Healthy Skepticism Library item: 14709

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Boehringer Ingelheim - Flomax: going with the flow?
PharmaGossip 2008 Nov 28
http://pharmagossip.blogspot.com/2008/11/boehringer-ingelheim-flomax-going-with.html

Full text:

The UK looks set to be the first country in the world to switch Boehringer Ingelheim’s Flomax to non-prescription status for treating benign prostatic hyperplasia (BPH).

The Medicines and Healthcare products Regulatory Agency (MHRA) has just started a public consultation on a proposal to switch Flomax (0.4mg tamsulosin hydrochloride) from prescription-only to pharmacy (POM-to-P) status.

According to consultation document ARM 56, the P medicine would be available to men over the age of 45 years under the brand name Flomax Relief. The daily dose would be one capsule, to be taken after the same meal each day.

The pharmacy model outlined here will involve a 14-day “starter” supply of Flomax Relief following completion of a “customer-symptoms questionnaire”. This will assess the duration and severity of the man’s symptoms and rule out any “red flag conditions”, such as pain on urination, blood in urine, cloudy urine, fever or excessive thirst.

Following a second consultation, pharmacists will be able to supply 28-day packs. After 10 weeks, however, Flomax Relief will only be supplied if a doctor has confirmed the diagnosis of BPH.

The pharmacy model allows Flomax Relief to be supplied for up to 12 months from the date of the initial doctor diagnosis or subsequent annual review.