The P medicines category has been steadily growing since its establishment in 1983. But two medicines moved out of the category last month – one to become prescription-only and another to become available for general sale. So what do these switches mean for the future of P medicines?
Nexium switches to GSL: A sign of trust in patients?
What prompted the switch: Nexium Control first came onto the market as a prescription-only medicine in 2000. In 2013, the European Commission allowed the medicine to be sold without a prescription across the EU. This prompted the MHRA to consult on whether Nexium (esomeprazole) should become a P or GSL medicine in 2014.
The response: The MHRA consultation received 10 responses – the majority of which included doubts over Nexium becoming a GSL medicine. Only two respondents were wholly in favour.
The Royal Pharmaceutical Society (RPS) was one of the respondents against GSL status. It said heartburn and acid regurgitation – which Nexium was designed to treat – could be the symptoms of a serious underlying condition. The medicine also had several interactions and was linked to an increased risk of fractures and gastrointestinal conditions such as Clostridium difficile, the RPS pointed out. Even the Royal College of Physicians, which supported a GSL classification, highlighted these risks and called for them to be explicitly mentioned in the safety documentation.
The decision: The MHRA said “no new issues” had been raised in the consultation to prevent Nexium from going on general sale and classified it GSL last month. It pointed out that the number of reported adverse reactions to esomeprazole in the UK – 1,155 over nearly 14 years – was low and most of these were non-serious. It also pointed to the US as an example of where the drug was successfully sold by self-selection in some retail outlets and used correctly by patients.
Another argument was that the patient information, which specifies the need to seek medical attention if symptoms do not improve after 14 days, should prevent long-term use masking a serious condition.
What it means: The faith placed in patient information could highlight a move towards putting more trust in individuals to look after their own health. It’s easy to see how this could prompt more P to GSL switches. Hayley Johnson, medicines information pharmacist at the Regional Drug and Therapeutics Centre in Newcastle, has witnessed this trend and believes it tends to only work "in theory". “In real life, what happens is they will use it [the medicine] for six months and one day will read the leaflet over their breakfast cereal.”
Diclofenac becomes a POM: A blow for pharmacy’s role?
What prompted the switch: Diclofenac tablets were originally only available on prescription and made the switch to the pharmacy category in 2008. But this decision came under scrutiny in 2013, when the EU raised concerns over the risks of cardiovascular side effects. The European Medicines Agency recommended including new contraindications, warnings and precautions on diclofenac marketing. The MHRA consulted on introducing these in the UK and also suggested switching it back to a prescription-only medicine (POM).
The response: The MHRA has not yet published responses to its consultation, which closed in 2013, so it is unclear how much support there was for the POM move. C+D could find only two publicly available responses to the consultation – the RPS and British Pharmacological Society (BPS) – which told very different stories.
The RPS deemed the issue “extremely complex” in its consultation response and, while championing the P category, said it could not evaluate the safety of diclofenac. The BPS took a more definitive line and said the medicine should become prescription-only, as it should only be supplied after a careful risk assessment. “It is unlikely that all pharmacists will be able to conduct a cardiovascular risk assessment in all individuals in all circumstances,” it argued. The decision to make diclofenac a POM suggests this was not an isolated opinion.
The decision: Nevertheless, the official reclassification of diclofenac as a POM this month was something of a surprise. In the consultation document, the MHRA’s own commission on human medicines had only recommended updating information – removing the treatment of cold and flu from its symptoms and strengthening on-pack warnings, for example – rather than reclassifying the medicine. This month, the MHRA strengthened its position and said patients would need to have a medical review before taking diclofenac, to assess their risk of incurring serious cardiac side effects.
What it means: The decision could be interpreted as a lack of trust in pharmacists to police medicines effectively – an attitude that could pose a threat to the P category. There may be some merit in the BPS’s argument that pharmacists wouldn’t have time to conduct assessments on everyone requesting diclofenac. But pharmacists expressed worries over perceptions of the profession. Graham Phillips, owner of Manor Pharmacy Group (Wheathampstead) Ltd in Hertfordshire, said he hoped the decision was not based on “unjustified assumptions about risk management in pharmacy”.
If Mr Phillips is right, this – coupled with greater trust in patients – could mean pharmacists will have a fight on their hands to keep the P category thriving.