Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Hot topics
New drug driving offence – changes to SPCs and product labelling
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 targets for this offence are 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 ‘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.
Similar wording is to be added to the PIL and product packaging.
In addition, a further consultation on the amphetamine limit for drug driving has just closed. For further information, click on the following links: MHRA information on changes, Drug driving proposed regulations.
Interim statement as LCP is phased out
The leadership Alliance for Care of Dying People (LACDP) has published an interim statement on its work following the publication of the independent report on the Liverpool Care Pathway in July 2013. For more information, click here.
Latest additions
PCF updated monographs
The online Palliative Care Formulary (PCF) is being continually updated. The following monographs have been updated during January 2014 and supersede those in the publication of the 4th edition of the Palliative Care formulary (PCF4) and the PCF4+ 2013 epdf. They can be accessed from the formulary section of the website:
Chapter 1: Rectal products for constipation, Pancreatin
Chapter 2: Glyceryl trinitrate, Systemic local anaesthetics Note: information relating to flecainide has been moved into systemic local anaesthetics monograph
Chapter 8: Methenamine hippurate, Tamsulosin
For a full list of all the monographs updated since the publication of PCF4, click here.
Prepared by Sarah Charlesworth and Andrew Wilcock