- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Ear, nose and throat and Respiratory disease and allergy
How to reduce risk of illicit use.
Article date: September 2009
Nasal decongestants that contain pseudoephedrine or ephedrine: risk of misuse
Pseudoephedrine and ephedrine are medicines used as nasal decongestants. There has been increasing concern that these active substances can be extracted from over-the-counter (OTC) medicines and used in the illegal manufacture of the Class A controlled drug methylamphetamine (crystal meth).
Action to minimise risk
In 2007, MHRA conducted a public consultation exercise on a proposal to reclassify OTC medicines containing pseudoephedrine or ephedrine to prescription only medicines (POM). After the consultation, the Commission on Human Medicines (CHM) advised that the pack size for OTC products containing pseudoephedrine or ephedrine should be restricted, and that there should be a restriction to one pack per sales transaction. CHM also advised that products containing pseudoephedrine or ephedrine should be reclassified from pharmacy (P) to POM in 2 years’ time (in July 2009) unless the risk of misuse in the illicit manufacture of methylamphetamine was contained.
A CHM Working Group on pseudoephedrine/ephedrine was also set up to advise CHM on the implementation of measures to minimise misuse of these medicines. The Working Group established links with pharmacy bodies (the Royal Pharmaceutical Society of Great Britain [RPSGB], the National Pharmacy Association, the Company Chemists Association); and with the Home Office, the Advisory Council on the Misuse of Drugs, the Association of Chief Police Officers, and the Serious Organised Crime Agency.
On April 1 2008, it became illegal to:
- to sell or supply any product that contains more than 720 mg pseudoephedrine or 180 mg ephedrine without a prescription
- 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
- to sell or supply a product that contains pseudoephedrine and a product that contains ephedrine in one transaction
The RPSGB issued professional guidance, advising that the sale and supply of products that contain pseudoephedrine or ephedrine must be made by a pharmacist or suitably trained pharmacy staff under the supervision of a pharmacist.
July 2009 review of impact of these measures
In July 2009, CHM considered a report from its Working Group on pseudoephedrine/ephedrine, which presented an update on the impact of the measures implemented to contain misuse of these medicines. CHM was asked to advise on whether small packs of medicines that contain pseudoephedrine or ephedrine should continue to be available as pharmacy medicines.
The report highlighted that following implementation pharmacies have seen a 25% drop in the number of pseudoephedrine tablets or capsules being sold. The report also showed that the pharmacy sector had taken steps to improve education and awareness of misuse.
The Advisory Council on the Misuse of Drugs, the Association of Chief Police Officers, and the Serious Organised Crime Agency supported the range of measures in place and considered that they were proportionate. The Advisory Council also noted no change in the scale of methylamphetamine misuse since 2007.
In light of the report, CHM agreed with its Working Group that medicines that contain pseudoephedrine or ephedrine may continue to be sold as pharmacy medicines, provided the measures put in place to contain misuse continue to be effective (see above).
CHM recommended that the present level of monitoring of misuse, education of pharmacists, and liaison with relevant bodies should be maintained. They also recommended that the Working Group be reconstituted to review the situation as necessary, and in any case on a yearly basis.
Advice for pharmacists
- note the legal position for the sale or supply of pseudoephedrine and ephedrine (see above)
- adhere to professional guidance from the RPSGB (as outlined above)
Article citation: Drug Safety Update Sept 2009, vol 3 issue 3: 5.