Seizures of illegal medicines grew by almost 60 per cent last year despite the Covid-19 pandemic.
Officials detained 1,610,295 dosage units of fake and other illegal drugs last year, compared to 1,018,678 in 2019, according to the Health Products Regulatory Authority (HPRA).
Sedatives accounted for over one-third of the products seized, and erectile dysfunction medicines for 30 per cent. Significant quantities of analgesics and anabolic steroids were also seized.
In one Garda and Customs joint operation, more than 370,000 erectile dysfunction tablets were seized.
Some 8,043 enforcement cases were begun, compared to 6,167 in the previous year, according to the HPRA’s 2020 annual report.
The authority initiated three prosecution cases in situations when it considered there was a significant risk to public health, and it issued 11 formal cautions. All three prosecutions related to the unauthorised supply of anabolic steroids.
HPRA officials also forced changes or the shutdown of 482 websites, e-commerce listings and/or social media pages during the year. The sale of medicines online is illegal.
The authority monitors the sale of some consumer health products in grocery shops, health food shops and pharmacies. Last year, 21 investigations were conducted into the sale of medicines lacking a valid registration number or authorisation number for the Irish market. As a result, 32 medicines were removed from sale. One other case concerned non-compliance with the regulations on paracetamol.
In addition, the monitoring of websites, online marketplace advertisements and social media sites throughout the year resulted in the amendment or shutdown of 482 websites, e-commerce listings and/or social media pages.
In 2020, there were 7,752 reports of suspected adverse reactions associated with the use of human medicines, down 16 per cent on the previous year. Reports from healthcare staff and members of the public were up 19 per cent.
By far the biggest category of reports concerned “antineoplastic medicines”, which includes immune-modulating medicines, monoclonal antibodies and endocrine medicines.
Of the new adverse reaction reports received, 137 patients were reported to have died while on treatment. “In many of these cases, the patients concerned had significant underlying illness and were treated with multiple medicines and/or surgery, which may also have contributed to the outcome. In addition, many of these cases were influenced by disease progression or other complications unrelated to the medicine,” the report states.
The majority were associated with medicines used in the context of products subject to close monitoring, those used in the management of severe underlying medical conditions, in patient support programmes and special patient monitoring programmes.
During the year, 72 human medicines were recalled, down from 125 in 2019.
HPRA chief executive Dr Lorraine Nolan pointed out that the pandemic affected almost every facet of life, and necessitated an almost immediate response from scientists and regulators.
"The HPRA was an active participant in that response, both through our work at the European Medicines Agency and via our contribution to international efforts to co-ordinate and streamline regulatory processes and decision-making."