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

8.2 When is a new treatment a therapeutic advance?

Before substituting an existing standard treatment with a new drug, prescribers need to be sure that the new treatment has advantages over what is already available. To be considered an advance when compared with existing treatment(s),2 a new treatment should have:

• better efficacy, and/or
• fewer or less severe adverse effects, and/or
• safer or more convenient administration.

Therapeutic advance should not be seen in isolation. When reviewing a new drug, cost is obviously an important consideration, although it has no bearing on whether a drug is a therapeutic advance. Section 8.6 of this chapter discusses how cost is considered in the evaluation.

Questions to ask about the new drug

At the start of a review of a new treatment, there are three main questions to consider:

1. Is treatment really necessary for the patient? That is, does the drug improve the appropriate outcome(s) in the targeted population, and is it relevant to the health of your country’s population? There is usually little or no available evidence from randomised controlled trials that have used appropriate outcome measures with which to answer the question (see Boxes 8.1 and 8.2 and Section 8.4 for a discussion of hierarchy of outcome measures and evidence). However, non-randomised studies, such as observational follow-up studies, with mortality as the outcome measure may be available and can be useful. For example, serum cholesterol concentrations of 6.21-6.71 mmol/L, which are considered high in western countries, occur in the healthiest people with the lowest mortality and living a normal life in Japan, and so it follows that in Japan such people should never be regarded as ‘patients’ with hyperlipidaemia needing treatment.3

2. If a treatment is necessary, is there an effective non-drug treatment?

3. If drug treatment is needed, what are the standard, or already available, drug treatments?

The next step will be to examine whether the new treatment is more effective, safer or more convenient to administer than what is already available.

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