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PAINSCAN LITERATURE REVIEW
Issue 1, Volume 3
Abuse-Deterrent Technologies
14 Articles in this Series
Introduction
The effect of a potentially tamper-resistant oxycodone
Commentary: Why Prescribers Need to Adopt Abuse-Deterrent Opioids
Review: The Impact of Abuse-Deterrent Formulations on Prescribing and Abuse
Abuse-Deterrence Guidance Further Highlights Federal Focus
The Burden of Undiagnosed Opioid Abuse Among the Commercially Insured
Reductions in Reported Deaths Following Introduction of Abuse-Deterrent Oxycodone ER (OxyContin)
Abuse-Deterrent Opioids—Evaluation and Labeling
Generic patches containing fentanyl: abuse deterrent evaluation
FDA Advisory Committee Meetings on Abuse-Deterrent Opioids
Regulatory Update: FDA Takes Additional Abuse-Deterrent Steps
Related: At-Risk Patients and Urine Drug Monitoring
Extended-Release Formulations Enter US Market
Development and Impact of Prescription Opioid ADF Technologies
Trends in Opioid Analgesic Abuse and Mortality in the United States

The effect of a potentially tamper-resistant oxycodone

A look at Australia’s opioid formulations
Lancet Psychiatry. 2018;5(2):155-166

Background: 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.

Methods: 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 analyzed 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 synthesize across data sources providing evidence for a given indicator.

Findings: 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 programs) indicated reduced controlled-release oxycodone use via tampering (mainly injection), with no evidence of switching to heroin or other drug use.

Interpretation: 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.

Commentary

Massiel Jimenez, MD, also contributed to this commentary.

The authors of the study conducted analyses of opioid sales data as well as other related health datasets from several Australian states. They also followed up with a cohort of individuals who tampered with pharmaceutical opioids before and after the introduction of the tamper-resistant formulation of controlled-release oxycodone, and analyzed annual surveys of individuals who have reported injecting these medications. The researchers did not report on or address mortality.

Following a meta-analyses review across sentinel populations (ie, the “opioid tamperers,” individuals who injected drugs, and clients of supervised injecting facilities or needle and syringe programs), the data indicated a reduction in tampering (mainly injection) with controlled-release oxycodone, with no evidence of switching to heroin or other illicit drug use. Reformulation did not appear to affect population-level opioid use or harm.

This study reinforced data from the United States that reformulating opioids to contain abuse-deterrent properties has benefits for those who may abuse these products by means of tampering. The data from Australia suggest that reformulation of a controlled-release oxycodone reduced tampering of prescription opioids among individuals who inject.

Abuse and misuse of prescription opioids are serious public health problems. In the US, Oxycontin was reformulated in 2010 to a tablet that was much more difficult to crush or dissolve, thereby resisting tampering that could lead toward common means of abuse. After this reformulation, abuse of Oxycontin decreased 36%, but there was a corresponding increase in the abuse of other short-acting oxycodone products by 20% and an increase in heroin use by 42%.

Prescribers needed to employ multimodal strategies, including prescription drug monitoring database queries, urine (or other matrix) drug screening, risk profile questionnaires, and other methods to prevent and screen for prescription drug abuse and misuse. Abuse-deterrent formulations offer an intervention to balance risk with appropriate patient access, and should be considered as first-line.

However, clinicians must understand that these formulations are just one small part of a risk-management strategy when prescribing opioids. Educating practitioners regarding the benefits of prescribing opioids with abuse-deterrent formulations may assist with the primary goals of safe prescribing in the current opioid landscape.

Next Article:
Commentary: Why Prescribers Need to Adopt Abuse-Deterrent Opioids
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