Reclassifying Medicines

What is Medicine reclassification?

Medicines in the UK have the following legal status:

  • Prescription-Only Medicine (POM)
  • Pharmacy (P)
  • General Sales List (GSL)

POMs in the UK are prescribed by doctors or other authorised health professional and fulfilled by via a pharmacist. To purchase a P (Pharmacy) medicine, prior consultation with a pharmacist is required, for example to purchase emergency contraception. GSL medicine can be bought from retail stores, etc., they are medicines bought as self-selection medicines e.g. cold and flu remedies.

As you move from POM to P to GSL classification, the involvement of the healthcare professional decreases.  For initial reclassification medicines, (POM to P) the intervention of a doctor or pharmacist, is deemed necessary to minimise the risk of inappropriate use, or misdiagnosis. GSL medicines are traditionally for easy to diagnose, short-term conditions – for example, a headache. A headache is a relatively common condition, most people know what a “normal” headache for them feels like and what the treatment would be; pain killers (paracetamol or ibuprofen). However, if that headache continued over several days, or extended past the period that was “normal” for the patient, the recommendation is to go to the doctor for help and advice. Headaches are easy to diagnose, but the individual themselves can’t diagnose the underlying cause. Often headaches are attributed to dehydration, but regular headaches could be a source of concern, leading to the consumer consultation with a professional. Pain killers are sold in small doses, as a GSL, to minimise misuse. In addition, GSL medicines are sold as small pack sizes e.g. 16’s for paracetamol. But the P medicines for the same produce would be 32’s as some people suffer regular aches and pain, needing larger pack to self-manage this condition and the risk is managed with consultation with a healthcare professional – the pharmacist.

Why are medicines reclassified?

Medicines are often reclassified for the following reasons:

  • Accessibility: improve wider and easier access
  • Power to the patient/consumer – more anatomy and choice
  • Commercial benefit – expand the POM brand to a consumer audience.

For a medicine to be reclassified, it must not pose a significant risk to the consumer when reclassified. This concerns both misuse and misdiagnosis. You can see from the list above, there are benefits to both the consumer and the company when reclassifying a medicine. However, reclassification must be a practical step. If reclassifying the medicine doesn’t add benefit to consumer, then there will be no commercial benefit as consumers won’t buy it. Just because a company can reclassify a medicine, doesn’t mean they should. Although the reclassification may be a regulatory success, it doesn’t mean it will be commercially viable.

Case Study: Why did the reclassification of Tamsulosin fail?

Not all reclassified medicines have been a commercial successes Simvastatin and Tranexamic acid have not continued to be commercialised as OTC medicines, I offer a view of why Tamsulosin is no longer sold as an OTC medicine.

In 2009 Tamsulosin was reclassified from POM to P, pharmacy. Tamsulosin is for the treatment of functional symptoms of benign prostatic hyperplasia (BPH) in men aged 45 to 75 years. The aim was to encourage consumers could go to the pharmacist, answer a questionnaire about their symptoms and receive a supply of Tamsulosin for around two weeks. However, within the first six weeks of treatment they would also need to visit their Doctor for a clinical diagnosis. It is debatable whether the reclassification provided any benefit to the consumer, although it provided increased access to a hard-to-reach patient population. As consumers ultimately have to go to the Doctor, why would they not make an appointment, combined with a direct cost to buy Flomax (more than the Prescription fee), the reclassification of Tamsulosin could be regarded as a regulatory success, but not a commercial one.

What makes a Successful Medicine Reclassification?

For a reclassification to be successful, it needs to meet the consumers wants and needs. This also relies on accurate self-diagnosis by the consumer and often works best with acute (short-term) conditions. Common, well known conditions will have intuitive solutions. Going back to a headache, you are experiencing pain, so you look for a pain killer. Headache meets the criteria, being self-diagnosable, acute and having an intuitive treatment. When conditions are difficult to diagnose by the consumer and require validation by a healthcare professional or a clinician then they could be less commercially viable as OTC options. What drives consumer behaviour to decides whether they go to their Pharmacist or Doctor? These questions highlight the importance Public and Professional input. When a company applies for a medicine reclassification, the MHRA may turn to Stakeholder groups or Public Consultations for their opinion. This provides a grass-roots consumer insight, and whether there is a push for this type of reclassification. Companies themselves can run these studies, in customer surveys, to provide a Go/No Go decision on submitting an application.

Successful Medicine Reclassifications at JensonR+

In summer of 2019, JensonR+ Limited successfully supported Trichocare Diagnostics Limited UK in reclassifying a POM product – Colourstart patch – to a GSL medicine. This type of switch is a fairly rare occurrence as usually the risk: benefit ratio is skewed towards the generation of non prescription sales to support the safety of the product to be a GSL medicine. Colourstart patch identifies potential allergic reactions to Paraphenylenediamine (PPD), a common colourant in hair dyes.