Sid Dajani, the Royal Pharmaceutical Society’s elected representative on the Pharmaceutical Group of the European Union, discusses the centralised ‘POM to P’ switch of ellaOne

The emergency hormonal contraceptive ellaOne has become the fourth product to be granted a switch from prescription-only to non- prescription status at European level. EllaOne will therefore, in principle, be available OTC in all EEA states. It is not clear whether some European countries will be able to invoke an exception under the EU medicines legislation that enables restrictions to be placed on contraceptive medication. EllaOne is the latest medicine to be switched centrally by the European Medicines Agency, which has reclassified Alli, Pantoprozole and Nexium Control in the same manner.

Although the centralised procedure has been available since 2007, only four products have been approved, while some high profile medicines such as Viagra and sumatriptan failed to switch. The procedure has not become the ‘game changer’ for switching that some believed it would. The CHMP, the European Medicines Agency committee that approves switches, has consistently taken what some view as a conservative position, including at times expressing a lack of confidence in the pharmacy profession. Other concerns have been raised about distribution of non-prescription medicines outside pharmacies, and the availability of qualified pharmacists inside the pharmacy to dispense medication.

Currently, 21 EU states permit the OTC sale of emergency hormonal contraception – a fact that made the task of promoting the switch somewhat easier. Nonetheless, supporters of switching will be encouraged by the fact that the centralised procedure can still be effective in cases where pharmacy intervention is generally considered paramount in order to ensure safe and appropriate use.

While the switch is an expression of confidence in the pharmacy profession, it also provides an opportunity to put pharmacy practice under the spotlight. As was the case for the first central switch, Alli, it is possible that ‘mystery shopping’ exercises for ellaOne will take place in some member states. French manufacturer HRA Pharma promised to put a comprehensive educational programme in place for pharmacists as part of the switch application.

The fourth switch is great news because it aligns with what we believe in the UK. Our aim at the Royal Pharmaceutical Society has always been to ensure patients get the most from their medicines and we'd always advocate that patients must be able to self care with the support of the professional expertise and judgment of a pharmacist.

Therefore, and within reason, when a product is being reclassified from prescription-only status it is in accordance with our policy of strengthening the armament of self care and adds to the value that we can provide more, when necessary, to those in need without a prescription or an appointment. Medicines are the common thread throughout healthcare in Europe and it shows the EU can at times exhibit straightforward common sense.