Dáil Éireann Debate, Wednesday - 3 June 2020
694. Deputy John Lahart asked the Minister for Health the restrictions in place to prevent minors from purchasing paracetamol tablets in supermarkets and other retail units at self-service tills and other such checkouts; his plans to introduce measures to prevent the abuse of such purchasing; and if he will make a statement on the matter. [9337/20]
View answerThere is no prohibition, on age grounds, as regards the retail sale of paracetamol-containing products. The sale of medicines is governed by the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended, with specific provisions which apply exclusively to the sale of medicines that consist of, or contain, paracetamol. These regulations provide that paracetamol may only be supplied, without prescription, from pharmacies and non-pharmacy outlets, subject to certain restrictions on presentation and quantities that may be supplied.
Under European and Irish legislation, before a medicine can be placed on the Irish market, the manufacturer must seek an authorisation from the Health Products Regulatory Authority (HPRA), or in the case of certain medicinal products, the European Medicines Agency (EMA). Restrictions on the sale of medicines are based on their licensed indications and the indicated patient population, as contained in the summary of product characteristics (SmPC). The SmPC is a legal document that forms part of the authorisation for a medicine.
The HPRA is the competent authority for the regulation of medicines in Ireland and is responsible for determining the method of sale and supply of a medicine. The HPRA may determine the classification of a medicine as suitable for supply without prescription having regard to the maximum single dose of the product concerned, the maximum daily dose; the strength of the product; its pharmaceutical form; its packaging; or any other circumstances relating to its use as the HPRA may consider appropriate, for example, for a particular indication only.
In determining if a product should be classified as available on general sale in non-pharmacy outlets, the HPRA must have regard to the nature and purpose of the product and must be satisfied that the product concerned can, with reasonable safety, be sold other than under the supervision of a pharmacist. There is generally no prohibition, on age grounds, as regards the retail sale of medicines because the medicines are normally indicated for use in minors as well as adults.
However, in non-pharmacy outlets the pack sizes available are restricted under the legislation to:
- 12 or fewer dosage units, each of which contains more than 120mg of paracetamol but not more than 500mg of paracetamol
- 10 or fewer dosage units, each of which contains more than 500mg of paracetamol but not more than 600mg of paracetamol
In the case of a medicine intended for use in children under 6 years of age:
- Packs must contain 12 or fewer dosage units, each of which contains no more than 120mg of paracetamol
- Pack size of liquid forms should contain 60ml or less with no more than 120mg of paracetamol contained in 5ml
In addition to these requirements, a non-pharmacy retailer may only supply one pack of a paracetamol medicine per sales transaction.
In recent years the HPRA has highlighted to retailers the need to adhere to the legal requirements with respect to selling paracetamol and to ensure that all staff are aware of the restrictions that apply. The HPRA has published a Guidance Note on the Sale of Paracetamol-containing Medicinal Products by Non-pharmacy Retailers: www.hpra.ie/homepage/about-us/publications-forms/guidance-documents/item?id=60380826-9782-6eee-9b55-ff00008c97d0&t=/docs/default-source/publications-forms/guidance-documents/guidance-note-on-the-sale-of-paracetamol-containing-medicinal-products-by-non-pharmacy-retailers
and highlighted in particular the need for vigilance around the responsible selling of paracetamol-containing medicines. http://www.hpra.ie/homepage/medicines/regulatory-information/retailers
In accordance with the HPRA’s guidance retailers are advised to:
- Ensure all staff are aware that only one pack of a medicine containing paracetamol may be sold to a customer per transaction and that this is emphasised in all training for future new staff.
- Use signage to remind staff that only one pack of a medicine containing paracetamol can be sold per transaction.
- Identify all products that contain paracetamol and ensure restrictions are in place so that only one pack of a medicine containing paracetamol can be sold per transaction.
- Ensure that all staff are vigilant for customers attempting to purchase different brands of medicines containing paracetamol.
- Have an alert on the cash register to signal to staff that the product scanned contains paracetamol and, therefore, only one pack may be sold per transaction.
- Implement ‘a block’ at the cash register and self-service tills that does not allow two packs of medicines containing paracetamol to be scanned/sold in one transaction.
- Emphasise to staff that it is not acceptable to bypass the requirement by selling more than one pack to a single customer by carrying out a second, separate, transaction.
Any specific concerns about the sale of paracetamol products can be raised directly with the HPRA via reportacase@hpra.ie.
