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Harm Reduction and Injection Drug Use: an international comparative study of contextual factors influencing the development and implementation of relevant policies and programs

Harm reduction in the Federal Republic of Germany

Overview

Over the past decade Germany has moved toward harm reduction in its policies and practices regarding illicit drug use and related problems. This has been in response to rising rates of HIV/AIDS, drug-related crime and mortality.

Germany approved the prescription of methadone and legalized needle/syringe exchanges in the early 1990s. More recently the federal government legalized supervised injection sites and approved heroin trials. Some large German cities, such as Frankfurt and Hamburg have developed comprehensive and successful approaches to illicit drug use problems.

The current policy context for harm reduction

Germany, with a population of 82.7 million, is a federal republic with 16 states (Laender). Up to the mid-to late-1980s, Germany's response to illicit drug use empathized law enforcement and drug-free treatment. Professionals such as social workers, doctors, researchers and drug counsellors, were generally reluctant to work with active drug users (Vogt and Schmid, 1998). Key informants noted that the federal government under Chancellor Kohl resisted many attempts to bring federal laws and policies in line with harm reduction policies and practices, and that resistance to changing drug policies was found among all federal parties and their supporters.

Germany's drug free service did not, however, attracted many clients and they had high dropout rates. This, and increasing rates of overdose deaths, drug-related crime and the emergence of open drug scenes in many large German cities contributed to a shift toward harm reduction. However, this has not been uniform across the country. In general, harm reduction services are more limited in the south than in the north and central regions. Harm reduction policies and programs are also less developed in the former East Germany where illicit drug use was traditionally less prevalent.

The current Social Democrat/Green Party coalition government of Chancellor Schroeder, which came to power in 1998, established new national priorities and shifted responsibility for demand and harm reduction from the Home Office to the Ministry of Health. The government also appointed a drug commissioner and established a multi-disciplinary advisory body made up of experts from the field.

Reports from Germany's Drug Commissioners (Nickels, 2000; Caspers-Merk, 2001) reflect a public health perspective on addiction and identify two major goals for drug policy: (1) prevention and (2) treatment.

The 1999 Drug Commissioner's report (Nickels, 2000) addressed issues concerning both legal and illegal drugs and proposed a greater focus on the social and health consequences of tobacco and alcohol use. The report also emphasized that a variety of measures are needed to address legal and illegal drug problems, including increased public awareness, pilot projects, research, co-ordination with the Laender and international cooperation.

One key informant noted that in addition to the national drug strategy, there are drug strategies at the state (Laender) and city levels. However, these are not always in complete harmony and not all city-level initiatives have state-level support.

Funding for harm reduction

In 1999, the federal Ministry of Health provided DM23.8 million for various measures to prevent and treat substance abuse. This included DM12.9 million for education and prevention, DM 6.9 million for new pilot studies, and DM2.3 million for research and monitoring. The remainder (DM1.7) was for various other initiatives such coordination, support for professional associations and international collaboration. The Laender, and some towns and cities also provide funds for primary, secondary and tertiary prevention and these makes up the bulk of the money that goes into the drug field. Money for law enforcement comes from the federal Home Office and as from equivalent offices at the state level.

The current status of specific harm reduction initiatives

Needle and syringe distribution and exchange

In the mid-1980s, concerns about the spread of HIV/AIDS among injection drug users convinced many front-line workers in the drug field of the need to provide injection drug users with clean needles/syringes. At that time, the sale and possession of syringes and needles was legal but many pharmacists would not sell syringes to drug users. Also the police often confiscated drug-injecting equipment from those suspected of using drugs illegally. This contributed to a shortage of clean needles and to needle sharing (Weber and Schneider, 1998).

Needle exchange programs were first established in the larger cities such as Frankfurt, Hamburg and Berlin and were made legal under federal law 1992. Needles are distributed through pharmacies, shelters, crisis centres, drug counselling offices, user groups and outreach workers (Weber and Schmidt, 1998). Needles are also provided by centres that offer a range of other health and social services. Fischer (1995) reports that 80% of all needles in Frankfurt are provided through mobile outreach services. In smaller cities and rural areas, particularly in the more conservative southern states, pharmacies provide the only legal source of clean needles and syringes. Weber and Schmidt (1998) reported that between 1995 and 1997, 6,000-7,000 syringes were exchanged daily.

Drug substitution treatment

The main drugs prescribed as substitutes for illegal narcotics are codeine and methadone. In accordance with the Narcotics Act these can only be prescribed in the context of comprehensive programs that include medical and therapy and psychosocial services (Nickels, 2000).

Codeine

German physicians were not able to prescribe methadone to narcotic addicts until the early 1990s. However, they used a loophole in the Narcotics Law to prescribe codeine. Though codeine is a controlled substance, regulations allowed it to be prescribed as an anti-tussive agent with no special restrictions if prescribed at concentrations of no greater than 2.5% in liquid preparations or no more than 100 milligrams in pills or capsules (Weber, 1997). The use of codeine is currently more common in southern Germany where access to methadone is more restricted (Krausz et. al., 1998).

However, codeine is generally regarded as inappropriate for maintenance purposes and is only prescribed now for patients who cannot physically tolerate methadone (Gerlach (2000).

Weber (1997) reports that codeine as a maintenance drug has been the subject of considerable debate in Germany and in 1994, the Federal Ministry of Health recommended that it should be illegal. However, the 1999 report from the Federal Drug Commissioner indicted support for both methadone and codeine as substitutes for illegal narcotics (Nickels, 2000, p.29).

Krausz et. al. (1998) studied patients on codeine over a three-year period. They found results similar to those with methadone with respect to improved physical and mental health, stability in living and working conditions and drug use. Krausz et al recommended that codeine maintenance treatment be further examined through controlled trials.

Methadone

The use of methadone as a substitution drug was only approved in 1991 in response to increases in drug-related crime and mortality, and evidence for the lack of effective alternatives. After successful pilot studies the statutory health insurance system approved methadone treatment and introduced treatment guidelines.

The current federal government has stated its commitment to improving the prescription of substitution drugs through the development of a central registry, special qualifications for physicians prescribing substitution drugs, and the development of guidelines. Nickels (2000) notes that methadone (and other substitution drugs) are successful therapeutic options, which, when compared with drug-free therapies, result in comparable rates of abstinence. The federal government has also lifted budget capping for prescribing substitution drugs and the drug commissioner has stated that drug substitution treatment should be part of the mandatory package of benefits covered under the statutory health insurance.

Methadone is regulated under Schedule 3 of the German Narcotics Act that allows its prescription for:

• treatment of opiate addiction with the goal of step-by-step recovery to abstinence, inclusive of improvement and stabilization of general health;
• treatment of patients addicted to opiates who have to undergo medical treatment for serious medical illness;
• to reduce the risks of opiate addiction during pregnancy and after delivery.

Only oral forms of methadone can be prescribed and doctors must use special prescription pads. The guidelines for treatment covered under statutory health services (AUB guidelines) also require evidence that methadone is being prescribed to treat comorbidity and severe illness, AIDS, during pregnancy, severe withdrawal symptoms, for severe pain or other severe illness such as hepatitis (Gerlach, 2000a &b). These guidelines do not permit the prescription of methadone for addiction per se.

Two other aspects of the German system of methadone treatment are of note: (1) the use of other drugs while on methadone is not officially permitted and can result in the termination of treatment (2) regulations under the Narcotics Law and the AUB guidelines require mandatory participation in psychosocial care and counselling. However, the extent to which prescribing doctors tolerate the use of other drugs and the provision of funding for psychosocial care vary widely across the country (Schmid et al., 1999, 2000; Gerlach, 2000).

The number of addicts prescribed methadone increased by from about 1,000 to about 40,000 over the past decade. Gerlach estimated that in 1998 about 30-50% of heroin users were receiving some kind of substitution treatment (including methadone and codeine). Fischer et al., (2000) estimated that the coverage was 35-55%.

Most of those receiving methadone do so from general practitioners with small caseloads. However, some major cities have specialized outpatient centres for substitution treatment. Gerlach (2000a) quotes high retention rates ranging from 66-84% after three years to 48-77% after seven years. Thus, although the ultimate goal of substitution treatment may be abstinence, it is clear that many patients are being maintained on methadone for considerable periods of time.

One key informant made the following comments about methadone treatment in Germany:

• methadone treatment in Germany has been positively associated with improved health and life expectancy among addicts and with decreased in involvement with the legal system
• it is debatable whether more spaces in methadone treatment are required since in cities with open drug scenes such as Hamburg and Frankfurt appear to have sufficient spaces to meet demand;
• most injection drug users living in large cities receive their methadone from clinics staffed by doctors, social workers and nurses who also provide medical care, including treatment for HIV infections. Doctors in such clinics do not discharge clients who use other drugs, but rather refer them for detoxification from these other drugs. In these settings, methadone is seen as a basis for treating severely ill addicts with the goal of stabilization rather than abstinence;

Prescribed heroin

A study involving the prescription of heroin is scheduled to start in fall, 2001.The commissioner's report (Nichols, 2000) describes this as a "multi-centre clinical study for non-residential heroin-based treatment for opioid addicts with a long-term addiction who have undertaken several unsuccessful attempts with abstinence-oriented therapy and cannot become stabilized in substitution". The study will examine the safety of heroin-based treatment, and will consider whether the prescription of heroin results in the stabilization or improvements in health, social functioning and motivation for further treatment.

The study will involve 1,100 patients recruited from seven cities (Hamburg, Hanover, Cologne, Bonn, Frankfurt, Karlsruhe and Munich) in five Laender. An experimental group will receive injectable heroin and a control group will receive methadone maintenance. Two psychosocial interventions will also be evaluated: case management in combination with motivational interviewing or psycho-education in combination with traditional psychosocial counselling. The Laender and the city councils will meet the costs of the heroin trial in the first place, and the federal government will be responsible for all research costs.

Other substitute drugs

LAAM was approved in 1999 and buprenorphine in 2000 (EMCDDA, 2000) and trials are being undertaken with these drugs. A pilot study of rapid detoxification under anaesthesia has also been undertaken (Nickels, 2000).

Supervised injection sites

The first supervised injection room was opened in Frankfurt in 1994 as part of a comprehensive approach to the open drug scene and related problems in that city. As of January 2000, there were 15 supervised injection sites in Germany. These have a total of 154 injecting spaces and, on average, admit 2,600 clients a day.

The Frankfort plan involved city staff, health and social service officials, the justice department, the police, housing officials and high-ranking members of the business community, especially from the banking sector. Representatives from these different departments and interest groups met (and continue to meet) to discuss ongoing problems of the open drug scene, drug politics and policies.

The first phase of the plan was the introduction of low-threshold methadone treatment. The second phase involved a comprehensive package of measures including shelter beds, multi-service crisis centres, expanded needle exchange and education programs, outreach workers and methadone dispensaries. These coincided with the police closure of the open drug scene near the city centre - and to a lesser extent the main train station. The third phase involved the establishment of five injection sites.

The comprehensive harm reduction approach in Frankfurt has coincided with a dramatic drop in overdose deaths (MacPherson, 1999; Nickels, 2000). Drug-related deaths have also declined in other cities with supervised injection sites. As well the drug scene has become less open and public security has improved. Other important outcomes include increased contacts between drug users and counsellors and increased rates of and referral to other service.

The role of injection sites in reducing drug-related deaths has been acknowledged by the federal government (Nickels, 2000) and appears to have been a significant factor in the decision to legalize them. The German federal government's approval of injection sites (drug consumption rooms) provided legal clarity to the services that had existed in large German cities for some time. A key informant provided the following information about the requirement for the establishment of supervised injection rooms:

• the community must already have a wide range of programs available for drug addicts, and the supervised injection room must be linked with these programs (counselling, medical outpatient care, therapy, etc.). In particular they should be linked to emergency services, syringe exchanges and overnight shelters.
• the target group should be intravenous drug users who are at least 18 years and not receiving methadone;
• first aid and medical care by a doctor must be guaranteed;
• addicts have to be "purposefully influenced" to make use of the following types of assistance to encourage them toward the goal of abstinence: counselling and care, detoxification/withdrawal management, placement and/or drug substitution treatment, medical care;
• measures must be taken to prevent drug trafficking within and in the vicinity of the supervised injection room;
• drug users are allowed to bring in only one dose of a drug per admission;
• injection should only be with equipment supplied by the staff;
• all critical activities must be documented
• the rooms must be managed and staffed by a multi-professional team of social workers, nursing staff and trained auxiliaries.
• users should be issued identification cards
• there should be clear house regulations regarding opening hours, banning users who infringe regulations, police reporting requirements regarding drug dealers, number of injecting spaces (max .12), provision of injecting paraphernalia, physical layout and the separation of the injecting room from other program areas.

The development and regulation of supervised injection rooms that conform with the basic criteria established by the federal government is left to the Laender. One key informant said that this allows some Laender the choice of not developing regulations or issuing regulations that are so stringent that they make the operation of injection rooms very difficult. Political differences between state and city governments may also impede the development and operation of injection rooms.

While further development of injection rooms may be slowed in Laender that do not support their establishment, the German Constitution does not allow the federal parliament to bypass the Laender in terms of the organization and financing of health care at the local level. Cities normally operate in accordance with the Laender government, and this holds for injection rooms, as well. However, some cities that are under severe pressure from open drug scenes may develop harm reduction services without approval of the Laender government. This seems likely in Karlsruhe, which is to participate in the national heroin trials without the approval of the state government of Baden-Wuerttemberg..

In 1999, under the auspices of the federal drug commissioner, Germany has hosted an international conference to develop guidelines for the operation and use of drug consumption rooms.. This was attended by representatives from the Netherlands, Switzerland, Austria, France and Australia. The conference working groups developed guidelines on planning, operation, documentation and data collection and the political acceptability of these services. A Web site (www.uni-oldenburg.de/) has also been established to share scientific knowledge and practical experience (Schneider and Stoever, 1999).

Drug user education and outreach

Germany is unique among European countries in having nationally defined standards for outreach work and for teaching outreach work skills in professional training settings (Korf et al., 1999). The nationally defined aims include identifying and contacting hard-to-reach populations, improving service access and uptake, promoting adequate services, and promoting safe drug use and safe sexual behaviour ( Korf et. al.,1999). Since 1995, the federal government has also been co-operating with the Laender in a pilot study of outreach and case management services to hard-to-reach addicts

In Hamburg it has been estimated that 80% of drug users are in contact with the treatment system, including its outreach component (Fischer,1995; Schmid et al., 1999, 2000). In Berlin, an outreach agency called Fixpunkt reaches a large proportion of the city's 8,000 injection drug users, especially those not in contact with other drug or health services agencies including drug users from the Russian migrant community.

Harm reduction in the justice system

Germany has about 60,000 people in prison and estimates indicate that 20-30% of males in prison these have a history of illegal drug use often involving injection drug use. Similar estimates for women run as high as 50-80% (Jacob and Stoever, undated). Stark and colleagues found that syringe sharing in prison is an important risk factor for HBV, HCV and HIV infection (Stark et al., 1995; Stark et al., 1997).

Methadone is available to addicts in some cases. However, decisions about the actual use of methadone are made by individual prison doctors. Although the use of methadone in prisons has increased along with the general increase in methadone prescribing, its use in prisons is mainly for detoxification or as a maintenance drug for those incarcerated for short time periods. The most recent EMCDDA Scientific Report (EMCDDA, 2000) indicates that there are about 800 methadone patients in penal institutions in Germany. However, only six of the 16 Laender provide methadone treatment to addicts in prison.

Germany has several pilot projects for the provision of clean injecting equipment in prisons. In Lower Saxony, there has been one such project in a prison for women and one in a prison for men. (Jacob and Stoever, 2000). In the women's prison, machines dispensing sterile equipment were set up for those who were drug-dependent, but not on methadone maintenance treatment. In the men's prison, clean needles were handed out by staff of the drug counselling services. As in the women's prison, the program is not available to those receiving methadone treatment. However, a prison in Hamburg has installed a machine for dispensing sterile needles and this can be used by prisoners on methadone.

An evaluation of the projects in Lower Saxony focused on the feasibility of the two needle exchanges, their acceptance by prison staff and inmates, changes in inmates drug-use patterns; and in knowledge and attitudes regarding health and health behaviour. Jacob and Stoever (2000) drew the following conclusions from this evaluation:

• needle exchange projects are feasible in that they can be incorporated into the everyday routines of the prison without causing major disruption;
• needle exchange projects highlight discrepancies in the way drug use is dealt with in prisons(control versus health maintenance and harm reduction);
• the level of acceptance among prisoners depends on the level of anonymity that is possible;
• needle-sharing is not ritualized, but rather a response to the lack of sterile injecting equipment;
• prevention measures and educational programs for prison staff and inmates are very important to help achieve the overall goal of preventing blood-borne infections;
• there was no evidence of threats of harm with dirty needles;
• health was improved with no evidence of abscesses caused by injecting, or new HIV or hepatitis infections;
• health-related knowledge about hepatitis was limited among both staff and inmates, but knowledge of HIV/AIDS was adequate.

The two prisons in Lower Saxony have also had peer support pilot projects. These involve peer leaders, staff and external agencies in the provision of education about safer drug use and safer sex (Stoever and Trautmann, 1998).

Factors influencing policies and practice

Published reports and key informant interviews indicate that the political parties in power at the federal, Laender and municipal levels have influenced and continue to influence the interpretation and implementation of national laws, and the availability of harm reduction programs. At the level of the Laender, there has been a north/south split, with the more conservative southern Laender being less supportive of harm reduction approaches. However, cities may deviate from the drug policies of their Laender (for example, Frankfurt in Hesse), and create their own drug policy. Thus, drug policies are created from the bottom up, as well as from the top down.

Trends in injection drug use

Like many countries, Germany experienced an explosion in use of illicit drugs in the late 1960s and early 1970s, beginning with cannabis and hallucinogenic drugs such as LSD and moving to heroin and other opioids (Vogt and Schmid, 1998). Between 1984 and 1994, the number of drug offences doubled and many people with drug problems spent time in prison (Vogt and Schmid, 1998).

Current estimates of the number of people addicted to heroin range from 100,000 to 200,000 or 1.2 - 2.5 per 1,000 (Gerlach, 2000a & b; Fischer, 2000). Fischer (2000) estimates that 75,000 to 120,000 people inject drugs. The GRN database indicates 80,000 to 165,424 "problem users" including as non-intravenous regular consumption of opiates, cocaine or amphetamines. The 2000 Annual Report from the European Monitoring Centre on Drugs and Drug Abuse (EMCDDA, 2000) quotes a problem drug use rate of 2-3 per 1,000. This rate is comparable to that of the Netherlands

An increasing number of drug-related deaths, particularly in big cities such as Frankfurt and Hamburg, played a significant role in shifting the agenda from law enforcement to a health approach. Gerlach (2000 a & b) reports that drug-related deaths in Germany increased from 0 in 1969 to 623 in 1979. Although these rates fell during the early 1980s, there were again substantial increases in the following years, peaking at 2,125 in 1991. Vogt and Schmid (1998) state that there is no simple explanation for this pattern, although by the end of the 1980s many of those with chronic drug problems had forsaken traditional abstinence-based treatment agencies. Although drug-related deaths have declined in some of the large German cities that have put in place comprehensive harm reduction programming such as Frankfurt and Hamburg, the drug commissioner's report (Nickels, 2000) indicates that drug-related mortality increased 8.2% in 1999. In many cases, deaths are attributable to use of several drugs at one time such as heroin, cocaine and alcohol. However, some deaths have also been attributed to the use of methadone with other drugs such as cocaine, crack, alcohol and benzodiazepines.

Trends in the rates of HIV and other infections among injection drug users

Estimates of the prevalence of HIV among injection drug users varies considerably, ranging from 0.6 to 3.8% (GRN database). The 2000 EMCDDA report reports rates of less than 5% for Germany (EMCDDA, 2000). However, this rate is for opiate users in treatment and thus may underestimate the overall rate among injection drug users. Gerlach, (2000a &b) estimates 20% of all injection drug users are HIV-positive with injection drug users making up 12% of all diagnosed AIDS cases in 1997 (Robert Koch Institute 1998 in Gerlach, 2000a & b). He also reports that the annual number of AIDS cases has decreased from 228 in 1989 to 125 in 1997 (Gerlach, 2000 a&b).

Gerlach (2000a & b) also reports on rates of HCV infection ranging from 70-90% among injection drug users. Similar rates (63%-95%) are reported in the GRN indicators database.

Attitudes of service providers

Until the mid 1980's most German doctors favoured abstinence-based treatment although a few used a loophole in the Narcotics law to prescribe codeine. Other powerful groups, such as the association of social workers and the DHS (German Council on Addiction Problems) also opposed substitution treatment at that time (Vogt and Schmid, 1998). However, with increasing evidence that traditional approaches was not working, physicians, social workers and others working in the field moved to support the new, harm reduction approaches. The medical profession is now clearly in favour of heroin prescription.trials.

Attitudes of police

The German Police Presidents came out in support of heroin trials in 1995/96. In large cities such as Hamburg and Frankfurt, the police have actively participated in the development of harm reduction policies and programs. In these cities, the police have also developed an approach somewhat similar to the Netherlands in that they do not arrest those found in possession of small quantities of drugs for personal use. However the police sometime put drug users from out of town on buses or trains bound for their hometowns. Of course, the police do arrest those suspected of trafficking in drugs.

Weber and Schmidt (1998) state that weekly meetings and good information exchange among all municipal policy-makers, including police, state attorneys, health department, drug policy division, drug user groups, drug user help providers, the business community, and political bodies, contributed to the success of the Frankfurt approach.

Europe

In the face of rising drug-related crime, overdose deaths and very visible open drug scenes, a number of large German cities, particularly Frankfurt, Hamburg and Berlin, pioneered harm reduction approaches to address their drug problems in concert with other European cities. The Frankfurt Resolution of 1990 initiated the European Cities on Drug Policy that recognized that attempts to eliminate the supply and consumption of drugs had been a failure and that a shift in drug policy was essential. It was agreed that this must involve not just a greater emphasis on prevention and education, but also treatment and harm reduction initiatives such as needle distribution and exchange, methadone maintenance, supervised injection sites, and the prescribing of other substitute drugs (ECDP, 1990).

Germany is also involved in various policy-making initiatives of the EU, including the European Union Drug Strategy (2000-04) that was approved in 1999. As well, it is working collaboratively with a number of other EU projects including the development of guidelines for drug services in prisons and peer education in prisons.

Research and evaluation

Compared with other countries Germany has been slow to evaluate its harm reduction policies and programs. However, the drug commissioner's reports recognizes the importance of research as a basis for drug policy and indicates that the federal government is supporting a variety of projects in the areas of epidemiology and monitoring, aetiology, clinical treatment research, social research and evaluation research. The government is, of course, financially supporting heroin trials. The 1999 drug commissioner's report indicates that the federal government has invested DM 2.3 million in research (Nickels, 2000).

Public opinion and the media

In the 1970s and '80s, changes to the Narcotics Law following the widespread increase in illicit drug use in the 1960s and '70s, led the public to see drug addiction as a serious social problem or "scourge" (to quote Vogt and Schmid, 1998). One key informant noted that the drug problem was, at one time, seen as one of the top 10 problems of German society. However, more recent surveys show that this is no longer the cases.

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