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Medicinal products and driving*

On behalf of the working Group “Medicinal products and automobile driving” created by Afssaps:
Christian RICHE (chairman), Charles CAULIN (vice-chairman), Jacques CARON, Anne
CHIFFOLEAU, Christian CORBE, Bertrand DIQUET, Alain ESCHALIER, Françoise HARAMBURU,
Georges LAGIER, Jean-Pierre LEPINE, Michel MALLARET, Charles MERCIER-GUYON, Louis
MERLE, Jean-Louis MONTASTRUC, Pierre PHILIP, Francis RODOR.
The technical and scientific coordination has been carried out by the “Risk monitoring and
assessment, and information on medicines” sector:
Anne CASTOT, Bernard DELORME, Aurore TRICOTEL.
1 - Introduction

The combat against road traffic accidents constitutes a major public safety concern and is a priority of
the governmental authorities. Given that there are about 40,000 deaths and 1,700,000 injuries on
European roads each year, the European Commission, in its 2003-2010 action program, proposed the
ambitious objective of halving the number of fatalities by 2010†. In France, the reduction has been
underway for several years. The lowest level was achieved in 2007, the sixth year of consecutive
reduction, with 4,620 people killed. However, the number of injured - like the number of accidents -
has increased slightly (1.1%) since 2006, showing that the mobilization must be maintained by acting
on all the factors contributing to road safety.
Besides the risk associated with infrastructures and vehicle equipment, most of the risk factors are
associated with behavior: excessive speed, alcohol intake, driving when tired, use of psycho-active
substances and medicinal products. A great number of medicinal products have, in fact, a patent
impact on the ability to drive a car. On the basis of the published data, exposure to a potentially
hazardous medicinal product is observed in about 10% of road accident victims. The percentage of
accidents related to medicinal product intake is, however, difficult to determine accurately. Hypnotics
and anxiolytics (particularly benzodiazepines) are the drugs most frequently identified. However, few
other pharmacotherapeutic classes have been studied‡,§.
In 2003, in the context of the action program defined by the Inter-Ministerial Committee for Road
Safety (CISR), The Director General of Health asked the French Agency for the Safety of Health
Products (Afssaps) to consider the usefulness of classifying, within three risk levels, the medicinal
products liable to impair the ability to drive, thus falling in line with the recommendations of the
National Academy of Medicine**. In order to do so, the Afssaps has put in place a group of experts (cf.
composition of this working group above) including both specialists in the various fields of
pharmacology (pharmacokinetics, toxicology, pharmacovigilance) and clinicians specializing in the
disciplines providing care for accident victims (neurology, ophthalmology, cardiology, legal expertise,
etc.).
The proceedings enabled development of a simple device that is readily understood by everyone: a
pictogram in three colors (yellow, orange, red) displayed on the outer packaging of the medicinal
products involved. The device is intended to deliver practical preventive measures and thus provide
concrete assistance to patients and healthcare professionals (mainly physicians and open-care
pharmacists). It is to be noted that the Afssaps classification evaluates the intrinsic risk of medicinal
* By extension, this update also covers the effects of medicinal products on the ability to drive all types of vehicles (with or without a motor), use machines (including domestic and leisure use) and implement tasks requiring attention and precision. † European Parliament resolution on the Commission communication to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions on the 'Priorities in EU road safety - Progress report and ranking of actions' (COM(2000)125 - C5-0248/2000 - 2000/2136(COS)) ‡ De Gier JJ. Estimation of psychotropic drug secondary effects on vigilance. Vigilance et Transports, aspects fondamentaux, dégradation et prévention. Presse Universitaires de Lyon ed, 1995. § Barbone F, McMahon AD, Davey PG, Morris AD, Reid IC, McDevitt DG, MacDonald TM. Association of road-traffic accidents with benzodiazepine use. Lancet.1998;352(9137):1331-6. ** Académie Nationale de Médecine. Rapport sur la Médecine face aux accidents de la route. June 17,2003.
products. However, the diseases for which they are administered may constitute decisive components
of the ability to drive and themselves also to be taken into account.
The medicinal products liable to have an impact on the ability to drive are identified in a specific
section (Effects on ability to drive and use machines) of the Summary of Product Characteristics
(SPC). Initially, the expert group determined the risk level of medicinal products acting on the central
nervous system and sense organs. Those products were considered, a priori, the most harmful with
respect to driving. The three-level pictogram has thus been gradually applied to the corresponding
proprietary medicinal products since 2005. Currently, the Afssaps has completed the risk grading of all
other medicinal products associated with a risk.
However, the classification of medicinal products on the basis of their impact on the ability to drive is
liable to change due to the marketing of new drug substances, emergence of new pharmacovigilance
data, and the emergence of new data generated by epidemiological studies.
Accordingly, the Afssaps is contributing to a research program designed to better identify and quantify
the impact of drug intake on road accidents. The program, entitled CESIR (Combination of Studies on
Health and Road Safety) is based on epidemiological and pharmaco-epidemiological studies
conducted in partnership with Inserm (National Institute for Health and Medical Research), Inrets
(National Institute for Research on Transportation and Safety) and Cnamts (National Salaried Worker
Health Insurance Organization). The program is to enable enhanced elucidation of the context of
medicinal product-related accidents in France and the pertinence of the operations implemented by
the Afssaps in a timeframe of one to two years.
In parallel, the work is being brought to the attention of other European Union member States with a
view to initiating reflection on a common reference system.
The prevention of medicinal product-related risk in driving is based more on educational measures
than on law enforcement or regulatory measures. The Afssaps is also committed to producing
recommendations for a proper use, particularly through an update targeting healthcare professionals.
The expert group having completed the review of all the substances associated with a driving risk, the
present document constitutes an update of the document published in 2005.
2 - Review of the regulatory context

The responsibility concept
Information on treatments and their consequences is to be given to the patient (act dated March 4, 2002). Patients are frequently doubly informed of the risks: when prescribed by the physician and at the moment of dispensing by the pharmacist. It is admitted that the healthcare professional is not bound by a “result” obligation but in the case of information on the risks associated with treatment, professionals may be asked to demonstrate that the information was indeed delivered and understood. To prevent any discussion, the professional is advised to report that information on the ability to drive a vehicle was given to the patient in the patient's medical file and to indicate on the prescription the risk level of the medicinal product(s) involved. In all cases, the driver, independently of the information due to him/her, is directly and solely responsible for complying with the medical opinion received. The list of medical diseases incompatible with obtaining or renewing a driver's license (depending on the category of vehicle involved) is defined in a decree dated December 21, 2005. Although the effects of a medicinal product on the ability to drive and the impact of the disease under management are generally different, there are numerous cases in which they are interdependent. In the current state of the legislation, no waiver of confidentiality rules is possible, even with respect to family members. In practice, if a patient does not agree with the medical opinion, he/she may contact the department Commission to obtain an 'official' opinion on his/her ability*. * Conduire malgré une inaptitude médicale. Concours Med,2007;129:1015-7.
Information relating to the medicinal product

The marketing authorisation data state the risk constituted by medicinal products liable to impair the
ability to drive. The risk is identified:
ƒ in the Summary of Product Characteristics (SPC) in the section 4.7: 'Effects on ability to drive and
ƒ in the user package leaflet under the item 'Drivers and machine users' where a special warning is ƒ on the secondary packaging of the medicinal products involved, on which, since 1999, a pictogram has been displayed. Since 2006, the pictogram has varied as a function of the level of risk associated with the medicinal product involved.
3 - Pictogram gradation by risk level

For achieving the categorisation of medicinal products, several point need to be considered:
the strengths of the effects of a medicinal product on the ability to drive generally increase as a function of the dose, without it being possible to precisely define risk thresholds; there is no standardised assessment method for the car driving risk that can be applied to all medicinal products, in particular during the registration procedures, the epidemiological and accidentology data are few, individual sensitivity induces a high variability in the effects (a given dose of the same drug substance may have very different effects depending on the subject). The qualitative classification of medicinal products using three risk levels adopted by the Afssaps was defined by practical recommendations. ƒ Level 1: the risk is low and largely depends on individual susceptibility; the patient is informed of the cases in which he/she should not drive in the user package leaflet (particularly when the patient has previously experienced potentially hazardous adverse reactions). ⇒ Medicinal products do not generally question the ability to drive but requiring patient information. Patients have
to read the leaflet carefully before driving.

ƒ Level
2: adverse effects on driving due to the pharmacodynamic profile predominate relative to individual susceptibility. It is appropriate to evaluate, on a case-by-case basis, whether medicinal product intake is compatible with driving. Most of the time, the medicinal product is only available on prescription and the physician will assess the patient's condition and/or response to the medicinal product. More rarely, the medicinal product may be available over the counter and thus the pharmacist's advice is of particular importance. ⇒ Medicinal products could affect the ability to drive and require medical advice, from a physician or a
pharmacist, before use.

Level 3: the pharmacodynamic effects of the medicinal product make driving dangerous. With medicinal products of that type (general anesthetics, hypnotics, mydriatic eye drops, etc.), the disability is generally transient but major. Given the possibility of a carryover effect, the physician is advised to tell the patient when he/she will be able to drive again (e.g. after a period of sleep induced by a hypnotic).
⇒ Medicinal products affect the ability to drive during their use. Patients have not to drive. Before driving again,
they have to seek medical advice.


As a function of the above classification, the pictogram has:
ƒ a specific color (yellow, orange and red),
ƒ a written indication of the risk level (1, 2 or 3),
ƒ a written warning followed by an informative message on how to act when using the medicinal The three components are systematically combined and shown on the secondary packaging of the
medicinal products involved.

How to raise the question with the patient?

Each time that a medicinal product showing a pictogram is prescribed or dispensed to a patient, the
patient is to be informed that intake of the medicinal product involved may impair his/her ability to drive
or use machines. The warning is to be accompanied by two types of advice:

General advice

The general advice is common sense but is nonetheless worth repeating:
Stop driving if warning signs are experienced: drowsiness, difficulty concentrating, difficulty steering, visual disorders. Do not take a medicinal product with which you have already experienced that type of symptom. Do not drink alcohol whose effects frequently potentiate those of medicinal products. Preferably take medicinal products liable to have an impact before going to bed.
In the event of long-term medicinal treatment, the patient is to be warned against changing the dosage
or concomitantly taking a new medicinal product. In particular, the patient is to be advised against
discontinuing treatment if the patient is on a treatment for a disease that, in itself, is associated with a
driving risk (epilepsy, arrhythmia, depression, etc.). Attention must also be paid to identifying drug
misuse or abuse and ensuring that the quantities prescribed and treatment durations do not promote
misuse or abuse.
Specific advice

The treatment is chosen, when possible, according to the specific impact of each pharmacotherapeutic
class (cf. next section) but also on the basis of individual risk factors:
⎞ Age.
Physical condition (tiredness, visual acuity). Psychological condition (stress, emotive state). Concomitant diseases and/or organ failures (kidney, liver). * Mura P, Kintz P, Ludes B, et al. Comparison of the prevalence of alcohol, cannabis and other drugs between 900 injured drivers and 900 control subjects: results of a French collaborative study. Forensic Sci Int,2003;133:79-85.
4 - MEDICINAL PRODUCTS WITH IMPACT ON THE ABILITY TO
DRIVE*

The effects of the principal pharmacotherapeutic classes liable to impair the ability to drive are
described below for the attention of physicians and pharmacists. The Afssaps expert assessment was
conducted using the WHO Anatomical Therapeutic Chemical (ATC) classification.
N.B.: the following description is indicative and, under no circumstances, is it a substitute for the
information contained in the 'Effects on ability to drive and use machines' section of the SPC for the
proprietary medicinal products involved. Moreover, special cases may exist within a given
pharmacotherapeutic class (the complete list appended to article R.5121-139 of the Code of Public
Health indicates the exact risk level allocated to each drug).

INDEX

Digestive tract and metabolism
Antineoplastic and immunomodulating agents
DIGESTIVE TRACT AND METABOLISM
- Dihexyverine and belladonna alkaloids, because of their anticholinergic effects, may induce visual accommodation disorders and behavioral disorders (irritability, confusion). - In certain proprietary medicinal products, the antispasmodic is combined with a neuroleptic. In that case, the risk of central adverse effects, particularly drowsiness, is always to be taken into - The patient is to be informed of the risk of drowsiness related to use of papaverine.
2 - Antiemetics and antinauseants
- Antiemetics pertaining to the setrons series are associated with few problems with regard to driving despite the possible occurrence of drowsiness and dizziness since they are only available on prescription and mainly used in hospitals in the context of cancer treatment. - Antinauseants are generally used in the prevention of motion sickness. They include: metopimazine which can induce drowsiness, dizziness and orthostatic hypotension. An OTC presentation is available. The user should be warned; H1 antihistamines more at marked sedation. Most are available OTC and it is important for the pharmacist to give advice when dispensing them; transdermal scopolamine is probably the antinauseant with the most adverse effects on the ability to drive. Due to its anticholinergic properties, scopolamine may induce severe visual disorders (disorders and paralysis of accommodation, mydriasis). * Taking into account data available until August 2008

3 - Antidiarrheals
- Proprietary medicinal products containing opium (paregoric) are liable to induce the characteristic adverse effects of morphine derivatives, particularly drowsiness. Abuse potential - Loperamide, an opiate that only crosses the blood-brain barrier to a limited extent, is not devoid of the adverse effects of the series. However, the effects are rare and transient. The level 1 grade is particularly justified in that certain products are available OTC and thus, as a minimum, the patient should be informed of the risk. The occurrence of an episode of hypoglycemia constitutes a major risk with respect to driving. In general, the risk is less associated with the specific effects of the medication than with inappropriate dosage, reduced food ration or strenuous physical exercise without dosage adjustment. Hypoglycemia is more frequent in patients on insulin therapy (more severe forms of diabetes) but may also occur with oral hypoglycemic sulfonylureas (hypoglycemia is more exceptional with thiazolidinediones, alpha-glucosidase inhibitors and biguanides). It is therefore appropriate to assess the control achieved with the treatment and to warn the patient about the factors promoting hypoglycemia. The patient should be made aware of the premonitory signs of a hypoglycemic episode and the corrective measures to be implemented (stop the vehicle, eat sugar).

CARDIOVASCULAR SYSTEM

1 - Antiarrhythmics
Antiarrhythmics, particularly those in class I of the Vaughan-Williams classification, may give rise to exacerbation or emergence of pre-existing cardiac disorders. The risk, related to the narrow therapeutic margin, calls for close monitoring by the physician. In addition, medicinal products in that class may have neurological effects such as dizziness, tremor, asthenia, drowsiness and visual disorders (blurred vision, diplopia). The patient must be informed. Nitrates, because of their vasodilatation properties, are able to induce orthostatic hypotension, which may be associated with dizziness, visual disorders, fainting or syncope, particularly at the start of treatment. The patient should be warned. - All antihypertensives can have an impact on driving, particularly due to their vasomotor effects. Hypotension and dizziness may occur, particularly at the start of treatment, but are generally benign and transient. After the treatment initiation or modification phase, antihypertensives are associated with few long-term problems. The patient is nonetheless to be informed of the effects and their potential potentiation by concomitant intake of other hypotensive medicinal products and alcohol. - However, the prescription of centrally-acting antihypertensives calls for particular attention. By inhibiting the centers responsible for wakefulness and alertness, centrally-acting antihypertensives may induce sedation, which is a risk with regard to driving. It is therefore necessary to evaluate the degree to which the medication is tolerated if the patient wishes to drive.

Source: http://ansm.sante.bsonetwork.net/var/ansm_site/storage/original/application/e5f2e48d5344bcfef6ca865ac63e7c3d.pdf

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