CardiovascularTighter Controls On Cold And Flu Remedies Help Fight Against Class A Drugs
Cold and flu remedies containing pseudoephedrine and ephedrine will remain as pharmacy (P) medicines after tighter controls were found to minimise the misuse of these ingredients in the illegal manufacture of methylamphetamine (crystal meth).
Following a public consultation in 2007, the Commission on Human Medicines (CHM) advised that these medicines should only be available in the pharmacy in reduced pack sizes and with tighter controls on their sale.
The CHM advised these changes were to be introduced with the view to reclassifying them to prescription only (POM) status in 2009, unless the risk of misuse was contained.
A Medicines and Healthcare products Regulatory Agency (MHRA) review on the impact of the tighter controls revealed no new reports of the misuse of these drugs in the past year. Pharmacies have also seen a 25 per cent drop in the number of pseudoephedrine tablets or capsules being sold.
MHRA director of Vigilance and Risk Management of Medicines, Dr June Raine CBE, said she was pleased the measures taken had been successful in containing the risk of misuse and were helping to protect public health.
"The tighter controls we initiated with the full co-operation of pharmacies and manufacturers are proving successful in supporting the safe and effective use of these products, and provide an additional safeguard in the fight against crystal meth," she said.
"However, we cannot be complacent. The MHRA and its stakeholders will continue to monitor the situation to ensure these items are sold and supplied safely and for the correct purpose."
Notes
1. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
2. The CHM is a statutory body under the Medicines Act, with a duty to advise ministers on matters relating to human medicines.
Commission on Human Medicines
3. Methylamphetamine was rescheduled to a Class A drug on 18 January 2007 under the Misuse of Drugs Act 1971. Please refer to the Home Office for queries about methylamphetamine (crystal meth).
Home Office (external link)
4. In April 2008, following the CHM advice and public consultation, the legislation was amended to replace large packs of pseudoephedrine and ephedrine with smaller packs of 720mg (the equivalent of 12 tablets/capsules of 60mg pseudoephedrine or 24 tablets or capsules of 30mg). Additionally, a limit of one pack per customer per sales was introduced.
5. Other initiatives included a requirement for dedicated training for all pharmacy staff.
6. The monthly MHRA Drug Safety Update was launched in August 2007. It provides the latest official safety news about medicines to healthcare professionals.
Drug Safety Update
7. An online system at http://www.yellowcard.gov.uk makes it quicker and easier to report suspected side effects of medicines to the MHRA.
MHRA