This article reviews the evidence on tamsulosin for benign prostatic hyperplasia (BPH) and considers whether its availability to be sold by pharmacists over the counter (OTC) to men aged 45–75 years confers any advantages. 

The review begins by looking at the background of BPH, including the symptoms, assessment and management of symptoms, with reference to the NICE guideline on managing men with lower urinary tract symptoms.  The article then discusses the efficacy of tamsulosin – a Cochrane review (14 RCTs; total n=3,418) found that tamsulosin (200-800mcg daily) provided a small to modest improvement in urinary symptom scale scores.  The weighted mean difference for the mean change in International Prostate Symptoms Score (IPSS; score from 0-35) from a baseline of 19.5 was −2.1 points (95% CI −3.4 to −0.9; based on two studies of 400mcg daily). The authors note that on average, men would have their IPSS reduced to around 17.4, which is still towards the top of the range of 8–19 defined as moderate severity.  They discuss reasons why the results from clinical trials cannot be easily extrapolated to primary care.  Adverse effects noted in the Cochrane review are then discussed.

In terms of the reclassification from a prescription-only to a Pharmacy medicine, the authors discuss the public consultation and issues raised/considered.  They go through the practice guidance issued by the RPSGB and note that it does not make clear that lifestyle advice is a first-line intervention, which could result in an overall emphasis on supplying tamsulosin for any man presenting with appropriate symptoms, leading to unnecessary treatment in some cases.  In terms of resupply, the CHM recommended that IPSS assessment should be performed at each visit to the pharmacy to help determine whether symptoms have improved with treatment and whether supply can be continued.  A worthwhile improvement is not however clearly defined in the RPSGB guidance.      

In their conclusion, the authors of the DTB review note that around half of men with lower urinary tract symptoms have no bladder outlet obstruction related to BPH.  They say that the OTC availability of tamsulosin might be seen as an advantage by some men who would not otherwise have consulted their GP and may draw more of them to seek healthcare sooner. “However, not all men with the symptoms will necessarily need, or want, drug treatment. We believe that the guidance for pharmacists does not place enough emphasis on offering lifestyle changes before OTC tamsulosin is considered. The drug's availability therefore could lead to unnecessary treatment. In our view, pharmacists should advise men to see their GP for a complete assessment of lower urinary tract symptoms to determine that OTC tamsulosin is appropriate before making a supply.”