By Evelyn Ring
Adverse reactions to medicines reported to the Health Products Regulatory Authority more than doubled last year, it has emerged.
The number of reports – 10,398, represents a 138% increase on the 4,402 received last year and the HPRA said the increase was largely due to a change in reporting requirements.
The legal obligation for marketing authorisation holders to report all serious adverse reactions was extended in November 2017 to include “non-serious” reports.
Such reports will have initially been notified to the companies by healthcare professionals, patients or consumers.
There were 252 patients reported to have died while on treatment last year, compared to 262 in 2017. In many of the cases the patients had a significant underlying illness and were treated with multiple medicines and/or surgery that may have contributed to the outcome.
There were 376 new medicines authorised last year following an assessment of their safety, quality and effectiveness, compared to 684 in 2017.
During the year 100 clinical medicine trials were approved, up slightly on the 96 given the go-ahead in 2017.
The number of medicine recalls increased significantly last year to 196, compared to 82 in 2017, a 73% increase.
Most of the recalls (80) were made because of a lack of sterility assurance, followed by contamination issues (55).
Over the year the HPRA initiated 4,534 enforcement cases, compared to 3,866 in 2017.
There was a reduction in illegal medicines seized – 619,213 doses, compared to 984,915 in 2017.
Illegal products seized included sedatives (36%), erectile dysfunction medicines (18%) and anabolic steroids (16%).
There were 118 new veterinary medicines added to the record 1,800 now authorised for the Irish market last year.
The authority’s chief executive, Dr Lorraine Nolan, said 2017 was an “incredibly busy” year because of the need to prepare for Brexit.
“Given the central role of the UK regulators within the European network over many years, this has been a difficult and complex task on many levels,” she said.