New drug driving offence – information for healthcare professionals and patients
A new liability offence will come into effect in the summer of 2014 regarding the use of drugs whilst driving.
It is important that information is provided to healthcare professionals who prescribe these medicines and to patients who are prescribed or have purchased medicines affected by this new offence.
Pharmaceutical companies are requested to update the SmPC, the patient information leaflet and product labelling with the UK specific warnings.
Full details regarding the new driving offence concerning driving after drugs have been taken in the UK and may be found here:
https://www.gov.uk/drug-driving-law [External Link]
Section 4.7 ‘Effects on ability to drive and use machines’ of the SmPC will be updated with the following:
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
The medicine is likely to affect your ability to driveDo not drive until you know how the medicine affects youIt is an offence to drive while under the influence of this medicineHowever, you would not be committing an offence (called ‘statutory defence’) if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
- It was not affecting your ability to drive safely"
Patient Information Leaflets will be updated with the following text under the heading:
Driving and using machines:
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Do not drive while taking this medicine until you know how it affects you.It is an offence to drive if this medicine affects your ability to drive.However, you would not be committing an offence if:
The medicine has been prescribed to treat a medical or dental problem and
You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Labelling will be updated as follows:
Flash (on front of pack) - New advice for drivers – see leaflet inside
Back of pack - This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information.