Adverse reports about medical devices grew 25 per cent last year and have doubled over the past four years, according to the annual report of the Irish Medicines Board (IMB).
Orthopaedic implants and surgical equipment account for a large proportion of the vigilance reports received by the board, the 2012 annual report says. In particular, the ongoing problems associated with DePuy artificial hips and PIP breast implants have contributed to the rise in concerns reported to the IMB. The report says the consistent upward trend in the number of vigilance cases received is a result of greater clarity in reporting criteria, better communication between EU states and the IMB encouraging reporting on an ongoing basis.
Counterfeit
Although there was a slight drop in the amount of counterfeit and illegal drugs seized last year, the board says it remains concerned about the dangers posed by smuggling. Some 758,276 dosage units of counterfeit and illegal medicines were detained by enforcement officials last year, down from 762,641 units in 2011. There was a big rise in the amount of sedatives seized, up from 153,042 units in 2011 to 246,951 last year. The quantity of anabolic steroids seized fell slightly.
IMB chief executive Pat O’Mahony said the supply of prescription-only medicines through the internet was illegal and could pose a danger to the public.
Last year, there were over 2,700 suspected adverse reaction reports in relation to medicines, according to the report. This was roughly similar to previous years and almost 70 per cent of reports came from the pharmaceutical company marketing the product. Suspected adverse reaction to veterinary products were up 7 per cent to 244. Some 141 medicines were recalled to protect the health and safety of patients.
During the year, 11 prosecutions were taken for breach of medicinal legislation. The IMB also reports that 77 clinical trials began last year, an increase of 13 per cent and the first rise in five years.
