Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

Public consultation MLX 337 - Proposals to restrict the availability of medicines containing pseudoephedrine and ephedrine by a change of legal status from pharmacy (P) to prescription only (POM) together with a restriction on pack size

Deadline for response:

29 June 2007

Background: MLX 337 seeks views on proposals to restrict the availability of medicines containing pseudoephedrine and ephedrine by a change of legal status from pharmacy availability (P) to prescription only medicine (POM), together with a restriction in pack size.  These proposals are being made in response to reports of misuse of these substances in the manufacture of the Class A controlled drug methylamphetamine (commonly known as "crystal meth").  This consultation follows the release of the International Narcotics Control Board Report 2006 on 1 March 2007.

Pseudoephedrine and ephedrine are nasal decongestants used either alone or in combination with analgesics or other active ingredients for the symptomatic relief of colds, flu and other similar conditions.  The majority of products are available as P medicines (available "over the counter" (OTC) in pharmacies), adn some are POM.  There are a range of pack sizes available covering solid dosage forms and liquid formulations.

There has been increasing concern from the Association of Chief Police Officers and the Serious Organised Crime Agency that pseudoephedrine and ephedrine can be extracted from OTC remedies relatively easily and used in the manufacture of methylamphetamine (commonly known as "crystal meth" or "ice").  Methylamphetamine is a highly addictive, potent stimulant which affects the central nervous system.  It can cause serious psychological and physical harm.  When smoked in its crystalline form it can produce effects similar to "crack cocaine" though considerably longer lasting.  Evidence also suggests that chronic use can lead to psychotic behaviour, characterised by paranoia and violent behaviour. 

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) PUBLIC CONSULTATION MLX 337 - PROPOSALS TO RESTRICT THE AVAILABILITY OF MEDICINES CONTAINING PSEUDOEPHEDRINE AND EPHEDRINE BY A CHANGE OF LEGAL STATUS FROM PHARMACY (P) TO PRESCRIPTION ONLY (POM) TOGETHER WITH A RESTRICTION ON PACK SIZE

The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on Public consultation MLX 337 - Proposals to restrict the availability of medicines containing pseudoephedrine and ephedrine by a change of legal status from pharmacy (P) to prescription only (POM) together with a restriction on pack size.

There appears to be general agreement that there is a significant risk of pseudoephedrine/ephedrine products being used to produce methylamphetamine and that the threat of methylamphetamine to society is a significant and increasing risk. There is therefore support for the proposal that pseudoephedrine/ephedrine containing products should be changed from P to POM. This means that patients for whom these drugs are considered to be necessary by their doctors can still have them prescribed. For other patients, replacement products are already available from pharmacy (P) prescribing. The College, therefore, supports this proposal.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[22 May 2007]