Pseudoephedrine and ephedrine: managing risk of misuse

Update on managing risk of misuse.

From:
Medicines and Healthcare products Regulatory Agency
Published
11 December 2014

Article date: September 2010

Pseudoephedrine and ephedrine are nasal decongestants in medicines available from pharmacies. Between 2007 and 2008, MHRA introduced restrictions because of concern that medicines containing these active substances can be used in the illicit manufacture of the Class A controlled drug methylamphetamine.

Sales restrictions

In April 2008, following consultation and advice from the Commission on Human Medicines (CHM), the following sales restrictions came into force and it became illegal to:

  • sell or supply any product that contains more than 720 mg pseudoephedrine or 180 mg ephedrine without a prescription
  • sell or supply a combination of products that between them add up to more than 720 mg pseudoephedrine or 180 mg ephedrine without a prescription
  • sell or supply a product that contains pseudoephedrine and a product that contains ephedrine in one transaction

The Royal Pharmaceutical Society of Great Britain advised that the sale and supply of these products must be made by a pharmacist or suitably trained pharmacy staff under the supervision of a pharmacist.

See Drug Safety Update October 2008.

Successful impact of restrictions—2010 update

CHM has continually reviewed the impact of these measures, which are helping to contain the potential problem of misuse (see Drug Safety Update, September 2009). Between July 2009 and July 2010, there have been no new reports of the misuse of these medicines (see Pseudoephedrine and ephedrine: Managing the risk of misuse of medicines - July 2010 update).

CHM commended the pharmacy profession for their significant contribution towards helping to keep the situation under control. It noted that implementation of the measures introduced to regulate sales, together with the additional voluntary actions overseen by the profession, had so far been effective. CHM recommended that the existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.

Article citation: Drug Safety Update Sept 2010, vol 4 issue 2: H1.

Published 11 December 2014
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