Starting or Strengthening a Drug Bulletin - A Practical Manual
(2005; 165 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentHow the manual was produced
View the documentAbout ISDB
View the documentExecutive summary
Open this folder and view contents1. Introduction
Open this folder and view contents2. Rational use of medicines
Open this folder and view contents3. What are drug bulletins?
Open this folder and view contents4. Defining aims, target and type of bulletin
Open this folder and view contents5. Planning resources
Open this folder and view contents6. Planning bulletin production: schedules and timing
Open this folder and view contents7. The editorial process
Close this folder8. Reviewing a new drug: is it a therapeutic advance?
View the document8.1 Introduction
View the document8.2 When is a new treatment a therapeutic advance?
Open this folder and view contents8.3 Collecting evidence about the drug
Open this folder and view contents8.4 Evaluation in terms of efficacy, harm and convenience
Open this folder and view contents8.5 Judging the overall value of the drug
Open this folder and view contents8.6 Cost
View the document8.7 What patients need to know
View the document8.8 References
Open this folder and view contentsAnnexe to Chapter 8: Evaluating harm
Open this folder and view contents9. Design and production
Open this folder and view contents10. Dissemination
Open this folder and view contents11. Organizational and legal issues
Open this folder and view contents12. Evaluating quality and usefulness
Open this folder and view contents13. Partnership and collaboration
Open this folder and view contents14. Keeping records and creating a memory
Open this folder and view contentsAppendix: Electronic sources of information

8.1 Introduction

Of the many new drug treatments that appear on the market each year (including new chemical entities, new licensed uses for existing drugs, and new formulations or methods of administration of existing drugs), only a few offer a real benefit to patients over existing treatments.1,2 Promotional claims for these new products can make it difficult for health professionals to distinguish those that offer real benefits from those that are no better, or sometimes worse, than what is already available. By publishing reviews of new drugs, bulletins have an important role in helping their readers recognise the products that really are an advance and which deserve to be included in the list of drugs they use.

This chapter outlines the principles of how to evaluate a new drug. It is mainly for editors from established bulletins looking to develop their working practices on evaluating drugs that are new in their country. See Chapter 7 for the more general aspects of planning, writing and editing an article.

Many independent bulletins publish their own evaluation of new medicines. It is a task that demands significant and specialised resources, including the ability to access relevant data, and editors skilled in critically appraising the data. Because of the time and energy involved in reviewing a new drug, bulletin editors could think of collaborating with each other or sharing information, rather than different groups repeating the same work again and again. Even if a bulletin reuses the evaluation of another, there is still a need to take account of local circumstances (e.g. local spectrum of morbidity and mortality, inter-racial variation in the activity of metabolising enzymes, availability of services, local cost, etc.) in making a recommendation about the value of a drug (see Section 8.5.1 of this chapter for more about this).

Some bulletins have become experienced and expert at certain aspects of evaluation. For example, the group producing the Japanese bulletins Informed Prescriber and Kusuri-no-Check routinely appraise preclinical and animal data in their evaluations, in particular looking for signals of harm associated with long-term use of drugs. This particular aspect is dealt with in the annexe to this chapter.

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