Benefits and Limits of Abuse-Deterrent Painkillers
By Hollie Hendrikson and Karmen Hanson | Vol . 24, No. 6 / February 2016
Did you know?
- Nearly 2 million people in the United States suffered from substance abuse disorders related to prescription opioid pain medicines in 2013.
- Women ages 45 to 54 have the highest risk of dying from a prescription painkiller overdose.
- Abuse-deterrent formulations of painkillers is one way to combat prescription drug misuse and abuse.
Abuse of opioid prescription products, meant to reduce pain, has been making headlines in recent years as a growing problem not only in rural and urban areas, but also across population groups. Policymakers looking for effective ways to reduce such abuse are employing various strategies, including setting up prescription drug monitoring programs. Another approach gaining attention involves encouraging or requiring the use of prescription drug formulas that can help deter abuse of opioid painkiller products.
Abuse-deterrent painkillers are formulations of prescription drugs that make them more difficult to chew, liquefy or crush—methods used to expedite a “high” from consumption. The U.S. Food and Drug Administration (FDA) has approved four extended-release prescription painkillers that can be marketed and sold for their abuse-deterrent properties. These drugs often are called “abuse-deterrent formulations” (ADFs) or “abuse deterrent opiates” (ADOs).
Extended Release Oxycontin and Extended Release Hysingla are more difficult to crush, break or dissolve. When crushed, the tablets form a viscous gel and cannot be easily prepared for injection. Extended Release Embeda and Extended Release Targiniq contain opioid antagonists. When crushed and snorted or injected, opioid antagonists are released to block some of the euphoric effects of the painkiller.
No formal studies currently demonstrate the effectiveness of abuse-deterrent prescription drugs on reducing drug overdoses or fatalities. The FDA requires pharmaceutical companies to conduct post-marketing studies to assess the effectiveness of the abuse-deterrent properties and to explore unintended consequences of the new drugs. These could include greater risk of abuse or addiction, changes in sensitivity to pain, and deaths associated with long-term use. It is important to note that, while abuse-deterrent formulas inhibit some of the ways users get high from the drugs, they do not affect the most common form of abuse—swallowing intact pills to achieve feelings of euphoria.
At lease nine states passed laws that relate to abuse-deterrent prescription drugs in 2015. Laws in Colorado, Nevada, Tennessee and Utah require state agencies or commissions to study the barriers to, and safety and efficacy of, using abuse-deterrent drugs to reduce prescription painkiller abuse. Maryland and Maine require health plans in each state to include abuse-deterrent drugs on any drug formularies or preferred drug lists. Maryland specifies that abuse-deterrent products must be on the lowest-cost tier of the insurance company’s formulary, while Maine’s law prohibits “an increase in enrollee cost sharing” by health plans to cover abuse-deterrent drugs. Indiana and Massachusetts require state drug licensing authorities to adopt standards and requirements for abuse-deterrent prescription drugs. Missouri’s law allows the Department of Social Services to consider making abuse-deterrent formulary versions of drugs available to prescribers to help mitigate addiction.
The U.S. Food and Drug Administration regulates labeling and marketing of abuse-deterrent prescription drugs. In April 2015, the agency released “Abuse-Deterrent Opioids: Evaluation and Labeling Guidance for Industry” to provide pharmaceutical companies information about the agency’s stance on abuse-deterrent prescriptions.
The Centers for Disease Control and Prevention has released a draft Guideline for Prescribing Opioids for Chronic Pain, to be released in early 2016. The document will provide recommendations and address the downsides of prescribing by primary care providers, who may have less experience treating chronic pain and selecting appropriate products and doses.
U.S. House Resolution 2335, introduced last spring, would require the FDA to deny approval of new oral prescription painkillers that do not have abuse-deterrent features. This resolution also would deny approval of generic oral prescription painkillers if an abuse-deterrent formulation of the same medication is currently on the market.
Seventeen members of Congress wrote a letter to Health and Human Services Secretary Sylvia Burwell last November to encourage the use of ADFs. The letter also asked the U.S. Department of Health and Human Services to study the idea of labeling requirements to educate physicians about proper ADF prescribing.
The American Academy for Pain Management has voiced concern about legislation that would mandate using only abuse-deterrent prescriptions, which may be more costly. In addition, automatically substituting new, non-generic abuse-deterrent painkillers for traditional opioids might limit the options for legitimate users of prescription painkillers.
While abuse-deterrent drugs may be less likely to help users achieve a physical high, clinical dependency or addiction to opiates and other drugs is a complicated disease. People with dependency also may have psychological addiction to the processes or behaviors associated with their drug use. For example, the behaviors and actions one must take before ingesting or injecting a drug may be just as important for the dependent person as the physical high he or she may experience. Abuse-deterrent products may play a part in reducing the chance for abuse; however, they may not reduce all opiate or prescription-related misuse and abuse.