Perceptions of extended-release buprenorphine injections for opioid use disorder among people who regularly use opioids in Australia

2019 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction Aims: To examine perceptions of extended-release (XR) buprenorphine injections among people who regularly use opioids in Australia. Design: Cross-sectional survey prior to implementation. XR-buprenorphine was registered in Australia in November 2018. Setting: Sydney, Melbourne and Hobart. Participants. A total of 402 people who regularly use opioids interviewed December 2017 to March 2018. Measurements: Primary outcome concerned the proportion of participants who believed XR-buprenorphine would be a good treatment option for them, preferred weekly versus monthly injections and perceived advantages/disadvantages of XR-buprenorphine. Independent variables concerned the demographic characteristics and features of current opioid agonist treatment (OAT; medication-type, dose, prescriber/dosing setting, unsupervised doses, out-of-pocket expenses and travel distance). Findings: Sixty-eight per cent [95% confidence interval (CI) = 63-73%] believed XR-buprenorphine was a good treatment option for them. They were more likely to report being younger [26-35 versus \u3e 55 years; odds ratio (OR) = 3.16, 95% CI = 1.12-8.89; P = 0.029], being female (OR = 1.67, 95% CI = 1.04-2.69; P = 0.034), \u3c 10 years school education (OR = 1.87, 95% CI = 1.12-3.12; P = 0.016) and past-month heroin (OR = 1.81, 95% CI = 1.15-2.85; P = 0.006) and methamphetamine use (OR = 1.90, 95% CI = 1.20-3.01; P = 0.006). Fifty-four per cent reported no preference for weekly versus monthly injections, 7% preferred weekly and 39% preferred monthly. Among OAT recipients (n = 255), believing XR-buprenorphine was a good treatment option was associated with shorter treatment episodes (1-2 versus ≥ 2 years; OR = 3.93, 95% CI = 1.26-12.22; P = 0.018), fewer unsupervised doses (≤ 8 doses past-month versus no take-aways; OR = 0.50; 95% CI = 0.27-0.93; P = 0.028) and longer travel distance (≥ 5 versus \u3c 5 km; OR = 2.10, 95% CI = 1.20-3.65; P = 0.009). Sixty-nine per cent reported \u27no problems or concerns\u27 with potential differences in availability, flexibility and location of XR-buprenorphine. Conclusions: Among regular opioid users in Australia, perceptions of extended-release buprenorphine as a good treatment option are associated with being female, recent illicit drug use and factors relating to the (in)convenience of current opioid agonist treatment

Diversion of prescribed opioids by people living with chronic pain: Results from an Australian community sample

Introduction and Aims There has been an increase in prescription of opioids for chronic non‐cancer pain, and concern exists over possible diversion of prescription opioids to the illicit marketplace. Recent media coverage suggests that elderly patients sell their prescribed opioids for additional income. This study investigated the extent to which an Australian community sample of chronic pain patients prescribed opioids reported supplying their prescribed opioids to others. Design and Methods Participants living with chronic non‐cancer pain and prescribed opioids for their pain (n = 952) were recruited across Australia via advertisements at pharmacies. A telephone interview included questions about their pain condition and opioid medication. Results Participants had been living with pain for a mean of 14.2 years; most common conditions included chronic back/neck problems and arthritis/rheumatism. Around half (43%) were currently prescribed one opioid, and 55% had been prescribed 2-5 opioids; the most common was oxycodone. Forty‐two participants (4%) reported ever supplying prescribed opioids to another person; one participant reported receiving payment. Participants who supplied opioids to others were younger (odds ratio 0.97, 95% confidence interval 0.95-0.99) and engaged in a greater number of aberrant behaviours relating to their opioid medication (odds ratio 1.77, 95% confidence interval 1.45-2.17), including tampering with doses, taking opioids by alternative routes, seeing doctors to obtain extra opioids and refilling prescriptions early. Discussion and Conclusion Few people with chronic non‐cancer pain divert their opioids to others. Media reports of elderly patients selling their opioids to supplement their income may be reflective of exceptional cases. Future studies may investigate the extent to which other patient groups divert prescription opioids to the illicit marketplace

Examining the integration of physical health in the treatment of substance use disorders

Background: The physical health burdens and health-related behaviours (e.g., smoking, poor nutrition, sedentariness) associated with substance use disorders necessitate an integrated treatment response. Yet service fragmentation can preclude physical health from being addressed within specialist alcohol and other drug (AOD) treatment services that typically operate outside of primary care settings. Relative to the general population, people living with substance use problems are at an increased risk for developing many types of chronic illness, including cardiovascular disease, respiratory disorders, hepatitis C, and diabetes. Moreover, individuals who attend AOD treatment are 2.3-2.7- times more likely to have multiple (i.e., two or more) physical diseases when compared to those who never attend AOD treatment. Despite this, there has been little research attention given to understanding how the physical health disparities of substance using populations can be managed during specialist AOD treatment. Social ecological models recognise the multiple environmental influences that interact to affect the provision of treatment and treatment outcomes. Recovery capital approaches suggest that treatment of substance use disorders needs to promote resources among individual service users, augmenting the short-term effects of clinical intervention. Using social ecological models and recovery capital as a conceptual base, this thesis comprises four studies which aim to explore the integration of physical health care within specialist AOD treatment. The aim of Study 1 was to examine what empirically based guidance was available to the AOD workforce when addressing the physical health of those attending treatment. Study 2 aimed to better understand the nature and prevalence of physical health morbidities of people attending treatment for substance use disorders and how these are identified. Study 3 sought to examine the facilitators and barriers to the integration of physical health care within specialist AOD treatment settings. The aim of Study 4 was to explore the perceived role of physical health in the process of recovery from the perspective of the AOD workforce and people attending treatment for substance use disorders. Method: Study 1 consisted of a systematic review of 33 clinical practice guidelines for the treatment of substance use disorders. A grey literature search was used to identify guidelines from Australia and other international jurisdictions. Eligible guidelines were subject to data extraction that included i) guideline characteristics, ii) the physical health problems identified by the guidelines and iii) the recommendations made by the guideline for managing physical health and health-related behaviours. Appraisal of guideline quality and rigour was conducted using the Appraisal of Guidelines Research and Evaluation II (AGREE-II) tool. Study 2 was a retrospective file review of client files (N = 127) collected as part of routine care at a specialist residential AOD treatment service in New South Wales, Australia. Studies 3 and 4 adopted a qualitative approach, where interviews were conducted with service users (n = 20) and staff (n = 13) of residential and outpatient treatment services in New South Wales, Australia. Interview data was transcribed and then systematically coded and analysed using iterative categorisation. Results: Study 1 found that 14 guidelines for the treatment of substance use disorders were considered high quality based on AGREE-II scores. Neurological conditions (90.9%) and hepatitis (81.8%) were the most frequent health problems addressed. Most guidelines recommended establishing referral pathways to address physical health comorbidities (90.9%). Guidance on facilitating these referral pathways was less common (42.4%). Guidelines were inconsistent in their recommendations related to oral health, tobacco use, physical activity, nutrition and the use of standardised assessment tools. Findings of Study 2 indicated that most clients attending residential treatment for substance use had at least one physical health comorbidity (80.7%). Just over half of clients (55.5%) with a co-occurring physical health condition were reported to have received a referral to a primary health service or practitioner. In Study 3 a social ecological approach helped to identify personal, professional and structural barriers and facilitators that may affect the capacity of the AOD workforce to adequately address client physical health. Study 4 found that opportunities to improve their physical health were valued by those attending treatment for substance use, and that enhanced physical health was perceived to offer variegated pathways for building recovery capital. Conclusions: Studies of this thesis suggest that a more proactive approach to addressing the physical health of people attending treatment for substance use disorders is needed. Findings highlight challenges for AOD services when assessing and managing client physical health and identify strategies that may be utilised to ameliorate such barriers. Improvements to physical health and health-related behaviour change were perceived by participants as providing a connection to sustained recovery, generating recovery resources that extended beyond disease management. Collectively, thesis findings suggest potential avenues for enhancing the integration of physical health care within routine AOD treatment that takes place outside of primary care

Agreement between definitions of pharmaceutical opioid use disorders and dependence in people taking opioids for chronic non-cancer pain (POINT): a cohort study

Background Classification of patients with pharmaceutical opioid use disorder and dependence varies depending on which definition is used. We compared how WHO\u27s ICD-10 and proposed ICD-11 and the American Psychiatric Association\u27s DSM-IV and DSM-5 classified individuals in a community-based sample of Australians with chronic non-cancer pain for which opioids have been prescribed. Methods We studied participants in the Pain and Opioid IN Treatment (POINT) cohort, a 2 year prospective cohort study of 1514 people prescribed pharmaceutical opioids for their chronic pain who were recruited in 2012–13 from community-based pharmacies across Australia. After giving patients the Composite International Diagnostic Interview about their opioid use, we assessed which patients would be categorised as having disorders of pharmaceutical opioid use by ICD-10, the draft ICD-11, DSM-IV, and DSM-5. We examined agreement between classification systems, and tested the unidimensionality of the syndrome with confirmatory factor analysis. Findings We included 1422 participants (median time of pain disorder 10 years [IQR 5–20]; median length of strong opioid prescription 4 years [IQR 1·5–10·0]; mean age 58 years). Similar proportions of individuals met lifetime criteria for dependence with DSM-IV (127; 8·9%), ICD-10 (121; 8·5%), and ICD-11 (141; 9·9%). Criteria in DSM-5 classified 127 (8·9%) participants with moderate or severe use disorder. There was excellent agreement between ICD-10, ICD-11 and DSM-IV dependence (κ\u3e0·90). However, there was only fair to moderate agreement between ICD-10 and DSM-IV dependence diagnoses, and DSM-5 use disorder (mild, moderate, or severe). There was only good agreement between moderate to severe use disorder in DSM-5 and the other definitions. Criteria for all definitions loaded well on a single factor; the best model fit was for the definition for dependence in the draft ICD-11, the worst was in DSM-5. Interpretation Classification of problematic pharmaceutical opioid use varies across editions of ICD and DSM. The much lower levels of agreement between DSM-5 and other definitions than between other definitions might be attributed to DSM-5 containing an increased number of criteria and treating dependence and problematic use as a continuum. The more parsimonious ICD-11 dependence definition showed excellent model fit and excellent agreement with previous classificatory systems

Same-day use of opioids and other central nervous system depressants amongst people who tamper with pharmaceutical opioids: A retrospective 7-day diary study

Objective The aims were to determine: (i) quantity and frequency of same-day use of opioids with benzodiazepines and/or alcohol amongst people who regularly tamper with pharmaceutical opioids; and (ii) socio-demographic, mental health, harms and treatment profile associated with same-day use of high doses. Method The cohort (n = 437) completed a retrospective 7-day diary detailing opioid, benzodiazepine, and alcohol intake. Oral morphine equivalent (OME) units and diazepam equivalent units (DEU) were calculated, with \u3e200 mg OME, \u3e40 mg DEU and \u3e4 standard alcoholic drinks (each 10 g alcohol) considered a high dose . Results One-half (47%) exclusively consumed opioids without benzodiazepines/alcohol; 26% had days of opioid use with and without benzodiazepines/alcohol; and 26% always used opioids and benzodiazepines/alcohol. Same-day use of opioids with benzodiazepines/alcohol typically occurred on 1-3 days in the past week. Six in ten (61%) participants reported high dose opioid use on at least one day; one in five (20%) reported high dose opioid and high dose benzodiazepine/alcohol use on at least one day. The latter group were more likely to use prescribed opioid substitution therapy, often alongside diverted pharmaceutical opioids. Socio-demographic and clinical profiles did not vary according to high dose opioid, alcohol and benzodiazepine use, and there was no association with harms. Conclusions Same-day use of opioids with benzodiazepines/alcohol, and high dose combinations, are common amongst people who tamper with pharmaceutical opioids. Assessment of concomitant benzodiazepine/alcohol use during opioid therapy, implementation of real-time prescription monitoring systems, and research to clarify upper safe limits for polydrug depressant use, are potential implications

Effect of cannabis use in people with chronic non-cancer pain prescribed opioids: findings from a 4-year prospective cohort study

Background Interest in the use of cannabis and cannabinoids to treat chronic non-cancer pain is increasing, because of their potential to reduce opioid dose requirements. We aimed to investigate cannabis use in people living with chronic non-cancer pain who had been prescribed opioids, including their reasons for use and perceived effectiveness of cannabis; associations between amount of cannabis use and pain, mental health, and opioid use; the effect of cannabis use on pain severity and interference over time; and potential opioid-sparing effects of cannabis. Methods The Pain and Opioids IN Treatment study is a prospective, national, observational cohort of people with chronic non-cancer pain prescribed opioids. Participants were recruited through community pharmacies across Australia, completed baseline interviews, and were followed up with phone interviews or self-complete questionnaires yearly for 4 years. Recruitment took place from August 13, 2012, to April 8, 2014. Participants were asked about lifetime and past year chronic pain conditions, duration of chronic non-cancer pain, pain self-efficacy, whether pain was neuropathic, lifetime and past 12-month cannabis use, number of days cannabis was used in the past month, and current depression and generalised anxiety disorder. We also estimated daily oral morphine equivalent doses of opioids. We used logistic regression to investigate cross-sectional associations with frequency of cannabis use, and lagged mixed-effects models to examine temporal associations between cannabis use and outcomes. Findings 1514 participants completed the baseline interview and were included in the study from Aug 20, 2012, to April 14, 2014. Cannabis use was common, and by 4-year follow-up, 295 (24%) participants had used cannabis for pain. Interest in using cannabis for pain increased from 364 (33%) participants (at baseline) to 723 (60%) participants (at 4 years). At 4-year follow-up, compared with people with no cannabis use, we found that participants who used cannabis had a greater pain severity score (risk ratio 1·14, 95% CI 1·01-1·29, for less frequent cannabis use; and 1·17, 1·03-1·32, for daily or near-daily cannabis use), greater pain interference score (1·21, 1·09-1·35; and 1·14, 1·03-1·26), lower pain self-efficacy scores (0·97, 0·96-1·00; and 0·98, 0·96-1·00), and greater generalised anxiety disorder severity scores (1·07, 1·03-1·12; and 1·10, 1·06-1·15). We found no evidence of a temporal relationship between cannabis use and pain severity or pain interference, and no evidence that cannabis use reduced prescribed opioid use or increased rates of opioid discontinuation. Interpretation Cannabis use was common in people with chronic non-cancer pain who had been prescribed opioids, but we found no evidence that cannabis use improved patient outcomes. People who used cannabis had greater pain and lower self-efficacy in managing pain, and there was no evidence that cannabis use reduced pain severity or interference or exerted an opioid-sparing effect. As cannabis use for medicinal purposes increases globally, it is important that large well designed clinical trials, which include people with complex comorbidities, are conducted to determine the efficacy of cannabis for chronic non-cancer pain

Opioid use and harms associated with a sustained-release tapentadol formulation: a postmarketing study protocol

Introduction It has been argued that tapentadol may pharmacologically have lower abuse potential than other pharmaceutical opioids currently available. However, there has been no comprehensive triangulation of data regarding use and harms associated with this formulation. A sustained-release formulation (SRF) of tapentadol (Palexia) was released in Australia in 2011 and listed for public subsidy in 2013. We summarise here the methods of a postmarketing study which will measure postintroduction: (1) population level availability, (2) extramedical use and diversion, (3) attractiveness for extramedical use and (4) associated harms, of tapentadol compared against other pharmaceutical opioids. Methods and analysis We evaluated key sources on pharmaceutical use and harms in Australia. This review indicateddata from four sources that disaggregate pharmaceutical opioid formulations and capture tapentadol SRF could be triangulated. These data sources comprised: (1) national pharmaceutical opioid community sales data from 2011 to 2017, (2) national pharmaceutical opioid poisonings reported to Poison Information Centres (PICs) from 2011 to 2017, (3) number of vendors on online marketplaces listing pharmaceutical opioids for sale and (4) data on pharmaceutical opioid extramedical use, attractiveness and harms from interviews with people who regularly inject drugs in Australia. Ethics and dissemination Ethics approval is not required for use of pharmaceutical sales data. Ethics approval has been obtained for use of national pharmaceutical opioid poisonings reported to PICs (LNR/16/SCHN/44) and for use of online marketplace data and interview data from people who inject drugs (HC12086). Key findings will be published mid-2018 in a peer-reviewed academic journal, and presented at various conferences and professional meetings.This work was supported by investigator-initiated untied educational funding from Seqirus Pty Ltd (the marketer of tapentadol SRF in Australia) granted to AP, BL, MF, RC, and LD. BL, AP and LD are supported by NHMRC research fellowships (#1073858, #1109366 and #1041472). The National Drug and Alcohol Research Centre at UNSW Australia is supported by funding from the Australian Government under the Substance Misuse Prevention and Service Improvements Grant Fund

Combating escalating harms associated with pharmaceutical opioid use in Australia: The POPPY II study protocol

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Introduction Opioid prescribing has increased 15-fold in Australia in the past two decades, alongside increases in a range of opioid-related harms such as opioid dependence and overdose. However, despite concerns about increasing opioid use, extramedical use and harms, there is a lack of population-level evidence about the drivers of long-term prescribed opioid use, dependence, overdose and other harms. Methods and analysis We will form a cohort of all adult residents in New South Wales (NSW), Australia, who initiated prescribed opioids from 2002 using Pharmaceutical Benefits Scheme dispensing records. This cohort will be linked to a wide range of other datasets containing information on sociodemographic and clinical characteristics, health service use and adverse outcomes (eg, opioid dependence and non-fatal and fatal overdose). Analyses will initially examine patterns and predictors of prescribed opioid use and then apply regression and survival analysis to quantify the risks and risk factors of adverse outcomes associated with prescribed opioid use. Ethics and dissemination This study has received full ethical approval from the Australian Institute of Health and Welfare Ethics Committee, the NSW Population and Health Services Research Committee and the ACT Health Human Research Ethics Committee. This will be the largest postmarketing surveillance study of prescribed opioids undertaken in Australia, linking exposure and outcomes and examining risk factors for adverse outcomes of prescribed opioids. As such, this work has important translational promise, with direct relevance to regulatory authorities and agencies worldwide. Project findings will be disseminated at scientific conferences and in peer-reviewed journals. We will also conduct targeted dissemination with policy makers, professional bodies and peak bodies in the pain, medicine and addiction fields through stakeholder workshops and advisory groups. Results will be reported in accordance with the REporting of studies Conducted using Observational Routinely collected Data (RECORD) Statement

A typology of predictive risk factors for non-adherent medication-related behaviors among chronic non-cancer pain patients prescribed opioids: a cohort study

Background: There has been no previous prospective examination of the homogeneity of chronic non-cancer pain (CNCP) patients in risk factors for non-adherent opioid use