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The Pharmaceutical Journal Vol 264 No 7091 p533
April 8, 2000 Clinical

Defining adverse drug reactions

A book of definitions of adverse drug reactions and minimum standards for the use of these terms when reporting reactions has been produced by the Council for International Organisations of Medical Sciences (CIOMS). The object of the book is to improve the consistency throughout Europe of the terminology used when reporting and diagnosing adverse events.
'Reporting adverse drug reactions - definitions and criteria for their use' is divided into chapters for all of the body's major systems, each of which comprises a list of disorders of that system. For each disorder, there is an explanation of areas of confusion in terminology, a definition of the disorder and an indication of the basic requirement for using the deefinition when reporting adverse drug reactions. The publication has been put together using input from a series of international working groups comprising regulatory bodies and pharmaceutical companies, together with clinical experts and members of CIOMS and the World Health Organisation (WHO). CIOMS is a non-governmental organisation that was set up by the WHO and UNESCO in 1949. One of its remits is to look at the ethical considerations to be taken into account in developing and implementing health policy.
'Reporting adverse drug reactions - definitions and criteria for their use' is available as a book and CD-ROM from the Stationery Office, PO Box 29, Norwich NR3 1GN or from its website (www.itsofficial.net), price £22.