Community Pharmacy Section of FIP Development and Implementation of Good Pharmacy Practice in Developing Countries Mrs. Bente Frokjaer Secretary Community Pharmacy Section of FIP Dear Mr. Chairman, ladies and gentlemen It is a great honour for me to be preset at the prestigoues second International Conference on Improving Use of Medicines. Let me first introduce myself. I am a Danish pharmacist, working in Pharmacy practice research and parttime at a pharmacy. I am here because I am heavily involved with FIP

International Pharmaceutical Federation - FIP FIP is a world-wide federation of national pharmaceutical associations FIP’s mission is to represent and serve pharmacy and pharmaceutical sciences around the globe Through its member associations, FIP connects, represents and serves more than one million pharmacists and pharmaceutical scientists around the world. What is FIP? It stands for Federation Internationale Pharmaceutique – or in English International Pharmaceutical Federation. FIP is a worldwide federation of national pharmaceutical associations and has more than 110 member organisations from all parts of world. FIP’s mission is to represent and serve pharmacy and pharmaceutical sciences around the globe. FIP has close collaboration with WHO. The two parties have together created regional pharmaceutical forums to further develop pharmacy practice. The Forums bring together the national pharmacy associations in a partnership with WHO to increase dialogue, understanding and activity in the regions, and enable the pharmacy profession to have a greater impact on improving pharmacy services and health. FIP has furthermore a close colllaboration with nurses and medical doctors in the World Health Professions Alliance. The alliance will benefit health, citizens, and health policy makers world-wide, by pooling the resources and strengthening collaboration among these core members of the health care team. FIP and represents more than 1 million pharmacists

FIP Community Pharmacy Section The aims of the Section are to improve professional standards of the profession and encourage the realisation of the social aims of the profession to plan and be responsible for the activities of FIP in the field of community pharmacy in particular. I am the professinal secretary of the Community Pharmacy Section of FIP. FIP has 9 sections representing all aspects of the practice of the profession of pharmacy throughout the whole world, regardless of any national or local issues. The Community Pharmacy Section is far the largest of FIP’s sections. Our aims are To improve professinal standards of the profession and encourage the realisation of the social aims of the profession To plan and be responsible for the activities af FIP in the field of community pharmacy in particular. The Section has on its Executive Commitee an observer from Developing Countries. The observer undertakes a project during his term of office and the present project: GPP in Developing Countries is an example of such a project. Apart from that the section has a number of working groups. The next presentation I am going to give is an example of a work undertaken by a Working Group.

Health is a human right “…. Health is a fundamental human right and the attainment of the highest possible level of health is a most important world-wide social goal”. Adequate pharmaceutical service, ideally provided by pharmacists, is a vital component of Primary Health Care. Both FIP and WHO believe that national pharmaceutical associations in individual countries are best able to decide what can be achieved in terms of Good Pharmacy Practice and within what timescale. 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. Adequate pharmaceutical service, ideally provided by pharmacists, is a vital component of Primary Health Care. This is recognised by the World Health Organization in the joint WHO and FIP document: Good Pharmacy Practice in Community and Hospital Settings (1996). This is an important document setting the quality standards for our profession. 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. 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 this working group 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. Hence this set of simple recommendations designed to be of help primarily in developing countries.

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 The aim is to assist developing countries to achieve Good Pharmacy Practice by devising a set of guidelines that can be adapted by stepwise implementation. Recognising the difference in levels of practice, it is the recommendation that implementation of Good Pharmacy Practice should follow a step-wise approach. It can be applied to a number of different components of pharmaceutical services. By proposing a step-wise implementation it is 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. 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 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.

Method A questionnaire was distributed to 171 developing countries. 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. A questionnaire was distributed to 171 developing countries in 1994-1995. The countries were selected based on UN classification. Some countries, however, were excluded due to insufficient mailing addresses. The questionnaire was available in French and Spanish apart from English. Each country was sent 2 copies of the questionnaire in the appropriate language along with the Good Pharmacy practice Guidelines. 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

Results The Working Group received responses from a wide range of countries. 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. It required a lot of patience and reminders to get sufficient responses. Becuase of that the working process took longer tahn anticipated. The working group responsible for developing the guidelines 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.

Recommendations Recognizing differences in levels of practice the Working Group recommends a step-wise implementation of Good Pharmacy Practice. Each association and person can identify the “step” 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. 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. 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.

Recommendations The recommendations focus on four areas: Personnel Training Standards Legislation and national drug policy The recommendations focus on 4 areas: Personnel Training Standards Legislation and national drug policy I do not have time here to go through all four areas but will explain two of the as examples, namely Personnel and National Drug Policy.. With respect to standards I just want to bring to your knowledge that this area is the most comprehensive as it covers standards for Premises Dispensing of medicine Medicine containers Labelling of medicine Instructions to the patient Patient records Health information and patient counselling Self medication Products

Stepwise implementation PERSONNEL Aim: all people should have access to a qualified pharmacist 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 community health care worker Step 3: Access to a qualified pharmacy technician with appropriate training Step 4: Direct access to a pharmacist. In developing countries it is accepted that due to insufficinet 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. In many cases it is perceived that the level of responsibility placed on health workers is disproportionate to the training they have received. It is assumed that at primary care level the medicines will be relatively simple and few in number. The communjty 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 being treated. Progressing upwards to the next level, it would be assumed that a worker with a greater level of training would be available. Aim: all people should have access to a qualified pharmacist 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 community health care worker Step 3: Access to a qualified pharmacy technician with appropriate training Step 4: Direct access to a pharmacist

NATIONAL DRUG POLICY - stepwise Aim: Ensuring equitable access to safe and effective drugs of good quality by establishing a National Drug Policy. Pharmacists 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 Guidelines Step 2: Create a suitable Essential Drug List. NATIONAL DRUG POLICY Aim: Ensuring 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 beneficial. Pharmacists 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 Guidelines Step 2: Create a suitable Essential Drug List

Manual for Health Care Workers A manual for training of health care workers was developed based on the report and the guidelines for stepwise implementation. The manual is intended for training community health care workers. The manual gives Standards for Workplace: the area from where you provide the service must be the best available Dispensing: make sure that the right patient receives the right medicine in the correct dose and form Containers: keep the medicine in good condition so that it will work Labelling: the container must be labelled with name, strength etc. Instructions to the patient: make sure that the patient knows how and when to take or use the medicine Records: make it easier and safer to look after the patient Health promotion: to promote good health and prevent ill health Legislation: You must obey the laws about medicines in your own country

Implementation The 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. Implementation The guidelines have been sent to all developing countries and are available on www.fip.org. Commonwealth Pharmaceutical Association has been of great help in the distribution process. Bosnia and Herzegovina followed the stepwise implementation process when they were rebuilding the pharmaceutical sector after the civil war in the area. They have been very successful and gave a report on this at the Congress of FIP in Sydney 2003.   Skift billede At present the guidelines are being followed in Ghana as a support in step-wise implementation of Good Pharmacy Practice. The implementation process in Ghana is being supported by Commonwealth Pharmaceutical Association. The first step was taken in 2003 where two Training the trainer sessions were held: one in Accra and one in Kumasi. At each session 20 pharmacists were trained – both community pharmacists and hospital pharmacists. They were trained in the principles of Good Pharmacy Practice and how to It is the intention that the trained pharmacists

Ghanese Pharmacy  

Chemical seller in Ghana  

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