Medicines Healthcare Products Regulatory Agency
Overview
The legal classification of a pack of medicine determines the level of control over its supply. In part, classification rests on how much health professional input is needed to diagnose and treat the conditions for which the medicine might be used. Currently, there are three categories that a medicine can be classified within:
- Prescription-Only Medicine (POM) - has to be prescribed by a doctor or other authorised health professional and it has to be dispensed from a pharmacy or from another specifically licensed place;
- Pharmacy (P) - an intermediate level of control, can be bought only from pharmacies and under a pharmacists supervision;
- General Sales List (GSL) - may be bought from retail stores, such as a newsagent, a supermarket or a vending machine in a shop.
The underlying principle for classifying medicines is to maximise timely access to effective medicines while minimising the risk of harm from inappropriate use.
Making medicines available over-the-counter: the trade-offs
| Benefits | Barriers |
|---|---|
| Quick relief of the disorder | Potentially troublesome or serious side effects |
| Individual can exercise more autonomy and choice | Possibility of misdiagnosis and delay in correct treatment |
| Rapid and convenient access to medicines | Potential for harm from incorrect use |
Public and professional input
We are committed to widening access to medicines for the benefit of public health when it is safe to do so, and we are seeking input from patients and health professionals into the reclassification process. In addition to safety considerations, a key factor in the reclassification process is focusing on issues that matter to patients and health professionals. In order to understand those issues we run stakeholder groups and public consultations.
Stakeholder groups
Stakeholder groups are composed of representatives from the public and health professionals. Their input takes the form of a half-day meeting on an ad hoc basis when we have an application for a specific medicine. Each meeting will discuss the possible reclassification of a specific prescription-only medicine to a pharmacy medicine or a pharmacy medicine to a general sales medicine. Stakeholder Groups consider a proposed reclassification in the early stages of processing a reclassification application.
Get involved!
We would like to hear from patients with an interest in medicines and self-care, and community pharmacists, GPs, nurses and healthcare professionals who are currently working in a patient-facing role and who are willing to reflect on professional issues and attend a short meeting if required. If you are interested in taking part, please email engagement@mhra.gov.uk. We will keep your details and contact you when a specific product is under discussion.
This work is supported by the UK Medicines Reclassification Platform.
Public consultations
We also run 21 day public consultations for some medicines that are being reclassified, and these are published on the consultations page when available. These consultations seek your views on the reclassification of a specific medicine. Public consultations are run later in the processing of a reclassification application, after the application has been considered by the MHRA Assessors and after independent advice has been sought from the Commission on Human Medicines.
Classifications of medicines
The three legal categories are explained here, with examples of medicines in each of the categories. We also explain how the categories relate to the term over-the-counter (OTC) medicines.
Prescription-only medicines
Medicine packs classified prescription only can be obtained only against a valid prescription issued by an authorised health professional. The prescription needs to be taken to a pharmacy where the medicine is prepared under the supervision of a pharmacist. Sometimes the prescription is filled at a dispensing doctors surgery. A member of the public cannot buy a prescription-only medicine (POM).
A rectangular box enclosing the letters POM appears on the packs of prescription-only medicines.
In general, prescription-only medicines are used for conditions that are best diagnosed and managed by health professionals. Examples of prescription-only medicines include virtually all antibiotics and medicines for treating high blood pressure.
Pharmacy medicines
People can buy products classified as pharmacy medicines (P) but only from a pharmacy and in the presence of a pharmacist. These medicines, also called pharmacy-only medicines, are not usually displayed on open shelves.A rectangular box enclosing the letter P appears on the packaging of pharmacy medicines.
Pharmacy medicine packs are generally for short term treatment of medical conditions that can be identified readily and are not likely to persist, although they may sometimes be available for the management of long term conditions. Pharmacy medicines need to be used more carefully than medicines sold in other retail outlets and people may require special advice on treatment.
Pharmacy staff may discuss with the purchaser how the medicine is to be used, ask questions to make sure that the chosen medicine is appropriate, and check if the person needs to see another health professional such as a doctor. The pack generally includes advice to see a health professional if the condition does not improve or gets worse or, in the case of long term conditions, if a doctor has not been consulted for some time.
Compared to the packs available in retail outlets, medicines like ibuprofen and paracetamol can be bought in larger packs under a pharmacists supervision. But there may still be a limit on how much pharmacy medicine a person can buy. This helps prevent inappropriate and possibly harmful long-term use and reduces delay in diagnosing a condition that requires different treatment.Other examples of pharmacy medicines include tablets for emergency contraception and medicines containing codeine for treating pain that is not relieved by aspirin, ibuprofen or paracetamol alone.
General sale medicines
People can buy general sale medicine packs from retail outlets such as corner shops and supermarkets. The medicinesalso called general sales list (GSL) medicinesare also available for self-selection in pharmacies.General sale medicines are taken for common, easily recognised ailments which usually last around 23 days. These medicines cause few troublesome side effects in normal use.
To reduce the chances of harm from inappropriate use, many general sale medicines packs contain only a few doses and they often carry advice to get help from a health professional if the ailment does not improve or gets worse.A general sale medicine may be advised for treating a limited range of conditions whereas the same medicine can be used for a wider range of conditions when it is sold as a pharmacy medicine and an even wider range of conditions when supplied on prescription. Prescription-only medicines and pharmacy medicines can be used at higher doses and for longer duration than general sale medicines. Also, medicines in general sale packs may be used for only certain groups of people; for example, they may not be advised for use by children or during pregnancy.
Examples of general sale medicines include small packs of painkillers and of antihistamines for hayfever and other allergies.
Over-the-counter medicines
Over-the-counter (OTC) medicines covers all general sale medicines and pharmacy medicines. The description conveniently distinguishes medicines that can be bought from those that must be prescribed.The term over the counter medicines is informal and is not used in the UK medicines regulations.
Changing the legal classification of a medicine
The legal classification of a medicine may sometimes changewe call this reclassification. It is also sometimes called switching. Growing confidence of the medicines role and improved understanding of its side effects can lead to a change in classification.