GovWire

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) - must be prescribed by a doctor or other authorised health professional and must be dispensed from a pharmacy or from another specifically licensed premises
• Pharmacy Medicine (P) - can be bought only from pharmacies and under a pharmacists supervision
• General Sales List Medicines (GSL) - may be purchased without the supervision of a pharmacist and are available in retail outlets, such as a newsagent, a supermarket, or a vending machine in a shop

The fundamental principle guiding the classification of medicines is to optimise timely access to effective treatments while reducing the risk of harm from improper use.

Making medicines available over-the-counter: the trade-offs

Classifications of medicines

The three legal categories are explained here, with examples of medicines in each of the categories. It also explains how the categories relate to the term over-the-counter (OTC) medicines.

Prescription-only medicines

Medicines classified as prescription only can be exclusively obtained 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 lettersPOMappears 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 antibiotics and medicines for treating epilepsy.

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 letterPappears on the packaging of pharmacy medicines.

Pharmacy medicine packs are generally for short term treatment of medical conditions that can be readily identified 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 for erectile dysfunction.

General sales list medicines

People can buy general sales list medicines from retail outlets such as corner shops and supermarkets. The medicines are also available for self-selection in pharmacies. General sales list 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 sales list medicines 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 sales list medicine may be recommended 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 sales list medicines. Also, general sales list medicines may be used for only certain groups of people; for example, they may not be recommended for use by children or during pregnancy.

Examples of general sales list medicines include small packs of painkillers, and of antihistamines for hay fever and other allergies.

Over-the-counter medicines

Over-the-counter (OTC) medicines covers all general sales list 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 change, we call this reclassification. It is also sometimes called switching. Growing confidence in the medicines action and improved understanding of its side effects can lead to a change in classification.

Prescription-only medicine (POM) to pharmacy medicine (P)

A medicine will be non-prescription unless it fulfils the criteria for prescription control as set out below.

Prescription only status will apply where:

• a direct or indirect danger exists to human health, even when used correctly, if used without medical supervision
• there is frequently incorrect use which could lead to direct or indirect danger to human health
• further investigation of activity and/or side-effects is required
• the product is normally prescribed for parenteral administration (by injection)

In the UK these criteria are laid down in the Human Medicines Regulations 2012, regulation 62(3).

Pharmacy Medicine (P) to General Sales List Medicine (GSL)

Under the provisions of The Human Medicines Regulations 2012, regulation 62(5),GSLis appropriate for medicines which can, with reasonable safety, be sold or supplied otherwise than by or under the supervision of a pharmacist.

The term with reasonable safety has been defined as: where the hazard to health, the risk of misuse, or the need to take special precautions in handling is small and where wider sale would be a convenience to the purchaser.

Reclassification may involve:

• introduction of one or more additional legal status for a particular medicine. For example, a prescription-only medicine may additionally be classified into a pharmacy medicine category or a general sales list medicine category. In such a case, the quantity, dose and the conditions for which the medicine is used for may be restricted when it is supplied within the new categories compared to the original prescription-only category.
• switching over entirely from one classification to another. For instance, all packs of a pharmacy medicine category could be changed to the general sale list medicine category. In this case, the previous pharmacy medicine category would no longer apply to that medicine.

Evidence to support the classification change

A proposal to change a medicines classification needs to be supported by good evidence that focuses on the risk to the public on changing the classification.

The evidence may comprise clinical studies, extensive clinical use indicating acceptable level of side effects, advice of experts, views of relevant health professionals and their professional bodies, as well as the views of relevant public associations and individuals with an interest in the medicine under consideration. The evidence needs to demonstrate that the risk to the public will be adequately managed.

Procedure for requesting a classification change

At theMHRA, we have set out a procedure for requesting a classification change. TheMHRAprocedure is straightforward and quick if a classification change concerns a med

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