©Ralf Gerlach

Methadone and other opiate substitution treatments in Germany

Methadone treatment has been comprehensively evaluated in Germany and is now a standard treatment for opiate addiction with high availability and retention rates, improvements in health and social (re)integration, and a reduction in the use of psychoactive substances. It has a strong preventive effect regarding the spread of HIV and most likely also hepatitis C. Another benefit observed is a high reduction in (addict) criminality rates.

In the following material, historical aspects of substitution treatment, the German legislative framework and the current state of the art will be described.

1. Institutional responses to the emerging problem of drug use

After heroin had found its way onto the German illegal drug market around 1970, there was a rapid increase in the number of users and addicts within only a few years (estimated number of opiate users in 1976: 30,000 to 40,000 /2004: 120,000 to 150,000 compulsive users plus about the same number consisting of problematic, controlled and recreational users). Following national developments in legal, medical, and political areas originating from the 1920’s the drug policies of German governments remained dominated by a rigid adherence to the abstinence paradigm and a ‘war on drugs mentality’ throughout the 1970s and the 1980s, and policies that would foster alternative approaches such as harm reduction were strictly blockaded.  The therapeutic ideal of achieving permanent abstinence for all opiate users was considered the only valid premise for providing practical survival support by drug advisory/counseling services and the only valid criterion for successful addiction treatment. As a consequence, therapeutic communities (TCs) and other drug-free residential rehabilitation programs (RRPs) were proclaimed as the ‘Royal Road to Recovery’, and doctors were only accepted to participate in addiction treatment within the scope of inpatient (non-agonist) detoxification.

Background: The Hannover experimental methadone program

The results gathered from a first experimental methadone program that had been carried out in Hannover from 1973 to 1975 allegedly confirmed the dominating drug-free position, despite the fact that measured against the original criteria of success identified by the initiators of methadone maintenance treatment (MMT), Dole and Nyswander, there was a success rate of “almost 100 percent” (Krach et al. 1978:292). However, the judgement of the authors of the Hannover final report was that the trial had been a failure, because “following cessation of methadone treatment, virtually all subjects relapsed to opiate use and the dramatic improvement in social function was reversed” (Newman 1988:27).

In contrast to MMT as introduced by Dole and Nyswander, the Hannover pilot project had been conceptualized as a maintenance-to-abstinence program and, corresponding with the abstinence paradigm dominating addiction treatment and policies at that time, the program staff interpreted the outcome of the trial as evidence of the superiority in effectiveness of  TCs/RRPs over MMT. Unfortunately, the vast majority of German drug experts, including researchers, professionals involved in drug counseling and addiction treatment, medical associations, the Federal Medical Board (Bundesärztekammer) and public health insurers, adopted this judgement without any further investigation.  Subsequently, for over a decade the Hannover methadone trial results were misrepresented as clear evidence that methadone programs are not adequate alternatives to TCs/RRPs.

As a consequence, a drug addiction treatment system was developed that excluded doctors from providing effective medical treatment to opiate addicts.

Rising problems and changes made

It was the emergence of AIDS in the mid-1980’s, rising addict criminality, increasing mortality rates among drug users, and the narrow range and unattractiveness of abstinence-oriented services that finally generated demands for alternative, harm-reduction-oriented concepts to be integrated into drug policy, addiction treatment and (social) drug work. Since the late 1980’s Germany has taken a number of legal steps which favour harm reduction, assistance and treatment, rather than law enforcement alone. As a result of this new commitment, Germany legalized methadone and other substitution treatments for opiate addiction (1992), needle and syringe exchange schemes (1992), consumption and injecting rooms (2000), and introduced a heroin-prescription trial (2001).

According to the German drug czar, Mrs. Caspers-Merk, the drug policies of the current government are based on a four-pillar model:

1. prevention
2. treatment
3. life-sustaining support
4. repression and demand reduction

Life-sustaining support is provided within the scope of

–         low-threshold services

–         drug substitution treatments (opioid replacement therapy)

–         heroin-based treatment (pilot project)

Low-threshold services are

–         contact or drop-in centres

–         streetwork (in open drug scenes)

–         emergency shelter (overnight accommodation facilities)

–         drug consumption/injecting rooms

Apart from low-threshold support facilities, needle- and syringe exchange programs, 22 consumption and injecting rooms, and several hundreds of counseling services the widespread availability of opioid replacement (substitution) treatments is believed to have played an important role in reducing drug-related death and diseases associated with drug use. In 2003 drug deaths in Germany dropped to the lowest level since 1989, continuing a consistent three-year trend: there were 2,030 fatalities in 2000, 1,835 in 2001, 1,513 in 2002 and 1,477 in 2003.

While the concept and practice of “harm reduction” as an integral component of the national drugs strategy appear increasingly to be effective in reducing drug-related morbidity and mortality, alarming numbers of alcohol- and tobacco related deaths have been reported: It is estimated that in 2003 40,000 to 60,000 people died as a result of immoderate and excessive consumption of alcohol, and 110,000 fatalities must be attributed to excessive smoking of cigarettes.

2. Development of methadone maintenance treatment

Until the early 1990s, methadone could only be administered in Germany to drug users when highly specific selection criteria had been met (e.g. emergency cases such as life-threatening conditions associated with withdrawal, conditions of severe pain, pregnancy or having AIDS). In general medical practice, however, German doctors were prevented from using methadone to treat heroin addicts, because opioid replacement had been considered to be a form of medical malpractice already since the late 1920’s. Nevertheless, there were a few office-based physicians who ignored the legal regulations and prescribed methadone to opiate addict patients. Most of these doctors, however, were persecuted and prosecuted on the basis of ‘evidence’ presented by medical experts. “For some doctors the result was shattered lives and permanently destroyed careers. For others, civil and criminal proceedings dragged on for years, robbing them of their time, energy, and their financial resources” (Newman 1995:28).

These court procedures, strongly suggestive of medieval witch trials, mark one of the darkest chapters in the history of medical treatment in Germany. As a result of these prosecutions, some GPs began prescribing codeine or dihydrocodeine (DHC) to addict patients as these substances were not restricted by law. Other doctors soon followed this example and, for many years, until February 1998, codeine or DHC could be legally prescribed to very large numbers of addicts, due to a loop-hole in the narcotics regulations.

In the late 1980’s and early 1990’s methadone pilot and/or evaluation programs were launched in several German states and cities (e.g. North Rhine-Westphalia 1988, Göttingen 1990, Saarland 1990, Bremen 1991, Hamburg 1991, Schleswig-Holstein 1991, Hesse 1992, Herford 1993, Rhineland Palatinate 1993,  and Lower Saxony 1994). In 1991 the German Public Health Insurers (PHI) (Gesetzliche Krankenversicherung – GKV) approved MMT, introducing methadone treatment guidelines called ‘NUB-Richtlinien’ (Richtlinien über neue Untersuchungs- und Behandlungsmethoden). One year on (1992) there followed a change of law, the German Narcotics Act was revised, finally clarifying the status of drug-substitution treatment as legal, and MMT was massively expanded.

Table 1: Growth of the number of methadone patients in Public Health Insurance (PHI) in Germany 1991 to 1996¹

¹ The number of those patients paying for treatment and medication costs on their own and on those participating in pilot programs is not included

² Numbers relate to the old German states („alte“ Bundesländer)

As is the case with nearly all other countries providing methadone and other substitution treatments, the results of the outcome evaluations were not even in (not one single final report had been published), when the decision was made for massive expansion of MMT. Since there was still a strong opposition against MMT at that time on the sides of health professionals and drug workers, it had been a political decision rather than a decision based upon the opinions of the majority of professionals involved in the treatment of drug addiction.

Right from the beginning the overwhelming majority of patients have received methadone prescribed by office-based physicians (doctors in independent medical practice).

3. Legislation on drug-substitution treatments and basic regulations on treatment characteristics

The modern German Narcotics Act (Betäubungsmittelgesetz – BtMG) was passed in 1971 and modified in 1982. Several amendments have been enacted. This act has priority over all other regulations regarding narcotics. As regards substitution treatment with methadone, it was only in 1992 that an amendment to the Act [a change of the Regulation on the Prescription of Narcotics (Betäubungsmittelverschreibungs-Verordnung – BtMVV)] was introduced, a directive that finally clarified the legal position of methadone prescribers.

Office-based physicians and other providers of substitution treatments (e.g. specialised doctors’offices, outpatient treatment centers) have to meet several specific legal regulations and binding guidelines. The main legal obligations to follow are given in the Narcotics Act, the Regulation on the Prescription of Narcotics, guidelines developed by the Federal Medical Board (Bundesärztekammer – BÄK), and guidelines introduced by the Federal Association of Physicians and Public Health Insurance Organizations (Bundesausschuss der Ärzte und Krankenkassen).

3. Narcotics Act (Betäubungsmittelgesetz)

According to section 13 (1) of the Narcotics Act (modified in and effective since 1992) all substances approved to be used in substitution treatment must only be prescribed when their use is justified. The use of these substances “is not justied, if the intended purpose can be achieved by other means”.

Regulation on the Prescription of Narcotics (Betäubungsmittelverschreibungs-Verordnung – BtMVV)

The principle regulations regarding substitution treatments, as documented in section five of the BtMVV (effective of July 1, 2001), are summarized below:

Doctors are entitled to prescribe the following maximum quantities of substitute substances to a patient within a period of 30 days: methadone 3,000 mg; levomethadone 1,500 mg; codeine and dihydrocodeine (DHC) 40,000 mg; buprenorphine (Subutex®) 720 mg. These substances have been approved for substitution treatment by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Doctors prescribing substitute substances have to keep to the “generally accepted state of the art of medical science” (BÄK guidelines) publicised by the Federal Medical Board (Bundesärztekammer – BÄK) which is the authoritative body to define the state of the art.

In accordance with section 13 (1) of the Narcotics Act, substitute drugs may be prescribed for the following regulation purposes (treatment goals):

1. treatment of opiate addiction with the goal of step-by-step recovery to abstinence inclusive of improvement and stabilization of the general health status;

2. treatment of patients addicted to opiates who have to undergo medical

treatment for severe medical illnesses and

3. to reduce the risks of opiate addiction during pregnancy and after birth.

Doctors are authorized to prescribe substitute substances if and as long as

1. the patient is eligible for substitution treatments;

2. substitution treatments are embedded in a comprehensive treatment concept incorporating necessary accompanying psychiatric, psychotherapeutic or psychosocial care/counseling;

3. they register their patients at the Federal Narcotics Control Board (Bundesopiumstelle):

[there is a central substitution registry which receives encoded information from the prescribing doctors, including

–         patient code

–         notification at the time of patient enrollment

–         substance prescribed

–         notification of patient termination

–         name and address of the prescribing physician or clinic]

4. there is no evidence that the patient

a. receives substitution substances on prescription from another doctor

b. refuses to participate in necessary accompanying treatment and care

c. uses substances that endanger the purpose of substitution treatment

d. uses the substitute in a manner not accepted by law

5. the patient sees his/her doctor regularly (usually once a week);

6. they have qualified for addiction treatment according to the guidelines of the relevant state or regional medical boards.

Doctors are obliged to document all relevant patient and treatment data. Upon request, they have to turn their files over to the relevant state authorities (local health authorities, public prosecutors’ offices). Prescriptions must be written on special narcotics prescription pads (Betäubungsmittel-Rezepte), and they must be marked with the letter “S”. When maximum quantities are exceeded, the prescription must also be marked with the letter “A”. The law on narcotics is a criminal law. For violations of the Regulation on the Prescription of Narcotics, a doctor may face a fine of up to 25,000 Euro or a prison sentence of up to five years.

Substitute drugs must not be prescribed for parenteral (intravenous) use. The substitute may be dispensed and/or taken in oral form under supervision in GP’s offices [either by the doctor himself/herself or by medically qualified staffers (nurses)], hospitals, community pharmacies or other facilities approved by the relevant state authorities.

Take-home medication of up to seven daily dosages is allowed when the determination of the appropriate maintenance dose has been resolved and when there is no noxious and/or intravenous concomitant use of other substances. In case of international (overseas) travel, a doctor may prescribe 30 take-home doses per patient per year (not calendar year) in exceptional circumstances, for instance, when continued treatment cannot be arranged in the country of destination.

BÄK guidelines on substitution treatments for opiate addiction

According to the BtMVV (§ 5, sub-section 11)  substitution treatments have to be delivered on the basis of the state of the art of medical science. The relevant authoritative body to define the state of the art is the Federal Medical Board (Bundesärztekammer – BÄK). The BÄK is under obligation to draw up guidelines on substitution treatments for opiate addiction. These guidelines (Richtlinien der Bundesärztekammer zur Durchführung der substitutionsgestützten Behandlung Opiatabhängiger) have been effective since March 2002. They apply to all doctors providing substitution treatments. The guidelines clearly state, that if services are provided within the scope of public health insurance schemes [PHI – Gesetzliche Krankenversicherung (GKV)] also the BUB guidelines (BUB-Richtlinien = Richtlinien über die Bewertung ärztlicher Untersuchungs- und Behandlungsmethoden),  drawn up by the Federal Association of Physicians and Social Health Insurance Organizations (Bundesausschuß der Ärzte und Krankenkassen), have to be met.

The principle regulations of the BÄK guidelines are summarized as follows:

The guidelines define addiction as a chronic disease that needs treatment. The main objective of substitution treatments is abstinence which may be achieved within the scope of a comprehensive treatment plan consisting of four steps:

–         safe–guarding of patients’ lives

–         stabilisation of the patients’ health and social state

–         professional and vocational rehabilitation and social reintegration

–         abstinence from opiates

Substitution treatments are indicated, if

–         there is a manifest state of opiate addiction for a longer period of time (no period limitation given!) and former attempts of cessation from opiate use have been to no avail

–         a drug-free therapy (TC, RRP or outpatient) cannot be carried out at the present time

–         substitution treatments offer the best chance for recovery or improvement compared to other treatment options

As a rule, substitution treatments have to be initiated as transitional treatment steps (in the direction of drug-free treatment) when there is a patient’s documented state of opiate addiction of less than two years. Primary addiction to alcohol, cocaine, benzodiazepines or other psychotropic substances is a contraindication to substitution treatments. Dangerous collateral use of psychotropic substances has to be treated before enrollment into substitution treatment. Providers of substitution treatments have to document, that the indication is justified, that multiple enrollment in treatment has been precluded, and that the patient has been informed on the ban on concomitant use of psychotropic substances.

Substitution treatments will only be authorized, if there is a comprehensive treatment plan including psychiatric and/or psychotherapeutic treatment or psychosocial support services that have been considered necessary for a given individual. Psychosocial care/counseling and medical treatment have to be coordinated. The treatment goals and the comprehensive treatment plan have to be formulated and documented.

The patient has to be informed on the modalities of the treatment planned. These include

–         substitute substance and possible side effects

–         mode of dispensing

–         necessity of abstaining from collateral use of other substances which endanger the purpose of treatment or which are considered dangerous from a medical standpoint

–         urine and alcohol testing

–         information on exclusion criteria

–         psychosocial support considered necessary

–         information on possible insuitability for driving

–         release from medical discretion towards other institutions involved in treatment (e.g. medical board, association of PHI-approved physicians, psychosocial services)

–         information on the duty of central notification in an encoded way to preclude multiple prescription

Doctors have to document the following when initiating substitution treatment (assessment):

–         thorough assessment of the patient’s biographic and drug-related history

–         careful (physical) examination of the patient

–         indication

–         treatment plan

–         drug-screening(s) to determine opiate use and the use of other psychotropic substances

–         preclusion of multiple prescription

–         arrangements for daily dosing, including dosing at weekends

–         having a release of professional confidentiality form undersigned by the patient and support services involved

–         comprehensive information of the patient on the substitute substance and its effect, possible interactions with other substances (alcohol, benzodiazepines, antidepressants, antiepileptics and neuroleptics), and on possible insuitability for driving

Doctors carefully have to examine and document whether a patient is eligible for take-home dosing. Take-home dosing is permitted, if a patient has been participating in substitution treatment for at least six months, if there is no concomitant use of other psychotropic substances, and if the patient is considered stable according to clinical impression. Exceptions to this rule are possible but must be documented. Within the scope of take-home the prescribing doctor is obliged to see his/her patient at least once a week and to take urine samples on a regular basis.

There is no legal claim for patients to be given take-home doses.

The prescribing doctor has to issue a substitution treatment card for the patient which contains the name of the substitute substance prescribed and the current daily dose in mg. The latest entry must not date back a period longer than three months.

Exclusion from substitution treatments is recommended, if

–         there is continued and problematic use of other psychotropic substances that endanger the treatment goals

–         the patient refuses controls (e.g. taking urine samples)

–         there is no sufficient willingness on the side of the patient to cooperate (lack of compliance)

–         the patient passes on or deals with illegal psychotropic substances

The prescribing doctor has to inform his/her patient on the physical, mental and social consequences resulting from exclusion of treatment. The patient must be offered the chance to be detoxified, either by the doctor himself/herself or in an inpatient setting (e.g. detoxification unit at clinic).

In summary, doctors’ obligation to document comprises of the following issues:

–         case/medical history and results of the (physical) examination

–         indication, diagnosis, treatment goals

–         formulating of and working towards necessary accompanying (ancillary) services, such as psychosocial care/counseling

–         encoded and anonymized notification of patients to the central substitution registry

–         frequencies and results of drug screenings and supervision of collateral use of psychotropic substances

–         release of medical confidentiality

–         information on the dangers and side effects of concomitant used psychotropic substances

–         information on possible insuitability for driving vehicles and operating machines

–         substitute substance, form, dose, and dispensing modalities

–         in case of take-home prescribing: justification of take-away doses and current state of treatment (especially in case of “early-bird” take-home prescription)

–         issueing a substitution treatment card

–         justification of exclusion from treatment (if possible in collaboration with the service responsible for psychosocial support and the patient)

–         health status of the patient at termination of treatment and possible further measures (to be) taken

As regards quality assurance, doctors are to conduct quality management regularly, in order to be able to continuously improve the quality of the substitution treatments they provide.

Measures to be taken in respect of quality assurance are

–         assurance of the diagnosis “manifest opiate addiction” and the indication for substitution treatments

–         drawing up individual treatment plans for each patient (commitment to period-limited and qualitative treatment goals, process and outcome controlling as well as psychosocial support)

–         commitment to controlling collateral use of psychotropic substances

–         commitment to determine exclusion criteria (involuntary termination of treatment)

For the purpose of internal quality assurance doctors are advised to use a manual on quality management, the “ASTO-Handbuch”, compiled and published by the Medical Board of Westfalen-Lippe (Ärztekammer Westfalen-Lippe), in which quality objectives, quality indicators and procedures on how to achieve the quality goals are put in concrete terms.

In accordance with the BtMVV (§  5 sub-section 2, clause 1, No. 6) doctors prescribing substitute substances must provide evidence of their being qualified in addiction medicine by having participated in special medical qualification programs (Fachkundenachweis “Suchtmedizinische Grundversorgung”). Training in these 50-hour programs covers topics such as opioid dependence and the role of substitute drugs, pharmacology, understanding and caring for the substitution patient, assessment and management, and clinical practice dosing procedures.

The BUB guidelines

In Germany, treatment and prescription (medication) costs are generally covered by public health insurance schemes [PHI – Gesetzliche Krankenversicherung (GKV)] that are legally mandatory for about 90 percent of the population. The vast majority of substitution treatments are provided within the scope of PHI. In addition to the regulations imposed by the Narcotics Act, the BtMVV and the BÄK special PHI guidelines have to be met by prescribing doctors or services:

In 1991 the German Public Health Insurers (PHI) approved substitution treatments, introducing treatment guidelines called ‘NUB-Richtlinien’ (Richtlinien über neue Untersuchungs- und Behandlungsmethoden). The ‘NUB-Richtlinien’ were drawn up by the Federal Association of Physicians and Public Health Insurance Organizations (Bundesausschuß der Ärzte und Krankenkassen). These guidelines, nowadays called BUB-Richtlinien (Richtlinien über die Bewertung ärztlicher Untersuchungs- und Behandlungsmethoden), focus on the reimbursement of costs for treatment and medication by public health insurers, i.e. they constitute the basis of financing/funding most of the substitution treatments in Germany. It was only with the latest modification of the BUB guidelines in 2002 (effective of January 1^st, 2003) that heroin addiction alone had been approved by the PHI as justification of maintenance treatment with substitute substances. The BUB guidelines may be ignored with a very small number of patients who have no public health insurance and pay for treatment and medication on their own.

The principle regulations of the BUB guidelines are summarized as follows:

The primary objective of treatment is to achieve abstinence with patients addicted to opiates. Doctors who have qualified for addiction treatment and who seek to provide substitution treatments funded by PHI first have to be accredited to do so by their relevant regional Association of PHI-Approved Physicians.

Indications for substitution treatments are:

Substitution treatments must only be provided,

1.  if a manifest opiate addiction has been diagnosed, physician-supervised attempts to become abstinent had failed, a drug-free therapy cannot be carried out at present, and if substitution treatments offer the best chance for recovery or improvement compared to other treatment options

2. if there is a comprehensive treatment plan covering the following issues:

–         a comprehensive medical history of the patient together with an assessment of relevant results of former medical examinations, former participation in drug treatment as well as medical treatments running parallel to substitution

–         a physical examination (inclusive of urinalysis) to assure the diagnosis “manifest opiate addiction”, to detect possible collateral use of other psychotropic substances and to clarify whether there are accompanying diseases related to drug use

–         the doctor must consider carefully, whether the patient is suitable for participating in drug-free or substitution treatments

–         the doctor must determine if and to which extent the patient needs psychosocial care or counseling

–         an individually tailored treatment plan which contains a period-limited and qualitative determination of treatment goals, the substitute substance and dosage, a dosing scheme as well as psychosocial care/counseling and/or psychiatric und psychotherapeutic treatment

–         process and outcome controls, inclusive of unannounced urine tests

–         a doctor-patient contract

With those patients having a documented history of opiate addiction of less than two years and with those patients of under 18 years of age substitution treatments should be initiated as a transitional step to drug-free therapy.

Patients have to be excluded from treatment when there is a primary addiction of psychotropic substances or when a patient uses such substances in a way and quantity that endangers the purpose and the objectives of  the treatment provided.

All patients have to be notified to the central substitution registry to avoid multiple enrollment in treatment. Admission to and termination of treatment also have to be notified to the relevant regional association of PHI-approved physicians and the patient’s health insurance company.

Substitution treatments have to be terminated,

–         if there is multiple enrollment in treatment

–         if the medication selected is not used as directed by the prescribing physician

–         if there is an increase in or consolidation of collateral use of other psychotropic substances

–         if a patient constantly fails to participate in psychosocial care/counseling sessions considered necessary

All regional Associations of PHI-Approved Physicians (KV) have established quality assurance commissions (Qualitätssicherungskommissionen). Such a commission consists of 6 members.  Three members are nominated by the KV (two of which must be experienced in drug addiction treatment), and another three are nominated by public health insurers. The commissions have to check whether indications for substitution treatments are consistent with the BUB guidelines. Also, they have to scrutinize the quality of PHI-approved substitution treatments. Per quarterly period at least two percent of all PHI-reimbursed substitution treatments in a given KV region are checked by random selection. For the purpose of scrutinizing the quality of treatments doctors have to present to a commission all patient-related documentations, respective treatment plans and treatment documentations together with a summary of interim treatment outcomes. Furthermore, doctors have to hand in to the commission the documentations on all patients that have been participating in treatment for over five years. Moreover, a confirmation from a psychosocial care/counseling service, which decides whether such assistance is necessary or not, has to be enclosed in the documentation papers, confirming entry in or continuation of psychosocial care/counseling.

According to the BUB guidelines a doctor must not enroll more than 50 PHI-funded patients in substitution treatment. To assure adequate health care in a given region ( e.g. lack of treatment providers) a local KV is authorized to give a doctor approval of treating more than 50 patients.

Over the past years there has been a dramatic and unreasonable increase in paperwork and regulations (disguised as quality assurance). It is quite evident that, ironically speaking, doctors need not only become experts in addiction medicine but also in legal matters. Treatment criteria are getting more and more rigid, both for the prescribing doctors and their patients. As a consequence, low-threshold treatment is threatened to die out.

Abstinence orientation and definition of success

As documented above, legislation and guidelines on drug substitution treatments remain oriented towards abstinence rather than maintenance, although research findings and experience gathered from medical practice clearly indicate that limiting the duration of participation in treatment does not prove successful for a majority of patients. It has been shown that achieving a status of lifelong abstinence from opiates/opioids, including all substitute substances and drug-free treatment modalities, appears to be an unrealistic goal for any treatment participant. Topics such as the maximum dose or maximum length of treatment should be left to the practioner’s clinical judgement, based on the assessment of the individual patient.

Some experts feel that the orientation towards abstinence is causing misunderstandings since abstinence is still perceived by quite a number of those engaged in drug policy and those involved in the drug treatment and judicial system as a general and inevitable goal to be achieved with all patients – general attorneys, for example, might use the orientation to abstinence to assign patients to treatments they consider more suitable for a given individual (e.g. drug-free oriented therapies). This interferes with the medical and social norms of stabilisation and social integration while in substitution treatment.

It has been suggested to drop abstinence from the hierarchy of treatment goals. A realistic hierarchy with the overall objective of improving the quality of life and coping strategies might include the following steps: survival support and survival assurance, harm reduction, stabilisation of health and living conditions, development and improvement of capabilities (empowerment). Such treatment goals do not necessarily preclude achieving abstinence (abstinence might be/become a positive “side effect”). Success must not be defined as abstinence. Success should be defined by taking into consideration the individual’s values, needs and perception and not by applying across-the-board standards.

Network of treatment providers and settings for prescribing/dispensing services

As of December 2003 only 2,400 of the total number of 8,000 doctors who have qualified in addiction treatment were actually prescribing substitute substances. It is the increase in paperwork mentioned above together with the fear of prosecution and low payments for substitution treatments that contribute to the development that more and more GPs either drop out or will not get engaged in treatment at all.

Still the majority of treatment providers are doctors in general medical practice. Doctors’ offices, however, usually treat a small numbers of patients, because of time-consuming paperwork to be done, low reimbursements, and because they fear that accepting more substitution patients might result in a drift off of “normal” patients to other offices not providing addiction treatment. Therefore, there are many offices with caseloads of 10 or even fewer patients.

On the other hand, there are specialised treatment centers in big cities that deliver treatment to between 100 to 300 patients each.

Lack of doctors’ knowledge

Despite the fact that doctors providing substitution treatments need to be qualified in addiction treatment there is a remarkable lack of knowledge on the effects of methadone. So far two studies on the attitudes and beliefs of doctors prescribing methadone or other substitute substances have been conducted that at the same time aimed at testing the participants’ knowledge. Some of the results on doctors’ knowledge are presented in the following tables:

[correct = questions answered correctly]

Table 2: Methadone maintenance can cause liver damage?
[percent roundings]

Table 3: Methadone maintenance can cause kidney damage?

[percent roundings]

Table 4: Methadone maintenance can cause disturbance of sexual function?

[percent roundings]

Table 5: Methadone maintenance patients’ risk of dying is highest in the first two weeks of treatment? [COBRA-Projekt 2004 (KLOTSCHE/APELT 2004)]

Table 6:  Healthy adults who don’t have a tolerance can die from the cumulative, toxic effects of daily doses of 30 mg to 40 mg of methadone? [COBRA-Projekt 2004  (KLOTSCHE/APELT 2004)]

The results clearly demonstrate that training of doctors providing substitution treatments needs to be intensified. Further improvements of knowledge could perhaps be achieved by initiating train-the trainer workshops.

Provision of medications by pharmacies

Since 1998 substitute substances may be legally dispensed via community pharmacies. The dispensation of these substances in pharmacies is backed by the umbrella organization of the German Associations of Pharmacists [Bundesvereinigung Deutscher Apothekerverbände (ABDA)]. In Hamburg, however, local pharmacies have, from the beginning, been involved in the dispensation of methadone. This treatment was introduced in 1988 in the form of state-specific regulations. According to a study conducted in 1996, 80% of all Hamburg methadone patients received their medication in community pharmacies during that year. Pharmacy dispensing is patient-friendly and saves patients long or time-consuming travels and/or waiting periods in doctors’ offices. So far, the Hamburg investigation into the dispensation of methadone in pharmacies is the only such study that has been conducted in Germany.

The change of law brought about a nationwide increase in community pharmacies dispensing methadone and other substitute substances. Meanwhile several pharmacies have even specialised in addiction counseling (Schwerpunktapotheken “Suchtberatung”) and pharmacists have been encouraged to qualify for addiction pharmaceutics by participating in workshops or training sessions (Fachkunde “Suchtpharmazie”) organised by the regional Boards of Pharmacists.

Substitution treatment and international travels

Information on import regulations and possible continuation of treatment can be obtained from the Coordinating and Information Resource Center for International Travel by Patients Receiving Methadone and other Substitution Treatments for Opiate Addiction (“The Travel Resource Center” – TRC), located at INDRO in Muenster, Germany.  This is the only agency providing such assistance worldwide (travel information is available on the internet via www.indro-online.de/travel.htm).

The TRC strongly criticizes that in case of national travel take-home medication of only up to seven daily dosages is permitted whereas in case of international/overseas travel, a doctor may prescribe 30 take-home doses per patient per year (not calendar year). For example, it is hard to understand why patients going on a biking tour through Ireland may carry 30 take-aways while patients being away on a construction job to an out-of-the-way (rural) area where neither substitution treatment is available nor a dispensing pharmacy may carry with them seven doses only. Take home dosing should be made more flexible according to the individual needs of patients.

Psychosocial care/counseling

Most professionals involved in substitution treatment have taken the view that the BtMVV, the BÄK guidelines as well as the BUB guidelines demand mandatory participation of patients in psychosocial care/counseling.  Moreover, there is an overwhelming majority of politicians, experts in addiction research and treatment, therapists and drug workers that generally consider added psychosocial care/counseling as being a necessary part of treatment to support the medical part of substitution treatments (medication). However, according to the BtMVV and the BÄK guidelines patients must only participate in psychosocial care/counseling, if the prescribing doctor considers such support necessary. The prescribing doctor alone is responsible for all measures to be taken and s/he alone (not a provider of psychosocial services!) bears all legal and existential risks surrounding substitution treatments. The nexus “Opiate addicts must only be treated with substitute substances, if the patients participate in psychosocial service provisions” can neither be found in the BtMVV, the BÄK or the BUB guidelines. However, in contrast to the BtMVV regulations and the BÄK guidelines the BUB guidelines lay down that it is a psychosocial service provider that decides on the necessity of psychosocial care/counseling. The relevant psychosocial care/counseling service hands over to the prescribing doctor a note confirming whether they consider psychosocial assistance necessary or not. The BUB guidelines do not demand that any information on the frequency, mode or scope of care/counseling has to be included in such confirming notes.

Usually psychosocial care/counseling is provided by drug advisory services. Some specialised doctors’ offices and treatment centers with caseloads of over 50 patients have hired social (drug) workers or psychologists themselves so that medical treatment and psychosocial care/counseling can be delivered under the same roof (multi-disciplinary teams).

All studies and practical experiences so far have shown that psychosocial support can have a positive effect on the course of substitution treatments and the developmental process of patients.  However, there is no empirical evidence of a general necessity for psychosocial assistance to all patients. Also, the taboo question has been raised whether psychosocial support might not also exert negative effects on patients, because there is a risk of overprotection involved possibly blocking lines of empowerment.

To date, there are no nationwide standards of how to organize and structure these supportive services. Problems arise because the medical part of substitution treatments is coupled with an additional service which is not clearly defined (psycho-social care, psychosocial counseling). Furthermore, no special qualification is required and psychosocial care/counseling is done by different  professions (e.g social workers, psychologists). Psychosocial care/counseling is a collective term that encompasses a number of different activities. These may include, for example, legal advice, managing financial problems (e.g. debts, rents), recreational activities, crisis intervention, (psychotherapeutic) group sessions, assistance with finding living accommodations and jobs, qualifying for school and vocational training, and case management (referring patients to specialised services according to their needs). There are great variations  in psychosocial provision between different states and communities, as well as differences in quality and funding. Psychosocial care/counseling is not funded by the PHI, i.e. it is financed separately from the medical component of substitution treatments. It is up to the states and/or local communities to provide funding to psychosocial care/counseling providers, which inevitably brings about a heterogeneous practice of this kind of support. Most states and local communities are hit by budget deficits resulting in budget cuts in the social and health sectors. Therefore, these services can no longer be financed in an adequate way. While there has always been a lack of sufficient capacities of psychosocial care/counseling services in rural areas, more and more larger cities are getting affected by reductions in funding (e.g. Hamburg and Bremen). In case psycho-social care/counseling cannot be provided, no confirming notes can be issued, and doctors and patients have no referral points and, according to the BUB guidelines, health insurers need not cover costs for treatment and medication.

Employment

Usually psychosocial supports are delivered by staffers of drug advisory services (social workers). Some specialised doctors’ offices and outpatient (ambulatory) services have hired social (drug) workers or psychologists themselves so that psychosocial care/counseling (including case management) and medical treatments can be provided under the same roof.

With regard to employment, the labour market is not easy to access for patients participating in substitution treatments, due to a high general unemployment rate (10.5% in August 2004) and negative attitudes and beliefs towards the patients on the part of employees. Also, the socio-demographic and biographical characteristics of patients participating in substitution treatments (e.g. minor school and vocational qualifications, criminal records) reduce their chances of employment. Though there are educational and vocational projects in several major cities, accompanying support regarding education and employment is still not generally available.

Substances prescribed

All substances approved for substitution treatment must only be prescribed for oral use.

Methadone

In contrast to other countries, there are two forms of methadone available in Germany, the racemic mixture (d,l-methadone) (this has only been available since February 1, 1994) and levomethadone (l-methadone, L-Polamidon Lösung zur Substitution®). In addition to the use in maintenance treatment, methadone is also used during detoxification in qualified units where doses are gradually reduced over a period of one to three weeks.

Buprenorphine (Subutex®)

Buprenorphine [BUP (Subutex®)] was approved for substitution treatment by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) in early 2000. As is the case with methadone, BUP is used both in maintenance and in detoxification treatments.

Codeine and Dihydrocodeine (DHC)

Since February 1998 codeine or DHC can only be used in specific medical cases, such as those in which patients show a non-tolerance of methadone (e.g. allergic reactions).

LAAM (Orlaam®)

LAAM [levacetylmethadol (Orlaam®)] had first been used within the setting of a controlled, randomized multi-center study in 1998 and was approved for opiate substitution treatment in 1999. On 19^th April 2001 the European Agency for the Evaluation of Medicinal Products (EMEA) recommended the suspension of  marketing authorization for Orlaam® because of dangerous side effects (life-threatening cardiac disorders, e.g. torsade de pointes). For this reason LAAM must no longer be used.

Slow-release Morphine

The use of slow-release morphine has not been approved in Germany.

Diamorphine (Heroin)

Diamorphine must only be prescribed by the seven specialized treatment centers participating in the heroin pilot study.

4. Treatment accessibility and coverage

Until 2002 there was no reliable documentation system in Germany, and the number of patients participating in substitution treatments had to be estimated. Since July 1^st, 2002 all patients have to be registered with the National Narcotics Control Board (Bundesopiumstelle) and reliable statistical data are available now.

Till the end of 2003 a total of some 113,000 substitution treatments had been registered, some 56,000 of which were current treatments, i.e. 57,000 treatments were already terminated within the first one and a half years after the obligation to notify patients to the substitution registry had come into effect. Often the same patients were repeatedly registered within a few months by the same doctor or by different doctors. This reflects a great fluctuation of patients. Some 260 multiple treatments could be detected in 2003.

As of December 1, 2003 there was a total of 56,000 patients participating in drug substitution treatments in Germany. Methadone was the substance most frequently prescribed, followed by buprenorphine. Due to a change of law (in 1998) the number of codeine/dihydrocodeine patients decreased markedly from 25,000 to 30,000 patients in early 1998 to less than 1,000 in December 2003.

Table 7: Substitution treatment patient numbers in relation to used substances (2003)

Substitution treatments in rural areas

In rural areas there are only very few doctors prescribing substitute substances. As a consequence, the offices of these doctors are being inundated with drug addicts. Real movements to the very few prescribing doctors can be observed. On the other hand, drug addicts intentionally leave big cities and move to rural areas to find a better setting in which to recover from addiction, and/or return to their families. Although the Association of PHI Approved Physicians (“Kassenärztliche Vereinigung” – KV) is under obligation to supply sufficient health care facilities, including GPs’ offices or specialised ambulatory services providing substitution treatment, there is still a shortage of supply in rural areas regarding substitution treatment.  Due to a poor infrastructure of public transport in the countryside drug users spend a lot of time travelling to their doctor to take their daily dose of methadone. As mentioned above (see BtMVV) drug addicts are not eligible for take home dosing until they have undergone a certain period of stabilization.

Not only are there too few doctors providing substitution treatment but there are also too few drug counseling services accompanying treatment, which often means a lack of psycho-social care and psychiatric treatment facilities. Since the BUB guidelines demand patients’ participation in psycho-social care/counseling as a prerequisite for doctors to be paid for medical treatment doctors practising in rural areas often prescribe substitute substances on private prescription pads only, and their patients have to pay for treatment and medication on their own. Jobless patients dependent on social welfare schemes cannot afford non-funded treatment. They are at risk of getting involved in criminality to get money in order to be able to pay for doctors’ fees or of switching back to illegalised opiate use. The situation in rural areas calls for specific strategies in order to overcome the many barriers that drug addicts have to face accessing substitution treatment.

Many office-based doctors working in rural areas are at risk of prosecution because of the difficulties they face in order to meet the requirements of juridical regulations (e.g. daily dispensing of methadone). Since they often have to work in grey areas of legality they have developed strategies for dodging the strict regulations (not to be described here).

Another problem for prescribing doctors in rural areas is to find stand-in colleagues when they go on vacation or get ill. The cooperation with other doctors or services is very poor, particularly in such cases. Even hospitals are often resistant to dispense substitute substances at week-ends.

5. Main sources and mechanisms of financing substitution treatments

In Germany, treatment and prescription (medication) costs are generally covered by public health insurance schemes (PHI) that are legally mandatory for about 90 percent of the population. Patients also have the freedom to choose their own general practitioner (GP) or hospital. Those patients without a health insurance have to pay all doctors’ fees and prescribed medications out of their own pockets. As already mentioned above the regional and local associations of PHI-approved physicians are responsible for paying the doctors, while psychosocial care/counseling providers are dependent on state or community funding.

The German system of funding addiction treatment services is very complex. A simplistic description is presented in the following table:

Table 8: funding of drug addiction treatment services in Germany

As can be seen funding of drug-free treatment (assigned to rehabilitation) and substitution treatments (assigned to medical treatment) lies in the hands of two different institutions. Public health insurance companies (PHI) had been opposing the introduction of methadone and other opiate replacement treatments for over two decades. The reason for not approving opiate substitution treatments as medical treatment was a very simple one: saving money. As mentioned above it was only in 1991 that the PHIs finally accepted reimbursement for MMT because of political pressure.

References: available on request

Contact details

Ralf Gerlach

Deputy Director

INDRO e.V.

Bremer Platz 18-20

D-48155 Münster

Germany

Phone: ++49 (0)251-60123 or ++49 2571-582765

Fax: ++49 (0)251-666580

Email: INDROeV@t-online.de

©Ralf Gerlach 2004