Stephen Mann


The Mann Consultancy


The reclassification of tamsulosin hydrochloride 0.4mg (Flomax Relief®) in the UK from prescription only medicine (POM) status to ‘P’ medicine (for sale under the supervision of a pharmacist) was announced in November 2009. This is the first time that a treatment for Benign Prostatic Hyperplasia (BPH), a chronic, progressive symptomatic condition, has been available for self care. This switch has important potential benefits for men’s health, both relating to BPH and other conditions that affect an aging population.

This approval also breaks new ground since it represents a model of ‘collaborative care’ between pharmacist and doctor never before seen in practice.  Specifically the doctor must see the patient to make a diagnosis and authorise continuation of self care with the drug. This new means for providing directed self medication might stimulate the fresh examination of some other chronic conditions for their self care potential. For the first time, the data which this reclassification relied upon, ostensibly from a study of the pharmacy supply model, have attracted 1 year of protection under European legislation.

This paper examines the innovative aspects of this development to stimulate debate on the possible implications, both positive and negative, for other potential switches. It may be that the very novelty of this self care model makes it a poor template for future switches in new indications.

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