Policy responses and statements

Name of organisation:
Medicines and Healthcare Products Regulatory Agency (MHRA)
Name of policy document:
ARM 56 - Request to reclassify Tamsulosin capsules (Flomax relief) from prescription only medicine (POM) to pharmacy availability (P)
Deadline for response:
15 January 2009

Background: Consultation ARM 56 seeks views on the reclassification from POM TO P of Tamsulosin Capsules (Flomax Relief).

This is a proposal for pharmacy availability for tamsulosin 0.4mg capsules for the treatment of functional symptoms of benign prostatic hyperplasia (BPH) in men over the age of 45 years.

The pharmacy model will involve an initial supply of tamsulosin for 2-10 weeks in response to a patient questionnaire. After 10 weeks tamsulosin will only be supplied if a doctor has confirmed the diagnosis of BPH. The patient may receive Flomax Relief for up to 12 months from the date of the initial doctor diagnosis, or subsequent annual review.


COMMENTS ON

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)

ARM 56 - REQUEST TO RECLASSIFY TAMSULOSIN CAPSULES (FLOMAX RELIEF) FROM PRESCRIPTION ONLY MEDICINE (POM) TO PHARMACY AVAILABILITY (P)

The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on ARM 56 - Request to reclassify Tamsulosin capsules (Flomax relief) from prescription only medicine (POM) to pharmacy availability (P).

The College has reviewed the proposal to reclassify Tamsulosin capsules (Flomax relief) from POM to P and, with the safeguards and recommendations proposed, we do not oppose this proposal. The College would like reassurance that there is a mechanism to monitor the pharmacists to ensure that the recommendations are followed and also that patients cannot attend different pharmacists to extend the period of treatment before they are required to see a physician.

 

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[14 January 2009]

 

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