Pseudoephedrine and ephedrine: regular review of minimising risk of misuse in the UK

Sales restrictions introduced in 2008 continue to be successful in managing the risk of misuse of pseudoephedrine and ephedrine.

Background

Pseudoephedrine and ephedrine are available from pharmacies as nasal decongestants. Between 2007 and 2008, we introduced restrictions on their sale because of concerns that medicines containing these active substances could be used in the illicit manufacture of the class A controlled drug methylamphetamine.

Sales restrictions

Since April 2008, after public consultation and following advice from the Commission on Human Medicines (CHM), the following sales restrictions have been in place to manage the risk of misuse of pseudoephedrine and ephedrine:

  • it is illegal to sell or supply any product that contains more than 720 mg pseudoephedrine or 180 mg ephedrine without a prescription

  • it is illegal to 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

  • it is illegal to sell or supply a product that contains pseudoephedrine and a product that contains ephedrine in one transaction

Furthermore, the Royal Pharmaceutical Society advises 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.

Continued monitoring

CHM and MHRA have regularly reviewed these measures and the impact on containing the potential problem of misuse (see Drug Safety Update October 2012, September 2015, and Public Assessment Report October 2015.

Impact of restrictions: 2017 review

Between April 2015 and July 2016, pharmacies continued to be vigilant about suspicious behaviour in relation to sales of medicines containing pseudoephedrine. One case of suspicious behaviour has been reported. We have also received reports of two small-scale methylamphetamine labs using pseudoephedrine medicines. These reports are not considered to reflect a wider concern.

The evidence suggests that the restrictions are successfully continuing to manage the risk of misuse. Further information is available in the June 2017 Public Assessment Report.

The measures to regulate sales, together with additional vigilance by pharmacists, remain in force.

Further information

Pseudoephedrine and ephedrine: regular review of minimising the risk of misuse in the UK – MHRA UK Public Assessment Report – June 2017

Pseudoephedrine and ephedrine: Look, Listen and Report your suspicions; a quick reference guide

Article citation: Drug Safety Update volume 10 issue 11, June 2017: 3.

Published 21 June 2017