The Pharmaceutical Journal
Vol 279 No 7476 p507
3 November 2007

Authoritative source on pharmacovigilance

‘Pharmacovigilance’, 2nd edition, by Ronald D. Mann and Elizabeth B. Andrews. Pp xiv+686. Price £175. Chichester: John Wiley and sons Ltd; 2007. ISBN 978 0 470 01803 3

In October 2007, it was the 50th anniversary of the launch of a sedative called Distaval (thalidomide). Marketed as a safe alternative to the toxic barbiturates used at the time, it sold well. Within four years Distaval was responsible for the deaths and deformities of thousands of children exposed in the womb.

Judgements on the safety of new drugs remains provisional, but the science of pharmacovigilance has developed over the past half century.

‘Pharmacovigilance’ is an excellent and detailed examination of the current state of both science and practice. Extensively revised, with chapters from internationally respected authorities, this second edition covers the basis (and legal framework) of pharmacovigilance, the principles of signal generation, current topics and future directions.

Although focused on spontaneous reporting systems, prescription-event monitoring systems and some databases, such as the UK General Practice Research Database, it is less focused on pharmacoepidemiology. The book therefore dovetails neatly with Strom’s recently updated ‘Pharmacoepidemiology’.

High profile drug safety issues with therapies such as coxibs, selective serotonin reuptake inhibitors and hormone replacement therapy are well described.

Chapters on specific adverse drug reactions do seem more suited to a clinically oriented book like ‘Meyler’s side effects of drugs’, but those who require an authoritative source on pharmacovigilance need look no further.


Anthony R. Cox
(pharmacovigilance pharmacist at the West Midlands Centre for Adverse Drug Reactions, City Hospital, Birmingham)