Memorandum from the Medicines and Healthcare
products Regulatory Agency (MHRA) (DDD 23)
1. INTRODUCTION
1.1 The pharmacological properties of some
classes of medicines are such that there is the potential for
driving ability to be impaired. The MHRA recognises the seriousness
of the impact which some medicines can have on a patient's ability
to drive, and medicines takers and their carers must be made aware
of the potential risks.
1.2 Communication of potential effect on driving
ability currently depends on the product information, label warnings
added in the pharmacy and wider education initiatives. While there
is overall a lack of evidence of significant harm from driving
impairment by medicines, the MHRA is exploring a strategy for
the further review and development of effective risk minimisation
measures centred on improving patient and health professional
awareness. This strategy will be risk-based, targeting classes
of medicines that have a significant potential to impair driving
ability according to known pharmacology, published evidence, and
reporting of suspected adverse drug reactions.
1.3 The issue of impairment of driving ability
by medicines is also being debated at a European level and the
MHRA is playing a leading role in developing a European consensus
on the optimal approach for medicines via risk categorisation
and labelling.
1.4 The Commission on Human Medicines (CHM),
the Government's independent scientific advisory committee on
medicines safety, has highlighted the need for improved safety
information for the public, communicated through various routes,
and an expert Working Group of the CHM is being convened this
autumn to consider this further.
2. BACKGROUND
2.1 The Medicines and Healthcare products
Regulatory Agency (MHRA) continuously monitors the safety of all
medicines in the UK, and where necessary, takes suitable action
to safeguard public health. The Agency uses a variety of methods
of collecting information on medicines safety, both prescription
and over the counter (OTC). Healthcare professionals, as well
as patients, are encouraged to report suspected adverse drug reactions
to the MHRA via the Yellow Card Scheme and there is a legal requirement
for pharmaceutical companies to report reactions to their products.
A database of these suspected adverse reactions is maintained
which helps provide early warnings of potential drug hazards.
2.2 Before taking regulatory action, the
MHRA seeks advice on medicines safety issues from the CHM. The
MHRA/CHM take action based on the available evidence of the risk
and benefit of a medicine and different courses of action are
necessary in different situations proportionate to risk.
2.3 As new information becomes available,
regulatory action undertaken by the MHRA to minimise the risk
of driving impairment by licensed medicines has included issuing
warnings to healthcare professionals about particular medicines
through our drug safety publication Drug Safety Update.
3. MEDICINES AND
DRIVING
3.1 There is a dearth of evidence that medicinal
drugs, as opposed to those taken for recreational purposes, contribute
significantly to road accidents. The Department for Transport
(DfT) collects extensive information about road casualties, including
information provided by the police on contributory factors. There
are significant limitations with this data—for example,
an officer is likely to identify drugs as a contributory factor
only where the related offence has been formally investigated.
The figures published for drugs—illicit or medicinal—as
a contributory factor are low, but are not considered to be a
correct representation of the incidence of accidents in which
impairing drugs may have been involved. The current offence of
driving whilst impaired by drugs does not distinguish between
illicit drugs or legitimate medicines. Therefore it is not possible
to distinguish from the data available from the Ministry of Justice
whether the main contributor in "drug driving" is the
recreational consumption of illicit drugs or the use of legitimate
medicines.
3.2 Medicinal drugs are used to treat medical
conditions, and are authorised on the basis that benefits outweigh
risks. Some medicines, such as benzodiazepines, can affect the
ability to carry out skilled tasks such as driving and operating
machinery, often by affecting cognitive function. Inexperience,
speed, alcohol, tiredness and illicit drugs are factors that contribute
to road traffic accidents and there is a high level of awareness
of these factors by both health professionals and the general
public. The contribution that some medicines may make is not,
however, well established, and this has been acknowledged in the
North review.
3.3 Medicines are widely used to prevent
and treat disease and although it is difficult to quantify their
impact, some have potential to impair driving skills. If a patient
has a particular medical condition treated by medicines which
may affect their ability to drive eg Parkinson's disease and dopamine
agonists, this is monitored by their doctors and the Driving Vehicle
and Licensing Agency (DVLA). In addition it is recognised that
some licensed medicines prescribed for therapeutic purposes, which
may affect ability to drive, may also be abused for recreational
purposes, eg benzodiazepines. Interactions between medicinal drugs
also need to be borne in mind. Non-impairing drugs may in combination
become "impairing" by exacerbating cognitive effects.
3.4 While it is recognised that some medicines
may affect the ability to drive It is recognised that some medicines
may affect ability to drive It is recognised that some medicines
may affect ability to drive It is recognised that some medicines
may affect ability to driveiiii It is recognised that some medicines
may affect ability to driveit is important to remember that some
diseases themselves such as Parkinson's disease, epilepsy, depression
and schizophrenia may impair driving performance. The use of medicines
in these conditions may alleviate the driving impairment associated
with the condition itself enabling patients to continue to drive.
4. THE NORTH
REPORT
4.1 The MHRA has worked closely with the
Department of Health (DH) and the Department for Transport (DfT)
on the review undertaken by Sir Peter North. The North report
makes two recommendations about the management of patients taking
medicine which might impair driving, on patient information with
medicines, and on education and awareness:
Patient information
— The Government, in conjunction with the
pharmaceutical industry, should address the issue of the quality
and clarity of the patient information provided with over-the-counter
medicines and the merits of a simple and easily communicated system
of advice related to driving, along the lines of that used in
France.
4.2 Patients are more informed about their
medicines today than they once were. All medicines are required
to be accompanied with a Patient Information Leaflet (PIL). Research
undertaken by the University of Leeds indicates that a large proportion
of patients read the PIL which accompany medicines.[1]
Since amendments to the European legislation in 2005, PILs are
subject to "user testing" to ensure that patients are
able to read and understand the written information to ensure
that it meets their needs. PILs are therefore key risk minimisation
tools in communicating messages about the impact of medicines
on driving.
4.3 The provision for warnings in PILs is
catered for in current National and European medicines regulation.
Where any medicine is known to affect cognitive function a warning
is included in the information for prescribers and patients. Updates
to particular PILs have regularly been undertaken when new safety
information has become available. The safe use of all medicines
depends on users reading the label carefully and being able to
act appropriately on the information presented, supported by healthcare
professional advice.
4.4 The use of pictograms on the product
packing to communicate a message about a medicine has not so far
been generally supported in the UK. There is a lack of robust
evidence about the effectiveness of pictograms in communicating
information, and resulting in appropriate action being taken.
An Expert Working Group of the Committee on Safety of Medicines
(now the CHM) advised that warning symbols were open to misinterpretation.
If warning symbols were introduced, the meaning of any such symbol
would need to be clear and patients, the public, and healthcare
professionals would need to be able to take appropriate action.
This would require a process of user testing.
4.5 The MHRA is keen to work together with
European regulators to strengthen information for prescription
and over-the-counter medicines. We are playing a key role in European
discussions and have been consulting with researchers in the European
Commission funded DRUID (Driving Under the Influence of Drugs,
alcohol and medicines) project to examine how other Member States
are addressing this issue.
4.6 The DRUID project has also examined
risk categorisation systems currently being used in some EU countries
for medicines which may impair ability to drive. There is no consistent
approach in Europe on the use of pictograms on medicines packaging,
and several different systems have been put in place over time.[2]
The effectiveness of these systems has been reviewed by the countries
concerned, leading to various adjustments. For example, the French
categorisation system has been amended with the introduction of
four levels of warnings and three different pictograms added to
those medicines considered to have an effect on driving ability.
In contrast, Spain had a four tier system and recently moved to
a two tier system with a single pictogram (launched 2009). Sweden
abandoned the pictogram as their categorisation system was considered
to be obsolete. It was also recognised that the pictogram was
not interpreted correctly, or even associated with driving ability.
Sweden now has a generic warning added to patient information
leaflets for medicines under a section entitled "driving
and using machinery."
4.7 The research findings of the DRUID project
concerning categorisation systems are to be presented and discussed
later this year with our European partners and the MHRA will be
contributing to the discussions and outcome.
Education and awareness
— The NHS, Department of Health and Driver
Vehicle Licensing Agency should ensure that doctors are consistently
reminded, in their training, their practice and their assessment,
of the importance of routinely providing clear advice to patients
on the effects of prescribed drugs on driving.
4.8 The MHRA are examining ways to focus
educational activities to different target audiences including
medicines takers and healthcare professionals. This is one of
the issues that the forthcoming CHM Expert Working Group will
consider.
5. CONCLUSION
5.1 The MHRA is exploring a strategy for
the further review and development of risk minimisation measures
in respect of taking medicines and driving, centred on improving
patient and health professional awareness.
5.2 The issues are being debated at a European
level and the MHRA is playing a leading role in developing a European
consensus on the optimal approach for medicines via risk categorisation
or labelling.
5.3 The CHM has highlighted the need for
safety information for the public, communicated through various
routes and an expert Working Group of the CHM is being convened
to consider the issues further.
August 2010
1 Raynor D K, Silcock, J, Knapp, P, Edmondson, H. How
do patients use medicine information leaflets in the UK? International
Journal of Pharmacy Practice, Volume 15, Number 3, September
2007, pp 209-218(10). Back
2
Review of existing classification efforts. Available from DRUID
website http://www.druid-project.eu/cln_007/nn_107534/Druid/EN/deliverales-list/deliverables-list-node.html?__nnn=true Back
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