An overview of abuse-deterrent opioids and recommendations for practical patient care

Abstract

Despite advances in the treatment of severe intractable pain, opioids remain a critical and appropriate component of treatment. However, abuse, misuse, and diversion of prescription opioids are significant public health concerns. Opioid abuse-deterrent formulations (ADFs) are one component of an opioid risk management plan to manage patient's pain relief and quality of life while offering some protection against potentially harmful consequences of opioids from misuse and abuse. Opioid ADFs are designed to make manipulation more difficult and administration via non-oral routes less appealing. There are currently nine extended-release and one immediate-release opioid pain medications with US Food and Drug Administration-approved ADF labeling. All use physical/chemical barriers or agonist/antagonist combinations to deter manipulation and abuse. Evidence suggests that opioid ADFs decrease rates of abuse and diversion of opioids in the USA; however, some opioid ADFs are not yet commercially available or have not been on the market long enough to undergo post-marketing data analyses. Opioid ADFs along with the use of prescription drug monitoring programs, clinical assessment tools, toxicology testing, and co-prescribing of naloxone are all tools that can be used to reduce opioid abuse. Patient education on the risks of abuse and diversion is vital and includes a discussion of appropriate use of medication and proper storage. Physician assistants and nurse practitioners are on the "front lines" in battling opioid abuse and serve a key role in recognizing and mitigating the risks of prescription opioid diversion, abuse, and misuse (intentional and unintentional) and in identifying patients at risk for abuse while still providing pain relief to patients.

Keywords: abuse; abuse-deterrent; diversion; misuse; opioid.

Figure 1

Drug overdose deaths involving opioids from 1999 to 2016. Note: Centers for Disease Control and Prevention, National Center for Health Statistics. Multiple Cause of Death 1999–2016 on CDC WONDER Online Database, released December, 2017. Data are from the Multiple Cause of Death Files, 1999–2016, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed at https://wonder.cdc.gov/controller/saved/D77/D38F188.

Figure 2

Source where pain relievers were obtained for most recent misuse among people aged 12 years or older who misused prescription pain relievers in the past year. Respondents with unknown data for Source for Most Recent Misuse or who reported Some Other Way but did not specify a valid way were excluded. The percentages do not add to 100 percent due to rounding. Note: Data from Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044, NSDUH Series H-52). Rockville, MD. 2017. Available from: https://store.samhsa.gov/shin/content//SMA17-5044/SMA17-5044.pdf.

Figure 3

Strategies for developing abuse-deterrent formulations of opioids. Abbreviation: ER, extended-release.

Figure 4

Example handout for patients to help reduce diversion risks.