The Pharmaceutical Journal
Vol 272 No 7292 p393
27 March 2004

New edition affirms place as key text in the area of pharmacovigilance

‘Stephens’ detection of new adverse drug reactions’, 5th edition, edited by John Talbot and Patrick Waller. Chichester: John Wiley & Sons Ltd; 2004. Pp 762. Price £100. ISBN 0 470 84552 X

Recent coverage of issues surrounding the measles, mumps and rubella vaccine highlights the importance of detecting new adverse drug reactions, and occasionally having to refute phantom reactions. The first edition of this book was published in 1985, and this fifth edition again affirms its place as a key text in the area of pharmacovigilance.

Covering all areas of a drug’s life — from clinical trials, marketing, post-marketing surveillance, to the eventual withdrawal of a drug — the book is extensively referenced and well written by leaders in the field. Five new chapters on vaccine safety, biotechnology, managing drug safety issues, operational aspects of drug safety and the future of pharmacovigilance have been added.

Coding of reactions, signal detection, causality assessment, and statistical presentation are expertly covered, and the pharmacovigilance process is wisely placed in the wider context of today’s regulatory and media environment — including the communication of drug safety messages. Justifiable attention is paid to the ethics of the pharmaceutical industry — an area which, if unattended, can lead to significant levels of public distrust, hindering the provision and acceptance of valid safety messages or reassurances.

Those already working in the area of drug safety will find this book a valuable resource; those wishing to enter it, essential.

Anthony Cox

Anthony Cox is adverse drug reactions pharmacist, West Midlands Centre for ADR Reporting, and teaching fellow at Aston University