12 April 2006

Take-aways in opioid replacement treatment - guidelines, safety and ethical issues

Tuesday March 28, 2006




Presenters:
Professor James Bell, Director, The Langton Centre, Surry Hills.

Professor Bob Batey, Hunter New England Area Health Service.



Chaired by Dr Richard Hallinan, Redfern Dependency Practice.


Professor Bell started with an overview of some issues and principles relating to opioid maintenance therapy. Over the last twenty years in Australia there has been an increase in the number of people on opiate treatment programs ('OTP'), but this rate of growth is slowing. Up to 2001 there was a rising availability of heroin and the increase in numbers of people on OTP reflect this. Following the "heroin drought" some heroin users changed their illicit drug use to other drugs, which may be related to a slow-down in the expansion of OTPs.
We were told that there are three measures useful in assessing the effectiveness of OTPs. They are:
1) stabilisation (ie decreased drug use and what he termed 'distress')
2) retention rates
3) minimisation of diversion
In terms of stabilisation of people on OTP in NSW, it is known that greater than 90% of people decrease their heroin use whilst on methadone maintenance treatment. Ongoing drug use is common, and persisting distress and health care seeking behaviour is three times the state average in this group of patients. Patients on MMT see a lot of doctors other than their prescriber and two factors are predictive of this. The first is the level of benzodiazepine use and the other factor is the level of psychological distress. As prescribers we have an important role in helping to contain the degree of distress by being empathic and genuine listeners and ensuring we allow enough time to review our patients.
James Bell showed us results of a study looking at retention rates of people on MMT over the period 1990 to 2006. He found that people on MMT in 1990 cycled in and out of treatment an average of four times up to the current year. He also found that retention rates of people on MMT diminished as the program expanded, so that people who entered MMT in 1990 stayed on the treatment longer than those who began MMT 10 years later in 2000. With increased numbers of places available on NSW programs in later years, this may have reflected an "easy-come-easy-go" attitude to treatment, from both patients and prescribers. His results also showed that longer episodes of treatment on MM were predictive of a decreased likelihood of return to MMT at a later date and that this perhaps suggests a "cure" among those people who no longer seek treatment programs.
A study by Lintzeris from Melbourne in 1999 showed that diversion and injecting among those on MMT was common. Another (NSW) study showed that 88% of black market methadone comes from take-aways that have been diverted. It is pertinent to note that two-thirds of the deaths associated with MMT are the result of diversion (ie fully one third come from other sources such as analgesic tablet prescription). Within the group studied, there was poor compliance of take-away guidelines.
Results from a Western Australian survey were presented, firstly to illustrate why people buy take-away methadone. The four reasons given by people were:
1) reluctance to get registered on a formal MMT programme so that privacy was protected
2) to detox for a short period of time (usually days)
3) because it was too hard to access a clinic due to working away eg on boats and in mines
4) to "get wasted."
The same survey asked people why they sold take-aways and three reasons were cited:
1) because they are asked.
2) to subsidise the cost of treatment.
3) to supply their partner.
The success of OTP in Australia is seen to be partly due to the distinctive model of care under which these programmes operate. OTPs are funded through our national health system of Medicare and this has allowed an expansion of access to occur. The treatment is seen as part of mainstream healthcare, and is office-based with the doctor being the primary care-giver and the doctor and pharmacist acting as a "team." It was emphasised that continued improvements to this model rely on an awareness that issues of opioid prescribing are relevant to all doctors who see patients, and not just the authorised prescribers.
A Melbourne study by Martyres in 2004 looked at the circumstances surrounding the cases of 203 fatal overdoses in young people. It was found that among this group there were high levels of doctor shopping (6 times the state average) and multiple prescriptions for opioids (eg. Panadeine forte, oxycodone, long-acting morphine) and benzodiazepines. In fact prescribed drugs were present at autopsy in greater than 90% of these people. Only a small percentage of people in this study died as a result of heroin overdose with no other drug present.
The presenters then went on to discuss the principles of opioid prescribing (and in fact this is relevant to any psychotropic drug). This revolves around:
1) information,
2) structure,
3) the therapeutic relationship
4) symptom relief.
Information involves assessment and formulation of a diagnosis, an exploration of expectations and goals of treatment, a treatment plan and ongoing monitoring and feedback. Assets, strengths and liabilities should be discussed between prescriber and patient, and it is important to ask the patient what their expectations of treatment are. It is very useful to give a full and honest explanation first-off of dosing arrangements and take-away rules to avoid subsequent haggling and negotiations in later consultations. Monitoring includes taking a drug use history, looking for track marks, and performing urinary drug screens. The analogy of not taking a blood pressure but assuring the patient that the medication is working well was given to emphasise the importance of careful follow-up.
Imposing some external structure on a patient's MMT regime may be therapeutically useful which of course includes being very thoughtful about how the dispensing should be done. In situations where people have lost a lot of control from their lives, take-away methadone can be very problematic, and lead to further destabilisation within the patient's life. Structure involves ensuring adequate frequency of patient review, understanding the physical and mental health symptoms of the patient, and monitoring the patient for any signs of continuing drug use. It was pointed out that if a prescriber regularly checks for signs like track marks and regularly performs urinary drug screens, the patient will not regard such monitoring as strange and will come to expect it as part and parcel of the routine MMT review. Dispensing arrangements should be reviewed as well, including setting up good communication between the prescriber and pharmacist, eg making sure the pharmacy is clear about what days the patient must attend for dosing and asking the pharmacy to let the prescriber know if the patient is missing doses.
Many opioid users have interpersonal difficulties and the "secondary gain" of acting out conflict with authority figures ("pushing the limits") is common. Managing this requires forethought and skill. Professor Bell outlined his philosophy that the doctor-patient relationship in this instance be based on skepticism, clarification and professionalism and that clear guidelines be set up from the beginning. The rules for take-aways should be absolutely transparent. Hasty decisions about take-aways should never be made; if more information is needed then more information should be sought and this should be made clear to the patient. This may be particularly important with regards to combination buprenorphine, where increased numbers of take-aways will be legally available to patients.
Professor Bell outlined guidelines for take-away prescription for those on MMT. People who are regularly injecting drugs, or are dependent on alcohol, BZD or stimulants are not suitable for take-away doses. Again he suggested this be assessed by clinical presentation, presence of track marks and results of urinary drug screens. Results of a risk assessment should also be considered when deciding whether a patient is suitable for take-away methadone or not. If someone is homeless it is a bad time to prescribe take-aways, similarly if a patient is psychotic or "at risk". Take-away opioids are contra-indicated in people with unstable psychosocial or mental health status, and we should all be aware of the dangers of take-away opioids to children who are inadvertently exposed.
We were informed that the new NSW Dept Health take-away guidelines will be available soon. The recent (as of April 1st 2006) availability of combination buprenorphine has triggered a review of all take-away processes attached not only to combination buprenorphine but also to methadone and buprenorphine. There is a lack of good literature on what take-away doses achieve, but there is a lot said about them.
Professor Batey presented us with the spectrum of views of which we would all be familiar. These include seeing take-aways as a privilege, as dangerous, as inevitably being diverted by some patients, as over-utilised, as necessary to gain freedom from daily clinic visits, and as a process that should be more strongly regulated. It is generally accepted that most patients want more take-aways, that take-away guidelines are not always followed, and that no particular policy guarantees a particular outcome for a particular patient or community. Professor Batey teased out the "facts" from this list to tell us that with or without take-aways, opioid replacement therapies will be diverted. He also emphasised that untimely provision of take-away doses can destabilise a patient, as can an overly strict adherence to take-away policies. Patients are ultimately human beings and unpredictable.
Prof Batey also told us that the more liberal a take-away policy, the more likely a drug is to be diverted. He reminded us that patients divert all sorts of medication (eg proton pump inhibitors, Ventolin etc) and that we ultimately cannot prevent diversion. We should perhaps be aiming for a process that seriously addresses the patient's need to grow whilst also aiming for a practice that is able to be adhered to and sets limits on both the patient and on ourselves as prescribers. There was some debate as to whether take-aways should be regarded as a right or a privilege. The characteristics of a good doctor-patient relationship in the context of methadone prescribing received some attention and the importance of an explicit contract was emphasised, as well as the need for transparency of all criteria for take-aways clarified right from the outset. This can prevent a lot of subsequent "argy-bargy" around the issue of take-away increases, and allows more empathy and connection to develop within the professional relationship when this "argy-bargy" is out of the way.
The issue of take-aways in combination buprenorphine prescribing were touched on near the end of the presentation. It is hoped that this drug combination will be diverted less, and that clinically stable patients may be able to have many more take-away doses in the future. The two contradictions to combination buprenorphine remain being pregnant or being allergic to naloxone.
The evening ended with presentations of five case studies sent in from the seminar participants. They illustrated many of the dilemmas faced by prescribers in deciding what appropriate and safe prescribing actually is. Dr Hallinan will summarise these and Dr Byrne will give a brief overview on clinical practicalities on another posting shortly.

Dr Jenny James. Daruk (NSW) Aboriginal Medical Service.