Over 250 patient deaths from adverse reactions to medicines reported

More than 250 Irish patients died last year while on treatment with medicines where an adverse reaction had been reported, according to the annual report of the Health Products Regulatory Authority (HPRA).

The 252 patients who died included 109 who were on anti-cancer medicines and 44 who were on psycholeptic (calm-inducing) medicines.

The report says many of these patients had significant underlying illnesses and were treated with multiple medicines and/or surgery that may also have contributed to their deaths, or were cases influenced by disease progression or other complications unrelated to the medicine.

Last year saw big increases in the number of adverse reaction reports, product recalls and quality defects for medicines, and quality defects for veterinary products, the 2018 annual report shows.

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The number of adverse reaction reports received by the authority last year more than doubled, to 10,398. This is four times the level seen in 2015.

The report says the increase last year is largely accounted for by a new requirement to include non-serious reports of adverse reactions in addition to serious ones.

Anti-cancer drugs accounted for more than half of all adverse reaction reports, at 5,302. There were 295 adverse reaction reports about vaccines.

Recalls

Quality defects relating to 925 medicines were reported, up from 650 the previous year. Critical quality defects more than doubled, to 325.

There were 196 medicine recalls during 2018, a 73 per cent rise on the previous year. Lack of sterility assurance, and contamination issues, were the main reason for recalls.

Investigations of consumer health products being sold in grocery stores, health food shops and pharmacies resulted in 18 medicines being removed from sale, according to the report.

Seizures of falsified or other illegal medicines were down significantly; 619,213 dosage units in 2018 against 948,915 in 2017. The seized products included sedatives, erectile dysfunction drugs and anabolic steroids.

The number of quality defects identified in veterinary products rose two-fold, from 48 to 125.

The imminence of Brexit dominated much of the work of the authority during the year. "Regardless of the UK's exit from Europe, we are confident that our focus on preparedness will help us to effectively manage the potential impact on health product supply and availability," HPRA chief executive Dr Lorraine Nolan said.