Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

Consultation MLX 343: Proposals to make the sale and supply of products containing more than 720mg pseudoephedrine and 180mg ephedrine subject to a prescription

Deadline for response:

13 November 2007

Background: MLX 343 sought views on proposals to make the sale and supply of products containing more than 720mg of pseudoephedrine and 180mg ephedrine subject to a prescription, in the light of reports of misuse of these substances in the manufacture of the Class A controlled drug, methylamphetamine.

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

There has been increasing concern that pseudoephedrine and ephedrine are being extracted from OTC remedies relatively easily and used in the manufacture of methylamphetamine (commonly known "crystal meth" or "ice"). Methylamphetamine was reclassified on 18 January 2007 by the Home Office as a Class A controlled drug, based on the recommendation of the Advisory Council on the Misuse of Drugs. Methylamphetamine was reclassified to reflect the true harms of the drug when misused and as a preventative measure against escalation of misuse within the UK.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
Consultation MLX 343: Proposals to make the sale and supply of products containing more than 720mg pseudoephedrine and 180mg ephedrine subject to a prescription

The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on Consultation MLX 343.

This consultation is a follow up to Consultation MLX 337, which this College supported.  Its purpose was to reclassify ephedrine and pseudoephedrine from P to POM because of the risk that they could be purchased for the illicit manufacture of methylamphetamine.

This additional order is to restrict the amount of these compounds which can be sold in a pack to 720mg total content of pseudoephedrine, or 180mg of ephedrine.  In addition, there would be a restriction on sale of one pack per transaction.

The College wholeheartedly supports these restrictions.

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

[7 November 2007]