AIMp Ltd

The Medicines and Healthcare products Regulatory Agency’s (MHRA) announcement today that cold and flu products containing the ingredients will remain available for sale over the counter from pharmacies is an opportunity for pharmacy to demonstrate it can confidently manage supply of these products and has been welcomed by the national pharmacy bodies including; the Royal Pharmaceutical Society of Great Britain (RPSGB), National Pharmacy Association (NPA), Company Chemists Association (CCA) and the Association of Independent Multiples (AIMp).

Community pharmacy has been given up to two years to demonstrate that sales of pseudoephedrine / ephedrine containing medicines can be properly controlled without the need for reclassification to prescription only status.

The MHRA has decided that the legal status of pseudoephedrine / ephedrine containing products should be reclassified from a Pharmacy (P) medicine to Prescription Only Medicine (POM) in July 2009, unless the misuse of these medicines in illicit manufacture is contained; or at any time before then should evidence emerge that misuse has not been contained.

Following a 16 week consultation the MHRA agreed that the intelligence picture on these medicines being used in the illicit manufacture of methylamphetamine in the UK is still limited and has advised that tighter pharmacy controls are considered to restrict the potential for widespread misuse.

The Commission on Human Medicines (CHM) has recommended a limit of one pack per sales transaction. The RPSGB advises that pharmacists should with immediate effect ensure that

sales are restricted to one pack per sales transaction.

The CHM has also made a recommendation to the pharmacy profession for personal sale of pseudoephedrine / ephedrine medicines by a pharmacist. The immediate issue of personal sales by pharmacist is being given urgent consideration by the RPSGB.

Pharmacy recording of sales and a requirement for customer identity to be checked have also been suggested and will be discussed in more detail by a CHM Expert Working Group set up to advise on the practical aspects of the measures proposed. The RPSGB plans to liaise with the other national pharmacy bodies and give further consideration to these issues.

Pharmacists also need to be aware that over the counter products will in due course be replaced by smaller packs containing up to 720mg of pseudoephedrine / ephedrine and larger packs will only be available on prescription.

Additional pharmacy controls proposed by the CHM relate to an awareness campaign for the pharmacy profession and other health care professionals and arrangements for sales tracking and monitoring.

In their response to the consultation process the pharmacy bodies presented a united front in arguing against the reclassification of these medicines.

Pharmacists are experts in medicines and are experienced in dealing with medicines liable to misuse. Allowing pharmacists and support staff to continue to manage the supply of pseudoephedrine and ephedrine containing medicines is good news for consumers and provides a clear signal of faith in the pharmacy profession.

In a joint statement the RPSGB, NPA, CCA and AIMp, said:

"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."

Pharmacists are urged pharmacists to continue with the voluntary measures that are supported by all pharmacy organisations by:

• Making pseudoephedrine / ephedrine medicines unavailable for self selection
• Limiting sales to one pack per transaction
• Increasing staff awareness of the problems associated with pseudoephedrine / ephedrine and crystal methamphetamine.

The RPSGB is currently looking in to the practicalities of implementing the controls suggested by the MHRA and training materials are being developed by the pharmacy bodies to help support the implementation of these changes within pharmacy.