Reclassification Encourages Men To Play A More Active Role In Their Healthcare

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology
Article Date: 06 Dec 2009 - 0:00 PDT

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The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the approval of the first over-the-counter (OTC) medicine to treat the symptoms of benign prostatic hyperplasia (BPH) in men, to be available through pharmacies without a prescription.

An estimated one-in-four men over the age of 40 suffer from BPH, the progressive enlargement of the prostate gland. Symptoms include urinary hesitancy, weak stream, and frequent urination, including at night.

Tamsulosin capsules will be available to buy under the brand name Flomax Relief, for short-term use in men aged 45 to 75 following a consultation with a pharmacist.

Patients will need to obtain a GP diagnosis prior to longer-term use and annual check-ups are recommended thereafter.

MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine CBE, said: "BPH affects millions of men in the UK every year and while symptoms can have a significant impact on the quality of life of both the patient and their family, many men do not seek help from their doctor.

"Today's move to make tamsulosin more widely available under pharmacist supervision will empower men to play a more active role in their own healthcare.

"The MHRA is committed to improving access to over-the-counter medicines for self care where it is safe to do so, providing greater choice and access for the public."

Flomax Relief is expected to be available in pharmacies in Spring 2010.

Notes

1. Tamsulosin is an alpha receptor blocker which binds selectively to the type of alpha receptors which are present in the urinary tract, and which bring about relaxation of the muscle in the prostate and the urethra, allowing the bladder to empty more completely.

2. A pharmacy questionnaire will be used to screen for lower urinary tract symptoms in men. Flomax Relief will be supplied for men with troublesome symptoms, who will then be reviewed by the pharmacist following a two week treatment period. In the event of an improvement in urinary symptoms, a further supply of four weeks will take place. At each pharmacy visit, patients will be referred to their general practitioner if symptoms are not relieved or it is not safe for the patient to take tamsulosin for any reason. After six weeks, Flomax Relief will only be supplied if a doctor has carried out a clinical assessment of the patient to confirm that pharmacy supply continues to be suitable for them.

3. Tamsulosin will also continue to be available on prescription.

4. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

Source
Medicines and Healthcare products Regulatory Agency

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