How to Develop and Implement a National Drug Policy (Second Edition): Part II: Key components of a national drug policy: 10. Research: 10.1 Introduction

How to Develop and Implement a National Drug Policy (Second Edition)
(2001; 96 pages) [French] [Spanish]

Table of Contents

Contributors
Abbreviations and acronyms
Preface
Part I: How to develop and implement a national drug policy
	1. Introduction
		1.1 Essential drugs are not used to their full potential
		1.2 What is a national drug policy?
		1.3 Key components of a national drug policy
	2. The national drug policy process
		2.1 Overview of the national drug policy process
		2.2 Formulating a national drug policy
		2.3 Implementing a national drug policy
		2.4 Monitoring and evaluation
	3. Legislation
		3.1 Importance of legislation and regulations
		3.2 Framework for drug legislation
		3.3 Developing drug legislation and regulations
Part II: Key components of a national drug policy
	4. Selection of essential drugs
		4.1 Essential drugs
		4.2 Old problems and new challenges
		4.3 Strategies for the selection of essential drugs
		4.4 Traditional and herbal medicines
	5. Affordability
		5.1 Challenges
		5.2 Strategies to increase affordability
	6. Drug financing
		6.1 Challenges
		6.2 Drug financing options
	7. Supply systems
		7.1 Public or private? Or mixed?
		7.2 Drug procurement
		7.3 Local manufacture
		7.4 Distribution strategies
		7.5 Drug supply in emergency situations
	8. Drug regulation
		8.1 Need for drug regulation and quality assurance
		8.2 Basic requirements for drug regulation
		8.3 Core elements of drug regulation
		8.4 Stepwise approach to drug registration
		8.5 Quality
		8.6 Safety
		8.7 Efficacy
		8.8 Information and drug promotion
		8.9 Information exchange with WHO and with other agencies
	9. Rational use of drugs
		9.1 Why is it important to promote rational use?
		9.2 Challenges
		9.3 Planning for activities to promote rational use of drugs
		9.4 Core strategies to improve drug use
		9.5 Educational strategies
		9.6 Managerial strategies to promote rational drug use
		9.7 Regulatory strategies to promote rational drug use
		9.8 Promoting rational drug use in the private sector
	10. Research
		10.1 Introduction
		10.2 Strategies to promote research
	11. Human resources development
		11.1 Introduction
		11.2 Strategies for human resource development
	12. Monitoring and evaluation
		12.1 Monitoring and evaluation are part of a national drug policy
References
Selected WHO publications and documents of related interest
Back cover

10.1 Introduction

Types of research

There are two categories of research that are of particular importance in the development and implementation of national drug policy. Operational research is aimed at better understanding of factors affecting drug use, and identifying the best methods of selecting, procuring, distributing and using drugs. Its results help to identify and implement practical and cost-effective measures, and should underpin management decisions. Drug research and development includes a broad range of activities, including research into new drugs, drugs for neglected infectious diseases, new dosage forms and manufacturing processes; basic research in chemistry and molecular biology; and clinical and field trials of drugs and vaccines.

Research as a component of a national drug policy

Operational research facilitates the implementation, monitoring and evaluation of different aspects of drug policy. It is an essential tool in assessing the impact of the drug policy on health service systems and delivery, in studying the economics of drug supply, in identifying problems related to prescribing and dispensing, and in understanding the socio-cultural aspects of drug use. It is one of the key ways of identifying which measures work and whether they are being implemented effectively. Operational research is needed at all levels of the health service in both industrialized and developing countries, and should be included in every national drug policy.

On the other hand, the capacity of countries to undertake drug research and development varies enormously. It is important that countries assess their capacity and consider carefully whether they can usefully be involved in drug research and development, and if so, what their priorities should be.

Challenges

Probably the most important challenge is that most health workers and policymakers, and even many staff members of academic institutions, have no time for operational research and are often not really interested in it. Having an open mind to the results of operational research also implies a critical attitude and a willingness to change. The second challenge is that when operational research is finally done, its results are often not fully used to improve strategies and prepare or adapt action plans. For this reason operational research studies should always be developed and carried out in close collaboration with policy-makers. Governments may need to fund such research, in order to ensure that it is undertaken.