GOOD PHARMACY PRACTICE (GPP)

IN DEVELOPING COUNTRIES

Recommendations for step-wise implementation

FOREWORD

Conscious of the need to help developing countries achieve good pharmacy practice, the FIP Community Pharmacy
Section Executive Committee established a working group to produce guidelines in this area in 1992. This was
chaired by Mike Rouse who, as the Committee's Developing Country Observer, first encouraged the establishment of
the group. Work commenced with a survey of 67 developing countries, to establish a baseline of existing
community pharmacy practice. The results of this survey provided detailed information about the standards
prevailing in the selected countries, and reflected a high degree of variation, including countries where community
practice as it is normally defined does not exist. The group then devised a simple set of recommendations, with the
intention of helping pharmacists in developing countries to achieve GPP.

The ensuing report was presented at the FIP Congress in The Hague (September 1998) when the recommendations
were accepted, having been endorsed by the Executive Committee of the Community Pharmacy Section. This
completed the task of the working group.

These guidelines are intended for pharmacists and others in developing countries. It is hoped that the
recommendations can be used where necessary to form the basis of negotiations with governments, regulatory bodies
and health care systems to ensure the optimum use of available pharmacists, to the benefit of the general population
of the country concerned. More extensive guidelines may be found in the FIP document “Good Pharmacy Practice
in Community and Hospital Settings” and other references.

Thanks are due to Mike Rouse for initiating the work, Elaine Harden (RPSGB) for producing the final report and all
the members of the working group for their patience and perseverance.

I am delighted to commend this report and its recommendations to you all in the hope that it will be found a useful
tool for those wishing to achieve good pharmacy practice.

Linda Stone
Chairman of the Working Group on GPP in Developing Countries from 1997

2
BACKGROUND AND OBJECTIVES
1. The Alma-Ata Declaration on Primary Health Care (1978) 1 states that "...health is a fundamental human right and
that the attainment of the highest possible level of health is a most important world-wide social goal". In addressing
the main health problems in the community, Primary Health Care (PHC) must "provide promotive, preventive,
curative and rehabilitative services". The Declaration states that PHC includes at least " ... prevention and control of
locally endemic diseases, appropriate treatment of common diseases and injuries and the provision of essential
drugs". It recognises the role played by all health workers and the need for suitable training to enable these people
to work as a health team to respond to the expressed needs of the community.

2. Clearly, an adequate pharmaceutical service, ideally provided by pharmacists, is a vital component of Primary
Health Care. This is recognised by the World Health Organisation (WHO), and several subsequent publications of
the WHO 2,3,4 emphasise the role of the pharmacist in the Health Care System. Standards are an important part in
the measurement of quality of service and at the International Pharmaceutical Federation (FIP) Congress in Japan
in 1993 the Tokyo Declaration on Good Pharmacy Practice (GPP) was adopted. FIP has drawn up guidelines which
can be used as the basis for the setting of national standards for pharmacy practice. The GPP document has been
subsequently reviewed by the WHO (primarily the Expert Committee on Specifications for Pharmaceutical
Preparations) and it is anticipated that an agreed text on GPP could be included in the WHO Technical Report
Series which would give the guidelines more formal status and ensure wider distribution. 5

3. It is recognised and accepted that conditions of pharmacy practice vary widely from country to country, but it is
also possible that conditions of practice may vary between different sectors/areas within a country. For example, in
developing countries there is likely to be a significant difference between the health services available in urban and
rural areas. In many cases this difference is due to the fact that the number of pharmacists is less than desirable.
The benefits that accrue from the direct supervision of the pharmacist in ensuring the quality of pharmaceutical
products and services throughout the distribution chain cannot be realised in areas where there are insufficient
numbers of pharmacists, or at least persons with formal pharmaceutical training. It has to be accepted that, for the
foreseeable future, pharmacists will continue to be in short supply in developing countries. For this reason, there is
a real need and role for trained support personnel, such as pharmacy technicians. In developed countries such
personnel would probably work only under the direct supervision of pharmacists. In developing countries, in most
cases they will work alone, without any meaningful supervision. They may have duties and responsibilities which
are inappropriate to their level of training.

4. Both FIP and WHO believe that national pharmaceutical associations in individual countries are best able to decide
what can be achieved in terms of GPP and within what timescale. However, based on the results of a survey
conducted by a Working Group established by the Executive Committee of the Community Pharmacy section of
FIP, it is concluded that, in many developing countries, national associations are either non-existent or else too
small to be in a position to carry out such an exercise. For this reason, the working group has decided to put
forward some simple recommendations designed to be of assistance primarily to developing countries.

3
DESIGN AND METHODOLOGY
1. Recognising the differences in levels of practice, it is the feeling of the Working Group that its recommendations
should follow a step-wise approach. Each person can identify the "step" (level) on which they are currently
operating and work towards reaching the next step (level of practice), thereby continually improving the quality of
pharmaceutical service offered to their community. This step-wise approach can be applied to a number of different
components of pharmaceutical services. Particularly in developing countries, it was recognised that some of the
areas of focus of the GPP Guidelines may not yet be relevant. It was, therefore, agreed that these recommendations
would concentrate on those aspects perceived to be most applicable and relevant to developing countries at this
point in time. Having gained some experience in implementing the principles of GPP, it is believed that countries
would be able to progress into the other areas on their own.

2. By proposing a step-wise approach, it is also believed that more countries are likely to take-up the challenge,
perceiving each step to be achievable. If an exercise is seen to be too difficult it is possible that it may not even be
attempted. It must be accepted that implementing and achieving GPP is not an overnight process. To the contrary, it
must be seen as an ongoing process.

3. The fundamental objective at all times must be the striving towards ever higher standards of practice, for the
benefit of the patients and community being served, by achieving better outcomes as well as the development of
the profession.

4. At the same time, there needs to be an effort to educate the public, government and all health professionals about
the services that can be offered by pharmacists and the benefits that can accrue from full use of their expertise and
knowledge. This increased awareness should also serve to raise public expectations, resulting in a parallel driving
force to raise standards of practice.

5. Every effort should be made to encourage the development of a formal National Drug Policy. A national drug
policy helps countries meet the objectives of universal good health by ensuring equitable access to, and rational use
of, safe and effective medicines of good quality.

6. However, the main driving force will have to come from pharmacists themselves. This may be difficult where their
numbers are small. It will be pharmacists who will have to decide what is the highest level of service that can be
provided, and achieving it will, and must be, a professional decision. The pharmacists will need to be committed to
change and to using their influence to convince the authorities of the need for change. In many cases the
government machinery within which they will have to work will be weak and there may need to be a major
upheaval of the existing system.

7. In developing countries, it is recognised that pharmaceutically trained personnel will be involved largely in a
distributive role. As the number of pharmaceutically trained personnel increases, more time should be available for
other functions, notably the dissemination of information aimed at improving the whole medicine use process. For
this reason no attempt has been made, in this document, to include "activities associated with influencing
prescribing and medicine use", one of the 4 main elements of GPP.

4
RECOMMENDATIONS

The 3 major areas on which this paper will focus are:

1. PERSONNEL
2. TRAINING
3. STANDARDS
4. LEGISLATION & NATIONAL DRUG POLICY

1. PERSONNEL
Aim: all people have access to a qualified pharmacist

Access to pharmaceutical personnel

1.1. In developing countries it is accepted that at present, and for some time to come in most cases, due
to insufficient numbers of pharmacists, it is not possible for people in all areas to have direct
access to a pharmacist. The level of pharmaceutical service that can be offered will, therefore,
largely be determined by location.

1.2. However, the underlying principle that has to be adopted is that all people should have access to an
adequate pharmaceutical service.

1.3. In many cases it is perceived that the level of responsibility placed on health workers is
disproportionate to the training that they have received. The working group recommends that all
community health care workers are given at least a basic training appropriate to the level of
pharmaceutical service they are required to render. It is assumed that at the primary health care
level, the medicines will be relatively simple and few in number. The community health care
workers need to be given basic training in how these medicines must be used to ensure that
patients are given medicines which are appropriate for the condition/problem being treated, along
with accurate instructions.

1.4. As one progresses upwards to the next higher level of health institution, it would be assumed and
recommended that a worker with a greater level of training/specialisation would be available. In
the step-wise approach, this would be represented as follows:

1.5. All people should have:

STEP 1 Access to a community health care worker with appropriate

pharmaceutical training

STEP 2 Access to a person trained to a higher level than a

community health care worker

STEP 3 Access to a qualified pharmacy technician with appropriate

training

STEP 4 Access to a qualified pharmacy technician working under

the direct supervision of a pharmacist

STEP 5 Direct access to a pharmacist

1.6. In the first instance this may represent simply a move up through the levels within the health
delivery service, but the recommendation is that each location offering a particular level of service
should attempt to progress to the next higher level of service.

5
 1.7. Governments need to be convinced of the need for, and value of, a quality pharmaceutical service
before they will make a commitment to allocating resources to the training of more pharmaceutical
personnel, and doing so at a higher level. It has to be borne in mind that health authorities in many
developing countries may be training and deploying community health care workers trained in a
number of health disciplines, namely nursing, "pharmacy", laboratory technology, public health,
etc. It is essential that, if this category of health care worker is perceived to be the solution where
resources and/or manpower are limited, they receive training appropriate to the level of
pharmaceutical service they are expected to deliver.

2. TRAINING
Aim: for the country to be self-sufficient in training pharmacy personnel

2.1. The requirement is to increase the number of pharmaceutically trained personnel, ultimately
pharmacists, as well as to continuously extend and improve the level of training, knowledge and
expertise of all pharmaceutical personnel. At each level the training must be appropriate to the
level of service provided and medicines used. For the community health care worker, this should
include a basic knowledge of the use and safe dosage of the medicine supplied within a limited
specified range.

2.2. It is recognised that in many smaller countries, it may not be cost effective to train pharmacists
within the country. In such cases, resources must be made available to enable pharmacists to be
trained elsewhere. Depending on the availability of suitably qualified/experienced personnel to
carry out the training, training of technicians and CHC workers may or may not be possible "in
country". In cases where this is not possible, it should be feasible to bring in outside trainers,
possibly under inter-government aid programmes.

2.3. Standards and curricula must be established for each level of training to ensure consistency and
appropriateness. In time, these standards can be raised to improve the competency and knowledge
base of all levels of pharmaceutical workers.

2.4. Protocols should be drawn up for the different services performed as well as medicine use
protocols, e.g. Zimbabwe's EDLIZ (Essential Drug List) Treatment Guidelines developed with the
assistance of WHO under the Essential Drug Action Programme.

2.5. STEP 1 Train local community health care workers with appropriate
pharmaceutical input

STEP 2 Train workers to a higher level with appropriate

pharmaceutical input

STEP 3 Train pharmacy technicians

STEP 4 Educate pharmacists to graduate level or provide access to

education elsewhere

STEP 5 Provide access to continuing education and continuing

professional development for pharmacists and pharmacy
technicians

Note: Step 1 workers deal with a very limited range of conditions and
medicines.
Step 2 workers deal with a broader range of conditions in greater
depth.

6
3. STANDARDS
It is recognised that in most developing countries, pharmaceutical services are virtually exclusively carried out
from the institutions or premises at which the worker is based. No attempt has, therefore, been made to include
domiciliary services.

3.1. Premises
Aim: that there should be adequate premises from which to provide services

Pharmaceutical services and products should be provided from an area which is separate from
other activities/services and products. The aim is to guarantee the integrity and quality of the
product and minimise the risk of dispensing errors. The requisites here (not ranked in order) are:

• Clean, tidy and hygienic conditions

• Adequate space
• Appropriate conditions for storage, re-packing, dispensing and distribution of medicines,
including security
• Adequate light
• Protection from exposure to excessive light and heat – refrigeration if required
• Availability of equipment appropriate to the tasks carried out (dispensing/compounding/
manufacturing)
• Access to basic reference texts
• Direct access to the public for instruction, counselling, etc.

If a clearly defined, separate area for the provision of pharmaceutical services is not available, this
should be the first objective. Thereafter, the premises can be upgraded allowing for clearer
separation of different activities e.g. dispensing, manufacturing, storage.

STEP 1 Secure, insulated container or area for storage

STEP 2 Secure area within a health facility specifically

designed for medicines

STEP 3 Area or room with facilities for storage and supply

STEP 4 Clearly defined, self-contained area or facility i.e.

community pharmacy or pharmacy department in
hospital

Premises must improve commensurate with the level of service provided and personnel involved,
e.g. need for running water, benches, light, refrigeration etc. The level of training of personnel
will vary at each step, e.g. service may be provided by an itinerant pharmacist or a community
health care worker may be based in a self-contained facility.

3.2. Dispensing
Aim: to ensure that the right patient receives the appropriate medicine in the correct dose and
form

The requisites here (not ranked in order) are:

• The right patient gets the right medicine

• Possible interactions are avoided
• The quality and integrity of the medicine are maintained throughout the indicated shelf life
• Correct and clear instructions are given to the patient to ensure correct and safe use of the
medicine, to the optimal benefit of the patient in line with the objective of the treatment

7
 • The patient is given, at the least, basic information regarding special instructions for use,
warnings if applicable, possible adverse/side effects and action to take in the event of certain
events occurring.

3.3. Containers
Aim: to preserve the integrity of the product

Tablets/capsules are dispensed in:

STEP 1 An air-tight plastic wallet (this is considered to be the

minimum requirement)

STEP 2 An airtight, rigid container

STEP 3 An airtight, rigid container with a child resistant closure

STEP 4 The manufacturer's original pack

Liquid preparations should be dispensed in "pharmaceutical" bottles so as to distinguish them from

non-pharmaceutical preparations - such as drinks/foods/consumer products

Poisonous products/products intended for external use should be packed in distinguishable bottles.

Recycled containers may be used if adequately cleaned internally and externally.

3.4. Labelling

The minimum requirements for a label (not ranked in order) are:

• Generic name & strength of medicine

• Dose, frequency & duration of course, if applicable
• Date of dispensing
• Name of patient
• Name/address of supplier
• Child safety warning

Every package should be marked in such a way that the potential danger to children is noted.

3.5. Instructions to the patient

Aim: to ensure that the patient knows how and when to take/use the product

STEP 1 Instructions are verbal

STEP 2 Instructions are verbal + hand-written and affixed to the

container

STEP 3 Instructions are verbal + printed/typed and affixed to the

container

STEP 4 In addition to step 3, verbal counselling is given to the

patient

STEP 5 In addition to step 4, supplementary written information

is given

STEP 6 GPP is observed

8
 3.6. Records
Aim: to facilitate patient care and provide an audit trail

STEP 1 A record of all medicines supplied should be kept detailing

name of patient, name & strength of medicine, dosage,
quantity supplied, date of dispensing

STEP 2 Individual patient medicine records should be maintained in

a system, manual or computerised, which allows for easy
retrieval of patient information

3.7. Health information, patient counselling & pharmaceutical care

Aim: to promote good health and prevent ill health

All personnel should be trained and equipped in terms of literature and support material to give
advice on general health matters as well as more specific information and services relating to
medicines supplied by them.

In terms of the provision of this service the steps would be as follows:

STEP 1 Provide health promotion literature and support materials on general health

STEP 2 Provide or identify an area suitable for the delivery of basic information,
counselling and pharmaceutical care

STEP 3 Provide a separate, confidential room or facility for the above activities

3.8. Self-medication

Where pharmacists or other pharmaceutically qualified personnel are involved in self medication
and response to symptoms, protocols should be devised to ensure that the advice is accurate and
appropriate.

3.9. Products

Legal mechanisms must be in place to ensure quality, safety and efficacy of medicines. The
Working Group feels that there is a role for the WHO and FIP here in terms of guidelines which
could be drawn up for countries who do not yet have adequate regulatory mechanisms in place.
(e.g. WHO Guidelines for Drug Donations (May 1996); WHO Certification Scheme for
Manufacturers; WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in
International Commerce; FIP Guidelines for Drug Procurement.)

4. LEGISLATION & NATIONAL DRUG POLICY

4.1. Legislation
Aim: to establish a national GPP policy that can be adequately enforced.

This is regarded as a fundamental prerequisite for GPP. Not only must it be in place, but it must be
adequately enforced.

STEP 1 Enact legislation to control:

• requirements for premises from which medicines are dispensed, distributed
or manufactured
• categories for distribution/supply
• labelling of medicines

9
 • control & ownership of pharmacies
• registration & control of pharmacists and pharmacy personnel
• import and export of medicines

This legislation must be practical and enforceable.

(WHO has draft legislation designed to assist countries
without adequate legislation in this area.)

STEP 2 Establish an autonomous body/bodies to control all aspects

of medicine registration, distribution, personnel, etc.
STEP 3 Access to facilities for quality assurance of medicines must
be available.

4.2. National Drug Policy

Aim: to ensure equitable access to safe and effective drugs of good quality by establishing a
National Drug Policy

The distribution of all medicines must come under the control and supervision of pharmaceutically
trained persons, ideally pharmacists. Wherever possible, this supervision should be direct.
However, indirect supervision will be required in areas where there are no pharmacists. As the
number of pharmacists increases, the degree and quality of supervision will improve and become
more meaningful/beneficial.

Pharmacists must be involved in all policy decisions that affect the distribution and use of
medicines and related products.

STEP 1 Establish a National Drug Policy based upon WHO guidelines

STEP 2 Create a suitable Essential Drugs List

10
References:

1 Primary Health Care - Report of the International Conference on Primary Health Care, Alma-Ata, USSR 1978

2 The Role of the Pharmacist in the Health Care System - Report of a WHO Consultative Group, New Delhi,
India 1993

3 Role of the Pharmacist in Support of the WHO Revised Drug Strategy, 47th World Health Assembly, 1994

4 Revised Drug Strategy, 49th World Health Assembly, 1996

5 Good Pharmacy Practice in Community and Hospital Settings, WHO 1997

6 Good Practice in Donations of Medicines, FIP 1997

7 WHO Guidelines for Drug Donations, 1996

Appendices:

1 Definitions

2 FIP GPP Document

3 RPSGB document on standards

4 Membership of Working Group

11
APPENDIX 1

Definitions

Community Pharmacy - The area of pharmacy practice in which medicines and other related products are sold or
provided directly to the public from a retail (or other commercial) outlet designed primarily for the purpose of
providing medicines. The sale or provision of the medicine may be either on the order or prescription of a doctor (or
other health care worker), or “over the counter” (OTC).

Pharmacist - A person with a formal higher qualification such as a three-year (minimum) university degree or diploma
in pharmacy.

Qualified Pharmacy Technician/Dispensary Assistant - A person with formal dispensing training (at a lower level
than a pharmacist) involved in the dispensing of medicines. (The training, or at least a part of it, would have taken
place at a recognised training institution and a certificate or licence would have been issued.)

Unqualified Pharmacy Technician/Dispensary Assistant - A person who is involved in the dispensing of medicine,
but who has only received “on the job” or “in house” training.

Community Health Care Worker - A person who is trained to provide simple, low level health care commensurate
with the level of training.

12
APPENDIX 4

Membership of Working Group

Over the years, this group has included:

Ross Holland Australia

John Ware Australia
Lu Li-Zhu China
Mohamed Abd El Gawaad Egypt
Yahra Fiagome Ghana
Jimi Agbaje Lagos
Jimi Adesanya Nigeria
Barbro Hammarström Sweden
Sue Putter South Africa
Linda Stone UK Chairman from 1997
Mike Rouse Zimbabwe Chairman until 1997