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