Pfizer Limited Walton Oaks Dorking Road Walton-on-the-Hill Surrey. KT20 7NS

1.  Life is our life’s work. POM to P Potentially wide ranging regulatory changes have been proposed regarding the sale and provision of prescription only medicines (POM). In many cases it has been suggested that POM medicines could be reclassified as Pharmacy (P) medicines, i.e. those which can be purchased at a pharmacy following consultation with a qualified pharmacist. A number of key issues are raised by these proposed changes in medicines regulation. Pfizer strongly agrees with the idea of reclassification of medicines as a mechanism for improving access to medicines for patients. However, it is important to recognise that any POM to P reclassification is only one of many methods which could be employed to achieve this goal, and that the paramount consideration in any decision to reclassify a medicine must always be that of patient safety. It is interesting to note that many of the medicines viewed as potential candidates for a new P status are used in the treatment of chronic conditions, and many of these conditions were not considered suitable for treatment by supplementary prescribers. Furthermore, it is necessary to recognise the complexities involved in the appropriate selection of initial treatments for certain patients, even for acute conditions. Areas where Pfizer believe there is a need for real consideration are: Concordance – maintaining patient concordance for long term conditions is difficult, especially with asymptomatic conditions, and where a patient is expected to fund the cost of treatment themselves this will become even more of a challenge. In this respect it is difficult to determine with whom the responsibility of care would lie, patient or prescriber? Monitoring and Titration – many medicines require an individual dose titration and ongoing monitoring to ensure appropriate treatment doses and efficacy, which also means specialist management. As such, it may be more appropriate for this to remain the responsibility of the initial prescriber. Infrastructure – wherever an intervention is required there is also a need for suitable premises, equipment and staff. This raises questions over the present suitability of the facilities in many pharmacy stores. Adverse-Event Reporting – Where a patient is managing their own condition and medication there is a reduced likelihood of any adverse-events being reported. Pfizer believes that the reclassification of any medicine from a POM to P status must be based upon a case by case evaluation, and with patient safety as the paramount concern. Any decision is likely to be complex, and we firmly believe that the manufacturer of any candidate medicine must be willing to see their product reclassified and should be fully engaged in the decision making process. POMP - 0903 Pfizer Limited Walton Oaks Dorking Road Walton-on-the-Hill Surrey. KT20 7NS www.pfizer.co.uk policyuk@pfizer.com Tel: 01737 330478 Fax: 01737 332526 2001 2000 2003 AWARDED TO PFIZER LIMITED