Class Period #2, 24 January 2007 Prof. Hazel H. Seaba

1. Paper on Current Controversy Team Assignment: Observational Visits National Drug Policy/Assessment Team Assignment: Pharm System Analysis Consultant Report Class Period #2, 24 January 2007Prof. Hazel H. Seaba With credit to Richard Laing, Department of Medicines Policy and Standards, WHO 046:127 Pharmaceutical Management for Underserved Populations

2. National Drug Policy (NDP) Objectives • Review the history of NDPs • Discuss the background to NDP’s • List the Components of a NDP • Review actors involved in the NDP process • Identify checklist for a medicines formulation policy • Review global implementation of NDPs • Correlate country income to status of NDP 046:127 Pharmaceutical Management for Underserved Populations

3. What is a National Drug Policy? A NDP is a guide. It is a document specifying the goals set by the government for the pharmaceutical sector, their relative importance, and the main strategies for attaining them. • Make essential drugs available and affordable to those who need them • Ensure the safety, efficacy and quality of all medicines provided to the public • Improve prescribing and dispensing practices and promote the correct use of medicines by health workers and the public MDS-2, p 56, 57 046:127 Pharmaceutical Management for Underserved Populations

4. History of National Drug Policies • 1985 Nairobi Conference of Experts on rational Use of Drugs • 1987 Working group of Experts to draft guidelines for NDP’s • 1988 Guidelines for NDP’s released • 1995 Expert Committee on NDPs met report issued • 2002 New Guidelines published 046:127 Pharmaceutical Management for Underserved Populations

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6. Background to NDP’s • Need for common framework to coordinate many different actors in the pharmaceutical field: • These include regulators (quality, safety and efficacy), producers (local & international), users (prescribers & consumers), health planners & managers, health finance authorities and researchers. • Each have valid interests in the field which may be contradictory or supportive • Involves both public & private sectors 046:127 Pharmaceutical Management for Underserved Populations

7. Components of a NDP • Legislation, Regulation and Guidelines • Selection of Drugs • Supply (incl. procurement & production issues) • Quality Assurance • Rational Drug Use • Economic Strategies for Drugs • Monitoring & Evaluation of NDP’s • Research • Human Resources Development • Technical Cooperation among Countries 046:127 Pharmaceutical Management for Underserved Populations

8. Overview of Components • Each component has a crucial part in the overall policy! • Emphasizing one component at the expense of others, weakens the entire policy • Many different actors are involved. Some are outside MoH, some outside government, some outside country • Means that NDP planners need to be aware, though not expert, in all areas! 046:127 Pharmaceutical Management for Underserved Populations

9. Formulating a NDP 046:127 Pharmaceutical Management for Underserved Populations

10. Many Actors Involved! Some pro, some against! • Doctors, specialists, public/private • Pharmacists retail and manufacturing • Local and international producers, importers • Consumers/Patients • Media • Regulators • Insurance Companies • Etc, Etc, 046:127 Pharmaceutical Management for Underserved Populations

11. Characteristics of a National Medicines Policy • Essential part of health policy, must fit within the framework of a particular health care system. • Goals should be consistent with broader health objectives • Health policy and the level of service provision in a particular country are important determinants of drug policy and define the range of choices and options. • Implementation of an effective drug policy promotes confidence in and use of health services. 046:127 Pharmaceutical Management for Underserved Populations

17. National Medicines Policies • Australia • http://www.psa.org.au/site.php?id=634 • Sri Lanka • http://www.who.int/medicines/areas/policy/NMDP_SriLanka.pdf • South Africa • http://www.doh.gov.za/docs/policy/drugsjan1996.pdf

18. Anon. How to develop and implement a national drug policy, WHO Policy Perspectives on Medicines. January 2003. http://mednet2.who.int/tbs/ndp/s4869e.pdf

19. Readings • How to Develop and Implement a National Drug Policy - WHO Policy Perspectives on Medicines, No. 6, 2002http://mednet2.who.int/tbs/ndp/s4869e.pdf Equitable Access to Essential Medicines: A Framework for Collective Action - WHO Policy Perspectives on Medicines, No. 8, 2004http://mednet2.who.int/tbs/ndp/s4962e.pdf • How to Develop and Implement a National Drug Policy (Second Edition)http://mednet2.who.int/tbs/ndp/s2283e.pdf (WHO; 2001; 96 pages)   • Using indicators to measure country pharmaceutical situationshttp://mednet2.who.int/tbs/ndp/ind.pdf 046:127 Pharmaceutical Management for Underserved Populations

20. CIA World Factbook • https://www.cia.gov/cia/publications/factbook/index.html • WHO Medicines • http://www.who.int/medicines/en/ • WHO Countries • http://www.who.int/countries/en/ • The World Bank • http://www.worldbank.org/ • Nation Master • http://www.nationmaster.com/cat/Health-health • Management Sciences for Health • http://www.msh.org/ 046:127 Pharmaceutical Management for Underserved Populations