Dáil Éireann Debate, Thursday - 20 April 2023
27. Deputy Duncan Smith asked the Minister for Health his views on reports his Department is seeking to change access to codeine-based medicines from over the counter to prescription supply; and if he will make a statement on the matter. [18477/23]
Amharc ar fhreagraAs a painkiller codeine is most often used in combination with other analgesics such as paracetamol or ibuprofen. But there is a potential for misuse. Codeine is therefore a controlled drug under the Misuse of Drugs Acts 1977 and 1984.
Low dose preparations are regulated as a Schedule 5 controlled drug. Medicinal products that contain low doses of codeine are available without a medical prescription but only though a pharmacy.
The PSI, as the pharmacy regulator, has extensive guidance in place for retail pharmacy businesses on the supply and sale of these products.
Any potential change to the prescription requirements for codeine containing medicinal products must be supported by sufficient evidence.
The Health Products Regulatory Authority are the competent authority for medicines in Ireland. They are currently conducting an independent review examining the method of sale and supply of codeine-containing medications.
Once this review is completed, my officials will engage with the HPRA and other stakeholder to assess the recommendations made. This assessment will include the recent recommendations from the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC). There will be full consideration given to any policy changes that may be required regarding the regulation of codeine-containing medicinal products.
