- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Infectious disease and Respiratory disease and allergy
The Commission on Human Medicines recommend that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.
Article date: October 2012
Pseudoephedrine and ephedrine are medicines used as nasal decongestants, which are available from pharmacies. Between 2007 and 2008, we introduced restrictions on their use because of concern that medicines containing these active substances could be used in the illicit manufacture of the Class A controlled drug methylamphetamine.
Since April 2008, after public consultation and following advice from the Commission on Human Medicines (CHM), the following sales restrictions have been in place in the UK 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.
This information was first published in the October 2008 issue of Drug Safety Update.
The CHM has continually reviewed these measures and the impact on containing the potential problem of misuse (see Drug Safety Updates from September 2009, September 2010, and September 2011, and a Public Assessment Report published in July 2011.
Impact of restrictions: 2012 review
Between July 2011 and July 2012 there was one report in the UK of limited misuse, possibly linked to these medicines. The evidence suggests that the restrictions are continuing to help manage the risk of misuse. Further information is available in our report: Pseudoephedrine and ephedrine: Managing the risk of misuse of medicines - July 2012 review.
Implementation of measures to regulate sales, together with the additional voluntary actions overseen by the profession, has made an important contribution to managing the risk of misuse of pseudophedrine and ephedrine. The CHM recommended that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained. We thank the pharmacy profession for their substantial contribution to managing the risk of misuse of these products.
BNF section 3.10 Systemic nasal decongestants
Royal Pharmaceutical Society website Article citation: Drug Safety Update October 2012, vol 6, issue 3: H2