In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the organisation that looks after the safety of prescribed medicines and other health devices and equipment. Its main job is to make sure that medicines and medical devices, from painkillers to pacemakers, work properly and are acceptably safe.
The MHRA works closely with the European regulator, the European Medicines Agency (EMA), which oversees the safety of medicines across Europe. In some cases, the EMA takes the lead in licensing medicines that are used in the UK.
Ensuring safety
No product is completely risk free, so the MHRA uses as much information as it can to ensure that the benefits of medicines to patients justify any possible risks.
The MHRA assesses the results of clinical trials to decide whether or not new medicines should be licensed for use. Clinical trials are research studies that carefully test the safety and effectiveness of medicines, using strict criteria.
No medicine or medical device can be used in the UK until the MHRA or EMA has given it a licence that sets out how it should be used and what health condition it should be used to treat. See Medicines information - licensing for more information.
However, no medicine is completely risk free and medicines can affect different people in different ways. For example, depending on your age and sex and what other medicines you may be taking, a medicine might cause you to have a side effect that someone else who is taking the same medicine does not have.
Ultimately, you and your healthcare professional have to weigh up the pros and cons of each medicine when deciding on the most appropriate treatment.
Monitoring safety
The MHRA also monitors the safety of medicines once they are in clinical use, and it takes action if a problem arises. This may mean alerting healthcare professionals about a potential issue with a medicine and withdrawing a medicine from the market if it becomes apparent that the side effects outweigh the benefits.
For example, in January 2010, the EMA recommended that the weight-loss medication sibutramine should be withdrawn across the European Union due to a safety concern. New evidence suggested that the increased risk of having a heart attack or stroke outweighed the benefit of using the medication. As a result, sibutramine is no longer prescribed in the UK.
Reporting an adverse effect
The Yellow Card Scheme is a special reporting system for possible adverse effects of medicines. If the healthcare professional who is treating you thinks that a medicine may have caused a potentially concerning effect, they will fill in a report and send it to the MHRA.
You can also use the Yellow Card Scheme yourself, or on behalf of a child or adult in your care, by:
- calling 0808 100 3352 to report an adverse effect over the phone
- logging onto the Yellow Card Scheme website to report an adverse effect online
