Abuse-Deterrent Formulations: Not All They’re Cracked Up To Be?

An abuse-deterrent formulation (ADF) of sustained-release oxycodone hydrochloride (sold as OxyContin) was introduced in 2010 to curtail its widespread non-medical use. Initially, this introduction correlated with a sharp decrease in reported rates of non-medical use, which ultimately plateaued over time. The current analysis of data from the Survey of Key Informants’ Patients Program examined the residual rates of non-medical use of reformulated oxycodone hydrochloride. Patients entering drug treatment with a diagnosis of opioid use disorder primarily misusing prescription opioids or heroin were included in the survey study (N=10,784); 2% of the sample (n=244) was interviewed to add context and expand on the structured survey.

• The ADF was associated with a significant reduction in past-month non-medical use of sustained release oxycodone formulations from 45% before introduction to 26% after introduction. This reduction was associated with an increased reports of using other opioids, particularly heroin.
• Up to 4 years after reformulation, 25–30% of participants still endorsed past-month non-medical use of sustained release oxycodone.
• Among 88 interviewed participants who endorsed non-medical use of oxycodone hydrochloride pre- and post-reformulation, 3 themes emerged to explain residual misuse: transition from non-oral routes to oral routes of use; successful efforts to tamper with the ADF mechanism; and exclusive use of the oral route of administration despite the formulation.

Comments:

Although ADFs of prescription opioids have the potential to curtail non-medical use, their effectiveness is not absolute and some unintended consequences may emerge, such as migration to heroin use. Efforts to address the prescription opioid epidemic in this country should not focus solely on creation of formulations that may decrease but not eliminate non-medical use, but also ensuring appropriate prescribing of opioid analgesics and a more comprehensive, public health approach to the problem.

Jeanette M. Tetrault, MD

Reference:

Cicero TJ and Ellis MS. Abuse-deterrent formulations and the prescription opioid abuse epidemic in the United States: lessons learned from OxyContin. JAMA Psychiatry. 2015;72(5):424–430.