Thank you for giving the National Pharmacy Association (NPA) the opportunity to comment on consultation letter ARM 30 on proposals to reclassify Cysticlear tablets from POM to P.

The NPA represents the interests of community pharmacies. We have, in voluntary membership, around 11,000 community pharmacies, which comprises the majority of the 12,000 pharmacies in the UK. The NPA provides a representative voice for its members as well as a range of services to help them with both commercial and professional aspects of running their businesses.

Rationale for reclassification

We agree that pharmacists are well placed to provide prompt treatment to patients suffering from cystitis. Community pharmacists already advise patients presenting with symptoms of cystitis on appropriate measures to manage their symptoms and will welcome the opportunity to be able to supply an effective treatment to treat patients promptly.

Self diagnosis

We are concerned about the requirement for a previous episode of uncomplicated cystitis to have been diagnosed by a doctor before a supply of Cysticlear can be made in the pharmacy. Pharmacists are able to supply existing treatments for the symptoms of cystitis to patients without a previous diagnosis being required. This requirement will delay effective treatment to patients who may have to wait, sometimes for one or two days, until they can see a GP. Pharmacists have for many years advised patients on the treatment of cystitis and if there is any doubt about the diagnosis of an uncomplicated UTI will refer patients to the GP.

Danger to health

Pharmacists already advise and counsel patients presenting with symptoms of cystitis as part of their existing practice. In addition, pharmacists already identify patients with alarm symptoms who require urgent referral to their GP. Therefore we believe that pharmacists will use their existing knowledge and experience, together with the customer questionnaire, to identify patients who may be suffering from another condition and these patients will be referred to their practitioner. Assessment of the patient will be in line with current medical guidance which does not require urinalysis to be performed in uncomplicated UTIs.

Resistance to trimethoprim

We believe that pharmacy availability is unlikely to affect resistance rates. Patients will be carefully assessed by pharmacists and in our opinion use of trimethoprim is unlikely to increase. The availability of trimethoprim through pharmacies will mean

that patients will receive treatment from their pharmacy instead of from their GP. Pharmacists will also help to minimise development of resistance by ensuring that patients only receive the product when appropriate and by careful counselling on the importance of completing the course. Availability of trimethoprim as a P product will ensure that patients can access an effective treatment promptly without enduring symptoms whilst waiting for a doctor’s appointment. This will also have implications for the NHS by reducing GP workload as has been demonstrated with existing minor ailment schemes and PGDs.

Pharmacy training

The NPA were consulted during the development of the training and support materials that will be provided to pharmacists and their staff. We believe that the questionnaire and training materials that will be provided will be useful to pharmacists and their staff and will aid the safe and effective use of this medicine.

The NPA welcomes extensions to the pharmacist’s armamentarium by expansion of the ‘Pharmacy’ only class with the proposed pharmacy availability of Cysticlear tablets. Therefore, the NPA supports this proposal.

8 August 2005