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| Marc Girard’s initial training
led to an MSc in mathematics.
He then became an MD in
parallel with his research on
mathematical modelling.
He works on drugs mainly as a
consultant for pharmaceutical
firms and also practises as
a psychotherapist in the
Freudian discipline. Besides a
number of scientific papers, he
has published literary criticism
particularly on Flaubert, Balzac
and Zola as well as on the
Grimm Brothers’ fairy tales.
As a medical expert witness,
he has been commissioned by
French judges to comment on
litigation involving drugs or
chemicals (growth hormone,
diethylstilbestrol, hepatitis B
vaccines, cerivastatin,
Gulf War syndrome, glycol
ethers, mercury). |
Principles of pharmacovigilance
Marc Girard
Independent pharmaceutical consultant
Address for correspondence:
Dr Marc Girard, MSc, MD
76 route de Paris
78760 Jouars-Pontchartain
France
Tel: +33-(0)1-3489-4229 Fax: +33-(0)1-3489-7608
Email: agosgirard@free.fr
Abstract
After a short historical survey of adverse drug
reactions, this paper summarises the current
organisation of pharmacovigilance in Europe, with
its principles of reporting, assessing, understanding
and preventing the adverse effects of medications.
Issues related to contrast media are included to
exemplify the principles. Respective responsibilities of
the various stakeholders are described: the European
Agency, EEC member states, manufacturers and, last
but not least, health professionals.
The paper then focuses more specifically on
spontaneous reporting, with the limits and biases
that result from inevitable under-reporting. In the
event of a new disease likely to be ascribed to a
drug or a class of drugs, a conceptual framework
for investigation is proposed, articulated on the
criteria of:
• credibility
• causation
• re-assessment of benefit:risk ratio
• course of action.
In spite of its awkward methodological limitations,
the author concludes that the principle of
spontaneous reporting may be appropriate for
investigating a new pathological entity such as
nephrogenic systemic fibrosis (NSF).
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