The Pharmaceutical Journal
Vol 268 No 7196 p597-604
4 May 2002

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Medicines Control Agency (www.mca.gov.uk)
Proprietary Association of Great Britain (www.pagb.org.uk)
Royal Pharmaceutical Society (www.rpsgb.org.uk)

Gear up for more POM-to-P switches

Medicines will be available over the counter through pharmacies more quickly under a new reclassification process launched on 1 May 2002.

Announcing the strategy, Health Minister Lord Hunt, said that it would slash red tape involved in legislation. "The new strategy will reduce by over half the time to get a product reclassified," he said. The change was consistent with the NHS plan which puts an emphasis on ensuring wider access to medicines, he added.

Over the past 10 years, 50 treatments have been switched from prescription only medicine (POM) to pharmacy medicine (P) status. "We want to increase this momentum," said Lord Hunt. "We want 50 to be reclassified over the next five years, maybe even more."

Pharmaceutical companies applying for reclassification under the new process will be given three months of marketing exclusivity as an incentive. "I look to industry now to use the new procedures to deliver the applications that will result in patients feeling the difference when they walk into their local pharmacy," he said.

Lord Hunt said that the new reclassification process would allow the wider use of pharmacists' skills than had been the case in the past. "Community pharmacists are incredibly well-trained professionals who I think have been frustrated for many years. This reclassification process is one element of encouraging pharmacists to take on more responsibility," he said.

Marshall Davies, President of the Royal Pharmaceutical Society, said: "We strongly support the principle of increasing the number of medicines available from pharmacies." He added: "Today's patient finds it acceptable to obtain a range of medicines from a pharmacy that were previously only available on prescription."

In order for medicines to be reclassified using the new strategy, changes to the law have been made, including amendments to the POM and GSL orders. These mean that the need to amend legislation each time the legal status of a medicine is changed, which used to happen twice a year on fixed timetables, is no longer required.

The first POM to be made available over the counter under the new process was announced on 1 May as Flixonase Allergy nasal spray. It has been granted its new legal status three months earlier than it would have under the old process.

Lord Hunt could not comment on other specific drugs that might be reclassified under the new process because he is the final signatory to any applications. However, a list of proposed categories for POM-to-P switches published earlier this year (PJ, 2 February, p131) provides a starting point.

Sheila Kelly, executive director, Proprietary Association of Great Britain, said that she did not expect to see a flood of products being reclassified during the next few weeks but that within the next year or so she expected the list to become reality.

The MCA will lead a small, focused reclassification strategy group of stakeholders, including representatives from industry, to see how appropriate advantage can be taken of the changes introduced.

News feature, p607