News Category: Regulatory news
The Health Products Regulatory Authority (HPRA) today expressed its concern at the significant increase in the number of illegal prescription medicines, intended for supply in Ireland, that were detained during 2017 and again warned the public of the risks that these unauthorised medicines pose to their health. The HPRA confirmed that its enforcement section detained some 948,915 dosage units (tablets, capsules, vials, etc.) of falsified and other illegal medicines last year as compared to 673,906 units in 2016 – an increase of more than 40%. The products detained in 2017, through both ongoing surveillance and targeted intelligence based operations, included anabolic steroids (47%), sedatives (23%) and erectile dysfunction medicines (13%). The HPRA confirms that the supply of these products into and within Ireland is illegal and stresses that consumers can have no guarantees about the safety or quality of prescription medicines they are seeking to buy outside of the regulated pharmacy setting.
The HPRA figures for 2017 highlight that:
- It was another year of significant increase in the volume of anabolic steroids being detained. 449,411 dosage units were detained in 2017, compared to 109,006 in 2016 and 38,049 in 2015;
- There was a further decrease in the number of sedative products detained; 222,470 last year compared to 271,545 in 2016 and 726,164 in 2015;
- The HPRA brought six prosecution cases in 2017 with a further six voluntary formal cautions issued during the year.
Commenting on the enforcement figures for 2017, John Lynch, Director of Compliance, HPRA said, “It is extremely concerning to see this year on year increase in detentions which indicates that people are continuing to put their health in the hands of individuals who operate unauthorised supply routes. We know from our investigations and prosecutions that those who seek to profit from illegal medicines have little regard for the health of the end users of the medicines they are supplying. It is of continuing concern that members of the public would use potent prescription medicines without medical supervision. We also know that there is absolutely no guarantee that these products contain the type or quantity of active ingredient that’s stated on the label. In some cases, they can contain different substances altogether which can have serious consequences for the health of those who use them.”
“The detention of close to one million dosage units of illegally supplied medicines in 2017 reflects our public health remit in preventing these illegal medicines from reaching Irish consumers and patients. Continued cooperation and intelligence sharing with our partners, both here in Ireland and abroad is central to achieving this. There is a significant inter-agency approach, both nationally, working with our colleagues from the Revenue Customs Service and An Garda Síochána, and internationally, including the Interpol co-ordinated Operation Pangea, in an all year round effort to detect and prevent the unauthorised flow of medicines, medical devices and other health products.”
“We are particularly concerned at the rate of increase in detentions of anabolic steroids which indicates a demand among some people for these highly potent prescription medicines. The abuse and misuse of anabolic steroids can have serious consequences for the long-term health of the individuals who take them. They have been linked to a range of significant side-effects including liver damage, blood clots, heart attacks and strokes. For men, the risks also include reduced sperm count and infertility. We would urge anyone using illegally sourced anabolic steroids to stop doing so and to seek advice from their healthcare professional if they have any concerns about their health.”
The HPRA also initiates prosecutions, particularly where it considers that there is a significant risk to public health. In 2017, six prosecution cases were initiated relating to the unauthorised supply of prescription medicines, including anabolic steroids and erectile dysfunction products. A further six voluntary formal cautions were issued while the HPRA also supported prosecutions brought by the Director of Public Prosecutions in relation to the illegal supply of prescription medicines.
To inform members of the public about the dangers associated with buying prescription medicines online, the HPRA has published an advice leaflet which is available freely on its website, www.hpra.ie.
ENDS
FOR FURTHER INFORMATION:
Weber Shandwick PR
Siobhan Molloy / Barry Ryan (086) 817 5066 / (01) 679 8600
ABOUT THE HEALTH PRODUCTS REGULATORY AUTHORITY:
The Health Products Regulatory Authority (HPRA) protects and enhances public and animal health by regulating medicines, medical devices and other health products. The products under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, organs for transplantation and cosmetics.
The HPRA works in partnership with Revenue Customs, An Garda Síochána, The Department of Agriculture, Food and the Marine, the Pharmaceutical Society of Ireland, Sport Ireland and the Food Safety Authority of Ireland, among others, at a national level and with other regulatory and law enforcement agencies worldwide, including Interpol, the EU Heads of Medicines Agencies Working Group of Enforcement Officers and the Permanent Forum on International Pharmaceutical Crime, in relation to the illegal manufacture, importation and distribution of medicines, medical devices, cosmetics and other health products.