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?
Close this folder8.3 Collecting evidence about the drug
View the document8.3.1 Where to find evidence on new drugs?
View the document8.3.2 What about using unpublished information?
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
 

8.3.1 Where to find evidence on new drugs?

The main sources of information about new drugs are:

ISDB member bulletins. It is worth finding out if an independent drug bulletin has reviewed the drug already. This may save you some work. You can do this by asking bulletin editors via the ISDB electronic network (see http://www.isdbweb.org).

The pharmaceutical company. Write to the medical director of the company that markets the product to ask for all the preclinical and clinical trial data. You may not get what you requested, but among the information supplied you may find important data indicating negative aspects of the product, such as no efficacy and/or potential or substantial evidence of harm.

It can be interesting to see how the medicine is being promoted. If asked, the company might send copies of adverts and other promotional material (such as detail aids, mailers). You can also find evidence on how the drug is being promoted in adverts published in professional journals, in the lay press, on the company’s web site, and by collecting material sent directly to health professionals. You should critically appraise the evidence on efficacy and harm, compare the results with what the company is claiming and discuss your findings in your article. (Examples of how bulletins can deal with misleading promotional claims include. ∇ Is Yasmin a truly different pill? Drug and Therapeutics Bulletin 2002:40:57-9; ∇ Yasmin advert withdrawn - why and how. Drug and Therapeutics Bulletin 2003;41:17-18).

Regulatory authority web sites, including the U.S. Food and Drug Administration (FDA), Japanese Pharmaceutical and Medical Device Agency (PMDA), and European Medicines Agency web sites (see the appendix at the end of the manual for addresses). Although useful, materials on these sites are usually summaries of the original full data submitted to the regulatory authority by the company that may exclude (perhaps intentionally) important findings: for example tacrolimus ointment (see Section 8An-3.5 in the annexe at the end of this chapter).

Web sites of authoritative drug evaluation organizations, including the UK Committee on Safety of Medicines, UK National Institute for Clinical Excellence, etc. (see the appendix at the end of the manual for addresses).

Databases of published information, e.g. PubMed. You should always do your own search to check for missing data (see Chapter 7 for a list of general sources to search).

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