Understanding how medications are classified is an important part of ensuring safe handling of medication. Medicines go through a rigorous process of testing, evaluation and regulation before being granted a licence. The Medicines and Healthcare products Regulatory Agency (MHRA) is the licensing body and oversees the classification process.
In the UK there are four categories of medication, based on intended use, clinical input needed and potential for abuse. Training in safe handling of medication is critical, delivered by specialist providers such as www.tidaltraining.co.uk/health-and-social-care-courses/safe-handling-of-medication-training
Over time, as they become more widely used, medicines may be reclassified. This process is overseen by the MHRA as described here:
General Sales List (GSL)
Medicines classified as GSL can be purchased in retail outlets, including supermarkets and newsagents. Although considered relatively safe, GSL products may have restrictions such as minimum age or maximum quantity. An example of a GSL is paracetamol.
Pharmacy (P)
Pharmacy medicines can only be bought from pharmacies, under a pharmacist’s supervision but without the need for a prescription. These medicines are kept behind the counter and staff may ask questions to ensure that the medicine is appropriate. An example of a P is chloramphenicol eye ointment.
Prescription Only Medicines (POM)
A prescription only medicine is prescribed by a doctor or other qualified clinician. It must be dispensed from a licenced pharmacy or other specifically licensed place. POMs may have harmful side effects and should only be used by the person for whom they have been prescribed. Examples of POMs are blood pressure tablets.
Controlled Drugs
Some POMs have potential for abuse and dependence, with implications for criminal or dangerous associated behaviour. These medications are specifically listed as Controlled Drugs and are subject to restrictions on storage, dispensing and administration. An example of a controlled drug is morphine.
How a clinical trial reaches MHRA approval
Before a medicine can be licensed and classified, it usually has to come through long clinical trials. Testing methods, such as home testing kits for infections, also go through trials to make sure they give reliable results.
The process starts with designing the trial: outlining the method, choosing participants and deciding how data will be collected. When researchers are ready to begin testing on people, they submit their paperwork and findings to the MHRA, which can help with questions along the way. The agency then reviews the application using a team of experts, including pharmacists, chemists and a statistician, so that every angle is considered.
Researchers often begin with animal studies to check whether a medicine is likely to be safe for people. Human studies tend to start small and then move to larger groups, with later stages running for longer so that long term effects can be studied. The whole journey can take many years and a lot of paperwork before a medicine is approved.
What the regulator checks before approval
The MHRA, the Medicines and Healthcare products Regulatory Agency, is part of the Department of Health and Social Care. Its role covers both medicines and medical devices, making sure they are safe and properly approved before patients use them.
Medicines cannot be sold or supplied in the UK until the MHRA has approved them. A company applying to market a product must give full details of how it is made, along with the evidence that supports its use. The agency also checks that manufacturers keep to high quality standards and that clinical trials of new drugs are carried out rigorously.
Its work continues after approval. The MHRA monitors medicines on the market to protect the public from unsafe products, and it can investigate and act against manufacturers who do not meet the required standards. That oversight sits behind every classification a medicine is given.
