poison List Order. By the year 2005,
a total of 32,456 drugs have been registered, not including cosmetics.
Cumulative data on products registered are shown in Table 1.
Table 1: Cumulative Number of Products Registered (2003-2005)
Cumulative Data
Year Prescrip-tion Over-the- Traditional Cosmetics Total

drugs Counter (OTC) medicines
products
2003 9,659 7,206 12,107 6,656 35,538
2004 10,012 7,432 13,077 47,418 77,939
2005 10,339 7,732 14,385 83,430 115,886
Source: National Pharmaceutical Control Bureau
Manufacturers, importers and wholesalers are licensed, monitored and Licensing

audited to ensure all premises and practices employed to manufacture,
store and distribute these products comply with the guidelines issued
by the NPCB. A total of 1,891 licenses were issued for the year 2005
(Table 2).

Table 2: Licenses Issued To Manufacturers, Importers And Wholesalers (2003-2005)
Year Manufacturers Importers Wholesalers Total
2003 217 316 875 1,408
2004 227 456 864 1,547
2005 296 652 943 1,891
Source: National Pharmaceutical Control Bureau
Monitoring for adverse drug reaction (ADR) arising from the use of Adverse drug
medications is handled by the Malaysian Adverse Drug Reactions reaction
Advisory Committee (MADRAC) under the NPCB. Manufacturers, monitoring
importers and wholesalers, as well as healthcare professionals, are
required to submit ADR reports to the MADRAC.
Monitoring the quality of registered drug and healthcare products is Post-market

done through post-market surveillance. Samples tested at the NPCB surveillance
laboratories are either for registration, surveillance or enforcement
activities. The NPCB will test products for compliance with required
standards in Malaysia.
Enforcement on unregistered drugs
In 2005, more than RM 9.5 million worth of unregistered products was Centrally-driven
seized by the PEB, compared to over RM 20 million seized in 2004. programme
Items seized in 2005, however, were much higher than those seized
in previous years.
In 2004, a national programme was implemented to combat unregistered

products. States were required to conduct major operations according
to schedule. As a result, the number of items seized escalated compared
to previous years. One seizure valued at RM 13.7 million involved a
syndicate illegally manufacturing and distributing locally-produced
unregistered products claimed to be imported from United Kingdom
(Table 3), of which RM 10 million were seized in Selangor.

Table 3: Seizure of unregistered drugs by states (2003-2005)
2003 2004 2005

State Items seized Value(RM) Items seized Value(RM Items seized Value(RM)
Perlis 32 9,230 33 9,350 160 64,271
Kedah 207 147,519 563 1,484,975 212 99,541
Penang 315 52,517 290 289,334 263 1,155,573
Perak 371 620,671 312 1,329,708 566 300,167
Selangor 654 2,267,247 470 13,725,858 4,170 2,429,770
K.Lumpur 684 1,912,920 735 1,342,592 1,265 2,626,299
N.Sembilan 152 22,286 1,367 159,536 126 54,421
Malacca 231 165,180 790 894,750 1,152 521,898
Johor 471 180,108 729 94,119 649 418,594
Pahang 142 43,460 1,041 148,533 518 62,938
Terengganu 299 129,890 183 111,225 1,324 195,775
Kelantan 717 477,150 614 699,132 431 1,026,870
Sarawak 1163 312,164 389 162,859 1,053 490,903
Sabah 233 88,539 132 146,326 208 150,534
Labuan 16 3,127 56 4,815 145 6,058
Malaysia 5,687 6,432,008 7,704 20,623,112 12,169 9,598,809
Source: Pharmaceutical Services Division
Unregistered products seized from night markets, unlicensed premises, Seizure of

direct selling outlets and from Internet sales consisted of products unregistered
containing scheduled poisons, non-poison over-the-counter (OTC) products
products, traditional medicines and cosmetics. Most of the products
seized were traditional medicines and health supplements, of which
sex stimulants contributed the largest item. In 2005, a total of 4,575
unregistered traditional medicines items valued at more than RM 4.9
million were seized (Table 4). The products were from manufacturers
without Good Manufacturing Practices (GMP) certification to
guarantee safety, efficacy and quality. The PEB also encountered a few
cases of imitation products which did not meet quality requirements.
In 2005, 458 cases were investigated under the Control of Drugs and Investigation
Cosmetics Regulations 1984, and 244 cases were brought to court for and prosecution
prosecution with collected fines of RM 680,950 (Table 5). Many of the
cases were in the Klang Valley region.

Table 4: Types of unregistered products seized (2005)
Item Value (RM)
Scheduled poisons 1,675 938,838
OTC (non-poisons) 1,531 1,439,020
Traditional medicines 4,575 4,911,386
Cosmetics 1,222 529,497
Table 5: Investigations & prosecutions of unregistered products 2005
Investigations Prosecutions
State
2004 2005 2005
Perlis 3 2 2
Kedah 5 28 3
Penang 22 19 14
Perak 57 46 13
Selangor 90 71 40
K. Lumpur 35 32 52
N. Sembilan 8 15 18
Melaka 50 66 7
Johor 5 32 40
Pahang 29 42 4
Terengganu 16 4 18
Kelantan 34 40 17
Sarawak 15 34 5
Sabah 33 27 11
Labuan 0 0 0
Malaysia 402 458 244
Total fines collected (RM) 680,950

Steps taken to control unregistered drugs and healthcare products
Besides strict enforcement on unregistered products, the PSD has Need of

been enacting deterrent legislation and enforcing mandatory security Hologram
hologram labels since 1 May 2005. The hologram is introduced to curb
imitation, counterfeit or unregistered health products on the market.
All products including traditional medicines, food supplements and
imported or locally manufactured drugs registered with the DCA,
are required to bear the hologram labels. The seals authenticate the
contents of the products. External personal care (EPC) products such
as medicated soaps, shampoos and cosmetics are exempted from the
hologram ruling, although these are still required to be registered
with the DCA.
The tendency for self-medication and the obsession to enhance The role of the
sexual performances or to have a svelte body has boosted the health consumer to
supplements and traditional medicines industry. Hence, consumer inform the PSD
education is important for health and safety. Publishing enforcement of suspicious
activities and adverse effects cases, holding exhibitions and lectures products
and distributing pamphlets are ways to raise consumer awareness.
The public must be educated to check for expiry dates, registration
numbers, manufacturer’s names and addresses, and hologram labels.
However, such public education activities are limited, due to budgetary
constraint.
Enforcement alone, without an informed public, is inadequate to The role of

overcome problems of use of unregistered products. The Public can retailers
obtain useful information from the PSD website at www.pharmacy.
gov.my for current enforcement activities or lodge any complaint
or provide any information via e-mail to the Pharmacy Division in
Ministry of Health at pharmacy1@pharmacy.gov.my.
Retailers must also exercise diligence in maintaining proper record

and keep inventories of their stocks with regards to batch numbers,
manufacturing and expiry dates especially for the traditional medicines
that have short shelf lives of 2 – 3 years similar to the modern medicines.
Unregistered products may be brought into Malaysia either by

authorization of the Director-General of Health, or as part of personal Increase
luggage in a quantity that does not exceed one month’s use by a person. surveillance
Such provision can be misused by syndicates to bring in unregistered activities
products from abroad. Intensifying enforcement activities and

surveillance at the entry point will curb smuggling activities across
the border and ports of entry. This is an on-going activity of the PEB
and is being actively pursued.
Pharmaceutical and healthcare products are one of the most highly

regulated industries in the world. All registered products should bear Products
the name and address of the actual manufacturer. Foreign companies registration
who wish to market health products in Malaysia must appoint a local holder
agent to be products registration holder. The appointed agent would
thus be accountable for all matters pertaining to the registration of
the products.
The resurgence in interest of the public in biotechnology and alternative

medicines has stimulated expansion of direct selling businesses. The Monitoring
PSD is monitoring direct selling companies that are using contract direct selling
manufacturers to produce health products to ensure that registered
products are from valid and licensed manufacturing sites to avoid
breach of product quality, safety and efficacy.
Conclusion
The Pharmaceutical Services Division plays an important role in

safeguarding the health and safety of the public through combating
illegal health products in Malaysia. The Division will continue
to intensify its national programme to increase surveillance and
operation activities, as well as study and promulgate deterrent laws
from time to time to achieve its vision and mission. However, with
large numbers of unregistered and illegal products flooding the
market, consumer education and surveillance of retailers assume
greater importance.

References:
1. Ministry of Health. The Pharmaceutical Services Division. Annual Report 2004, Ministry
of Health Malaysia.
2. Government of Malaysia. Sales Of Drugs Act 1952 (Revised 1989), Amendment A 1084,
31 August 2000

INFORMATION VERSUS ADVERTISING
SUMMARY
The use of traditional print or electronic media for the propagation of health
information or advertising of products and services is well established. The advent
of the global information highway and newer interactive information technology
has revolutionised the way health information is presented to the consumer. Medical
advertisements now are highly sophisticated and consequently, promotional strategies
adopted by advertisers have resulted in the blurring of the once-clear demarcation
between health information and medical advertisements. Without question, medical
advertisements empower consumers by providing valuable health information
towards more rational decisions. However, abuses must be curbed. It is for this
reason that the Medicine Advertisement Board (MAB) scrutinises all information on
medical advertisements before publication. At the same time, recognising changes
in the field of advertising, the MAB has introduced measures aimed at liberalising
many aspects of medical advertisements.
Introduction
I
nformation explosion has been the hallmark of modern day Information
innovations and health information is no exception. Technological exploration
breakthroughs have permitted consumers to access medical
information in unprecedented volume. The arrival of media like
the internet has forever changed the landscape resulting in an urgent
need for regulators all over the world to redefine borders.
In the early days, manufacturers of potions and pills and other Information
purveyors of human health fought for consumer attention with large, through
often outrageous promises and colourful, dramatic advertisements. advertisements
Although many of these advertisements were not truthful or were
misleading, they played the traditional role of providing so-called
health information to the consumers. However, dubious products and
services have resulted in consumer movements to regulate the medical
advertisement industry.
Medical science has since made strident progress with the discoveries
of new products and treatment options that not only save lives but also
enhance the quality of life. The reality today is that information about
these products and services constantly vie for our attention through
various media that includes the internet.

This article reports on the role of the Malaysian Medicine Advertisement
Board (MAB) in exercising control and balance on health and medical
information and advertisement.
Few would question the enormity of the advertising machine that Advertisement
runs within our society. Advertisements are omnipresent and totally today
pervasive in our modern day culture. Despite or because of its ubiquity,
advertising is not an easy term to define. Usually, advertisements
attempt to persuade their audience to purchase a product or service.
Thus, there is constant clamour from consumer groups that advertisers
should not be given free reign and that there should be stricter vetting
of information that goes into an advertisement.
Most governments of the world realise that consumer vulnerability to

deceptive advertising is particularly acute in the area of health products
and services. Such advertisements are often the result of complex
promotional strategies and they wield enormous persuasive power
over unsuspecting individuals who have very little knowledge of the
information provided. Because of this great inequality of bargaining
power, governments often back up consumers with protective laws.
Today, advertisements of medical products and services are one of the

most highly regulated aspects of our life. It has been argued that this
is rightly so, as medical product and services are different from that
of other commodities. Medical products and services are by definition
and nature intended to have therapeutic effect, and influence the health
status of the sector of the population that has very little capacity to
evaluate the information presented.
Advertisement and information: the pros and cons
Detractors of medical product advertisements have argued that despite Exaggerated

governmental controls and self-regulation by the industry, most of information in
the advertisements present information in an exaggerated manner advertisement
designed to exploit the consumers’ lack of knowledge in medical
matters. They claim that these advertisements are very likely to arouse
unwarranted and unrealistic expectations leading to dangerous self-
diagnosing.Studies have shown that in the absence of proper controls,
advertisers of medical products tend to omit facts, downplay risks,
publish unsubstantiated claims and mislead consumers.
In the midst of these controversies, one pertinent question is whether Raising

advertisements themselves might serve a more positive purpose. consumer

Proponents of medical advertisements argue that advertisements serve awareness
to bring information to the people and thereby confer considerable
health benefit to the consumer. This is exemplified by Direct-to-
Consumer advertisements in countries that allow them, where one of
the main benefits is raising people’s awareness of disease states and
the treatment options available1. As a result, the argument continues,
patients become better educated, better equipped to discuss their
treatment with doctors, and better prepared to maintain the treatment
regime they determine jointly with their doctors.
In the case of health services, similar views have been put forward. Seeking
The Malaysian Medical Council (MMC) holds the traditional view publicity
that doctors should not resort to blatant publicity in the media in the through media
guise of providing health information to the public. It believes that
doctors have distinct ethical obligations to the public. These obligations
include professional competency, integrity, honesty, confidentiality,
objectivity and any attempts to dilute these values by promoting their
own professional advantage is considered an affront to the nobility
of the profession.
Bodies like the MMC have defined borders that serve as warning
when overstepped when it comes to information and advertisements.
It defines these two terms in the following manner2 :
Information - Providing information in relation to the medical profession Defining

is the act by which a registered medical practitioner as a health care provider, ‘Information’’
disseminates factual information to the public generally on health promotion
and specifically on diseases, their prevention, control and treatment, and
on any other aspects related to these modalities, without the practitioner
contravening the ethical codes of professional conduct, or without any designs
to obtaining patients, profiting financially or materially, or, appearing directly
or indirectly, to promoting his own professional advantage or product, or
appearing to be for these purposes.
Advertising - The word ‘advertising’ in relation to the medical profession Defining

must be taken in its broadest sense, to include all those ways by which a person ‘Advertising’
is made publicly known, either by himself or by others, without objection on
his part, in any manner or channel which can be fairly regarded as for the
purpose of obtaining patients, or promoting his own professional advantage,
or as appearing to be for these purposes.
The practices of touting or canvassing for patients are considered to

fall under the definition of advertising and are unethical.

The above definitions highlight the fine line between ‘advertising’ Thin line
and ‘information’. Admittedly, at the extreme ends of the spectrum, between
advertisements and information are clearly distinguishable. The information and
issue is when advertisers present information masked with indirect, advertising
innovative references which leave trails that ultimately lead consumers
directly to the product owners or service providers. In such cases, when
does information stop and advertisement begin?.
Matters become complicated with the entry of a third party - Treading the fine
the advertising agency. Today’s advertising industry is highly line
sophisticated. The most striking development is its ability to devise
highly subtle advertisements. The modern advertisers’ ability to blend
aspects of product information and health information into a highly
entertaining advertisement has been hailed as one of the finest example
of the industries’ contribution towards creativity, and its ultimate
success in providing one of the fundamental pillars of the modern
day advertising business.
Many examples abound. Institutional advertising with emphasis on Advertising

neither product nor service is meant to enhance corporate reputation, ingenuity
thereby indirectly ensuring credibility and loyalty for their products
and services. Disease awareness campaigns that are in vogue in recent
years are another example. There are arguments that disease awareness
campaigns sponsored by pharmaceutical companies are thinly veiled
attempts to advertise a particular health product. Hence, the collapse
of barriers between product information and advertisement has been
a significant development within the medical advertisement industry.
There is no discounting the fact that modern media is a uniquely
versatile medium for dissemination of health information whether in
the form of advertisement or not.
The Medicine Advertisement Board
The Medicine Advertisement Board (MAB) under the chairmanship Regulating

of the Director General of Health takes on a more pragmatic view of medicine
what constitutes an advertisement and how much control is exercised advertisement
on information that is placed in an advertisement. It is aware of the
winds of change that is sweeping the entire world in the field of
advertisements and is mindful of the effects of globalisation that has
brought on these changes. The Board tries to strike a balance between
stakeholders. These range from advertisers who believe healthcare
legislation that limits medical advertisements is outdated to consumer
groups that believe that uncontrolled advertisements present a recipe
for an impending health disaster.

While the MAB does not impose any restrictions on bona fide medical Key points
information or news that is not associated with any particular product in advertising
or health services rendered by a health institution or clinic, it considers control
any promotional attempts of specific products and services as clear
advertisements and therefore subject to control under the Medicine
(Advertisement and Sale) Act 1956. The following are some of the key
points adopted by the MAB in its control of medical advertisements.
• The MAB does not impose restrictions on information directed

exclusively to healthcare professionals.
• Editorial contents, bona fide health information and news of public
interest that is not associated with any commercial product or
service are not subjected to any regulatory control.
• Commercial sponsorship must not influence articles and editorial
contents purporting to provide heath information. Editorial
contents and health articles must be clearly discernible from
advertisements.
The MAB expects information concerning medicinal products and Information

services to be reliable, accurate, truthful and informative, balanced, up must be reliable,
to date, capable of substantiation and consistent with claims approved accurate,
by the Drug Control Authority if they are registered medicinal truthful,
products. It can be hard to judge the accuracy and credibility of balanced and up
medical information that appears in the form advertisements in the to date
mass media. Even people with medical background sometimes find
this a daunting task.
While MAB is mindful of the World Health Organisation’s stand

on self-medication, it takes special interest in ensuring information
appearing in advertisements do not result in consumers forsaking
timely professional intervention for serious ailments.
Since mid-2005, the MAB has introduced major changes to information Allowing
allowed in advertisements by healthcare providers. Health facilities advertisements
like private hospitals and clinics are now allowed to advertise freely by healthcare
in newspapers and magazines, pamphlets and brochures and even providers
on the internet. Restrictions on frequency of publication in the case
of print media and distribution points in the case of pamphlets and
brochures have been lifted allowing more meaningful and easier
access to consumers. More importantly, the Board now allows
medical practitioners to publish in advertisements their photographs,
qualifications and areas of specialisaton and services offered.

Conclusion
It is acknowledged that health information must reach the consumer

untainted by any bias or apparent self-interest. Skewed information
that accrues monetary gains in some form ceases to be information
per se but takes on a new role as an advertisement. There is consensus
that health information in the mass media must be more responsible.
In the case of advertisements, they must avail themselves to scrutiny
and control by the relevant authorities so that information provided
is accurate, fair and not misleading to consumers.
References:
1. Flynn LT, Alper PR. Does direct to consumer advertising of prescription drugs benefit
the public’s health? American Council on Science and Health, October 1999.
2. The Malaysian Medical Council. Guideline on dissemination of information in the

medical profession, 2005.

HEALTH TECHNOLOGY ASSESSMENT IN MALAYSIA
SUMMARY
Health Technology Assessment (HTA) aims at promoting the adoption and use of
appropriate, safe and cost-effective technologies in the provision of healthcare service.
The establishment of the HTA Unit in the Ministry of Health in 1995 has created greater
awareness on proper technology assessments before their adoption, and demand for
such service at the top management level. Besides conducting technology assessments
and reviews to support evidence-based policy decisions, the Unit also develops clinical
practice guidelines and clinical pathways. The HTA Unit has been designated as a
WHO Collaborating Center for Evidence Based Health Care Practice for the Asia
Pacific Region for four years effective from 27 July 2004. With rapid growth and
development of medical technologies globally, the HTA Unit faces many challenges,
the most crucial being capacity building to cope with increasing need and demand
for its core services. While health technology assessments have been initiated in the
public sector, in particular the Ministry of Health, there is a need to promote such
practices in the private sector to optimize use of resources and enhance the quality
of patient care service.
Introduction
T
he ever increasing demand for technologies, and a need to Establishment of
ensure the safety, effectiveness and cost-effectiveness of such HTA Unit
technologies, has led to the establishment of a Health Technology
Assessment (HTA) Unit in the Medical Development Division at
Ministry of Health Malaysia in August 1995. The Unit caters to the
health technology assessment needs for all Divisions and Programs
in the Ministry of Health (MOH). Requests from the private sector
are currently restricted to those received from members of the HTA
Council and those sent through MOH policy-makers in the Ministry
of Health. In addition, rapid assessments (referred to as technology
reviews) to meet the needs of top policy-makers and various technical
divisions, are carried out based on requests. For these technology
reviews, reports are usually made available within a month or two
after receipt of the issue. Reports on technology reviews and health
technology assessments, after approval by HTA-CPG-Council are sent
to the requesting units and relevant departments or agencies, which
are inputs to formulation of the policies for implementation.

To ensure quality of health care through use of safe, effective and Mandatory HTA
appropriate technology, MOH has made mandatory that all medical requirements
equipment within MOH hospitals using new technologies costing
more than RM 200,000 per unit, should undergo a health technology
assessment prior to acquisition.
Since April 2001, clinical practice guidelines have been brought under CPGs came
the purview of the Health Technology Assessment Unit. Efforts have under the
since been made to have clinical practice guidelines (CPG) on a more purview of HTA
evidence-based footing. CPG’s are assisting healthcare used as a Unit
means of translating policy to practice, assist healthcare providers in
managing some of the common medical conditions seen in the clinical
setting so that inappropriate decisions can be reduced, if not totally
avoided.
Mission
To encourage the appropriate use of health technology by providing

input to decision-makers through collection, analysis, dissemination of
information on the safety, effectiveness, cost-effectiveness and health
impact of technologies.
Function, core activities and other activities
The function of the Health Technology Assessment (HTA) unit include: Functions
• providing input for policy making on adoption or use of

technology;
• disseminating HTA information to healthcare providers; providing
HTA expertise to healthcare facilities; advising on standards and
norms;
• acting as a clearing house for HTA; and
• coordinating the formulation and implementation of evidence-
based clinical practice guidelines.
The core activities of the Health Technology Assessment (HTA) Unit

include conducting technology assessment on prioritized issues at Core activities
national as well as hospital level, carry out technology reviews and
facilitate/coordinate the development of evidence-based clinical
practice guidelines.
Other activities include production of HTA newsletters, training on

systematic reviews for development of CPG/s and conduct of HTA Other activities
for clinical specialists and other allied personnel, co-coordinating

research activities for MOH Medical Program, provide consultancy
on matters relating to technology assessment and CPG development,
and networking with other HTA and CPG related organizations at
regional and international level.
Creating awareness in evidence-based policy making
Many changes have taken place since the introduction of health

technology assessment in the Ministry of Health. The immediate benefit Strengthening
is greater awareness amongst policy makers and health professionals evidence-based
on the importance of health technology assessment consideration policy making
in the formulation of health policies. There has been an increasing
number of requests from top management in various Divisions of the
Ministry of Health (MOH), as well as from outside the MOH to carry
out health technology assessments, for example in the introduction of
new programme, activity or service that utilizes a certain technology,
purchase of expensive drugs and equipment, and others.
Mechanism for HTA
The process of health technology assessment starts with receival of

requests from various sources and at various levels, including from the Expert
Health Minister and the Director-General of Health. Identified issues committee
are prioritized using a set of criteria, adopted from other international
HTA organizations.
Prior to conduct of an HTA issue, an appointed expert committee will

be formed. Such expert committees are multidisciplinary, involving all
those related to the issue. The scope and scale of the assessment will
depend on the nature of the problem, the availability of resources, the
expert committee capabilities in reviewing and interpreting evidence.
The completed HTA report is then forwarded to the HTA Technical
Advisory Committee. This committee then examines the methodology
and technical content. If acceptable, it is then forwarded to the HTA-
CPG Council, chaired by the Director-General of Health for approval.
The approved reports are then forwarded to the requesting department
or agencies.
Development of Clinical Practice Guidelines (CPG)
A new work process has been drawn up, which among others, involves
establishing a mechanism for clinicians to identify topics for CPG Technical
advisory

development; the setting up of a Technical Advisory Committee to committee on
vet the quality of CPG; and formal approval of all new guidelines CPG
by the HTA-CPG Council chaired by the Director-General of Health
before release.
To improve acceptability of CPG, members of the expert committees Multi-

responsible for developing CPGs are recommended to be as disciplinary
multidisciplinary as possible, involving healthcare providers from members
all sectors namely public, academic and private sectors. Draft CPGs
are uploaded in the MOH website to invite feedbacks and comments.
Where necessary, the draft CPG’s will also be sent to external reviewers
for further comments on the content of the CPG’s.
Clinical pathways
Implementation of CPG has always posed a problem, and this is Use of clinical
compounded by the fact that there is no effective strategy to monitor pathways
the degree of utilization of the guidelines. Questionnaires on utilization
would inevitably produce positive responses. These, however, may
not reflect the actual situation. It is felt that this can best be achieved
through the use of clinical pathways. It is expected that clinical
pathways would eventually replace the current case notes. This will
assist in providing data for auditing purposes. Using clinical pathways
encourages adherence to the guidelines and change in practice. The
clinical pathways that have been introduced in MOH hospitals are
based on MOH evidence-based CPG’s which takes into account local
practices and constraints, in the management of individual patients.
Training
It has been identified that creating awareness on HTA is a crucial Annual training
strategy in propagating the evidence-based approach amongst our course
health care professionals. An annual training course has been organized
for the past ten years. Training on the conduct of health technology
assessment is provided to specialists, hospital directors and other
allied MOH personnel. Each year about 45 personnel are trained in
one course.
To assist in the development of evidence based CPG, systematic review Systemic review
workshops were introduced in 2002. Two workshops are planned each workshops
year, with about 40 participants per course.
The 1st Asian Regional Conference in Health Technology Assessment Regional

was held in 2000 is jointly organized by the Ministry of Health of conferences
Malaysia in collaboration with the Malaysian Society of Quality in on HTA in
Health. Subsequently, the Ministry of Health in collaboration with Malaysia
the Malaysian Society of Health Technology Assessment organized
the 2nd Asian Regional Conference in Health Technology Assessment
in 2003. Both conferences had an overwhelming response with about
300 participants both internationally and locally. In September 2003
MOH once again with the Malaysian Society of Health Technology
Assessment organized the first Evidence Based Nursing Conference
in the ASEAN Region.
Hence, from 1996 to 2005, 10 health technology assessment courses

were conducted and 347 clinicians and allied health personnel were
trained. Since 2002 until 2005, 6 systematic review workshops were
conducted and 286 clinicians were trained.
International recognition
One of the proudest achievements of the HTA Unit in MOH is its HTA Unit
designation as a WHO Collaborating Center for Evidence Based Health as WHO
Care Practice for the Asia Pacific Region, effective from 27 July 2004 for collaborating
4 years. The term of reference for this collaborating center is as follows:- centre
• to contribute to creating awareness on the importance and

application of evidence-based health service provision, health
services evaluation and health technology assessment (HTA) in
the Asia Pacific Region;
• to provide training in evidence-based health service provision,

for example, through the use evidence-based clinical practice
guidelines (CPG), health service evaluation and HTA;
• to provide technical advice and support in evidence-based health

service provision, health service evaluation and HTA for countries
in the Asia Pacific region, and to assist in setting up evaluation,
HTA and CPG programmes or in strengthening existing ones;
• to provide opportunities for work attachments at the HTA Unit in

Malaysia for countries in the Asia Pacific region;
• to carry out activities in collaboration with WHO to further

strengthen existing evidence-based health service provision or

• health technology assessment activities;
• to work with WHO to set up network for collaboration in health

services evaluation, evidence-based practice of health technology
assessment and CPG; and
• to collaborate with WHO and other associations to strengthen

evidence-based policy-making in countries in Asia Pacific region.
HTA performances
Since the establishment of the Health Technology Assessment Unit

in 1995 until 2005, HTA has produced 43 HTA reports, 85 technology
reviews, 31 evidence-based CPGs and 3 clinical pathways (figure 1).
Figure 1 : HTA performances, Min. of Health,1997-2005
HT A
T ECH REV
16
CPG
14
12
10
Number
8
6
4
2
0
1997 1998 1999 2000 2001 2002 2003 2004 2005
Year
In year 2000 a web page for Health Technology Assessment unit was
developed. This web page contains outputs of the HTA unit namely,
HTA reports, CPGs and technology reviews. This web page is attached
to the MOH main web page. The address is http://www.moh.gov.my.
Challenges in health technology assessment

1. Strengthening HTA capacity to support evidence-based decision
making in 9MP development plans
With the 9MP being planned, HTA unit is expected to play a bigger
role in providing evidences for the development of services and
facilities in the 9MP. HTA demands that personnel be skilled and
have expertise in key areas like evidence search, critical appraisal,
analysis and synthesis of data. Apart from carrying out technology
assessment, HTA unit staff has to guide members of expert
committees and provide formal teaching at related workshops /
seminars. While in-house training is being provided, they would
also benefit from training overseas and attending international
conferences. The latter is constrained by limitation of funds. To
enhance the credibility of the trainers it is proposed that more
exposure such as overseas training for staff on conduct of HTA and
CPG development as well as implementation based on evidence-
based approach should be offered. This will ensure maintenance
of the current high standards in all activities including the conduct
of health technology assessment and training.
2. Sustaining HTA capacity
Efforts by the HTA Unit in creating awareness amongst healthcare

professionals and training given to them has yielded results in that
evidence-based approach in decision making are being adopted
in the hospitals and other health institutions. The existing critical
mass of trained professionals in HTA should act as ambassadors
to advocate the evidence based approach on the conduct of health
technology. Knowledge and skill in the conduct of HTA can be
inculcated through continuous medical education and establishing
health technology assessment units in their settings.
3. Engaging the private sector in health technology assessments
With rapid introduction of new technologies in the global market,

coupled with the absence of regulation on medical devices in the
country currently, it is important to ensure that Malaysia does
not become a dumping ground for obsolete, unproven or unsafe
technologies. While an organized health technology assessment
mechanism exists in the public sector, especially in the Ministry
of Health, this is not so in the private sector where adoption of

new technologies is largely left to individual hospitals based on market
forces and economic considerations. Hence, there is a real need
to transfer skills in HTA to the private sector, especially at the
management level, to ensure all technologies used in the provision
of patient care are safe and cost-effective.
4. Strengthening the implementation of CPG through clinical

pathways
As is a common feature in most parts of the world, application

and use of the guidelines pose a great challenge. Apart from areas
of suggested improvement mentioned above, there needs to be a
concerted drive towards producing clinical pathways based on
CPG. This involves adaptation of the general recommendations
of the CPG into specific work process reflecting the practice and
preferences of the individual health professionals in the local
setting. It is envisaged that these clinical pathways can be used
in place of patients case notes since they would involve total
management of the patient, and can allow for computerization
as well.
5. Local research data for policy formulation through HTA and CPG
The lack of local data pertaining to technologies is another

challenge that is frequently faced when carrying out a health
technology assessments. Data on the epidemiology of common
diseases are frequently not available. In addition, information
on current practices and procedures, types of equipment being
utilized, and existence of specific types of equipment, are also not
readily available. More research on these areas should be carried
out locally to fill the knowledge gaps and ensure that evidences
used in the HTA reflects the local context.
Conclusion
Rapid advancements in medical technologies and pressure imposed

by end users to introduce new technologies in the market pose
a great challenge to the Health Technology Assessment Unit.
Decisions on whether to disengage an old technology, continue using
existing technologies, or introduce new technologies require careful
consideration to ensure adoption of appropriate, cost-effective and
safe technologies in our Malaysian health care system. This is crucial
in ensuring the most efficient and cost-effective use of resources,

especially where resources are always limited while demands are
never ending, in delivering good quality and affordable health care
services to the population.
References:
1. Banta H D, Andreasen PB. The political dimension in health care technology assessment
programs. International Journal of Technology Assessment in Health Care 1990; 6 :115-
123
2. Busse R et al. Best practice in undertaking and reporting health technology assessments.
Int J Tech Asssss Health Care, 2002; 18(2): 361-422.
3. Campbell J, Hotchkiss R, Bradshaw N, Porteous M (1998), Integrated care pathway,

BMJ, pp 133-7
4. EUR-ASSESS. Report from the EUR-ASSESS Project. Int J Tech Ass Health Care, 1997:
13(2)
5. European Commission, Directorate-General for Employment, Industrial Relations

and Social Affairs. ed. “Best practice”: State of the Art and Perspectives in the EU for
Improving the Effectiveness and Efficiency of European Health Systems. Luxembourg:
Office for Official Publications of the European Communities, 1999.
6. Griffiths S. Prioritising care in resource-limited health service (2002). Current Paediatrics

2002; 12 : 481-486
7. Panerai R.B., Pena-Mohr, J. Health technology assessment methodologies for developing

countries. Washington D.C.: Pan American Health Organization, 1989.

DEVELOPMENT AND IMPLEMENTATION OF MEDICAL
DEVICES REGULATION IN MALAYSIA
SUMMARY
Medical devices have always been the integral part and indispensable tools in medical
diagnosis and therapy. However, these devices pose public health and safety issues
and issues related to trade. This article provides an overview on the development
and implementation of medical devices regulation to manage and address issues
related to medical devices. It outlines the rationales for the development and
implementation of medical devices regulation in Malaysia; the framework and the
scope of the regulation; the important aspects in ensuring safety and effectiveness
of medical devices; as well as the activities involved in medical devices regulation.
This article also outlines how the regulation can help the Malaysian medical devices
manufacturers to position themselves in the global arena. Finally, this article provides
a brief account on the progress in the development and implementation of medical
devices regulation in Malaysia.
Introduction
T
he term medical device refers to medical technology, supplies Definition of
and equipment. It encompasses a very broad range of healthcare medical device
products used in healthcare for the diagnosis, prevention,
monitoring or treatment of illness or handicap but exclude drugs.
In contrast with medicinal products the intended primary mode of
medical device action to human body is not metabolic, immunological
or pharmacological.
The Global Harmonisation Task Force (GHTF)* defines medical device

as any instrument, apparatus, implement, machine, appliance, implant,
in vitro reagent or calibrator, software, material or other similar or
related article;
i) intended by the manufacturer to be used, alone or in combination,

for human beings for one or more of the specific purpose(s) of :
• diagnosis, prevention, monitoring, treatment or alleviation of

diseases;
• diagnosis, monitoring, treatment, alleviation of or compensation
for injury;

• investigation, replacement, modification, or support of the
anatomy or of a physiological process;
• supporting or sustaining life;
• control of conception;
• disinfection of medical devices;
• providing information for medical purposes by means of in vitro
examination of specimens derived from the human body; and
ii ) which does not achieve its primary intended action in or on the

human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means 1.
In the provision of healthcare, the use of medical devices has always

been an integral part and often indispensable tools in medical diagnosis
and therapy. Medical devices encompass a wide array of products with
myriad use. In 2001, it was reported that more than 50,000 different
types of medical devices are available on the global market2 ranging
from simple contact lenses to precise robotic arm and sophisticated
computed tomography machines, radiation-emitting equipment,
lasers, implanted hip joints, defibrillators and heart valves. These
devices can be categorised into 12 categories according to the Global
Medical Devices Nomenclature (GMDN)* system3.
In the provision of healthcare, the use of medical devices has always

been an integral part and often indispensable tools in medical diagnosis
and therapy. Medical devices encompass a wide array of products with
myriad use. In 2001, it was reported that more than 50,000 different
types of medical devices are available on the global market 2 ranging
from simple contact lenses to precise robotic arm and sophisticated
computed tomography machines, radiation-emitting equipment,
lasers, implanted hip joints, defibrillators and heart valves. These
devices can be categorised into 12 categories according to the Global
Medical Devices Nomenclature (GMDN)7 system3 .
Footnote :-
* GHTF is a voluntary body which was established in 1993 by the governments and industry
representatives of Australia, Canada, Japan, the EU and the USA in an effort to harmonise the
regulatory practices to ensure safety and effectiveness of medical devices. The objective of the
GHTF is to encourage convergence in the evolution of medical devices regulatory system at
the global level. The regulatory system is aimed at protecting of public health and safety and
facilitating trade.
7
GMDN is a nomenclature system developed to classify medical devices on the market developed
by the European Standards Body CEN and sponsored by the European Commission, with full
participation and parallel acceptance by the ISO. It is the only nomenclature system in use
within the European Economic Area and is being endorsed by many legislators. It is endorsed
by the GHTF as the global nomenclature system.

Rationales for Medical Devices Regulation
It was estimated that in the year 2000, more than RM 500 billion Medical devices
worth of medical devices were available on the global market. With market
innovation and the rapid advancement of technologies, the global
market figure for 2006 is expected to exceed RM 960 billion4. Malaysia
imported about RM 1.8 billion worth of medical devices5 in 2004 and
approximately RM 300 million was spent annually to maintain and
service these devices. The demand for medical devices will continue
to grow due to the growing population, longer life expectancy,
rising living standards, growing affluence and increasing consumer
awareness. This growing trend will also take place in Malaysia with
the implementation of upgrading and replacement programmes under
the Ninth Malaysia Plan.
Medical devices pose a number of issues ranging from accessibility to Issues related to
safety, appropriate use as well as issues related to trade. The pace of medical devices
innovation and increasing use of medical devices have caused many
countries in the world to come up with regulatory controls designed
to protect public health and safety and at the same time facilitate
technological advancement and advances in patient care.
Public health and safety issues
The safety and effectiveness of medical devices are important aspects Public health
that need to be addressed as all medical devices carry certain degree and safety
of risks and safety implications. Some of the public health and safety
issues associated with medical devices in Malaysia are;
i) Unavailability of pre-market control to assess safety, effectiveness

and quality of medical devices resulting in the dumping for sub-
standard, unsafe and ineffective devices.
ii) Inadequate information for the public and health professionals to

make informed choices on medical devices. This will deprive the
patients from getting appropriate treatment and may even result
in patient or user injury.
iii) Lack of control over the usage of various medical devices, the
usage of various medical devices without appropriate training by
non-medical professionals and the usage of medical devices that
have not been properly maintained and calibrated.

iv) The absence of formal post-market reporting system to identify
and monitor medical devices with problems in the market. Neither
manufacturers nor importers are currently required to keep
distribution records of medical devices or report adverse incidents
related to medical devices to the authority.
The Government has identified the medical devices industry as one Medical devices
of the strategic industries for economic growth in Malaysia. Various manufacturing,
incentives have been introduced to attract companies to invest in this a national
industry. Malaysia is currently a gateway to Asia’s market, the fastest strategic
growing economy where 75% of the world’s population resides. industry
Asia’s healthcare market constitutes approximately 34% of the global
healthcare market and this share has increased to 45% by 2005. A
diverse range of medical equipment and products are imported to
cater the Asian growing healthcare needs. In ASEAN alone, the market
constitutes a combined GDP of about RM 2,800 billion and a total trade
of RM 2,700 billion6.
Malaysia is the world’s leading manufacturer of rubber-based products Malaysia,

such as medical gloves, condoms and catheters. In total, these 3 world leading
products accounted for approximately 85% of the total exports7. In manufacturer
addition, Malaysian manufacturers also produce syringes, needles, of rubber-based
procedure kits, surgical and dental instruments. products
Today, the industry is currently shifting into manufacturing products

made from plastics, silicone and metal alloys. There is also a huge
potential for the industry to move into the manufacturing of more
sophisticated devices such as those used in cardiovascular, orthopaedic,
transplants, ultrasound imaging and patient monitoring systems. It
is envisaged that many more downstream and non-manufacturing
services related to medical devices industry will also be created along
with the manufacturing sector.
In 2005, there were 159 medical devices manufacturers in Malaysia Investments in

with a total investment of RM 6.3 billion, of which 40% was domestic medical devices
investment whilst the remaining 60% was foreign. The exports of manufacturing
medical devices grew by 23% to RM 4.8 billion during the period of in Malaysia
January to November 2005 compared to RM 3.9 billion during the
corresponding period in 2004.
With this trend, it is natural for the Malaysian medical devices industry
to be cautious and concern about ensuing competition with the rest of
the world. To reduce trade barrier and to facilitate our local

manufacturers to market their products globally. Development of and
compliance to regulation that is based on internationally acceptable
standards is of paramount important
Regulating medical devices in Malaysia
In February 2005, the Ministry of Health was given the task to develop Medical devices
and implement a regulatory framework for the control of medical regulatory
devices in this country. This framework will encompass the following; framework
i) Formulation of Medical Devices Act and its subsidiary legislations

to provide legislative support for medical devices regulatory
programme;
ii) Establishment of an appropriate agency to implement and enforce
medical devices regulation;
iii) Appropriate training and capacity building to develop competent
and trained manpower to ensure effective implementation of the
regulation;
iv) Development of appropriate infrastructures and mechanisms
for effective and efficient implementation of medical devices
regulation;
v) Development of Medical Devices Registration and Surveillance/
Vigilance System; and
vi) Financial requirements for the development and implementation
of regulatory programme.
Aims of medical devices regulation
The medical devices regulation is generally aimed at providing

an appropriate framework for ensuring public health safety and Aims of
facilitating trade. In the context of safety, the regulation will ensure regulation
the timely availability and access to only safe and state-of-the-art
technologies in diagnosis and treatment modalities. At the same time
the regulation will prevent sub-standard, unsafe and ineffective devices
from reaching the market. In the context of trade, the regulation will
provide a favourable environment to stimulate the development of the
medical devices industry by ensuring safeguard mechanisms are put
in place for fair and rules-based trade harmonisation with Malaysian
trading partners.
Classification and level of control
All medical devices carry certain level of risks depending on the

intended purposes. The effectiveness of the applied risk management Four risk classes

techniques during design, manufacture and use will also contribute
to the amount of risks associated with the devices. In regulating these
devices, the degree of control should be proportional to the level of
the associated risks, taking into account the benefits offered by use of
the devices. Based on a set of rules, medical devices are classified into
four risk classes. In general, low-risks devices are those that are applied
external to the body; and if applied correctly, involve minimum risk
to the patients. The higher risk devices are those that penetrate the
human body, and involve a high- energy source, or used to sustain life8.
Scope of medical devices regulation
The life span of a medical device is calculated from its design and
development to manufacture and its subsequent disposal. These
phases can be divided into three common stages, namely pre-market,
placement on-market and post-market stages as illustrated in Figure
1. Each of these phases of the life span may affect its safety and
performance.
Figure 1: The phases and corresponding stages in the l

ife span of a medical device(4)
Advertising,
Design, Packa- Mainte-
sale/ Installation Usage
develop - ging, nance/
Manufac - distribution (T&C) Disposal
ment labelling calibration
ture
PRE-MARKET PLACE-MENT POST-MARKET

ON-MARRKET
Therefore it is important that the scope of the regulatory control covers

the manufacturing process, the device, the representation of the device,
the manufacturer or local authorised representative (of foreign

manufacturer of imported medical device) and the user (including
those involve in maintaining/calibrating the device).
Factors affecting safety and performance of medical devices and the

corresponding regulatory activities
Pre-market stage
At the pre-market stage the concept, design, development and testing Concept,
(including verification, validation and clinical evaluation) require the design and
scrutiny of scientific experts to ensure that design parameters and development
performance characteristics do not impose unwarranted risks4,12.
Good management of the manufacturing process is important in the

production of medical devices9. Poor manufacturing management Manufacturing
may bring about inconsistency in the quality of products even when process
the original prototype has been well designed.
Following its manufacture, ensuring the delivery of clean, sterile and Packaging and
protected medical devices to the point of use through a well developed delivery
packaging system will be important. Proper labelling including the
relevant hazard warnings or cautions and clear instructions are crucial
in identifying a medical device and specifying instructions for its
proper use10. Mislabelling of medical devices can result in serious
consequences for the users4. In addition, the address of manufacturer
or local authorised representative (of foreign manufacturer) must be
available.
Pre-market review of a medical device is performed to ensure that Pre-market

a medical device satisfies not only safety and performance but also review to ensure
quality system and labelling requirements before market clearance is safety and
given. The degree of scrutiny during pre-market review depends on the quality
potential risks of the device according to the risk-based classification
system4,9.
Thus, only products that have complied with the above requirements Registration
will be registered. It is the responsibility of manufacturers or local only if
authorised representatives to demonstrate that their devices meet the complied with
requirements for product registration. requirements

Placement on-market stage
When a medical device is placed on the market, advertisement has Regulating

the potential to create expectations and influence the belief in the vendor activities
capabilities of the device. Misleading or fraudulent advertising of a
medical device may deprive patient of more appropriate treatment
and could lead to injury. For this, the vendors play a critical role and
there is a need to regulate their activities. Registering the local vendors
will enable authorities to track the responsible parties in the event of
difficulty or emergency situation associated with medical devices. This
control also enables the authority to carry out regular inspections and
audits to ensure ongoing compliance4,9.
All local manufacturers involved in the manufacture, alteration or Registration of

re-packaging of medical devices to be sold in Malaysia and local local manufac-
authorised representatives of imported devices need to be regulated turers and
and registered. Local authorised representatives for imported medical importers
devices must maintain linkage with their foreign manufacturers and
should be able to obtain the support of their foreign manufacturers
whenever required. To ensure correct product representation and
to prevent misleading or fraudulent advertisements or claims,
advertisement control is performed.
Post-market stage
Assuring medical devices safety entails more than the functioning of Familiarity
the device, it requires oversight of the use of the devices at the post- of users with
market stage. Unfamiliarity with a certain technology or operating technology
procedure, and the use of a device for clinical indications outside its
scope can cause device failure even in the absence of inherent design
or manufacturing defects. In addition, the re-use of disposable devices
not in accordance with the instructions, and without proper control
or precautions for minimising associated risks, can be detrimental.
To ensure devices function properly, there is a need for proper Proper

installation (including testing and commissioning) prior to usage and installation
scheduled maintenance and calibration. The lack of, or inappropriate,
testing, maintenance and calibration of such devices may jeopardise
their safety and performance. The disposal of devices should follow
specific safety rules as the possibility of their contamination can present
hazards to the public and the environment.
Post-market control is essential after market clearance. Monitoring Post-market

the performance and reporting the problems associated with the use surveillance
of medical devices are important components of regulatory control
as failures or incidents arising from the use of a device could not be
predicted or totally prevented during the pre-market stage. At the
post-market stage, manufacturers or local authorised representatives
are required to perform two major activities, namely post-market
surveillance study and adverse event reporting.
In post-market surveillance study, manufacturers are required to

establish a system to collect post-market surveillance data of medical
devices.
Adverse event reporting is important to carry out timely intervention Reporting of

and it provides an opportunity for identification and remedial action adverse events
for problematic medical device such as modification or product recall.
It also allows for timely dissemination of information that is necessary
to prevent recurrence of similar incident. Adverse incident reporting
requires manufacturers or local authorised representatives to report
adverse incidents that reasonably suggest that death or serious injury
has been caused or contributed by the use of a medical device. The
manufacturers or their representatives are required to investigate and
carry out follow-up actions, such as product recall, and report the
results to the authority. Healthcare professionals are also encouraged
to notify manufacturers or local authorised representatives of adverse
incidents. Injuries arising from the use of medical devices by non-health
professionals should also be reported4,9,11.
Operation and usage
Some sophisticated medical devices require specialised and trained Trained

personnel to ensure their safe operation and performance. The objective operators
of operation and usage control is to prevent unnecessary harms or
complications arising from the improper use of medical devices.
Thus, owners and users of such sophisticated devices are required to

get the approval to possess and use these devices. In addition, they
must also undertake to comply with a set of requirements which
include requirements for qualification and training, safety precautions
and maintenance/calibration.
Quality system
The key advantage of a quality system is it represents a preventive Quality system

approach to assuring medical device quality. The introduction of a to ensure device
quality system has been proven to be more efficient and cost effective quality and
in controlling manufacturing processes and maintaining medical safety
device quality.
A quality system identifies the organisational structure, responsibilities,

procedures, processes and resources required to implement quality
management. It imposes strict quality assurance on every aspect of
the production of medical devices. By complying, this reduces the
likelihood of non-conforming products, ensures consistency in the
quality of a device and provides the basis for greater reliability in its
safety and performance4,12. The quality system is subject to periodic
audits and management reviews by the authority or third party
agencies4,9.
Harmonisation and the use of standards
In developing the Malaysian medical devices regulatory framework, the Harmonisation

Ministry of Health will be guided by the current global harmonisation of medical
trend as promoted by the GHTF and Asian Harmonisation Working devices
Party (AHWP)7 and supported by the World Health Organisation regulatory
(WHO)4. The harmonised system supports the commitment of the requirements
ASEAN Economic Ministers for the development of a common system
for medical devices in ASEAN by the end of 2006. A common system
for medical devices is one of the identified measures to realise the
vision of the ASEAN leaders on the establishment of the ASEAN
Economic Community (AEC) by the year 2020. The AEC is envisaged as
a single market and production base with free flow of goods, services,
investment, skilled labour and free flow of capital.13
The harmonised system encourages convergence in standards

and regulatory practices and hence minimises regulatory barriers,
facilitates international trade and reduces the cost of implementing
the regulations. It also promotes technological innovation and more
importantly enables our products to gain access and compete in the
global market.
Footnote :-
7
AHWP is an informal group of experts from medical devices regulatory authorities and the
medical device industry from the Asian region. It was formed around 1996–97 to work towards
a harmonised medical devices regulatory system in Asia in line with the GHTF approach

Standards are widely used to demonstrate conformance to essential Conformity to
principles of safety and performance of medical devices14. This includes national and
conformity to process, product and management standards. The use international
of national or international standards in establishing medical devices standards
regulation is essential as it helps in simplifying the regulatory process
and promoting the global harmonisation efforts.
Industry assistance and international relations
The Government recognises the contribution of the medical devices Regulatory

industry to the growth of the Malaysian economy. One of the essential control to
requirements to be a global player in the production of medical devices facilitate local
is to ensure that the devices produced are in compliance with the manufacturing
international standards for safety, quality and effectiveness. In this context, industry
the Ministry of Health will formulate appropriate regulation to facilitate
local manufacturers to position themselves in the global arena.
Besides developing the regulatory framework, the Ministry of

Health has initiated bilateral and multilateral negotiations with other
countries. This is an important step to help the Malaysian medical
devices industry to broaden the global market access. The Ministry
of Health is taking the lead role in the AHWP and the Medical Device
Product Working Group (MDPWG) under the ASEAN Consultative
Committee for Standards and Quality (ACCSQ)7 to spearhead the
harmonisation of medical devices regulatory requirements in the
ASEAN and Asian regions. Both the ASEAN and Asian groups are
embarking on various projects towards harmonisation, one of which is
the development of a common submission dossier template for medical
devices product approval within the ASEAN and Asian regions
Progress in the development and implementation of medical devices

regulation
Policy in the control of medical devices and legislative support
Footnote :-
7
MDPWG was formed in 2005 as a result of the decision of the ASEAN Leaders on the
establishment of the AEC by the year 2020 and fast-track integration of eleven priority sectors
including healthcare sector. MDPWG assists the ACCSQ in implementing specific measures to
facilitate the integration of the medical devices sector under the ASEAN Roadmap for Healthcare
Integration

The policy and the framework for medical devices regulatory Establishment of
programme was approved by the Cabinet in February 2005. A core Medical Devices
team known as the Medical Devices Bureau has been established Bureau
for this purpose. The responsibility of this Bureau in addition to
developing the regulatory framework, is also to formulate policies,
undertake planning, registration and licensing, activities monitoring
and surveillance, provide industry assistance and seek international
relations.
The policy will be supported by Medical Devices Act. The object of

this Act is to provide for the establishment, implementation and
maintenance of a system of control related to performance and safety
of medical devices. The Medical Devices Act is targeted for promulgation
by the end of 2006.
Standards and guidance documents
Development, adoption and adaptation of standards related to medical Establishment

devices are undertaken by the Industrial Standard Committee for of the Industrial
Medical Devices (ISC R) which was established in collaboration with Standard
the Standards and Industrial Research Institute of Malaysia (SIRIM) Committee for
and Department of Standards Malaysia. ISC R has identified various Medical Devices
international standards to be adopted and adapted as Malaysian (ISC R)
standards.
Guidance documents form a set of references for the regulatory Guidance

system. The documents elucidate various aspects of the regulation in documents
greater detail. These include amongst others, details of the regulatory for regulatory
requirements, the implementation mechanisms, the regulatory tools, system
the roles and responsibilities of the authority and all the parties
involved. The drafting of guidance documents is undertaken by the
Medical Devices Technical Committee of the Ministry of Health with
the assistance of three working groups, namely Working Group on
Pre-Market Assessment, Quality System and Auditing, Working Group
on Post-Market Surveillance and Vigilance and Working Group on
Proper Usage of Medical Devices.
Registration and surveillance / vigilance
Registration of medical devices and their manufacturers or local Registration

authorised representatives is considered to be the first and most – first stage
important component in medical devices regulatory control. A medical of regulatory
device will only be listed in a registry after it has complied with control

the essential requirements for safety and performance. For medical
devices manufacturers, listing in the registry is an important means
to demonstrate that their devices have undergone the scrutiny of the
competent authority in pre-market review and have complied with
the essential requirements for safety and performance.
A registration system must contain all the relevant information Info for public
discussed in the earlier sections. In addition, a list of medical devices
that have obtained market clearance will be made available for public
and clinical community to assist them in making informed choices on
medical devices that are safe and effective to treat or diagnose health
problems.
In the post-market stage, traceability is crucial as it allows immediate Traceability

corrective actions to be taken. A post-market surveillance/ vigilance
system includes major post-market components such as distribution
record, recall procedures, reporting and complaint handling.
The design and development of registration and surveillance/ Regislation and

vigilance systems will be done in stages and are expected to be ready surveillance /
for implementation by the end of 2008. A centre that receives and vigilance system
manages information from all sources will be established. The system by 2008
will provide facility for information sharing with local users as well
as users from other countries.
Voluntary Registration Scheme for Medical Devices Establishment

(MeDVER)
An important milestone in the development and implementation Launching of

of medical devices regulatory programme in Malaysia is the MeDVER
implementation of the voluntary registration scheme for medical
devices (MeDVER). The latter which was launched on 12th January
2006 was introduced for the following purposes:
i) to familiarise all the affected parties with the registration process;

ii) to gauge the readiness of medical devices establishments in
conforming to the regulatory requirements;
iii) to prepare a smooth transition into the mandatory phase and full
enforcement of medical devices regulation in Malaysia;
iv) to obtain a profile of the Malaysian medical devices industry.
MeDVER is an on-line voluntary registration scheme and those
dealing with medical devices in Malaysia are encouraged to
voluntarily register their establishments and list their medical

devices with the Ministry of Health Malaysia15.
Conclusion
The need to develop and implement the medical devices regulation

in this country is recognised by the Government. The aims of the
regulation are to protect public health and ensure safety from the
risks arising from the use of medical devices and to facilitate trade.
The proposed regulation is in line with current global harmonisation
approach. It encompasses the entire life cycle of a medical device and it
covers the device itself, the manufacturing process, the representation of
the device and the manufacturer. Various activities in the development
of the regulation have been initiated. The launching of MeDVER was
an important step towards achieving the full implementation and
enforcement of medical devices regulation by 2008.
References:
1. Global harmonisation task force. Information document - definition of “medical device”.

SG1/N029R11, GHTF Study Group 1 ( May 20 2005).
2. Robert C. Eccleston, A model regulatory programme for medical devices: an

international guide. Pan-American Health Organisation, 2001.
3. Global Medical Device Nomenclature. What is GMDN? GMDN website http://www.

gmdn.org/.
4. C. Michael. Medical device regulations: global overview and guiding principles. World
Health Organisation, Geneva, 2003.
5. Department of Statistics Malaysia. Medical devices import and export data, 2004.
6. Malaysian Industrial Development Authority. Malaysian medical device industry,

MIDA 2003 http://www.mida.gov.my
7. Malaysian Industrial Development Authority (MIDA). Performance of the

Manufacturing and Related Services Sectors, 2005. Malaysian Medical Device Industry,
MIDA 2006.

8. Global Harmonisation Task Force. Medical Devices Classification. SG1/N015R18 GHTF
Study Group 1, May 2002 .
9. Global Harmonisation Task Force. Guidance on Quality Systems for the Design and
Manufacture of Medical Devices GHTF.SG3.N99-8, GHTF Study Group 3, June 1999.
10. Global Harmonisation Task Force. Labelling for Medical Devices. GHTF-SG1-N009R6,
GHTF Study Group 1, February 2000.
11. Global Harmonisation Task Force. Precis - GHTF Study Group 2: Vigilance and
Postmarket Surveillance SG2 N12 R9, GHTF Study Group 2, March 2002.
12. International Standardisation Organisation. Medical Devices : Quality Management

Systems – System Requirements for Regulatory Purposes ISO 13485:2003.
13. ASEAN Economic Ministers (AEM). Joint Media Statement of the 35th AEM Meeting,
Phnom Penh, Cambodia, 2 September 2003. ASEAN website http://www.aseansec.
org.
14. Global Harmonisation Task Force. Essential principles of safety and performance of
medical devices (including in vitro diagnostic devices). GHTF.SG1.N041R6, GHTF
Study Group 1, October 2002.
15. Voluntary Registration for Medical Devices Establishments (MeDVER) in Malaysia

MeDVER website https://www.medicaldevices.gov.my, January 2006.

MEETING OUTPATIENT EXPECTATIONS AT PUBLIC
HOSPITAL SPECIALIST CLINICS IN PENINSULAR
MALAYSIA
SUMMARY
The health care industry has undergone tremendous improvements and changes in
recent years. Providers have gone beyond satisfaction; attempting to delight their
consumers by meeting their wants or unarticulated needs. The objective of this
study was to measure the extent of meeting such needs through services provided
at the specialist clinics. Using the self administered questionnaire (SERVQUAL), 14
hospitals with specialists were selected by stratified random sampling. Only 8.0%
of patients were unhappy with the services provided. However, the participating
hospitals had not been able to meet 73.9% of the patients’ expectation. There appeared
to be significant association between patient satisfaction and age, ethnicity and
educational level. Younger patients were more dissatisfied than the older age group,
whilst the higher the educational level achieved, the more dissatisfied they were.
Most dissatisfied dimension as reported from the SERVQUAL questionnaire was for
Reliability. Patients were not happy with the waiting time at the specialist clinic and
with staff promptness. Besides recruiting more staff, the management must develop
strategies to create a conducive waiting environment to reduce the agony of waiting.
Introduction
T
he health care industry has undergone tremendous improvements Definition
and changes in recent years. Many organizations are now focusing
on continuously improving the quality of the services that they
provide in order to attain patient satisfaction. One of the earlier
definitions of patient satisfaction was developed by Linder-Pelz in 1982
who defined patient satisfaction as the “individual’s positive evaluations
of distinct dimensions of health care”1.
In recent times, health care providers have attempted to go beyond

ensuring patient satisfaction. According to Carson et al2, providers can
ultimately delight consumers by meeting their wants or unarticulated
needs. “Delighted” customers are those whose expectations or needs
were not only met, but have been exceeded. The purpose of this study
was to explore the capacity of the specialist clinics in government

facilities to meeting such needs and expectations. Local study 3
had found the were more problems at the outpatient department
in hospital with specialist as compare to outpatient department in
hospitals without specialist. Courtesy was found to be less practiced
at specialist clinics.
Methods
To measure patient satisfaction, the study had used the self- SERVQUAL
administered SERVQUAL4 which assessed satisfaction through 5
dimensions namely:
(i) Tangibles Physical facilities, equipment, and appearance of

personnel
(ii) Reliability Ability to perform the promised service dependably

and accurately
(iii) Responsiveness Willingness to help customers and provide prompt

service
(iv) Assurance Knowledge and courtesy of employees and their

ability to inspire trust and confidence
(v) Empathy Caring, individualized attention
The instrument was modified by the researcher to accommodate Study

our local setting. Additional dimensions were further added to the Instrument
instrument by the researcher.
SERVQUAL
• Tangible Q1+Q2+Q3
• Reliable Q4+Q5+Q6
• Responsiveness Q7+Q8+Q9
• Assurance Q10+Q11+Q12
• Empathy Q13+Q14+Q15

Outcome
• Outcome Q16 (treatment)
Corporate Culture
• Caring Service Q4+Q8+Q9+Q12

• Teamwork Q11+Q18
• Professionalism Q3+Q6+Q16+Q19+Q20
A cross-sectional study was conducted amongst government hospitals Sampling and

with specialists. A two-phased sampling strategy was used. Using analysis
stratified random sampling, 14 hospitals from a total of 39 hospitals
with specialists were selected. The EPI INFO software programme
was used to calculate the patient sample size needed and patient
selection done using systematic random sampling. Self-administered
questionnaires were given to the study respondents at the pharmacy.
The “Statistical Package for Social Sciences” (SPSS) was used for
analysis.
Findings
A total of 7,417 patients from 14 hospitals were selected. Their mean

age was 36.08 years, with the majority of the respondents being Malays
(74.5%) as shown below (Table 1).
Table 1 : Respondents’ characteristics
Malay 5443 (74.5%)

Chinese 1049 (14.4%)
Ethnicity Indian 709 (9.7%)
Others 108 ( 1.5%)
Total 7,309 (100.0%)
Male 3263 (44.5%)
Gender Female 4062 (55.5%)
Total 7,325 (100.0%)
Single 1608 (22.0%)
Marital Status Married 5694 (78.0%)
Total 7302 (100.0%)
No formal 389 (5.4%)
Primary 1529 (21.2%)
Education level Secondary 3843 (53.2%)
Tertiary 1465 (20.3%)
Total 7226 (100.0%)

Considering perception alone, about 8.0% of patients were dissatisfied
with the services provided by the hospitals at the specialist clinics.
However using SERVQUAL, the dissatisfaction rate increased to
73.9%; with only 20.2% and 3.3% being moderately and severely
dissatisfied respectively (Table 2).
Table 2 : Level Of Patient Satisfaction
Satisfaction level Frequency Percent

Most satisfied 5 -0.10%
Moderately satisfied 27 -0.40%
Mildly satisfied 1838 -25.60%
Mildly dissatisfied 3627 -50.40%
Moderately dissatisfied 1455 -20.20%
Severely dissatisfied 240 -3.30%
Total 7192 -100%
There appeared to be a significant association between patient

satisfaction and age (p = 0.002), ethnicity (p = 0.000), occupation (p =
0.000) and educational level (p = 0.000).
Younger patients, Malays, those with higher educational status and

working in the public sector were more dissatisfied (Table 3, Table
4, Table 5 and Table 6 respectively). About 38% of the workers in the
public sector had tertiary education compared with 23% of private
sector workers (table 7).
Table 3 : Age Group And Patient Satisfaction
Age group Satisfied Not satisfied Total
< 40 years 949 (24.4%) 2939 (75.6%) 3888 (100%)
40 – 55 years 437 (24.1%) 1374 (75.9%) 1811 (100%)
>/= 56 yearse 329 (29.4%) 791 (70.6%) 1120 (100%)
P=0.002

Table 4 : Ethnicity And Patient Satisfaction
Ethnic group Satisfied Not satisfied Total

Malay 1269 (24.0%) 4010 (76.0%) 5279 (100%)
Chinese 297 (29.3%) 718 (70.7%) 1015 (100%)
Indian 229 (33.1%) 463 (66.9%) 692 (100%)
Others 32 (30.2%) 74 (69.8%) 106 (100%)
P=0.000
Table 5 : Education And Patient Satisfaction
Education Level Satisfied Not satisfied Total

No formal education 135 (35.4%) 246 (64.6%) 381 (100%)
Primary education 463 (31.0%) 1032 (69.0%) 1495 (100%)
Secondary education 948 (25.5%) 2770 (74.5%) 3718 (100%)
Tertiary education 254 (17.9%) 1168 (82.1%) 1422 (100%)
P=0.000
Table 6: Occupation And Patient Satisfaction
Occupation Satisfied Not satisfied Total

Public sector 325 (20.5%) 1257 (79.5%) 1582 (100%)
Private sector 406 (24.3%) 1263 (75.7%) 1669 (100%)
Self employed 319 (31.2%) 704 (68.8%) 1023 (100%)
Others (Housewife, 399 (30.8%) 895 (69.2%) 1294 (100%)
student, pensioner, etc)
P=0.000

Table 7 : Education Level And Working Sector
Public sector Private sector Self employed Others
No formal education 12 (0.7%) 22 (1.3%) 85 (8.3%) 147 (11.2%)

Primary education 133 (8.2%) 246 (14.4%) 342 (33.2%) 347 (26.4%)
Secondary education 862 (53.0%) 1043 (61.2%) 511 (49.7%) 638 (48.6%)
Tertiary education 619 (38.1%) 393 (23.1%) 91 (8.8%) 181 (13.8%)
Total 1626 (100%) 1704 (100%) 1029 (100%) 1313 (100%)
P=0.000
In addition, it was also observed that the more times the patient visited
the specialist clinics, the more dissatisfied they were as shown in table
8 below.
Table 8: Patient Satisfaction And Frequency Of Visits To Specialist Clinic
Education Level Satisfied Not satisfied Total

No. of visit Satisfied Not satisfied Total
First time 510 (30.7%) 1151 (69.3%) 1661 (100%)
Second time 377 (28.2%) 961 (71.8%) 1338 (100%)
Third time 177(25.2%) 526(74.8%) 703 (100%)
More than three times 645 (21.1%) 2405 (78.9%) 3050(100%)
P=0.000
The mean for patient satisfaction score in this study was -0.5651 (table
9). With regard to the dimension of SERVQUAL, least dissatisfaction
was in the dimension of “Assurance” and the greatest dissatisfaction
was for the dimension on “Reliability”. In the dimension concerning
the Ministry of Health Corporate Culture, the least dissatisfaction
was reported for the dimension on “Professionalism” and the greatest
dissatisfaction was in the dimension of “Caring”.
Considering the individual questions (table 10), out of the three

questions under the dimension of “Reliability” (Q4, Q5 & Q6) which
obtained the greatest dissatisfaction, Q5 had the highest negative

value. Q5, Waiting times in Hospital are appropriate obtained a score of
-0.7833. Among the twenty questions, Q8 It is realistic for patients to
expect prompt service from hospital staff, obtained the highest negative
score (-0.8343). However Q3 Hospital staff always appear neat, obtained
the lowest negative score (-0.3578).
Table 9: Satisfaction Score According To Dimension/Grouping
Dimension/ Mean Std. Error of Mean Std

Grouping Deviation
1 Tangible -0.5327 0.00930 0.79806
2 Reliability -0.6420 0.01104 0.94709
3 Responsiveness -0.6189 0.00975 0.83646
4 Assurance -0.5080 0.00863 0.74074
5 Empathy -0.5693 0.00975 0.83638
6 Outcome -0.4747 0.00956 0.82131
7 Caring service -0.6428 0.00961 0.82258
8 Teamwork -0.4927 0.00843 0.72320
9 Professionalism -0.4656 0.00767 0.65656
10 Total -0.5651 0.00813 0.68963
Discussion
For our study, dissatisfaction was defined as not being able to meet Dissatisfaction
patients’ expectations. Hence, following this definition, only 8.0% of
patients were dissatisfied with the services provided by the specialist
clinics. Nevertheless using SERVQUAL, our services had not been
able to meet the expectations of 74.7% of the patients. In the USA,
Scardina5, using the same instrument to measure levels of satisfaction
with nursing care, also found low levels of satisfaction. Similar findings
were also reported by Fayek6 in their study of the quality of NHS health
care in a survey of 174 patients in the UK. Hart7, attributed his low
level of satisfaction findings to the methodology used in the calculation
of satisfaction. Nevertheless, other researchers using different sets of
instrument, have come up with different findings. In a meta-analysis
of 221 studies, Hall8 found patient satisfaction to be moderately
high ranging between 76% and 84% of all patients studied. Calnan
and colleagues9 also found high levels of satisfaction amongst those
receiving in-patient care in hospitals in UK. Carmel10, using her own
instrument, found that 80% of patients in her hospital in Israel, were
satisfied with the services provided.

Table 10 : Mean Of Satisfaction For Individual Question
No. Parameter Mean Std. Error

of Mean
1 Hospital always has up-to-date equipment. -0.6637 0.01225

2 Facilities at the waiting area are visually appealing -0.5750 0.01238
3 Hospital staff always appear neat -0.3578 0.00897
4 Hospitals provide their services at the time they. -0.6438 0.01298
promise to do so
5 Waiting time in Hospital are appropriate. -0.7833 0.01426
6 Hospital performs the services right every time. -0.4976 0.01091
7 Hospital staff tells patients exactly when services -0.4775 0.01119
will be performed.
8 It is realistic for patients to expect prompt service. -0.8343 0.01331
from hospital staff
9 When patients have problems, hospital staff will be -0.5397 0.01049
willing to help with sincere interest.
10 Relevant hospital staff gives clear information -0.4720 0.01006
about the illness suffered by the patient.
11 Hospital staff is knowledgeable. -0.5031 0.00995
12 Hospital staff is polite. -0.5482 0.01102
13 Hospital staff will always understand the. -0.5404 0.01144
patients’ needs
14 Hospital staff gives patients personal attention. -0.5770 0.01123
15 Hospital has patients’ best interest at heart. -0.5884 0.01084
16 Hospital will give effective treatment. -0.4747 0.00956
17 Public toilets in Hospital are clean. -0.6582 0.01249
18 Hospital staff works together among them in -0.4796 0.00977
giving treatment.
19 Hospital staff displays good work discipline. -0.4709 0.00975
20 Hospital staff does their jobs with high commitment. -0.5277 0.01030
The mean for patient satisfaction score in this study was -0.5651. Fayek6
in his study of the quality of NHS health care found the overall mean
SERVQUAL score was -0.9950. However this does not mean that our
hospitals are better than NHS. These findings suggest that the patients
obtaining services from NHS were more dissatisfied than those in our
study. Possible reasons for the differences may be attributed to differing
patient characteristics and expectations between the two sites.
The younger patients in our study had been reported to be more

dissatisfied that the older age group. Our findings were supported by
those by Pascoe11, Young12 and Breemhaar13 whom all reported older
patients as being more satisfied.
There were no significant relationship between satisfaction and

gender in this study. Studies on the relationship between gender and
satisfaction had varying results. Similar findings to our study were
reported also by Carmel10, Hall15 and Weiss16. However, Pascoe11 and
Zastovny14 identified women as being more satisfied than men.
Among the ethnic groups, the Malays were more dissatisfied in contrast
to findings by Weiss16 and Hall15 both found no relationship between
satisfaction and ethnic group. Our study also reported an association
between educational level and satisfaction. This phenomenon was
fairly well documented in other studies. Linn17, Hall15 and Anderson18,
all came to a similar conclusion where they all found dissatisfaction
greatest among the more educated.
Our study also reported those serving in the public sector were
more dissatisfied than others. Probably this may also be attributed to
educational status as more than one-third of the workers in the public
sector had tertiary education. Further, probably the more times the
patient visited the specialist clinic the more dissatisfied they were
as they may have discovered or experienced more negative things
following these visits.
Using SERVQUAL, our study reported least dissatisfaction for the

dimension of “Assurance” and the greatest dissatisfaction was in the
dimension of “Reliability”. Similar findings had been reported by
Fayek6 on NHS hospitals. Our study indicated that the patients were
dissatisfied with the waiting time at the specialist clinics because Q5,
(Waiting times in Hospital are appropriate) obtained the second highest
negative score. Usually long waiting times are caused by (i) the system
not functioning (ii) too many patients (iii) shortage of staff.
The “staggered appointment system” can sometimes jeopardise the

system. The patient comes at 10.00am according to her appointment but
is only seen by the doctor at 11.30am is worse off than a patient who
comes at 8.30am, takes a number and waits for her turn, finally being
seen by the doctor at 12.30pm. Patients often perceive it as normal to
wait for their turn even though they have to wait for several hours.
Patients also perceive unresponsiveness as not only delay on taking

action but also when proper explanation was not given at the time the
services were not provided as promised. For example, if the doctors
came late to the clinic because of urgent and important matters in the
wards, patients should be informed. However it is not professional if
clinics always started late and all sort of excuses are given frequently. If
a clinic starts late, the backlog will be felt at the pharmacy, where there
will be overcrowding of patients waiting to get medicine before lunch
time. Sometimes, doctors come late to the clinic because of grand ward
rounds. A way around this is for one or two doctors to start the clinic
running before the grand rounds are finished. Apart from ineffective
system, there were too many patients and the hospital does not have the
required staff to provide prompt services. Other than recruiting more
staff, management should develop a strategy to create a conducive
waiting environment to reduce the agony of waiting.
The next dissatisfaction was in the dimension of “Responsiveness”.

Patients were also not happy with the staff promptness in giving
services as evidence from Q8 (It is realistic for patients to expect
prompt service from hospital staff), obtained the highest negative score.
Management should identify the delay in service delivery were due
to manpower shortage or staff attitude. Management must ensure
that all staffs are given the opportunity to undergo training that can
improve their competency and capability to perform their daily work
effectively. Problematic staff should be sent for counseling.
Conclusion
The SERVQUAL was a useful instrument to be used for the

measurement of patients’ expectations. The 5 dimensions assessed
in this instrument will facilitate the identification of strengths and
weakness; and it is hoped that health care facilities nationwide will
learn to use this instrument to further help improve the quality of
services provided.

References:
1. Linder-Pelz S. “Towards a Theory of Patient Satisfaction”. Journal of Social Science

and Medicine (1982). Vol. 16 : 577-582.
2. Carson PP, Carson KD, Roe CW. Towards Understanding the Patient’s Perception of
Quality. The Health Care Supervisor (1998). Vol. 16 (3) : 36 – 42.
3. Roslan MG; Chong TS; Noriah B; Tahir A. The practice of Noble Values by Counter
Staff at Ministry of Health Hospitals. Institute for Health Management (2006).
4. Parasuraman A; Zeithaml VA; Berry LL. SERVQUAL : A multiple-item scale for

measuring consumer perceptions of service quality. Journal of Retailing 1988; 64: 12-
40.
5. Scardina SA. SERVQUAL : A tool for evaluating patient satisfaction with nursing care.
Journal Nursing Care Quality 1994; 8: 38-46.
6. Fayek Y; Dean N; Bovarid T. “Health Care Quality in NHS Hospitals”. International

Journal of Health Care Quality Assurance 1996; 9: 15- 28.
7. Hart M. Incorporating outpatient perceptions into definitions of quality. Journal of

Advanced Nursing 1996; 24: 1234-1240.
8. Hall JA; Dornan MC. What patients like about their medical care and how often they
are asked a meta analysis of the satisfaction literature. Social Sci Med 1988; 27: 935-939.
9. Calnan M. Towards a conceptual framework for examining lay evaluation of health

care. Soc. Sci. Med 1988; 27: 927-929.
10. Carmel S. Satisfaction with hospitalisation : a comparative analysis of three types of

service. Soc. Sci Med 1985; 21: 1243-1249.
11. Pascoe GC. “Patient Satisfaction in Primary Health Care : A Literature Review and
Analysis.” Evaluation and Program Planning 6 1983; 185-210.
12. Young GJ; Meterko M; Desai KR. Patient satisfaction with Hospital care : Effects of
demographic and Institutional Characteristics. Medical Care 2000; 38: 325-334.
13. Breemharr B; Visser Ph: Kleijnen GVM. Perceptions and Behaviour among elderly
hospital patients: Description and Explanation of Age Differences in Satisfaction,
Knowlege, Emotions and Behaviour. Soc. Sci. Med. 1990; 31: 1377-1385.

14. Zastowny TR; Roghman KJ; Hengst A. Satisfaction with medical care: replications
and theoretic reevaluation. Med. Care 1983; 21: 294-299.
15. Hall JA; Dornan MC. Patient socio demographic characteristics as predictors of
satisfaction with Medical care : a meta analysis. Soc. Sci. Med. 1990; 30: 811-818.
16. Weiss GL. Patient satisfaction with Primary Medical Care : Evaluation of Socio
demographic and predispositional factors. Medical Care 1988; 26: 383-392.
17. Linn LS. Factors associated with patient evaluation of health care. Milbank Mem.
Fund Q 1975; 53: 531-542.
18. Anderson LA; Zimmerman MA. Patient and Physician Perceptions of their Relationship
and Patient Satisfaction: A Study of Chronic Disease Management. Patient Education
and Counseling 1993; 20: 27-36.

JOB SATISFACTION AMONG STAFF IN SELAYANG
HOSPITAL
SUMMARY
The purpose of this study was to document job satisfaction level and issues arising
from the information technology (IT) environment in Selayang Hospital. This cross-
sectional study utilised a self-administered questionnaire involving all staff at the
hospital. About 60% of staff professed job satisfaction. However, there were a high
proportion of doctors claiming job dissatisfaction, heavy workload and severe work
stress. There was a significant association between perceptions of job satisfaction,
overwork, and stress at work. Staff who perceived to be overworked were likely to
perceive being under severe stress, and were more likely to be dissatisfied with their
job. The main factors that contribute to job dissatisfaction were inadequate support
service, demanding patients and bad attitude among staff. In terms of the Total
Hospital Information System (THIS), majority agreed the system has many benefits,
but that too much time was spent entering data than in communicating with patients.
There was unhappiness with the response time to solve IT problems. These problems
had contributed to longer waiting times for patients.
Introduction
L
ocke (1976)1 defines job satisfaction as an emotional reaction Defining job
that “results from perception that one’s job fulfils or allows the satisfaction
fulfilment of one’s important job values, providing and to the
degree that those values are congruent with one’s needs”. Not
every employee is happy with his or her job. Overwork can cause stress.
Job dissatisfaction is sometimes associated with overwork and stress.
Studies have also shown that overwork leads to stress2. Although a
little stress is motivational, severe stress can lead to job dissatisfaction
and burnout. It all depends on how someone takes it’. However, severe
stress is associated with job dissatisfaction and health problems3-5.
There are many challenges in the Ministry of Health (MOH) that put Current
a strain on its personnel. Due to bureaucracy, the decision-making challenges in the
process in the MOH is slow. Lack of resources, especially manpower, MOH
and an increasing number of patients using public health facilities also
overload current facilities. An increasingly educated community has
led to more complaints if individual rights are not met.

Increasngly too, MOH hospitals are based on information technology
(IT). Selayang Hospital was the first hospital built with the Total
Hospital Information System (THIS). The purpose of this study was
to document the level of job satisfaction among staff working in the IT
environment of Selayang Hospital. The study also sought to identify
issues of staff working with THIS, and where possible, to develop
strategies to address these issues.
Methodology
This is a cross-sectional study using a self-administered questionnaire Sampling

developed by the research group. The questionnaire was pre-tested to and use of
test its validity. The dependent variables were job satisfaction, stress questionnaire
and workload. The study involved all staff working in Selayang
Hospital. Staff were given a week to complete the questionnaire and
reminders were sent to their immediate supervisors to increase the
response rate. Descriptive analysis of data was undertaken using the
Statistical Package for Social Sciences (SPSS).
Findings
There was 1,853 staff working in Selayang Hospital and 81.2% (1,515) Profile of
responded. However, there were several non-responses to individual respondents
items in the questionnaire with only 1,494 responding to job category
and ethnic grouping (Table 1). The respondents were mainly nurses
(65%) and more than 90% were Malays (Table 1).
Table 1 : Job Category and Ethnicity of Respondents in Selayang Hospital
Category Malays Chinese Indian Others Total
Specialist 29 (1.9%) 10 (0.7%) 8 (0.5%) 1 (0.1%) 48 (3.2%)

Medical Officer 83 (5.6%) 16 (1.1%) 16 (1.1%) 1 (0.1%) 116 (7.8%)
Nurse 928 62.1%) 11 (0.7%) 26 (1.7%) 6 (0.4%) 971 (65%)
Medical Assistant 47 (3.1%) 1 (0.1%) 5 (0.3%) 0 53 (3.5%)
Others 266 17.8%) 10 (0.7%) 28 (1.9%) 2 (0.1%) 306 (20.5%)
Total 1,353 (90.6%) 48 (3.2%) 83 (5.6%) 10 (0.7%) 1,494 (100%)

21 respondents did not state their occupation

Mean age was 29.4 years. Majority were females, married and had
being working in Selayang Hospital for less than 3 years (Figure 1).
Figure 1: Profile of Respondents
1400 1295 (85.8 %)
1200
1000 877 (57.9 %)

819 (55.1 %)
800 638 (42.1 %) 668 (44.9 %)
600
400
215 (14.2 %)
200
0
Male Female Single Married Less than 3 years or
3 years more
Gender Status Duration working
More than 60% of staff was happy with their job (Table 2). However, Level of job
only half of doctors were satisfied (49.7%) and this was significantly satisfaction
different from others (p=0.001). However, there appeared to be no
significant association between job satisfaction and gender, marital
status, ethnicity or educational level.
Table 2 : Job Satisfaction Among Staff
Job Satisfaction Doctor Nurse Others Total

Level
Satisfied 80 (49.7%) 600 (62.3%) 251 (66.9%) 931 (62.1%)

Dissatisfied 33 (20.5%) 134 (13.9%) 58 (15.5%) 225 (15%)
Uncertain 48 (29.8%) 229 (23.8%) 66 (17.6%) 343 (22.9%)
Total 161 (100%) 963 (100%) 375 (100%) 1,499 (100%)
16 did not respond

In terms of workload, 57.7% of doctors perceived they were Perception on
overworked (Table 3), a higher proportion than other categories. workload
Apart from occupation, there appeared to be no significant association
between workload and gender, marital status or ethnicity.
Table 3: Perception on Workload among Staff
Perceived Overwork Doctor Nurse Others Total
Yes 94 (57.7%) 355 (36.7%) 139 (37.0%) 588 (39.0%)
No 44 (27.0%) 352 (36.4%) 157 (41.8%) 553 (36.7%)
Uncertain 25 (15.3%) 260 (26.9%) 80 (21.3%) 365 (24.2%)
Total 163 (100%) 967 (100%) 376 (100%) 1,506 (100%)
9 did not respond
More than 45% of doctors claimed having severe work stress (Table 4), Perception on
followed closely by nurses (43%). Apart from category of occupation, work stress
there appeared to be no significant association between severe work
stress and gender, marital status or ethnicity.
Table 4 : Perception of Work Stress among Staff
Perceived work stress Doctor Nurse Others Total
Yes 73 (45.1%) 326 (43.0%) 117 (31.3%) 516 (34.5%)
No 57 (35.2%) 420 (43.8%) 189 (50.5%) 666 (44.5%)
Uncertain 32 (19.8%) 213 (22.2%) 68 (18.2%) 313 (20.9%)

Total 162 (100%) 959 (100%) 374 (100%) 1,495 (100%)
20 did not respond
There seems to be a relationship between perception of being Overwork and

overworked and working under severe stress (p=0.000). Staff who work stress
perceived themselves to be overworked were also likely to claim being
under severe stress (Table 5).

Table 5 : Overwork and Working under Severe Stress Among Staff
Perceived Perceived under severe stress
overwork No Yes Uncertain Total
No 465 (70.2%) 30 (5.8%) 54 (17.3%) 549 (36.8%)
Yes 88 (13.3%) 423 (82%) 72 (23.1%) 583 (39.1%)
Uncertain 109 (16.5%) 63 (12.2%) 186 (59.6%) 358 (24.0%)
Total 662 (100%) 516 (100%) 312 (100%) 1,490 (100%)
P =Total
0.000 662 (100%) 516 (100%) 312 (100%) 1,490 (100%)
There also seems to be a relationship between overwork and job Overwork

satisfaction level (p=0.000). Staff who perceived themselves to be and job
overworked were also likely to have job dissatisfaction (Table 6). dissatisfaction
Table 6 : Overwork and Job Satisfaction Among Staff
Perceived Job Satisfaction
overwork No Yes Uncertain Total
No 493 (53.3%) 14 (6.2%) 43 (12.5%) 550 (36.8%)
Yes 229 (24.8%) 180 (80.0%) 170 (49.6%) 579 (38.8%)
Uncertain 203 (21.9%) 31 (13.8%) 130 (37.9%) 364 (24.4%)
Total 925 (100%) 225 (100%) 343 (100%) 1,493 (100%)
Total 662 (100%) 516 (100%) 312 (100%) 1,490 (100%)

P = 0.000
Perception of working under severe stress also seemed to be associated Severe stress and
with job satisfaction (p=0.000). Staff who perceived themselves under job satisfaction
severe stress was also likely to have job dissatisfaction (Table 7).

Table 7 : Severe Stress And Job Satisfaction Among Staff
Perceived Job Satisfaction
severe stress No Yes Uncertain Total
No 585 (63.4%) 21 (9.5%) 60 (17.5%) 666 (44.8%)
Yes 174 (18.9%) 176 (79.3%) 159 (46.4%) 509 (34.2%)
Uncertain 163 (17.7%) 25 (11.3%) 124 (36.2%) 312 (21.0%)
Total 922 (100%) 222 (100%) 343 (100%) 1,487 (100%)
Total 662 (100%) 516 (100%) 312 (100%) 1,490 (100%)

P = 0.000
When asked on factors that contribute to job satisfaction, exposure to Factors that
new technologies was cited as the main factor that accounted for job influence job
satisfaction (Figure 2). The other positive factors for job satisfaction satisfaction
were co-operative staff and co-workers, and work challenges. .
Figure 2: Factors that contri butes to staff job satisfaction
None 3.0%
Others 0.8%
Internal recognition 0.3%
Duration of working hours 0.6%
Flexibility of work schedule 0.7% Factors
Empower to make decision 1.2%
Public recognition 2.0%
Good relationship with management 2.5%
Business Process Re-engineering 4.1%
Professional development 5.9%
Conducive work environment 6.6%
Potential for career advancement 7.9%
Selayang Hospital is progressive in ICT 10.6%
Work challenges 10.9%
Cooperation among staff and co-workers 11.7%
Exposure to new technologies 31.1%
The main factors cited to contribute to job dissatisfaction were Factors that
inadequate support service, demanding patients, bad attitude among contribute to job
staff, no teamwork, inadequate resources and leadership problems dissatisfaction
(Figure 3).

Figure 3 : Factors that contributes to staff job dissatisfaction
33.80%
17.90%
11.90%
9.40%
7.40% 8.10%
6.70%
4.70%
Inadequate Demanding Bad attitude No Inadequate Leadership Others None

support patients amongst teamwork resources
service staff
Total Hospital Information System (THIS) in Selayang Hospital
Nearly 60% of staff agreed that THIS in Selayang Hospital facilitates Perception on
daily work by easing retrieval of patient data. They also agreed that THIS among
the system facilitates integration and interfacing of clinical work staff
among departments. However, 25.5% of clinical specialists and more
than 30% of medical officers felt that the system did not ease their
workload (Table 8).
Table 8 : Perception of Workload and THIS in Hospital Selayang
Eases Clinical Medical Nurses Medical Others Total

workload Specialist Officer Assistant
Yes 22 (46.8%) 46 (40.4%) 577 (59.7%) 35 (66.0%) 184 (60.7%) 864 (58.2%)
No 12 (25.5%) 35 (30.7%) 171 (17.7%) 9 (17.0%) 66 (21/8%) 293 (19.7%)
Uncertain 13 (27.7%) 33 (28.9%) 219 (22.6%) 9 (17.0%) 53 (17.5%) 327 (22.0%)
Total 47 (100%) 114 (100%) 967 (100%) 53 (100%) 303 (100%) 1,484 (100%)
31 did not respond

Further, less than half of staff perceived that THIS in Selayang Hospital Perception on
is user-friendly (Table 9). ease of use
Table 9 : Perception of THIS as User-friendly in Selayang Hospital
Eases Clinical Medical Nurses Medical Others Total

friendly Specialist Officer Assistant
Yes 16 (33.3%) 42 (36.2%) 438 (45.6%) 24 (46.2%) 159 (53.0%) 679 (46.0%)
No 20 (41.7%) 40 (34.5%) 146 (15.2%) 12 (23.1%) 40 (13.3%) 258 (17.5%)
Uncertain 12 (25%) 34 (29.3%) 377 (39.2%) 16 (30.8%) 101 (33.7%) 540 (36.6%)
Total 48 (100%) 116 (100%) 961 (100%) 52 (100%) 300 (100%) 1,477 (100%)
31 did not respond
Majority of staff (60.7%) claimed that they spend more time entering Decreased
data into the system than communicating with patients. This was interaction with
more pronounced among the medical officers compared to other staff patients
(Table 10).
Table 10 : IT and Patient Communication
More time
entering
data than Clinical Medical Nurses Medical Others Total
communi- Specialist Officer Assistant
cating
with patient
Yes 28 (59.6%) 85 (73.3%) 600 (62.2%) 30 (57.7%) 147 (51.2%) 890 (60.7%)
No 15 (31.9%) 20 (17.2%) 167 (17.3%) 13 (25.0%) 31 (10.8%) 246 (16.8%)
Uncertain 4 (0.3%) 11 (9.5%) 198 (20.5%) 9 (17.3%) 109 (38.0%) 331 (22.6%)
Total 47 (100%) 116 (100%) 965 (100%) 52 (100%) 287 (100%) 1,467 (100%)
48 did not respond

Majority of doctors were not happy with support services in terms of Solving IT
the time taken to solve problems related to ICT (Table 11). downtime
Table 11 : Perception on Response Time to Solve ICT Problems
Good Clinical Medical Nurses Medical Others Total

respond Specialist Officer Assistant
time
Yes 14 (29.2%) 35 (30.7%) 443 (45.9%) 19 (35.8%) 122 (39.9%) 633 (42.6%)
No 21 (43.8%) 61 (53.3%) 283 (29.3%) 22 (41.5%) 95 (31.0%) 482 (32.4%)
Uncertain 13 (27.1%) 18 (15.8%) 239 (24.8%) 12 (22.6%) 89 (29.1%) 371 (25.0%)
Total 48 (100%) 114 (100%) 965 (100%) 53 (100%) 306 (100%) 1,486 (100%)
29 did not respond
Majority of staff agreed that on-the-job training using THIS is adequate Adequacy
for them to improve their skills in operating the ICT system (Table 12). of hands-on
training
Table 12 : Perception on THIS On-the-job Training
Adequate Clinical Medical Nurses Medical Others Total

on-the-job Specialist Officer Assistant
training
Yes 23 (47.9%) 52 (44.8%) 610 (63.1%) 29 (55.8%) 167 (54.8%) 881 (59.2%)
No 15 (31.3%) 41 (35.3%) 195 (20.2%) 16 30.8%) 68 (22.3%) 335 (22.5%)
Uncertain 10 (20.8%) 23 (19.8%) 162 (16.8%) 7 (13.5%) 70 (23.0%) 272 (18.3%)
Total 48 (100%) 116 (100%) 967 (100%) 52 (100%) 305 (100%) 1,488 (100%)
27 did not respond
Majority of the problems (41%) faced by the staff were, overwhelmingly Problems faced
related to information technology (Figure 4), while an equal 41% by staff
perceived no problems at all.

Figure 4 : Problems faced by staff
No problem at all 41.0%

Others 8.8%
Lot of administrative work 0.1%
Staff incompetence 0.7%
Not enough time 0.9%
Problem with superior 1.4%
Problems
Poor communication 1.5%
Attitudinal problem among staff 2.6%
Not enough resource 2.7%
No cooperation 3.3%
Problem associated with management 3.6%
Heavy workload 4.2%
Problem associated with work process 5.2%
Shortage of Staff 6.1%
Total Hospital Information Technology 41.0%
If given a chance to change or improve condition, 25.1% of the Hypothetical

respondents would like to improve the conditions related to THIS change to
(Figure 5). system
Figure 5: Changes That Staff Would Like to Make (Grouped Under Dimension)
450 401
2 0
34 3 5
400 2 4
25 1
350
300
250
200
150 5 0
1 5
100 50
3 40
2 13 2
50 0 0 1
0
y
e
IT
e
le
ne
rs
siv
om
nc
th
bl
TH
ib
he
no
lia
pa
ra
ng
on
tc
Ot
Em
Re
su
Ou
Ta
sp
As
Re

Discussion
There was a good response rate from staff of Selayang Hospital. Job
Althoug, almost two-thirds of staff had job satisfaction, a high dissatisfaction
proportion of doctors professed job dissatisfaction, heavy workload among doctors
and severe work stress. The results of a national survey on job
satisfaction among general practitioners in England reported about
22% of doctors intending to quit6. The intention to quit was due
mainly to a reduction in job satisfaction. Based on workshops with
doctors in the United States and United Kingdom, Nigel Edwards et
al. (2002)7 concluded that heavy workload and low pay were obvious
causes of unhappiness among doctors. In this study, the main factors
that contribute to job dissatisfaction were inadequate support service,
demanding patients and bad attitude among staff.
This study also found an association between perceived overwork and Association
severe stress. Staff who perceived to be overworked and under severe between
stress were also likely to have job dissatisfaction. The results concur overwork,
with that of a survey conducted by Rasidah et al. (2006)8 on medical stress and job
doctors working in public hospitals in Malaysia. Other studies have dissatisfaction
also linked increased stress and reduced job satisfaction with high
nursing workloads9-11.
Although the majority was of the opinion that THIS has many benefits, Disadvantages
staff, especially doctors, also felt that too much time is spent on entering of THIS
data than communicating with patients. Majority of problems faced
were related to IT. Personnel were not happy with the response time
from the ICT support team to solve IT problems. These problems had
contributed to longer waiting times for patients. There is therefore,
a need for more stringent monitoring of the vendor responsible to
maintain and to solve the ICT problems in reasonable time.
Hospital management should focus on doctors’ claims of being Need to

overworked and under severe stress. Stress management should be address issues
introduced to increase coping skills. Some work processes may also
need to be reviewed or re-engineered to address this issue.
Conclusion
This study found advantages and disadvantages of the THIS in

Selayang Hospital from the perspective of staff. While the IT-based
system is seen to increase integration and interfacing between
departments, it is also seen to detract from communication time with

patients due to the need to enter data real-time. Many of the problems
cited seem to be associated with the need for more timely responses
to solve IT problems.
Many of the factors that contribute to perceptions of job dissatisfaction,

overwork and stress may or may not be associated with the IT-based
system per se, as these factors may apply equally to other staff in other
healthcare facilities. It is recommended that the hospital management
of Selayang Hospital address issues within control such as introducing
stress coping skills, reviewing and re-engineering processes and
exercising more stringent control and monitoring of the ICT vendor
responsible for maintenance of the system.
References:
1. Locke, EA. The nature and causes of job satisfaction: Role of negative affectively. J
Applied Psychology 1976: 1297-349
2. Clare D. Stress case paves way for damages claims. Brit Med J 1994; 309:1391-3
3. Weissman CS, Alexander CS, Chase GA. Job satisfaction among hospital nurses: a
longitudinal study. Hlth Serv Res 1980;15: 341-64
4. Price JL, Mueller CW. Professional turnover: the case of nurses. SP Medical and Scientific
Books, Jamaica, 1981
5. Bedeian AG, Armenakis AA, Curran SM. The relationship between role stress and
job-related, interpersonal and organizational climate factors. J Soc Psychol 1981; 113:
247-60
6. Sibbald B, Bojke C, Gravelle. National survey of job satisfaction and retirement intentions
among general practitioners in England. Brit Med J 2003; 326 (7379):22-4
7. Edwards N, Kornacki MJ, Silversin J. Unhappy doctors: what are the causes and what
can be done? Brit Med J 2002; 324(7341):835-8
8. Rasidah SS, Roslan J, Haliza AM. The future of medical doctors in the public sector. J
Health Management. 2006;1(1):61-9
9. Fagerstrom L, Rainio AK. Professional assessment of optimal nursing care intensity

level: a new method of assessing personnel resources for nursing care. J Clinical Nursing
1999;8:369-79

10. Stordeur S, D’hoore W, Vandenberghe C. Leadership, organisational stress and
emotional exhaustion among hospital nursing staff. J Advanced Nursing 2001;:35:533-42
11. Buchanan J, Considine G. Stop telling us to cope! Aust Centre for Industrial Relations
Research and Training, Sydney, 2002

NATIONAL LABORATORY BIOSAFETY
SUMMARY
Public concern has increased regarding the use of biological materials as agents
of terrorism and as potential risk of spread from the laboratory to the public, or
environment due to inappropriate handling and practices. However, these same
agents are essential in clinical and research microbiology laboratories. Traditional
biosafety guidelines for laboratories have emphasized use of optimal work practices,
appropriate containment equipment, well-designed facilities, and administrative
controls to minimize risk of worker injury and to safeguards against laboratory
contamination. In Malaysia, although there are various public health laws they are
mainly for the prevention and control of infectious diseases, the issue of laboratory
biosafety need to be addressed as a matter of urgency. The National Laboratory
Biosafety and Biosecurity Committee has been set up by the Ministry of Health to
formulate a national biosafety policy and address local biosafety issues. A national
biosafety policy, under the Ministry of Health will renew the commitment of the
government, in ensuring adequate levels of protection in biomedical laboratories, to
ensure that there will be no adverse effects on human health and the environment.
Introduction
B
iological materials, pathogenic and nonpathogenic, are used Biohazardous
and cultured in many laboratory procedures. These biological materials in
materials include but are not limited to bacteria, virus, parasites, laboratories
fungi, prions, recombinant products, allergens, cultured animal
cells, infected clinical specimens and tissue from experimental animals.
These agents are termed biohazardous because they are capable of
producing deleterious effects to the health of the individual exposed
to the agent. Laboratories handling biohazardous agents have a unique
work environment and may pose infectious disease risk to person in or
near them, to the environment and public should the material escape
the containment procedures established for the laboratory.
Over the last decade, the scientific community has witnessed the Recent new
emergence of new infectious agents, for example Nipah and SARS emerging
corona virus. These agents post a threat to laboratory personnel infectious
working in laboratories with inadequate containment facilities. diseases

Considerable information has been compiled in recent years from a
variety of sources concerning the accidental infection of laboratory
workers working with pathogenic microorganisms1,2.
Global events in the recent past have also highlighted the need to Concern
protect laboratory personnel and materials. When the SARS epidemic over Safey of
ended in July 2003, the World Health Organization was worried laboratory
about a new epidemic emerging from SARS samples stored in many personnel
laboratories working with the virus. Those fears were confirmed by
three laboratory accidents documented in Singapore (August 2003),
Taiwan (December 2003) and in China (March 2004)3.
Principles Of Biosafety
Laboratory biosafety is a term used to describe containment principles, Containment

technologies and practices that are implemented to prevent accidental of biohazard
exposure to pathogens and toxins. “Containment” is used in describing materials in
safe methods for managing infectious materials in the laboratory laboratories
environment where they are being handled or maintained. The purpose
of containment is to reduce or eliminate exposure of laboratory workers,
other persons, and the outside environment to potentially hazardous
agents. The most important element of containment is strict adherence
to standard microbiological practices and techniques. Persons working
with infectious agents or potentially infected materials must be aware
of potential hazards, and must be trained and proficient in the practices
and techniques required to handle such material safely.
Despite a great awareness of biosafety and biocontainment practices, Biosafety and

handling infectious micro-organism remain a source of infection or even biocontainment
mortality among laboratory workers. The World Health Organisation are important
(WHO) has long recognized that safety, including biological safety, international
are important international issues. The WHO in their three editions issues
of “Laboratory Biosafety Manual” has encouraged countries to accept
and implement basic concepts of biological safety and to develop a
national code of practice for the safe handling of pathogenic micro-
organism in laboratories 4.
National Laboratory Biosafety
The Government of Malaysia has various laws in place for the

prevention and control of infectious diseases in Malaysia. These
include, Prevention and Control of Infectious Diseases Act 1988,
Malaysia Civil Aviation Regulation 1996, Environmental Protection

Act 1990, Occupational Safety and Health Administration (OSHA) Act
1994 and Regulation (2000).
Recently, there is an increase in the number of government public health Guidelines on

laboratories, research institutions, universities and private laboratories import and
handling microbiological agents and pathological specimens. These export of micro-
institutions also import microorganisms and infectious materials for organisms
research and commercial purposes. Understanding the threat that
these may pose to the spread of infectious diseases, the Disease Control
Division, Ministry of Health (MOH) in 2001, revised the guidelines for
the import and export of infectious materials. These guidelines outline
the procedures involved in the safe handling, packaging for the import
and export of microorganism, and also assist in the issuance of license
permit to the relevant authorities.
The OSHA regulation 2000 provides the means whereby the associated Occupational
occupational safety and health legislations and approved industry Safety and
codes of practice operate in combination with the provisions of the Health Act 2000
Act designed to maintain or improve the standards of safety and
health. The Act also ensures personnel protection at the place of work
with control of risks to safety or health arising out of their activities
at work. It also promotes an occupational environment for persons
at work which is adapted to their physiological and psychological
needs. Although these laws related to safety are in place, there is still
an urgent need to address laboratory biosafety.
The WHO at the 58th World Health Assembly on 25 May 2005 urged
member states to “review the safety of their laboratories and their
existing protocol for the safe handling of microbiological agents and
toxins consistent with WHO biosafety guidance”5.
The Director General of Health Malaysia, Datuk Dr. Hj Mohd Ismail National
Merican convened a meeting on 10 May 2005 to set up the National Laboratory
Laboratory Biosafety and Biosecurity Committee. The proterm Biosafety and
committee comprised of heads of government departments, senior Biosecurity
government officers and representatives from local universities (table Committee.
1). National Biosafety and Biosecurity issues were discussed at the
meeting. The committee agreed in principle that biosafety is an issue
of national importance.
The Terms of Reference (TOR) are :
i) To develop and establish a National Laboratory Biosafety &

Biosecurity Policy

ii) To assess the biosafety and biosecurity capability of all laboratories
that handle biological agents and toxin
iii) To raise awareness on the importance of biosafety amongst
personnel working in diagnostic and biomedical research
laboratories
iv) To provide appropriate training programs for upgrading skills and
competencies of laboratory personnel particularly those handling
pathogens of high risk (BSL-3 and BSL-4)
v) To formulate the National Biological Agents and Toxins Act
Three sub-committees were set-up under the main committee:

Committee
(1) Policy and Act: Chairman: Director of National Institute for
members
Natural Product, Vaccines and Biological (NINPVB)
(2) Assess capability: Chairman: Director of Medical Development
Division
(3) Education and training: Chairman: Directors of IMR & NINPVB
Table 1: List of members for the National Laboratory Biosafety and Biosecurity
Committee (NLBBC)
Chairman Director General of Health Malaysia
Secretary Director, NINPVB
Members Ministry of Health :

Institute for Medical Research
Disease Control Division
National Public Health Laboratory
Hospital Development Division
Ministry of Education :
University of Malaya (UM)
Universiti Kebangsaan Malaysia (UKM)
University of Science Malaysia (USM)
University Malaysia Sarawak (UNIMAS)
University Islam Malaysia (UIA)

Ministry of Agriculture :
Malaysian Agricultural Research and
Development Institute (MARDI)
Veterinary Research Institute (VRI)
Ministry of Natural Resource and Environment:

Forest Research Institute Malaysia (FRIM)
Secretariat for Biosafety
Ministry of Defense :
Malaysia Palm Oil Board (PORIM)
The sub-committee for Biosafety Policy and Act would be formulating

the National Biosafety Policy and later, the Biologicals and Toxins Act.
The Education and Training sub-committee would develop educational
programmes on biosafety for laboratory personnel in biomedical
facilities in the form of printed material to enable them to understand
their rights, roles and responsibilities and to carry out their duties in
a safe manner. The role of the sub-committee on the assessment of
laboratory capabilities is to have an active database on all biomedical
laboratories in Malaysia.
The scope of activities for the National Laboratory Biosafety

Scope of
and Biosecurity Committee would cover all Ministry of Health
activities of
employees who could reasonably be anticipated to face contact with
NLBBC
potentially infectious materials as a result of performing their job
duties occupational exposure; BSL3 and BSL4 laboratory workers and
managers and trainers on biosafety and biosecurity. This is to ensure
that the people involved in biosafety decision-making are competent
and confident to handle specific training needs of the department.
The scope would also include all diagnostic and biomedical research
laboratories personnel, including universities, private laboratories
and Army (MINDEF).
Conclusion
The WHO recommends each laboratory organization to have a

comprehensive safety policy, a safety manual and supporting
programmes which are specific to the institution needs. Most biomedical
laboratories in Malaysia adhere to these and have implemented their
local guidelines on biosafety with biosafety policies and programme
which are specific to the scope of activities in their laboratories.

Local biosafety guidelines are mostly adopted from international
guidelines for example the WHO Laboratory Biosafety Manual and
the Centre for Disease Control, United States (6). A National Biosafety
Framework, involving all biomedical laboratories, government and
non-government is important to address technical, scientific, legal and
socio-economic and political issues governing biosafety in Malaysia.
It is apparent that a National Laboratory Biosafety Policy, under the
Ministry of Health will renew the commitment of the government,
in ensuring adequate levels of protection in biomedical laboratories;
to ensure that there will be no adverse effects on human health and
the environment, based on international biosafety guidelines, for
the benefit of the present and future generations. This policy would
support all related legislation and biosafety policies and programmes
existing in biomedical institutions and is intended to be complementary
and not to replace or undermine them.
References:
1. Collins, C.H., and Kennedy, D.A. Laboratory-acquired infections. In: Laboratory-

acquired infections: history, incidence, causes and preventions. Oxford, UK:
Butterworth-Heinemann, 1999:1-37.
2. Harding, A.L., and Brandt Byers, K. Epidemiology of laboratory-associated infections.

In: Fleming, D.O., and Hunt, D.L. Biological safety: principles and practices. Washington,
DC: ASM Press, 2000:35-54.
3. Altman L . The Doctor’s World; SARS’s second act, playing in laboratories. New York
Times. May 18, 2004
4. World Health Organization. Laboratory Biosafety Manual 3rd Edition. WHO, 2004.
5. Report of the World Health Organization 58th World Health Assembly on 25 May
2005. http://www.who.int/csr/labepidemiology/WHA58_29-en.pdf
6. CDC Biosafety in microbiological and biomedical laboratories. Fourth Edition. US

Government Printing Office, 1999.

2
part
EDITORIAL COMMITTEE
CONTRIBUTORS
ACKNOWLEDGEMENT
part two
EDITORIAL COMMITTEE

Principle
Advisor • Tan Sri Datuk Dr. Hj Mohamad Ismail Merican
Director General of Health, Malaysia
Advisors
• Dato’ Dr. Shafie B. Ooyub
Deputy Director General of Health
(Public Health)
• Datuk Dr. Abdul Gani b. Mohammed Din

Deputy Director General of Health (Medical)
• Datuk Ir. Dr. M.S. Pillay

Deputy Director General of Health (Research
and Technical Support)

Chief Editor
• Dr. Ang Kim Teng
Director of Health
Selangor State Health Department

Editors • Dr. Nor Izzah Hj Ahmad Shauki
Selangor State Health Department

• Dr. Khairiyah Abdul Muttalib
Oral Health Division,
Ministry of Health Malaysia
• Dr. Azman Abu Bakar

Institute for Health System Research
• Dr. Mohammad Amir Kamaluddin

Division of Epidemiology and Statistics
Institute for Medical Research, Kuala Lumpur

Production
• Dr. Lailanor Hj Ibrahim
Planning and Development Division

LIST OF CONTRIBUTORS
1 Emergency Medical and Trauma Care Service in Malaysia

Dr Mathyvany a/p Umapathy, Dr. Mahathar b. Abdul Wahab,
Dato’ Dr. Abu Hassan Asaari b. Abdullah

2 Rehabilitative Services in Malaysia
Dr. Asmah Samat , Dr. Thevaraj a/l Ponnudurai;
Dr. Wan Masliza Wan Daud

3 Specialisation and subspecialisation in the Ministry of Health
Dr. Sukumar Mahesan

4 Hospital Infection Control
Dr. Mohd Shah Dato’ Idris

5 Optimising Intensive Care Service in Malaysia
Dr. Ng Siew Hian, Dr. Rachael Mathew,
Dr. Zahirah Mohd. Juraimi

6 Chronic Pain Management Service
Dr Mary S. Cardosa

7 Advances in Oral Healthcare in Malaysia
Dr. Tan Bee Siew, Dr. Wan Noraini Abu Bakar

8 Challenges for Generic Drugs
Puan Noorizam Ibrahim

9 Dengue Control in Malaysia
Dr Mohammad Ikhsan Selamat

10 Prevention and Control of Zoonotic Diseases
Dr. Rosmawati Ariffin

11 National Influenza Pandemic Preparedness Plan
Dr. Rohani Jahis, Dr. Zainuddin Abdul Wahab


12 Harm Reduction in the Prevention and Control of HIV/AIDS
Dato’ Dr. Faisal Ibrahim

13 Suicide Prevention in Malaysia
Dr. Sharifah Rohani Syed Abu Bakar,
Dr. Nurashikin I., Prof. T. Maniam.

14 New Generation Hospital - IT Hospitals
Dr. Supathiratheavy Rasiah

15 Control of Unregistered Drugs and Healthcare
Products in Malaysia
Mr. Adnan bin Salimin

16 Information Versus Advertising
Mr. Selvaraja Seerangam

17 Health Technology Assessment
Datin Dr. Rugayah bt. Bakri, Noormah Mohd Darus

18 Development and Implementation of Medical Devices
Regulation in Malaysia
Mr. Ahmad Shariff Hambali

19 Meeting Outpatient Expectations at Public Hospital
Specialist Clinics
Dr Roslan Johari Mohd Ghazali, Dr Tahir Aris,
Dr Paa Nasir Abdul Rahman

20 Job Satisfaction Among Staff in Selayang Hospital
Dr. Roslan Johari Mohd Ghazali,
Dr.Haliza Abdul Manaf

21 National Laboratory Biosafety
Dr. Norshahidah Khairullah

ACKNOWLEDGEMENT
The Editorial Committee wishes to thank the Director-General

of Health Malaysia for his invaluable guidance and direction in
the preparation of this Report. The Committee also wishes to
acknowledge various Divisions in the Ministry of Health for their
support and for the provision of relevant information towards the
production of this Report :
• Planning and Development Division

• Family Health Development Division
• Disease Control Division
• Food Quality Control Division
• Oral Health Division
• Health Education Division
• Medical Development Division
• Medical Practice Division
• Engineering Services Division
• Pharmaceutical Services Division
• Manpower Planning and Training Division
• Institute for Medical Research
• Institute of Public Health
• Institute of Health Management
• Clinical Research Centre
Special thanks are also accorded to all those who have assisted in one
way or another in the compilation and production of this report, in
particular, the Information and Documentation System Unit, Ministry
of Health Malaysia.

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foreword

The Ministry of Health, as the lead agency in healthcare

The 2005 report covers several current issues, among

We will continue to strive towards further improvements

TAN SRI DATUK DR. MOHAMAD ISMAIL MERICAN

• Attain fully their potential in health.

CHAPTER 1 - HEALTHCARE SERVICE

11 Emergency Medical and Trauma Care Service in Malaysia

CHAPTER 2 - POPULATION HEALTH

129 Dengue Control in Malaysia

177 New Generation Hospital - IT Hospitals

CHAPTER 4 - RESEARCH AND DEVELOPMENT

227 Meeting Outpatient Expectations at Public Hospital Specialist Clinics in

261 EDITORIAL COMMITTEE

CHAPTER 1 HEALTHCARE SERVICE

CHAPTER 2 POPULATION HEALTH

CHAPTER 3 HEALTH SYSTEM MANAGEMENT

CHAPTER 4 RESEARCH AND DEVELOPMENT

To provide initial, comprehensive and holistic emergency medical

The objectives of emergency medical and trauma care service are as

i) Providing holistic emergency care with emphasis on technical

Scope and service system

14 MALAYSIA’S HEALTH 2005

This is a first responder service provided by all Ministry of Pre-hospital

ii) Emergency medicine

iii) Emergency medicine specialist service

iv) Medical observation

Providing temporary on-bed monitoring of patients pending decision Observation

• Commonwealth Games (SUKOM ) in 1998

This is one of the ‘core business’ of EMTS. Emergency departments Disaster

vii) One Stop Crisis Centre (OSCC)

Human resource and training

The Ministry of Health is going towards the training of a skilled group

i) Short training courses

Training is one of the most important aspects of human resource Short-training

• Basic Life Support (BLS)

16 MALAYSIA’S HEALTH 2005

A new course on handling of casualties of weapons of mass destruction

ii) Post-basic Emergency Medicine

This is a 6 months post-basic training opened to medical assistants and Post-basic

iii) Emergency medicine specialist training

Table 1 : Distribution Of Emergency Medicine Specialist in Malaysia, 2005

Hospital Kuala Lumpur 6

i) Ambulance control and dispatch control centre

ii) Motorcycle squad

This squad moves on a motorcycle and acts as a First Responder to

iii) Pre-hospital care project

The pilot project involving the establishment of ‘Pre-hospital Care Unit’

iv) Hyperbaric chamber service

The first hyperbaric chamber service providing mainly decompression

Issues and challenges

18 MALAYSIA’S HEALTH 2005

Attractive career path in Emergency Medicine should be established

• Condition of patients – whether critical and semi critical

iv) Pre-hospital care

The Ambulance service in the country has to be upgraded and Upgrading of

vi) Service standards

Work processes development including clinical guidelines and critical Introduction

• Preventable trauma death