The Pharmaceutical Journal
Vol 279 No 7481 p662
8 December 2007

Society summary

An occasional feature, prepared in the Royal Pharmaceutical Society’s Professional Standards Directorate, to highlight problems and inquiries currently being handled

Law and Ethics Bulletin, 2001 to present

• Update on sale and supply of pseudoephedrine and ephedrine containing medicines

• Change to the status of midazolam on 1 January 2008

Update on sale and supply of pseudoephedrine and ephedrine containing medicines

At its October 2007 meeting, the Council of the Royal Pharmaceutical Society discussed whether sales of medicines containing pseudoephedrine or ephedrine should be restricted to pharmacists only, following a recommendation by the Medicines and Healthcare products Regulatory Agency that sales of these medicines should only be made by a pharmacist.

The Council decided not to support the MHRA recommendation, but to issue the following guidance:

Pharmacists are reminded that the Society’s Code of Ethics for Pharmacists and Pharmacy Technicians states that they must ensure that individuals to whom tasks are delegated must be competent and fit to practise. Pharmacists must ensure that all staff involved in the sale or supply of over-the-counter medicines are trained, or are undertaking training relating to pseudoephedrine and ephedrine issues,¹ and are aware of situations where referral to the pharmacist may be necessary. If support staff have not been trained in pseudoephedrine and ephedrine awareness, personal sale by the pharmacist is recommended.

Following discussions with the Commission on Human Medicines (CHM) Expert Working Group, the Society advises that pharmacists review their written sale of medicines protocols. The written protocols should incorporate details of any medicines containing pseudoephedrine or ephedrine held in stock.² They should also make reference to criteria for referral of sales to the pharmacist.

Pharmacists and pharmacy staff should continue to be alert to unusual requests for any items or products containing pseudoephedrine or ephedrine and refuse to make a supply where there are reasonable grounds for suspecting misuse.

Requests for more than one product containing pseudoephedrine or ephedrine should have personal involvement from a pharmacist and supplies should only be made in exceptional circumstances.

Pharmacy medicines must not be accessible to the public for self-selection.

1. Training modules are available from www.MethguardUK.learnsomething.com and www.npa.co.uk/members.
2. A list of pseudoephedrine containing products is available online (Microsoft Word document) (7 March 2007).


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Change to the status of midazolam on 1 January 2008

Pharmacists are advised that on 1 January 2008, midazolam’s legal classification will change from its current status as a Schedule 4 Part I Controlled Drug to a Schedule 3 Controlled Drug.

Pharmacists should refer to p24 and pp36–37 of the “Medicines, Ethics and Practice: a guide for pharmacists and pharmacy technicians” (31st edition) for a summary of the legal requirements for Schedule 3 Controlled Drugs.

When it is reclassified, midazolam will be exempt from the requirements relating to safe custody, and will not legally require storage in a controlled drug cabinet meeting the requirements of legislation.

Midazolam will be the only Schedule 3 Controlled Drug that, in certain circumstances, can be included in a patient group direction (PGD). Under no other circumstances can any other Schedule 3 Controlled Drug be legally included in a PGD.