Dáil Éireann Debate, Wednesday - 9 February 2022
157. Deputy Marian Harkin asked the Minister for Health if he will consider updating the current regulations in order that painkillers containing addictive substances, such a codeine, would be regulated and not available for sale over the counter without a doctor’s prescription; and if he will make a statement on the matter. [6954/22]
View answerCodeine is a mild to moderate opioid (narcotic) analgesic which, due to its potential for misuse, is a controlled drug under the Misuse of Drugs legislation.
As an analgesic, codeine is most often used in combination with other analgesics such as paracetamol or ibuprofen and is currently authorised in Ireland in such non-prescription products for pain relief. It is also available in single ingredient, non-prescription products, as a cough suppressant. These authorised products are available without a prescription through retail pharmacy businesses (pharmacies) only.
The Pharmacy Act 2007 and the Regulation of Retail Pharmacy Businesses Regulations 2008 require that all medicines supplied through a pharmacy must be supplied by or under the personal supervision of a pharmacist and that all non-prescription medicines supplied must be the subject of appropriate counselling.
The pharmacy regulator, the Pharmaceutical Society of Ireland (PSI), issued guidance to pharmacists in 2010 on the safe supply of non-prescription products containing codeine. This guidance was updated in 2015, 2017 and most recently in October 2019. The Guidance covers the requirements set out above and, in addition, contains further restrictions which apply to the supply of codeine-based products.
These restrictions include a requirement that codeine-based products are not available to the public for self-selection and should only be supplied when a pharmacist deems such a supply to be necessary and only when a non-opioid analgesic, e.g. paracetamol, aspirin or ibuprofen, has not proven sufficient to relieve the patient’s symptoms. The guidance also states that codeine medicines should be used for the shortest time possible and for no longer than three days without medical supervision. Pharmacists must also ensure that patients are advised of the importance of adhering to the recommended dosage and duration of use, as well as the risks associated with overdose and/or prolonged use. Patients should also be counselled in respect of potential adverse reactions or side effects.
The full guidance document, along with information on current legislative requirements, is available on the PSI website: thepsi.ie/Libraries/Folder_Pharmacy_Practice_Guidance/01_3_Safe_supply_of_Codeine_to_patients.sflb.ashx.
