The MHRA have just announced that pseudoephedrine and ephedrine contained in nasal decongestants in cold and flu remedies are to have tighter controls. This follows a public consultation initiated by the MHRA as there has been an increasing concern about the potential for pseudoephedrine and ephedrine to be extracted from over-the-counter (OTC) medicines and used in the illegal manufacture of methylamphetamine (crystal meth).
Judy Viitanen and the PRimage team, along with many interested stakeholders from the pharmacy profession and OTC industry, have been awaiting this announcement from the MHRA. The MHRA news release is detailed below:
Nasal decongestants get new sales restrictions
The Medicines and Healthcare Products Regulatory Agency (MHRA) has announced today that pseudoephedrine and ephedrine contained in nasal decongestants in cold and flu remedies are to have tighter controls. This follows a public consultation initiated by the MHRA as there has been an increasing concern about the potential for pseudoephedrine and ephedrine to be extracted from over-the-counter (OTC) medicines and used in the illegal manufacture of methylamphetamine (crystal meth).
The MHRA received views from industry, other organisations and public bodies about the continuing availability of pseudoephedrine and ephedrine. The consultation ended on the 29 June 2007. The Commission on Human Medicines (CHM) considered the responses to the consultation and proposals from interested parties.
The Commission has recommended that large packs of pseudoephedrine and ephedrine will be replaced by smaller packs of 720mg (the equivalent of 12 tablets or capsules of 60 mg or 24 tablets or capsules of 30mg) and there will be a limit to one pack per customer. The Commission also recommended to the pharmacy professions that the sale should be carried out by a pharmacist.
An Expert Group of CHM is to be set up to advise on the practical aspects of the measures proposed. The impact of the strengthened pharmacy controls will be regularly monitored and evaluated by this group. The group will also carry out a full review of all decongestants in this class, looking at the effectiveness and potential safety concerns of these medicines and their alternatives.
The legal status of products containing pseudoephedrine and ephedrine should be reclassified from pharmacy only to prescription only (POM) in 24 months time (2009) or earlier if necessary, unless the risk of the misuse of these OTC medicines in the illicit manufacture of methylamphetamine is contained by the measures outlined.
Dr. June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA, said “The MHRA is introducing these measures to protect the public health following concern that was highlighted during the consultation process. All stakeholders will be working together to ensure the controls are effective. The Expert Group will be carrying out a continuous programme to monitor the situation.”
Watch this space for more analysis of comment and reaction from the pharmacy profession, manufacturers and the media …
Statement from pharmacy bodies:
As a specialist healthcare agency, with several pharmacy clients in its portfolio, PRimage was particularly heartened that the professional bodies representing pharmacy created a unified position in arguing against the reclassification of these medicines.
The profession appears to welcome today’s decision from the MHRA: its representative organisations – the Company Chemists’ Association (CCA), RPSGB, NPA and AIMp – have issued a joint response, saying:
“Pharmacy bodies are united on this issue, and will continue to work closely together to ensure the measures proposed enhance existing pharmacy controls. This outcome allows for more choice, convenience and better access to medicines for patients, and utilises the skills and expertise of pharmacists as experts in medicines. We ask for understanding from the public that while the restrictions may seem inconvenient, they are preferable to the alternative of restricting these medicines to prescription only.”
“We are pleased that the CHM has given pharmacy the chance to demonstrate its ability to control pseudoephedrine / ephedrine sales and involve pharmacy in addressing this important public health issue. But our performance will be monitored and the option to reclassify to prescription-only status is still open.”