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The Codeine Regulations: A Bitter Pill to Swallow?

DATE: 23.06.2011


August 2010 saw the introduction of guidance by the Pharmaceutical Society of Ireland on ‘Non-Prescription Medicinal Products Containing Codeine’ (the “Guidance”).

The Guidance has been introduced to address safety concerns over the misuse of non-prescription medicinal products containing codeine. It warns of the risks of consumption of quantities in excess of the recommended dose or over a prolonged period of time, which can result in dependence on or tolerance of products containing codeine, withdrawal symptoms and other adverse effects.

The Guidance aims to ensure the safe supply of the products and to assist pharmacists, in discharging their legal and professional obligations.The key points of the Guidance

  1. Single ingredient products such as ibuprofen, paracetamol or aspirin should be used as ‘first line’ products, in accordance with pain protocols.
  2. Non-prescription products containing codeine may only be supplied by or under the personal supervision of a pharmacist.
  3. Codeine-containing medicinal products may be supplied as ‘second line’ products when single ingredient products have been ineffective and only when the pharmacist is satisfied, in his or her professional judgment, that such supply is the most appropriate therapy and is in the best interests of the patient.
  4. Where non-prescription products containing codeine are supplied, the patient must be fully advised of the correct use of the product and risks associated with misuse. They must be facilitated and encouraged to obtain medical assistance in relation to any such misuse.
  5. Non-prescription products containing codeine should only be supplied and used for periods no longer than three days, which is in accordance with the terms of the product’s marketing authorisation.
  6. Any patient who has the need to use codeine medicines for periods in excess of three days should be referred to a medical practitioner.
  7. Products containing codeine should be stored in an area under the direct control of the pharmacist out of view of the public.
  8. Pharmacists must ensure that there are appropriate policies and procedures within the retail pharmacy in relation to compliance with the guidelines.
  9. The advertising of codeine medicines is prohibited as are window displays in pharmacy promotions and promotional displays and leaflets.
  10. All suspected adverse reactions, as with all medicines, should be reported to the Irish Medicines Board. The Irish Times reported in September 2010 that some customers felt disgruntled at being faced with questions when attempting to buy non prescription medications containing codeine. Similarly, pharmacists have indicated that it has resulted in interruptions in the workflow preparing prescriptions.

A spokesperson for the Irish College of General Practitioners has suggested that patients will simply have to become used to being “quizzed as to what they are using it for”(1). (1).


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