Increase in reports to Irish Medicines Board about medicines ranging from antivirals to new drugs on the market
MORE THAN 3,200 reports of adverse reactions to drugs were made by patients, doctors and pharmacies to the Irish Medicines Board (IMB) last year. A small number resulted in a fatal outcome.
Figures released by the IMB yesterday show 3,276 suspected adverse reaction reports were lodged in 2009, up from 2,742 in 2008.
The increase can be accounted for by the introduction of the national swine flu vaccination programme last November, with more than 900 reports of suspected adverse reactions to the pandemic H1N1 vaccines lodged by the end of 2009.
Asked about the fatal outcomes which were linked to adverse drug reactions (ADRs), the IMB said: “It is not possible to be definitive in relation to the number of cases that resulted in a fatal outcome as some ADRs are also associated with other treatments and/or surgery, as well as the underlying illness and/or disease progression.”
There were also ADR reports in relation to a range of other medicines ranging from antivirals to new drugs on the market.
“Reports were frequently received in association with pandemic vaccines, childhood vaccines, and established medicines subject to specific monitoring requirements . . . reporting tends to be highest for newly authorised innovative medicines during the first one or two years on the market and then decreases over time as experience with the product is gained in real life clinical setting,” the IMB said.
Meanwhile, last year saw a 19 per cent increase in the number of investigations undertaken by the IMB into breaches of medicinal product legislation, including the illegal importation of prescription-only drugs bought online.
Some 3,729 such investigations were initiated and 494,502 tablets/capsules, 1,650 packs of liquids, 449 packs of creams and 3,582 packs of assorted products deemed to be unauthorised medicinal products were seized.
Among the tablets confiscated were 65,469 for treatment of erectile dysfunction.
All intended recipients were contacted to advise them that the supply of prescription-only medicines through mail order is illegal. All detained products were subsequently destroyed.
Other products seized included weight-loss and body-building substances. The majority of unauthorised medicinal products supplied into Ireland were found to have originated in India.
Pat O’Mahony, chief executive of the IMB, said his staff identified 1,009 websites seeking to supply medicinal products into Ireland illegally.
“All were reported to the appropriate authority LegitScript, which is a US organisation that facilitates the closing of rogue internet pharmacies,” he said.
At the end of 2009, LegitScript reported that it had shut down nearly 4,000 non-spam sites over the preceding year and acknowledged the IMB as one of the most frequent notifiers of such rogue sites.
The IMB strongly recommends that members of the public never purchase medicines online as it says there are no guarantees as to the safety, quality or effectiveness of them.
Meanwhile, Mr O’Mahony has been unanimously re-elected as chairman of the European Medicines Agency for a further three years.
The agency is the EU body responsible for co-ordinating the scientific resources available in the member states for the evaluation and supervision of medicinal products.