EXECUTIVE SUMMARY
The review of the evidence on opioid medications in Tasmania, and also nationally and internationally, has brought up a number of important observations on the changing landscape in Schedule 8 (S8) opioid medication availability, prescribing, and the changes in the regulation of these potent medications that have occurred in Australian jurisdictions and internationally.
In Section One, the review of the international and national literature identifies consistent and substantial increases in opioid analgesic prescribing across a range of developed nations since the early 1990s. These changes have occurred mainly in the developed and resource rich countries, in particular North America and Western Europe. The increase in prescribing has been in large part a consequence of the pharmaceutical industry developing new products that include slow- release formulations. Much of this increase is driven by prescribing for chronic non-malignant pain, a condition about which there is considerable debate regarding the role of opioids in management. Increases in prescribing have occurred in Tasmania since the late 1990s, with a six- to seven-fold increase in prescribing authorities for opioids over a 12-year period. The increase in authorities for opioid analgesics, which are required for prescribing beyond two months, suggests an increase in chronic opioid therapy (COT) for chronic non-cancer pain.
There is growing concern both internationally and locally about the harms associated with these drugs amongst chronic pain patients, and about extra medical use and diversion. These concerns are based on peer reviewed studies of opioid-related deaths and other harms amongst chronic pain patients and injecting drug users (IDU), primarily in the United States; are shared by a number of medical practitioners and other health professionals in Tasmania; and are borne out by the analysis of Tasmanian and Australian data in Section Two.
Prescribing in Tasmania
Opioid analgesic prescribing in Tasmania has increased from around 19,300 scripts in 1999 to around 127,400 scripts in 2010. These increases are similar in proportion to those seen nationally, although time series analysis of prescribing by jurisdiction shows that overall opioid prescribing in Tasmania has grown at a slower rate than in the larger jurisdictions (Section Two). Nevertheless, a comparison with other jurisdictions found that Tasmania is also one of the higher prescribing jurisdictions for morphine and oxycodone per 100,000 persons, along with the Northern Territory and the Australian Capital Territory. The increase has been largely driven by oxycodone, with morphine prescribing falling over that period. Methadone tablet sales to pharmacy have increased from 736 tablets per 1000 persons in 1999 to 904 tablets per 1000 persons in 2009. Sales of methadone tablets in Tasmania are currently around 2.5 times the national rate per 1000 persons.
Harms in Tasmania
Are these changes in prescribing reflected in the harms arising from opioid analgesics? An analysis of all opioid- related deaths in Tasmania from 2000 to 2009 shows a sharp increase in these deaths from 2000 to 2001, with a relatively unchanged pattern since then (Section Two). When benzodiazepine deaths are included, there is a sustained increase from 2004 onwards. Presentations for opioid overdose, intoxication, withdrawal or dependence to the Emergency Departments (ED) of the three major hospitals in Tasmania (Royal Hobart, North-West Region, and Launceston General) have increased from 30 per annum in 2004 to 90 per annum in 2010. Most of this increase occurred between 2004 and 2005, and ED presentations have been stable since 2005. Thus, it appears that there was a large increase in harms in the early part of the last decade (2000 to 2005). Since then, harms have plateaued despite increases in prescribing. This may be the result of a number of factors. Firstly, the Tasmanian Pharmaceutical Services Branch (PSB) has worked to contain these harms in the face of increasing prescribing, using methods of monitoring and regulation that have been consistently verified by international evidence as reducing the harms arising from opioid prescribing. Secondly, since the mid-2000s there have been concerted efforts in Tasmania to more closely supervise Opioid Substitution Treatment (OST) whilst increasing the number of treatment places available. The introduction of OST guidelines in the UK in 1996 requiring fewer take away doses and greater supervised dosing also led to a reduction in methadone deaths (Strang, Manning, Mayet, Ridge, Best, & Sheridan, 2007).
Despite the plateau in harms mentioned above, when prescription opioid-related deaths are compared across jurisdictions, Tasmania has a higher accidental death rate per million people than all Australian jurisdictions except the Northern Territory. It also has a higher rate of all oxycodone-related deaths than all jurisdictions. Thus, although Tasmania has been effective in containing the harms arising from prescription opioids, there is more to do to reduce the harms amongst those with chronic pain, drug dependence, or both.
Harms amongst IDUs were examined via the Illicit Drug Reporting System (IDRS) data. Tasmania has much higher rates of prescription opioid use amongst IDU, and much less heroin use, trends evident since 2001. Even when using prescription opioids for pain, Tasmanian IDU were more likely to obtain the drug from a dealer than their mainland counterparts. Similarly, more Tasmanian IDRS participants reported that they had experienced a morphine or methadone overdose in the past 12 months in 2010 than nationally. They were far less likely to have experienced a heroin overdose.
Our estimates of the contribution of IDU to opioid prescribing suggest that a significant proportion of morphine and oxycodone is being diverted and/or misused in Tasmania relative to other jurisdictions. Again, this may in part be due to the very low availability of heroin in Tasmania. Nevertheless, it does indicate a need for more careful prescribing and greater assessment by prescribers of diversion and misuse by patients. The Tasmanian coroner’s office has raised methadone deaths as a significant concern in Tasmania. Their findings have provided some of the impetus for new OST guidelines which provide for closer supervision of OST dosing amongst ‘at-risk’ patients. The coroner’s office has commented that the focus of its recent findings has been to encourage these new guidelines to be adopted.
Clinical practice
At the same time, there is recognition that general practitioners (GPs) find it difficult to manage extreme ‘at-risk’ patients who have legitimate ailments along with addiction and psychiatric disorders. Despite GPs’ best efforts, many of these patients are resistant to other interventions and refuse referrals to specialists. Coroners also commented on the fact that many of the deaths occur amongst people who have had several attempts at rehabilitation and who have relapsed to polydrug use.
This alludes to the impoverished social and economic circumstances of many such patients: Chronic pain increases with age, female gender, lower levels of completed education; not having private health insurance; receiving a disability or unemployment benefits; being unemployed for health reasons; having poor self-rated health; and high levels of psychological distress (Blyth, March, Brnabic, Jorm, Williamson, & Cousins, 2001).
The biopsychosocial model of pain is based on the premise that chronic pain and the experience of pain is grounded in and influenced by biological, psychological, and social factors (Gatchel, Bo Peng, Peters, Fuchs, & Turk, 2007). Thus, assessment and management of chronic pain needs to address all three of these domains. The social factors can present a challenge for clinicians and for policy makers, if ‘social’ is interpreted to include employment status, income, personal and family support networks, marital status and so on. There is indeed evidence that lower socioeconomic status is associated with higher prevalence of pain, and with greater disability resulting from pain (Dorner, Muckenhuber, Stronegger, Rasky, Gustorff, & Freidl, 2011, Loyland, 2010), just as there is evidence that occupational stress, job loss, anxiety, depression, and marital status play a role in chronic back pain (Kikuchi, 2008).
Increasingly, it is acknowledged that amongst chronic pain patients there is a high prevalence of childhood trauma (Nicolson, Davis, Kruszewski, & Zautra, 2010; Sachs-Ericsson, Cromer, Hernandez, & Kendall-Tackett, 2009; Sachs-Ericsson, Kendall-Tackett, & Hernandez, 2007). In addition to an increased risk for physical and psychiatric disorders, research from both clinical and general population samples has identified links between childhood physical and sexual abuse and chronic pain, disability, a range of other health problems, and health service utilisation (Chartier, Walker, & Naimark, 2007) that is independent of comorbid depression (Sachs-Ericsson, Kendall-Tackett, et al., 2007).
Although clinicians can and should work with as many of these factors as is feasible, the current report focuses on issues related to prescription opioids, their use and misuse, and regulatory systems that are within the remit of the Tasmanian DHHS to influence such prescribing. Whilst acknowledging the important role that these structural determinants have, reducing the unemployment rate, addressing income inequity, and reducing the rates of child abuse and neglect are beyond the scope of this report. It is, however, worth noting that recent increases in childhood abuse at the population level will have longer-term consequences for a wide range of adult health problems and the consequent burden upon the health system (Chartier, Walker, et al., 2007; Lamont, 2011).
None of these studies have identified that all chronic pain patients have a history of childhood trauma: some of the associations were quite modest. Nevertheless it is worth noting that these childhood experiences are risk factors for a range of other problems – personality disorder, depression, post-traumatic stress disorder (PTSD), and substance use disorders – that are likely to interfere with the treatment of chronic pain.
As part of the project, a number of prescribers (GPs and specialists) were interviewed using a semi-structured interview. Section Three presents the views of the participants, which are summarised below.
Reliance on opioid analgesics for chronic pain managment
Several prescribers expressed concern about chronic pain management in general practice and about the reliance on opioid analgesics for chronic pain. There was widespread acknowledgement that COT was not very effective for many chronic pain patients, and that once they started taking them it was (a) hard to get them to stop, and (b) rare for the patient to do well on the medications. Nevertheless, there are some patients who benefit from COT, and one of the challenges is to identify, perhaps via a clearly communicated trial of the medication, those patients who do benefit. Given the difficulties reported in getting patients to stop taking these drugs, this approach requires an assertive, structured and well supported approach to trialling the drug.
Five principles can be distilled from the literature that might underpin the prescribing of opioids to patients with chronic non-cancer pain:
- The experience of chronic pain has biological, psychological and socio-environmental contributions, each of which needs to be assessed.
- Drug therapy – for symptom control – is an adjunct to a more comprehensive care plan that may include other health professionals.
- Opioid pharmacotherapy for patients with chronic pain is an ongoing trial, asking the question, ‘Is this person's predicament opioid-responsive?’
- A trial of opioid analgesics requires goal-setting, explicit agreements, skilled titration of dose and regular monitoring of the "5As" (analgesia, affect, activity, adverse effects, and aberrant behaviours).
- Difficulty in achieving or maintaining the goals of an opioid trial should trigger comprehensive reassessment, which may require referral.
Influences on prescribing
This reliance on opioid analgesics to treat chronic non-malignant pain (CNMP) was commonly thought to be due to lack of education about effective chronic pain treatment, a shortage of specialists, a lack of knowledge about the extent of diversion and misuse, and the structure of general practice where short consultations are not conducive to treating complex chronic pain patients. Several very experienced medical practitioners emphasised this last point very strongly. Other influences included PBS listing of some medications for chronic pain but not others (e.g. pregabalin); a waiting list for OST in Tasmania which might lead doctors to prescribe opioids for maintenance treatment of opioid dependence; a waiting list for surgery (e.g. hip and knee replacements) which can lead to chronic pain; and limited access to, and the high cost of, some other treatments; the nature of the relationship between doctor and patient; and the difficulties inherent in treating patients with multiple physical and psychiatric comorbidities. These constraints may leave opioid analgesics as one of a small number of more accessible options for the patient.
Clinicians, backed by research evidence, emphasised the need for early analgesic interventions to reduce the incidence of chronic pain after surgery. The Acute Postoperative Pain (APOP) Project identified a number of key messages:
- Beginning postoperative pain management in the preoperative period;
- Measuring pain regularly; ensuring that all postoperative patients receive safe and effective analgesia;
- Monitoring for and managing adverse events; and
- Communicating the ongoing pain management plan to patients and primary healthcare providers at discharge
There was also significant concern about the influence of pharmaceutical companies on prescribing rates and patterns, whilst acknowledging that they currently fill a gap in the delivery of education. It was suggested that education about chronic pain management should be delivered by unbiased, authoritative providers, and that this education was best provided in the context of individuals prescribing feedback against normative data, in a case-based format, and, where the practice had liberal prescribing patterns, as a practice-wide intervention.
Some groups of doctors were thought to be more vulnerable to prescribing pressures than others. There is a view supported by anecdotal evidence that new doctors, particularly in certain regional areas, were targeted by drug seekers, some of whom use intimidation and manipulation to get their prescriptions. This alludes to a need to ensure that inductions for new doctors include strategies to deal with these issues and that the practice’s prescribing boundaries also protect them from these tactics. An additional concern was doctors who ‘buy into’ their patients helplessness and suffering and who lack the assertiveness to refuse a prescription and direct their patients towards non-pharmacological treatment. Education in the doctor-patient relationship in Tasmania was thought to be stronger than in other jurisdictions, but lacking with respect to this particular issue.
Managing diversion and extra medical use
GPs were, in the main, reluctant to assess diversion and misuse of opioid analgesics amongst their patients. A number of reasons were put forward to explain this, including lack of awareness about the problem, discomfort in raising the topic with patients, the fear of damaging long-term relationships with patients, and a lack of knowledge/skill in assessing and managing these risks. It was suggested that a simple tool to assess the risk of diversion and extra medical use would be helpful, along with video clips demonstrating how to refuse a prescription to a patient who has requested it, perhaps made available on the Tasmanian PSB website.
Other suggestions for improving prescribing practices
Some experienced prescribers commented that it is essential for GPs and their patients to understand that chronic pain cannot be ‘fixed’ and to reframe their role from ‘curing patients’ to managing chronic problems, with the GP co-ordinating care from psychologists, physiotherapists and the like. This approach was consistent with both a multimodal model of treatment and with the principles of chronic disease management (outlined in Section Four). Nevertheless, there was a widely held perception that in order to adopt this approach, GPs needed greater support from specialist services and easier referral pathways, including better access to psychologists, mental health services, pain clinics, and pain group programs, particularly in the North and North West of the State.
There was also a view that many doctors do not appreciate the bigger picture that the Tasmanian PSB faces in dealing with harms and diversion. In the main, education that is case-based, conducted in small groups, with feedback to doctors about their prescribing patterns was thought to be an effective delivery strategy. The feedback was viewed as a way of doctors recognising the need for peer support and educational activities. A structured peer support network, where cases could be discussed, was also mentioned as valuable in managing more complex patients. There was a suggestion that some of this support could be connected to the Tasmanian PSB. Others stated that there is an important role for the GP Divisions (now Medicare Locals) in holding education events. The education events that have been run by the Division were viewed as very helpful, but not sufficient, and that there needed to be a range of training options from short seminars to more intensive on-the-job training.
When considering changes to clinical practice, clinicians emphasised the need for procedures and guidelines to be integrated with existing systems. For example, treatment plans and patient information could be set up in Medical DirectorTM or as part of the Tasmanian PSB’s authority process. Others stressed the need for community education. As a starting point, it was suggested that patients who request or are prescribed opioids should negotiate a treatment agreement with their prescribing doctor about the duration of treatment, the need for ongoing review of opioid effectiveness, the importance of monitoring for unwanted adverse events and aberrant behaviours and the use of other pain management strategies.
Managing chronic pain in the opioid dependent patient
The co-occurrence of opioid dependence and severe chronic pain poses significant challenges for patients, families and carers, health practitioners and health systems. Many such patients experience poorly co- ordinated and inadequate treatment and stigma from family, friends, the community and health providers. These, in turn, can impair treatment outcomes and overall quality of life for the patient. OST patients reporting pain have been found to have more severe medical and psychological problems and greater health service utilisation than those without pain (Trafton, Oliva, Horst, Minkel, & Humphreys, 2004). Pain was associated with increased likelihood for misuse of analgesics, suggesting that ongoing pain contributes to more severe drug-seeking behaviour. This highlights the need for such patients to have their pain treated. Patients with pain did not differ from patients without pain in use of heroin, alcohol, cocaine or in injecting practices. There are a small number of published reviews or guidelines for managing co-occurring opioid dependence and chronic pain (Ballantyne & LaForge, 2007; Roberts, 2008; Savage, Kirsh, & Passik, 2008). Section Two of this report provides some key principles for managing chronic pain in opioid-dependent patients. A protocol for the management of acute pain in opioid-dependent patients who are treated with methadone or buprenorphine is currently under review at the Royal Hobart Hospital.
Reviewing the monitoring and regulation of drugs of dependence
Most clinicians interviewed supported the role of the Tasmanian PSB in monitoring and regulating the prescribing of these drugs. Many were eagerly awaiting the roll out of real time reporting and remote access to the Tasmanian Drugs and Poisons Information System (DAPIS) (via the DAPIS Online Remote Access System) that will allow prescribers and pharmacists to view patients’ schedule 8 prescribing history. There were, nevertheless, requests for greater transparency in the decision-making process and criteria, more feedback about why individual decisions were made, and an appeals process for patients for whom the PSB held forensic information and who were therefore subject to pick-up or supervision restrictions. It is important that prescribers are apprised of the decision-making process and criteria. A small minority felt that the regulatory process had made GPs unwilling to prescribe opioid analgesics.
All Australian jurisdictions and other developed nations have adopted some form of monitoring and regulation of drugs of dependence. In Australia, all states bar New South Wales, Victoria and Queensland, require a doctor to obtain an authority to prescribe any S8 opioid beyond two months. Where the patient is opioid or drug dependent, all jurisdictions require doctors to obtain an authority before prescribing any S8 opioid medications. Most jurisdictions have a database which allows them to examine a patient’s S8 prescription history and to ensure that the appropriate authorities are in place.
Monitoring programs can adopt an inappropriately legalistic approach rather than focus on the quality use of medicines (QUM) and other important aspects of good clinical practice to ensure safe prescribing and better health outcomes. There is a need for the regulatory interface to take on more than a punitive approach, and to engender a shared sense of sound clinical governance from the industry partners, prescribers, pharmacists, and educators. Interestingly, the approach in Tasmania is not a punitive or policing approach; rather, it is aimed at providing a clinical- regulatory interface with QUM. And, although not conclusive, the evidence from Tasmania suggests that their approach to monitoring and regulation has at least contained the harms arising from rapidly increasing opioid analgesic prescribing.
There are two points upon which most of the clinicians consulted agreed. First, that the decision to prescribe S8 opioids is a clinical one. Second, that when there is evidence that patient or the community is at risk, the regulators have a role to place conditions and restrictions on prescribing, and in extreme cases, to refuse an authority to prescribe. The recommendations below incorporate these findings.
Minimising the misuse of pharmaceutical opioids
The findings thus far have covered a range of clinical, education, and regulatory issues. A recent editorial in the Medical Journal of Australia identified a number of strategies available to government to reduce pharmaceutical opioid misuse (Hall & Farrell, 2011).
These were:
- Improving education for doctors and patients about the risks of dependence and overdose, particularly with higher doses. Patients need to be informed by their doctor and their pharmacist about these risks, particularly when used in combination with other central nervous system (CNS) depressants;
- Providing clearer clinical guidelines for primary health practitioners on the place of opioids in the treatment of chronic non-malignant pain in order to ensure that opioids are not used as a first line treatment;
- Giving clinical priority to reducing suicides amongst patients with chronic pain and who are prescribed opioids;
- Prescribing smaller quantities of opioids to allow for more regular review of their effectiveness in relieving pain, and monitoring compliance with the medication regimen;
- Enhancing prescription monitoring systems to reduce doctor-shopping and imprudent prescribing. These systems should be computerised and should operate in real-time;
- Ensuring that the pharmaceutical industry markets to prescribers in responsible ways and that the clinical information provided for patients discusses the risks of using these drugs in combination with other CNS depressants; and
- Increasing access to OST for people who use opioids illicitly.