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Why the resurgence of OTC reclassifications in the UK is a good thing

Illustration of over-the-counter products

After a dwindle in the number of reclassifications of prescription-only to pharmacy medicines in the UK, things are starting to look up, writes Natalie Gauld.

The reclassification of prescription-only to pharmacy (POM-to-P) medicines has received an important boost since early 2017, with three consultations out on proposed reclassifications: atovaquone/proguanil hydrochloride for malaria; sildenafil for erectile dysfunction; and calcipotriol for psoriasis.

The UK had a global reputation as the leader in POM-to-P medicines reclassification from the mid-1990s to around 2010, enabling consumer access to effective drugs and the pharmacist’s role to progress[1][2][3]. To reclassification stakeholders in developed countries[4], the UK was the country everyone looked on to lead. For example, New Zealand had the confidence to reclassify chloramphenicol eye drops because the UK had done it. Other countries, particularly Singapore and Japan, also look to the UK in their reclassification work[5].

But then, the world-leading reclassifications in the UK stopped[6], even though the UK had more enablers for reclassification than either the United States, Canada, Australia, New Zealand, Denmark, the Netherlands, Singapore or Japan[4]. Such enablers include the pharmacy category (as opposed to a general sale category), interest from pharmacy organisations, a large population and government support. And the Medicines and Healthcare products Regulatory Agency, which regulates medicines in the UK, has continued to be proactive and supportive of reclassification[7]. The UK government still wants more POM-to-P reclassification[8]; and the think-tank King’s Fund report published in 2016 said “general practice is in crisis”,[9] indicating an urgent need for pharmacy to step up, and more POM-to-P reclassifications enables that. But reclassifications in the UK have dwindled since 2010 and came almost to a complete halt until recently.

There are several reasons for this. A number of innovative reclassifications were not commercially successful, including simvastatin for lowering cholesterol, sumatriptan for migraines and tamsulosin for benign prostate hyperplasia. Government-funded medical visits and prescriptions do not help encourage self care for chronic conditions or prevention of illness. The requirement for centralised European reclassification if the medicine had been registered centrally has been another major barrier for reclassifying newer medicines. Finally, reclassifying a medicine for 27 or 28 member states at once requires a lot of alignment and confidence from the members of the committee of experts on the classification of medicines, and sumatriptan and sildenafil did not make it.

Patient group directions (PGDs) — a written instruction for the sale, supply and administration of medicines to groups of patients who may not be individually identified before presentation for treatment — and pharmacist prescribing are increasing access to medicines, and perhaps reduce the need for reclassification. However, availability of medicines through PGDs and pharmacist prescribing are far from universal in pharmacies, and such availability from the pharmacist will not be widely advertised in the way that a reclassified medicine usually would be. The somewhat similar Australian availability of pharmacist-only medicines without consumer advertising has been dubbed by the pharmaceutical industry as the ‘product graveyard’[10].

More appropriate reclassifications of medicines could relieve GP workload and help drive the self-care agenda 

More appropriate reclassifications of POM-to-P medicines could help to maximise the benefits of pharmacists relieving some of the GP surgeries’ workload in dealing with minor ailments and help drive the self-care agenda.

Benefits outweigh risks

POM-to-P reclassifications encourage timely and more convenient consumer access to medicines. They save patients’ time in booking appointments with GPs, taking time off work, and travelling to the GP surgery. Importantly, they empower consumers to self-manage — something the UK government has been driving for decades. Reclassifications can also remove pressure from other parts of the health system. For example, following the reclassification of emergency hormonal contraception in the UK in 2000, many women started using the pharmacy to obtain it rather than their GP[11]. Managing the access of such medicines via pharmacies instead of the emergency departments of hospitals can help the NHS save money[12].

The availability of prescription medicines via the internet is common, particularly drugs used to treat erectile dysfunction, typically without a healthcare professional assessment to check suitability for the medicine or monitor the outcome. Furthermore, there is a risk of counterfeit medicine supply.

Reclassification may reduce the incentive to obtain prescription medicines via the internet 

Reclassification may reduce people’s incentive to obtain POMs via the internet and pharmacy staff can help ensure appropriate use. It could also reduce the demand for dubious herbal remedies that contain, for example, undeclared prescription ingredients for erectile dysfunction[13], and the associated compliance costs for governments. The effect of reclassifying sildenafil in New Zealand (2014) and Poland (2016) could usefully be investigated in terms of demand for internet supplies and availability of remedies containing undeclared medicines.

Reclassification may encourage earlier assessment of patients, as suggested with sildenafil in New Zealand. Anecdotally, New Zealand pharmacists report high blood pressure readings and other concerns at sildenafil consultations, stimulating GP referral. More research is required to understand the effect of this on men’s GP visits.

There have been studies that have shown pharmacists often appreciate POM-to-P reclassifications[14][15]. Most pharmacists appreciate the greater clinical responsibility and ability to better help their patients.

There are, of course, potential risks with reclassifying a POM. These include inappropriate use, delayed medical diagnosis, overuse, and resistance (with antimicrobials). It is important for pharmacists and pharmacy staff to manage these risks in order to maximise the benefit–risk of the medicine. To mitigate risks, they are considered in the reclassification approval process and addressed where possible in the classification used, packaging, training and screening tools, and the dose, indications and pack size. A reclassification application will not be approved if the risk management does not satisfy the committee and regulator.

Taking lessons from other countries

It may be possible to learn from other countries that have been active[6]. The United States recently reclassified transdermal oxybutynin in 2013 (to treat an overactive bladder), topical nasal corticosteroids in 2013, albeit two decades behind the UK, and topical adapalene (for acne) in 2016. In New Zealand, oral contraceptives, the antiviral drug oseltamivir (Tamiflu; Roche), sildenafil, various vaccines, calcipotriol, adapalene and the antibiotic trimethoprim are just some of the drugs that have been reclassified to a P medicine in the past decade.

Encouraging drug reclassification

There are different enablers of reclassification for both countries. In the United States, a large market size, unmet need, and a three-year market exclusivity for the manufacturer help encourage reclassification[4]. In New Zealand, the existence of a pharmacist-only category (where the pharmacist must be actively involved in the sale), and the flexibility of the reclassification committee and regulator help increase the number of POM-to-P switches[4]. Research has played an important role in showing the effects of these policy changes and informing (and enabling) further changes. The ability of anyone to submit a reclassification application (not just product sponsors) has been important, with 10 of the last 11 progressive reclassifications not being driven by a pharmaceutical company.

Singapore is another country that is flexible with its reclassification rules. It will consider reclassifying medicines on application from product licence holders or allow exemption to prescription supply when the medicine is supplied by a pharmacist, without a sponsor application. Singapore has recently reclassified topical adapalene, the antibiotics clindamycin and erythromycin for acne, and encouraged health professionals and industry stakeholders to submit proposals for reclassification. Similarly, in Australia, the opioid blocker naloxone was recently reclassified following an application from a pharmacist.[16] Perhaps the UK could change its processes to follow suit, choosing its own candidates for reclassification, or encouraging non-industry applications. Or perhaps the UK could follow the United States or Japan in allowing three years of market exclusivity.

The return on investment needs to work for companies to apply. Some complex reclassifications in the UK are commercially unsuccessful. For example, Zocor Heart Pro (simvastatin) was discontinued in 2010, with the manufacturer citing low sales[17]. It is expensive for a company to plan a reclassification, prepare the application, educate pharmacists and other staff, create and test screening tools and consumer materials, understand the over-the-counter drug market, and create awareness for consumers.

Potential return is also influenced by free GP visits and prescriptions for many patients, and early generic competition, as in the UK. In our international research on reclassification[4], we found that because most of the “easy” reclassifications (i.e. medicines with relatively few side effects, contraindications and precautions) have already been done, companies want a longer period of market exclusivity to make the remaining more complex reclassifications or reclassifications for niche markets work financially.

Consultant physician and clinical pharmacologist Jeffrey Aronson’s[18] idea in 2009 of a pharmacist-only category for the UK, possibly with training required, is worth consideration. This is popular in New Zealand where there are pharmacist-only, pharmacy-only and general sales categories. From my experience as a member of the Medicines Classification Committee, researching reclassification, and preparing reclassification applications, I have no doubt that a pharmacist-only category enables reclassification of appropriate medicines. This model has been adapted further in New Zealand with additional controls to that usually used in pharmacist-only medicines, effectively a ‘controlled pharmacist-supply’.

Controlled pharmacist-supply model

This model can have pharmacist training mandated before supply, strict criteria for supply, screening tools, and comprehensive documentation. This is not a new regulation as such, but an innovative way of approaching the existing regulations. For trimethoprim, evidence indicates that pharmacists like the model[15], and quantitative research indicates no adverse antibiotic use has occurred[19]. Given concerns about antimicrobial resistance, it is difficult to see an antibiotic for cystitis reclassified through a less restrictive mechanism. A common concern with reclassification is that patients will not be comprehensively questioned, as seen in some pharmacies in pseudo-patient studies[20][21][22]. Mandating training or having a screening tool may help pharmacists take the medicine seriously and adhere to guidelines. Research on community pharmacy has shown promising results with guidelines and protocols in pharmacy[23].

With the UK leaving the EU, there could be changes in the number of reclassifications, but reclassification could be applied for in the UK regardless of whether the product was registered centrally in Europe or not. Perhaps other restrictions might be removed, e.g. that injectable drugs must be a POM. Market exclusivity for companies applying for a reclassification could be made easier to achieve, and potentially extended beyond a year to encourage more reclassifications. The UK could remove the restriction that only product sponsors (pharmaceutical companies or distributors) can apply for reclassification. Alternatively, reclassifications could be allowed without a formal application, as has occurred in Singapore and New Zealand, after consultation. As noted above, a pharmacist-only category, possibly with mandatory training, might also help because pharmacists would be supported to optimise the benefit–risk equation.

These changes would see the British public gain convenient access to effective treatments, the NHS (and GPs) would have a little less pressure, and pharmacists would be better utilised. The UK reclassification model has a good pharmacy workforce, pharmacy organisation support, a medicines regulator with a positive outlook towards switching, useful guidelines, availability for meetings, and protection of the applicant’s information. I look forward to seeing future leadership from the UK in widening access to medicines.

Natalie Gauld is a pharmacist and reclassification consultant at Natalie Gauld Ltd. She is an honorary research fellow at the Department of General Practice and Primary Health Care, University of Auckland, New Zealand.

Declarations of interest: Natalie Gauld has received funding for reclassifications including trimethoprim, vaccinations, calcipotriol, adapalene, sildenafil and oral contraceptives. She was on the Medicines Classification Committee in New Zealand (2004–2009). She has acted as a consultant to Green Cross Health, the pharmaceutical industry and pharmacy organisations. She has received travel funding for speaking engagements at conferences from industry and pharmacy organisations. She received unrestricted research grants from Green Cross Health, the Pharmacy Guild, the Pharmaceutical Society of New Zealand and ProPharma for the trimethoprim research. She is a member of the National Executive of the Pharmaceutical Society of New Zealand. The opinions expressed in this article are the author’s, and not as a representative of any organisation.

Citation: Clinical Pharmacist DOI: 10.1211/CP.2017.20202645

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