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MHRA: Reclassification Alliance relaunch will ‘open doors’ for POM to P switches

A collaborative working group made up of government, industry and regulatory officials could help ease the way to a slew of medicines reclassifications, the head of the UK’s medicines watchdog has said.

A working group called the Reclassification Alliance comprising government representatives, regulators, manufacturers and pharmacy groups was relaunched at an event hosted by the Proprietary Association of Great Britain (PAGB) on Tuesday (December 12).

Speaking at the event, Dame June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said that the group would be “setting out some open doors” for manufacturers contemplating the switch from prescription-only medications (POMs) to pharmacy (P) medicines.

Read more: Half of pharmacies shun ‘unlikely-to-sell’ P contraceptives, research finds

And she said that medicines reclassifications would see a “big kickstart” due to the government’s primary care delivery plan, part of which has seen money set aside for a national Pharmacy First service in England. Under the scheme, pharmacists will be able to provide treatment for seven common conditions without the need for a prescription.

The reinstated Reclassification Alliance brings together the Department of Health and Social Care (DH), the MHRA, the PAGB and its members, and “pharmacy organisations”, according to a press release issued by the PAGB on December 12.

It remains unclear when the group, which was first formed in 2001 with the aim of “switching” 50 products by 2007, was put on hold.


“Great success” possible


Michelle Riddalls, chief executive of the PAGB, said at the relaunch event that the organisation had long been pushing for “reinvigorating reclassification”.

And she said that “great success was possible”, adding that she was “pleased” by the government’s commitment to “identify medicines suitable for switching” in its primary care recovery plan, launched in May. 

According to the plan, the DH will work with the MHRA, NHSE and industry “to identify medicines which could be reclassified from POM to P”.

Read more: Greater use of OTC drugs could save NHS £3.1bn per year, report claims

Dame June said that the established model of medicine reclassification, which she dubbed the “switch model”, involved the MHRA “waiting for [manufacturers] to knock” when they have a product that they feel might suit reclassification to POM or even general sales list (GSL).

She said the regulator would be “a bit more proactive”, while keeping “safety in use” at the forefront of its mission following the re-establishment of the alliance.

“There is an immense body of evidence, hundreds of papers that show that empowered members of the public, and patients have better outcomes with managed self care,” she said.

Read more: MHRA mulls codeine linctus P to POM switch amid ‘recreational’ use concerns

Anna Maxwell, chief executive of manufacturer Maxwellia – which makes the reclassified oral contraceptive Lovima and hormone replacement therapy (HRT) product Gina – said that the reconstruction of the Reclassification Alliance could be “a pivotal moment”.

She said that it showed “a renewed enthusiasm for and recognition of the transformative value of reclassified medicines”, and looked forward to “a faster [regulatory] process that facilitates a higher probability of success”.

Ms Maxwell stressed that Maxwellia has its “foot firmly on the accelerator” by “gearing up” new applications for assessment to the MHRA.


POM news


Earlier this month, C+D reported that new research from Kingston University looking at medicine POM to P switches found that community pharmacists are reluctant to offer desogestrel and estradiol, citing a lack of patient demand.

In July, a report commissioned by the PABG found that greater use of OTC medicines could save the NHS up to £3.1 billion annually, with 1.4bn of that coming from the reclassification of more POMs.

Read more: Maxwellia mulling 'next step' after oxybutynin drug reclassification rejected

But reclassification moves have not only moved in one direction this year. In July, the MHRA launched a month-long public consultation on whether to make the OTC codeine linctus, an opioid cough medicine, prescription-only.

And in May, the MHRA announced that it would not reclassify oxybutynin Aquiette 2.5mg tablets to make them available without a prescription, following an application by its manufacturer Maxwellia. In response, Maxwellia said that it was “considering its next step”.

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