Written answer
Pharmacy Services
Existing rules limit paracetamol pack sizes, quantities and transactions, while pharmacists must ensure safe use and prevent misuse. The Department is working with regulators and stakeholders through a suicide-prevention working group to promote compliance and assess whether further nationally consistent guidance or awareness measures are needed.
445. Deputy Colm Burke asked the Minister for Health whether consideration will be given to issuing clear and nationally consistent guidance to pharmacies and non-pharmacy retailers regarding the sale of paracetamol and other commonly available medicines to children and adolescents. [67824/26]
Comment on this
A range of legislative and regulatory measures are currently in place governing the sale and supply of paracetamol and other non-prescription medicines, including safeguards designed to promote safe use and reduce the risk of misuse.
The sale of medicines is governed by the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended. These regulations place specific restrictions on the sale of paracetamol-containing products, including limits on pack sizes and quantities that may be supplied. In pharmacies and non-pharmacy retailers, only one pack of a paracetamol medicine may be supplied per sales transaction.
The Pharmaceutical Society of Ireland (PSI), as the statutory regulator of pharmacists and pharmacies, has responsibility for regulating retail pharmacy businesses. Under the Regulation of Retail Pharmacy Businesses Regulations 2008, pharmacists must be satisfied, before the sale or supply of a non-prescription medicine, that the purchaser is aware of its appropriate use and that, insofar as the pharmacist is aware, the product is not intended for abuse or misuse.
To support compliance with these requirements, the PSI has issued guidance for pharmacists on the safe sale and supply of non-prescription medicines. Pharmacies are also required to comply with the legislative controls that apply to the supply of paracetamol and other medicines.
In relation to non-pharmacy retailers, the Health Products Regulatory Authority (HPRA) is responsible for determining whether a medicine is suitable for supply without prescription and, where appropriate, for sale through general retail outlets. The HPRA is also responsible for oversight of the relevant medicines legislation. Retailers selling paracetamol products are required to comply with the statutory restrictions that apply to their sale.
Under Connecting for Life, Ireland's national suicide prevention strategy, a multidisciplinary Working Group on Preventing Paracetamol-Related Intentional Drug Overdose has been established to support measures aimed at reducing access to medicines commonly used in intentional overdose. The Working Group includes representatives from the Department of Health, the HSE, the National Office for Suicide Prevention, the HPRA, the PSI, the Irish Pharmacy Union, the National Suicide Research Foundation and retail representative bodies. Its work includes promoting awareness of, and adherence to, the existing legislative requirements governing the sale of paracetamol.
Through this work, a number of communications and awareness initiatives have already been undertaken for pharmacy and retail staff to promote the safe sale of paracetamol. The Department will continue to work with the HPRA, PSI and other stakeholders to keep these measures under review and to consider whether any further guidance or awareness measures may be required.