The introduction of tamper-resistant opioid tablets in Australia has led to less tampering with the tablets, but it hasn’t had any significant impact on rates of opioid use or harms at a population level, new research shows.
“The opioid problem is complex, and tamper-resistant formulations are one part of a multipronged approach that is needed, incorporating both regulatory and clinical responses,” study investigator Briony Larance, PhD, of the National Drug and Alcohol Research Center, University of New South Wales, Sydney, Australia, told Medscape Medical News.
The study was published online January 11 in Lancet Psychiatry.
No Single Solution
The tamper-resistant formulation of controlled-release oxycodone rapidly replaced the non-tamper-resistant formulation after it was introduced in Australia in April 2014.
Dr Briony Larance
As part of the National Opioid Medication Abuse Deterrent (NOMAD) study, Dr Larance and colleagues analyzed data from multiple sources, including opioid sales data, multiple health datasets, annual surveys of people who inject drugs, and a cohort of 606 people who reported tampering with opioids before and after introduction of tamper-resistant oxycodone.
“To our knowledge, our study is the most systematic and comprehensive examination of the effect of a new opioid formulation to date, studying the impact of a tamper-resistant formulation of controlled-release oxycodone on population-level opioid use and opioid-related harm (overdose, help-seeking, treatment-seeking); and opioid use, tampering, and attractiveness of tampering among sentinel populations likely to tamper with pharmaceutical opioids,” the researchers write.
The investigators found that injection drug users were less likely to tamper with the crush-resistant pills and did not appear to switch to other opioids, such as heroin.
But at a population level, tamper-resistant oxycodone has had no effect on the rates of opioid use, the investigators found. Opioid use continued to tick upward at a similar rate before and after the introduction of tamper-resistant oxycodone. Tamper-resistant oxycodone also had no effect (positive or negative) on hospital admissions and overdoses or on help- or treatment-seeking behavior.
“As a population-wide strategy to reduce harm of overuse or overprescription of opioids, the introduction of tamper-resistant formulations alone will not be sufficient to affect these outcomes,” Dr Larance said in a statement.
“We need to enhance approaches to pain management and comorbidity, including improving access to nonmedication approaches,” said Dr Larance. “For people already experiencing problematic opioid use, improving the accessibility and attractiveness of treatments for opioid use disorders is essential, as are measures to reduce opioid-related harm, such as scaling up take-home naloxone programs,” she added.
Reconsider Assumptions
In a linked comment, Nabarun Dasgupta, PhD, of the Injury Prevention Research Center and Eshelman School of Pharmacy, University of North Carolina in Chapel Hill, notes that “drug use has been long recognized to be an interaction between drug, individual-level influences, and social context. The NOMAD study leads us to consider whether abuse deterrence is an inherent property of the drug itself, or its intended effect lies in an interaction with social context.
“In the NOMAD study, population-level changes in overdose rates were not statistically significant. If we [incorrectly] believe that a single product caused the opioid crisis, we are likely to be skeptical if that product’s replacement does not result in gross change. Perhaps we must reconsider our assumptions,” Dr Dasgupta suggests.
Funding for the study was provided by Mundipharma Australia, the Australian government, and the National Health and Medical Research Council. Dr Larance has received investigator-initiated untied educational grants from Reckitt Benckiser/Indivior for studies of buprenorphine-naloxone and buprenorphine depot and the development of an opioid-related behavior scale; and an untied educational grant from Seqirus for studies of tapentadol. The original article contains a complete listing of the other authors’ relevant financial relationships. Dr Dasgupta has disclosed no relevant financial relationships.
Lancet Psychiatry. Published online January 11, 2018. Abstract, Comment
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