Larance Briony, Dobbins Timothy, Peacock Amy, Ali Robert, Bruno Raimondo, Lintzeris Nicholas, Farrell Michael, Degenhardt Louisa
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
Lancet Psychiatry. 2018 Feb;5(2):155-166. doi: 10.1016/S2215-0366(18)30003-8. Epub 2018 Jan 11.
Escalation of pharmaceutical opioid use and harm in North America is well-documented, with similar issues emerging in Australia. One response is the development of tamper-resistant formulations of opioids. A potentially tamper-resistant formulation of controlled-release oxycodone was introduced in Australia in April, 2014, rapidly replacing the non-tamper-resistant formulation. Our study is the most systematic and comprehensive examination of the impact of a new opioid formulation to date, assessing the effect of tamper-resistant formulation of controlled-release oxycodone on population-level opioid use and opioid-related harm (ie, overdose, help-seeking, and treatment-seeking); and opioid use, tampering, and preference for the tamper-resistant formulation of controlled-release oxycodone compared with other drugs or formulations among sentinel populations likely to tamper with pharmaceutical opioids.
We conducted interrupted time-series analyses of opioid sales data and multiple routinely collected health datasets, followed up a cohort of people who tamper with pharmaceutical opioids before and after the introduction of the tamper-resistant formulation of controlled-release oxycodone, and analysed annual surveys of people who inject drugs. Data were collected from several Australian states: New South Wales, South Australia, and Tasmania. Meta-analyses (weighted Z tests) were conducted to synthesise across data sources providing evidence for a given indicator.
At the population level, we found reduced sales of higher strengths of controlled-release oxycodone and increased sales of other oxycodone formulations. No significant effect was observed among population-level indicators of opioid overdose, or help or treatment-seeking. Mortality data were not available for inclusion at the time of our study. Meta-analyses across sentinel populations (ie, prospective cohort, surveys of people who inject drugs, and clients of supervised injecting facilities or needle and syringe programmes) indicated reduced controlled-release oxycodone use via tampering (mainly injection), with no evidence of switching to heroin or other drug use.
This formulation of controlled-release oxycodone reduced tampering with pharmaceutical opioids among people who inject drugs, but did not affect population-level opioid use or harm.
Mundipharma Australia, the Australian Government, and the National Health and Medical Research Council.
北美地区药用阿片类药物使用量增加及其危害已有充分记录，澳大利亚也出现了类似问题。一种应对措施是开发具有抗篡改功能的阿片类药物制剂。2014年4月，一种具有潜在抗篡改功能的缓释羟考酮制剂在澳大利亚推出，迅速取代了无抗篡改功能的制剂。我们的研究是迄今为止对新型阿片类药物制剂影响进行的最系统、最全面的考察，评估了缓释羟考酮抗篡改制剂对人群层面阿片类药物使用及阿片类药物相关危害（即过量用药、寻求帮助和寻求治疗）的影响；以及与可能篡改药用阿片类药物的哨点人群中其他药物或制剂相比，缓释羟考酮抗篡改制剂的使用、篡改情况及偏好。
我们对阿片类药物销售数据和多个常规收集的健康数据集进行了中断时间序列分析，对引入缓释羟考酮抗篡改制剂前后篡改药用阿片类药物的人群队列进行了随访，并分析了对注射吸毒者的年度调查。数据来自澳大利亚的几个州：新南威尔士州、南澳大利亚州和塔斯马尼亚州。进行了荟萃分析（加权Z检验），以综合不同数据源，为给定指标提供证据。
在人群层面，我们发现高剂量缓释羟考酮的销售量减少，其他羟考酮制剂的销售量增加。在阿片类药物过量用药、寻求帮助或寻求治疗的人群层面指标中未观察到显著影响。在我们研究时，无法获取死亡率数据纳入分析。对哨点人群（即前瞻性队列、对注射吸毒者的调查以及受监督注射设施或针头和注射器项目的客户）的荟萃分析表明，通过篡改（主要是注射）使用缓释羟考酮的情况减少，没有证据表明转向使用海洛因或其他药物。
这种缓释羟考酮制剂减少了注射吸毒者对药用阿片类药物的篡改行为，但未影响人群层面的阿片类药物使用或危害。
澳大利亚萌蒂制药公司、澳大利亚政府和国家卫生与医学研究委员会。
