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How a POM-to-P culture change may be thwarting pharmacists’ ambitions

By Debbie Andalo

Does the recent withdrawal of applications by Actavis and Goldshield to reclassify their antibiotics for cystitis from prescription-only to pharmacy medicines threaten the expansion of community pharmacists’ clinical role? Debbie Andalo investigates

 

The ambitions of community pharmacists to develop their clinical skills may be thwarted by the changing culture around allowing more medicines to be made available over the pharmacy counter without a prescription.

Two drug companies recently withdrew their applications for antibiotics for the treatment of cystitis to be moved from the prescription only medicine to the pharmacy medicine category.

Drug manufacturers Actavis and Goldshield say they are still committed to the POM-to-P agenda, but they refused to give a reason for their decision, although it is thought that they have bowed to the pressure from microbiologists of the risk the switch may have posed for antibiotic resistance.

At the same time a feature appeared in the Daily Mail last month (April 2010) under the banner headline “Pharmacists are selling more drugs over the counter, but is your chemist putting your life at risk?”.

The article, which focused on the recent POM-to-P switch of tamsulosin, expressed doubts by leading GPs that community pharmacists have the clinical skills to take on an extended diagnostic and prescribing role on the high street.

The two incidences indicate the obstacles appearing on the POM-to-P landscape — regardless of the desire of pharmacy professionals to expand their clinical role. Neal Patel, director of corporate communications the Royal Pharmaceutical Society, says: “There are no more easy POM-to-P switches left — those days have gone.”

Pharmacist and doctor John Blenkinsopp, whose consultancy works with drug companies to help pave the way for medicine switches, admits that the announcements to withdraw the reclassification of trimethoprim and nitrofurantoin as over-the-counter medicines has been a “setback.”

He told The Journal: “I think what has not happened on this occasion with these two produces is a setback. Now the manufactures and people like me have got to put our thinking caps on for putting forward better arguments for making these medicines more accessible.”

But he is still optimistic that the drive to switch more medicines from POM to P will continue. He said: “The move to reclassify medicines from POM to P continues and manufacturers still have some appetite for switching. My consultancy is still busy from that point of view.”

A trawl through the database of POM-to-P switches held by the Proprietary Association of Great Britain shows how things have changed in recent decades. The first medicine to be switched from POM to P was ibuprofen in 1983. Most drugs since then have tended to cover minor conditions; for example they have included pain relief, antifungal treatments and medicines for allergies, such as hay fever.

But in 2005 came the landmark decision by the Medicines and Healthcare products Regulatory Agency, to allow the first antibiotic — chloramphenicol eye drops — to be made available without a prescription on the advice of a pharmacist. Three years later the first oral antibiotic to be given P status for the treatment of chlamydia was approved.

And last year (2009) the UK achieved a global first when the MHRA decide that tamsulosin — a medicine for the treatment of benign prostatic hyperplasia — should be granted P status.

Opposition

But it was the switch of tamsulosin that, according to some doctors, has been a switch too far. GP Bill Beeby, chairman of the British Medical Association’s General Practitioners Committee clinical prescribing subcommittee, has been outspoken in his opposition to the move, which he insists has nothing to do with any “turf war” between GPs and community pharmacists.

He told The Journal: “I don’t want to make this into an issue about turf wars because those arguments are counterproductive. I am very much in favour of POM-to-Ps and a lot of new things being made available OTC because in a lot of cases it does help the individual. My concern is about this drug tamsulosin in that the UK is the first country in the world to make it a P drug, which is bold move. But it’s a drug with significant side effects — we aren’t talking about a topical antifungal. My concern is who is going to be shouted at if somebody fails to diagnose prostate cancer.”

And he adds: “From my experience pharmacists don’t want to take on this extended role of diagnosing — they are comfortable with doctors taking that on that role. Maybe they don’t have the time or the skills.”

Dr Beeby’s comments about the reluctance of community pharmacists to take on roles traditionally offered by GPs, including diagnosis and prescribing, would be challenged by many pharmacists and professional organisations, including the Royal Pharmaceutical Society. His comments are also not borne out by the results of a recent PAGB survey of community pharmacists. The association asked the profession what kind of conditions they would feel comfortable recommending switched products for in the future.

More than 60 per cent of those quizzed suggested urinary tract infections, stable asthma, oral contraception, menorrhagia, impetigo and erectile dysfunction. Sunayana Shah, PAGB scientific and medical affairs manager, reckons the current trend to switch more complex drugs from POM to P status will continue.

She says: “Recent reclassifications of medicines, from prescription only to pharmacy status, have seen a move towards more therapeutic areas and prevention of ill health, with areas that have traditionally been within the domain of the doctor now beginning to be explored.”

The MHRA business plan for 2009–10 is also committed to more POM-to-P switches as a way of increasing patient access to medicines. This commitment has also been adopted as the long-term goal of the special ministerial industry strategy group new technologies forum, set up by the Department of Health and medicines manufacturers in 2006 to look at drug regulation as part of a long-term strategy for medicines in the UK and Europe.

The forum’s latest report published in December 2009 called for more research evidence to be created to support “earlier switches and to establish the public health value of switches”. But it acknowledged: “Real progress will depend on all stakeholders fully committing to achieving this vision.”

As POM-to-P switches focus on more complex medicines — moving away from the safer ground of treatments for minor ailments — this vision is still achievable. The frustration, though, for community pharmacists waiting to play their part, is that it may not happen as quickly, or as seamlessly, as they might wish.

Citation: The Pharmaceutical Journal URI: 11010122

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