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Specialists warn of heightened OTC risks

The risks of increasing access to over-the-counter medicines may outweigh the benefits, specialists have warned.

Writing in this week’s British Medical Journal, they suggest OTC medicines should be kept under close review and patients urged to report any adverse reactions.

Professor Robin Ferner, director of the West Midlands Centre for Adverse Drug Reactions, Birmingham, and Dr Keith Beard, consultant physician at Victoria Infirmary, Glasgow, UK, say that when regulatory authorities decide whether a medicine should be reclassified to make it available OTC, they should balance the benefits of easier access against potential harm from unsupervised or inappropriate use.

The authors note that once medicines have been reclassified they remain subject to safety review.

Patients, doctors and pharmacists can all benefit if medicines are available OTC.

For example, patients can call at a pharmacy any time rather than waiting to see a doctor, GPs no longer need to write prescriptions for minor ailments and pharmacists can make better use of their professional skills.

Drug companies and retail pharmacies can also expect to benefit commercially from reclassification.

However, the authors cite worries about OTC medicines.

For instance, a patient who makes the wrong diagnosis and uses an inappropriate medicine may present late with a potentially serious condition.

Prescribers also have no opportunity to reinforce instructions for safe use as they can with prescribed medicines.

Regulators can reduce the potential for harm of OTC medicines by specifying the concentration, dose or pack size a pharmacist can supply without prescription.

However some drugs, such as statins, are probably less effective in low doses than in the higher doses usually prescribed.

Internet shopping now also makes it straightforward, if risky, to order medicines without involving a doctor or pharmacist.

The Royal Pharmaceutical Society of Great Britain estimates that two million Britons obtain their medicines that way.

So, the authors ask, what needs to be done to increase OTC medicines’ safety?

They say safety has to be continually reviewed, even though this is difficult in practice.

Healthcare professionals may not be involved so have to rely on patients to report adverse effects.

A new website allowing patients to report adverse drug reactions to the UK Yellow Card scheme could be helpful. The scheme helps the Medicines and Healthcare Products Regulatory Agency monitor the safety of medicines on the market.

Regulators should also ask for clearer evidence of benefit at the OTC dose if this is lower than the dose usually prescribed, they conclude.


Your comments: (Terms and conditions apply)

“I agree with your concern! In Brazil it is very common for a patient to use only OTC and never go to a doctor. They remain undiagnosed and sick.” – Iolanda Szabo, Brazil

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