drugs over the counter, but is your chemist putting your life at risk?

The glossy posters are lining the pharmacy windows, the witty TV advertising campaign is in full swing and, if all goes to plan, in the weeks and months to come thousands of middle-aged men will be popping along to their pharmacist to buy Flomax MR, an over-the-counter relief for their lower urinary tract problems - a weak bladder to you and me.
But this is no government-backed health campaign aiming to reach a segment of the population which is notoriously slow at asking for medical help.
This £5 million marketing campaign is the brainchild of a pharmaceutical company trying to sell their drug.
Tamsulosin, the active ingredient in Flomax MR, has been used successfully for many years as a first-line treatment to alleviate the symptoms of a very common condition called benign prostatic hyperplasia, which affects around one in four men over the age of 40, and occurs when an enlarged prostate presses on the bladder, obstructing urine flow.
The drug works by relaxing the muscles in the bladder and around the prostate so that the urine can flow more freely.
But now, instead of having to visit a GP, who may decide that his symptoms warrant further investigation for conditions such as prostate cancer, someone suffering from symptoms of benign prostatic hyperplasia will be able to visit a pharmacy.
The pharmacist will make the decision as to whether or not to provide the drug for an initial period of two weeks, followed by another four weeks' supply.
This reclassification means that Britain is the first country in the world to allow Tamsulosin to be sold over-the-counter.
It is also one in a long line of nearly 100 drugs that were once available only by visiting the GP, but can now be bought over-the-counter after consultation with a pharmacist.
But while the government is pushing the move to make drugs available without a visit to your doctor as part of their Self-care Agenda - that is, encouraging people to take responsibility for their own health - other parties are more concerned.
Where once drugs for mild conditions such as fungal infections and joint pains were being deregulated, the list now includes drugs that are treating more serious conditions - with more serious consequences for misuse. 
In the last year alone, drugs for for the relief of nausea and vomiting, itching skin and dermatitis, gastric ulcers and most recently Tranexamic acid, which relieves period pain, have all been downgraded from prescription to over-the-counter.
While the government is pushing the move to make drugs available without a visit to your doctor as part of their Self-care Agenda, other parties are more concerned
But while we all turn to our friendly pharmacist for remedies like asprin and antacids, using them as the first port of call for our minor family ailments, have the scales tipped too far?
Would you really trust your pharmacist to diagnose you and prescribe pills - without a trip to your GP?
Not surprisingly, many medical experts say we shouldn't.
'It is one thing to sell a product over-thecounter that treats an ongoing condition that has been previously diagnosed by a GP,' explains Dr Bill Beeby, chair of the clinical prescribing committee of the GPs' committee of the British Medical Association.
'However, it is very difficult thing to expect the pharmacist to diagnose a condition from scratch, on a stranger for whom he has no medical notes or records.
'Many pharmacists will have excellent diagnostic skills. Others may not. GPs spend ten years learning diagnostic skills before they are let loose on the general public,' Dr Beeby continues.
'Another concern is that there is no formal record kept of their medication and no follow-up procedure in place should the patient not go back to the pharmacist.
'And there is nothing to stop the patient from leaving one pharmacist after six weeks and then going to another one and starting the whole process again.
'As a GP I certainly have reservations which I know are shared by many of my colleagues about the reclassification of certain drugs and we need to be watching very carefully to ensure that selling these drugs over-the-counter does not result in harm for patients.'
While we all turn to our pharmacist for remedies like asprin, using them as the first port of call for our minor family ailments, have the scales tipped too far?
While we all turn to our pharmacist for remedies like asprin, using them as the first port of call for our minor family ailments, have the scales tipped too far?
Despite such reservations, the Medicines and healthcare products Regulatory Agency, which is in charge of deciding which drugs can be de-classified, i.e. made available over-the-counter, is proceeding apace.
Last week, Tranexamic acid, a previously prescription-only drug used for period pain relief, was approved for over-the-counter sales under the trade name Cyklo-f.
The move was described as 'an important step for women, helping improve their quality of life and provide them with the greater convenience of better access to medicines'.
But speak to a consultant gynaecologist and you get a different perspective.
'I feel very uneasy about this particular declassification,' says Dr Peter Barton-Smith of the London Clinic and the royal Surrey County Hospital.
'Tranexamic Acid works by increasing clotting in the blood. Therefore, whoever issues it has to be very certain of the patient's family history and personal medical history - otherwise you could be putting a patient at risk of blood clots such as DVTs,' Dr Barton-Smith continues.
'GPs tend to prescribe it as stop-gap treatment until they can refer their patient on to a consultant, or settle their periods with the contraceptive pill.
Up until now Britain has had what is widely recognised one of the most rigorous drug classification processes in the world
'But my main cause for concern is that heavy periods can be a symptom of all sorts of problems, which should really be checked out by a specialist as soon as possible.
Women over 35 have an increased risk of endemetrial cancer or she could be suffering from uterine fibroids.
'This particular drug has potentially significant side-effects, it can mask other conditions and its use should be monitored by a medical professional, not handed out over-the-counter without any record of use or follow-up care.'
Tamsulosin breaks new ground in that pharmacists will be diagnosing symptoms of benign prostatic hyperplasia themselves, using guidance notes from the drug company.
Although these notes are extensive and designed to reduce the risk of misdiagnosis, Dr Beeby is concerned that what is essentially 'flow- chart' medicine, may delay a diagnosis of a more serious condition.
'Some of the symptoms for the benign condition, BPH, are similar to symptoms for prostate cancer,' explains Dr Beeby.
'But the pharmacist is not able to carry out a rectal examination or order a PSA test. Probably the vast majority of people who come through the door will be fine.
'But a minority may have a more serious problem and there is a risk they could not receive treatment as quickly as they may have if they had gone directly to their GP.'
Steve field, Chairman of the royal College of GPs, agrees. 'This trend to deregulate significant-drugs such as Tamsulosin does worry me,' he says.
'Pharmacists definitely have a growing role in the provision of healthcare to patients and no one would dispute that.
Now, instead of having to visit a GP, someone suffering from symptoms of benign prostatic hyperplasia will be able to visit a pharmacy
Now, instead of having to visit a GP, someone suffering from symptoms of benign prostatic hyperplasia will be able to visit a pharmacy
'If we are expecting them to make a diagnosis and issue drugs such as Tamsulosin, we need to ensure that we have extremely strict protocols in place. This could include the GP being informed of the drug issue and follow-up procedures with the patient.'
He adds: 'In the very long-term, it could mean the sharing of patient medical information between the GP and the pharmacist but there are a lot of hurdles to cross before that happens.
'I think all of us should be proceeding with drug declassification with the utmost caution.'
In return, the MHRA and drug company argues that all the research shows that many of these men are actually currently not going to their GPs with this problem anyway, and therefore pharmacists are, at the very least, providing some healthcare intervention for this group of patients
'Figures show that up to 89 per cent of men with lower urinary tract symptoms have not visited their GPs because they were either embarrassed, or they thought it was a part of ageing that they had to accept, or that it was simply too much trouble to get an appointment,' says Kate Evans, from the pharmaceutical manufacturers, Boehringer Ingelheim.
'We are running and funding a huge awareness campaign through the media which is telling men about the condition, demystifying it and encouraging-them to seek help, and also giving-them information via our website.
'The campaign launched on March 31, and within four days we had more than 10,500 hits on our website. That's 10,500 men who have more knowledge about their condition than they did a week before.
'And yes, of course we hope that some of those men may come into the pharmacist and ask for the product. But if they don't, and go to their GP instead, it still means that they have got help earlier than they would have otherwise done.'
Perhaps not surprisingly, the pharmacists are also welcoming the new era of 'greater patient choice'.
'Fifteen years ago, if you had a bad toothache you couldn't get Ibruprofen over-the-counter, or buy a decent cold sore remedy,' says Howard Duff, Director for England at the Royal Pharmaceutical Society of Great Britain, which is one of the advisers in the declassification process.
'The regulations were so strict it was ridiculous and it meant that people were denied choice and convenience.
  over the counter medicines

'We understand that the GP may be concerned about misdiagnosing, but all of these declassifications are granted only after a huge amount of research and consultation with pharmacists and doctors. Nothing is 100 per cent safe.
'We could be giving cough lozenges which are masking the symptoms of someone who has lung cancer.
'On the other hand, in my own practice, a colleague spotted that a customer was coming back too often for cream for his haemorrhoids and sent him to his GP.
'It transpired that he had bowel cancer which was caught early because of the intervention of the pharmacist.'
Howard Duff believes that the future of first-line healthcare is going to be an ever-growing partnership between GPs , the patients and the pharmacist.
'Looking to the future I can see for example contraceptive pills being issued on repeat by the pharmacists,' says Mr Duff.
'We already have the equipment to check blood pressure and weight, it would make sense for us to do that.
'That would mean we have access to some form of medical records so we can alert the GPs formally that the patient has had a certain drug. It is joined-up medicine and it makes perfect sense.'
The argument is certainly set to continue, not least because the declassification of drugs seems certain to gather pace in the months and years to come.
For reasons of 'commercial confidentiality', the MHRA was unable to provide us with a list of drugs under assessment for reclassification, but the drug companies are eyeing up the highly lucrative market of over-the-counter medicine.
If they can obtain declassifications for their drugs there are huge profits to be made. And while for many of, this move, will mean great choice and convenience, it comes with a risk.
Up until now Britain has had what is widely recognised one of the most rigorous drug classification processes in the world. Let's hope, for the sake of our health, that it stays this way.


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