The Pharmacy Regulator's Guidance On The Sale Of Codeine Medicines - A Legal Perspective

Author:Mr Mark Ryan

Pharmacists will be all too aware of the Pharmacy Regulator's recent Guidance on the safe supply of non-prescription medicines containing codeine which took effect on 1st August.

The Guidance contains two requirements which, from a legal perspective, raise serious doubts regarding their validity and enforceability. The first of these is the requirement to store codeine medicines "out of the sight of the public". The second is the requirement that the sale of these products be conducted only by the pharmacist.

By all accounts, the implementation of the Guidance in pharmacies throughout the country is having a serious impact on pharmacy businesses. The fact that these products may not be displayed has resulted in a sharp fall in sales. Some pharmacies are reporting a drop of up to 50%. The requirement that the sale of these products be made only by pharmacists is increasing their workload and causing delays for patients. There have also been many accounts of patients who have felt humiliated in a very public way by a refusal to supply, which does nothing to create goodwill with patients.

I will leave it to others to argue the merits of whether the safety issues surrounding these products justify the requirements contained in the Guidance (which the Regulator has said will be strictly enforced against non-compliant pharmacists) and will consider the legal status of the Guidance itself. Suffice to say, however, that the safety of medicines is a matter for the Irish Medicines Board, and not for the Pharmacy Regulator, and it is also worth pointing out that the medicines the subject of the Guidance have been classified by the IMB by reference to their quality, safety and efficacy as available over-the counter, without prescription for at least 30 years.

It is important to note that the Pharmaceutical Society of Ireland not only has the power to draw up codes of conduct and guidance for pharmacists but the Pharmacy Act of 2007 which established the Society imposes a duty on it to do so. So also the Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008), which regulate how pharmacy businesses are to operate, provides that "[t]he Council of the Society may, with the prior approval of the Minister, publish detailed guidelines for the purpose of facilitating compliance with these Regulations."

However, it is equally important to stress that such codes of conduct, guidelines and other "soft law" documents of this nature have a...

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