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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

Review: The Impact of Abuse-Deterrent Formulations on Prescribing and Abuse

Dart et al. Do abuse deterrent opioid formulations work? J Opioid Manag. 2017:13(6).
J Opioid Manag. 2017;13:

A systematic review by Dart et al set out to determine whether opioid analgesics with abuse-deterrent properties have impacted overall abuse rates since 2009.1

In this paper, the authors shared varying perspectives among the industry regarding the effectiveness of abuse-deterrent formulations (ADF), which aim to deter abuse by making product manipulation (ie, crushing, chewing, dissolving) difficult or by reducing the product’s effect upon tampering via the release of opioid antagonists. ADF proponents view the technology as a “seat belt” that may prevent abuse but is not 100% fault-proof, according to the paper, while opponents point to a lack of proven effectiveness in abuse prevention and a concern that the technology may provide prescribers with a false sense of security.1 The authors contended, however, that enough postmarketing data was available to effectively measure the impact of abuse-deterrent formulations on prescribing and abuse, pointing out that it has been seven years since OxyContin was reformulated and approved for ADF labeling.2

The review included 44 published reports on delayed onset opioids—hydrocodone (n = 7), morphine (n = 5), and oxycodone (n = 32)—between the years 2009 and 2016. The authors used the following search terms for evaluation: misuse, abuse, overdose, addiction, and death. FDA definitions were utilized for each term and Bradford-Hill criteria (eg, strength, consistency, temporality, plausibility, coherence, etc.) was followed. Medications included abuse-deterrent labeling that falls under the Food and Drug Administration’s approved three categories for evaluation:3

  • manipulation and extraction
  • pharmacokinetic studies
  • clinical abuse studies.

Authors determined that the only data within their review set considered valid for evaluation—based on labeled claims and postmarketing measures of abuse—was for oxycodone extended-release (ER) products. Reports from Australia, Canada, and the United States demonstrated a wide range of marked decrease (10 to 90%) in measures of abuse with abuse-deterrent formulated oxycodone ER.

Given the limited usable data, the authors explained the evaluations behind the Bradford-Hill criteria as part of their discussion. “Whether other interventions constitute a traditional confounder relationship between ADF exposure and abuse outcomes is unclear because most of the interventions routinely cited did not intend to influence ADF prescribing directly,” they wrote, “but were efforts to reduce abuse and diversion in general.”1

Prescribing and abuse levels based on geography were also deemed unquantifiable as the switch from original oxycodone to its ADF formulation occurred across the board without prescriber choice, stated the authors. (They did, however, call out a 12-15 month time period in Florida after oxycodone reformulation occurred but before interdiction had taken place).

The reviewers further concluded that the rise in prescription monitoring and legislation tied to opioid prescribing for pain may have affected the potential for abuse.1 Decreases in illicit demand—categorized by doctor shopping, fraudulent purchase, or borrowing/stealing—was also offered as a possible indication of decreased prescribing and abuse.

While sampling and misclassification bias was deemed to be present in the literature reviewed, the authors found that consistency across studies combined with specific sources of bias alone was unlikely to impact the overall findings.

While more postmarketing data is needed for other abuse-deterrent opioid formulations, the authors did offer a conclusion, stating that, “Although there is continued debate on the effectiveness of ADF products, the data for oxycodone ER document a substantial reduction in abuse and diversion that occurred following reformulation.”1

-Reported by Angie Drakulich

 

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Abuse-Deterrence Guidance Further Highlights Federal Focus
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