The Pharmaceutical Journal
Vol 268 No 7183 p131-132
2 February 2002

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Overhaul of POM-to-P reclassification could mean big changes for pharmacy

A document detailing potential candidates for POM-to-P reclassification is published this week. Its implications could be far-reaching for pharmacy. Clare Bellingham reports on the opportunities and the threats

Pharmacists are a step closer to extending their roles this week. A document giving details of potential candidates for reclassification from prescription only to pharmacy medicine status provides pharmacists with much-needed light at the end of the tunnel.

If many of the drugs mentioned in the document are reclassified, the implications for pharmacy are enormous. Patients could have chronic diseases, such as hypertension and asthma, managed at the pharmacy.

Although issues exist over things such as the need for additional training and access to patients' medical records, the important message for the profession is to focus on the opportunities the document provides.

The strategy document was produced by a working group led by the Royal Pharmaceutical Society (see Panel right). It highlights a large number of potential candidates for POM-to-P reclassification. The therapeutic classes mentioned are wide-ranging and include antihypertensives, statins, inhaled beta2-agonists and corticosteroids, oral contraceptives and hormone replacement therapy (see Panel below, p132).

Availability of such drugs as P medicines opens the way for pharmacists to take on roles extended beyond a GP-directed supply function. Sheila Kelly, executive director, Proprietary Association of Great Britain, commented: "The document should be seen in the context of pharmacists managing repeat prescribing and of pharmacist prescribing: it is one move in that continuum."

The NHS has been driving to increase the number of medicines that are available over the counter since the publication of the NHS plan in July 2000, which committed the Government to introduce a wider range of OTC medicines by 2002. The proposed POM-to-P switches in the new strategy document certainly fit in with the Government's desire to increase accessibility to medicines and to reduce health inequalities.

A spokesman for the Medicines Control Agency said this week: "The Government is committed to widening the availability of medicines where it is safe to do so and to enabling people to make informed choices about their own treatment." He added that the MCA "fully supports the principle of making more medicines available without prescription where it is safe to do so and of encouraging debate of the types of medicines which might be made more widely available under appropriate circumstances".

Marshall Davies, President, Royal Pharmaceutical Society, commented: "The Society welcomes the publication of the list. This is one of a number of important initiatives that will enhance the pharmacist's professional role. We hope it will stimulate debate and ultimately help to achieve the Government's aim of increasing the range of medicines available over the counter from pharmacies."

Implications for pharmacists

What are the implications for pharmacists? A larger number of OTC medicines increases the scope of conditions for which pharmacists can provide treatment. Some of the proposed switches will also allow pharmacists to manage chronic conditions.

If chronic conditions are to be managed in the pharmacy, pharmacists will need to be able to provide monitoring services. Many pharmacists already offer blood pressure or cholesterol measurement, both of which could be used for monitoring a patient's condition rather than as a risk-assessment tool. Although some of the candidates for change would require point-of-care testing that is not currently widely provided by pharmacies, this is not the case for them all. Mrs Kelly points out that recognising influenza could be done as easily by pharmacists as by doctors and that, by having zanamavir (Relenza) available in pharmacies, patients could get it more quickly than having to wait for an appointment with their GP. She also suggested that working out body mass index in order to supply anti-obesity drugs is relatively easy for pharmacists to do.

Prescribing issues

How pharmacists would actually supply new OTC medicines — whether by OTC sale or pharmacist prescribing — remains to be seen. One rule might not be appropriate for all cases: some patients might purchase their medicines; others, perhaps those in low-income groups, might have theirs prescribed by pharmacists. "If drugs are made available OTC then there is no reason why pharmacists should not prescribe them," said Mrs Kelly. She explained that some patients would get their medicines on repeat prescriptions from pharmacies; others would be assessed as being able to manage their condition and will be able to purchase medicine from the pharmacy and get advice from the pharmacist, or GP, as they need it.

Another option might be the introduction of nationwide patient group directions to allow the supply of medicines to patients on the NHS. However, if pharmacists are allowed to prescribe these items then this would not be necessary.

"The changes suggested in the document are not about rationing or saving money for the NHS," Mrs Kelly said. The MCA also stressed that this is not a cost-cutting exercise. "Any medicines which are currently available on NHS prescription will continue to be available by that route. Pharmacy supply will widen patient choice to access medicines," a spokesman said.

Benefits for patients

Making medicines more accessible is beneficial for patients. Those patients who have chronic conditions managed by their GP might find it faster and easier to access treatment and monitoring at a pharmacy instead. In addition, making more OTC medicines available means that some patients who currently do not receive treatment might now do so. Mrs Kelly believes that it will put pharmacists in the front line. "It changes the whole balance: patients will see pharmacists first, not after their doctor."

Dr Ian Banks, a GP and GP representative to the British Medical Association, said that the proposed POM-to-P switches are a good idea. "They will allow patients more control of their own health. In the past, we have been poor at allowing people to take this kind of responsibility," he said.

From a GP's viewpoint, he thought that some GPs would be cautious about the proposed changes. However, concerns have been expressed in the past about POM-to-P switches, for example with emergency hormonal contraception and ranitidine (Zantac). "Most fears so far have been unfounded," he said. "If there are sufficient incentives for industry and safeguards in place then it should go as well as for EHC and ranitidine."

Training

One issue all groups agree on is the need for professional practice guidance. The medical and pharmaceutical professions need to work together, with industry, to produce appropriate guidance on OTC use of these medicines.

To accompany the reclassification strategy document, an additional document about information and training needs has been produced by another working group, led by the PAGB. It highlights that the challenge for health care organisations is to provide the necessary support to enable people to manage chronic conditions effectively with optimum use of resources. "The future management of health care should be centred on the patient. There is a need for more collaborative work to provide quality information in support of making more medicines available over the counter as an alternative to, but not in place of, going to the doctor," it says.

The document suggests the introduction of a "reclassification code of practice" in which manufacturers should demonstrate that they have addressed the issue of health professional training when planning to implement a change of classification. Information should include product details, how it should be used in the context of current treatment options, common questions likely to be raised by users, the information to be given on side effects, alternative treatment options where appropriate and self-help options.

Patient records

One of the problems for pharmacists is access to patient records. At the moment, different records exist at hospitals and GP surgeries. In the long term, electronic records are likely to provide the solution. "Only patient-held records would work," said Mrs Kelly. "Rather than getting bogged down waiting for new technology, we should be encouraging people to tell their doctor about self-medication and to tell their pharmacist about prescription medicines they are taking. The information stream should be under the patient's control."

What happens next?

Interested parties are invited to comment on the proposals outlined in the document by 29 March (see Panel). The large number of potential candidates for reclassification, and the obvious amount of work that would be needed in preparation, indicate that this is a long-term plan. Changes will not happen overnight. "A lot of discussion will be needed for some candidates and some changes might never happen," said Mrs Kelly. "The document is about stretching people's thinking."

A spokesman for the Association of the British Pharmaceutical Industry said that he expects individual companies to be commenting directly. "I daresay that some will be expressing concerns," he added.

If companies chose to apply for reclassification, each drug will be assessed on an individual basis. Proposed changes to the reclassification process in the MLX279 document (PJ, 5/12 January, p3) could mean that drugs will now be classified on a product rather than active ingredient basis. In addition, marketing authorisation holders will be given a three-month competitive advantage before later applicants are allowed on the same data. However, there is concern in the industry that this period is not enough (although under the current system, no such exclusivity exists). The Society's Community Pharmacists Group this week expressed concern that this regulation change could even result in a decrease in the number of POM-to-P switches (see p157).

A spokesman for the ABPI commented that the industry does have some concerns about the MLX279 document. "Our concerns are to do with the inadequacy of market exclusivity: 90 days is totally inadequate." This would mean that the first company to apply for market authorisation would have to put in all the effort with insufficient reward.

Does changing to P-status offer sufficient advantages for this three-month period of exclusivity to be seen as a minor problem? P medicines can be advertised directly to patients which could lead to increased sales beyond those expected if a medicine remains prescription only. In the case of medicines for chronic conditions, successful advertising could result in long-term financial gains for the manufacturer as consumers often remain loyal to one brand.

Comments about MLX279 can be made until 8 February. A possible outcome of the consultation period is that the three-month period would be extended. If it remains, and becomes an issue, then the NHS drive for increased availability of medicines might mean that the Government will have to intervene.

Debate

This week's reclassification proposals document means the start of a long process in which the current OTC market could be extended to include drugs in a large number of new therapeutic categories. It also marks a recognition of the clinical role that pharmacists can play in managing long-term conditions and provides a stepping stone towards introduction of pharmacist prescribing.

The purpose of the document is to stimulate debate: it will certainly achieve that.