BMJ  2004;329:E320 (11 September), doi:10.1136/bmj.329.7466.E320

BMJ USA: Letter

Letter

RAPID RESPONSES FROM BMJ.COM

Following is an edited excerpt from a Rapid Response generated by this editorial. It can be read in its entirety at http://bmj.bmjjournals.com/cgi/eletters/329/7456/7.—Editor

Loke has highlighted the importance of knowing the frequency of a side effect of a drug. In 1995 the Council for International Organizations of Medical Sciences (CIOMS)¹ 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) [indicated] that at that time they could not.² 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 license 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.

Monmouthshire, UK

References

1. Council for International Organizations of Medical Sciences. Guidelines for preparing core clinical safety information on drugs. Geneva: CIOMS, 1995.
2. Bracchi R. Drug Companies should report side effects in terms of frequency. BMJ 1996;312: 442.[Free Full Text]

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