BMJ  2004;329:6-7 (3 July), doi:10.1136/bmj.329.7456.6

Editorial

Collecting and sharing information about harms

Appropriate strategies to communicate this information are essential

The first 150 words of the full text of this article appear below.

Prescribing a drug represents a trade-off between its benefits and harms. The harm to benefit ratio varies according to the condition being treated, the drug's pharmacology, and the availability and safety of other therapeutic options. A decision to prescribe a drug therefore has to be made on the basis of all the information available. There is, however, often an imbalance in such information. Although high quality data regarding benefits usually come from randomised controlled trials, systematic reviews, and evidence synopses, information on harms may be limited. This is particularly the case for new drugs, which usually have been given to only a few thousand patients, and often for relatively short periods before licensing.¹ This allows common adverse events to be detected, but not rare events or those that occur only with prolonged exposure. Consequently, established compounds continue to cause much harm²—for example, approximately 5% of all admissions to US . . . [Full text of this article]

Department of Pharmacology, University of Liverpool, Liverpool L69 3GE (munirp@liv.ac.uk)

MRC Clinical Trials Unit, London NW1 2DA (jhd@ctu.mrc.ac.uk)

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