Substance Abuse Br 9046109 En

ABUSE OF ILLEGAL DRUGS AND MEDICATION P. 12

ALCOHOL ON OUR ROADS P. 24

PREVENTION, SUBSTITUTION AND THERAPY P. 30

MEDICAL AND ILLEGAL DRUGS ON THE ROADS P. 36

SUBSTANCE ABUSE ANDDIAGNOSTIC TECHNIQUES

WWW.DRAEGER-SAFETY.COM

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CONTENTS

IMPRESSUM

January 2006Editors:Burkard DilligDr. Andreas MannsDr. Stefan SteinmeyerDr. habil. Johannes LagoisDr. Jürgen Sohège

Dräger Safety AG & Co. KGaARevalstraße 123560 Lübeck

Tel. +49 451 882 4012Fax +49 451 882 [email protected]

www. draeger-safety.com

EDITORIAL

HISTORY

From beer tap to breath alcohol measurement –

over 110 years of Dräger and 50 years of Alcotest

ABUSE OF ILLEGAL DRUGS AND MEDICATION

Indulgence, cure or abuse?

BREATH-ALCOHOL ANALYSIS

How to determine the alcohol concentration?

ALCOHOL ON OUR ROADS

Interlock – contributing to improved road safety

PREVENTION, SUBSTITUTION AND THERAPY

Drug and alcohol testing in addiction prevention, treatment and medicine

MEDICAL AND ILLEGAL DRUGS ON THE ROADS

Possible approaches to road safety

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Drug abuse in the social contextWhen people talk about drugs, it alwaysseems obvious what they mean. Often, how-ever, it quickly becomes clear that the termcan be used to refer to many differentthings. For instance, someone who enjoys aglass of wine or beer may well be unwillingto accept that their "tipple" is also classifiedas a drug, while tea and coffee drinkers willno doubt find it equally hard to understandthat their "fix" counts as one of the common(legal) drugs.In most societies, certain substances are tolerated as drugs, and intoxication and ecstasy are permitted within the frameworkof certain norms.In distinguishing between hard and softdrugs, it is not only the drug's addictive potential that counts – the degree of psycho-tropic effect is also taken into consideration,as are health, political, cultural and eco-nomic aspects. Another classification whichis just as common and just as problematicinvolves determining the legal status ofdrugs. Alcohol, for example, enjoys a highstanding in some cultures (where an officialreception without wine or champagne wouldbe unthinkable), while in other regions it isstrictly forbidden.

Dividing drugs up into natural and man-made substances is somewhat easier. Some parts of plants can be consumed asdrugs without much in the way of proces-sing, while others first need to be treatedchemically before the desired narcotic effect is obtained.

If we look at how patterns of social con-sumption have evolved and at the preva-lence of drugs such as alcohol, we can seethat the popularity and consumption of these substances has been determined bysocial and economic circumstances. Archae-ological research, for instance, tells us thatpeople were brewing alcohol long beforethey started baking bread.

The history of drug development showsclearly that it was last century's technologydrive and the huge increase in productionthat produced the phenomenon we see to-day, namely the socially and geographicallywidespread consumption of alcohol, tobaccoand indeed illegal drugs. Tobacco and alco-holic drinks are now among the most readi-ly available goods in many countries.The consequences of "substance abuse",however, can be devastating not only for

Editorial


P. 04 | 05EDITORIAL SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

the person concerned, but also for their families, friends and work colleagues, andindeed for the general public (e.g. on theroads).

Alcohol consumption – a mixed blessingAlcohol in the form of fermented or distilledbeverages is freely available (with few ex-ceptions) as a legal substance, and drinkingalcohol is deeply rooted in many differentcultures. At the same time, alcohol is a celltoxin and a neurotoxin, and results in addic-tion. There are hardly any organs in the human body which are not damaged by excessive alcohol consumption.Alcohol abuse became a social problemwith the rise of the proletariat; at the begin-ning of the 20th century, public interest inalcohol-related problems waned as peoplewere caught up in the world economic crisisand the First World War. In the second halfof the 20th century the problem once againreturned to the public eye as "alcoholism ofthe affluent classes". This dispensed withthe stigma of it being an "evil vice" and madeit, by definition, a pathological condition. Indeed, alcohol dependence is a seriousillness from which it can take months to recover.The mass consumption of alcohol and theproblem of alcoholism, with its marked tendency to generate addiction, results in amuch greater problem quantitatively speak-

ing – in terms of the number of those affected and the associated health and social costs – than consumption of all other drugs combined!

Smoking: Russian rouletteNowadays it is a well-known fact that smok-ing can cause illness and death, as well asaccelerate many other diseases. In otherwords, many people, and especially the young, harm their health by smoking des-pite being aware of the risks. Tobacco con-sumption has now become the leading pre-ventable cause of illness and death. As faras the frequency of consumption and thedamage to health that it causes is con-cerned, tobacco is the number one drug.

Medicine: boon or bane?Medicine not only cures illness, but is alsoa socially recognized and tolerated "drug".Prescription drug abuse is when medicationis taken without medical grounds or in un-necessary quantities. In practice, such abuseusually involves psychoactive substances,especially barbiturates (sleeping pills), analgesics (painkillers), sedatives and stimulants. Substances containing benzo-diazepines in particular, which can cause alow-dose dependence after just four weeksor so of regular consumption, are regularlytaken over long periods of time.Although prescription drug abuse is rampant

in our society, it rarely receives much publicattention. It is often very difficult to draw aclear line between normal (medically neces-sary) consumption and abuse. Six to eightpercent of all prescribed drugs have someaddictive potential.

Illegal drugsUnlike with alcohol and tobacco, there isstill some controversy as to whether "legalconsumption" of cannabis products shouldin fact be possible, or whether such con-sumption should always be treated as sub-stance abuse, though in the case of drugswith high addictive potential the concept ofnormal consumption is categorically ruledout. The fact that drugs such as cannabisand cocaine are illegal, for example, is theresult of social appraisals of the use of thesedrugs in industrialized countries. Both can-nabis and coca leaves have been known asremedies, cult and narcotic substances forthousands of years.

However, narcotic drugs also have a nega-tive impact on the way an industrial societyfunctions, and the consumption of illegaldrugs is by no means a uniform phenom-enon. Drug use can cover different sub-stances which are consumed independently,in succession or in combination, and in vary-ing quantities.


Monitoring abuse: testing and measuringEuropean countries generally base theirdrugs policy on the so-called "four-pillarmodel", i.e. repression, prevention, survivalassistance and treatment. Today, DrägerSafety measurement technology is used in all four of these areas.

First and foremost, tests and measurementsare performed to diagnose and detect sub-stance abuse. Despite widespread precon-ceptions to the contrary, the majority ofdrug addicts do not live up to the classicimage of a junkie or drunk. The number ofunreported cases is extremely high(especially as regards alcohol and prescrip-tion drug dependence), and the addictiontends to go undetected for a long time.Those concerned appear to lead a well-or-dered life, have a normal job and are oftenleft alone with their problem. In other words, diagnosing the problem ofaddiction or abuse is the first step towardshelping the person concerned, e.g. by making treatment available. Both as regardsdiagnosis and further-reaching prevention,treatment and assistance measures, alcoholand drug tests constitute an indispensablemeasurement instrument for the attendingdoctor and in some cases even for the person concerned.Monitoring activities (alcohol and/or drugtests) as part of various campaigns and pro-

grammes, e.g. traffic checks or medical examinations, can not only help detect sub-stance abuse, but can also have a preventive– and in some cases even a teaching – effect. A person's inhibition threshold be-comes greater the higher their risk of beingdiscovered. Quick measurements which canbe performed on site enable police to clas-sify strange and dangerous behaviour ex-hibited by drivers and to judge the extent to which they can be made accountable fortheir actions. The situation is similar in acourt of law where the accountability of offenders or the reliability of witness state-ments needs to be assessed. Drug moni-toring programmes in prisons are used todetect any substance abuse by prisoners ontemporary release, inmates and visitors.

What is more, alcohol and drug testing canhelp monitor a person's compliance with pa-role requirements or with the requirementsnecessary for them to re-obtain their drivinglicence. Drug testing also plays an import-ant part in the investigations conducted bycustoms officials.

Monitoring of possible substance abuse isalso extremely important in emergency medi-cine as it reveals whether particular condi-tions should be treated as the consequenceof alcohol or drug abuse or whether theyhave other causes. In rehabilitation pro-

grammes, alcohol and drug tests can beused to check whether patients are "clean"and whether they are following their treat-ment plan. Testing and measurement sys-tems for the detection of substance abusein occupational medicine and at the work-place have gained an equally firm foothold.

At Dräger, we have devoted more than 50years to the topic of breath alcohol measure-ment in all its technological diversity, in itsvarious fields of application and with a widevariety of products. For over a decade, wehave also been focusing on how to detectother drugs apart from alcohol, especially il-legal drugs such as cannabinoids (marihuana,hashish), cocaine and its derivative, opiatesand the designer drugs (speed, XTC, etc.)using saliva samples. In recent years, DrägerSafety has presented various new develop-ments, products and services in this field.This special edition takes a closer look atthe subject of drug testing and introducesthe reader to monitoring systems and ser-vices which allow test subjects to undergotargeted, precise, hygienic and easy-to-usesubstance measurements.

Dr. Andreas MannsDräger Safety AG & Co. [email protected]


HISTORY SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

How Dräger beganEven at the time of its establishment on 1 January 1889, the foundations for the Dräger company's success were alreadyclosely linked to the consumption of alco-hol. Together with an associate, HeinrichDräger founded a small shop-cum-work-shop named "Dräger und Gerling“, whichsoon devoted its attention to carbonic acidpressure reduction valves for beer taps.Carbonic acid is used to expel the beerfrom the tap, and the valve was designed to bring the highly pressurized carbonicacid in a gas cylinder down to the pressurerequired in the beer barrel, allowing thebeer to bubble gently out of the tap.

Local pub landlords frequently came to the workshop to complain about "faulty"pressure reduction valves, claiming that theflow of beer from the tap would regularlypeter out. In the workshop, however, thevalves were found to have nothing wrongwith them. Closer inspection revealed thatthe inside of the valve was being cooled down by the expanding carbon dioxide tosuch an extent that the carbonic acid wasfreezing inside the valve, thus blocking it.Once the valve had been removed and

warmed up, however, the beer was able toflow freely again and the valve was fully functional.As a result of these findings, a reductionvalve was designed in which sufficientwarmth was supplied from the ambient airto the critical point, preventing the carbonicacid from freezing. The patented design ofthis invention, known as the "Lubeca valve“,soon proved to be superior to rival devices(Figure 1). For the first time, it was possibleto tap the carbonic acid stored in com-pressed gas cylinders safely and withoutrisk, on a continuous basis and at an evenand controllable pressure, ensuring a con-stant supply of beer in pubs and restaur-ants. Soon after, in 1891, the company was therefore renamed "Lübecker Bier-druckapparate- und Armaturenfabrik Heinr.Dräger“ (Lübeck beer pressure apparatusand accessories factory Heinr. Dräger).

The early days of gas detection technologyOver the following years, the company,which in 1902 was renamed Drägerwerk,began to broaden its focus to include otherapplications for compressed gas techno-logy. For instance, among other things

respiratory protective devices with a supplyof compressed air were manufactured, aswere protective masks which were used, forexample, by miners. In these masks, toxiccarbon monoxide was removed by means of catalytic oxidation (combustion) of thecarbon monoxide, turning it into perfectlysafe carbon dioxide. During development of filters, it was dis-covered that the oxidation of carbon mono-xide generates considerable heat. This ledto the idea that this heat could be measur-ed as a way of determining the concentra-tion of carbon monoxide [1]. By the end ofthe 1920s, this development resulted in thefirst Dräger carbon monoxide measuring instruments (Figure 2). The principle ofmeasurement used in these instruments is still widely used today, for example tomeasure the concentration of combustiblegases for explosion protection in many Dräger instruments.

Building on these early beginnings with thefirst instruments for the measurement ofgas concentrations, Dräger has evolved tobecome one of the world's largest manu-facturers of gas detection technology forprofessional applications, where concentra-

From beer tap to breath alcohol measurement – over 110 years of Dräger and 50 years of Alcotest

Figure 1: Patent application forthe “Lubeca” pressure reductionvalve, dated 31 March 1889

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tions of explosive and toxic gases, oxygenand indeed alcohol need to be measured.

Alcohol and road trafficEven long before the invention of motorizedvehicles, the effects of alcohol on people'sperception and performance led to seriousaccidents. This resulted in 1872 in the issue of the British Licensing Act, whichstates that it is an “offence to be drunk while in charge on any highway or other public place of any carriage, horse, cattle,or steam engine” [2]. When motorization began, the number ofroad accidents involving drivers under theinfluence of alcohol rose. In a magazinepublished in 1904 [3], for example, 25 serious accidents involving automobiles arereported in which there were 23 fatalitiesand 14 serious casualties. 19 of the auto-mobile drivers were under the influence ofalcohol. As a result, the British LicensingAct extended its definition of an offence in1925 to cover "any mechanically propelledvehicle“ [2].

Measuring breath alcohol concentrationRoad traffic accidents caused by excessivealcohol consumption very soon showed

Figure 2: Dräger carbon monoxidemeasuring instru-ment in a smelting plant in the year1929


carry out more frequent road traffic checksto combat the sharp rise in alcohol-relatedtraffic accidents due to increasing volumesof traffic.Consequently, when the "blow tube" devel-oped by Dräger in 1953 was launched withits sampling bag to determine the breath alcohol concentration of road traffic users,the police immediately responded with greatenthusiasm (Figure 4). This tube made itpossible to conduct an objective on-sitemeasurement which could be used to enforce further actions to secure evidence.The fact that the tubes were easy and safeto use made them well-known all over theworld and popular among law enforcementofficers and test subjects alike [5]. The "Alcotest®" brand name, which was coinedat the time and protected for Dräger, hasnow become synonymous worldwide withbreath alcohol measurement. What prompted the development of thisbreath alcohol test is described in an

Figure 3: Drunkometer by Hager fromthe year 1938 (photo: Honolulu Police Department, USA)

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Expirationsluft” (On the expulsion of alco-hol in exhaled air), Swedish scientists Liljestrand and Linde published the first simultaneously measured concentration curves for breath and blood alcohol in 1930 [4]. This paved the way for a quickand easy method of determining the extentto which a car driver was under the influ-ence of alcohol by measuring the breath alcohol concentration.

On the basis of this and other studies, thefirst breath alcohol measurement device,known as the "Drunkometer", was develop-ed over the following years (Figure 3). Thisinstrument used a wet chemical analysisprocedure and was thus more reminiscentof a portable laboratory than an easy to useinstrument.

The Alcotest tubeAlthough it was possible to determine a driver's breath alcohol concentration usingthe methods which had been developed,the procedures were not particularly prac-ticable and, more importantly, were more or less impossible to use on site. FollowingWorld War II, there was a pressing need to

that it was necessary to eliminate the risksituations resulting from alcohol-impaireddriving. One of the most important and efficient methods of combating alcohol onthe roads are frequent traffic checks. Forthis purpose, breath alcohol measurementis a much quicker and simpler method thanblood sampling and analysis.

Initial fundamental research into the corre-lation between blood and breath alcoholconcentrations was conducted as early asthe end of the 1920s. In the work “Über die Ausscheidung des Alkohols mit der

Figure 4: The firstAlcotest tubes, de-veloped in the year1953, in use


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anecdote. One morning after a party in Dräger's test tube department, the chemistsall accused each other of smelling moststrongly of alcohol. To put an end to the debate, an objective and accurate methodof measurement was needed – and thiswas how the Alcotest test tube came about,based on the many years of Dräger experi-ence in the development of methods tomeasure gas concentrations.

The BreathalyzerIn the USA, Robert F. Borkenstein also pre-sented his "Breathalyzer" in 1953: the first"easy to use" breath alcohol measurementinstrument (Figure 5). This was a chemicallaboratory instrument whose result was analysed electrically. The instrument waseven recognized in the USA as a substitutefor the blood sample, and continues to beused today – in somewhat modified form –in some states of the USA and Canada. In the 1980s, Dräger took over productionand sale of the Breathalyzer from the orig-inal manufacturer Smith & Wesson, and the instrument continued to be manufac-tured by Dräger until just a few years ago (Figure 6).

The handheld Alcotest 7310 instrumentOver the years, the requirements for accu-racy, speed and test frequency, as well aseffective and economical use, have increas-ed considerably. Thanks to the huge ad-vances in sensor technology, the chemical processes have been replaced by small, reliable sensors, making possible the devel-opment of reliable and easy to use breathalcohol measuring instruments .

The first outcome of these developmentswas the launch in 1980 of an electronichandheld instrument which used a so-calledsemiconductor sensor (based on tin dioxi-de) to determine the breath alcohol con-centration [6]. The instrument, called theAlcotest 7310, was the first to display ameasured value within several seconds toshow the alcohol concentration. With its digital display of results, the instrument allowed easy, objective assessment, makingit much easier to carry out – and boostingthe acceptance of – alcohol checks. Because of the semiconductor sensor usedin the Alcotest 7310, with the limited long-term stability typical of such sensors, the instruments had to be calibrated within fourweeks at the latest.

The handheld Alcotest 7410 instrumentIn the area of sensor technologies, the de-velopment of electrochemical gas sensorsin particular was dramatic in the 1980s, enabling a level of sensitivity, accuracy and,above all, long-term stability to be achievedwhich had previously been thought impos-sible. Within just a few years, electrochemi-cal gas sensors completely replaced semi-conductor gas sensors in most professionalapplications, for example the measurementof hazardous gases. This also resulted in anew generation of handheld detectors forbreath alcohol instruments measurements.

The first member of the Alcotest 7410 fami-ly, one of the most successful handheld instruments in the world to date, waslaunched by Dräger in 1988 (Figure 7). Itachieved its extraordinary measurement ac-

curacy, reliability and its calibration intervalof six months by using an electrochemicalDrägerSensor [7]. In its different designs(Alcotest 7410 Plus, Alcotest 7410 Plus RS, Alcotest 7410 Plus com, Alcotest 7410med), the Alcotest 7410 family is still theinternational standard for professionalbreath alcohol testing by the police and inindustry and hospitals.

In 1996, the Alcotest 7410 Plus RS saw thedawn of the computer era in handheld in-struments for breath alcohol measurement.Thanks to the RS-232 interface, the storedmeasurement results can be sent to a PC,where they can be analysed according tovarious criteria such as number of tests,measured concentrations or time of test.

In the year 2001 the family was enlarged toinclude the Alcotest 7410 Plus com, whichset new standards in handheld instruments[8]. The instrument combines the sturdi-ness and measurement accuracy of all

Figure 5: Robert F.Borkenstein withthe Breathalyzer he developed inthe year 1953(Photo: Depart-ment of CriminalJustice, Indiana University, USA)S

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Alcotest 7410 devices with complete text on a graphic display. Information for theuser and tested person is no longer givenin coded form but in plain text, greatlyfacilitating user-guidance and intuitive device use and making the instrument ex-tremely convenient to use and operate.Texts can be viewed in a huge number ofdifferent languages and alphabets, includ-ing for example Vietnamese and Chinese (Figure 8).Of course, development did not stop there.In 2003, for instance, an Alcotest measur-ing system has been presented which (the respective legal regulations permitting) willallow a handheld instrument to producemeasurements which are admissible as evidence in courts.

Evidential breath alcohol measurementAs use of breath alcohol measurement became more widespread, many countries

demanded improved measurement resultsto allow them to be used as evidence incourts and, as such, to be recognized asequivalent to a blood sample. This prompt-ed the development of infrared optical DrägerSensors. The first trials with thistechnology were carried out back in 1978with a prototype known as the Alcytron [9](Figure 9). This led in 1982 to the station-ary Alcotest 7010 breath alcohol measuringinstrument (Figure 10). The infrared opticalDrägerSensor located in the handset useda light wavelength in the range of 3.4micrometres [10].The disadvantages of the device, which wasstate-of-the-art at the time, were the sizeand weight of the handset containing theinfrared optical sensor, the instrument's limited ability to distinguish alcohol fromother substances possibly being exhaled by the tested person, and the high level of power consumption which meant that theinstrument could only be used on a mainspower supply.

The Alcotest 7110In 1985, when the first generation of the Alcotest 7110 was introduced, the founda-tion stone was laid for a new family of stationary breath alcohol measuring instru-ments which were also suitable for mobileuse. The integrated infrared optical Dräger-Sensor allowed residual alcohol in themouth to be detected, and the light wave-

length in the 9.5 micrometre range meantthat highly selective determination of thebreath alcohol concentration could beachieved. An integrated printer also allowedmeasurement results to be printed out im-mediately on site. The further development of the Alcotest7110 over the course of several generations,offering among other things much more powerful electronics and software, peakedin the Alcotest 7110 Evidential which since1998 has marked a milestone in breath alco-hol measurement (Figure 12). The instru-ment, which can be used in mobile and sta-tionary applications, boasts a dual sensorsystem (infrared optical and electrochemi-cal), breath temperature measurement,integrated printer, and pressure and volumesensors – its measurement results meet thestrictest requirements worldwide and haveset the standard in many countries [11]. InGermany, the Road Traffic Act and a judge-ment by the Federal Supreme Court havedeemed the instrument's measurementsequivalent in court to the results of a bloodsample.

InterlockFrequent police checks are an importantand efficient method of reducing the num-ber of road accidents caused by excessivealcohol consumption. A further step is onlyto allow a vehicle to be started once abreath sample has been submitted. This is

Bild 8: Chinese display on Alcotest 7410 Plus com in the year 2002

Figure 9: The Alcytron prototypewith an infrared optical sensorin the year 1978

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Figure 6: Dräger Breath-alyzer using wet chemicalanalysis procedure

Figure 7: Alcotest 7410 with an electrochemical sensor in the year 1988

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where alcohol ignition interlock devices, so-called alcohol interlocks, come in. Onceinstalled in a vehicle, the engine can onlybe started if a breath sample containing no alcohol is given. Nowadays, such instru-ments are in widespread use, mainly inNorth America.Dräger has applied its many years of ex-perience in the development and produc-tion of breath alcohol measuring instru-ments to this area, too, resulting in 1995 in the launch of the first Dräger Interlock(Figure 11). This device is the successfuloutcome of Dräger's investment of its decades of experience in this new area of application for breath alcohol measurement[12].

50 years of AlcotestIn developing and launching Alcotest pro-ducts, the Dräger company has returned to alcohol, to the beer tap, and therefore to the very roots of its more than 110-year history.

In 2003 Dräger was celebrating 50 years of Alcotest products. The company boasts a50-year history in the development, produc-tion and sale of products for breath alcoholmeasurement. Today, Dräger Alcotest instruments are in use in every conceivabledesign worldwide. What started with the Alcotest tube has now evolved to includecomputer-controlled measuring instruments

which prevent external influence andtampering during determination of thebreath alcohol concentration [13].As such, Dräger Alcotest instruments helpimprove safety on our roads. The techno-logy has changed over the years, and thequality of the results and the ease of usehave improved continuously – proud testi-mony to 50 years of the name Alcotest.

Dr. habil. Johannes LagoisJörg SteuerDräger Safety AG & Co. [email protected]@draeger.com

Bibliography[1] Fritz Bangert, 30 Jahre Dräger-CO-Messer,

Drägerheft 233, p.5074, 1958

[2] Referenced in: A.W.Jones, Medicolegal AlcoholDeterminations – Blood- or Breath-alcohol Concentration?, Forensic Science Review, Vol. 12, p. 23, 2000

[3] The Quarterly Journal of Inebriety, Vol. 26, p. 308, 1904

[4] G.Liljestrand, P.Linde, Über die Ausscheidung des Alkohols mit der Exspirationsluft, Scand. Arch. Physiol. Vol. 60, p. 273, 1930

[5] Lutz Grambow, Messung der Atemalkohol-konzentration am Arbeitsplatz, Drägerheft 323, p. 14, 1982

[6] Lutz Grambow, Hans Matthiessen, Martin Schmidt, Alcotest 7310, Dräger Review 49, p. 23, 1982

[7] Burkhard Stock, Fritz Thiele, Alcotest 7410: Compact and precise, Dräger Review 65, p. 15, 1990

[8] Johannes Lagois, Jürgen Sohège, Breath-alcohol testing Dräger Alcotest 7410 Plus com, Dräger Review 89, p. 19, 2003

[9] Alcotest 7010 bestand Polizeiprüfung, Drägerheft 318, p. 32, 1980

[10] Lutz Grambow: ADAC-Juristentagung 1980, Drägerheft 318, p. 23, 1980

[11] Johannes Lagois, Alcotest 7110 Evidential – the measuring instrument for evidential breath-alcohol analysis in Germany, Dräger Review 86, p. 12, 2000

[12] Johannes Lagois, Jürgen Sohège, Dräger Interlock XT – contributing to improved road safety, Dräger Review 376, p. 24, 2003

[13] Instruments for breath-alcohol analysis, Internet www.alcotest.com

Bild 11: Alcotest 7110 Evidential with infrared optical and electrochemical sensor in the year 1998

Bild 12: The Dräger Interlock, an alcohol ignition interlock device, in the year 1995

Bild 10: Alcotest 7010 with infraredoptical sensor in the year 1982

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ABUSE OF ILLEGAL DRUGS AND MEDICATION SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

When people talk about drugs, they gene-rally mean "natural, semi- or fully-syntheticsubstances which affect the central nervoussystem (CNS) and are taken with the pur-pose of bringing about a change in cons-ciousness and/or experience“. There aretwo essential factors operating in tandemwhen it comes to defining the word "drug"– a substance's pharmacological effect (asan objective property) and the way it isused or the reason for its use (as a subjec-tive property). The psychoactive substancesreferred to in this article tend to have con-siderable addictive potential.

Alongside the most widespread of the legalstimulant drugs, namely alcohol and nicotine,the range of psychoactive substances whichhas been available since the 1960s in parti-cular has widened considerably. Almost allof these substances, many of which wereoriginally developed as pharmaceuticals,were classified as illegal by the western in-dustrialized nations. At the present time,cannabis is the most commonly used illicitdrug, with numbers of users increasing, es-pecially among young people. In Germany,more than 10 tons of hashish and marijuanawere seized in 2003. The consumption of

party and fashion drugs like amphetamine("speed“), MDMA ("ecstasy“) and cocainehas also remained high. In 2003, more thana ton of cocaine was seized in Germany,and a total of nearly 500 kg of ampheta-mine and methamphetamine was confisca-ted in almost 4,000 separate incidents [1].

How illicit drugs affect people and the symp-toms they cause vary greatly. Amphetamine("speed“) is similar in terms of its chemicalstructure to the human neurotransmittersadrenalin and dopamine. It is primarily takenin powder form and suppresses fatigue, re-duces a person's need to sleep, curbs theappetite and lowers the aggression thres-hold. MDMA ("ecstasy“) is usually taken intablet form, causes changes in mood andalso suppresses hunger, thirst and tiredness.Its widespread use in the rave scene is duein part to its ability to heighten the danceexperience. The stimulating and de-inhibitingeffect of cocaine induces people to continueusing the drug until they are heavily psy-chologically dependent on it; typical of thisdrug is the need to increase the dosage.Cannabis products (hashish, marijuana)contain the active ingredient delta-9-Te-trahydrocannabinol, �9-THC, and bring

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about acute changes in thinking and be-haviour, though these can be perceived differently from person to person, and in-deed each time the drug is consumed. Typically, the effects include slower move-ment and thought, reduced attentiveness,lessened grasp, euphoria, (unfounded) happiness, relaxedness, inertia, reduced drive, lack of drive or apathy, sleepiness,mood swings, dysphoria, irritability, and in-creased appetite. Especially if high doses of �9-THC are taken, hallucinations and visionary states can occur – these may manifest themselves in a distorted or lackingsense of time, space, person and situation.In addition, medical drugs such as pain-killers, tranquilizers and sleeping pills areabused on a grand scale. Medical drugs are those pharmaceuticals which (in specificdosages) are used to cure, prevent or al-leviate an illness. Since time immemorial,certain plants, plant extracts and animalsubstances have been used for these pur-poses, though in recent times mainly syn-thetic substances are used. A number ofmedical drugs – especially those which affect the CNS – can also be addictive.Benzodiazepines in particular, which areused as sleeping pills and tranquilizers to

dispel fears and improve the mood, are oftenused for too long and in too high doses. Itis presumed that most of the 1.4 million peo-ple in Germany who are addicted to medicaldrugs are dependent on benzodiazepines.

Pharmacological relationsPharmacology, the branch of science whichstudies how chemical substances interactwith biological systems, has a number ofsubdisciplines. Pharmacokinetics, for example, describes the changes in con-centration of consumed substances and/ortheir metabolites in the organism over time.By observing pharmacokinetic processessuch as the absorption, distribution and, finally, elimination of a biologically activesubstance, it is possible to determine howthe organism reacts to the consumed substance. Pharmacodynamics provides information about how a pharmacological effect is brought about after a biologically activesubstance has been consumed. In order to be able to draw logical toxicolo-gical conclusions about the effects of a drugfrom the measured blood concentration, aparallel and, ideally, linear time progressionof both curves (rise, maximum values, fall)

would be useful. However, this type of rela-tionship is generally not possible to deter-mine for drugs and pharmaceuticals.When a person smokes a joint, for example,the concentration of the active substance inthe blood increases immediately, even thoughthe effect is felt only very gradually. Whilethe effect is still subjectively felt to be in-creasing, the blood concentration is alreadyfalling again. In other words, the effect lagssomewhat behind the concentration pro-gression of the active substance. It is onlysome time later that the relationship is re-versed, with the effects decreasing fasterthan the active substance is eliminated fromthe blood. This relationship can be portrayedas an anticlockwise curve [2].

In the case of alcohol, the relationship be-tween concentration and effect is exactlythe opposite: in this case, the subjective effect at the beginning is felt to be greaterthan the concentration in the blood, while at the end the alcohol is broken down muchmore quickly than the time it takes for theeffects to disappear. This time, the result isa clockwise curve [3].The different progressions of effect andconcentration are attributable not only to


ABUSE OF ILLEGAL DRUGS AND MEDICATION SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

the chemical properties of the consumedsubstances, but also to the way they areconsumed. The effects of smoking cannabis,for instance, are felt within minutes, peakwithin 15 minutes, and start to fade around30 minutes after smoking. On average, theintoxicating effects are over after two tothree hours. If cannabis cakes ("space cakes") are eaten, the effect is felt with some delay, some half an hour to two hoursafter consumption – making it much moredifficult to control the intoxicating effect.If several different substances are in the body at the same time (alcohol and drugs,alcohol and medication, different types ofmedication), the substances can interact toadd together or even multiply the differentindividual effects, though in some casesthey can weaken or even (temporarily) cancel each other out. This means, however,that it is virtually impossible for a person tosubjectively "plan" their degree of intoxi-cation or for somebody to assess the be-haviour of the intoxicated person.

Analytical methodsWhich analytical methods to use is dictatedfirst and foremost by the application. Thefollowing factors need to be taken into ac-count [4]:– Which substance or metabolite profile is

likely to be found in the material to be analysed?

– Which analytes need to be determined to draw which conclusions?

– Which analytical requirements does the intended method meet?

– To what extent can the intended method be routinely used?

Immunological screening testsTo reduce the number of analyses that needto be carried out, the samples can be sub-jected to an immunochemical screeningtest. This allows samples to be preselectedquickly on the basis of the presence of spe-cific substances or substance classes, witha high level of sensitivity, and without sig-nificant preparation. Immunological testing has its origins in theUSA, where immunoassays have been wide-ly used for drug detection purposes – aswell as in toxicology – since the end of the1980s within the framework of pre-employ-ment and workplace testing for drug use.Accordingly, manufacturers of immunoas-says base their "positive" and "negative"cut-off values on American decision-makingcriteria, i.e. the guidelines of the NIDA [5].All assays take advantage of the antigen-antibody reaction principle, according towhich the analytes compete with antigensto bind to specific antibodies. The numberof immune complexes formed by the anti-bodies and analytes is an indication of theanalyte concentration in the sample. The

antibody-antigen bond, however, is not di-rectly accessible for analysis in most immu-noassays. This problem is solved by couplingone of the two components, either the anti-gen or the antibody, to an easily detectable"label". Enzymes (biocatalysts), dyes, fluoro-phors and, though less and less often,radioactive components are examples ofpossible labels [6].

Besides being used in urine analysis, immu-noassays can also be used to detect drugsin other bodily materials. For example,microtiter plate tests have been on the market for a few years which allow directand highly sensitive enzyme-immunochemi-cal detection of drugs and metabolites inuntreated whole blood or serum. No recom-mended cut-off values are (as yet) available.Immunoassays are a useful way of determi-ning whether samples contain drugs, but theirresults must be confirmed by other reliablemethods offering a higher degree of specifi-city, as this is the only way to ensure re-liable identification and precise quantification.

Confirmatory analysisReliable quantitative determination of differ-ent drugs in a complex matrix such as serumdemands the use of a selective method.Because of the low concentrations (in thenanogram range) of drugs in the blood, and indeed in oral fluid, complex analytical

Blood concentration

Time

Subjective effect

� -THC

Blood concentration

Subjective effect

ALCOHOL

Concentration plottedagainst effect followingsmoking of a cannabis ci-garette (left) and afterconsumption of alcohol(right).

Time


P. 14 | 15

methods have to be employed which allowmeasurements to be performed close to the detection limit.The relevant literature describes numerousmethods of identifying and quantifying ana-lytes in physiological samples, though pre-ference tends to be given to a combinationof gas chromatography and mass spectro-metry with stable isotopes as internal stan-dards. Gas chromatography mass spectro-metry (GC-MS) has long been known as a"definitive method" which is "correct" andspecific; i.e. it delivers a definitive (correct)value as the best approximation to the "truevalue" [7]. The "Mandatory Guidelines forFederal Workplace Drug Testing Programs"in the USA also list GC-MS as a "confirma-tory drug test" [5]. Another definitive methodwhich is used is liquid chromatography(LC), likewise in conjunction with a massspectrometric detector.

Sample materialTo determine whether pharmaceutical ornarcotic substances are present in the body,toxicological analyses can be performedusing different bodily materials. The ma-terials should be chosen to match the re-quirements of the particular application; oral fluid and blood, for instance, can beused to detect recent consumption, whilehair gives a clearer picture of consumptionlonger ago.

BloodBlood is very well suited to testing fordrugs and medication because, right fromthe outset, it contains the pharmaceutical or narcotic substance at the point the sub-stance is introduced into the body and thentransports it to all tissues, including the places where the substance takes effectand the organs which expel it once againfrom the body. Blood cannot be tamperedwith, has a fairly homogeneous composition,and the concentration of the substance is in a state of dynamic equilibrium with the

concentration of substances absorbed intothe central nervous system and, therefore,regarding any effect – at least to a limitedextent. For all these reasons, blood is theonly sample material which fulfils the Germanlegal requirements of § 24a Subsection 2of the Road Traffic Code. Since Germanyoperates a policy of "obligatory tolerance", a blood sample can be ordered by policeofficers if a traffic offence is committed. Taking of a blood sample, however, is a highly invasive process and therefore notsuitable for conducting at the roadside.

UrineTesting a urine sample can serve as a com-plement to a blood analysis. Urine's advan-tage as a sample material is that it can ge-nerally be provided by test subjects in largerquantities without the need for invasive tech-niques. As a rule, any foreign substancesand their metabolites can be found in a higher concentration than is the case inblood, and can be detected for longer. The broader metabolite profile can also provide additional information. One dis-advantage, however, is the fact that the results of urine testing are only comparableto blood test results to a limited extent. For example, measurable concentrationscan usually be found in the blood immedi-ately after consumption, yet the processes

by which the drugs are broken down in thebody mean that they cannot yet or canhardly be detected in the urine. On theother hand, a positive urine result does notnecessarily point to very recent consump-tion; in the case of cannabis consumption inparticular, THC carboxylic acid, which is themain metabolite used for detection, can befound in the urine even after several weeks.The fact that urine testing requires suitablefacilities in which the test subject can pro-vide a sample often entails a great deal oftime and personnel. It is impossible not tointrude upon a person's privacy if supervisedsampling is required. It is also possible forthe test subject's urine sample to be tam-pered with in many different ways, and in-deed a sample is not always possible for various reasons. In other words, althoughurine is in principle a suitable test mediumfor detecting drug consumption, it is notpracticable, and is not permitted by law inmany countries.

Saliva / Oral fluid(Physiological) saliva is colourless andtransparent, low in viscosity and producedby the salivary glands situated in and nearthe oral cavity. Every day, these glands produce around 1 to 1.5 litres of saliva.Samples of oral fluid (which is slightly differ-ent from saliva) provide detailed information

Minutes Hours Days Weeks Months Years

Hair & Nails

Blood

Oral Fluid

Urine

Sweat

Analytical detection window for different sample materials [8].


P. 16 | 17ABUSE OF ILLEGAL DRUGS AND MEDICATION SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

about a person's current state of drug influ-ence because, like blood samples, they correlate more accurately with the time ofdrug consumption and the extent of the effect than urine samples. It is also easierto obtain an oral fluid sample from a personthan a urine sample, as there is no seriousinvasion of their privacy and the sample cantherefore be obtained directly at the test site under constant supervision, without theneed for any special facilities. As a result,far less time and far fewer personnel are involved in performing the test than is thecase with urine testing. What is more, tampering on the part of the test subject is virtually impossible. Experience has shown that those tested, especially peoplesuspected of driving under the influence ofdrugs, are generally much more willing toundergo an oral fluid screening test than aurine screening test.

Hair, fingernails and toenailsMaterial containing keratin such as hair and nails can also be used for the purposesof analysis. Because drugs are incorporatedinto the keratin structure, information aboutthe "drug history" of the person under inves-tigation and, to some extent, about their con-sumption can be obtained, taking the aver-age rate of hair growth into account (approx.1 cm per month). This does not provide anydetails of recent drug consumption, however,so no conclusions can be drawn as to whethera person is actually under the influence ofdrugs. Hair and nails do not represent suit-able sample material for screening tests.

DiscussionIn today's society, drug and medication abu-se is being taken increasingly seriously.Analytical proof is thus also becoming in-creasingly important to allow preventive

action to be taken, and to make boundariesclear to drug abusers through the use ofsanctions. Alongside laboratory-based analytical methods, it is those analytical techniqueswhich are easy to use and can quickly produce a result which are particularly useful for on-site use. Drug screening testsin particular can be crucial in providing aquick and reliable qualitative indication ofdrug consumption. The requirements whichsuch tests need to meet are quite differentto those placed on instruments used in a laboratory. The test conditions in a chemicalor medical laboratory are completely differentto those, for example, during a "roadsidetraffic control". Testing at night, in bad weather, in chaotic situations etc. has a hugeinfluence on the way a test is performedand does not reflect a test system's usabilityand reliability under ideal, reproducible lab-

Comparison of oral fluid testing with blood and urine testing for drugs of abuse [9].

Oral fluid Blood Urine

Sample collection Non-invasive Highly invasive Intrusion of privacy

Principle analyte Parent drug and/or metabolites Parent drug and/or metabolites Metabolites

Analyte concentration Low Low to moderate Moderate to high

Interpretation 1 Can be used to determine Can be used to determine Limited use in

pharmacokinetic parameters pharmacokinetic parameters pharmacokinetics

2 Potential correlation with Potential correlation with No correlation with

impairment impairment impairment

3 Used to estimate blood Cannot be used to estimate

levels and free drug fraction blood levels

Potential problems 1 Contamination from smoke, Limited sample availability Possibility of adulteration

intranasal and oral administration

2 Changes in pH during Changes in pH of urine

collection may change saliva during storage

to plasma concentration

ratio (S/P ratio)

3 Drug excretion influenced

by pH


oratory conditions (good lighting, room tem-perature, trained laboratory personnel etc.).This also affects the sample material; whilethe samples are treated in the laboratory(freezing, centrifugation etc.) for ease ofanalysis and can thus be standardized to acertain extent, such methods are generallynot available on site, and this needs to havebeen taken into account as far as possibleduring development of the test system. Adrug screening test system must be basedon a principle which reflects the problem situation and, despite the potential diffi-culties which can occur during a road trafficcontrol, for example, need to function pre-cisely within clearly defined error limits.

Dr Stefan [email protected]äger Safety AG & Co. KGaA

Bibliography[1] Drogen und Suchtbericht der Bundesregierung,

Stand April 2004. Available at http://www.bmgs.bund.de

[2] Chiang, C.W. & Barnett, G. Marijuana effect and delta-9-tetrahydrocannabinol plasma level. Clin Pharmacol Ther 36 (1984) 234-238

[3] Drogenerkennung im Straßenverkehr – Schulungsprogramm für Polizeibeamte. Bundesanstalt für Straßenwesen (BASt) (Hrsg.):Reports from the Bundesanstalt für Straßenwe-sen, Mensch und Sicherheit, M 96. Wirt-schaftsverlag NW. Verlag für neue Wissen-schaft GmbH, Bremerhaven (1995).

[4] Aderjan, R. Toxikologischer Cannabisnachweis. In: G. Berghaus & H.P. Krüger (Hrsg.): Cannabis im Straßenverkehr, Gustav Fischer Verlag, Stuttgart (1998) 153-178

[5] National Institute of Drug Abuse. Mandatory Guidelines for Federal Workplace Drug Testing Programs Draft 4 (2002); available at http://workplace.samhsa.gov/DrugTesting/NatlLabCertPgm/MGuidelines.htm

[6] Polzius, R., Manns, A. (2002): Immunoassays: highly sensitive and selective analysis. Dräger Review 88, 31-35

[7] Bundesärztekammer. Richtlinien der Bundesärztekammer zur Qualitätssicherung in medizinischen Laboratorien (bis 31.12.2001) (1993); available at http://www.bundesaerztekammer.de/30/Richtlinien/Richtidx/Labor/index.html

[8] Caplan, Y.H., Goldberger, B.A. (2001): Alternative specimens for workplace drug testing. J Anal Toxicol. 2001 Jul-Aug;25(5):396-9.

[9] Cone, E.J. Saliva testing for drugs of abuse. In: Malamud, D., and Tabak, L., eds. Saliva as a Diagnostic Fluid. Vol. 694, New York: The New York Academy of Sciences, 1993. pp. 91-127.

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P. 18 | 19BREATH-ALCOHOL ANALYSIS SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

How to determine the alcohol concentration?

Alcohol and societyAlcohol, loved by some and cursed byothers, is appreciated by most people as ameans of stimulation and relaxation. We allknow that consumption of alcohol has a negative impact on our perception and im-pairs our performance.However, this change in state does not ne-cessarily need to be unpleasant, and it isnot without reason that alcohol plays an im-portant "supporting role" in our social life.Alcohol stimulates, inspires, liberates andexhilarates. It removes inhibitions and ma-kes establishing contact easier. Alcohol ismissing at no celebration, at no reception,at no banquet. Alcohol is a firm fixture ofour everyday life, and has been for manycenturies.Over the centuries, however, the require-ments placed upon us in our social lives have changed considerably. Today we livein a modern world in which speed and tech-nology define our daily life. Alcohol can bepleasant and fun, but the consumption of alcohol also holds many dangers.

Road users under the influence of alcoholWhen a person's consciousness is cloudedby alcohol, this exposes us to many risks.Nowadays, we often encounter situationswhich demand our concentration and swiftreactions. Who can tell how much alcohol is in his or her blood after two glasses ofwine? Only our conscience can help us decidehow much "too much" is, yet it is preciselyour conscience which becomes increasinglyunable to function with each sip of alcohol.In Germany, for example, 70,000 road acci-dents involving people under the influenceof alcohol are recorded each year. The pro-portion of people killed and seriously injuredin these accidents is particularly high, andfor more than 10,000 people in the Euro-pean Union, and more than 15,000 peoplein the USA, the accident proves fatal. Everysingle accident which occurs due to exces-sive consumption of alcohol is one accidenttoo many!Such accidents show us where the limitsare, making it clear what the difference between moderate and excessive can mean. Our sense of responsibility towardsourselves and others decides how we answer the question "alcohol, yes or no?".

Figure 1: Diagram ofalcohol distribution inthe body

Measurement using air fromthe lungs(breath-alcoholconcentration BrAC)

Measurement using venous blood(blood-alcohol concentration BAC)


Bild 1: Schema der Alkoholverteilung im Körper

We all have a duty to accept this responsi-bility to prevent risk situations and dangersfrom occurring in the first place. However,only accurate, unmistakable proof of alcoholcan show where the limits are, and this ac-curate proof can be obtained only by meansof technical apparatus.

The physiology of alcoholAfter drinking, the alcohol, or to give it itsmore accurate chemical name, ethyl alcoholor ethanol, is taken up by the blood in thegastro-intestinal tract and transported, viathe heart and the lung, to the arteries ofthe brain. From the heart the blood is circu-lated around the rest of the body, into thearteries of the arms for example. From thereit is distributed throughout the tissue and,finally, flows back through the veins.

Effects on reaction speedOnce alcohol reaches the arteries of thebrain, it affects our speed of reaction and,in sufficient quantities, instantly provokesunusual, alcohol-related (driving) behaviour.The extent to which the speed of reactionis affected determines whether a personcan still safely drive a car or whether thereis an increased risk of accident.

From there the blood is distributed through-out the tissue and, finally, flows backthrough the veins. A sample of this venousblood is taken from the inside of the elbowand used to determine the blood alcoholconcentration indirectly by means of a further multistage procedure (Figure 2).

Alcohol screening testWhen determining a person's breath-alcoholconcentration, a distinction is made betweena preliminary screening test and an eviden-tial analysis. A screening test is used by thepolice officer at the roadside to help decideobjectively whether, if a particular limit isexceeded, an evidential breath-alcohol analy-sis needs to be carried out afterwards orwhether a blood sample will be taken.Alcohol screening tests are performedusing Alcotest tubes, in which chemicalsare discoloured by the alcohol in the breath(Figure 3), or using electronic hand-held instruments (Figure 4).

The familiar Alcotest tube with the samplebag is probably the oldest method of obtain-ing proof of alcohol in a screening test.However, requirements with regard to accuracy, speed, test frequency and effec-

Bild 1: Schema der Alkoholverteilung im Körper

To judge whether or not a person is fit todrive would require a method of directlymeasuring this reduction in reaction speedat the roadside, but this is too expensive tobe a viable option.To obtain nevertheless a useable procedure,"auxiliary variables" are used which permitan indirect conclusion to be drawn about aperson's speed of reaction: a sample of airfrom the lungs or a sample of venous bloodfrom the inside of the elbow is taken andits alcohol concentration determined.

Henry's lawThe alcohol concentration is measuredusing air from the lungs or venous blood(Figure 1).In accordance with Henry's law, diffusionprocesses, which are also what causes oxy-gen to be taken up in the lungs, achieve abalance between the alcohol concentrationin the blood in the lungs and the alcoholconcentration in the air in the lungs. Thebreath-alcohol measurement involves direct-ly determining this concentration.

From the heart, the blood is circulated around the rest of the body, into the arteriesof the arms for example.

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tive and economic use rose considerablyover the years. A screening test must beable to be performed swiftly and supply ac-curate results, and today mainly electronicdevices are used.

Evidential measurementAfter a positive screening test an evidentialalcohol analysis must be performed. Law-makers in different countries have set appropriate limit values for the two proce-dures, i.e. breath and blood alcohol analysis.The breath-alcohol concentration (BrAC),

a gas concentration, is expressed for example in milligrams of ethanol per litre exhaled air (mg/l). The blood alcohol con-centration (BAC), a liquid concentration, isexpressed in per mille (‰) and refers tothe amount of ethanol in grams in each litre of blood.In many countries the lowest limit valuewhich constitutes an offence is a blood alcohol concentration of 0.5 per mille (‰),the corresponding limit for breath-alcoholconcentration being 0.25 milligrams per litre (mg/l) of exhaled air.

Breath-alcohol concentration – a moreaccurate measureEven though the limit values for both proce-dures may be equivalent from a legal view-point, the breath-alcohol concentrationnevertheless offers a more direct measureof actual impairment of driving ability.This is because of the path that alcohol takes through the body. From the placewhere the breath sample is taken from thelung, the blood transports the alcohol viathe heart directly to the arteries of the brain,where the rapid increase in alcohol concen-tration impairs speed of reaction. Beforethe blood sample can be collected from thevenous blood inside the elbow, however,the blood containing the alcohol is first distributed in tissue throughout the body.A further advantage of the breath-alcoholanalysis is that the alcohol content can bedetermined directly and documented im-mediately, even on site, for instance at theroadside.

Measuring the breath-alcohol concentrationModern breath-alcoholmeasuring instru-ments usually determine the breath-alcoholconcentration using two different measuringsystems: an infrared sensor or an electro-Comparison with limit value

Calculation of whole bloodconcentration (‰) based on blood

serum using mean divisor 1.2

Determination of alcohol concentration (‰) in blood serum

(liquid concentration)

Blood serum

Separation of the solid constituents

Transport

Sampling of venous whole blood

Veins of the arms

Arteries of the armsArteries of the brain

Capillaryblood in the alveoli

Blood / heart

Alcohol in thegastro-intestinal tract

HeartLung air(Henry's law)

Direct comparison with limit value

Collection ofa breath sample of lung air

In each case direct determinationof alcohol concentration (mg/l)

in lung air(gas concentration)

Figure 2: Effects of alcohol and taking a sample

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P. 20 | 21

chemical sensor. Screening devices like theDräger Alcotest 6510 use the electrochemi-cal system of measurement.In evidential analysers like the Dräger Alco-test 7110, both systems are used at the sa-me time. By using two measuring systemswith different analytical specificity, the deviceis able to reliably detect any interfering sub-stances which may be present in the ex-haled air and which might influence the result in any way, such as petrol, paint orsolvent vapours.

The electrochemical measuring systemThe sampling system in an electrochemicalmeasuring system (Figure 5) conveys asample of air with an exact volume to theelectrochemical sensor (Figure 6). Thesensor selectively and highly accuratelyanalyses the breath sample for the pre-sence of ethanol. The sensor contains a membrane which issoaked in electrolyte and carries the measurement electrode and the counter-electrode. The electrolyte and the electrodematerial are chosen such that the alcohol tobe analysed will be electrochemically oxi-dized on the catalyst layer of the measure-ment electrode. The electrons released bythe reaction at the electrode cause a current

to pass through the connection wires to thedevice's electronics (Figure 7). When thesensor current is analysed, the entire elec-trical charge released by the electrochemi-cal reaction is determined, as this dependson the alcohol content in the sample cham-ber. This coulometric measurement methodgives the sensor its particular long-term stability.The electrochemical sensor only reacts withthis high level of specificity to alcohol. Thismeans that acetone, for instance, which issometimes to be found in the air exhaled bydiabetics or persons on a starvation diet, can-not distort the measurement result, as keto-nes do not react at the electrodes. This pre-vents any false-positive measurement results.

Figure 4: Alcotest 6510 in use

68XXXXX06 95 ARJF-0033

Figure 6: Cross-sectional view of an electrochemical sensor Figure 5: Electrochemical measuring system

Connection wiresMeasurement electrode with catalyst layer on both sides

PistonElectric pump motor

Electrochemical Sensor Sampling chamber

Figure 3: Test tubes

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The infrared measuring systemIn an infrared optical sensor (Figure 8), a light source emits light at different wave-lengths (colours) in the infrared range ofthe spectrum (i.e. not visible to the humaneye). In the schematic diagram (Figure 9),the colours of visible light are used ratherthan the invisible infrared spectrum. The lightpasses through two windows and an interfe-rence filter which only allows penetration ofcertain wavelengths (the green light in thediagram). A detector measures the intensityof the incoming light and transmits a corre-sponding signal to the device's electronicssystem. If a gas (ethanol, for example)which absorbs part of the light at a particu-lar wavelength (the green light in the dia-gram) is present between the two windows,the light intensity measured by the detectorwill drop, as will its electrical output signal.The higher the alcohol concentration, themore the signal will be reduced, which isthus a measure for the alcohol concentration.

Breath temperatureThe alcohol concentration in the exhaled air(BrAC) increases as the body temperatureand exhalation air temperature rise, due tothe fact that an increased body temperaturecauses more alcohol in the lungs to evapo-rate out of the arterial blood in the lungs in-to the lung air. This takes place in accord-ance with a fixed physical principle knownas Henry's law. Furthermore, as the body

temperature rises, the exhalation air in theupper airways loses less of its alcohol con-centration.For this reason, some countries (Germany,for example) require measurement of thebreath temperature when a sample of breathis given for evidential measurements. When calculating the measurement result,breath temperature sensors are used to always relate the breath-alcohol concen-tration to a fixed exhalation temperature of34 °C, ensuring that persons with for exam-ple a higher than normal body temperatureare not disadvantaged by a higher measure-ment result.

Ways to breathe, hyperventilation andhypoventilationHow the test subject breathes directly before giving the breath sample, and theambient temperature, also have an influenceon the measurement of the breath-alcoholconcentration at the end of the exhalation. For instance, if the test subject hyperventi-lates (breathes excessively) or if ambienttemperatures are low, the area of the mouthand throat and the windpipe are cooled tobelow normal levels. This causes the tem-perature of the exhaled air to fall and, con-sequently, the uncorrected breath-alcoholconcentration is lower.

Sen

sors

trom

[µ

A]

Zeit [s]

10 20 30 4000

400

500

300

200

100

Pump drawsin sample

Figure 7: Sensor current of the electrochemical sensorduring analysis of a breath sample containing approx.0.5 mg/l of ethanol

Bild 8: Infrared optical sensor withelectrochemical sensor

Time [s]

Sen

sor

curr

ent [

ÌA]

Side of the light source

Electrochemical sensorwith sampling unit

Side of thedetector

Flow sensor


BrA

C [

mg/

l]

Expiration time [s]

with temperature correction

HypoNormalHyper

0

0,1

0,25

0,2

0,15

0,05

0 3 6 9 12 15

BrA

C [

mg/

l]

0

0,1

0,25

0,2

0,15

0,05

Expiration time [s]

without temperature correction

0 3 6 9 12 15

HypoNormalHyper

2

0 2 4 6 8

Time [Min.]

BrA

C [

mg/

l] 5

4

3

1

0

Cherry liqueur chocolateMouth sprayBrandy chocolate

P. 22 | 23

Likewise, hypoventilation (shallow breathing)or high ambient temperatures can increasethe temperature of the breath and thus re-sult in a higher uncorrected breath-alcoholconcentration. If on the other hand the ac-tual measured breath temperature is usedto correct the final result and relate it to anexhalation temperature of 34°C, the way thetest subject breathes and the ambient tem-perature will not affect the result of themeasurement (Figure 10).

Mouth alcoholIf shortly before the breath-alcohol concen-tration is measured the test subject con-sumes a substance containing alcohol (liqueur-filled chocolates, for example, or a breath freshener containing alcohol), theexhaled air absorbs alcohol not only fromthe lungs, but also from these substancesin the upper part of the mouth and throat.As a result, the alcohol concentration de-tected in the exhaled air will be higher thanthe concentration in the lung air. However,

within a few minutes this effect is com-pletely cancelled out as the remaining alco-hol in the mouth is taken up by the saliva orabsorbed into the body (Figure 11). Waitingfor at least 10 minutes before the measure-ment is performed and, possibly, comparingthe results of the two individual measure-ments at intervals of two to five minutes canexclude the possibility of residual alcohol inthe mouth influencing the final result.

Reliability of the measurement resultsThe various measuring systems now avail-able to determine the breath-alcohol con-centration have reached a very high level of technological advancement, guaranteeingreliability even under difficult conditions.Precision instruments allow the exact andunmistakable detection of alcohol, neutral-izing risk situations and preventing danger.

Dr. habil. Johannes LagoisDräger Safety AG & Co. [email protected]

Figure 9: Schematic prin-ciple of measurement ofthe infrared optical sensor

Light source

Spectrallines

Gas Infraredspectrum

Window Window Interferencefilter

Detector

Figure 10: How different ways of breath-ing affect the breath- alcohol concentra-tion (BrAC) (Source of diagrams: Prof.Slemeyer, Giessen-Friedberg Universityof Applied Sciences, Germany)

Figure 11: Decrease in breath-alcoholconcentration over time following con-sumption of alcoholic substances(Source of the diagram: Prof. Slemeyer,Giessen-Friedberg University of AppliedSciences, Germany)


P. 24 | 25ALCOHOL ON OUR ROADS SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

Every year, more than a million people world-wide lose their driving licence as a result ofdriving under the influence of alcohol. InGermany, for example, there are 70,000 road accidents a year involving people whoare alcohol-impaired. For more than 10,000people in the European Union and morethan 15,000 people in the USA, these alcohol-related accidents prove fatal.In view of the statistics regarding road trafficaccidents and fatalities attributable to alcoholconsumption, which remain worryingly highworldwide, attempts have been made in re-cent years to find ways to reduce the figures.In North America, for instance, large num-bers of so-called alcohol interlocks (breathalcohol ignition interlock devices, BAIID)are used to prevent alcohol-impaired driversfrom starting and driving their vehicles.In most US states, interlocks have been alegal requirement for offenders who havebeen prosecuted for driving under the in-fluence of alcohol, and today some 70,000interlocks from different manufacturers arein use. Some Canadian provinces have alsochosen to use interlocks in drink-driving offender programmes, while Australia and a number of European countries – Swedenand Finland, for example – have already

introduced such programmes or have plansto do so.The European Commission and the Councilof the European Union are also looking intothe question of how to raise safety standardson Europe's roads and, in particular, how toreduce the number of accidents caused byalcohol. The Council of the European Union,for instance, has decided to investigate the"scope for using devices which prevent theengine from starting if the maximum blood-alcohol level authorised at national level hasbeen exceeded“ [1]. The worldwide experience of interlocks todate and recommendations for countrieslooking at introducing this system are des-cribed in considerable detail in a positionpaper published by the International Councilon Alcohol, Drugs and Traffic Safety(ICADTS) [2]. Furthermore, the EuropeanCommission has ordered a feasibility studyto be carried out to investigate the intro-duction of alcohol interlocks [3].

What is an interlock?An interlock is a breath alcohol measuringinstrument with vehicle immobilizer (Figure 1)which can be easily installed in a motor ve-hicle. Before the vehicle can be started, a

Interlock – contributing to improved road safety

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Figure 2: Submitting a breath sample to an interlock


breath sample has to be given. Once thebreath alcohol measurement has been per-formed (Figure 2), the interlock preventsalcohol impaired drivers from starting theengine. An interlock comprises two main compo-nents: the breath alcohol measuring instru-ment with the measuring system and withthe display, which is situated inside the vehicle (Figure 3), and the central unitwhich is generally installed under the dash-board and allows or prevents current beingsupplied to the vehicle's starter system.When the ignition is switched on, the inter-lock requests a breath sample from the driver (Figure 4). The result of the breathalcohol concentration measurement deter-mines whether the vehicle's starter is released and the engine can be started.

Dräger InterlockThe Dräger Interlock XT was developed onthe basis of Dräger's 50 years of experiencein the area of breath alcohol concentrationmeasurement. The device meets all world-wide interlock requirements, offers thegreatest possible convenience for the userand is even tamper-proof – thus settingnew standards for alcohol interlocks.

Measuring the alcohol concentrationA reliable interlock these days uses an electrochemical sensor to determine thebreath alcohol concentration. The samplingsystem conveys a breath sample of a pre-cisely defined volume to the electrochemicalsensor similar to the one used in the screen-ing devices [4,5] and evidential instruments[6] of the Alcotest family. The sensor de-termines the ethanol content of the breathsample selectively and with a high degreeof accuracy.

The sensor contains an electrolyte-soakedmembrane which carries the measurementelectrode and the counter-electrode. Theelectrolyte and the electrode material arechosen such that the alcohol to be analysedis oxidized electrochemically on the catalystlayer of the measurement electrode. The electrons released from the reaction at theelectrode dissipate as current through theconnecting wires to the instrument's elec-tronics. When the sensor current is analysedthe entire electric charge generated duringthe electrochemical reaction is determined.This coulometric measurement method gives the sensor its particular long-term stability.

The electrochemical sensor only reacts withhigh specificity to alcohol. As a result, ace-tone, for example, which can be found inthe breath of diabetics and those on star-vation diets, cannot distort the measure-ment result because the ketone group doesnot react at the electrodes. This preventsany false-positive measurement results.During development of an interlock, particu-lar attention must be paid to ensuring thatthe instrument will be ready for use quickly,as car drivers find long waits after switchingon the ignition particularly annoying. At nor-mal or high ambient temperatures, the Dräger Interlock XT is ready for use withinjust 10 seconds. To allow a quick and re-liable measurement at low temperaturestoo, the sensor and parts of the samplingsystem are heated. And because the in-terlock even works perfectly at -40°C (during the Scandinavian winter, for example)and at 85°C (in blazing sunlight, for example),it was given the name "XT", for "eXtendedTemperature".

Comparing different sensor systemsBesides interlocks with electrochemicalsensors like the Dräger Interlock, devicesequipped with semiconductor sensors are

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Figure 1: Dräger Interlock XT

Figure 3: Interlock installed in a vehicle

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ALCOHOL ON OUR ROADS SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

also available. Essentially, the semiconduc-tor sensors have two disadvantages. Because of their lack of selectivity, othersubstances such as cigarette smoke, exhaust gases, petrol or acetone can pro-duce a measurement result and, possibly,cause the starter to be blocked. Indeed, it has already been pointed out in many papers that interlock devices fitted with semiconductor sensors are extremely susceptible to interference [7, 8].

The second disadvantage concerns thelong-term stability of the sensors. Deviceswith semiconductor sensors tend to requiremonthly calibration, while devices with anelectrochemical measurement system caneasily be used for six months before nee-ding to be calibrated.The lack of reliability of interlock deviceswith semiconductor sensors was one of the main reasons why use of the devices in the USA initially took a long time to become widespread, despite the necessarylegal framework already being in place. The ICADTS report therefore expressly recommends the use of electrochemicalsensors [2].

Effects of residual alcoholIf any residual alcohol or other substancesin the mouth cause the starting motor to be blocked, a repeat breath sample can be

given after a few minutes. During this period the driver must not smoke, drink oreat anything. After this time, it is certainthat any residual substances will have been completely removed from the mouthand throat, so the test result can no longerbe affected.

ApprovalsIn Europe, an interlock must be approved inaccordance with the EC Directive on thesuppression of radio interference in motorvehicles [9], which has been a condition forthe installation of electrical devices in motorvehicles since 2002. In addition, as an inde-pendent "alcohol ignition interlock device",it also requires a "general type-approval"from the German Federal Bureau of MotorVehicles and Drivers.

Requirements and standards for interlockdevices are to be found worldwide: there is a European Standard [10], the require-ments of the National Highway Traffic Safety Administration (NHTSA) in the USA[11], the Alberta requirements in Canada –introduced on account of the Province's extreme climatic conditions [12] – and therespective Australian standard [13].

InstallationTo install the interlock, the voltage supplybetween the vehicle's ignition switch

(position starter relay) and the starter relayis interrupted. This means that no voltage issupplied initially to the starter relay whenthe key is turned to the starter position, sono voltage is available to start the startermotor (Figure 5). The interlock is fitted intothe interrupted lead with a relay that onlyreleases the voltage supply to the startersystem when a breath sample with a suffi-ciently low breath alcohol concentration hasbeen given.This installation procedure ensures that aninterlock can only ever intervene in the engine starting process but can never influence a running engine, i.e. while the vehicle is moving. This is an important argument for the operational safety of the interlock.

Adjustable parametersIn the Dräger Interlock XT, authorized ser-vice centres can set a number of para-meters using special software. The set values for the parameters, for example, can be defined by the authorities if the interlock is to be used in the area of driverlicensing law. In its default setting, the instrument doesnot display the measured breath alcoholconcentration, but states merely whetherthe measured concentration is above or below the set limit value. This is designedto prevent a driver from using the interlock

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Figure 4: Procedure for interlock use

1. Turn ignition key 2. Receive request to blow into Dräger Interlock

3. Measurement of the breath alcohol concentration

4. Breath sample accepted: motor starter released

5. Start engine


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to drink up to (but not exceed) the con-centration limit. For several minutes after the engine hasbeen switched off, the vehicle can be started again without the need for a repeatbreath sample. This is in the interests of road safety, allowing the vehicle to be started again immediately if the enginestalls in a critical situation or after briefstops.

To ensure that the driver remains under the legal limit even during longer journeys, interlocks can be set to request repeatbreath samples at random intervals. Even if the breath sample is not successful, however, the running engine will not bestopped. Instead, the interlock's data log

records that a breath sample has been refused or that the alcohol concentrationmeasured was too high. This allows the data to be analysed subsequently and such incidents detected.

Data log and data recordWhile the vehicle is in use, all relevant incidents are recorded in the interlock's data log. The data recorded are the date, time, submission of or refusal to submit abreath sample, measured alcohol con-centration, engine starts and stops, electricalbypassing of the interlock and any other attempts to tamper with the device. If so desired, an authorized service centre,using special software, can download thedata, compile a data record and then print

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Figure 5: Installation circuit diagram of the Dräger Interlock XT


ALCOHOL ON OUR ROADS SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

it out. When the interlock is used in drink-driving offender programmes, this recordcan be sent to the driver vehicle licensingauthority or other supervisory body for analysis, allowing proper use of the vehiclefitted with the interlock to be monitored.

The interlock systemWhen interlocks are introduced in a par-ticular country, it is not only the device itself and its technical specifications whichare important: how the devices are to be installed and regularly calibrated also needsto be clarified. A sufficiently dense networkof service stations is necessary to allow calibration and, possibly, parameter setting,to ensure that a driver can reach a servicestation in a reasonable period of time. Thestored data may also be downloaded at theservice station and, if necessary, passed onto the supervisory authority.

Areas of application for interlocksThere are two distinct areas in which inter-locks may be used: as a preventive measureor as ordered by a court as part of a drink-driving offender programme. Installing an interlock as a preventive measure in transport vehicles such as

hazardous goods transporters, lorries (Figure 6), coaches and taxis can reduceaccident damage and downtime, improvethe image of the transport company, andmake customers feel safer. In private vehicles driven by persons with a possibleor recognized alcohol problem, the voluntaryinstallation of an interlock as a preventivemeasure can help the person to overcometheir problem and can give considerablereassurance to partners (Figure 7) or to parents, for example, whose children alsodrive a car. The second area in which interlocks areused is when a court or other authority orders an interlock to be installed in the vehicles of drivers who have a history of offences due to driving under the influenceof alcohol. Discussions about this type ofuse have recently started in Europe, too,and in some European countries prepa-rations are currently underway to changethe laws accordingly – in Sweden and Finland this has already happened.

Arguments against the use of interlocksAny discussion regarding interlocks shouldalso take into account some of the argumentsagainst their use. These include the costs

of an interlock and, more importantly, thescope for tampering with and circumventingan interlock.The costs of purchasing or renting and in-stalling an interlock can initially be seen asan obstacle to deciding to use an interlock.This is without doubt a justified objection,especially in the case of people who areless well off. However, if we look at thecosts of using an interlock, we soon realizethat the sum is roughly equivalent to thecost of one or two glasses of schnapps perday. Indeed, if the interlock prompts a personwho habitually drinks alcohol to reducetheir consumption, it may even turn out to cost no extra.

The use of tools to circumvent the inter-lock, e.g. a pump or filter, will be detectedby the Dräger Interlock XT and the engineprevented from starting. Any attempt tostart the vehicle without first having givenan acceptable breath sample is also recog-nized as tampering and recorded in the data log.

A commonly cited argument against inter-locks is the possibility of a sober personproviding a breath sample on behalf of a

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Figure 7: Preventive use of an interlock

Figure 6: Use of an interlock in the transport industry

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drunk driver. Because of the specific waythe breath sample has to be delivered, how-ever, this person would have first had topractice how to do this. What is more, atleast one sober person would have to be in the vehicle throughout the journey toprovide acceptable breath samples when-ever the repeat tests are activated. Finally,it is extremely unlikely that a sober personwould knowingly provide a breath sample to enable a drunk driver to drive a vehicle.The simplest way to get around using theinterlock is to drive a different vehicle inwhich no interlock is installed. However, if a person has been ordered to use an interlock as a condition for being permittedto drive, this is exactly the same as drivinga vehicle without a driving licence. Obvious-ly, as this is always possible even if a personhas been banned from driving completely, aninterlock cannot prevent it from happening.

Experience of interlocks [2], however, especially in the US, where interlocks have been used in large numbers for several years now, indicates that tamperingis very rare and that it is given far moreweight in theoretical discussions about interlocks than it actually happens in practice.

ConclusionToday, state-of-the-art interlock devices like the Dräger Interlock XT are available:such devices are quickly ready for use even under extreme temperature conditions,prevent tampering and, thanks to the use of electrochemical sensors, offer long cali-bration intervals.

Installing an alcohol interlock is a reliablemeans of avoiding accidents caused by alcohol, as it can immediately separate

alcohol consumption from driving. What ismore, the interlock can support long-termbehavioural changes with relation to alcoholconsumption, thereby making an importantcontribution to improving road safety.

Dr. habil. Johannes LagoisDräger Safety AG & Co. [email protected]

Bibliography[1] Council Resolution of 26 June 2000 on the

improvement of road safety, Official Journal of the European Communities No. C 218 from 31.7.2000, p.1

[2] Paul R.Marques et al., Alcohol Ignition InterlockDevices – 1st Position Paper, July 2001, http://raru.adelaide.edu.au/icadts/reports/AlcoholInterlockReport.pdf

[3] Charlotte Bax, Otto Kärki, Claudia Evers, Inger Marie Bernhoft, René Mathijssen, Alcohol Interlock Implementation in the European Union; Feasibility Study, Internet www.swov.nl/rapport/D-2001-20.pdf

[4] Burkhard Stock, Fritz Thiele, Alcotest 7410: compact and precise, Dräger Review 65, p.15, 1990

[5] Johannes Lagois, Jürgen Sohège: Breath-alcohol testing Dräger Alcotest 7410Plus com, Dräger Review 89, p.19, 2003

[6] Johannes Lagois, Dräger Alcotest 7110 Evidential - das Messgerät zur gerichtsverwert-baren Atemalkoholanalyse in Deutschland, Blutalkohol 37, p.77, 2000; and: Dräger Alcotest7110 Evidential - the measuring instrument for evidential breath-alcohol analysis in Germany, Dräger Review 86, p.12, 2000

[7] Thomas Gilg, Gerd Hutzler, Detlef Tourneur, Wolfgang Eisenmenger, Medizinische und technische Evaluation der alkoholsensitiven Zündsperre (Breath Alcohol Ignition Interlock Device, BAIID) "alcolock system“ - Anwendungsmöglichkeiten und Verkehrssicher-heitsaspekte, Blutalkohol 35, p. 331, 1998

[8] Jan Sperhake, Michael Tsokos, Klaus Püschel, Praktische Erprobung der alkoholsensitiven Zündsperre Alcolock-System, Blutalkohol 35, p. 344, 1998

[9] Commission Directive 95/54/EC of 31 October 1995 adapting to technical progress Council Directive 72/245/EEC on the approximation of the laws of the Member States relating to the suppression of radio interference produced by spark-ignition engines fitted to motor vehicles and amending Directive 70/156/EEC on the approximation of the laws of the Member Statesrelating to the type-approval of motor vehicles and their trailers, Official Journal of the EuropeanCommunities No. L 266 from 8.11.1995, p.1

[10] European Standard EN 50436-1, Alcohol interlocks – Test methods and performance requirements Part 1: Instruments for drink-driving offender programmes

[11] National Highway Traffic Safety Administration, Model Specifications for Breath Alcohol IgnitionInterlock Devices (BAIIDS), Federal Register, Vol 57, No.67, 7.4.1992, p. 11772

[12] Qualification Test Specification for Breath Alcohol Ignition Interlock Devices (BAIID) for use in the Province of Alberta, Electronics Test Centre, Document No. 355A02-01, October 1992

[13] Australian Standard AS 3547, Type 4, Breath alcohol testing devices for personal use


PREVENTION, SUBSTITUTION AND THERAPY SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

Modern addiction prevention is a cross-functional task which involves tackling themulticausal problem of substance abuse onan interdisciplinary level, with pedagogical,psychological, medical and legal stepsbeing taken in schools, in youth welfareprogrammes, by the police, by health insur-ance companies, in self-help groups and inmedical professional associations [1].

To ensure an effective and sustainable pro-gramme of "prevention", a number of con-ditions have to be met. Among other things,these include ensuring the quality of addic-tion monitoring and treatment, concludingproperly founded service agreements bet-ween treatment providers and health insur-ance companies, taking the often very spe-cific local circumstances into account, andprerequisites as regards those taking partin the programmes.

The role played by substance monitoring in the form of drug testing is an importantone, especially in drug substitution treat-ment and therapy following substance abuse. In the interests of quality assurancein this area, guidelines have been issued,regulations drawn up and processes des-

cribed, demanding or recommending amongother things the use of specific test pro-cedures or equipment.

Substitution treatmentDependence on drugs, and especially onopiates, is a chronic illness which requirestreatment. The main objective of treatmentis abstinence. The possible stages of acomprehensive treatment strategy are setdown in the German Narcotic Drugs Pre-scription Order (BtMVV), § 5 Subsection 11 [2] and, on the basis of the generally recognized state of knowledge, by the German Medical Association in its guide-lines for the substitution treatment of opiate addicts [3].

Substitution treatment ("methadone substi-tution“) is only permissible when embeddedwithin a comprehensive treatment pro-gramme. This includes among other thingsagreeing with the patients on the modalitiesof the planned treatment and explaining allthe measures in detail. The patient must betaught about the substitution substance andits effects, possible interaction with othersubstances and how it affects a person'sfitness to drive.

Monitoring concomitant substance abu-se during substitution treatmentOne essential aspect of treatment is sub-stance monitoring (i.e. testing for drug oralcohol consumption). Drug tests carriedout at the beginning of treatment to deter-mine whether a person is still consumingopiates or other substances must be docu-mented. "Monitoring of concomitant sub-stance abuse", as it is known, is required by the German Narcotic Drugs PrescriptionOrder (BtMVV) [2].

At the start of substitution treatment, closemonitoring of any concomitant substanceabuse is necessary. Unannounced, randomtesting must be carried out to determinewhether there is concomitant use of otherlegal or illegal addictive substances, and todetermine whether the substitute substanceis being used properly. Testing is necessaryto determine whether substances such asother opiates, cocaine, amphetamines/me-thamphetamines, benzodiazepines, metha-done, cannabinoids, barbiturates or alcoholare being used concomitantly. If currentconcomitant use of other substances is de-tected, the substitution drug must be with-held if this could have a detrimental effect

Drug and alcohol testing in addictionprevention, treatment and medicine


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on health when taken in combination withthe other substances. It is particularly im-portant to remember that taking the substi-tute substance in combination with alcoholand/or sedatives could, in the worst casescenario, cause death.

This shows just how important it is to con-duct alcohol and drug tests throughout thephases of diagnosis and treatment. The attending doctor has a duty to carefully document any concomitant use and to observe any considerations and conse-quences which this may entail. This docu-mentation duty arises as a result of theexisting employment law, the German Narcotic Drugs Prescription Order (BtMVV)and the particular requirements for substi-tution treatment of opiate addicts. Amongother things, the frequency and results oftests for concomitant substance abuse mustbe recorded. These and all other measuresmust be documented and made availableupon request in anonymous form to thecompetent Regional Medical Association,the competent Association of StatutoryHealth Insurance Physicians and/or thecompetent regional authority for the pur-poses of assessing the quality assurance

measures. Modern drug and alcohol testingsystems and procedures support and facili-tate comprehensive documentation of con-comitant abuse monitoring.

Quality assurance in substitution treatmentWhen providing a patient with substitutiontreatment, doctor's practices and outpatientclinics need to cooperate with numerousexternal partners (e.g. drug counsellors,providers of psychosocial support, otherdoctors, health insurance companies andsocial welfare providers, police, prisons andother authorities). It is essential to optimizethis cooperation, e.g. with regard to infor-mation sharing. As a result, a central aspectof substitution treatment is the continuousquality management of the attending doctor,his representative or – if legally permitted –the pharmacist or other medical professio-nal with the appropriate qualifications whois working on behalf of the doctor.Among the measures undertaken to ensurethe quality of substitution treatment are thefollowing:– creation of an individual control and treat-

ment plan for each patient, containing thegoals of treatment and when they are to

be achieved, and monitoring progress and outcomes, and

– commitment to concomitant abuse moni-toring (for alcohol, drugs and medication).

Quality assurance in outpatient substitutiontreatment programmes should attach parti-cular importance to the conditions prevailingin the facilities themselves, e.g. the medicalteam, cooperation networks and space avail-able. This also includes having the neces-sary equipment in terms of breath-alcoholand drug testing systems which conform tothe legal requirements (e.g. MDD [4], IVD[5], German MPG [6]). Quality assurancealso concerns how the facilities and their workprocesses are organized, i.e. arranging thedaily handout of the substitute substances,carrying out monitoring for concomitant sub-stance abuse and admitting new patients.

Monitoring for concomitant substance abuseMonitoring a patient for concomitant sub-stance abuse by means of an oral fluid orurine sample does not necessarily have tobe performed by an external laboratory, astests which can be carried out in any prac-tice are readily available nowadays. There

Bild 1: Dräger Alcotest 7410 med in use

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are, however, significant differences in termsof quality and price between the availabletest kits. The objective of a high-quality diagnosticanalysis – including the procedure itselfand its analytical value – is to take full andimmediate account of each patient's indivi-dual circumstances. Bearing this in mind,test systems based on oral fluid samples offer a key advantage [7, 8, 9], as such methods of drug testing are able to add"quality" to the medical treatment process.This is because they are much more likelythan the so-called "visually monitored urinesamples" to meet the necessary medical(e.g. monitoring for concomitant abuse) and documentation requirements, and better reflect the patient's own – often subjective – capabilities.

What is more, there is no need for the laborious steps aimed at preventing adul-teration and manipulation which have to be performed during urine testing. The factthat equipment is purchased to electroni-cally measure the urine temperature, or that CCTV systems are installed in toilets,or that patients are requested to undresscompletely before visiting the toilet, servesto illustrate just what sort of difficulties drugtesting can involve. Many doctors prefer notto use such measures, and seek instead tobuild up a doctor-patient relationship whichis not founded on excessive mistrust. In thiscontext, oral fluid-based drug testing canact as a "bridge" and help to generate trust,as a sample can be provided anytime andanywhere, without having to violate a pa-tient's private sphere [10].

When it comes to monitoring for the con-comitant consumption of alcohol, high-qualityelectronic breath-alcohol detectors, prefer-ably with electrochemical sensor systems,should be used to meet the requirementsfor quality assurance in substitution treat-ment [11].

Who pays for the concomitant substance abuse monitoring during substitution treatment?Because the guidelines issued by the German Medical Council (Bundesärztekam-mer - BÄK) [3] expressly state the neces-sity for breath-alcohol monitoring, breath-alcohol testing was included in 2003 in the"assessment standard for services providedby a doctor (BMÄ)“ [11]. Since then, deter-mining alcohol in a person's exhaled airwithin the framework of substitution treat-ment can be charged to the CompulsoryHealth Insurance (Gesetzliche Krankenver-sicherung - GKV) at a rate of currently 1 EUR. At the same time, the highest ratesfor drug testing within the framework ofsubstitution treatment are currently around3 EUR per substance and/or group of sub-stances [12].The number of drug measurements whichcan be performed for patients who undergosubstitution treatment in accordance withthe guidelines of the Federal Association of Physicians and Health Insurance Organi-zations and whose treatment is paid for byCompulsory Health Insurance is limited. At the present time, up to 125 EUR can becharged in the first two quarters of treat-ment, and 64 EUR per quarter from thethird quarter on. As a rule, much the sameapplies for patients whose substitution treat-ment is paid for by a social welfare provider,who normally base their practices on thoseof the Compulsory Health Insurance.

Medical devices and CE markingIn the European Union, the requirementsfor products and devices used for medicalpurposes are set out mainly in two EuropeanDirectives. EU Directive 93/42/EEC dealswith medical devices (MDD Directive) [4],while EU Directive 98/79/EC deals with invitro diagnostic medical devices (IVD Direc-tive) [5] (in vitro = in a test tube). Both Directives were transposed together intonational law in Germany in the form of the

Medical Devices Act (MPG) [6].If products comply with one of the two direc-tives, they are CE marked (and possiblymarked with the ID number of the notifiedbody) and the manufacturer issues a de-claration of conformity. This serves as docu-mentation that all the relevant requirementsof the EU Directives have been met. Theserequirements may also demand a specialquality assurance system, including auditingby an external body.Once the product has been reported to thecompetent authority, the product with theCE mark can be placed on the market. Inaddition, the company responsible for theproduct creates a product file to allow all information relevant to the product to be recorded and made available at any time. The manufacturer of the product is also required to establish and maintain a syste-matic procedure to provide information about incidents which could result or haveresulted in the death or serious harm tohealth of a patient or user.

Does drug testing equipment classify as medical devices?Deciding whether drug testing proceduresfall within the scope of the in vitro diagnosticmedical devices directive of the EuropeanUnion (IVD Directive) [5] or in Germanywithin the scope of the Medical Devices Act(MPG) [6] depends on what they are usedfor.The IVD defines an in vitro diagnostic medical device as follows:“An in vitro diagnostic medical device me-ans any medical device which is a reagent,reagent product, calibrator, control material,kit, instrument, apparatus, equipment, or system, …, intended by the manufacturer to be used in vitro for the examination ofspecimens, …, derived from the human body, solely or principally for the purpose ofproviding information:– concerning a physiological or pathological

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– concerning a congenital abnormality, or– to determine the safety and compatibility

with potential recipients, or– to monitor therapeutic measures.”Drug testing procedures in the domain ofsubstance abuse are used – especially insubstitution treatment and therapy – to determine whether patients are consumingother drugs besides the substitute. Further-more, the patient is monitored to check thatthe substitute itself is being taken correctly.In other words, this application correspondsto the definition of in vitro diagnostic medicaldevices contained in the MPG, and as such,devices and monitoring systems used forthese purposes must meet the relevant legal requirements for in vitro diagnosticmedical devices.

Do breath-alcohol measuring instrumentsfall within the scope of the Medical Devices Directive and the GermanMedical Devices Operator Ordinance?Deciding whether breath-alcohol measuringinstruments fall within the scope of the Medical Devices Directive of the EuropeanUnion (MDD) [4] or in Germany within thescope of the Medical Devices Act (MPG)[6] and the Medical Devices Operator Ordinance (MPBetrV) [13] depends onwhat they are used for.

The MDD defines a medical device as follows:“An medical device means any instrument,apparatus, … , whether used alone or incombination, … intended by the manufactu-rer to be used for human beings for thepurpose of: – diagnosis, prevention, monitoring, treat-

ment or alleviation of disease, – diagnosis, monitoring, treatment, alle-

viation of or compensation for an injury or handicap,

– investigation, replacement or modificationof the anatomy or of a physiological process,

– control of conception, …”

Based on this definition of a medical devicewithin the meaning of the relevant legal regulations a decision can be taken for individual applications – as shown below –as to whether breath-alcohol measuring instruments fall within the scope of the respective regulations. In individual cases,however, the manufacturer cannot ultimate-ly decide which alcotest device is allowedto be used for which application and withwhich regulations it must therefore comply.This decision must be taken by users themselves.

Breath-alcohol measuring instruments insubstitution treatmentThe German Narcotic Drugs PrescriptionOrder (BtMVV) states the following in § 5 [2]:"(2) ... Prescribing a substitute substance is permissible if and for as long as theinvestigations undertaken by the doctor donot indicate that the patient ... c) is usingsubstances whose consumption, depending on type and quantity, could endanger thepurpose of the substitution. ... (9) The doctor shall document the com-pletion of the measures required in thepreceding sections. The documentationshall be presented or sent in to the com-petent regional authority upon request forinspection and assessment.“

Furthermore, the guidelines issued by theGerman Medical Council for the substitutiontreatment of opiate addicts [3] state thefollowing in Subsection 11 (monitoring treat-ment / concomitant substance abuse):"Monitoring of concomitant substance abuseis required by the BtMVV. ... In this context,the concomitant abuse of other opiates, andalso of benzodiazepines, cocaine, ampheta-mines and alcohol – depending on the cir-cumstances of the individual case – shouldbe checked. ... The substitute substancemust not be issued if recent concomitantsubstance abuse is detected such as woulddamage the patient's health if the substitutewere additionally administered. In particular,it should be noted that taking the substitutein combination with alcohol and/or sedativescan result in respiratory depression and death. ... The attending doctor has a duty tocarefully document any concomitant sub-stance abuse and the considerations andconsequences resulting from this. ... “

According to the above, breath-alcoholtesting during substitution treatment is intended to "prevent disease", meaning that the devices fall within the scope of theMDD, and must have the necessary approval.

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Breath-alcohol measuring instrumentsduring operations and medical emer-genciesBreath-alcohol measurements are oftenconducted during surgical operations. Thebreath-alcohol measuring instrument isused to diagnose vascular injuries, e.g. during transurethral resection of prostate in urology (TUR-P) [14] or transcervicalresection of the endometrium in gynaeco-logy (TCRE). If an ethanol-based irrigationsolution is applied prior to this type of sur-gery, the ethanol will be quickly detectablein the patient's exhaled air in the event of avascular injury.When a breath-alcohol measuring instru-ment is used to prevent absorption of irriga-tion solutions during surgery, this is donewith a view to "diagnose injuries and pre-venting disease“.

The same applies equally to breath-alcoholmeasurements carried out during medicalemergencies and in the A&E department ofa hospital in order to determine whether aperson requiring emergency treatment whomay not be responsive is under the influenceof alcohol or suffering from some othercondition. Here too, the measurement isconducted to "diagnose injuries and preventdisease“.Such applications, carried out during oper-ations and medical emergencies or in theA&E department, clearly fall within the scope of the MDD, and the breath-alcoholmeasuring instruments must therefore havethe relevant medical device approval.

Breath-alcohol measuring instruments inaddiction and detox clinics If a patient who is not undergoing substi-tution treatment is tested in a clinic (anaddiction or detox clinic, for example) todetermine whether he or she has infringedregulations by consuming alcohol, this isnot done for the purposes of "diagnosis,prevention, monitoring, treatment or allevia-

tion of disease", and also does not corre-spond to any of the other intended pur-poses listed. Just as when the devices areused by the police, this procedure is per-formed simply to determine whether a person has consumed alcohol and, in doingso, has violated the applicable laws or regu-lations. For these applications, then, it is not essen-tial for a breath-alcohol measuring instru-ment to be approved in accordance withthe MDD. However, since addiction and detox clinicsoften also employ breath-alcohol measure-ments to monitor concomitant substanceabuse during substitution treatment, it is recommended that breath-alcohol measur-ing instruments with the relevant medicaldevice approval should be used whentesting for "compliance with regulations".

Functionality and safety checksThe use of medical devices requires regulartesting of their proper function and, in thecase of measuring instruments, of correctcalibration, as otherwise the risk of harmingthe patient would be too great and not acceptable.The German Medical Devices Operator Or-dinance [13] states the following: "The usershall check the function and proper conditionof the medical device prior to use.“ This canbe done by conducting a simple functionaltest, for example.

In addition, safety inspections must be car-ried out at certain intervals [13]: "In the caseof medical devices for which the manufactu-rer has prescribed safety inspections, theoperator shall perform these inspections, orhave them performed, in accordance withthe manufacturer's instructions and the ge-nerally recognized rules of technology, andwithin the intervals stated by the manufac-turer. The safety inspections include testingof the measurement function. A record shallbe made of the safety inspection.“

Determining functionality and conductingsafety inspections constitutes another partof quality assurance.

Dräger Alcotest devices with medicaldevice approvalAs part of the Dräger Alcotest family [15, 16],which has been widely used for many years,the Alcotest 7410 med (Figure 1) and Alco-test 6810 med (Figure 2) models were developed. These are specially designed for use as medical devices and bear the respective CE mark in accordance with EUDirective 93/42/EEC for medical devices[4]. Besides the high quality and proven re-liability of the electrochemical DrägerSensor,the devices boast a number of featureswhich facilitate routine medical use.The devices of the Alcotest med series arespecifically designed for determining thebreath-alcohol concentration in medical applications. For example, they can be usedto diagnose vascular injuries (during transu-rethral resection of prostate in urology, forinstance) following prior application of anethanol-based irrigation solution. They arealso suitable for testing patients for prior alcohol consumption in the A&E depart-ment or before methadone substitution.The electrochemical DrägerSensor, whichoffers fast response times and long-termstability, is ready for the first measurementsoon after power up, rapidly analyses themeasurement signal, and boasts a low standard deviation. The device's illuminated display screen (which contains informationsuch as the test number, date, time,measurement result and error messages),the colour LEDs and the audible signal guide the user smoothly through operationof the device.During the automatic measurement which is triggered when a breath sample is given,the respiratory flow is measured and theminimum volume adjusted such as to ensurethat air from deep inside the lungs is sampled. The manual measurement option


P. 34 | 35

allows the device to be used even on peoplewho are unconscious, anaesthetized or notresponsive for any other reason and aretherefore unable to consciously provide abreath sample.

The integrated data log in the breath-alcoholdetectors can store around 8,000 sets ofdata for personal measurement results. Thedata interface allows the results to be trans-ferred to a PC once the measurement hasbeen completed, ensuring continuous docu-mentation during, for example, medical treat-ment or substitution treatment as part of adrug therapy programme.To ensure before use that the devices arefunctioning properly, a self-test is performedwhen the devices are switched on. This,combined with a straightforward check ofmeasurement function (which should beperformed once a week), guarantees thequality of measurement. In addition, a six-monthly safety inspection, also encompas-sing the measurement function, is to becarried out in accordance with the GermanMedical Devices Operator Ordinance.Apart from the breath-alcohol measuring instruments themselves, the special mouth-pieces which are used with them also countas medical devices. Other accessories suchas the documentation software, charger andtransport case, however, are not classifiedas medical devices.Dräger Alcotest med devices are medicaldevices which should be used for systematicquality management in every doctor's prac-tice, outpatient facility and clinic to ensuresafe and error-free processes. They supportthe organization of operating processes andthe documentation systems required by thelegal regulations for medical devices.

Dr. habil. Johannes [email protected]. Andreas [email protected]äger Safety AG & Co. KGaA

Bibliography[1] W.A. Schmidt, Jahrbuch Sucht 2004, p. 171,

Neuland-Verlagsgesellschaft, Geesthacht

[2] Order concerning the prescription, dispensing and recording of the whereabouts of narcotic drugs (Narcotic Drugs Prescription Order - Betäubungsmittel-Verschreibungsordnung BtMVV), amended by the Federal Law Gazette Part I No. 16, p. 757 from 17.03.2005

[3] Richtlinien der Bundesärztekammer zur Durchführung der substitutionsgestützten BehandlungOpiatabhängiger, 22. March 2002, http://www.bundesaerztekammer.de/30/Richtlinien/Richtidx/RlSubstitution.pdf

[4] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Official Journal of the European Communities No. L 169 from 7.12.1993, p.1

[5] Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Official Journalof the European Communities No. L 331 from 7.12.1998, p.1

[6] Medical Devices Act (Medizinproduktegesetz – MPG), new version from 7.8.2002, BGBl I, 2002, p.3147

[7] G. Möller et al., Suchtmed 7 (2) 138, 2005

[8] G. Möller et al., 14. Kongress der DGDS e.V., 4.-6.11.2005 – in print

[9] M. Zorec-Karlovsek et al., XIII. GTFCh – Symposium ”Ausgewählte Aspekte der Forensischen Toxikologie“, 3.-5.4.2003, Mosbach (Baden)

[10] Rainer Polzius et al., Dräger DrugTest, Dräger Review 92, p.13, 2005

[11] Änderung des Bewertungsmaßstabs für vertragsärztliche Leistungen (BMÄ), Deutsches Ärzteblatt 100, 30. May 2003, p. A-1562

[12] Änderungen des Einheitlichen Bewertungs-maßstabes (EBM), Deutsches Ärzteblatt 96, 8. January 1999, p. A-68

[13] Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (Medizin-produkte-Betreiberverordnung - MPBetreibV), new version from 21.8.2002, BGBL I, Jahrgang 2002, p.3397

[14] H.Gehring: Die Messung der Atem-Alkohol-konzentration als Monitoring der Einschwem-mung von Spülflüssigkeit während endourologi-scher Eingriffe - Klinische Bedeutung und tech-nische Anforderungen, Anästhesiol. Intensivmed.Notfallmed. Schmerzther. 35, p.82, 2000

[15] Johannes Lagois, Dräger Alcotest 7110 Evidential – the measuring instrument for evidential breath-alcohol analysis in Germany, Dräger Review 86, p.12, 2000

[16] Johannes Lagois, Jürgen Sohège: Breath-alcohol testing Dräger Alcotest 7410 Plus com, Dräger Review 89, p.19, 2003

Figure 2: Dräger Alcotest 6810 med

ST-

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5


MEDICAL AND ILLEGAL DRUGS ON THE ROADS SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

Worldwide, around one million people dieevery year as a result of traffic accidents,and another ten million are injured. On Europe's roads alone, more than 40,000people are killed every year and 1.7 millionare injured, some of them remaining disabled for the rest of their lives. The esti-mated direct and indirect financial costs inEurope total more than 160 billion euros ayear [1].Because of the severity of the accidents itcauses, driving under the influence of alcoholand/or drugs is one of the biggest problemson our roads. However, road users underthe influence of "other intoxicating sub-stances", i.e. illicit drugs or medication, arenot easily detected by routine roadside police checks, and are therefore only re-flected in the accident statistics to a limitedextent. All the same, the number of re-gistered traffic accidents involving a driverwho has been proven to be under the in-fluence of drugs or medication has risenconstantly during the course of recentyears. In Germany, for example, 1,457 acci-dents involving personal injury and a driverunder the influence of "other intoxicatingsubstances" were registered in 2004, and51 accidents resulted in fatalities. In addition,

842 serious accidents involving damage toproperty were recorded [2]. What is more,there is also thought to be a very high num-ber of unrecorded cases, as drug detectionis subject to a complex and sophisticatedclassification process. Research into the real number of cases indicates that onlyone in at least 1,000 drivers under the in-fluence of drugs is caught [3]. It is not aseasy to tell whether someone is under theinfluence of drugs as is the case with alcohol(e.g. from the typical smell of alcohol).

Medical and illegal drugs on the roads –the legal situationLaws relating to "medical and illegal drugson the roads" differ from country to country.Generally speaking, proof of a person's un-fitness to drive is required in all countries to allow them to be prosecuted for drivingunder the influence of alcohol or "other intoxicating substances" ("impairment law").In addition, some countries (such as Ger-many, Belgium, Sweden France and Finland)have adopted other laws which do not de-pend on proof of influence; mere toxicolo-gical evidence of an intoxicating substanceis sufficient to impose a legal penalty ("zero tolerance").

In June 2003, the European Legal Databaseon Drugs (ELDD) published a comparativestudy of the legal situation relating to"Drugs and Driving" in 16 countries. It wasfound that although driving under the influ-ence of drugs constitutes an offence in allcountries, there are considerable differencesregarding the rights of the police to test drivers, the substances consumed and theapplicable legal penalties [4].The legislative and executive situation in anumber of countries (in alphabetical order)is described below.

AustraliaUnder the "Road Transport (Alcohol andDrugs) Act 1977", it is prohibited in all statesof Australia to drive a motor vehicle underthe influence of intoxicating substances (listed in the Act).Until recently, no Australian states had lawsallowing random drug testing. Reasonablesuspicion was necessary to demand a bloodor urine sample. In reality, this only everhappened once a driver had already beeninvolved in an accident.As a result of toxicological studies which in2001 showed 29.3 percent of drivers killedin road traffic accidents to have "other in-

Possible approaches to road safety


S. 36 | 37

toxicating substances" in their blood (in16.5 percent, THC and/or stimulants werespecifically detected) [5], a fundamentaldecision was taken when the "Road Safety(Drug Driving) Act 2003" was amended inthe state of Victoria in December 2003.The change in the law allows police to conduct random roadside testing of drivers,with oral fluid screening tests being used todetect exclusively THC and designer am-phetamines; THC is the drug most common-ly found (after alcohol) in fatally injured drivers in Victoria, and methamphetamine is the most commonly found drug in lorrydrivers killed in Victoria.In February 2004, tenders were publicly in-vited for oral fluid-based screening systems,and various systems were tested for pos-sible suitability. The testing programme covered not only trials with synthetic samplesin the laboratory, but also testing of volun-teers in controlled clinical studies andtesting under controlled conditions at theworkplace. An acceptable test system needed to offer a high level of specificity in order to spare the drivers tested (themajority of whom tested negatively) the unpleasantness of a false-positive result.Great importance was attached to mini-

mizing potential risks and to improving roadsafety.The new regulation came into force in Victoria on 1 July 2005. Under the new legislation, oral fluid laboratory analysis hasbeen approved as "evidential", i.e. admissibleas evidence in a court of law. Offenders canface anything from a fine of around 175 euros to a fine of some 700 euros plus asix-month ban [6].A law has also been in force in Tasmaniasince July 2005 which allows random road-side drug testing of motor vehicle driverswithout any prior suspicion. The programmesin Victoria and Tasmania serve as pilot projects, and no such legal initiatives exist(as yet) in the other states of Australia.

AustriaUnder the Austrian Road Traffic Act (StVO)of 1960, "drivers impaired by narcoticdrugs“ who are not able to drive a vehiclesafely are not permitted to drive or start amotor vehicle. An official doctor determineswhether the driver is impaired, and in thecase of a positive test result arranges for a blood sample.In the case of impairment which is not obviously due to drugs, oral fluid-based

screening test devices can be used underthe 21st amendment of the StVO. Theamendment came into force on 1 July 2005and states explicitly that no screening testsmay be performed where there is a clearsuspicion of drug influence; in such casesthe driver must be presented to an officialdoctor. If an oral fluid test shows a positiveresult, a medical examination is conductedwhose result will determine what happensnext.The Interior Minister determines by decreewhich oral fluid screening tests can beused. At the present time, various methodsare being investigated by a study commis-sioned by the Federal Transport Minister.

BelgiumLaws which make driving under the influ-ence of drugs an offence have been in place in Belgium for many years.In response to the results of the "BelgianToxicology and Trauma Study" [7], whichfound evidence of drugs in 19 percent of injured drivers, the law in Belgium waschanged in March 1999. As a result, it isnow forbidden to drive a motor vehicle if toxicological evidence of intoxicating sub-stances can be found in the driver's blood.



Although an initial suspicion is needed, thelaw takes effect even without any concreteevidence of the influence. The followingsubstances and detection limits (in theblood plasma) are covered by the law: amphetamine (50 ng/ml), the designerdrugs MDMA, MDEA, MBDB (50 ng/mleach), THC (2 ng/ml), cocaine or ben-zoylecgonine (50 ng/ml), and free morphine(20 ng/ml).Roadside drug testing takes place in threestages: – observation of external signs which

arouse suspicion that the driver is under the influence of one of the defined substances (standardized recognition procedure),

– taking of a urine sample which is checkedusing a urine screening test for drugs,

– medical examination and blood sample.The use of oral fluid as a screening testmaterial is currently being tested as part of the ROSITA-2 project [8]. An internalsurvey of police officers indicates that oralfluid is given clear preference over urine as sample material.

FinlandUnder the revised version of Chapter 23 ofthe Penal Code, any driver of a motor ve-

hilce whose blood is found to contain "anactive narcotic substance or its metabolite"will be charged with drinking while intoxi-cated, except in such cases where the substances were prescribed by a doctor. If, however, it can be proven that a person'sfitness to drive is impaired, the driver willbe charged with drinking while intoxicatedregardless of whether the substance wasprescribed by a doctor or not.

FranceIn 1999, an article was incorporated into theexisting legislation in France to demand asystematic search for drugs as the possiblecause of fatal road traffic accidents. Since it proved insufficient to restrict thesearch to fatal accidents, the law was ex-tended to generally include "driving underthe influence of substances or plants classedas narcotics“ (law no. 2003-7 of 3 Feb.2003). Now, if evidence of consciousness-changing substances is found in the blood,this automatically constitutes an offencewhich will have legal consequences. Thereare no specified limits. According to the law, all drivers involved ina fatal road traffic accident must now be tested, as must drivers involved in a roadtraffic accident involving personal damage

where there are reasonable grounds to suspect the consumption of drugs. Further-more, facultative testing can be carried outfollowing general road traffic accidents orother offences.Drug screening tests can be used by medi-cally trained personnel as an additional aid.A urine sample can only be taken in hospi-tals, emergency wards or the surgery of thedoctor asked to take the sample. By theend of 2005, the police should have beensupplied with the first oral fluid-based drugscreening tests. If a person tests positively,a medical examination and blood sampleare necessary.

GermanyDriving under the influence of alcohol and"other intoxicating substances" is treated asan offence in Germany and is punishableunder § 316 of the German Criminal Code,StGB, or under § 315c StGB ("endangeringroad traffic"). No specific endangering ofroad traffic or erratic driving is necessaryfor a punishment to be imposed in accord-ance with § 316 StGB, though a person'sunfitness to drive must be proved. Sincetoo little data is available (as yet) regardingthe link between the concentrations of ac-tive substances and a person's ability to


P. 38 | 39

drive, no specified limits exist for the "otherintoxicating substances" which, if exceeded,would constitute evidence of a person'scomplete unfitness to drive – in contrast toalcohol, for which the limit is 1.1 ‰. As aresult, besides relevant analytical evidence,the driver must be found to exhibit behav-ioural disorders caused by drugs. Impair-ment can be determined on the basis of vegetative symptoms (e.g. size and reactionof pupils), coordination problems (includingdifficulties with walking and other tests ofcoordination) or noticeable psychologicaleffects (e.g. a mental slowness or inabilityto concentrate, with thoughts wandering).Several such symptoms must be in evidenceto prove a person's unfitness to drive, al-though one single but very pronouncedsymptom can also suffice. A laboratory reading alone, regardless of how high thedetected concentration(s) may be, is notenough to prove a person's unfitness to drive.The blood sample taken is examined for thepresence of "other intoxicating substances"and a toxicological report is compiled. If thisshows evidence of impairment, and a courtcomes to the same conclusion in view ofthe documented behavioural disorders, theoffender's driving licence will be withdrawn.

An application for a new licence cannot bemade until the driving ban has elapsed(usually 6 to 12 months).Under § 315c StGB, the punishment will be more severe if a person who is unfit todrive due to the consumption of "other intoxicating substances" has actually causeddanger to life, limb or property of significantvalue.

The lack of specified thresholds to describetotal unfitness to drive makes it relativelydifficult to successfully prosecute drug-driving in practice. Sanctioning of driving under the influenceof drugs became considerably easier following amendment of § 24a of the RoadTraffic Code, StVG, as of 1 August 1998,which serves as an important complementto the existing criminal laws. Under Sub-section 2, a person driving a motor vehicleon a public road under the influence of anintoxicating substance is now guilty of anadministrative offence. This is assumed tobe the case if analytical evidence of the active substance or its decomposition product is found in the person's blood. The intoxicating substances to which thisprovision applies are not specified in thelaw, but are listed in a separate annex,

which can be extended by executive orderto include further substances if currentscientific knowledge deems this necessaryfor the sake of road traffic safety and if reliable toxicological evidence can be provided.

The substances listed can only be detectedin the blood for a short period of time afterconsumption, so police officers need towatch for symptoms such as red eyes, slowpupil reactions etc. which are indicative ofrecent consumption. These initial observa-tions can then be corroborated using drugscreening tests. A blood sample is orderedand analysed for confirmation purposes in alaboratory. If the blood sample tests positivefor one of the substances listed in the annexto § 24a StVG, a driving ban of up to onemonth and a fine can be imposed.Since at the present time analytical evidencein the blood is the only thing that constitutesan offence, § 24a (2) StVG redresses theproblem of there being a lack of penaltiesfor instances of drug-driving without conse-quences – in other words, situations inwhich it is not possible to prove conclusivelythat a person is unfit to drive within themeaning of §§ 316/315c StGB. As such,the administrative regulation can be seen

List of intoxicating substances and substances to be detected as specified in the

annex to § 24a StVG.

Intoxicating substance Substance to be detected

Cannabis Tetrahydrocannabinol (THC)

Heroin Morphine

Morphine Morphine

Cocaine Benzoylecgonine

Amphetamine Amphetamine

Designer amphetamines MDMA, MDEA



as a "catch-all element" which complementsthe criminal law regulations with correspon-dingly lower legal consequences. The intro-duction of analytical thresholds to ensuresome degree of correspondence betweenthe duration of effect and detection is currently under discussion.

ItalyUnder Article 187 of law 285/1992 in Italy,it is "… prohibited to drive a vehicle in an altered physical or mental condition resultingfrom the use of narcotic or psychotropicsubstances“. If road traffic police officerssuspect a driver to be under the influence,they have the right under Article 12, Sections1 and 2 to accompany the person in questionto a mobile or fixed sanitary facility for thepurposes of conducting a screening test ortaking a blood sample.

NetherlandsAccording to Article 8 of the Dutch RoadTraffic Law, drivers are not permitted to drive a motor vehicle under the influence"of a substance whose use – either on itsown or in combination with another sub-stance – they know or should reasonablyknow to be capable of impairing a person'sability to drive". No analytical limits are specified by the law.

Legal proof that the driver is under the influence of intoxicating substances otherthan alcohol must be provided by detectinga substance potentially able to influencedriving ability in the blood or urine, by proving intention, and by demonstrating alink between the detected substance andthe effect which was actually brought about.At the present time, the inclusion of speci-fied limit values for "other intoxicating sub-stances" in the existing legislation is underdiscussion. This would require the use ofreliable screening test equipment, prefer-ably based on an oral fluid sample obtainedon site.

SpainPolice in Spain can conduct drug testing atany time, even without any initial suspicion.Like in the German laws, analytical evidenceof drugs in the driver's blood is enough toconstitute an administrative offence. Nospecific limits exist, as the "zero tolerance"principle applies. For a person to be guilty of an offence, Article 379 of the Spanish Criminal Coderequires evidence of influence.

SwedenOn 1 July 1999, a new provision for drivingunder the influence "of other intoxicatingsubstances" was included in the SwedishRoad Traffic Offences Act. Drivers are prosecuted who are found to have toxi-cological evidence of narcotics and benzo-diazepines exceeding specified limits intheir blood.

SwitzerlandAs of 1 January 2005, a zero limit came into force for certain drugs in Switzerland.Under Article 2, Subsection 2 of the RoadTraffic Ordinance (VRV), a person is deemed unfit to drive when certain sub-stances are found in their blood. Althoughthe police still cannot conduct drug testingwithout any reason – unlike with alcohol – a road user can be subjected to a drugscreening test if he or she is found to beimpaired due to the influence of narcoticsand/or pharmaceuticals. If the result of thetest is positive, a blood sample, a medicalexamination and a chemical toxicologicalanalysis are ordered.According to ASTRA, the Swiss FederalRoads Authority, a person is regarded asunfit to drive if there is evidence of at least1.5 ng/ml of THC in their whole blood or aconcentration of at least 15 ng/ml of cocaine,free morphine, amphetamine, methamphe-tamine, MDMA and/or MDEA in their wholeblood. There is no need to prove any effect.On the basis of the results of the examinati-

ons, sanctions are imposed under criminalor administrative law.

United KingdomUnder Section 3A/4 of the Road Traffic Actfrom 1988, a person is guilty of an offenceif he or she drives or attempts to drive amotor vehicle under the influence of "otherintoxicating substances".To provide a legal basis for how to recognizedrivers under the influence, the new “UKRailways and Transport Safety Act” from2003 gives an officer on site the authorityto order drug screening tests. The samplematerial is not explicitly stated.

The legal situation in the USALaws governing how to recognize motor vehicle drivers under the influence of drugsvary greatly from state to state in the US,with no uniform country-wide regulation in place. In the majority of cases, the pro-visions are to be found in the transport ormotor vehicle laws of the individual states,while in three states they are contained inthe penal code. A detailed overview is pro-vided by the "Walshgroup" and the "RobertWood Johnson Foundation" [9].In accordance with the laws, prosecution ofoffenders in most states requires proof thatthe consumed substance/s is/are respon-sible for the impaired ability to drive. In eightstates (Arizona, Georgia, Iowa, Indiana, Illinois, Michigan, Rhode Island, Utah) a"per se" regulation is in force under whichevidence of an intoxicating substance in thedriver's blood or urine is sufficient. Eightother states also have "per se" regulations,though these do not necessarily requireproof of intoxicating substances in the body.While only blood testing is permitted in Texas and Maryland, blood and urinetesting is possible in the majority of states(40). Five states (Colorado, Montana, NewYork, North Dakota, Oklahoma) explicitlypermit oral fluid testing besides blood andurine, while other human sample material


P. 40 | 41

besides blood and urine is admissible ineight other states. Three states do not permit testing of any human material at all.Immunological screening tests are not routinely used by police in any states at the present time.

The ROSITA and ROSITA 2 projectsFrom January 1999 to September 2000,different methods of screen testing for drug effects were assessed as part of theROSITA [10] project to determine theirpossibilities and limitations for use by policein traffic monitoring. During the course ofthis EU research project, drug screening

tests were carried out throughout Europeon nearly 3,000 persons suspected to beunder the influence of drugs.The results indicate that the targeted use of drug screening devices offers the policeimportant advantages:– they provide immediate confirmation of

an initial suspicion, thereby rapidly boosting the confidence of police officersas regards recognizing the effects of drugs as exhibited by road users

– the use of screening test devices re-duces the number of unjustified blood samples

– the per case costs for police are greatly reduced.

From an analytical point of view, it is parti-cularly important to minimize incorrect results (false-negative or false-positive).Drivers who test false-negatively pose a potential threat to road traffic safety, whilefalse-positive results generate unnecssarycosts, reduce confidence in the measure-ment technology and harm the reputation(and authority) of those conducting thetests at the roadside.Furthermore, it can be assumed from thedata collected during the studies that thedrop in the number of road traffic accidentsand the reduction in the number of thosekilled and injured in such accidents can beattributed to the roadside drug screening

Overview of the laws in European countries governing driving under the influence of "other intoxicating substances". [12]

Country Type Administrative / Fine (€) Prison Licence

Criminal withdrawal

Austria Impairment Administrative 581 – 3633 1 months

Belgium “Per se” Criminal 1000 – 10000 15 – 180 days Possible

Impairment Criminal 1000 – 10000 15 – 180 days Possible

Denmark Impairment Criminal Fine 365 days

Finland “Per se” Criminal Fine 182 days Max 60 months

Impairment Criminal 60 day fines 700 days Max 60 months

France “Per se” Criminal 4500 730 days 36 months

Germany “Per se” Administrative 250 1 months

Impairment Criminal Fine 365 days Withdrawal

Greece Impairment Criminal 147 60 days 3 – 6 months

Ireland Impairment Criminal 1270 180 days 24 months

Italy Impairment Criminal 260 – 1030 30 days 0,5 – 3 months

Luxembourg Impairment Criminal 250 – 5000 8 – 1095 days Possible

Netherlands Impairment Criminal Accident: 11250 1095 days 60 months

Impairment Criminal Fatal: 45000 3285 days 60 months

Norway Impairment Criminal 365 days 12 months

Portugal Impairment Criminal 360 – 1800 365 days 2 – 24 months

Spain “Per se” Administrative 302 – 602 8 – 12 weeks 3 months

Impairment Criminal 302 – 602 8 – 12 weeks 12 – 48 months

Sweden “Per se” Criminal Day fines 730 days 1 – 36 months

United Kingdom Impairment Criminal 7000 180 days At least 12 month


tests conducted by police as part of theROSITA project [11].There is a clear need for police to beequipped with drug screening test systemsto help them identify drivers under the influence of drugs. Police throughout theGerman state of Saarland, for example, were equipped with drug screening tests in 2001 following a decision taken by theSaarland Interior Ministry. The pattern ofdrug consumption among road users asidentified by the ROSITA project showsclearly that the reliable detection of cannabisand amphetamines and designer drugs bydrug screening tests is currently the mostimportant aspect of identifying drivers underthe influence of drugs.The project has resulted in action being taken not only in Germany, and has alsobeen watched with international interest,with road traffic policy changing in severalEuropean countries as a result. For thisreason, the research partners which par-ticipated in ROSITA have been asked bythe EU to take part in a follow-up project.This follow-up project, known as "ROSITA2“, has been approved by the EuropeanCommission [8]. Besides German partici-pation, partner institutions from Spain, Belgium, France, Finland and Norway areinvolved, as are the National Institute onDrug Abuse and the National Traffic High-

way Safety Administration (NTHSA) fromthe USA. The main focus of the project'sstudies is to examine the usefulness for police of screening test systems based solely on oral fluid; urine screening test devices will not be covered by the field study. The project will be completed by the end of 2006, and the results then published.

DiscussionIn today's society, drug-related road trafficoffences are being treated increasingly seriously. This trend is reflected in moreand more countries around the world, whichhave been continuously updating their lawsover the past few years to ensure that drivers under the influence of "other intoxi-cating substances" can be identified moreeasily, quickly and reliably, and to directlyprevent such persons from driving. The use of drug screening tests has alreadystarted to be incorporated into some of therespective laws. Such tests are excellentdiagnostic detection instruments which allowa person's consumption of drugs and/orcurrent state of drug influence to be quicklyand easily determined and – depending onthe particular situation – to clarify whetheror not they are "fit to drive". Although policeofficers who are practised in recognizingdrug users can generally determine

whether a person is acting dangerously orstrangely as a result of drugs, the topic of"drugs on the roads" is still unfamiliar groundto the majority of police officers. Such offi-cers are often uncertain whether it is enoughfor a person to be demonstrating unusualmental or physical behaviour for this to beattributed to the effects of drugs and forthem to initiate the relevant legal steps.However, it should always be rememberedthat immunochemical drug screening tests,regardless of their quality and possible ap-plications, are just one of several of the mosaics which form the basis for a policeofficer having grounds for suspicion. Ulti-mately, especially under German law, otherunambiguous signs are necessary (strangebehaviour, slow pupil reactions etc.) beforea driver can be suspected of consumptionof one or more drugs. A positive screeningtest cannot and should not be used as thesole reason for taking a blood sample dueto the fact that courts require the results tobe corroborated by a "conclusive and con-sistent overall impression of impairment“before they can be admitted as reliable evidence. Analytically speaking, too, parti-cular attention must be paid to how the results of immunological drug testing pro-cedures are interpreted. In the case of a"non-negative" result, the screening testmaterial or – depending on the particular


P. 42 | 43MEDICAL AND ILLEGAL DRUGS ON THE ROADS SUBSTANCE ABUSE AND DIAGNOSTIC TECHNIQUES

circumstances and legal situation – otherbodily materials (oral fluid, blood, urine, keratin fibres) must be subjected to a confirmation analysis using a recognizedmethod of measurement (e.g. GC-MS, LC-MS, GC-MSMS or similar) to allow the appropriate legal action to be taken on a completely dependable analytical basis.

Dr Stefan SteinmeyerDräger Safety AG & Co. [email protected]

Bibliography[1] http://europa.eu.int/comm/transport/road/

roadsafety/index_en.htm

[2] Statistisches Bundesamt, Fachserie 8, Reihe 7: Verkehrsunfälle 2004. Available at http://www.destatis.de/

[3] Reports of the Bundesanstalt für Straßenwesen,BASt (2001), Mensch und Sicherheit, Heft M 132: Fahrten unter Drogeneinfluss – Einflussfaktoren und Gefärdungspotential

[4] European Legal Database on Drugs: Drugs and Driving. ELDD Comparative Study, Version 2. June 2003. Available at http://eldd.emcdda.eu.int/

[5] Drummer, O.H., Gerostamoulos, J., Batziris, H., Chu, M., Caplehorn, J., Robertson, M. , Swann, P. (2004): Accident Analysis & Prevention, Vol. 36, Issue 2, 239-248

[6] Saliva Testing For Illicit Drugs – New Drugs Legislation. Published by the “Transport WorkersUnion (TWU) of Australia”, Vic/Tas Branch, 2005.

[7] Belgian Toxicology and Trauma Study Rearch Group. A scientific study on the presence of alcohol, medicines and illegal drugs in drivers who were victim of a traffic accident and the relationship between these substances and the accidents. Report of the Study. Belgian Road Safety Institute 1996.

[8] European Union (EU). ROSITA-2 - Roadside Assessment Project Number SUB-B27020B-E3-SO7.18222-2002. European Union (EU), Brussels (2002);

[9] Driving under the Influence of Drugs (DUID). Legislation in the United States. The Walshgroup & The American Bar Association’s Standing Committee on Substance Abuse. November 2002. Available at http://www.walshgroup.org/

[10] European Union (EU). ROSITA - Roadside Assessment Project Number DG VII RO 98-SC.3032. European Union (EU), Brussels (2000); available at www.rosita.org

[11] Moeller, M.R., Steinmeyer, S. & Bregel, S. EU-Projekt ROSITA – Können Drogenkontrollenvor Ort helfen, Unfälle zu vermeiden? In: Bundesanstalt für Straßenwesen (BASt) (Hrsg.): Berichte der Bundesanstalt für Straßenwesen. Mensch und Sicherheit., Kongressbericht 2001 der Deutschen Gesell-schaft für Verkehrsmedizin e.V. Wirtschafts-verlag NW. Verlag für neue Wissenschaft GmbH,Bremerhaven (2001)

[12] Verstraete, A.: Survey of European DUID Legislation. In: Symposium Report of the "2-Day International Symposium on Developing Global Strategies for Identifying, Prosecuting, and Treating Drug-Impaired Drivers", held on Feb 23-24, 2004 in Tampa, Florida, USA; available onhttp://www.icadts.org/coreports/duidreport.pdf


RUBRIK KAPITEL

Dräger Safety AG & Co. KGaARevalstraße 123560 LübeckTel +49 451 882 0Fax +49 451 882 2080www.draeger-safety.com

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