Further Information:
A new liability offence relating to driving whilst under the influence of certain drugs will come into effect in the summer of 2014, in the United Kingdom. The principle target for this offence is dangerous drivers who are impaired after recreational use of drugs either used illegally or abused.
In addition to illegal or abused recreational drugs, licensed medicines that are controlled under the Misuse of Drugs Act, such as morphine, amphetamine and some benzodiazepines are also included within the scope of this updated legislation.
This new liability offence being introduced in the UK also has implications for some medicines authorised in Ireland, as they are marketed in joint Irish / UK packs (the Irish medicines share the same product information and outer labelling, as the medicine authorised in the UK). As a result of this, the product information of some medicines that have been updated in the UK will also be updated in Ireland.
Below is the wording agreed by the HPRA for the updates to the summary of product characteristics (SmPC), patient information leaflet (PL) and outer labelling of the medicines affected by the new liability offence.
Please note that the Irish legislation in relation to drug driving is currently being revised and the HPRA are liaising with the Department of Transport in this regard. Once the updated Irish legislation comes into effect, Marketing Authorisation Holders will be required to implement any necessary changes for medicines authorised in Ireland.
Patients are advised to discuss any concerns arising from these changes to the product information with their doctors.
Proposed IE text for SmPC, PL & labelling – drug driving
SmPC – section 4.7
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. 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 may be an offence to drive while under the influence of this medicine
PL - section 2
This medicine can affect your ability to drive
Do not drive whilst taking this medicine until you know how this medicine affects you
It may be an offence to drive if your ability to drive safely is affected
There is further information for patients who are intending to drive in Great Britain – go to https://www.gov.uk/drug-driving-law
Labelling
Add the following prompt and warning to the product label.
FLASH
“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