The Pharmaceutical Journal
Vol 280 No 7502 p587
17 May 2008

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Manufacturers obliged to tell patients to report ADRs

Pharmaceutical companies are to be obliged to tell patients to report adverse reactions to their drugs as part of a revised voluntary code of practice for the industry that comes into effect on 1 July 2008. The current code only suggests that information included with medicines should direct patients who suffer adverse effects to the website of the national yellow card reporting system.

Drug companies have also been expected under the current code of practice developed by the Association of the British Pharmaceutical Industry to ask that patients inform the drug company as well if they suffer any side effects from their medication

But after 1 November 2008 all patient information produced by drug companies will have to stipulate that patients “should” report any adverse reactions to the yellow card system as well as to the pharmaceutical company.

The change in emphasis follows a request from the Medicines and Healthcare Products Regulatory Agency, a spokesman from the ABPI confirmed this week.