Thank you for giving the National Pharmacy Association (NPA) the opportunity to comment on consultation letter ARM 33 on proposals to reclassify Fluconazole 150mg capsules as a GSL product. The NPA does not support this proposal, as the organisation is not convinced that it can be used safely and effectively without the supervision of a healthcare professional.
Rationale for reclassification
The consultation states that vaginal candidiasis presents with easily recognisable symptoms. However in our view vaginal candidiasis is difficult to self-diagnose, as the symptoms are similar to other disorders such as bacterial vaginosis or genital herpes. In studies investigating the cause of recurrent vaginitis, presumed to be candidal by patients, candidal species were in fact isolated in only 16% of cases1.
Symptoms of vaginal discharge and vulval itching could be due to a sexually transmitted disease (STD) such as herpes simplex or gonococcal infection. Pharmacists and their staff can, as part of their public health role, inform patients about STDs such as chlamydia and refer patients as appropriate. This opportunity for intervention and distribution of the health education message regarding sexual health would be lost if fluconazole capsules were available from non-pharmacy outlets.
At present, fluconazole capsules are only available from pharmacies where staff are trained to ensure that the patient has been previously diagnosed with candidal vaginitis and to refer patients with alarming symptoms. Current guidance for pharmacists and their staff on advising on the treatment of vaginal candidiasis lists ten circumstances when the patient would be referred to the GP including pregnancy, patients aged under 16 or over 60, pain in the lower abdomen, the presence of vaginal sores or blisters, etc2. Results from a study of a minor ailment scheme has shown that 8% of patients presenting to the pharmacy for the treatment of vaginal thrush were referred to their practitioner3. If the product is purchased at non-pharmacy outlets the advice and guidance of pharmacists and their staff will not be immediately available to these patients.
Risk of misuse
The product will not be indicated for patients under 16 or over 60 years of age and is contraindicated in pregnancy. The consultation document states that counselling by a doctor or pharmacist is likely to reduce the risk of inappropriate risk. However if the product is available through non-pharmacy outlets then it is likely that patients will self medicate without seeking advice from a healthcare professional leading to inappropriate use of the product.
Specific GSL requirements
The consultation states that the advice of the CSM was that the use of the product should be restricted to women who have previously had thrush diagnosed by a doctor. However this does not appear to be reflected in the proposed patient information leaflet. We support the view that women suffering from thrush for the first time should discuss their symptoms with a
1Vulvovaginal candidiasis BMJ 2003;326:993-994
2 PJ Practice Checklist Vaginal Candidiasis produced by the Pharmaceutical Journal and the CPPE
3 Variation in the incidence, presentation and management of nine minor ailments in community pharmacy PJ Vol 266 p429
healthcare professional, such as a pharmacist, to ensure correct diagnosis and treatment. Due to the embarrassing and inconvenient nature of the symptoms it is likely that patients may decide to self medicate even if thrush has not been previously diagnosed by the doctor. We believe that even with clear pack warnings, without the supervision of pharmacy staff, it will be difficult to ensure that patients without a prior diagnosis do not purchase the product.
Safety profile
We believe that safety issues are of particular concern as this is a systemic product. Fluconazole has the potential to interact significantly with a number of drugs. The proposed patient information leaflet lists over twenty potential drug interactions and advises patients to consult their doctor or pharmacist. It will be difficult for patients to check such a long list particularly as some drugs are listed only as drug classes and not all individual drug names are included. Even if patients are prepared to check through such a long list before starting treatment they may not realise that their drug is included in a particular drug class and that there is a risk of an interaction. When the product is supplied in a pharmacy the pharmacist and their staff are able to advise patients on the risks of drug interactions with their other medication.
Fluconazole has serious systemic effects including risks of hepatic toxicity and prolongation of the QT interval. Without the input of the pharmacist patients with heart conditions who should avoid the product may risk serious adverse effects.
Convenience
Due to the wide distribution of pharmacies throughout the country, many of which have extended opening hours, we believe that convenience is not a relevant consideration for reclassification.
Advertising and Patient Information Labels and Leaflets
We do not support this proposal however if the application is approved we recommend that the product advertisements, labels and leaflets for Fluconazole 150mg capsules state that vaginal thrush must have been diagnosed by a healthcare professional and that further advice is available from the pharmacist.
We hope you take our comments on board.
October 2005
