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Chapter: Pharmacovigilance: Keynote Clinical Lessons from Pharmacovigilance

Pharmacovigilance is all about the safety of drugs in their conditions of normal routine use.


Pharmacovigilance is all about the safety of drugs in their conditions of normal routine use. It does involve collection and analysis of information about drugs as they are used in a community. No longer is the major focus that of the randomised controlled clinical trial where a well-defined subset of the popu-lation is exposed under carefully controlled circum-stances to a medicine of interest and followed for a defined duration thereafter. We now enter the area of observational studies with all the problems in inter-pretation that such studies entail. It is important to realise that the interpretation of observational data can be much more complex than the interpretation of randomised controlled clinical trials. Such studies are, by their very nature, full of incomplete information and are likely to need careful recognition of confound-ing, either at the design or analysis stage. Indeed, some such studies cannot be interpreted because of insurmountable problems with bias or other distor-tions. The various types of studies involved have been covered in earlier chapters in this book. They fall broadly into three categories:

·   The anecdotal study in which reports of suspected problems are solicited and analysed to see if they can give hints about possible drug-related prob-lems, exemplified by the spontaneous reporting schemes.

·   More detailed observational studies, but still with-out appropriate comparator groups who are not exposed to the medicine of interest, for example ad hoc follow-up studies.

·   Controlled studies, including case–control and cohort studies.

As long ago as 1987, giving the keynote address on pharmacoepidemiology and public health policy at the International Society for Pharmacoepidemiol-ogy meeting in Minneapolis, one of us (DHL) made several points about this subject which we think are worthwhile repeating here. These are as follows:

·   It is the duty of pharmacoepidemiologists to ensure that spontaneous reports of suspected adverse reac-tions are used wisely in the full knowledge of their substantial limitations.

·   It is our duty as pharmacoepidemiologists to ensure that other sources of information are avail-able which can be interpreted in a reasonably rapid time frame. Good data in 6 years is no substitute for usable data in 6 months or less.

·   Pharmacoepidemiology will not prosper if it devel-ops as an intellectual subject which plots the history of why drugs fall from favour. It must be a live and contemporary subject, providing answers to current problems of drug use and drug safety in real time.

These aphorisms are as relevant today as they were when first spoken. They apply across the board to all types of studies. Thankfully we have made progress in the intervening years, albeit not as much as we would have liked.

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