When people talk about drugs, it always seems obvious what they mean. Often, however, it quickly becomes clear that the term can be used to refer to many different things. For instance, someone who enjoys a glass of wine or beer may well be unwilling to accept that their "tipple" is also classified as a drug, while tea and coffee drinkers will no doubt find it equally hard to understand that 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 framework of certain norms. In distinguishing between hard and soft drugs, it is not only the drug's addictive potential that counts – the degree of psychotropic effect is also taken into consideration, as are health, political, cultural and economic aspects. Another classification which is just as common and just as problematic involves determining the legal status of drugs. Alcohol, for example, enjoys a high standing in some cultures (where an official reception without wine or champagne would be unthinkable), while in other regions it is strictly forbidden. Dividing drugs up into natural and manmade substances is somewhat easier. Some parts of plants can be consumed as drugs without much in the way of processing, while others first need to be treated chemically before the desired narcotic effect is obtained. If we look at how patterns of social consumption have evolved and at the prevalence of drugs such as alcohol, we can see that the popularity and consumption of these substances has been determined by social and economic circumstances. Archaeological research, for instance, tells us that people were brewing alcohol long before they started baking bread. The history of drug development shows clearly that it was last century's technology drive and the huge increase in production that produced the phenomenon we see today, namely the socially and geographically widespread consumption of alcohol, tobacco and indeed illegal drugs. Tobacco and alcoholic drinks are now among the most readily available goods in many countries. The consequences of "substance abuse", however, can be devastating not only for the person concerned, but also for their families, friends and work colleagues, and indeed for the general public (e.g. on the roads).
Alcohol in the form of fermented or distilled beverages is freely available (with few exceptions) as a legal substance, and drinking alcohol is deeply rooted in many different cultures. At the same time, alcohol is a cell toxin and a neurotoxin, and results in addiction. There are hardly any organs in the human body which are not damaged by excessive alcohol consumption. Alcohol abuse became a social problem with the rise of the proletariat; at the beginning of the 20th century, public interest in alcohol-related problems waned as people were caught up in the world economic crisis and the First World War. In the second half of the 20th century the problem once again returned to the public eye as "alcoholism of the affluent classes". This dispensed with the stigma of it being an "evil vice" and made it, by definition, a pathological condition. Indeed, alcohol dependence is a serious illness from which it can take months to recover. The mass consumption of alcohol and the problem of alcoholism, with its marked tendency to generate addiction, results in a much greater problem quantitatively speaking - in terms of the number of those affected and the associated health and social costs - than consumption of all other drugs combined!
Nowadays it is a well-known fact that smoking can cause illness and death, as well as accelerate many other diseases. In other words, many people, and especially the young, harm their health by smoking despite being aware of the risks. Tobacco consumption has now become the leading preventable cause of illness and death. As far as the frequency of consumption and the damage to health that it causes is concerned, tobacco is the number one drug.
Medicine not only cures illness, but is also a socially recognized and tolerated "drug". Prescription drug abuse is when medication is taken without medical grounds or in unnecessary quantities. In practice, such abuse usually involves psychoactive substances, especially barbiturates (sleeping pills), analgesics (painkillers), sedatives and stimulants. Substances containing benzodiazepines in particular, which can cause a low-dose dependence after just four weeks or so of regular consumption, are regularly taken over long periods of time. Although prescription drug abuse is rampant in our society, it rarely receives much public attention. It is often very difficult to draw a clear line between normal (medically necessary) consumption and abuse. Six to eight percent of all prescribed drugs have some addictive potential. Illegal drugs Unlike with alcohol and tobacco, there is still some controversy as to whether "legal consumption" of cannabis products should in fact be possible, or whether such consumption should always be treated as substance abuse, though in the case of drugs with high addictive potential the concept of normal consumption is categorically ruled out. The fact that drugs such as cannabis and cocaine are illegal, for example, is the result of social appraisals of the use of these drugs in industrialized countries. Both cannabis and coca leaves have been known as remedies, cult and narcotic substances for thousands of years. However, narcotic drugs also have a negative impact on the way an industrial society functions, and the consumption of illegal drugs is by no means a uniform phenomenon. Drug use can cover different substances which are consumed independently, in succession or in combination, and in varying quantities.
European countries generally base their drugs policy on the so-called "four-pillar model", i.e. repression, prevention, survival assistance and treatment. Today, Dräger Safety measurement technology is used in all four of these areas. First and foremost, tests and measurements are performed to diagnose and detect substance abuse. Despite widespread preconceptions to the contrary, the majority of drug addicts do not live up to the classic image of a junkie or drunk. The number of unreported cases is extremely high (especially as regards alcohol and prescription drug dependence), and the addiction tends to go undetected for a long time. Those concerned appear to lead a well-ordered life, have a normal job and are often left alone with their problem. In other words, diagnosing the problem of addiction or abuse is the first step towards helping the person concerned, e.g. by making treatment available. Both as regards diagnosis and further-reaching prevention, treatment and assistance measures, alcohol and drug tests constitute an indispensable measurement instrument for the attending doctor and in some cases even for the person concerned.
Monitoring activities (alcohol and/or drug tests) as part of various campaigns and programmes, e.g. traffic checks or medical examinations, can not only help detect substance abuse, but can also have a preventive – and in some cases even a teaching – effect. A person's inhibition threshold becomes greater the higher their risk of being discovered. Quick measurements which can be performed on site enable police to classify strange and dangerous behaviour exhibited by drivers and to judge the extent to which they can be made accountable for their actions. The situation is similar in a court of law where the accountability of offenders or the reliability of witness statements needs to be assessed.
Drug monitoring programmes in prisons are used to detect any substance abuse by prisoners on temporary release, inmates and visitors. What is more, alcohol and drug testing can help monitor a person's compliance with parole requirements or with the requirements necessary for them to re-obtain their driving licence.
Drug testing also plays an important part in the investigations conducted by customs officials. Monitoring of possible substance abuse is also extremely important in emergency medicine as it reveals whether particular conditions should be treated as the consequence of alcohol or drug abuse or whether they have other causes. In rehabilitation programmes, alcohol and drug tests can be used to check whether patients are "clean" and whether they are following their treatment plan. Testing and measurement systems for the detection of substance abuse in occupational medicine and at the workplace have gained an equally firm foothold.
At Dräger, we have devoted more than 50 years to the topic of breath alcohol measurement in all its technological diversity, in its various fields of application and with a wide variety of products. For over a decade, we have also been focusing on how to detect other drugs apart from alcohol, especially illegal drugs such as cannabinoids (marihuana, hashish), cocaine and its derivative, opiates and the designer drugs (speed, XTC, etc.) using saliva samples. In recent years, Dräger Safety has presented various new developments, products and services in this field. This special edition takes a closer look at the subject of drug testing and introduces the reader to monitoring systems and services which allow test subjects to undergo targeted, precise, hygienic and easy-to-use substance measurements.
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When people talk about drugs, they generally mean "natural, semi- or fully-synthetic substances which affect the central nervous system (CNS) and are taken with the purpose of bringing about a change in consciousness and/or experience“. There are two essential factors operating in tandem when it comes to defining the word "drug" - a substance's pharmacological effect (as an objective property) and the way it is used or the reason for its use (as a subjective property). The psychoactive substances referred to in this article tend to have considerable addictive potential. Alongside the most widespread of the legal stimulant drugs, namely alcohol and nicotine, the range of psychoactive substances which has been available since the 1960s in particular has widened considerably. Almost all of these substances, many of which were originally developed as pharmaceuticals, were classified as illegal by the western industrialized nations. At the present time, cannabis is the most commonly used illicit drug, with numbers of users increasing, especially among young people. In Germany, more than 10 tons of hashish and marijuana were seized in 2003. The consumption of party and fashion drugs like amphetamine ("speed“), MDMA ("ecstasy“) and cocaine has also remained high. In 2003, more than a ton of cocaine was seized in Germany, and a total of nearly 500 kg of amphetamine and methamphetamine was confiscated in almost 4,000 separate incidents.
How illicit drugs affect people and the symptoms they cause vary greatly. Amphetamine ("speed“) is similar in terms of its chemical structure to the human neurotransmitters adrenalin and dopamine. It is primarily taken in powder form and suppresses fatigue, reduces a person's need to sleep, curbs the appetite and lowers the aggression threshold. MDMA ("ecstasy“) is usually taken in tablet form, causes changes in mood and also suppresses hunger, thirst and tiredness. Its widespread use in the rave scene is due in part to its ability to heighten the dance experience. The stimulating and de-inhibiting effect of cocaine induces people to continue using the drug until they are heavily psychologically dependent on it; typical of this drug is the need to increase the dosage. Cannabis products (hashish, marijuana) contain the active ingredient delta-9-Tetrahydrocannabinol, _9-THC, and bring about acute changes in thinking and behaviour, though these can be perceived differently from person to person, and indeed each time the drug is consumed. Typically, the effects include slower movement and thought, reduced attentiveness, lessened grasp, euphoria, (unfounded) happiness, relaxedness, inertia, reduced drive, lack of drive or apathy, sleepiness, mood swings, dysphoria, irritability, and increased appetite. Especially if high doses of _9-THC are taken, hallucinations and visionary states can occur - these may manifest themselves in a distorted or lacking sense of time, space, person and situation. In addition, medical drugs such as painkillers, tranquilizers and sleeping pills are abused on a grand scale. Medical drugs are those pharmaceuticals which (in specific dosages) are used to cure, prevent or alleviate an illness. Since time immemorial, certain plants, plant extracts and animal substances have been used for these purposes, though in recent times mainly synthetic substances are used. A number of medical drugs - especially those which affect the CNS - can also be addictive. Benzodiazepines in particular, which are used as sleeping pills and tranquilizers to dispel fears and improve the mood, are often used for too long and in too high doses. It is presumed that most of the 1.4 million people in Germany who are addicted to medical drugs are dependent on benzodiazepines.
Pharmacology, the branch of science which studies how chemical substances interact with biological systems, has a number of subdisciplines. Pharmacokinetics, for example, describes the changes in concentration of consumed substances and/or their metabolites in the organism over time. By observing pharmacokinetic processes such as the absorption, distribution and, finally, elimination of a biologically active substance, it is possible to determine how the organism reacts to the consumed substance. Pharmacodynamics provides information about how a pharmacological effect is brought about after a biologically active substance has been consumed. In order to be able to draw logical toxicological conclusions about the effects of a drug from the measured blood concentration, a parallel and, ideally, linear time progression of both curves (rise, maximum values, fall) would be useful. However, this type of relationship is generally not possible to determine for drugs and pharmaceuticals. When a person smokes a joint, for example, the concentration of the active substance in the blood increases immediately, even though the effect is felt only very gradually. While the effect is still subjectively felt to be increasing, the blood concentration is already falling again. In other words, the effect lags somewhat behind the concentration progression of the active substance. It is only some time later that the relationship is reversed, with the effects decreasing faster than the active substance is eliminated from the blood. This relationship can be portrayed as an anticlockwise curve.
In the case of alcohol, the relationship between concentration and effect is exactly the opposite: in this case, the subjective effect at the beginning is felt to be greater than the concentration in the blood, while at the end the alcohol is broken down much more quickly than the time it takes for the effects to disappear. This time, the result is a clockwise curve. The different progressions of effect and concentration are attributable not only to the chemical properties of the consumed substances, but also to the way they are consumed. The effects of smoking cannabis, for instance, are felt within minutes, peak within 15 minutes, and start to fade around 30 minutes after smoking. On average, the intoxicating effects are over after two to three hours. If cannabis cakes ("space cakes") are eaten, the effect is felt with some delay, some half an hour to two hours after consumption - making it much more difficult 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 of medication), the substances can interact to add together or even multiply the different individual effects, though in some cases they can weaken or even (temporarily) cancel each other out. This means, however, that it is virtually impossible for a person to subjectively "plan" their degree of intoxication or for somebody to assess the behaviour of the intoxicated person.
Which analytical methods to use is dictated first and foremost by the application. The following factors need to be taken into account: - 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?
To reduce the number of analyses that need to be carried out, the samples can be subjected to an immunochemical screening test. This allows samples to be preselected quickly on the basis of the presence of specific substances or substance classes, with a high level of sensitivity, and without significant preparation. Immunological testing has its origins in the USA, where immunoassays have been widely used for drug detection purposes - as well as in toxicology - since the end of the 1980s within the framework of pre-employment and workplace testing for drug use. Accordingly, manufacturers of immunoassays base their "positive" and "negative" cut-off values on American decision-making criteria, i.e. the guidelines of the NIDA. All assays take advantage of the antigenantibody reaction principle, according to which the analytes compete with antigens to bind to specific antibodies. The number of immune complexes formed by the antibodies and analytes is an indication of the analyte concentration in the sample. The antibody-antigen bond, however, is not directly accessible for analysis in most immunoassays. This problem is solved by coupling one of the two components, either the antigen or the antibody, to an easily detectable "label". Enzymes (biocatalysts), dyes, fluorophors and, though less and less often, radioactive components are examples of possible labels.
Besides being used in urine analysis, immunoassays can also be used to detect drugs in other bodily materials. For example, microtiter plate tests have been on the market for a few years which allow direct and highly sensitive enzyme-immunochemical detection of drugs and metabolites in untreated whole blood or serum. No recommended cut-off values are (as yet) available. Immunoassays are a useful way of determining whether samples contain drugs, but their results must be confirmed by other reliable methods offering a higher degree of specificity, as this is the only way to ensure reliable identification and precise quantification.
Reliable quantitative determination of different drugs in a complex matrix such as serum demands the use of a selective method. Because of the low concentrations (in the nanogram range) of drugs in the blood, and indeed in oral fluid, complex analytical methods have to be employed which allow measurements to be performed close to the detection limit. The relevant literature describes numerous methods of identifying and quantifying analytes in physiological samples, though preference tends to be given to a combination of gas chromatography and mass spectrometry with stable isotopes as internal standards. Gas chromatography mass spectrometry (GC-MS) has long been known as a "definitive method" which is "correct" and specific; i.e. it delivers a definitive (correct) value as the best approximation to the "true value". The "Mandatory Guidelines for Federal Workplace Drug Testing Programs" in the USA also list GC-MS as a "confirmatory drug test". Another definitive method which is used is liquid chromatography (LC), likewise in conjunction with a mass spectrometric detector.
To determine whether pharmaceutical or narcotic substances are present in the body, toxicological analyses can be performed using different bodily materials. The materials should be chosen to match the requirements of the particular application; oral fluid and blood, for instance, can be used to detect recent consumption, while hair gives a clearer picture of consumption longer ago.
Blood is very well suited to testing for drugs and medication because, right from the outset, it contains the pharmaceutical or narcotic substance at the point the substance is introduced into the body and then transports it to all tissues, including the places where the substance takes effect and the organs which expel it once again from the body. Blood cannot be tampered with, has a fairly homogeneous composition, and the concentration of the substance is in a state of dynamic equilibrium with the concentration of substances absorbed into the central nervous system and, therefore, regarding any effect - at least to a limited extent. For all these reasons, blood is the only sample material which fulfils the German legal requirements of § 24a Subsection 2 of the Road Traffic Code. Since Germany operates a policy of "obligatory tolerance", a blood sample can be ordered by police officers if a traffic offence is committed. Taking of a blood sample, however, is a highly invasive process and therefore not suitable for conducting at the roadside.
Testing a urine sample can serve as a complement to a blood analysis. Urine's advantage as a sample material is that it can generally be provided by test subjects in larger quantities without the need for invasive techniques. As a rule, any foreign substances and their metabolites can be found in a higher concentration than is the case in blood, and can be detected for longer. The broader metabolite profile can also provide additional information. One disadvantage, however, is the fact that the results of urine testing are only comparable to blood test results to a limited extent. For example, measurable concentrations can usually be found in the blood immediately after consumption, yet the processes by which the drugs are broken down in the body mean that they cannot yet or can hardly be detected in the urine. On the other hand, a positive urine result does not necessarily point to very recent consumption; in the case of cannabis consumption in particular, THC carboxylic acid, which is the main metabolite used for detection, can be found in the urine even after several weeks. The fact that urine testing requires suitable facilities in which the test subject can provide a sample often entails a great deal of time and personnel. It is impossible not to intrude upon a person's privacy if supervised sampling is required. It is also possible for the test subject's urine sample to be tampered with in many different ways, and indeed a sample is not always possible for various reasons. In other words, although urine is in principle a suitable test medium for detecting drug consumption, it is not practicable, and is not permitted by law in many countries.
(Physiological) saliva is colourless and transparent, low in viscosity and produced by the salivary glands situated in and near the oral cavity. Every day, these glands produce around 1 to 1.5 litres of saliva. Samples of oral fluid (which is slightly different from saliva) provide detailed information about a person's current state of drug influence because, like blood samples, they correlate more accurately with the time of drug consumption and the extent of the effect than urine samples. It is also easier to obtain an oral fluid sample from a person than a urine sample, as there is no serious invasion of their privacy and the sample can therefore be obtained directly at the test site under constant supervision, without the need for any special facilities. As a result, far less time and far fewer personnel are involved in performing the test than is the case with urine testing. What is more, tampering on the part of the test subject is virtually impossible. Experience has shown that those tested, especially people suspected of driving under the influence of drugs, are generally much more willing to undergo an oral fluid screening test than a urine screening test.
Material containing keratin such as hair and nails can also be used for the purposes of analysis. Because drugs are incorporated into the keratin structure, information about the "drug history" of the person under investigation and, to some extent, about their consumption can be obtained, taking the average rate of hair growth into account (approx. 1 cm per month). This does not provide any details of recent drug consumption, however, so no conclusions can be drawn as to whether a person is actually under the influence of drugs. Hair and nails do not represent suitable sample material for screening tests.
In today's society, drug and medication abuse is being taken increasingly seriously. Analytical proof is thus also becoming increasingly important to allow preventive action to be taken, and to make boundaries clear to drug abusers through the use of sanctions. Alongside laboratory-based analytical methods, it is those analytical techniques which are easy to use and can quickly produce a result which are particularly useful for on-site use. Drug screening tests in particular can be crucial in providing a quick and reliable qualitative indication of drug consumption. The requirements which such tests need to meet are quite different to those placed on instruments used in a laboratory. The test conditions in a chemical or medical laboratory are completely different to those, for example, during a "roadside traffic control". Testing at night, in bad weather, in chaotic situations etc. has a huge influence on the way a test is performed and does not reflect a test system's usability and reliability under ideal, reproducible lab- oratory conditions (good lighting, room temperature, trained laboratory personnel etc.). This also affects the sample material; while the samples are treated in the laboratory (freezing, centrifugation etc.) for ease of analysis and can thus be standardized to a certain extent, such methods are generally not available on site, and this needs to have been taken into account as far as possible during development of the test system. A drug screening test system must be based on a principle which reflects the problem situation and, despite the potential difficulties which can occur during a road traffic control, for example, need to function precisely within clearly defined error limits.
Modern addiction prevention is a crossfunctional 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 insurancecompanies, in self-help groups and inmedical professional associations.To ensure an effective and sustainable programmeof "prevention", a number of conditionshave to be met. Among other things,these include ensuring the quality of addictionmonitoring and treatment, concludingproperly founded service agreements betweentreatment providers and health insurancecompanies, taking the often very specificlocal circumstances into account, andprerequisites as regards those taking partin the programmes.The role played by substance monitoringin the form of drug testing is an importantone, especially in drug substitution treatmentand therapy following substanceabuse. In the interests of quality assurancein this area, guidelines have been issued,regulations drawn up and processes described, demanding or recommending amongother things the use of specific test proceduresor equipment.
Dependence 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 PrescriptionOrder (BtMVV), § 5 Subsection11 and, on the basis of the generallyrecognized state of knowledge, by theGerman Medical Association in its guidelinesfor the substitution treatment ofopiate addicts.Substitution treatment ("methadone substitution“)is only permissible when embeddedwithin a comprehensive treatment programme.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.
One essential aspect of treatment is substancemonitoring (i.e. testing for drug oralcohol consumption). Drug tests carriedout at the beginning of treatment to determinewhether a person is still consumingopiates or other substances must be documented."Monitoring of concomitant substanceabuse", as it is known, is requiredby the German Narcotic Drugs Prescription Order (BtMVV).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/methamphetamines,benzodiazepines, methadone,cannabinoids, barbiturates or alcoholare being used concomitantly. If currentconcomitant use of other substances is detected,the substitution drug must be withheldif this could have a detrimental effect on health when taken in combination withthe other substances. It is particularly importantto remember that taking the substitutesubstance in combination with alcoholand/or sedatives could, in the worst casescenario, cause death.This shows just how important it is to conductalcohol and drug tests throughout thephases of diagnosis and treatment. Theattending doctor has a duty to carefullydocument any concomitant use and toobserve any considerations and consequenceswhich this may entail. This documentationduty arises as a result of theexisting employment law, the German Narcotic Drugs Prescription Order (BtMVV)and the particular requirements for substitutiontreatment 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 purposesof assessing the quality assurance measures. Modern drug and alcohol testingsystems and procedures support and facilitatecomprehensive documentation of concomitantabuse monitoring.
When 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 informationsharing. 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 professionalwith 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 treatmentplan for each patient, containing thegoals of treatment and when they are to be achieved, and monitoring progressand outcomes, and- commitment to concomitant abuse monitoring(for alcohol, drugs and medication).Quality assurance in outpatient substitutiontreatment programmes should attach particularimportance to the conditions prevailingin the facilities themselves, e.g. the medicalteam, cooperation networks and space available.This also includes having the necessaryequipment in terms of breath-alcoholand drug testing systems which conform tothe legal requirements (e.g. MDD, IVD, German MPG). 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 substanceabuse and admitting new patients.
Monitoring a patient for concomitant substanceabuse 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 practiceare readily available nowadays. There 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 individualcircumstances. Bearing this in mind,test systems based on oral fluid samplesoffer a key advantage, as suchmethods 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, andbetter reflect the patient's own - oftensubjective - capabilities.What is more, there is no need for thelaborious steps aimed at preventing adulterationand manipulation which have tobe performed during urine testing. The factthat equipment is purchased to electronicallymeasure the urine temperature, orthat 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 patient'sprivate sphere.When it comes to monitoring for the concomitantconsumption of alcohol, high-qualityelectronic breath-alcohol detectors, preferablywith electrochemical sensor systems,should be used to meet the requirementsfor quality assurance in substitution treatment.
Because the guidelines issued by theGerman Medical Council (Bundesärztekammer- BÄK) expressly state the necessityfor breath-alcohol monitoring, breathalcoholtesting was included in 2003 in the"assessment standard for services providedby a doctor (BMÄ)“. Since then, determiningalcohol in a person's exhaled airwithin the framework of substitution treatmentcan be charged to the CompulsoryHealth Insurance (Gesetzliche Krankenversicherung- GKV) at a rate of currently1 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 substances. The number of drug measurements whichcan be performed for patients who undergosubstitution treatment in accordance withthe guidelines of the Federal Associationof Physicians and Health Insurance Organizationsand 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 treatment,and 64 EUR per quarter from thethird quarter on. As a rule, much the sameapplies for patients whose substitution treatmentis paid for by a social welfare provider,who normally base their practices on thoseof the Compulsory Health Insurance.
In 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),while EU Directive 98/79/EC deals with invitro diagnostic medical devices (IVD Directive) (in vitro = in a test tube). BothDirectives were transposed together intonational law in Germany in the form of the Medical Devices Act (MPG).If products comply with one of the two directives,they are CE marked (and possiblymarked with the ID number of the notifiedbody) and the manufacturer issues a declarationof conformity. This serves as documentationthat 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 allinformation relevant to the product to berecorded and made available at any time.The manufacturer of the product is alsorequired to establish and maintain a systematicprocedure to provide information about incidents which could result or have resulted in the death or serious harm tohealth of a patient or user.
Deciding whether drug testing proceduresfall within the scope of the in vitro diagnosticmedical devices directive of the EuropeanUnion (IVD Directive) or in Germanywithin the scope of the Medical Devices Act(MPG) depends on what they are usedfor.The IVD defines an in vitro diagnosticmedical device as follows:“An in vitro diagnostic medical device meansany medical device which is a reagent,reagent product, calibrator, control material,kit, instrument, apparatus, equipment, orsystem, …, intended by the manufacturerto be used in vitro for the examination ofspecimens, …, derived from the humanbody, solely or principally for the purpose ofproviding information:- concerning a congenital abnormality, or- to determine the safety and compatibilitywith potential recipients, or- to monitor therapeutic measures.”Drug testing procedures in the domain ofsubstance abuse are used - especially insubstitution treatment and therapy - todetermine whether patients are consuming other drugs besides the substitute. Furthermore,the patient is monitored to check thatthe substitute itself is being taken correctly.In other words, this application corresponds to the definition of in vitro diagnostic medical devices contained in the MPG, and as such,devices and monitoring systems used forthese purposes must meet the relevantlegal requirements for in vitro diagnosticmedical devices.
Deciding whether breath-alcohol measuringinstruments fall within the scope of theMedical Devices Directive of the EuropeanUnion (MDD) or in Germany within thescope of the Medical Devices Act (MPG) and the Medical Devices OperatorOrdinance (MPBetrV) depends onwhat they are used for.The MDD defines a medical device asfollows:
“An medical device means any instrument,apparatus, … , whether used alone or incombination, … intended by the manufacturerto be used for human beings for thepurpose of:
- diagnosis, prevention, monitoring, treatmentor alleviation of disease,- diagnosis, monitoring, treatment, alleviationof or compensation for an injuryor handicap,
- investigation, replacement or modificationof the anatomy or of a physiologicalprocess,
- control of conception, …”
Based on this definition of a medical devicewithin the meaning of the relevant legalregulations a decision can be taken forindividual applications - as shown below -as to whether breath-alcohol measuringinstruments fall within the scope of therespective regulations. In individual cases,however, the manufacturer cannot ultimatelydecide which alcotest device is allowedto be used for which application and withwhich regulations it must therefore comply.This decision must be taken by usersthemselves.Breath-alcohol measuring instruments insubstitution treatmentThe German Narcotic Drugs PrescriptionOrder (BtMVV) states the following in § 5:"(2) ... Prescribing a substitute substanceis permissible if and for as long as theinvestigations undertaken by the doctor donot indicate that the patient ... c) is usingsubstances whose consumption, dependingon type and quantity, could endanger thepurpose of the substitution. ...(9) The doctor shall document the completionof the measures required in thepreceding sections. The documentationshall be presented or sent in to the competentregional authority upon request forinspection and assessment.“Furthermore, the guidelines issued by theGerman Medical Council for the substitutiontreatment of opiate addicts state thefollowing in Subsection 11 (monitoring treatment/ 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, amphetaminesand alcohol - depending on the circumstancesof 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 anddeath. ... The attending doctor has a duty tocarefully document any concomitant substanceabuse and the considerations andconsequences resulting from this. ... “According to the above, breath-alcoholtesting during substitution treatment isintended to "prevent disease", meaningthat the devices fall within the scope of theMDD, and must have the necessary approval.
Breath-alcohol measurements are oftenconducted during surgical operations. Thebreath-alcohol measuring instrument isused to diagnose vascular injuries, e.g.during transurethral resection of prostatein urology (TUR-P) or transcervicalresection of the endometrium in gynaecology(TCRE). If an ethanol-based irrigationsolution is applied prior to this type of surgery,the ethanol will be quickly detectablein the patient's exhaled air in the event of avascular injury.When a breath-alcohol measuring instrumentis used to prevent absorption of irrigationsolutions during surgery, this is donewith a view to "diagnose injuries and preventingdisease“.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 operationsand medical emergencies or in theA&E department, clearly fall within thescope of the MDD, and the breath-alcoholmeasuring instruments must therefore havethe relevant medical device approval.
If a patient who is not undergoing substitutiontreatment 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 alleviation of disease", and also does not correspondto any of the other intended purposeslisted. Just as when the devices areused by the police, this procedure is performedsimply to determine whether aperson has consumed alcohol and, in doingso, has violated the applicable laws or regulations.For these applications, then, it is not essentialfor a breath-alcohol measuring instrumentto be approved in accordance withthe MDD.However, since addiction and detox clinicsoften also employ breath-alcohol measurementsto monitor concomitant substanceabuse during substitution treatment, it isrecommended that breath-alcohol measuringinstruments with the relevant medicaldevice approval should be used whentesting for "compliance with regulations".
The 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 notacceptable.The German Medical Devices Operator Ordinance 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 carriedout at certain intervals : "In the caseof medical devices for which the manufacturerhas prescribed safety inspections, theoperator shall perform these inspections, orhave them performed, in accordance withthe manufacturer's instructions and the generallyrecognized rules of technology, andwithin the intervals stated by the manufacturer.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.
As part of the Dräger Alcotest family,which has been widely used for many years,the Alcotest 7410 med (Figure 1) and Alcotest6810 med (Figure 2) models weredeveloped. These are specially designedfor use as medical devices and bear therespective CE mark in accordance with EUDirective 93/42/EEC for medical devices. Besides the high quality and proven reliabilityof 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 medicalapplications. For example, they can be usedto diagnose vascular injuries (during transurethralresection of prostate in urology, forinstance) following prior application of anethanol-based irrigation solution. They arealso suitable for testing patients for prioralcohol consumption in the A&E departmentor 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 lowstandard deviation. The device's illuminateddisplay screen (which contains informationsuch as the test number, date, time,measurement result and error messages),the colour LEDs and the audible signalguide the user smoothly through operationof the device.During the automatic measurement whichis 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 issampled. The manual measurement option 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 transferredto a PC once the measurement hasbeen completed, ensuring continuous documentationduring, for example, medical treatmentor 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 sixmonthlysafety inspection, also encompassingthe measurement function, is to becarried out in accordance with the GermanMedical Devices Operator Ordinance.Apart from the breath-alcohol measuringinstruments themselves, the special mouthpieceswhich 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 practice,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.
