Warning on under-reporting of adverse reactions to drugs

Only one in 10 Irish GPs and even fewer hospital doctors are reporting the adverse side-effects of pharmaceuticals to the Irish…

Only one in 10 Irish GPs and even fewer hospital doctors are reporting the adverse side-effects of pharmaceuticals to the Irish Medicines Board (IMB) each year, an Oireachtas subcommittee heard yesterday, writes John Downes.

Research published in Australia this year has suggested that serious adverse drug reactions are detected in 50 per cent of new drugs after their approval for market following clinical trials, the health and children subcommittee was told.

Dr Orla O'Donovan, of the Department of Applied Social Studies at University College Cork, said the number of such adverse reactions reported to the IMB stood at 1,727 in 2004, of which 277 reports were submitted by GPs.

She noted that more than 2,500 GPs in the Republic prescribe to at least 100 people per week, many of whom receive more than one medicine. This indicated that one in 10 practitioners on average submit just one adverse reaction report a year. Assuming every report came from a different doctor, it was also estimated that fewer than 4 per cent of some 4,000 hospital doctors made one report per year, Dr O'Donovan added.

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"The under-reporting of adverse drug reactions poses a serious problem to ensuring the safety of medicines," she said in her presentation. "The moral obligations on health professionals to report adverse drug reactions needs to be emphasised."

Dr O'Donovan said the length of time it took for new products to be authorised by the IMB had decreased from a median of 73 weeks in 1999 to 34 weeks in 2004.

"Drug regulation policy in recent decades has witnessed measures that serve the commercial interests of the pharmaceutical industry [ eg speedy drug licensing] rising to the top of the policy agenda in a way that measures that protect public health did not," she said.

She also questioned the implications of drug companies such as Pfizer sponsoring school health education programmes.

Subcommittee chairman Paudge Connolly TD (Independent) said one possible way to incentivise doctors to report adverse drug reactions might be to offer financial payments.

This had proven effective in a previous pilot project, he said.