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Consultation ARM 56 sought your views on the reclassification from POM to P of tamsulosin capsules (Flomax Relief).
A total of 31 responses to the consultation were received, of which seven organisations were in favour (total nine favourable responses) while seven organisations were not (total 17 non-favourable responses); two raised issues but expressed no definitive views, while three had no comment.
Those in favour considered wider availability of tamsulosin represents a considerable public benefit for the vast majority of the men who suffer from benign prostatic hyperplasia (BPH) but do not currently receive any positive treatment. Wider availability of treatment will enable more men to benefit from treatment, and access from a pharmacist is generally considered to be less threatening than a visit to a GP. It will also encourage men to take greater involvement in their own healthcare.
The pharmacy protocol will help avoid inappropriate sale to anyone who does not meet the treatment criteria and, where necessary, men will be referred to their GP for earlier investigation. A limit of six weeks initial treatment will ensure that patients receive the benefit of GP scrutiny within a short period of starting treatment.
Pharmacy availability of tamsulosin supports self-care. Pharmacies are conveniently located and have more flexible opening hours, including at weekends. Pharmacists are accustomed to dealing with patients who wish to discuss sensitive, confidential issues or symptoms.
Organisations supporting the reclassification
These included:
- medical colleges – Royal College of Physicians of Edinburgh
- pharmacy organisations – Royal Pharmaceutical Society of Great Britain, Pharmaceutical Society of Northern Ireland, National Pharmacy Association, Company Chemists Association and other representative organisations
- nursing organisations – Nursing and Midwifery Council, British Association of Urology Nurses.
Organisations not supporting the reclassification
These included:
- The British Medical Association, The Royal College of General Practitioners, The British Association of Urological Surgeons and other representative organisations.
Those raising issues but not expressing a definitive view included the Royal College of Ophthalmologists.
A number of issues were raised by respondents in relation to aspects of the pharmacy provision, including the need for a diagnosis of BPH before commencing treatment with tamsulosin, misdiagnosis and delay in diagnosing cancer of the prostate, the risks for those having cataract surgery, concern about the safety of tamsulosin when taken with anti-hypertensive drugs and a missed opportunity for 'watchful waiting' rather than use of medication.
Copies of the responses (excluding those marked as 'in confidence') are available below.
The following table summarises how pharmaceutical bodies, medical bodies and others responded to the consultation.
| Professional pharmaceutical societies, individual pharmacists, prescribing advisers and other pharmaceutical bodies |
|---|
|
Yes to reclassification |
|
No comment |
|
No to reclassification
|
| Medical profession and royal colleges |
|---|
|
Yes to reclassification |
|
Yes to reclassification but issues raised |
|
No comment |
|
No definitive views on proposal |
|
No to proposal
|
| Patient groups, consumer groups, charities and members of the public |
|---|
|
No to proposal
|
