Public Servant Lifestyle

Drowsiness warning for drivers using over-the-counter medicine.

The labelling of some over-the-counter medicines is inconsistent, inaccurate and could be a danger to drivers, according to research published by the Department for Transport (DfT).

The study forms part of the DfT's programme of research into the impairment effects of drugs and driving. It was undertaken by the Sleep Research Unit of Loughborough University.

Key findings include:

The British National Formulary's (BNF) recommended range of advisory labels warning of possible drowsiness are not always followed closely by manufacturers.

The accuracy of information regarding drowsiness provided by manufacturers is inconsistent. Medicines containing the same active ingredient at similar doses ought to have the same advice regarding their potential to produce drowsiness, this is not always the case.

Some products' labels give different drowsiness advice on the patient information leaflet enclosed and on the exterior packaging, often with the more substantial warning in the small print of the patient information leaflet, where it is less likely to be read.

Few products have clear and well-presented labels. Label visibility is often inadequate and most require improvements.

There is a need for improved guidelines for manufacturers on these issues. The introduction of a standard symbol, warning of drowsiness, should be considered in the UK. The use of a standard symbol on medication, warning of drowsiness, is already present in some countries.

Road Safety Minister, David Jamieson said: "There are more than one hundred over-the-counter medicines with a potential to cause drowsiness. To ensure that motorists drive can safely, it is vital that they are warned about the dangers of about drowsiness.

"Labelling must be clear and understandable to people and I understand that the Department of Health Medicines and Healthcare products Regulatory Agency (MHRA) are examining the issue. Particularly in the hayfever season, people should check with their pharmacist if they are in doubt and pull over if they feel drowsy when driving.”

The following links may be useful:

Food Standards Agency Labelling Advice

British National Formulary website

Allergens: Label Guidance - How the FSA are working to improve food labelling.

Department for Transport website

Loughborough University website

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