WORKING GUIDELINES

FOR THE ESTABLISHMENT AND OPERATION

OF DRUG THERAPEUTICS COMMITTEE

DRUG ADMINISTRATION
AND CONTROL AUTHORITY OF
ETHIOPIA
ADDIS ABABA, ETHIOPIA
DECEMBER 2004

Working Guideline For the Establishment and Operation of

Drug and Therapeutics Committee
1. Introduction
Drugs are such vital substances that need expert handling from the inception of their discovery until they reach
the end user-the patient. In such a complex and resource-consuming process, the eventuality of shortage, misuse
and abuse, erratic supply, adverse reactions, irrational prescribing, dispensing and use are common. Especially
where there is no viable system of ensuring good supply management and rational use of drugs, the extent of the
problem and its consequence is immense. Though it is also common in the developed world, the magnitude and
extent of the problem is huge and chronic in many countries in the developing world.
International experience has shown that mismanagement and irrational use of drugs can only be alleviated and
quality pharmaceutical services can be achieved through a formal and regular consultation between concerned
health professionals in a given health establishment. The operation of Drug and therapeutics committee (DTC) in
health establishments has become a norm to ensure good management and rational use of drugs. The availability
of functional DTC in hospitals is a prerequisite for accreditation in the USA, and almost all hospitals in Australia
and United Kingdom have DTCs.
Some years back there was an initiative taken by the Ministry of health to establish DTC in some hospitals in the
country. As a result few hospitals were able to establish as well as able to operate the DTCs. However because of
lack of strong support and follow up of responsible bodies the committees had ceased functioning. However the
conditions, which had necessitated for the establishment and operation of DTC still need to be addressed. In fact
probably the problem of mismanagement and irrational use of drugs in the Ethiopian health establishments is
getting worse with the expansion of the services and availability of drugs.
Therefore, the Ministry of Health (MOH) and Drug administration and Control Authority (DACA) are hereby reintroducing the need for the establishment and operation of DTC in order to promote good drug supply
management and rational use of drugs. For this purpose this national guideline is developed to serve as a tool to
establish and operate the committees at regional, Zonal/woreda and health institution level.
The committee is entrusted to make maximum use of available resources, professional skills and judgments to
alleviate the problems that have hindered the provision of quality health and pharmaceutical services in the health
establishments.

2. Short Title
This Guideline may be cited as Working guideline for the establishment and operation of Drug and
Therapeutics Committee .

3. Definitions
In this guideline unless the context provides otherwise:
1.

Drug and therapeutics Committee means a group of health professionals that that advices a health
establishment on matters related to drug management.

2. "Adverse Drug Reaction means a noxious and unwanted reaction to drugs that occurs at a dose used in
human for diagnosis, treatment or prophylaxis.
3. Authority refers to the Drug Administration and Control Authority, DACA.
4. Proclamation refers to the Drug Administration and Control Proclamation 176/1999.
5. Health establishment refers to Regional Health Bureau, Zonal, Woreda and health institution (Including
Public, private, Ngo and others).
6. Drug Means any substance or mixture of substances used in the diagnosis, treatment, mitigation or
prevention of a disease in man or animal. This includes Drugs, Vaccines, radio active pharmaceuticals,
blood and blood products, sanitary articles, sera, Medical supplies and Medical equipments

4. Objectives
The guideline is expected to achieve the following objectives:
1. To enable Health establishments recognize the purpose, responsibilities, functions and roles DTCs play in
the promotion of good drug supply management and rational use of drugs.
2. To improve the long standing poor drug supply management and irrational use of drugs.
3. To foster teamwork sprit among health professionals.
4. To provide a general framework on how to establish and operate DTCs in respective health
establishments.

5. Organization of DTC
Drugs and Therapeutics Committee shall be established at Regional, Zonal/ Woreda and Health institution
levels and will have the following members:
5.1. At Health institutions Level
5.1.1 Hospital
DTC established at Hospital level shall have the following members:

Medical Director-Chair person

Head of the pharmacy section-Secretary

Head of the nursing section-Member

Heads of no less than four departments-members

Head of administration and finance section- Exofficio member

5.1.2 Health Center

DTC established at Health center shall have the following members:

Head of Health center-Chair person

Head of the pharmacy section-Secretary

Head of the nursing section-Member

Heads of any other two Sections-Members

Head of administration and finance-Exoffocio Member

5.2. At Regional/zonal /woreda Level:

DTC established at Regional Health Bureau/zonal Health Department /woreda Health office shall have
the following members:

Head of the technical unit of the region/zone/woreda-Chairperson

Head of the pharmacy unit-Secretary

Heads of three other sections -Members

Head of administration and finance-exofficio Member

6. Duties and Responsibilities of a DTC

The DTC established at the above health establishments shall adopt the following responsibilities as per their area
of jurisdiction.

Develops guidelines for the evaluation, selection, quantification, and procurement of drugs for
the respective health establishment.

Reviews and adopts the National Standard Treatment guideline to comply with the morbidity pattern
observed by the health establishment.

Prepares own list of drugs (with reference to Essential Drug List/National drug list) that should be
available in the health establishment, based on different criteria including, safety, efficacy, quality, cost
effectiveness, availability by using available data and information.

Develops a system of monitoring rational use of drugs

Monitors the occurrences of adverse drug reactions (ADR), keep record and sends report to a responsible
body.

Decides on the classification of drugs as prescription or OTC on the basis of the national list on such
categorization at Health institution level. And further categorizes which drugs should be prescribed by
whom.

Evaluates objectively clinical data regarding new drugs or agents proposed for use in the health

institution, after taking into consideration of:

An independent literature search, which includes the use of the pharmacological agent
and other treatment options for the particular condition is conducted.
The evidence utilization outcomes
An economic appraisal of the newer pharmacological drug is conducted, where possible
A comparison with the treatment options presently used is done.

Designs and organizes educational programs regarding drugs and drug use.

Recommend additions and deletions from the list of drugs accepted for use in the health
establishments

Facilitates the establishment of Drug information unit and assess its impact in the promotion of rational
drug use.

Prepares annual plan of action and budget.

Evaluates its annual performance

Gives recommendations concerning drugs to be stocked in health institution patient units or services.

Initiates and coordinates Studies on problems related to rational use of drugs, proper distribution and
labeling of medications.

Facilitates the Management of Medication Errors.

6.1. Duties and Responsibilities of the chairperson

The chairperson of the DTC will have the following responsibilities.

Ensures that the aims and objectives of the DTC are applied

Ensures that decisions of the committee are based on scientific evidence, where such
evidence is available.

Establishes good relationship between the committee and the management of the
health establishment

Appoints an acting chairperson from the members if he/she is to be absent.

Presents performance report to the Health establishment management

Represents the committee in the management meetings and other relevant events

Calls regular and extraordinary meetings

Chairs the meetings.

6.2. Secretariat
The secretariat of the DTC shall be the head of the pharmacy section of the health establishment.

6.2.1. Duties and Responsibilities of the secretariat

The secretary will have the following responsibilities

In consultation with the chairperson, prepares the notice and agenda for all meetings.
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Prepares the minutes of all meetings and disseminates these to all members.

Follows up the action plans of the committee.

Conduct literature searches and disseminate the material at least seven days before the
committee meets.

Ensures that the decisions taken by the committee are submitted to the head of health
establishment for his/her notification.

Correlates and circulates all pertinent material for meetings to all members and their task
team at least three days before the meeting.

Acknowledge the receipt of ADR report

Participate in other activities of the committee

6.3. Duties and responsibilities of a member

Demonstrates professional competence through active participation in the meetings.

Proposes issues that need to be discussed

Participates in other activities of the committee

Each member should give prior notification if will not be attending the next meeting.

6.4. Meetings of the DTC

The Drugs and Therapeutics Committee should meet regularly, no less frequently than six times per
year and should meet on call when necessary.

The committee may invite to its meetings persons within or outside the health institution who can
contribute from their specialized knowledge or experience.

Issues to be discussed will be determined jointly by the chairperson and the secretary.

An agenda is desirable and should be prepared and submitted to members of the committee in
sufficient time before the meeting.

Minutes should be kept by the secretary and should be maintained in the permanent records of the
health institution.

Recommendations of the Drugs and Therapeutics Committee shall be presented to management

committee for adoption of recommendations.

50% of the membership of the committee will constitute a quorum for any meeting.
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Correspondence shall be addressed to the secretariat of the committee.

7. SCOPE

The DTC is not intended to intervene in the administration of the health establishment but to
act on technical and budgetary (Only Drug Budget) aspects of drug supply management and
use.

The DTC is responsible to make close follow-up of the implementations of its approved
recommendations by the management or the staff. If the staff does not implement the
recommendations, the committee should discuss the recommendations with the staff again
and urge the management to take necessary measures.

8. Effective Date:
This guideline is effective as of __________ 2005.

Appendix

Roles of the Drugs and therapeutics Committee:

The following activities would be applied as appropriate to the level of Health establishment in which
the DTC is established:

1. POST MARKETING SURVEILLANCE

Post-Marketing Surveillance is a system, which is concerned with the collection, analysis, and dissemination of
information on the occurrence of adverse reactions or the relative safety, efficacy and quality of drugs, at any time
after they are marketed.
This activity is supposed to be carried out by the Authority, but if it done by others (Pharmacy and Therapeutic
Committee) the authority should be made aware and the result of the post marketing surveillance should be
forwarded to the Pharmacy and Therapeutic Committee and finally to the Drug Administration and Control
Authority, where the result is centrally collected and analyzed.

2 In Drug Product Defect Reporting Programme

There are times when defective drug products escape the Pharmaceutical industry, the regulatory
authorities and ultimately reach the consumer. However, Pharmacy professionals at the contact level
have the opportunity of identifying such products before they are delivered to patients. One way by
which defective drug products can be identified is by routine physical inspection at the time of
procurement/purchase, in the storage area and at the dispensary.
Reportable defects of any product include inadequate packaging; confusing or inadequate labels or
labeling; deteriorated, contaminated, or defective dosage forms; inaccurate fill or count of a drug
product; faulty drug delivering apparatus etc. Obviously, the professionals should report anything, which
is undesirable, associated with the product.

a. The Drug Defect Report Form (See Annex 2) need to be filled at each level of the health institution
by Pharmacy professionals or chief of the Pharmacy section or by other health professionals; and
should be reported to the Pharmacy & Therapeutic Committee.
b. The Pharmacy & Therapeutics committee should then send directly to Drug Administration and
control Authority or its nearest branch and make a copy of the report to the Zonal health
department/regional health bureau.
c. The Drug Administration and Control Authority, collects and analyzes the report and forwards the
information to the manufacturer or importers and distributors involved for their reaction (the
authority can also take action) and provides feed back to the reporter with appreciation.
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3. In Promoting Rational Use of Drugs

One of the major activities undertaken by Drug Administration and Control Authority in order to
rationalize the use of drugs including Narcotic drugs & Psychotropic Substances is the provision of
printed prescription papers (serially numbered, coded & separate for ordinary drugs,Narcotics &
Psychotropic) to be used at all levels be it private, public or owned by Non Governmental
Organizations. A guideline, has been issued to all concerned units and health institutions on the
purchase, handling, utilization... etc. of these prescription papers.
a.

The Pharmacy and Therapeutic Committee

should make aware all medical staffs and responsible health personnel of the objectives and
purpose of the guideline and strictly follow its implementation

b.

The Pharmacy and Therapeutic Committee

should take a role in implementation of standard treatment guidelines.

c.

The Pharmacy and Therapeutic Committee

should also take active role in educational activities be it to the public or to the health
professionals.

d.

The Pharmacy and Therapeutic Committee can

communicate with the authority about recent findings and other relevant issues so that others can
learn from it.

e.

The Pharmacy and Therapeutic Committee can

request any assistance from the authority or Ministry of Health in matters that promote health/
Rational Use of Drugs.

f.

The Pharmacy and Therapeutic Committee may

participate in control of illegal, counterfeiting or substandard drugs.

4. In Developing Emergency Drugs Lists

Because in most emergencies time is of the essence, it is imperative that emergency drug or "stat" boxes
containing drugs and supplies be readily available in the emergency room. The Pharmacy and
Therapeutic Committee should develop a list of drugs and supplies, which ought to be in an emergency
box. The committee should inform the pharmacist and the head nurse of their joint responsibility to have
the box ready for use at all times.
In order to develop emergency drug list, the Pharmacy and Therapeutic Committee can use the National
Drug List or the National Essential Drug List and/or the sub-lists or the health institution's Drugs list.
Once the emergency boxes have been placed on the emergency room, regular checking by the Pharmacy
Professional or by the Nursing Supervisor is mandatory.
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5. In Drug Utilization Review

Drug utilization is defined as the marketing, distribution, prescription and use of drugs in a society with
special emphasis on the resulting medical, social and economic emergencies. Clearly the magnitude of
the problems associated with drug utilization is of great public concern and guarantees the attention of
health care practitioners.
Within the health institution the Pharmacy and Therapeutics Committee provides the institutional
authority for the formulary system of drug-use control as well as the mechanism for the
continuing education of Physicians, Nurses, Pharmacy Professionals, and other health professionals.
The drug utilization review needs to be initiated to enable the Pharmacy Professionals to monitor drug
utilization, in hospitalized and ambulatory patients. This activity assures whether drugs are utilized
correctly. It is used as a controlling system field enables the Pharmacy Professionals to have more
clinical orientation.
In some countries, health institutions have developed patient drug utilization profiles and medication
history taking to monitor drug utilization. Simple and applicable forms like patient prescription
recording book (Annex 3) can be used as a first step in our situation. The book is prepared with certain
variables. And it should be kept at a dispensary room (In-patient and out -patient Pharmacy). The
information obtained from patients card and filled prescriptions will be recorded in the book after

dispensing takes place. Then, periodically drug utilization within the health institutions could, be
assessed. The result of the assessment serves the Pharmacy Professionals to gain technical &
professional information; and also helps health institution to:

Know the actual drug consumption

Determine drug budget

Identify the prevalent diseases

Select drugs based on the prevalent disease

Assess drug utilization (e.g. prescribing practice) within the health institution

Know the actual drug consumption

The result of the drug utilization review needs to be presented to the Pharmacy & Therapeutics
Committee, so as to use it in promoting rational drug use.
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Annex 1

Adverse Drug Reaction Reporting Form

Patients Name: (Initials only)_________________ Card No: _____________ Age: ________ Sex: _________ Weight:_______
Habit: _______________________ Address:______________________________________________________________
Adverse Drug Reaction Description (Including Laboratory test results):
Date and time of onset of Reaction: _____/______/____
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
___________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
Reaction necessitated: Discontinuation of drug/s/ Yes No
Prolonged HospitalizationYes No

Information on Suspected Drug

Drug Name (use Brand Name . if generic name

Route

Dose

Frequency

are used Please indicate manufacturer and batch no. if

applicable.)

Date Drug
Started Stopped
D|M|Y
D|M|Y

Other Drugs Taken Including self-medication

Reaction subside after D/C of Suspected Drug

Reaction reappear after Restart of Suspected Drug

12

NA
NA

Therapeutic Indication

Treatment of reaction:
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
Outcome:

Died due to adverse reaction Died, drug may be contributory Died Unrelated to drug
Not yet recovered Recovered with out sequelae Recovered with squeal Unknown

Squealed:
__________________________________________________________________________________________________
Additional information: (e.g. relevant history such as allergies, chronic disease, pregnancy etc.)

___________________________
________________________________________________________________________________________

Reported by: Name _______________________ Profession: _________ Signature: __________ Date: _______________
Name of health Institution: ________________________ Address: _____________ Tele No:
Continued

For office use only

Received On: _____________________ Registration No: __________________________
Key: D|M|Y Date |Month |Year; D/C Discontinue Treatment; Y Yes; N No; NA Not available

What to report
All suspected reactions to drugs
Unknown or unexpected ADRs
Serious adverse drug reactions
Unexpected therapeutic effects

13 All suspected drug interactions

< SMe Se MKA n l` HQ2

From __________________________________

Business Reply Service Licence No.HQ2

Annex 2

__________________________________

Postage
Prepaid

DRUG DEFECT REPORT FORM

__________________________________
__________________________________

Date Received ________________________

(of the report)

__________________________________

1. Name, Dosage Form Strength, Pack Size___________________________________

2. Batch Number_________________________________________________________
3. Date Purchased/Procured________________________________________________
4. Source of Product (Manufacturer)__________________________________________
5. Name & Address of Procurement Agency (Supplier)____________________________
Drug Administration and Control Authority
_____________________________________________________________________

ADR Monitoring & promotion control Division,

_____________________________________________________________________
P. O. Box 5681,

Addis Ababa,

6. Country of Manufacturer__________________________________________________
Ethiopia.
7. Defects Noted or Suspected_______________________________________________
______________________________________________________________________
_____________________________________________________________________
8. Name & Address of Reporting Health Institution_______________________________
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9. Action taken by the health institution________________________________________

Return to
Drug Administration and Control
Authority of Ethiopia (DACA)
P.O. Box 5681 Addis Ababa

15

Annex 3
Patient Prescription Registration Book
Ser.
No.

Date

Patient Name of Card

Number

Age

Sex

Diagnosis

Treatment (Name
Strength Dosage
form & Dose of
Drugs

16

Free/Paying write
"F" or "P"

Unit Price
Birr

Write "N" for New

C

or "R" for Repeated

Patients

Remark