Course : B.

PHARM
Branch : PHARMACY
Subject Name : PHARMACY PRACTICE
Subject Code : BP-703T
 UNIT 1
HOSPITAL- STRUCTURE AND ORGANIZATION

HOSPITAL AND ITS ORGANIZATION

Hospitals provide various facilities to the patients along with their diagnostic and surgical
facilities. Now-a-days tools like X-rays, ultrasound, E.C.G., etc., have become an integral part of
the hospitals.

Definition: - Hospital can be defined as an institution of community health or a specialized

complex organization which makes use of physicians, surgeons, and team of technical staff. It
also provides facilities for diagnosis, therapy, rehabilitation, prevention, education and
research.
Functions of a hospital

1. To raise the quality of law and general standards of medical practice.

2. To estimate the needs for facilities, supplies and equipment and then utilize these
facilities for evaluation, control and maintenance.
3. It provides a common link between the general public and policy makers.
4. It lowers the incidences of disease through early detection and treatment.
5. It stimulates the growth of medical science whereby doctors and nurses receive their
training in large teaching hospitals.
6. To develop and to maintain an effective system of clinical and administrative records
and reports.
7. To participate in the financial plan for the operation of hospital.
8. To provide facility for continuing education for all the persons.
9. To participate in and put into practice, the safety programmes of the hospital.
10. To initiate, utilize and participate in research projects designed for improvement of
patient care and other hospital services.
Classification of hospitals
A. On the basis of care
a) Primary hospital:- Primary care is the day to day healthcare given by a healthcare
provider. Typically this provider acts as the first contact and principal point of
continuing care for patients within a healthcare system. It is generally regarded as
the ‘gateway’ to receiving more specialist care.
e.g.Upazila health complex.
Primary health care also denotes the first level of contact between individuals and
families with the health system. Primary hospital include care for mother and child
 which include family planning ,immunization, treatment of common disease, health
education etc.
b) Secondary hospital:-Secondary health care refers to a second tier of health system,
in which patients from higher hospitals for treatment.
District hospitals and community health centre at block level.
c) Tertiary hospitals:- Tertiary healthcare refers to a third level of health system, in
which specialized consultative care is provided usually on referral from primary and
secondary medical care.
Specialized ICU, advanced diagnostic support services and specialized medical
personnel.
B. On clinical and non-clinical basis
a) Clinical basis
 Medicine – Paediatrics, psychiatric and nervous diseases, T.B., general medicine
 Surgery – Orthopaedic, gynecology, ENT
 Maternity – Short term, long term
b) Non clinical basis
 Governmental
1. Army hospital 2. Navy hospital
3.City hospital 4. Civil hospital
5. Big hospital 6. AIIMS/PGI etc.
 Non- governmental
1. Private hospital for profit 4. Non-profit hospital
2. Church hospital 5. Community hospital
3. Missionary hospital 6. Charitable hospital
C. On the basis of size

a) Large hospital have 1000 and above beds.

b) Medium hospitals have beds between 500-1000.
c) Small hospital has beds between100-500.
d) Very small hospital have beds less than 100.
D. On the basis of cost

a) Elite hospitals: - These are symbols of high technology and advances in medical sciences.
They have deluxe rooms. The room rates vary from rs. 500 to 1200 per day.
b) Budget hospital: - These hospital are meant for moderate budget and low budget persons.
e.g. civil and charitable hospital
E. On the basis of system of medicine
a) Allopathic hospitals d) Unani hospitals
b) Ayurvedic hospitals e) Nature cure
c) Homeopathic hospitals f) Veterinary hospitals

ORGANISATION OF HOSPITALS

Organisation is a dynamic process in which various managerial activities bring people together
and binds them together for the achievement of common objective or goals. The most
important body of any hospital is the governing body or board of directors or board of trustees.
It comprises of various eminent personalities in the field of medical education, research and
administration. It may also include politicians. The governing body is responsible for framing of
all major policies, plans and programmes of any hospital. Various committees are appointed by
governing body. It appoints a hospital administrator to getthe various functions.

Detailed review of these services performed by any organization is given as under:

 Nursing services- This department is large and functions for all 24 hours. Nurses are
assigned for specified no. of beds. They are trained for prenatal care, observation,
comfort of patient during labour.
 Out patient services- It includes comfort for out-patients as they come for their
major or minor illness.
  Radiological services- These are performed under the direction of competent
radiologist. It includes utilization of various equipments like sonography, X-rays,
E.C.G, C.T. Scan etc.
 Central supply services- All medical and surgical supply services meant for diagnosis,
prevention, research and education. It involves their collection, processing, storing
and issuing them against an indent form.
 Hospital pharmacy services – This department fill prescription and dispenses no. of
requisition from the wards. It is responsible for proper drug delivery, information
system, storage of drugs, manufacturing, sterilization, for advising the physician on
drug use.
 Medical records – Medical records are valuable reference material as they help
medical and para-medical staff for evaluation. They contain history of patients, lab
test reports, physical examination, physician’s advice etc.
 Stores – Stores generally store, receive and issue the material against requisition
forms of various department and wards. They always maintain a buffer stock of
certain articles.
Medical staff involved in hospital

The health care team consists of a group of people who coordinate their particular skills
in order to assist a patient. The personnel, who comprise a particular team will depend
upon needs a patient.
 Physicians
 Nurses
 Social workers
 Trained dais
 Village health guides
 Health assistants
 Auxiliary personnel
Physician: - In hospital, the physician is responsible for the medical diagnosis and for
determining the therapy required by a person who is ill or injured. It is a person who is legally
authorized to practice medicine in particular jurisdiction.

Nurse: - A number of nursing personnel may be involved in the health team and may have their
own nursing team. Nursing team comprised of personnel who provide nursing services to a
patient. “Head nurse” is responsible for delegation of duties to members of her team and care
given to the patients.
The dietitian: - When dietary and nutritional services are required a dietitian may also the
member of the health team. Dietitians supervise the preparation of meals according to doctor’s
prescription. The nutritionist in a community setting recommends health diets for people and is
frequently involves in board advisory services in regard to purchase and preparation of food.
The Physiotherapist: - it provides assistance to a patient who has problem related to
musculoskeletal system. Their functions include; assessing mobility and strength, providing
therapeutic measures and teaching patients news skills and measures.
The social worker:-The patient and his family member are assisted by social worker with such
problems such as finances, rest home accommodation, counselling or marital problems, and
adoption of children.
The occupational therapist assists patients with some impairment of function to gain skills as
they are related to activities of daily living (ADL) and help with a skill that is therapeutic.
The paramedical technologist includes laboratory technologies, radio-logic technologists. The
laboratory technologists examine and study specimens such as urine, faeces, blood and
discharges from wound.
The pharmacist prepares and dispenses pharmaceuticals in hospital and community settings.
The role of pharmacist in monitoring and evaluating the actions of medications on patients is
becoming prominent.
The inhalation therapist or respiratory technologist is skilled in therapeutic measures used in
care of patients with respiratory problems. These therapists are knowledgeable about oxygen
therapy devices, intermittent positive pressure breathing respirators, artificial mechanical
ventilators, accessory devices used for inhalation.
The clinical psychologist constitutes an important member in healthcare team.
 HOSPITAL PHARMACY
Hospital pharmacy is one of the most important department among several departments of a
hospital .Hospital pharmacy may be defined as that department of the hospital which deals
with procurement ,storage ,compounding, dispensing, manufacturing ,testing, nd distribution
of drugs. It is also concerned with education and research in pharmapackaging aceutical
services. A hospital pharmacy is controlled by a professionally qualified pharmacist.
Functions:-Pharmacy is recognized as an essential hospital service in all the major hospitals .It
has been realized that only trained pharmaceutical personnels are capable of
purchasing,storing,handling,pricing and dispensing of medications. It is the pharmacist who is
an expert to provide all information regarding drugs to the health professionals and also to the
public .Therefore he acts as a link between the physician and the patient.
1) Providing specifications for the purchase of drugs, chemicals and biologicals
etc. 2)Proper storing of drugs.
3) Manufacturing and distribution of medicament such as transfusion fluids,
parentralproducts,tablets, capsules,ointment and stock mixtures.
4)Dispensing and sterilizing parentral preparations which are manufactured in hospital.
5)Dispensing of drugs as per the prescription of medical staff of the hospital.
6) Filling and labelling of all containers from which medicines are to be administered.

7) Managementof stores which includes purchase of drugs, proper storage condition and
maintenance of records.

8) Establishment and maintenanceof ‘Drug Information Centre’which will provide information

regarding medications.
9) Patient counselling service while supplying drugs especially from out-patient department.

10) Providing cooperation in teaching and research programmes.

Objectives: - the practice of hospital pharmacy started in India in 1941. The objectives of
hospital pharmacy are-

 To ensure the availability of the right medication, at the right time, in the right dose at
minimum cost.
 To professionalize the functioning of pharmaceutical services.
 To act as a counselling department for medical staff, nurses and for patient.
 To act as a data bank on drug utilization.
 To participate in research projects.
 To plan, organize and implement pharmacy policy procedures.
 To implement decisions of Pharmacy and therapeutic committee.
Location and layout:-

The pharmacy should be located in the hospital premises so that patients and staff can
easily approach it. In multi-stored building of a hospital, the pharmacy should be located on
the ground floor especially the dispensing unit.

Out-patient pharmacy should give a pleasant appearance and must have

enough space for seating of patients. Space must be provided for routine manufacturing of
stock solution, bulk powders, ointment etc. medical stores of a pharmacy should be
adjacent to the pharmacy itself or should be directly connected with pharmacy. Pharmacy
receives materials from two sources: Medical stores and manufacturing division of the
hospital.

Fig:- A typical layout of hospital pharmacy

Medical stores and manufacturing units issue against requisition from various departments.
Pharmacy department exercises quality control of materials.
REFERENCE:- Dr. Nand P, Dr. Khar Roop K; “A textbook of Hospital and Clinical Pharmacy”,
15th edition, Published by Birla Publications Pvt. Ltd, Page no. 3 to 27.
Fig:- General flow chart for outpatiens
Fig:-General flow chart for Inpatients
 Adverse Drug Reaction Management

INTRODUCTION
 It describes the procedure for identifying, recording and reporting of Adverse Reactions(AE) and Serious
Adverse Reactions (SARs)

 It also describes the procedure for reporting Suspected Unexpected Serious Adverse Reactions(SUSARs)

ABBREVATIONS
 AE/AR Adverse Event/Reaction

 SAE/SAR Serious Adverse Event/Reaction

 SUSAR Suspected Unexpected Serious Adverse Reactions

 CTIMP Clinical Trail of an Investigational Manufacturing Product

 NIMP Non Investigational Medicinal Product

DEFINITIONS
ADVERSE EVENTS
Any Untowarded medical occurance in a patient or a clinical trial participant administered an
investigational product,and which does not necessarily have a causal relationship with the drug

ADVERSE REACTIONS
All untowarded and unintended responses to the IMP related to any dose administered to that participant.

SERIOUS ADVERSE REACTIONS

Any untowarded medical occurance that at any dose
 Results in death

 Is life-threatening
  Requires hospitalisation,or prolongation of existing hospitalisation

 Results in persistent or significant disability or incapacity

 Is a congenital anomaly.

SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS

• The trail protocol or IB should include a list of known side effects for each drug in the study.

• This should be consulted when a SAR occurs, to determine expectedness. If the event is not listed, or has
occurred in a more serious form,or more frequently than expected, it should be considered to be a SUSAR

Identifying of Adverse Events

• The protocol should state whether any NIMPs are to be supplied to participants in the trail.

• The procedure for notifying such adverse events to the Principal Investigator must be clearly documented in the
trail protocol.

• The trial protocol should define how AEs will be recorded, and states that all SAEs will be reported to the
Sponsor.

• AEs may also be identified by support documents, for example clinical biochemistry, hematology, and radiology.

Assessment of Adverse Event

• AEs must be assessed for seriousness, causality, expectedness, and severity

• It is the responsibility of the PI to assess each AE for seriousness, causality, expectedness, and severity

• The sponsor should review if a SAR reported to them is expected or not. If the event is not expected it will be
considered as a SUSAR.

Assessment of Severity
 The CI or PI or delegated medically qualified research team member should make an assessment of severity for
each AR.

 The assessment should be recorded on the SAE form and reported to the sponsor according to the following
categories:

• Mild: A reaction that is easily tolerated by the subject.

• Moderate: A reaction that is sufficiently discomforting to interfere with normal everyday activities.

• Severe: A reaction that prevents normal everyday activities

Reporting of Adverse reactions

 Patient details

Initials

Gender
Age and date of

birth Weight
 Height
 Suspected drugs

Generic name of the drug *

Indication(s) for which suspect drug was prescribed or

tested. Dosage form and strength

Daily dose and regimen (specify units - e.g., mg, ml,

mg/kg) .. Route of administration.

Starting date and time of day.
Stopping date and time, or duration of treatment
 Other Treatment(s)

Provide the same information for concomitant drugs

 Details of Suspected Adverse Drug Reaction(s) Full description of reaction(s) including body site and severity, as
well as the criteria for regarding the report as serious,whenever possible, describe a specific diagnosis for the
reaction

• Start date (and time) of onset of reaction

• Stop date (and time) or duration of reaction

 Outcome

Information on recovery; results of specific tests and/or treatment.

For a fatal outcome, cause of death and its possible relationship to the suspected reaction; any
post-mortemfindings.
Any Other information relevant to facilitate assessment of the case, such as medical history of
allergy, drug oralcohol abuse; family history; findings from special investigations etc
 Details about the Investigator*

Name

Address

Telephone

number
Profession (speciality)
Date of reporting the event to Licensing Authority:
Date of reporting the event to Ethics Committee overseeing

the site:Signature of the Investigator

Responsibilities
Responsibilities of Sponsor
• SAE should be reported to the licensing authority within 14 calendar days

• Submit status report to the licensing authority periodically

Responsibilities of Investigator
 Ensure adequate medical care is provided to the subject

• SAE and unexpected AE should be reported to the sponsor within 24 hrs

• To the EC within 7 working days

• Regular reporting of adverse events is done through data collection in case report forms

• Adverse events are already known as potential risks when participating in a research study with a specific
investigational product

• It is important to have a documented baseline assessment that is detailed with health history and current health
issues prior to exposure to the investigational product

• As the participant is exposed to the investigational product, the research team must document any changes in
health that may be due to the research study product and report these adverse events through normal data
collection tools provided by the sponsor

• Most reports require a brief history of the event

• Key information that is helpful to the reviewers of the reports are:

• participant demographic information, when the participant started the research study, what research
intervention the participant was receiving,

• previous medical history, concomitant medications

• last exposure to investigational product,

• abnormal labs or diagnostic tests,

• when the study team was notified of the event, description of the actual event, relationship of the AE to the
investigational product,

• whether the participant was hospitalized,

• the event has resolved or not,

• whether the participant will be removed from the research study or continue to receive the research product
IDENTIFYING OF ADVERSE REACTIONS

Summary
• Adverse event - Any Untowarded medical occurance in a patient or a clinical trial participant
administered aninvestigational product , and which does not necessarily have a causal
relationship with the drug

• Adverse reactions- All untowarded and unintended responses to the IMP related to any dose
administered tothat participant