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EDITORIALS: Yoon Kong Loke Assessing the benefit-harm balance at the bedside BMJ 2004; 329: 7-8 [Full text]

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Reporting the frequenncy of Adverse Drug Reactions

robert christopher bracchi   (1 August 2004)

Reporting the frequenncy of Adverse Drug Reactions 1 August 2004
robert christopher bracchi, GP Tudor Gate Surgery, NP& 5DL Send response to journal: Re: Reporting the frequenncy of Adverse Drug Reactions	Dear Sir Loke has highlighted the importance of knowing the frequency of a side effect of a drug (1). In 1995 the Council for International Organisations of Medical Sciences (2) advised that drug companies should report adverse reactions in terms of frequency. I wrote to 120 drug companies in 1996 to see if they could do this and the majority (45 out of 46 replies ) felt that at that time they could not (3) I repeated my survey in 2002 and received 27 replies from 50 letters to drug companies. Twenty one of these companies stated that their current policy was to follow the guidelines. Seven of these companies stated that they could provide such information for new products only at present and would review older drugs at the time of licence renewal. Companies that could not follow the CIOMS guidelines stated that such information was at present unreliable due to under-reporting of adverse drug reactions and not knowing the number of patients taking the drugs in question. It appears that drug companies can now provide this information and drug information textbooks should now request and publish this information. 1. Loke Y K Assessing the benefit-harm balance at the bedside BMJ, Jul 2004; 329: 7 - 8. 2. Council for International Organisations of Medical Sciences. Guidelines for preparing core clinical safety information on drugs. Geneva: CIOMS, 1995 3. Bracchi R Drug Companies should report side effects in terms of frequency BMJ 1996;312:442. Competing interests: None declared