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New drug driving offence Ė changes to SPCs and product labelling

7th January 2014

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued information about changes that will be made to UK SPCs, PILs and product packaging for all medicines controlled by the Misuse of Drugs Act. This is in anticipation of the new drug driving offence that is due to be debated in parliament and come into effect later in 2014.

The main target for this offence is dangerous drivers who are impaired after recreational use of drugs, including illicit as well as controlled drugs such as morphine, amphetamine and some benzodiazepines (see our news item 08-08-2013). A statutory defence has been included in the draft legislation for patients who have been prescribed the drugs for medical or dental purposes and are taking them in accordance with the prescriber’s directions and information given by the manufacturer. The information given by the manufacturer in section 4.7 of the SPC is now to include the following text:

“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 drive
  • Do not drive until you know how the medicine affects you
  • It is an offence to drive while under the influence of this medicine
  • However, you would not be committing an offence (called ‚Äėstatutory defence‚Äô) 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‚ÄĚ.

Similar wording is to be added to the PIL and product packaging.

In addition to this a further consultation on the amphetamine limit for drug driving was opened on 19th December 2013, closing on 30th January 2014.

MHRA information on changes

Drug driving proposed regulations

Consultation on amphetamine limit