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The Pharmaceutical Journal
Vol 268 No 7198 p694-696
18 May 2002

Meetings and Conferences

European Society of Clinical Pharmacy summary

More adverse event reporting called for

More reporting of adverse drug events (ADEs) is needed, according to MARIE LINDQUIST, Uppsala monitoring centre (World Health Organization collaboration centre), Sweden.

Ms Lindquist suggested that feedback needed to be given to health professionals in order to increase the reporting rate. "This should not just be a 'Dear Doctor' letter but something relevant to the individual," she explained. This approach also applied to pharmacists and patients. "It would allow people to feel like part of a team rather than just being expected to make a report," Ms Lindquist added.

Health professionals also needed help in recognising or diagnosing an ADE and in how they should be dealt with, she said. Under-reporting of ADEs contributes to difficulty in diagnosing them and hence a vicious circle is formed.

Dr MARTIN MOZINA, head of the national pharmacovigilance centre, Slovenia, said that recent data indicated that almost 5 per cent of hospital admissions result from serious ADEs, so the expected number of ADE reports would be high. However, the actual number of reports is low indicating under-reporting.

Dr Mozina did not believe the problem behind this was a lack of knowledge or a lack of report forms. Instead, he suggested that it could be because of interpreting symptoms that are similar to those seen with some diseases.

"Professionals might know that something is seriously wrong but not know exactly what," he said.

New database Since December 2001, pharmacovigilance data has been exchanged using a new electronic database called EudraVigilance, said NOEL WATHION of the European Agency for the Evaluation of Medicinal Products (EMEA). Before, information was exchanged using paper mail.

The new system is accessible to all European regulators to collect, collate and analyse pharmacovigilance data. The next step will be to make it available to pharmaceutical companies.

The system will be expanded to include new member states of the European Union when the EU is enlarged, which is expected to happen in 2004. At some point, it will also be made available (with different levels of access) to health professionals and the public.