Drug and Therapeutics Committees - A Practical Guide: 4.Assessing new medicines

Drug and Therapeutics Committees - A Practical Guide
(2003; 155 pages) [French] [Spanish]

Table of Contents

	Acronyms and abbreviations
	Preface
	1. Introduction
		1.1 Why are drug and therapeutics committees (DTCs) needed?
		1.2 Goals and objectives of the DTC
		1.3 Functions of the DTC
		1.4 Role of the DTC in the drug management cycle
	2.Structure and organization of a drug and therapeutics committee
		2.1 Principles in setting up a DTC
		2.2 Steps in setting up and managing the DTC
		Annex 2.1 Example of a declaration of interest form
		Annex 2.2 Model terms of reference for a DTC in Zimbabwe
		Annex 2.3 Example of a mandate for a DTC: excerpts from the Zimbabwe National Drug Policy 1998
	3. Managing the formulary process
		3.1 The formulary process
		3.2 The formulary list (essential medicines list)
		3.3 Formulary manual
		3.4 Standard treatment guidelines (STGs)
		Annex 3.1 Application forms to be filled in by applicants when applying for a new drug to be added to the hospital formulary list
		Annex 3.2 Drug information included in a comprehensive formulary
	4.Assessing new medicines
		4.1 The need for critical assessment of new medicines
		4.2 Sources of information to assess new medicines
		4.3 Assessing the efficacy and safety of new medicines from the literature
		4.4 Measuring and comparing clinical treatment outcomes
		4.5 Measuring and comparing drug costs
		Annex 4.1 Sources of information
		Annex 4.2 Checklist to detect common problems encountered in articles
	5.Ensuring medicine safety and quality
		5.1 The need for ensuring medicine safety and quality
		5.2 Monitoring and addressing medication errors
		5.3 Monitoring and ensuring medicine quality
		5.4 Safety of medicines
		Annex 5.1 Basic analytical medicine tests
		Annex 5.2 Examples of adverse drug reaction reporting (ADR) reporting forms
		Annex 5.3 Naranjo algorithm for assessing the causality of an ADR
	6.Tools to investigate the use of medicines
		6.1 Stepwise approach to investigating the use of medicines
		6.2 Analysis of aggregate medicine use data
		6.3 WHO/INRUD drug use indicators for health facilities
		6.4 Qualitative methods to investigate causes of problems of medicine use
		6.5 Drug use evaluation (DUE) (drug utilization review)
		Annex 6.1 Defined daily doses (DDD) of some common medicines
		Annex 6.2 DUE criteria on data collection form for amikacin
	7.Promoting the rational use of medicines
		7.1 Changing a medicine use problem
		7.2 Educational strategies
		7.3 Managerial strategies
		7.4 Regulatory strategies
		7.5 Choosing an intervention
		7.6 Evaluating interventions
		Annex 7.1 Examples of structured order forms from a hospital in Nepal
	8.Antimicrobials and injections
		8.1 Antimicrobials, resistance and infection control
		8.2 Safe and appropriate use of injections
	9. Getting started
		9.1 Addressing the problem
		9.2 Stepwise approach to starting a DTC where none exists
		9.3 Revitalizing non-functioning DTCs
		9.4 Using this manual to solve problems
	Glossary¹
	References
	Further reading
	Useful addresses and websites
	Back cover

4.Assessing new medicines

Summary

The assessment of new medicines is critical to managing a formulary list, which involves adding new medicines and deleting old ones. Drugs should be evaluated and compared on the basis of:

• efficacy, comparative efficacy
• effectiveness, comparative effectiveness
• safety, comparative safety
• cost of use
• quality.

Efficacy, effectiveness and safety can be evaluated from a critical assessment of the literature. Much of the information may be biased and it is very important that those evaluating new medicines have the necessary skills and time to assess the literature critically. Once efficacy and safety are established, medicines should be compared according to cost of use and, if possible, cost-effectiveness. Drug costs and quality will vary with locality.