The Pharmaceutical Journal
Vol 280 No 7495 p377
29 March 2008

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

•  Restriction on sale of pseudoephedrine and ephedrine products
•  Prescribing of Controlled Drugs by pharmacist and nurse independent prescribers

Restriction on sale of pseudoephedrine and ephedrine products

From 1 April it will be unlawful to sell or supply a product or products containing more than 720mg of pseudoephedrine salts or more than 180mg ephedrine base (or salts) to a person at one time (ie, in one transaction). Sale or supply in such cases will require a prescription.

Provided the total amount supplied does not exceed the above limit, sale or supply without a prescription may be of more than one product containing only one of these substances. However, it will be unlawful to sell or supply a pseudoephedrine product at the same time as an ephedrine product in one transaction.

This supply restriction is similar to that placed on other medicines, such as aspirin and paracetamol preparations, where the quantity that may lawfully be sold or supplied without a prescription is restricted.

This action was taken because of the concern that pseudoephedrine and ephedrine can be used in the illicit production of methylamphetamine.

Pharmacists and their staff must be alert to requests for large quantities and abnormally frequent requests and refuse to make a supply where there are reasonable grounds for suspecting misuse.

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Prescribing of Controlled Drugs by pharmacist and nurse independent prescribers

On 1 April 2008 an amendment to the Prescription Only Medicines (Human Use) Order 1997 will come into force. It goes part way to enable pharmacist independent prescribers to prescribe Controlled Drugs. The amendment also paves the way for the removal of the restriction on the Controlled Drugs that a nurse independent prescriber may prescribe. However, allowing pharmacist independent prescribers and nurse independent prescribers to prescribe an unrestricted range of Schedule 2, 3, 4 and 5 Controlled Drugs requires a change to the Misuse of Drugs Regulations 2001, which will not be in place by 1 April.

Until the Misuse of Drugs Regulations 2001 are amended pharmacist independent prescribers will not be able to prescribe Controlled Drugs. Nurse independent prescribers will continue to be limited to the range of Controlled Drugs they can currently prescribe for particular indications.

A Law and Ethics Bulletin will be published to inform pharmacists when the Misuse of Drugs Regulations 2001 are amended. Further guidance will be issued at that time.
Supplementary prescribers can still prescribe all Controlled Drugs as long as they are part of an agreed clinical management plan and the supplementary prescriber is working within his or her level of competence.