Development and Implementation of Good Pharmacy Practice Standards in Developing Countries Author: Frokjaer B, International Pharmaceutical Federation.

Development and Implementation of Good Pharmacy Practice Standards in Developing CountriesAuthor: Frokjaer B, International Pharmaceutical Federation (FIP) Community Pharmacy SectionProblem Statement: Adequate pharmaceutical service is a vital component of primary health care. Yet it is recognized and accepted that conditions of pharmacy practice vary widely from country to country. The International Pharmacy Federation (FIP) and the World Health Organization (WHO) have adopted a set of Guidelines for Good Pharmacy Practice (GPP). They form the basis for development of quality care standards worldwide.Objective: To help developing countries achieve GPP by devising a set of guidelines that can be adapted for the country environment.Design: The FIP Community Pharmacy Section established a Working Group to devise the guidelines. The working group consisted of pharmacists from Australia, China, Egypt, Ghana, Nigeria, South Africa, Sweden, United Kingdom (co-chair), and Zimbabwe (chair). Setting and Study Population: The FIP working group developed a questionnaire and distributed it to pharmaceutical organisations in developing countries (based on UN list). The results from the questionnaire formed the basis for the development of the guidelines.Intervention: Recognizing the differences in levels of practice, the recommendations follow a stepwise approach. Each institution or service provider can identify the “step” on which they are currently operating and work toward reaching the next step (or level of practice), thereby continually improving the quality of pharmaceutical service offered to their community. This stepwise approach can be applied to various components of pharmaceutical service.Results: Guidelines for stepwise implementation focus on four major areas: personnel, training, standards, legislation, and national drug policy. The goals for each area can be summarized as follows. (1) Personnel: It is the aim that all people have access to a qualified pharmacist. (2) Training: It is the aim that the country can be self-sufficient in training pharmacy personnel. (3) Standards: It is the aim that there should be adequate premises from which to provide services in a number of areas: dispensing, containers, labeling, instructions to patients, etc. (4) Legislation and National Drug Policy: It is the aim to establish a national GPP policy that can be adequately enforced.Conclusions: 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. As a supplement, the Working Group has also developed a resource tool, Community Health Care Workers’ Manual for Dispensing Medicine, to address the reality that pharmacists are scarce in most developing countries.Study Funding: International Pharmaceutical Federation

Background and setting

1. The Alma-Ata Declaration on primary Health Care (1978) 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”. It recognises the role played by all health workers and the need for suitable training.

2. Adequate pharmaceutical service, ideally provided by pharmacists, is a vital component of Primary Health Care. This is recognised by the World Health Organization (WHO) in the joint WHO and FIP document: Good Pharmacy Practice (GPP) in Community and Hospital Settings (1996).

3. It is recognised and accepted that conditions of pharmacy practice varies widely from country to country and it is likely to see significant differences between the health services available in urban areas and rural areas.

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.

Aims

To help developing countries achieve Good Pharmacy Practice by devising a set of guidelines that can be adapted by stepwise implementation.

The overall aim is the striving towards ever-higher standards of practice for the benefit of the patients and the community being served:

– by achieving better outcomes

– by developing the profession

A questionnaire was distributed to 171 developing countries in 1994-1995. The questionnaire should give an overview of:

– availability of pharmacies, pharmacists and support staff or health workers

– education and training of pharmacists and of pharmacy support staff

– existing standards for pharmacy practice

– legislation on distribution and dispensing of medicine

Methods

Results and Recommendations (1)

The Working Group received responses from a wide range of countries (66 countries responded, corresponding to 40%). Replies were received from countries in South and Central America, Europe, Middle East, Africa, Asia and Oceania.

The replies showed big differences in levels of practice, availability of pharmacies and pharmacists, in level of education and in regulation of medicine distribution and dispensing.

Based on the results from the questionnaire and the WHO – FIP document: Good Pharmacy Practice in Community and Hospital Settings, the working group developed a set of guidelines.

Recognizing differences in levels of practice the Working Group recommends a step-wise implementation. Each association and person can identify the “step” (level) on which they are currently operating and work towards reaching the next step, thereby continually improving the quality of pharmaceutical service offered to their community. The step-wise implementation can be applied to a number of different components of pharmaceutical services.

Results and Recommendations (2)

It is also the recommendation of the Working Group that there 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.

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.

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.

The recommendations focus on 4 areas:– Personnel– Training– Standards– Legislation and national drug policy

Personnel and TrainingPERSONNELAim: all people should have access to a qualified pharmacist

Step 1: Access to a community health care worker with appropriate pharmaceutical trainingStep 2: Access to a person trained to a higher level than community health care workerStep 3: Access to a qualified pharmacy technician with appropriate trainingStep 4: Direct access to a pharmacist

TRAININGAim: The country should be self-sufficient in training pharmacy personnel

Step 1: Train local community health care worker with appropriate pharmaceutical inputStep 2: Train workers to a higher level with appropriate pharmaceutical inputStep 3: Train pharmacy techniciansStep 4: Educate pharmacists to graduate level or provide access to education elsewhereStep 5: Provide access to continuing education and continuing professional development for pharmacists and pharmacy technicians.

Standards (1)

PREMISESAim: There should be adequate premises from which to provide services

DISPENSINGAim: Ensuring that the right patient receives the appropriate medicine in the correct dose and form

CONTAINERSAim: Preserving the integrity of the product

LABELINGThe minimum requirements are

– Generic name and strength of medicine

– Dose, frequency and duration of course

– Date of dispensing– Name of patient– Name/address of supplier– Child safety warning

Standards (2)

INSTRUCTION TO THE PATIENTAim: Ensuring that the patient knows how and when to take the product

Step 1: Instructions are verbalStep 2: Instructions are verbal and hand-written, affixed to the containerStep 3: Instructions are verbal and typed and affixed to the containerStep 4: In addition to step 3, verbal counseling is given to the patientStep 5: In addition to step 4, supplementary written information is given.Step 6: Good Pharmacy Practice is observed

RECORDSAim: Facilitating patient care and provide an audit trail

Step 1: A record of all medicines supplied should be kept detailing name of patient, name and strength of medicine, dosage, quantity supplied, date of dispensing.Step 2: Individual patient medicine records should be maintained in a system, which allows for easy retrieval of patient information.

Legislation and National Drug Policy

LEGISLATIONAim: Establishing a national drug policy that can be adequately enforced

Step 1: Enact legislation to control:– Requirements for premises from

which medicines are dispensed, distributed or manufactured

– Categories for distribution– Labeling of medicines– Control and ownership of

pharmacies– Registration and control of

pharmacists and pharmacy presonnel

– Import and export of medicinesStep 2: Establish an autonomous body to control all aspects of medicines registration, distribution, personnel etc.Step 3: Access to facilities for quality assurance of medicines must be available

Legislation and National Drug Policy

 NATIONAL DRUG POLICYAim: Ensuring equitable access to safe and effective drugs of good quality by establishing a National Drug PolicyPharmacists must be involved in all policy decisions that effect distribution and use of medicines and related products.

Step 1: Establish a National Drug Policy based upon WHO GuidelinesStep 2: Create a suitable Essential Drug List

ImplementationThe guidelines have been sent to all developing countries and are available on www.fip.org.  At present the guidelines are being followed in Ghana as a support in step-wise implementation of Good Pharmacy Practice A manual: Community health care workers’ manual for dispensing medicines has been developed by the same working group

More informationFIP Community Pharmacy SectionEmail: [email protected]: www.fip.org