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Document name: Drugs and Driving: Update Portfolio Document type: Medicines Management Communication Staff group to whom it applies: All prescribers, pharmacy and clinical staff within the Trust Distribution: The whole of the Trust How to access: Intranet Issue date: Feb 2015 Next review: Feb 2016 Approved by: Drug and Therapeutics Sub-Committee Developed by: Mark Payne, Senior Clinical Pharmacist Director leads: Medical Director Contact for advice: [email protected] Communication: Drugs and Driving: Update Introduction The Department for Transport has introduced a new offence of driving with certain controlled drugs above specified limits in the blood; this is likely to come into force on 2 March 2015. As the list of drugs covered by this legislation includes medications which we may prescribe / supply to our clients all clinicians should be aware of the impact these changes should have on their practice. Abbreviations MHRA – Medicines and Healthcare products Regulatory Agency Impairment of ability to drive The guidance on advising patients about the risk which medications may pose to their fitness to drive remains unchanged: at the point of prescription, and at regular reviews of medication which may affect driving ability the following advice should be given: Check the leaflet that comes with your medicine for information on how your medicine may affect your driving ability It is against the law to drive if your driving ability is impaired by this medicine Do not drive while taking this medicine until you know how it affects you (especially just after starting or changing the dose of the medicine) Do not drive if you feel sleepy, dizzy, unable to concentrate or make decisions, or if you have blurred or double vision Patients should be advised that if they drive whilst their ability is impaired that this is a crime in itself, and the fact that the medication is prescribed for them is not a defence to prosecution. New legislation The new offence refers to driving, attempting to drive or being in charge of a vehicle with a specified controlled drug in the body, in excess of a specified limit (Section 5A of the Road Traffic Act 1988 as amended in April 2013). The drugs to be covered by this offence are defined in regulations supporting the offence and are listed below. Those individuals who have taken their medicine(s) in accordance with the advice of the prescriber or supplier of the medicine(s) (and/or the product information included in the medicine pack) who are found to have a blood level higher than that specified in the regulations are entitled to raise the statutory “medical defence” at any stage (see below for full explanation), and might then not be asked to provide a blood sample. If the police had evidence that the patient's driving was impaired due to drugs, whether prescribed or not, they can prosecute under the existing offence of driving whilst impaired through drugs offence described in section 4 of the Road Traffic Act 1988, for which there is no statutory “medical defence” Medicines / drugs which are affected by the new regulations The following substances will covered by the regulations with effect from March 2015 Low levels allowed by law - commonly abused drugs - less likely to be used for therapeutic effects - any dosing likely to breach regulations Higher levels allowed by law - subject to misuse - commonly used in therapeutic practice - therapeutic dosing unlikely to breach regulations Cannabis (THC)* Cocaine (and a cocaine metabolite, BZE) MDMA (Ecstasy) Lysergic Acid Diethylamide (LSD) Ketamine Heroin/diamorphine metabolite (6-MAM) Methylamphetamine Clonazepam Flunitrazepam Oxazepam Diazepam Lorazepam Temazepam Methadone Morphine Amphetamine*** ***Whilst amphetamine will not be included in the current regulations to go before Parliament in 2014 it is expected to be included later in 2015 once a limit has been agreed [June 2015 D&T approved update – law changed 14Apr15 which adds amfetamine to the existing list of drugs specified in The Drug Driving (Specified Limits) (England and Wales) Regulations 2014] The statutory "medical defence" This new offence does not alter in any way the clinical advice that should be given to patients in future, which, as now, is based on a proper professional judgement for each patient of what is the appropriate discussion concerning the risks of their medicines. A patient who was investigated for drug driving would generally be entitled to raise the statutory “medical defence” if: a) The drug was lawfully prescribed, supplied, or purchased over-the-counter, for medical or dental purposes; and b) The drug was taken in accordance with advice given by the person who prescribed or supplied the drug, and in accordance with any accompanying written instructions (so far as the latter are consistent with any advice of the prescriber). Recommendations 1. Prescribers can continue to use these medications where clinically appropriate and within the terms of their license / Trust policy 2. Periodically review the total amount of sedative medication, particularly when prescribing any new sedative medication, and document these reviews. 3. Although blood levels have been set for the purposes of regulation, there is no need to monitor these in clinical practice, as this is independent of therapeutic effect. 4. When prescribing these medications for inpatients it is not necessary to inform the patient, however at the point of authorising leave / discharge these issues must be addressed. 5. All community patients should be advised about the risk before the legislation comes into effect. (See Appendix B for standard letter advising of the risk) 6. Where it is necessary to prescribe one of the specified medications the following advice should be given, and a record of this made in the clinical notes: a. To check their medication information leaflet to see what effects the medication may have on them b. Not to drive where they feel that their fitness to drive may be impaired c. To avoid driving immediately following; i. Initiation / change of dose until the effects of this are known ii. Changes to other medications they take, as these may interact iii. Changes to their physical health, as these may combine with the medication to affect their fitness to drive d. To avoid drinking any alcohol and then driving as there may be additive effects on fitness to drive 7. All patients prescribed these medications should be advised to keep copies of suitable evidence with them whilst driving e.g. copy of prescription. The MHRA has produced an information leaflet which may be helpful to facilitate these discussions. Appendix A- Version Control Sheet This sheet should provide a history of previous versions of the policy and changes made Version Date Author Status Comment / changes 0.1 Oct 2014 Mark Payne Draft 1.0 Feb 2015 Mark Payne Approved June 2015 Jane Riley Approved Updated wording in line with D&T review Added letter advising of the risk (D&T approved update – law changed 14Apr15 which adds amfetamine to the existing list of drugs specified in The Drug Driving (Specified Limits) (England and Wales) Regulations 2014] Name of office/team Location address Address Address Address Postcode DATE Name Address Postcode Tel: Fax: Ref: Email address Dear , Re: Changes to the law regarding medication and driving On the 2nd of March 2015 the law regarding prescribed medication and driving is changing, there will be legal limits introduced on the amount of the following medications which you can have in your system: Clonazepam Diazepam Methadone Flunitrazepam Lorazepam Morphine Oxazepam Temazepam Amphetamine If you are prescribed one of these medications, please keep a copy of your prescription with you when you are driving as proof that you are taking this under the direction of a prescriber. Please note: if at any time you are concerned that your fitness to drive is impaired due to medication please do not drive. Having a copy of your prescription will not prevent you from being prosecuted in this situation. Yours sincerely, Name Title Cc: if required