Introduction - Uppsala Monitoring Centre

Mrs L Lake SRN, SCM for help with the translation of Otto Seifert’s book
Dr You-Ping Zhu of Groningen University for information on Adverse Drug Reactions in
Traditional Chinese Medicine
Sir John Crofton for help with the toxicity of streptomycin
Mr George Mann for his advice and superb crafting of the book from my rough manuscript.
Illustrations
I am very grateful for permission to use the following images and graphs:
Wellcome Collection Library, London for the images of arsenic adverse effects, mercury
adverse effects, Morison’s Pills, the doctors dispensatory, antimoine, opium poppy,
Hyoscyamus niger and black hellebore
Scribd Library for World average income per person and Global population growth from
Alasdair Laurie’s book Proving Jesus
The American Medical Association for the Phenacetin warning leaflet
I am very grateful to Lee W. Gilbert of Manly NSW, Australia, for permission to use his
photograph of ‘Dawn, Tasman Sea’ for the cover of this book.
Introduction
A
broad definition of pharmacovigilance is ‘the watchfulness in guarding
against danger from drugs or providing for drug safety’ (Abenheim et al.,
1999). There are many different definitions, some place emphasis on
post-marketing activities while others cover both pre and post marketing
activities (Stephens, 2004). The definition given by the WHO in 1969 was:
‘pharmacovigilance: one means by pharmacovigilance the notification, the
registration and the systematic evaluation of the adverse reactions to medicines
delivered with or without a prescription’; this was the earliest reference to
‘pharmacovigilance’ that I have found (WHO, 1969). The information on these
reactions can be obtained, either by voluntary notifications by general
practitioners or from hospitals and centres previously designated (spontaneous
pharmacovigilance), or by the application of epidemiological techniques allowing
the systematic collection of information from certain sources: hospitals,
representative samples of the medical profession, etc. (intensive
pharmacovigilance).
The pharmacovigilance cycle starts with the patient, who after taking a drug and
then having an adverse event reports it to a health professional who reports it to a
national authority (or pharmaceutical company) which investigates it, establishes the
full facts, and assesses them before passing it to the WHO monitoring centre. If this