Review of methadone treatment in Australia

7 Evaluation of clinical outcomes in different clinical settings

Page last updated: October 1995

There is little detailed documentation available which compares the nature of treatment delivered and the outcomes achieved in methadone programs in Australia in the public and private sectors. During the course of this study, consultations were held with providers in both sectors throughout Australia. While these consultations provided considerable anecdotal information about the different ways in which methadone treatment is provided between the two sectors, there was no evidence provided to demonstrate any systematic differences in outcomes achieved. However, a study has been recently been conducted by the National Drug and Alcohol Research Centre (NDARC) into services provided in large private and public clinics in New South Wales.

The key results of this study are provided in this section as the basis for a discussion of clinical outcomes achieved in different practice settings. The comments made in regard to the nature of the services provided in each setting are consistent with the anecdotal evidence provided through consultations during the course of this study.

It should be noted that the study was restricted to larger specialist methadone clinics, and did not include methadone treatment delivered in primary care settings and dispensed through retail pharmacies. This is particularly important, considering that, apart from NSW, the primary care setting represents the main form of private sector involvement in methadone maintenance treatment. In this regard, there is a need to undertake an independent evaluation of the outcomes achieved in primary care settings, including the role of the community pharmacist in the dispensing of methadone. Such a study should seek to identify factors influencing these types of services, with a view to maximising their effectiveness.

7.1 Nature of the study
7.2 Clients in private clinics
7.3 Treatment delivered
7.4 Urine tests
7.5 Takeaways
7.6 Methadone dose
7.7 Monitoring of treatment
7.8 Outcomes of treatment
7.9 Conclusions
7.10 Policy implications
7.11 Accreditation of clinics
7.12 Recommendations
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7.1 Nature of the study

The study comprised two parallel arms. In the private sector, three clinics were studied, with a total of 304 clients recruited and interviewed three times over 12 months. In the public sector, 349 clients were studied using the same core data collection instruments. The psychiatric status of clients was investigated using a structured interview, the Composite International Diagnostic Interview.

7.2 Clients in private clinics

About half the clients in private clinics were employed, and unemployed clients were 6 times more likely than employed subjects to leave the private clinics. This presumably reflects the economic difficulty of those without jobs paying dispensing fees, and is consistent with recent American research which demonstrated that dispensing fees increase attrition from treatment. In those areas where only private treatment is available, there is a problem of access to treatment for people in financial hardship.

Based on the last six months' symptoms, 21% of private clinic clients met the criteria for major depression, 26% social phobia, 8% panic disorder, and 36% antisocial personality disorder.

These figures indicate a high prevalence of significant psychiatric disability.

Despite reporting high levels of satisfaction with medical treatment received in the private clinics, over 60% of clients had seen a doctor outside the methadone clinic in the previous month, with more distressed clients likely to visit general practitioners.

7.3 Treatment delivered

There are important differences between treatment delivered in the public and private sectors. It appears that in NSW methadone treatment has been delivered in a two-tier system, each with their own characteristics. Key differences between the public and private clinics are that private clinics charge dispensing fees (usually free in public clinics), have more regular and frequent medical consultations, have no other form of formal counselling, have lower staff to client ratios, and provide more takeaway doses of methadone. The differences in some of these factors are summarised in Table 13 below.

In the private clinics, all clients see their prescriber weekly or fortnightly. Such consultations are funded through Medicare, and provide the doctors' remuneration. In the public clinics, only a little over half of the clients had seen their prescriber in the month prior to interview, and the mean number of consultations was less than 1 per month. In the private clinic, almost all the formal interaction (other than dispensing) is with the prescriber. The public clinics had more emphasis on counselling, with about 1 client in 3 having attended a counselling session in the month prior to interview.

In the private clinics which were studied, long term stable clients who seem to be doing well continue to receive weekly appointments with their prescribers. This seems to be an unnecessarily intensive approach, and may in part be attributed to the fee-for-service funding of methadone prescribers in these clinics. An alternative basis for funding methadone programs may reduce the necessity for frequent medical consultations, and reflect the fact that the core of treatment is regular attendance for dispensing.

Table 13: Characteristics of pubic and private methadone clinics in NSW

Public Clinics Private Clinics
Dispensing fees No fees $40-$50 per week
Counselling30% had seen a counsellor No formal counselling
Medical consultations per client in previous month 57% saw prescriber, Mean 0.8 consultations 100% saw prescriber, Mean 3.2 consultations
Take-aways per client Average <3 take-aways per monthAverage of 16 take-aways per month
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7.4 Urine tests

In the 6 clinics sampled, there was poor agreement between self-reported drug use and drug use as detected by urine tests, with urine tests invariably detecting less drug use than was reported by clients. In some clinics, the agreement was negligible, and it was observed that urine testing was carried out selectively. Several prescribers stated that if a client reports having used heroin, there was no need to do a urine test. While this may seem reasonable, it means that the record of urine test results gives a distorted record of the extent of drug use. Two of the private prescribers reported that they used the results of urine testing to determine whether clients needed higher doses. This is considered inappropriate, as urine testing should not be a substitute for talking to clients and determining what they feel they need. Secondly, since testing performed in this way is misleading, reliance on urine test results to determine whether clients need dose increases contributes to systematic suboptimal dosing, as infrequent heroin use is not detected.

Nursing staff in both private and public clinics were generally of the view that there was little value in urine testing, although prescribers tended to see it as being valuable. Several prescribers interviewed in the course of this study indicated that urine testing had most value as a means of positive reinforcement to clients of non-drug use, and was best used on a voluntary basis rather than on a compulsory basis.

There are a number of sound theoretical reasons for performing urine drug testing in methadone clinics, but in practice the rationale for testing as performed in many clinics is not clear - urine testing simply becomes part of the ritual of methadone maintenance. In order to justify the use of urine tests, a clinic should have a clear, consistently applied policy and rationale for such testing, and this - along with the results of testing - should be regularly reviewed within the treatment team.

7.5 Takeaways

Despite the higher cost to clients in purchasing their methadone doses in private clinics, the compensating factor for many clients was the ready availability of takeaway doses. Although there were stated policies in some private clinics regarding the use of takeaways, all clients who had been in treatment for 3 months routinely received regular takeaways. Factors such as employment status, self-reported dug use, urine test results and social functioning had virtually no bearing on the availability of takeaway doses. In contrast, takeaway doses of methadone were the exception in public clinics, with most clients being required to attend daily for treatment.

However, the clinic with the least heroin use gave most takeaways, while the least effective clinic gave the least takeaways. By contrast, the limited number of takeaways in public clinics did not result in better clinical outcomes. In combination, these observations suggest that the ready availability of takeaways has no adverse effects on treatment outcomes.

It is difficult to discern the clinical rationale for takeaway policies in either the public or private sector. The median duration of treatment of clients in public clinics is greater than 4 years, and it seems unduly restrictive that long term stable clients should be required to attend daily. Although liberal access to takeaway doses does not seem to be associated with worse outcomes, the routine availability of takeaway doses in the private clinics is problematic, in view of the widespread injecting of methadone (as evidenced by the large demand for 20 ml syringes from needle and syringe exchange units), and the ready availability of street methadone. While it might seem rational that decisions about take-aways should be based on individual consideration, the stark differences in policy between the public and private clinics suggest that staff find it simpler to have a blanket policy - either very restricted, or almost unrestricted takeaways - in order to avoid haggling and conflict over their availability.

7.6 Methadone dose

In most clinics, an adequate dose of methadone was prescribed. However, in two of the private clinics there was suboptimal dosing, with 52 and 54 mg/day of methadone being the stable maintenance doses. In both of these clinics, more than 50% of subjects reported having used heroin in the month prior to interview, consistent with the observation that they were being inadequately dosed. In contrast, the clinic with the lowest rate of heroin use maintained almost all clients on a stable maintenance dose of 80mg/day. Such an approach is recommended.
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7.7 Monitoring of treatment

Most clinicians reported that they used urine tests to monitor the extent to which the goals of treatment were being achieved. However, as noted above, in both the public and private clinics, urine testing was not a reliable indicator of heroin use, and is not very useful as a way of monitoring the effectiveness of the clinic.

Analysis of clinical record keeping in the 6 clinics revealed very uneven standards of documentation of treatment. Even minimal documentation of progress was absent from many files. There was no systematic review of treatment in any of the clinics studied.

There is thus no currently available monitoring of outcomes on which to base a quality assurance program aimed at ensuring optimal treatment of individuals and optimal outcomes from the clinic.

7.8 Outcomes of treatment

On entry to all clinics, there was a prompt and substantial reduction in heroin use, associated with a parallel reduction in social dysfunction, crime and HIV risk-taking.

About half of the clients continued to use heroin for a period of time, usually using infrequently. There were large differences in the level of continuing heroin use in both the public and private clinics. Clients in the least effective clinic were much more likely to use heroin than those in the most effective clinic (Odds Ratio 2.4, 95% confidence intervals [1.2, 4.8]).

Higher methadone doses were associated with less heroin use and lower dependence on heroin. In two private clinics, there was also a progressive reduction in the number of clients using heroin with increasing duration of treatment. In the third private clinic, no such association was found.

In all the private clinics, approximately 10% of clients continue to use heroin frequently, compared to 4% in public clinics. On entering treatment, non-opioid drug use (cannabis, amphetamines, alcohol and benzodiazepines) was found to continue at the same patterns of pre-treatment use. With increasing duration of treatment, amphetamine use declined, but there was little change in alcohol or benzodiazepine use.

There was a marked reduction in involvement in crime among clients during treatment, attributable to reduced heroin usage. Cannabis use was found to be a major predictor of continued involvement in crime during methadone treatment.

Clients with the least psychological dysfunction were most likely to benefit from the treatment delivered in the private methadone clinics.

Apart from methadone dose, the most important aspect distinguishing more from less effective clinics appeared to be the overall clinic "ethos", represented by how the clinic functioned and in particular how staff related to clients. The least effective private clinic was characterised by poor management, the lowest staff to client ratio, poor communication among staff and between staff and clients and poor clinical records. This clinic had the lowest client rating, the highest rate of heroin use, and the lowest retention rate in treatment.

7.9 Conclusions

Despite systematic differences between the sectors in the treatment delivered, the range of outcomes achieved in the public and private clinics were very similar. Importantly, within both the public and private sectors, there were large differences in the quality and effectiveness of treatment delivered in different clinics.

Although clients in public clinics reported greater satisfaction with counselling services, there was no evidence that the greater emphasis on formal counselling contributed to less heroin use or greater psychological stability among clients of public clinics. Similarly, the considerable difference in takeaway availability did not seem to affect clinical outcomes, although there are clearly other disadvantages associated with their more ready availability in private clinics.

Adequate doses of methadone were associated with the lowest rate of heroin use. By comparison, low levels of non-opioid use, good levels of social functioning and high client rating of services were associated with clinics which had a more clinical and therapeutic approach to treatment and client relationships.
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7.10 Policy implications

The study has highlighted a number of issues relating to standards of care provided, and the need for consideration to be given to changes in policies in three main areas. These issues have also been raised through the consultations held with service providers and clients in all States, and are consistent with the majority of views held.

7.10.1 Takeaways

The significant differences that exist between the public and private clinics in regard to the availability of takeaways have not been demonstrated to be associated with differences in clinical outcomes among clients undergoing methadone maintenance. However, the greater availability of takeaways is clearly associated with an increase in diversion of methadone, and greater injection of methadone. It has been suggested that one of the contributing factors to methadone selling is the high cost of attending private methadone clinics. On the other hand, the limited availability of takeaways to clients of public clinics who have been in treatment for prolonged periods and appear to be stable and functional appears to be unnecessarily restrictive.

While the deregulation of takeaway approvals in NSW in 1991 was based on the premise that the approval of takeaways should be a clinical decision based on the needs of individual clients, it is clear that this policy has not been effective. While guidelines exist in this area, these are obviously not being followed by private prescribers in large clinics. There is a need to ensure that prescribing patterns are subjected to some form of peer review or clinical audit.

7.10.2 Urine testing

Urine testing in public and private clinics is problematic, and does not provide an accurate picture of drug use by those in treatment. It is seen as being used in some instances as an (inappropriate) alternative to talking to clients, and as the basis for setting dose. Urine tests are also disliked by staff and clients, are expensive, and are often conducted in manner leading to unreliable result. If they are to be conducted, it is probably best done on a random, occasional basis, or as a diagnostic tool when clients appear intoxicated and deny drug use. Either of these uses appears preferable to the current approach, in which urine testing has become part of the ritual of methadone maintenance and detracts from the effectiveness of treatment.

7.10.3 Frequency of consultations

Regular contact with clients in the early stages of treatment is an important aspect of methadone maintenance treatment. However, the value of weekly, very brief consultations for clients who have been in treatment for prolonged periods, and who are stable, is questionable.

Clearly the fee-for-service method of funding is major determinant of this behaviour, and encourages the potential for over-servicing. Alternative methods of funding methadone maintenance are discussed later in this report. An alternative, or perhaps complementary approach, is to subject frequency of consultations to a structured peer review process.

7.11 Accreditation of clinics

The uneven outcomes of treatment in both the public and private clinics mean that to maintain clinical standards within both private and public sectors, there should be quality assurance (QA) programs. Such programs may be evaluated by a formal accreditation process by an independent assessor such as the Australian Council on Healthcare Standards (ACHS) or the Community Health Accreditation and Standards Program (CHASP). CHASP in particular is in the process of finalising a set of standards specific to drug and alcohol services which include methadone services. To give weight to the process, accreditation could be a requirement for a clinic to continue as an approved provider of methadone treatment.

The following approach to the development of an accreditation program has been suggested as the basis for further discussion of this concept. Importantly, the program provides an indication of the types of performance indicators which may be used to monitor and evaluate effectiveness of services provided in both public and private clinics.
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7.11.1 General approach to QA programs

Along with an adequate dose of methadone, the attitudes, skills, policies, and team cohesion of the clinic constitute the treatment factors which influence outcomes. The approach to QA outlined here assumes that staff in methadone clinics function as a team, sharing responsibility for the quality of treatment delivered. To review and maintain the quality of treatment, staff need to meet regularly. Such team meetings, to discuss clinical and administrative issues, are not a routine part of the operation of some private methadone clinics, and having such regular meetings is in itself an important quality assurance activity. Superimposed on this, it is suggested that one meeting every 1-2 months should be devoted to formal QA review.

The following Quality Assurance activities are based on monitoring of key outcomes, and review within the treatment team. Such documentation of the outcomes can also be used as a form of external accountability.

7.11.2 Key outcomes

  • Retention in treatment is an index of program effectiveness, particularly retention in the first 12 months of treatment. Retention in treatment should be quantified as the proportion of all new entrants to treatment during the preceding 12 months who are still in treatment at 3, 6, 9 and 12 months.

    All Australian jurisdictions require that clients receiving methadone maintenance be centrally registered, and the starting date and exit date from treatment, (and in some jurisdictions, the reason for leaving treatment) are documented for all clients. It should be possible for state authorities to supply each clinic with their retention data on a regular basis, along with a comparison with state averages. Such a policy would provide clinics with feedback on their performance.

  • Continuing heroin use is a critical measure of treatment efficacy. Self-reported heroin use is likely to underestimate heroin use if availability of takeaway doses is contingent on clients not using heroin. Therefore heroin use is best monitored by a combination of well-conducted urine tests and self-reporting. It is suggested that each client has a formal six-monthly review of treatment, at which the drug use scale of the Opiate Treatment Index (or similar instrument) is administered. Results for the clinic as a whole should be reviewed regularly, and reported as (1) the proportion of clients who either by urine test or self-reporting had used heroin in the month prior to their most recent treatment review, and (2) the proportion whose average daily heroin use is 0, 0-0.2, 0.2-0.9, >0.9. Such data provide a basis for identifying clients who are not doing well, as well as providing a measure of clinic performance.

    Collating the results would not be a time-consuming task if the data is systematically recorded.

  • Use of non-opioid drugs - particularly, cannabis, benzodiazepines, and stimulants (usually amphetamines, increasingly cocaine), can be carried out in the same way as that outlined above for heroin use.

  • Psychological well-being. While there are many valid goals of treatment, most are directly attributable to reduction in use of heroin. However, evidence from the recent evaluation study of private clinics indicates that there is a high prevalence of psychiatric problems which are potentially treatable and which do not automatically improve with reduction in heroin use. Administering the GHQ (or SF36) at 6 monthly treatment reviews is a way to identify individuals expressing high levels of symptomatology, and a way of monitoring whether overall psychological symptoms are improving over time in treatment.
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7.11.3 Other components of quality assurance

In addition to monitoring outcomes, it is important that treatment process is monitored. There are a number of simple ways to systematically carry out such quality assurance activities.
  • Client feedback into ways of improving clinic functioning should be sought. The simplest way to do this is by having a suggestion box, whereby anonymous comments can be made to staff about problems with the program, and ways in which it could be improved. Each clinic should also have a mechanism in place whereby individual client grievances, including appeals against decisions about treatment, can be heard and discussed.

  • Case review should be regularly conducted. All critical incidents - such as episodes involving threats of, or actual violence, dosing errors - should be discussed by the treatment team. Any death of a client should be discussed. Review of randomly selected records, focussing not only on management but on the quality of record keeping - should also be part of case review sessions.

  • Clinical supervision. Methadone maintenance has always generated controversy, as the approach of providing support and care to heroin users is at odds with prevailing community attitudes towards deviant behaviour. This conflict influences all staff working in methadone clinics, and staff need the opportunity to reflect on their interaction with clients. As a minimal requirement, team meetings at which the goals of treatment and the basis of clinical decisions can be discussed, provide a form of peer supervision.

  • Participation in continuing education. Involvement in continuing education is not only a way of maintaining staff knowledge, but also their sense of professionalism.

7.12 Recommendations

  1. That a study be undertaken to evaluate methadone maintenance treatment in smaller primary care settings compared to treatment provided in larger public and private specialist clinics with a view to identifying factors which will maximise the effectiveness of services across practice settings.

  2. That a study be undertaken to examine the outcomes achieved through the use of community pharmacies compared to clinic-based pharmacies and the factors influencing outcomes.

  3. That a formal quality assurance (QA) process be designed which provides a basis for monitoring and evaluating the processes of methadone service delivery and the outcomes achieved in both public and private methadone clinics.

  4. That a formal accreditation process be established for methadone clinics, based on the QA protocols, with ongoing accreditation to be a requirement for approval of a clinic as a provider of methadone treatment.
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