The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has a difficult job, given that it is meant to license all medications to ensure the public are using properly tested medications safely. But it is doing a difficult job increasingly badly.
Over the last few years it has made a number of decisions which seem neither fact-based nor helpful. One of these, in 2006, was the decision to allow manufacturers of homeopathic preparations to make health claims about their products, in spite of a lack of evidence. This seemed a rather dangerous precedent. We need strong evidence and information about medicines, and the MHRA should be upholding rigorous standards.
Then we have the move to make antibiotics for eye infections, themselves of questionable value, available from pharmacists without a doctors’ prescription. And now we have another: the decision to approve the purchase of tamsulosin, or Flomax, from a pharmacist, again without the need for a prescription.
The MHRA say that obtaining the drug, which is used to treat prostatic enlargement, will “encourage men to play a more active role in their healthcare”. I find this argument utterly patronising. I fail to see how going along to a pharmacist, who will do a questionnaire, supply two weeks worth of the drug, and then, after a further meeting, four weeks more, followed then by instructions to see a GP, improves anything at all.
The thing about benign prostatic hypertrophy is that it needs to be diagnosed. That means a discussion, an examination, and, possibly, referral for further tests. NICE are due to bring out guidelines next year: but here are some guidelines from the European Association of Urology, and the NHS Centre for Reviews and Dissemination, who say much the same.
The MHRA say that the questionnaire pharmacists will use has been “developed and validated by Boehringer Ingelheim” (the manufacturers of Flomax.) They also say that they have reduced the time a man can have the prescription for, without seeing a doctor, from 10 to six weeks after consultation. I find both these decisions questionable, and the petition for pharmacy-only prescribing from Boehringer is, I think, inconsistent. They point out that NHS guidance says cases of prostate cancer are no more frequent in men with mild prostate enlargement than the general population. But they ignore guidance saying that all men should have a rectal exam in making a diagnosis. For that is the key – diagnosis.
The move does not, in reality, improve access to healthcare. Nor is there any evidence that men will take more of a role in their healthcare because of this scheme. Instead, people may have to pay more money, make more visits to healthcare professionals, and have their disorder treated outwith the usual and recommended way to a diagnosis. If this is an advance for healthcare, I think it is a very sorry one.