POLICY POSITION
Pharmacotherapies
June 2003
Discussion The availability of effective pharmacotherapy based drug treatment is a central element of 1 Australia’s National Drug Strategic Framework 1998-99 to 2002-03. The framework acknowledges: • • • •
It is important to provide treatment services for people who are drug dependant to reduce drug use and prevent drug related harm; That drug treatment is effective in reducing harmful drug use, hospital costs, drug-related crime, violence and welfare costs; Pharmacotherapies (substitution therapies) as one of the options used for managing opioid dependence and that within Australia methadone- maintenance treatment is most widely used in Australia; That research is being conducted into a range of new substitution therapies both for opioids dependence and for psychostimulant dependence.
The National Drug Strategic Framework 1998-99 to 2002-03, was authored in November 1998. AIVL notes that since this time little has changed in reality for people that are drug dependent seeking pharmacotherapy based drug treatment. While there has in most recent times been the introduction of Subutex, (high dose buprenorphine) for the treatment of opioid dependence which has had mixed successes, no other pharmacotherapies have been introduced into Australia to benefit people who are dependent on drugs. Unlike certain countries overseas, Australia is remaining conservative in its hesitation and in certain cases blatant refusal to introduce clinically proven pharmacotherapies to assist people who are dependent on drugs to improve and control their health and realise their potential within the community. It also remains the case that in Australia there are still no formal pharmacotherapy based treatment programs for individuals dependent on Amphetamine Type Substances (ATS). The pharmacotherapies that have been introduced to date are: • •
not the options that are preferred or which have shown significant success in attracting people into drug treatment; and are being dosed in such a way as to make participation in the programs unattractive or impractical for consumers.
In addition to the lack of choice when entering treatment it is also important to acknowledge the way in which the current pharmacotherapies are prescribed. Many aspects of drug treatment counter act the rationale as to why they exist:
1
National Drug Strategic Framework 1998-99 to 2002-03. ‘Building Partnerships’, A strategy to reduce the harm caused by drugs in our community. Commonwealth of Australia 1998.
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Position While there are a variety of pharmacotherapies prescribed and dispensed in a number of different ways across the country, there are a number of fundamental issues that apply in most situations. •
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The cost of pharmacotherapies is a serious impediment to the uptake of treatment however this is particularly the case for those whose sole source of income is welfare benefits. Costs can be the equivalent to 25% of a persons weekly income and this significantly contributes to an individual being unable to pay for their treatment. The stress resulting from actions taken to deal with late payment - including having take-away privileges withdrawn, and even the denial of being dosed – often leads to individuals leaving their program, rather than managing the day to day confrontation and public humiliation that can occur. Given that pharmacotherapies are a significant cost-saving measure for public health further investment to ensure free or affordable access for welfare beneficiaries is a justified and important step. Individuals should be free to set their own goals – abstinence from illicit drugs is not the only appropriate outcome of pharmacotherapy based drug treatment. Urine screening should not be used as justification for punitive measures such as the denial of take-away doses. Users should be kept informed of their dose, and alterations should only be made with informed consent or when requested. Violations of confidentiality can result in loss of employment, relationship stress and social discrimination. Phone communications where a program representative contacts a consumer should only take place under exceptional and urgent circumstances, and all care should be taken to ensure the number they are calling from is blocked and that the call can therefore not be returned by an employer, workmate, or parent, nor the source of the call identified. Chemists should ensure dosing is done in a discreet but relaxed manner. Participants in pharmacotherapy should be treated with respect. Dosing should take place in a timely fashion; those on methadone or Subutex programs at chemists should be served as if they were any other customer and not made to wait until everyone else is out of the shop. Subutex High dose Buprenorphine is marketed as a pharmacotherapy in Australia under the brand-name Subutex. Of the drugs trialled around the country in the late 1990s, Subutex is the only one to have been made more widely available and has gained this popularity with health departments for several reasons. Firstly, it has a fairly unique agonist/antagonist action, meaning that while it works effectively to maintain an opiate dependency (after a brief period of discomfort), it also blocks the effects of any other opiates consumed while it is active. Secondly, it also differs from most other opiates in that it has virtually no respiratory suppressant effects (it does not slow breathing), making overdose less likely. Subutex has proven popular with some users seeking particular outcomes from their involvement in a maintenance program. A proportion of consumers are able to stabilise on one dose every two days, potentially halving the amount of contact that they would need to have with the pharmacy when compared with a methadone program, and resulting in less expense. The side-effects associated with Subutex are considered to be far less intense than those experienced from methadone. The process of withdrawal can also be easier. The major impediment to Subutex not being taken up by more opiate-dependent users is the absence of take-away doses. Heroin Trials When a program of trialling pharmacotherapies for opiate dependent people was envisaged in the early 1990s, a diacetylmorphine (heroin) trial was considered a cornerstone of the plan. The heroin trial was first to take place within the ACT, with the plan of expanding the trial to take in Sydney & Melbourne.
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After several years of planning, report-writing and lobbying, it seemed that, having secured the support of state and federal health ministers, a heroin trial was almost certain. The Prime Minister, Mr John Howard, intervened directly in the process in order to scuttle the trial. Further developments have been almost impossible given the Prime Minister’s vow that “there will never be a heroin trial while I am Prime Minister.” Diacetylmorphine has shown itself in overseas trials of being able to deliver equal or better performance indicators tan other pharmacotherpies. Heroin maintenance programs generally require a registered user to attend the clinic 2 or 3 times a day, and a daily dose of up to 500mg (1/2 gram) of injectable heroin is split across these visits. In both Switzerland and The Netherlands heroin maintenance programs have resulted in significantly improved physical health for the individual, incidence of mental illness dropping from well above national averages to being on par with or below these averages, a significant decrease in the frequency with which crimes were committed, and other increases in ‘social indicators’ such as the presence of stable housing in a user’s life and whether they are in employment. The Swiss authorities noted no instances of heroin being diverted away from the program and onto black market. At the time of the debate in Australia, the United Nations anti-drugs agencies suggested that provision of heroin would place Australia outside the boundaries proscribed by the 1961 Single Convention on Narcotic Drugs, the 1971 Convention on Psychotropic Substances and the 1988 United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. Legal advice provided to the Swiss government and to Australian reform campaigners, however, suggests that the treaties have the scope to allow governments to introduce internal policies designed to increase the health and well-being of their population and to decrease drug-related harms. Heroin maintenance has shown itself capable of meeting this stipulation. •
While trials and maintenance programs of other opiates may provide a range of choices for a dependent user, only heroin maintenance is likely to generate significant enough results and be taken up by enough users to be able to bring about major changes in the day-to-day existence of opiate-dependent drug users.
Dilaudid Trials Out of all the opiates which can be legally prescribed within Australia, Dilaudid (hydromorphone) is considered to be the one which can create an effect closest to that of heroin. A number of doctors in Sydney have already flagged their intentions to run ad-hoc hydromorphone maintenance programs in the near future, while attempting to create a trial which is properly funded and scientifically valid. It appears that the first formal study of the use of Dilaudid will take place in the ACT during 2004. Some campaigners and supporters of a heroin trial are of the belief that the word ‘heroin’ is capable of stirring a range of emotions amongst politicians and the public that are not attached to other opiates; indeed the fact that hundreds of opiate forms are used in medical treatment every day in this country suggests this is the case. They argue that in order to progress the debate around heroin maintenance programs, a trial which delivered a very similar drug, in an identical fashion would deliver the types of results that are needed to convince those members of the government and the public who have not considered the outcomes of the Swiss trials to be evidence sufficient enough to warrant a heroin trial in Australia. An opposing viewpoint contends that a Dilaudid trial will relieve the pressure which remains on the government to introduce heroin trials. Further, they are concerned that if hydromorphone maintenance did not deliver very positive outcomes, this evidence would be used to set back the chances of a heroin trial even further.
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It is AIVL’s contention that, while the focus of campaign efforts should remain focused on a heroin trial, hydromorphone maintenance offers a choice which is likely to have a significant positive impact on the day-to-day lives of people who are dependent on opiates, and is therefore worthy of support. Substitution therapy for amphetamine-type substances As previously mentioned, while people dependent on opiates do have some, albeit limited, options for pharmacotherapy treatment, users of amphetamine-type substances and/or cocaine have no such options, officially. The health bureaucracy contends that the absence of a painful withdrawal process (which is itself a partial misunderstanding) makes providing a maintenance program of substitution therapy unnecessary. Unofficially, some doctors do provide substitution therapy – replacing methamphetamine with prescribed dexamphetamine - on a needs basis. Most amphetamine users are, however, unaware of this possibility, or do not know where to access it. To date, their have been very few scientific trials examining the efficacy of dexamphetamine substitution. The following is taken from Department of Psychiatry and Behavioural Sciences, University College Medical School, Whittington Hospital, London, UK: “The standardized records of 220 users receiving dexamphetamine prescriptions were examined retrospectively: Settings: The amphetamine users had all attended and received treatment by Cornwall Community Drug Team, in the far South-West of England, during the period 1992-96. Findings: Oral and intravenous users had remarkably similar outcomes, with intravenous users making more overall gains in treatment. Over half the injectors stopped injecting and more than a third within 2 months of coming into treatment. Variables predicting a good outcome differed between oral and intravenous users; although for both groups being female was associated with a slower change in drug-use behaviours, but a longer period in treatment. Conclusion: Dexamphetamine prescribing appears to be reasonably safe, and is associated with improvements in drug-use. Randomised trials are warranted to determine the specific efficacy of the treatment.” With the popularity of methamphetamine use on the rise, more and more consumers will seek assistance in controlling their use. Despite the absence of significant research into amphetamine substitution therapy, what is clear is that the treatment methods promoted as being successful for amphetamine users – counselling and behaviour modification aimed at achieving abstinence – will not meet the needs of many users.
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Recommendations •
A review of the programmatic requirements for individuals engaging in treatment programs and the negative social and economic impacts that the programs have on individual lives.
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That the private sector for example pharmaceutical companies work in partnership with drug user organisations in the development and delivery of pharmacotherapy based drug treatments.
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The immediate implementation of the heroin trial program previously planned and outlined for the ACT, NSW and Victoria.
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The implementation of controlled randomised trials to determine the effectiveness of pharmacotherapy based drug treatment for the users of Amphetamine Type Substances (ATS).
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That relevant jurisdictions ensure that dependent drug users regardless of the substance that they use are able to easily and affordably access pharmacotherapy based drug treatment and that the fullest range of pharmacotherapies are made available.
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That the Commonwealth Government in consultation with all stakeholders including consumers develops quality assurance standards for drug treatment providers and includes the implementation of complaints procedures.
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That the rights of consumers in drug treatment are considered and addressed for example the unethical of withholding medication, limited access to pharmacotherapies, supervised dosing and the difficulty for individuals engaged in drug treatment to travel.
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AIVL Member Organisations ACT: Canberra Alliance for Harm Minimisation (CAHAMA) - 02 6262 5299 NSW: New South Wales Users AIDS Association (NUAA) - 02 8354 7300 NT: Network Against Prohibition (NAP) – 08 8942 0570 Territory Users Forum (TUF) – 08 8941 2308 QLD: Drug Users Network and Support (DUNES) – 07 5520 7900 SA: SA Voice of IV Educaiton (SAVIVE) – 08 8362 9299 USERS Association of South Australia - 0423653896 VIC: Victorian Drug Users Group (VIVAIDS) – 03 9419 3633 WA: WA Substance Users Association (WASUA) 08 9227 7866
AIVL Contact Details
Postal Address: GPO Box 1552 Canberra City 2600 ACT Telephone: 02 6279 1600 Fax: 02 6279 1610 Email: info@aivl.org.au Website: www.aivl.org.au
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