046:127 Pharmaceutical Management for Underserved Populations Paper on Current Controversy Team Assignment: Observational Visits National Drug Policy/Assessment.

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 2007Prof. Hazel H. SeabaWith credit to Richard Laing, Department of Medicines Policy and Standards, WHO

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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

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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

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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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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

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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

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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!

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Formulating a NDP

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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,

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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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National Medicines Policies

• Australia– http://www.psa.org.au/site.php?id=634

• Sri Lanka– http://www.who.int/medicines/areas/policy/NM

DP_SriLanka.pdf

• South Africa– http://www.doh.gov.za/docs/policy/drugsjan19

96.pdf

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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

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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.pdf

   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.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 situations http://mednet2.who.int/tbs/ndp/ind.pdf

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• 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/