Assessing Abuse-Deterrent Formulations: Much Work Still Remains

Faculty Perspectives in Chronic Pain: Epidemiologic Assessments of Abuse-Deterrent Formulations
Gary M. Owens, MD

The human toll from opioid-related abuse and misuse in the United States is a serious public health problem that must be addressed on all fronts. According to the American Society for Addiction Medicine, 46 Americans die each day from prescription opioid overdoses, which translates to 2 deaths per hour and 17,000 deaths annually.1 In addition, more than 8500 Americans die each year of heroin overdose.1 When these statistics are juxtaposed with data from the Centers for Disease Control and Prevention, which show that in 2012, healthcare providers wrote 259 million prescriptions for painkillers2—enough for every American adult to have a bottle of opioids—the magnitude of this public health issue becomes even more apparent.

Also important from the payer perspective is the cost associated with the epidemic of abuse. According to data published by Birnbaum and colleagues, total US societal costs of prescription opioid abuse were estimated at $55.7 billion in 2007 (USD in 2009).3 Workplace costs accounted for $25.6 billion (46%), healthcare costs for $25.0 billion (45%), and criminal justice costs for $5.1 billion (9%).3 Much of this human and economic burden may be prevented by concerted efforts to manage this pervasive, growing problem.

In the main article in this publication, the author explores the current evidence on the impact of opioid abuse-deterrent formulations (ADFs) on this crisis, concluding that, “The accumulated evidence from post-marketing epidemiologic studies of opioid ADFs describe declines not only in ADF abuse patterns, but also in unintentional therapeutic errors, accidental exposures, and diversion of prescription opioids.” In line with this decrease in abuse and diversion of ADF formulations, however, are data indicating that this decline has been associated with the increased abuse of other opioids and illicit drugs. In fact, a recent study by Larochelle and colleagues showed a 23% increase in heroin overdoses, which ran parallel to a decrease of 20% in overdoses of ADFs over the 2-year period of the study.4 Clearly, although a step in the right direction, the introduction of these formulations is not sufficient by itself to solve this escalating problem.

The opioid abuse and misuse epidemic must be tackled from all perspectives by all involved stakeholders. At a minimum, this approach must include the following:

  • Improved education of the public regarding the benefits and risks associated with medically prescribed opioids
  • Physician education about responsible prescribing of opioid medications, and the ways in which to monitor patients for signs and symptoms of abuse and misuse
  • Ongoing development of tamper-resistant products that will be difficult to abuse or misuse
  • Stricter regulations at the state and federal levels of prescribers and dispensing pharmacies
  • Collaboration among payers, dispensers, and prescribers to better manage opioid abuse and misuse.

With the collaborative, interdisciplinary efforts of the various teams involved, we can help to alleviate the substantial human and economic burden of this serious public health issue.

References

  1. American Society for Addiction Medicine. Opioid addiction disease: 2015 facts and figures. www.asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf?sfvrsn=0. Accessed May 9, 2015.
  2. Centers for Disease Control and Prevention. Vital signs: opioid painkiller prescribing. www.cdc.gov/vitalsigns/opioid-prescribing/. Accessed May 9, 2015.
  3. Birnbaum HG, White AG, Schiller M, et al. Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011;12:657-667.
  4. Larochelle MR, Zhang F, Ross-Degnan D, Wharam JF. Rates of opioid dispensing and overdose after introduction of abuse-deterrent extended-release oxycodone and withdrawal of propoxyphene. JAMA Intern Med. 2015;175:978-987.
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