Archive 2009
Consultation Document on Codeine Guidelines
December 21, 2009
The PSI (Pharmaceutical Society of Ireland), the pharmacy regulator, has published draft guidance for pharmacists on the safe supply of non-prescription medicinal products containing codeine.
Speaking at a briefing to outline the draft guidelines, PSI Registrar and CEO, Dr Ambrose McLoughlin formally announced a public consultation process and called for members of the public, healthcare professions and the wider health sector to make comments and submissions on the issues relating to pharmacy products containing codeine. “The safety concerns around the misuse of non-prescription medicinal products containing codeine are well established and this is an important medication safety issue. The Standards and Practice Committee of the PSI Council has developed this draft guidance with the aims of ensuring the safe supply and use of these medicines and assisting pharmacists in discharging their professional obligations to patients seeking advice, guidance or assistance in using these medicines.”
“This will ensure compliance with the new regulations under the Pharmacy Act 2007 and with the Code of Conduct for pharmacists which place the patient as the primary concern of a pharmacist. Once the consultation process is complete, pharmacists and pharmacies will be required to comply in full with the finalised guidance.”
Non-prescription medicines containing codeine are available in Ireland in pharmacies only. The draft guidance states that superintendent pharmacists must ensure that policies and procedures in the pharmacy or pharmacies under their control adhere to this guidance. The guidance also outlines that the regulations under the Pharmacy Act 2007 mean these medicines must not be accessible to the public for self-selection and therefore they must be stored in an area of the pharmacy where patients cannot self-select, either physically or visually.
Additionally, the guidance states these medicines must only be supplied by, or under the personal supervision of, a pharmacist. Codeine medicines should only be used when considered necessary and for the shortest period necessary. Patients should be advised of importance of adhering to the recommended dose and duration of use and should be informed of risks of developing tolerance and dependence. Patients should also be advised of added risks from ‘combination products’ – painkillers containing codeine and another drug such as paracetamol or ibuprofen - and should be counselled about other potential side effects.
The guidance also states that patients should be facilitated in obtaining medical assistance for any health problems related to misuse. The advertising of these medicines to the public is prohibited (as codeine is a controlled drug) – this includes window displays, in-pharmacy displays, shelf stickers and promotional leaflets.
This consultation is now closed.
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