DRUID Project Research Articles

Drug driving in Italy. The results of the first roadside drug testing service utilizing on-site confirmatory analysis between 2019 and 2022

BackgroundDrug driving represents a public safety concern, and the size of this issue in Italy is not fully known. Drug testing is composed of two steps: 1) screening and 2) confirmatory analysis. The second step, and the associate medical examination to assess the state of impairment, usually are not performed right after the screening as they require specialized personnel and instrumental equipment that are not historically available at roadblocks. These pitfalls make this process both complicated and time-consuming. MethodsA mobile laboratory was set up in 2019 by the Forensic Lab Service S.r.l. (limited liability company) to improve roadblock timing, planning, as well as to shed light on the extent of the drug driving issue in Italy. Drug screenings were performed using DrugWipe® Saliva testing. Confirmatory analysis was performed on oral fluids by liquid chromatography coupled with tandem mass spectrometry. A dedicated room of the mobile laboratory was also designed for drug driving medical assessment. Result2082 samples were collected during 88 road safety services held in different locations across Italy. In total, 9 % of the tested subjects were positive to both the screening and the confirmatory analysis. The most prevalent illicit drugs found in this study were THC (72 %), followed by cocaine (41 %). Drug drivers were mostly male (93 %) and younger than 30 years of age (58 %). ConclusionsThe prevalence of drivers testing positive for illicit drugs resulted to be higher compared to the results obtained in the DRUID project and to other surveys previously performed in Italy. These data demonstrate the need for control services to improve road safety in regards to drug driving.

Alcohol and illicit drugs in drivers involved in road traffic crashes in Italy. An 8-year retrospective study

This study aims to investigate the prevalence of alcohol and drugs of abuse in Italian drivers involved in road traffic crashes between 2011 and 2018. Toxicological analyses were performed on the whole blood of 7593 injured drivers. Alcohol and illicit drugs, namely tetrahydrocannabinol (THC; cut-off 2ng/ml), cocaine (cut-off 10ng/ml), illicit opiates (cut-off 10ng/ml) and amphetamines (amphetamine, methamphetamine, MDMA, MDA; cut-off 20ng/ml) were investigated. The age and gender of the driver, the time of the crash (weekend/weekday and day/night), the road crash year and Blood Alcohol Concentration (BAC) were also considered.The 16.2% of samples tested positive for alcohol, 2.5% for cocaine, followed by opiates (2.0%), cannabinoids (1.5%), and amphetamines (0.5%). The overall prevalence of alcohol and drugs was lower than those reported in previous epidemiological studies of the DRUID project. The year 2011 showed the highest prevalence of drug-positive cases (24.1%), while the lowest prevalence was found in 2016 (16.8%), after the update of the Road Traffic Law (RTL) that increased punishments for driving under the influence. A progressive increase in the number of alcohol-positive female drivers was observed from 2011 to 2018, and the highest prevalence was found in the 26–35-year-old age range. Illicit drugs showed the highest overall prevalence in drivers <26 years of age but, if considering single drugs, cocaine and opiates were mostly found in subjects older than 36 years of age. A higher percentage of drug-positive drivers was found on weekend nights for alcohol and on both weekend and weekday nights for drugs. The types of drugs used by drivers did not change during the studied period.

Toxicological oral fluid results among Spanish drivers testing positive on on-site drug controls from 2013 to 2015

BackgroundDriving under the influence of drugs (DUID) increases the risk of serious injury or death in traffic accidents. The aim of this study was to provide information about DUID in Spanish drivers. Methods10,064 oral fluid samples were collected from Spanish drivers that tested positive on the roadside using the Dräger DrugTest 5000 (DDT5000) between 2013 and 2015. Samples were collected using Quantisal™ and analysed by LC–MS/MS at the Toxicology Laboratory of the Institute of Forensic Science of the University of Santiago de Compostela. ResultsDrivers were mainly young men (85.1% male, 29.7 ± 8.1 years old). In 98.5% of cases, LC–MS/MS results confirmed at least one of the positive results detected on the roadside. Cannabis (82.4%) and cocaine (42.1%) were the most commonly detected drugs. Poly-drug use was observed in 42.7% of drivers, mostly for all illicit drugs (>80%) except for cannabis (42.6%). Illicit drug and single-drug use was more frequent among drivers under 35 years old, and medicines and poly-drug use more common among drivers older than 35 years old. The on-site device performance was calculated using both the DDT5000 cut-offs and the LC–MS/MS method LOQs. Sensitivity (>73% vs >58%), specificity [>94% for all the compounds regardless the cut-offs used, except for cannabis (71%)] and accuracy (>87.5% with both cut-offs) fulfilled the DRUID Project requirements in all cases. ConclusionLC–MS/MS confirmation result was negative in only 1.5% of the cases. The DUID driver profile was a young man, consuming cannabis or a combination of cannabis and cocaine.

Drug detection on Spanish roadsides

Objective The objective of the present communication is to give an overview of the Spanish legal situation with regard to drug detection in drivers. In addition, protocols for roadside drug controls and confirmation analysis in our country will be given. Methods The Spanish participation in RoadSide Test Assessments (ROSITA) and Driving Under the Influence of Drugs, alcohol and medicines (DRUID) European projects had the direct consequence of the Penal Code modification in 2010 in order to reflect the obligation of Spanish drivers to participate in on-site drug controls if required by the police. Confirmation analysis should be done using a methodology that allows drug identification with a high degree of confidence, and enough sensitivity to detect expected drug concentrations in oral fluid and blood. We developed and validated a LC-MS/MS method for the simultaneous determination of 23 drugs of abuse and medicines including opiates, amphetamines, cocaine, methadone, benzodiazepines, z-drugs, one antidepressant and one antihistamine in oral fluid and blood. This method has been applied to thousands of real specimens since the beginning of DRUID project in 2008. Results In Spain, on-site drug controls are performed in oral fluid and, if a positive result is obtained, a second oral fluid specimen is collected and sent to homologate laboratories for confirmation. In addition, drivers have the right to ask for blood confirmation. The LC-MS/MS methodology developed in our laboratory requires a solid phase extraction procedure for sample clean-up, using 0.5 mL of oral fluid or blood. Limits of quantification (LOQ) are 1 ng/mL for all the analytes, lower than those required in the DRUID project, and the linearity ranges are 1–200 ng/mL and 1–500 ng/mL in oral fluid and blood, respectively. The methods were validated, achieving satisfactory results for all the evaluated parameters. Since 2011, on-site drug controls in Spain have significantly increased over the years. We received 64 oral fluid specimens in 2011 for on-site results confirmation, 1083 in 2012, 1284 in 2013, 8722 in 2014, and 2066 until February 2015. On-site results were confirmed in 98.5% of the oral fluid specimens received in our laboratory from 2014. Poly-drug use was observed in 42.7% of the positive cases. Confirmed drugs of abuse, consumed alone or in combination, were cannabis (83.7%), cocaine (42.8%), followed by amphetamine and derivatives (14.4%) and opioids (8.2%). Other drugs detected were ketamine (2.2%), methadone (5%), benzodiazepines (3.9%), codeine (0.6%) and zolpidem (0.1%). False positive results (1.5%) were due to cocaine (44.4%), amphetamine (24.8%), cannabis (19.6%), methamphetamine (18.3%) and opioids (12.4%). Blood specimens sent to the laboratory for on-site results confirmation are incidental compared to oral fluid specimens, although increasing over the last years. Thus, we received 4 blood specimens in 2013, 52 in 2014 and 247 in 2015. Conclusions On-site drug controls in Spain have dramatically increased since 2011. Positive on-site results are confirmed by LC-MS/MS using a second oral fluid specimen, or/and blood in exceptional cases. Results for specimens analyzed since 2014 shows a high degree of agreement between on-site and oral fluid confirmation results.

Detection of illicit drugs in oral fluid from drivers as biomarker for drugs in blood

AimTo assess whether analysis of oral fluid can be used to identify individual drivers with drug concentrations in blood above 25ng/mL for amphetamine and methamphetamine, 10ng/mL for cocaine and 1.0ng/mL for tetrahydrocannabinol (THC), which are the cut-off concentrations used in the European DRUID Project, by calculating the diagnostic accuracies when using the analytical cut-off concentrations in oral fluid as well as for the optimal cut-off concentrations. MethodsPaired samples of whole blood and oral fluid collected with the Statsure SalivaSampler were obtained from 4080 drivers in four European countries and analysed for amphetamine, methamphetamine, cocaine and THC using GC-MS or LC-MS. The vast majority (89%) were random drivers not suspected of drug-impaired driving. Receiver-Operating Characteristic analysis was used to evaluate the analytical results. ResultsThe prevalence of drug findings above the cut-off concentrations in blood was 1.3% for amphetamine, 1.0% for methamphetamine, 0.6% for cocaine and 1.3% for THC. The cut-off concentrations in oral fluid that gave the highest diagnostic accuracy were for amphetamine 130ng/mL (accuracy 99.8%), methamphetamine 280ng/mL (accuracy 99.9%), cocaine 570ng/mL (accuracy 99.6%), and THC 38ng/mL (accuracy 98.3%). The proportion of false positives were 0.2%, 0.1%, 0.1% and 0.9%; and the proportion of false negatives were 0.1%, 0.0%, 0.3% and 0.8%, respectively, when using those cut-offs. The positive predictive values were 87.9%, 92.9%, 84.6% and 35.7% for amphetamine, methamphetamine, cocaine and THC, respectively. ConclusionsAnalysis of concentrations of illicit drugs in oral fluid could not be used to accurately identify drivers with drugs concentrations above the selected cut-offs in blood in a cohort of drivers with low prevalence of drugs.

Alcohol interlocks and prevention of drunk-driving recidivism

IntroductionAlcohol interlock programs (AIP) are aimed at preventing drunk-driving recidivism. They first appeared in Europe in the nineties. ObjectivesThe purpose of this study was investigate whether AIPs are effective in reducing recidivism and determine what factors of such programs contribute to their positive impact. MethodWe performed a follow-up of AIP participants (n=175) and control participants (n=234) for five years. Data such as blood alcohol concentration (BAC) at time of arrest, previous and subsequent violations (alcohol-related or other types) were collected from the official driver's license files. For self-evaluation and evaluation of the program (since November 2009 only), we used questionnaires based on two theoretical models: the Transtheoretical Model of Change (Prochaska & DiClemente, 1984) and the Diamond of Change Model from the DRUID project, build to explain which are the elements of driver rehabilitation training courses that favor behavioral modification (Bukasa et al., 2009). ResultsThe data obtained allowed us to describe these populations of alcohol-drinking offenders, for both the interlock program group and the control group. Two salient features were male proneness to alcohol-related violations and a very high BAC (between 1.5 and 2g/l) among the majority of drivers who drink under the influence of alcohol. In terms of recidivism reduction, the interlock program was not clearly linked to a beneficial effect. An analysis of behavioral change among the AIP participants showed that consciousness raising took effect more quickly than did environmental reevaluation or reinforcement management. ConclusionsThe application of Prochaska et al.’s model to the follow-up of AIP programs would be more fruitful in the future if psychologists are involved in the program. As we have seen, medical/psychological monitoring may not have been strong enough in the program studied here.

Performance evaluation of on-site oral fluid drug screening devices in normal police procedure in Germany

There is a need for quick and reliable methods for rapid screening of drug-influenced drivers on the roadside by police. Because the window of detection in oral fluid is more similar to blood than to urine, this matrix should therefore be appropriate for screening procedures. The performance of the Rapid STAT® (Mavand Solution GmbH, Mössingen, Germany), DrugWipe5/5+® (Securetec Detektions-Systeme AG, Brunnthal, Germany) and Dräger DrugTest® 5000 (Draeger Safety AG & Co. KGaA, Luebeck, Germany) on-site oral fluid devices was evaluated with random oral fluid specimens from car drivers in North Rhine-Westphalia (Germany). Additionally, some drivers were checked using an on-site urine device (DrugScreen®, NAL von Minden, Regensburg, Germany). During a 11-month period, 1.212 drivers were tested. Both OF and urine on-site tests were compared to serum results.The following sensitivities were obtained by the oral fluid devices: THC 71% (DrugWipe®), 87% (Dräger), 91% (RapidSTAT); opiates 95% (Dräger), 100% (DrugWipe®, RapidSTAT®); amphetamine 84% (DrugTest® 5000), 90% (RapidSTAT®), 100% (DrugTest® 5000); methamphetamine 50% (DrugTest® 5000), 100% (RapidSTAT®); cocaine 76% (DrugTest® 5000), 100% (DrugWipe®, RapidSTAT®); methadone 33–63%, and benzodiazepines 0–33% (both with a low number of positives). THC specificity was especially low (29% [DrugWipe®] and 47% [DrugTest® 5000]) due to low cut-off concentrations. These data were similar to those obtained from the literature (e.g., DRUID project). The urine screening device showed a good sensitivity (THC 93%, opiate 94%, amphetamine 94%, methamphetamine 75% (low number of positives), cocaine 100%) and also an acceptable specificity (39%, 86%, 63%, 77%, 47%, respectively). Although oral fluid may be a useful matrix for on-site testing of drugged drivers, it is evident that oral fluid devices still show a lack of sensitivity (methamphetamine, benzodiazepines) and specificity (THC). Poor results for benzodiazepines may be explained by the small positive test number. Although the sensitivity for THC came out higher than compared to the literature, specificity is not yet satisfactory (only <90%). Furthermore, specificity was poor due to lowered cut-offs resulting in multiple false positive tests.

A European approach to categorizing medicines for fitness to drive: outcomes of the DRUID project

To illustrate (i) the criteria and the development of the DRUID categorization system, (ii) the number of medicines that have currently been categorized, (iii) the added value of the DRUID categorization system and (iv) the next steps in the implementation of the DRUID system. The development of the DRUID categorization system was based on several criteria. The following steps were considered: (i) conditions of use of the medicine, (ii) pharmacodynamic and pharmacokinetic data, (iii) pharmacovigilance data, including prevalence of undesirable effects, (iv) experimental and epidemiological data, (v) additional data derived from the patient information leaflet, existing categorization systems and (vi) final categorization. DRUID proposed four tiered categories for medicines and driving. In total, 3054 medicines were reviewed and over 1541 medicines were categorized (the rest were no longer on the EU market). Nearly half of the 1541 medicines were categorized 0 (no or negligible influence on fitness to drive), about 26% were placed in category I (minor influence on fitness to drive) and 17% were categorized as II or III (moderate or severe influence on fitness to drive). The current DRUID categorization system established and defined standardized and harmonized criteria to categorize commonly used medications, based on their influence on fitness to drive. Further efforts are needed to implement the DRUID categorization system at a European level and further activities should be undertaken in order to reinforce the awareness of health care professionals and patients on the effects of medicines on fitness to drive.

An Evaluation of On-Site Oral Fluid Drug Screening Devices DrugWipe(R) 5+ and Rapid STAT(R) Using Oral Fluid for Confirmation Analysis

In this study, the performance of two on-site oral fluid drug-testing devices, DrugWipe 5(+) (Securetec) and Rapid STAT (Mavand), was assessed. The results obtained by the devices were compared with gas chromatography-mass spectrometry confirmation analysis results in oral fluid. Sensitivity, specificity, and accuracy of the tests, as well as positive and negative predictive values, were calculated based on the classified results of the comparison. Both of the devices were evaluated for their ability to meet toxicological cutoffs as set in the DRUID project (www.druid-project.eu) as well as those reported by the manufacturers. The evaluation was performed for relevant drug groups of both devices: amphetamines, cannabis, cocaine, and opiates. Additionally, Rapid STAT has a test for benzodiazepines included in the same device. Both tests seemed to perform quite well for amphetamines although they also gave negative results for cases with high concentrations. Also, the benzodiazepine test of Rapid STAT was at a relatively good level although only half of the positive test results were true positives using the test cutoffs. The same phenomenon was detected for the cannabis tests of both devices. The proper evaluation of cocaine and opiates tests was not applicable because of the very low number of positive cases.

NARKOTIKŲ PAVILIOTI AUDITORIJOS SUOLE NESĖDI

The authors‘ of the article assumption that the majority of traffic accidents are caused by drivers – drug and psychotropic substances abusers – is based on the findings of the European Union DRUID Project. Drug addiction is spreading rapidly in Lithuania. The statistical data of the Drug Control Department under the Government of the Republic of Lithuania prove that the majority of drug abusers are young people of 20–39 years of age. Young people whose efforts and time should be directed towards education and studies. The authors focus attention on the increasing delinquency among drug abusers and the lethal outcome of the drug overdosage. However, it is not a specific national feature. This phenomenon is widely spread from both time and geographical perspective. The established in vitro methods of detection at major extent facilitate the struggle against drug abuse and distribution. In many European cities this method is already being applied when detecting islands of cocaine abusers by the chemical analysis of communal sewage, thus quantitatively identifying the concentration of benzoilekgonin - the stable cocaine metabolite. The article provides a description of the SYNCHRON CX test for identification of cocaine in urine produced by „Beckman Coulter“. Key words: drugs, the metabolite of cocaine, urban wastewater treatment.

EU DRUID project: results of a questionnaire survey amongst participants of driver rehabilitation programmes in Europe

AbstractPurposeThis study was one part of the research activities of work package 5 “Rehabilitation” of the integrated EU DRUID project (6th Framework Programme). It aimed at gathering information about the cognitive–affective and behavioural processes that participants undergo while attending driver rehabilitation (DR) programmes. The primary objective was to analyse the outcomes of group interventions for alcohol offenders in order to assess any cognitive, motivational and behavioural modifications within individual participants and to identify the relevant variables which initiate and support this change process.MethodsThe general methodological concept of the study was a prospective cohort design of participants of group-based European driver rehabilitation programmes, carried out via a participant feedback questionnaire survey. In totalN = 7.339 DUI offenders in 9 European countries (Austria, Belgium, France, Germany, Great Britain, Hungary, Italy, Netherlands and Poland) participated in the survey.ResultsThe results indicate that DR participants feel such programmes provide strong support for their cognitive and behavioural change processes. The findings suggest that participants feel encouraged to establish new behavioural goals and the commitment to stick to them. At the same time, the participants’ ratings emphasise the important role of the course leader in encouraging such changes.ConclusionsThe findings of this explorative questionnaire survey are promising. Although it is impossible to draw any conclusions regarding long-term behavioural changes or effects on recidivism rates, participants of DR courses express positive feedback on completion of the programme. The positive outcomes of the study can motivate decision-makers to launch DR measures and to regard them as an essential part of a comprehensive countermeasure system against DUI.

The modern trends in alcohol, drugs and driving research

Research on alcohol, drugs and driving can be broadly separated into experimental and epidemiological studies. Every approach has its inherent advantages and disadvantages. Experimental studies can result in an interpretation by single cause, but can only identify potential risks, and the results can sometimes be of limited value because of the use of non-realistic doses or because of the drug use history or inter-individual differences of the volunteers. Recent studies have used higher, more realistic doses and paid more attention to the combination of alcohol and drugs and have shown that the chronic use of illicit drugs can be associated with some cognitive and/or psychomotor impairment, and can lead to a decrease in driving performance even when the subject is no longer intoxicated. Epidemiological studies include roadside surveys, studies in a subset of drivers, accident risk studies, responsibility analyses, surveys and pharmaco-epidemiological studies. Between studies, results may be incomparable due to testing different populations, different kinds of samples, etc. More large-scale roadside studies are conducted now. Advances in analytical toxicology have also contributed to a better understanding of the risks associated with driving under the influence. While older studies measured the inactive metabolite THC-COOH and did not show an increased risk in cannabis-positive drivers, more recent studies measured the active THC in blood and did show a concentration dependent increase in crash risk. The use of LC–MS/MS has allowed more broad-range screening as this technique can measure many different drugs in a small sample volume. While some older studies used saliva but had many analytical problems (including an insufficient sample volume in up to a third of the cases), newer methods of saliva sampling and analysis give better results. The use of saliva for roadside surveys allows non-invasive sampling, but the lack of correlation with the concentrations in blood makes interpretation of results difficult. The results of both epidemiological and experimental studies should be combined to obtain a good estimate of the impact of certain drugs on driving performance and accident risk. In 2006–07 a committee of international experts drafted guidelines for future research into drugs and driving. These have been taken on board by the DRUID project, a large-scale EU funded project on driving under the influence of drugs, alcohol and medicines.

Liquid chromatography/tandem mass spectrometry for the qualitative and quantitative analysis of illicit drugs and medicines in preserved oral fluid

A qualitative and quantitative analytical method was developed for the simultaneous determination of 24 illicit drugs and medicines, in preserved oral fluid samples collected with the StatSure Saliva Sampler collection device. The samples were prepared by liquid-liquid extraction followed by liquid chromatography/tandem mass spectrometry (LC/MS/MS) analysis. The chromatographic separation was performed with an Atlantis T3 (100 x 2.1 mm i.d., 3 microm) reversed-phase column using an acetonitrile/2 mM ammonium formate buffer pH 3.4 gradient and the MS/MS detection was achieved with two precursor-product ion transitions per substance. The method was fully validated, including specificity and capacity of identification, limit of detection (0.2-2.1 microg/L), limit of quantitation (0.8-6.4 microg/L), recovery (34-98%), carryover, linearity (the method was linear in the range 1-200 microg/L), intra-assay precision (coefficient of variance (CV) <20% for 20 microg/L and CV <10% for 100 microg/L) and inter-assay accuracy (mean relative error <15%) and precision (CV <20%). The method showed to be specific and sensitive. It has already been successfully used in four proficiency tests and subsequently applied to oral fluid samples collected from road traffic volunteers in the driving population of Portugal (districts of Lisbon, Coimbra and Porto), within the DRUID project.