LONDON, August 29 /PRNewswire/ --     The Medicines and Healthcare products Regulatory Agency's (MHRA)
announcement today that cold and flu products containing pseudoephedrine /
ephedrine 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. This 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 / 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 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.

Notes to Editors:

More information on the MHRA consultation MLX 337 to reclassify ephedrine
and pseudoephedrine containing medicines can be found on the MHRA's website
http://www.mhra.gov.uk under 'Publications' and then 'Consultations'.

The Royal Pharmaceutical Society of Great Britain (RPSGB) is the
regulatory and professional body for pharmacists in England, Scotland and
Wales. The primary objective of the RPSGB is to lead, regulate and develop
the pharmacy profession.

The National Pharmacy Association (NPA) was established in 1921 as the
trade association of community pharmacy owners. To reflect the changes in the
pharmacy environment the NPA now extends membership and its associated
benefits to all members of the community pharmacy infrastructure.

The Company Chemists Association (CCA) provides a forum for the major
businesses engaged in community pharmacy to work together to help create an
environment where community pharmacy can flourish, and where pharmacy
contractors compete in a fair and equitable way. The CCA's nine member
companies are: Alliance Boots, Co-operative Group Pharmacy, Lloydspharmacy,
Tesco, J Sainsbury, Wm Morrison Supermarkets, Asda Wal-Mart, Rowlands
Pharmacy and Superdrug. Between them they own over 6,000 pharmacies,
representing over 45% of the pharmacies in the United Kingdom.

The Association of Independent Multiples (AIMp) has over 1200 pharmacies
in membership and represents the interests of the independent multiple
sector. Its members have between 5 to 300 shops, and include: Day Lewis,
Co-op Healthcare, HI Weldricks and PCT Healthcare.