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

2. 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

3. 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

4. 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

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6. 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

7. 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

8. 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!

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

10. 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,

11. 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.

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17. 17 National Medicines Policies Australia –http://www.psa.org.au/site.php?id=634http://www.psa.org.au/site.php?id=634 Sri Lanka –http://www.who.int/medicines/areas/policy/NM DP_SriLanka.pdfhttp://www.who.int/medicines/areas/policy/NM DP_SriLanka.pdf South Africa –http://www.doh.gov.za/docs/policy/drugsjan19 96.pdfhttp://www.doh.gov.za/docs/policy/drugsjan19 96.pdf

18. 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 http://mednet2.who.int/tbs/ndp/s4869e.pdf

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

20. 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/

21. Global Pharmaceutical Market 2006 U.S.$566 billion Source www.ims-global.com/insight/report/global/report.htm US, Europe & Japan 78% 1.3% Market projected to grow 7.8% annually 5% Situation in 2002, U.S.$406bn

22. 046:127 Pharmaceutical Management for Underserved Populations 22 Drug and health commodity management cycle Selection Procurement Distributio n Use Policy and Legal Framework Managemen t Support Organization Financing Information Mgt Human Resources