Medication use by the driving population

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, VOL. 5: 255-261 (1996) ORIGINAL REPORT Medication Use by the Driving Population M. CARMEN DEL RIO MD AND F. JAVIER ALVAREZ MD Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Valladolid, 47005 Valladolid, Spain SUMMARY This study investigated patterns of medicine use among Spanish drivers. The study was conducted in the fall of 1993 on 1500 drivers aged over 16, all of whom completed accordingly and then returned the questionnaires. Among those surveyed, 45.1% had used drugs at least once in the previous year, while 17.3% of drivers surveyed were using medicines chronically. Chronic users, the majority of whom were female and belonging to the older age group, were using an average of two drugs. Central nervous system drugs (21.7%), respiratory system drugs (19.2%), cardiovascular system drugs (14.9%) and alimentary tract drugs (14.3%) were the most frequent groups of medication used, Of those surveyed 76.5% who took drugs regularly had never been warned by health professionals about the effects of the medication use on driving skills. The study shows both how often drivers use medication as well as the need to inform patients and drivers about the effect of medication on driving performance. KEY WORDS - drugs; drugs and driving; traffic safety INTRODUCTION Road traffic accidents have become an important health problem in developed countries and their prevention has long been a priority issue. Undoubtedly, alcohol consumption is one of the main causes of road traffic accidents. Nevertheless, it is often forgotten that other substances, such as certain forms of medication and illegal drugs, impair psychomotor skills related to driving.] The relation between drugs, driving and road traffic accidents is a complex one. In laboratory experiments therapeutic doses of several drugs have been shown to impair psychomotor skills related to driving.2 However, there are certain aspects which need clarifying. One is the relation between drug concentration and driving impairment; another, the legal consideration of drug levels similar to those of alcohol, et~.~ In addition, information relating to the frequency of drug-use by drivers and the percentage of people who drive Addressee for correspondence: F. Javier Alvarez, Department of Pharmacology and Therapeutics. Faculty of Medicine, University of Valladolid, 47005 Valladolid, Spain, tel: +(34 83) 423077, fax: +(3483) 423022 and +(3483) 423073. while under the influence of psychopharmacological agents is scarce, and the figures available differ significantly. Perhaps this may be attributed to the diversity of exploratory methods used in the course of the studies undertaken; these include mailed questionnaires, prescription records, personal or telephone interviews, et~.~-~ What is more, drugs have very often been found in body fluids among drivers involved in road traffic accidents . 4-8 It has recently been estimated that at least 10% of all people killed or injured in road accidents were using some kind of psychotropic medication that could have been considered a contributory factor. This represents a direct cost each year to the European Community of at least 7 billion ECUs, 5000 deaths and 150,000 injuries.l0 Under European Community Council Directive 91/439/EEC, authorities responsible for the issuing of driving licences must determine the applicant's lack of impairment due to their use of alcohol, illegal drugs and medicines," although there exist difficulties concerning the implementation of this Directive. lo In most countries information about medication use and road safety is scarce and incomplete, and CCC 1053-8569/96/040255-07 C 1996 by John Wiley & Sons, Ltd. Received I I May 1995 Accepted 13 December 1995 256 M. C. DEL RIO AND F. J. ALVAREZ the present national study was carried out on a sample of Spanish drivers with a view to analysing the patterns of medication used by this section of the population, and how the use of medication could impair driving ability. Consideration has also been given to the information received by health professionals concerning the effect of medication on driving performance, thereby facilitating the proposal of measures as regards road safety. The study also analyses health status, illegal drugsI2 and alcohol cons~mption,’~ the results of which have been published elsewhere. and returned. All the questionnaires were checked for completeness and accuracy. Of these, 1500 were properly completed. Further questionnaires received (220 by mid1994) were not considered for analysis. Of the mailed questionnaires, 2405 were sent back by mid-1994 because a wrong address was given. The analysis of the data was carried out in the Data Processing Center at Valladolid University, using the statistical package SAS 6.07 version (under the VAX/VMS 5 version). RESULTS METHODS The questionnaire used included, among other items, sociodemographic data and patterns of medicine use and driving. Drivers were asked about the medicines they had used in the previous year and were using at present (when the survey was carried out). All the information pertaining to the medication (up to seven different drugs) was recorded: in each case they were asked about the registered name of the medicine they were using, the reasons for using it, the intake duration, and whether the medicine used was over-the-counter or medically prescribed. Each registered pharmaceutical preparation was coded following the Anatomical Therapeutic Chemical classification system.I4 Chronic drug use was assessed among those surveyed who, at the time of the study, were using medication. Chronic or regular use was defined as when the person concerned had been using the drug on a daily basis for at least 1 month. The Summary of Product Characteri~tics’~ for each medication was reviewed, and it was stated whether or not there was a warning about the effect of the medication on the ability to drive or use machinery. Those who drank at least once a weekI3 were termed current alcohol drinkers. The target population were those members holding a driving licence. A sample of 12,000 drivers was randomly selected (by age group and sex) from the National Official Register of Spanish Drivers. The sample size selection was based on response figure rates obtained from this register, and the aim was to obtain a final sample of at least 1500 individuals. The questionnaire, with instructions for completion, were mailed to selected drivers between 26 September and 15 October 1993. By 15 December of that year, 1598 questionnaires were completed The response rate (1720 out of 12,000: 14.3%) was as expected, and similar to that obtained earlier from this register (1116 out of 8200: 13.6%). However, we must recognize that this is a very low rate when compared with those obtained in other developed countries. The reasons for this could be: (i) the complexity of the questionnaire, dealing with information on matters as diverse as health status, use of medication, alcohol and illegal drugs. Therefore, completion of the questionnaire could be difficult for some people with a low education level. (ii) As it was clearly indicated in the questionnaire that the study was being carried out by the National Traffic Agency, many drivers could have been discouraged from answering the questionnaire. (iii) Possibly, yet most probably, the fact that in the official register of Spanish drivers a great number of addresses are incorrect, although every drivers should, according to law, give notification of any change in address. The said register is used for notification of sanctions and fines; a wrong address in the register prevents the driver from being notified, and prescription ensues if, after a certain length of time, the driver is not This study is based on 1500 drivers who, as has already been stated, completed the questionnaire.I2-l3 The sample distribution of respondents (by age group and sex) did not differ (p > 0.05) from that of all Spanish drivers. Table 1 shows the gender distribution of the sample as regards their sociodemographic characteristics. The sample could not be compared with the entire driving population on additional variables because the official register of Spanish drivers has information regarding only age, sex, type of driving licence and address. Of the Spanish drivers surveyed, 45.1 YO (676 out of 1500, Table 2) had used drugs at least once in the 0 1996 by John Wiley & Sons, Ltd. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY. VOL. 5: 255-261 (1996) MEDICATION USE BY SPANISH DRIVERS 257 Table 1 -Sociodemographic characteristics of the driving population surveyed Male Female n YO n YO Total 1016 67.7 484 32.3 Age range 16-20 21-30 31-40 41-50 5 1-60 61-70 > 70 Marital status Single Married Divorcee Widowed Educational level No schooling Primary Middle Secondary High University 88 27 1 26 1 180 133 70 13 363 62 1 20 12 11 175 212 264 115 200 8.6 51 26.7 213 25.7 119 17.7 73 13. I 26 6.9 1 1.3 1 35.7 259 61.1 193 2.0 22 1.2 10 1.1 3 17.9 40 21.7 78 27.0 150 11.8 83 20.5 120 10.5 44.0 24.6 15.1 5.4 0.2 0.2 53.5 39.9 4.5 0.1 0.6 8.4 16.5 31.6 17.5 25.3 pervious year (43.4% among males and 48.5% among females, p < 0.05). As regards the number of medicines, most of them had used either one (58.0%) or two (28.8%). Three or more drugs were used by 13.2%. Of drivers surveyed, 17.3% (259 out of 1500 surveyed, Table 2) were using medicines chronically (16.9% of males and 18.0% of females, p < 0.05), and, the older the individual the more Table 2-Patterns of medication use by Spanish drivers common this phenomenon was. Of these, 39% were using one drug, 39% two drugs, and 22% were using three or more drugs. Each of these individuals (n = 259, 5 1 1 drugs, Table 2) was using an average of 1.97 k 1.10 (mean SD) medicines (1.87k0.98 for males - n= 172, 323 drugs - and 2.16f 1.29 for females - n = 87, 188 drugs, p = 0.0506). The four most common chronically used groups of drugs (Table 3) were central nervous system drugs (21.7%), respiratory system drugs (19.2%), cardiovascular system drugs (14.9%) and drugs for the alimentary tract and metabolism (14.3%). Table 3 shows also the gender distribution regarding the medicines used. For 26.4% (Table 3) of the medication used chronically (135 out of 51 1) there was a warning in the Summary of Product Characteristics about the effect of the medication on the ability to drive and the safe use of machinery. Most medications supplied with this warning are cardiovascular system drugs (29.6%), central nervous system drugs (3 1.1 YO) and respiratory system drugs (22.2%). This data shows that 4.6% of drivers (26.4% of the drugs taken chronically by 17.3% of the population) were using medication that impairs driving performance. Table 3 also shows registered drugs in Spain, as well as those with a warning concerning the effect of the medication on driving ability (503 out of 3720: 13.5%). Among all those surveyed, 62.9% (943 out of 1500) were current alcohol drinkers,') and 64.5% (167 out of 259) were among those who took medicines regularly. Only 21.6% of those using medicines (56 out of 259) admitted not having consumed alcohol when using medicines. It was Sample distribution Medication use in past year Chronic use of medication n n YO n YO Total 1500 676 45.1 259 17.3 Sex Male 1016 Female 484 16-20 139 21-30 484 3 1-40 380 41-50 253 51-60 159 61-70 71 > 70 14 Age range x2 = 3.5 p < 0.05 x2 = 0.25 p < 0.05 441 43.4 172 16.9 235 48.5 87 18.0 66 47.5 235 48.5 157 41.3 105 41.5 70 44.0 38 53.5 5 35.7 28 20.1 66 13.6 50 13.2 42 16.6 40 25.2 28 39.4 5 35.7 0 1996 by John Wiley & Sons, Ltd. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY. VOL. 5: 255-261 (1996) 0 5 Y 6 r Table 3 - Types of medication used by Spanish drivers, and warning about medication used and driving ability Anatomical Therapeutic Chemical Medication used Registered medication classification system Chronic use in Spain Past year Total Male Female Warning* Total Warning* n YO n% n YO n YO n YO n% n Alimentary tract and metabolism 125 11.4 73 14.3 55 17.0 18 9.6t 8 5.9 748 103 13.8 Cardiovascular system 76 6.9 76 14.9 63 19.5 13 6.9$ 40 29.6 294 116 39.4 Blood and blood forming organs 27 2.5 27 5.3 7 2.2 20 10.6$ 1 0.7 350 3 0.8 Dermatologicals 7 0.6 4 0.8 2 0.6 2 1.1 0 0.0 386 0 0.0 Genito-urinary system and sex 22 2.0 19 3.7 6 1.9 13 6.9$ 1 0.7 143 7 4.9 hormones excluding sex hormones 8 0.7 5 1.0 3 0.9 2 1.1 52 1 1.9 0 0.0 Antineoplastic and immunomodulating 0 0.0 0 0.0 0 0.0 0 0.0 57 0 0.0 0 0.0 Systemic hormonal preparations, General antiinfectives for systemic use 164 14.9 43 8.4 26 8.0 17 9.0 6 4.4 287 31 10.8 agents Musculoskeletal system 59 5.4 34 6.6 19 5.9 15 8.0 7 5.2 159 18 11.3 Central nervous system 331 30.2 111 21.7 65 20.1 46 24.5 42 31.1 357 129 36.1 Antiparasitic products 0 0.0 0 0.0 0 0.0 0 0.0 13 1 7.7 0 0.0 Respiratory system 238 21.7 98 19.2 65 20.1 33 17.6 30 22.2 548 88 16.0 Sensory organs 10 0.9 6 1.2 6 1.9 0 0.0 0 0.0 212 4 1.9 Various 30 2.7 15 2.9 6 1.9 9 4.8 0 0.0 114 2 1.7 Total sample 1097 100.0 511 100.0 323 100.0 188 100.0 135 26.4 3720 503 13.5 ~~~~~ ~~ *There is a warning about the effect of the medication on the ability to drive or use machinery in the Summary of Producr Characreristics.'4 Chi-square male compared to female: tp < 0.05, $p < 0 005. r P 5 MEDICATION USE BY SPANISH DRIVERS 259 not common for those surveyed (5.8%, n = 15; 4.6%. n = 8 for males, and 8.O%, n = 7 for females, x2 = 1.22, p < 0.05) to report that the medication used regularly affected their driving performance. Surveyed drivers who took drugs regularly were asked if they had been warned by health professionals about the effects of the medication used on driving skills: of these, 76.5% had never been warned, 19.4% had been warned on some occasions, and 4.1 YO had frequently been warned. Similar figures (x2 = 0.24, p < 0.05) were found between sexes (never: 75.6% males and 78.5% females; some occasions: 20.1% males and 17.7% females; frequently: 4.3% males and 3.8% females). DISCUSSION The present study shows a series of interesting data, the first of which is that medicines are frequently used by the population. Certain medications have been used by 45.1 YO during the last year and 17.3% use them chronically. It has to be pointed out that among regular users, the majority take an average of two medications. Another remarkable fact is the frequency of joint use of alcohol and medication. Finally, and what is more important, is that in three out of four cases concerning regular drug users, health professionals do not provide the patient with any information as regards the effect of the medication on driving ability. A comparison with the data obtained in other studies is difficult, due to a lack of standardization and the different types of methodology used. For instance, a study among the Austrian population revealed that drug intake was reported by 44% in the 3 months prior to the interview, and 27% in the previous week; furthermore, the average number of drugs used was 1 .84.5 In a French study on victims of road traffic accidents, 23.6% admitted having taken medication 5 days before the accident.6 In a Finnish study on casualties attending emergency departments, 31.6% said that they had used some medication a week earlier, whilst 15.3% admitted having used some medication a week prior to the a~cident.~ In the United Kingdom, the frequency with which medicines are used among samples of the general driving population ranges from 5.5% to 22%; for those medications likely to have an effect on the central nervous system, the frequency is between 2% and 5%.8 The present study also shows that these people often use various types of medication at the same time: 61% use two or more types of medication. This makes interactions more common and, consequently, causes a greater deterioration of psychomotor performance in certain cases. What is not surprising, given the fact that alcohol is usually consumed in many European countries, is that alcohol consumption among the drivers surveyed is frequent: 62.9% among all those surveyed and 64.5% among those who usually use medication; this confirms the previous finding~.'~ A fact to be considered, is that consuming alcohol and using medication have negative effects on psychomotor performance, and, as a result, there is a greater accident risk. What is more, it is appropriate to mention that only a small number of those who normally use medication (5.8%) admit that that medication affects their driving performance. Within the European community, package inserts include a statement regarding the effects of medication on the ability to drive or use machinery." Furthermore, there has recently been accepted a three-tier warning system to identify the hazard potential of drugs on driving ability in the Summary of Product Characteristics." There is a statement concerning medication effects on the ability to drive among 26.4% of chronically used types of medication (4.6% for all surveyed). This is important, and it is logical to think that these individuals might experience impairment of certain of the faculties needed for safe driving. However, although the data do not permit us to state whether these people were in the habit of driving under the influence of medication, they do demonstrate the frequency with which medication that could impair driving performance is used. Furthermore, among all registered medications in Spain, 13.5% contain a warning regarding their effect on driving ability. Age and sex are among the major factors influencing the level of drug use:16 elderly and female are the most common characteristics of drug users. In the present study, chronic use of medication is more common among the aged population, while no significant differences were found between sexes (although the figures for women were higher than those for men). The reason could be related to the fact that most female drivers in Spain belong to the younger age groups. In 1993 there were about 15,882,000 drivers in Spain, men (67.3%) are more than twice as likely than females (32.7%) to be drivers. Finally, and more significantly, in 76.5% of cases, health professionals have never warned their patients about the effect of medication on driving 0 1996 by John Wiley & Sons, Ltd. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, VOL. 5: 255-261 (1996) 260 M. C. DEL R10 AND F. J. ALVAREZ performance. This finding coincides with the data encountered in previous studies.17 In spite of product information and labelling, we believe'' that health professionals - doctors and chemists - should give advice to their patients about the extent to which the medication prescribed (as well as illness and alcohol consumption) might interfere with their driving ability. The present study is not without several limitations (a low response rate, its descriptive nature, etc.), but it does highlight the large number of drivers using medication that could impair driving performance. Even so, we will admit that some possible variations in the gathered information could exist, because we cannot exclude overor underreporting medication use. There is a need to standardize the methodology employed in this field,lg in order to characterize the extent of this phenomenon. In the last few years, not only have legislative rules been introduced, but special attention has been devoted to assessing the risk of being involved in a traffic accident while driving after using medication. Several st~dies'~-~' have shown the increased risk of being involved in a road accident when driving under the influence of some medication, mainly psychotropic medication. The full impact of medication on driving is difficult to establish, but it is easy to accept that some kinds of medication interfere with driving performance and, therefore, could increase the risk of road accidents.' Road accidents represent one of the main public health problems worldwide, and the need to develop policies geared towards their reduction is becoming more and more urgent. The role of medication as regards road safety should not be forgotten. Doctors should be aware of the possible influence of the medication prescribed on driving performance, and should inform their patients about it. 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