1. Aschenbrenner,, Diane S. MS, RN


* In continuing to address prescription opioid abuse and overdose, the U.S. Food and Drug Administration (FDA) is focused on immediate-release opioids, which are frequently prescribed and may be a gateway to prescription and illegal opioid abuse.


* The FDA's current action plan includes policy changes within the agency, promoting the development of new abuse-deterrent generic opioids, and expanding provider education on opioid use and misuse.



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The opioid crisis in the United States has been called an epidemic. Prescription opioid abuse and overdose deaths continue to rise, and appear to directly correlate with increased sales of prescription opioids. Between 1999 and 2015, both U.S. sales of prescription opioids and deaths from prescription opioid overdose quadrupled.1 In 2015, nearly 40% of Americans over the age of 12 had used a prescription pain reliever (either as prescribed by a physician or by misusing prescription drugs).2 Ninety-one Americans die daily from opioid overdose, and nearly half of those deaths are related to prescription opioid overdose.1, 3 According to the Centers for Disease Control and Prevention (CDC), the opioids most commonly associated with overdose include methadone, oxycodone, and hydrocodone. Those most likely to die from overdose of a prescribed opioid are adults between the ages of 25 and 54 years, non-Hispanic whites and American Indians or Alaskan Natives, and men.1 Prescription opioid use is also a leading risk factor for use of illegal opioids such as heroin, with approximately three out of four new heroin users reporting having previously abused prescription opioids.4

Box. Understanding O... - Click to enlarge in new window Understanding Opioids with Abuse-Deterrent Properties.

In July 2017, the U.S. Food and Drug Administration (FDA) released an action plan to confront the growing problem of prescription opioid abuse and overdose, and released more details on this plan in September 2017. The plan is multipronged and includes proposals related to new opioid drugs as well as to opioids already on the market. It also builds on previous steps taken by the FDA to decrease the risk and incidence of opioid misuse and overdose. These prior actions include revising label warnings about the risk of addiction and death from opioid overdose; revising label warnings about the additive overdose risk if an opioid is combined with a benzodiazepine; creating a risk evaluation and mitigation strategy (REMS) program for extended-release opioids; using clearer language about potential risks in the medication guide that comes with each filled prescription; approving nasal spray formulations of naloxone; and encouraging the development of opioids with abuse-deterrent technology.


The FDA's revised plan heavily focuses on immediate-release opioids because, according to FDA commissioner Scott Gottlieb, "about 90 percent of all opioid pain medications prescribed-or 160 million prescriptions a year-are for [immediate-release] formulations."5 Introduction to immediate-release opioids is now understood to be a gateway to opioid misuse, abuse, and addiction.


The FDA's revised 2017 action plan includes6:


* Expanding the use of advisory committees. An external expert panel will now provide input prior to the approval of any new prescription opioid without abuse-deterrent properties, or with those properties if the formulation is new and unique. The pediatric advisory committee will also provide feedback on the labeling of opioids for pediatric use.


* Revising warnings and safety information on labeling. Changes to the labeling of immediate-release opioids will be patterned after those made to the labeling of extended-release opioids in 2013.


* Strengthening requirements after initial approval. The FDA will require drug companies to collect and report data on long-term use of extended-release opioids and the relationship of long-term use to opioid abuse.


* Updating the REMS program. Currently, drug manufacturers of extended-release opioids are required to fund continuing medical education (CME) for clinicians who prescribe these opioids. The CME must be based on a content outline supplied by the FDA. The updated REMS program will offer CME to those who prescribe immediate-release opioids as well. The FDA is also modifying the content of the CME curriculum to include safe prescribing practices and consideration of nonopioid alternatives. The intended CME recipients have also been broadened to include nurses and pharmacists. The possibility of requiring mandatory CME is also being explored by the FDA. The updated REMS program is expected to be fully implemented by the fall of 2018.


* Promoting access to abuse-deterrent formulations. Currently, drugs with abuse-deterrent formulations are available as trade-name drugs only. The FDA will provide guidance to encourage manufacturers of generic drugs to incorporate abuse-deterrent formulations.


* Supporting better treatments for opioid overdose. The FDA is considering how to ensure greater access to overdose treatment, and how to make naloxone products more easily accessible to the public.


* Reassessing the risk-benefit approval framework for opioid use. The FDA will actively seek input from its Science Board and from the National Academies of Sciences, Engineering, and Medicine to keep pace with the evolving understanding of the risks to the patient and the public of opioids.



Nurses have a key role to play in curbing the opioid abuse crisis. It is crucial to provide patients and families with accurate information on the safe use of prescription opioids. Nurses and NPs can find helpful information and resources online in order to become more familiar with the problems of opioid abuse and how to assess and converse with patients on the issue. The FDA sponsors a website for prescribers produced by the Partnership for Drug-Free Kids entitled Search and Rescue: Empowering Prescribers to Identify Opioid Drug Abuse. The website has numerous resources and tools for self-development and patient education to reduce opioid addiction. NPs may find especially helpful the short videos on how to have a conversation about suspected opioid misuse with both new and established patients in your practice. The resources can be accessed via the website's home-page:




1. Centers for Disease Control and Prevention. Opioid overdose: prescription opioid overdose data. 2017. [Context Link]


2. Center for Behavioral Health Statistics and Quality. 2015 National survey on drug use and health: detailed tables. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2016 Sep 8. [Context Link]


3. Centers for Disease Control and Prevention. Opioid overdose: understanding the epidemic. 2017. [Context Link]


4. Centers for Disease Control and Prevention. Opioid overdose: heroin overdose data. 2017. [Context Link]


5. Gottlieb S FDA takes important steps to stem the tide of opioid misuse and abuse. Washington, DC: U.S. Food and Drug Administration 2017 Sep 28. FDA voice; [Context Link]


6. U.S. Food and Drug Administration. Drugs. Information by drug class: FDA opioids action plan. 2017. [Context Link]