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FDA Continues to Address Opioid Epidemic

March 15, 2017:

The latest step forward in the fight to reduce opioid abuse, addiction, and injury or death is the February 8, 2017, release of the Food and Drug Administration’s updated action plan to address the opioid crisis. The guidelines join other efforts by the FDA and other organizations to reverse the alarming trend that became apparent a few years ago of increased opioid use with catastrophic results for patients.

The action plan includes efforts aimed at consumers and providers. To promote informed consumers, the agency has clarified the labeling of immediate release and extended release/long-acting (ER/LA) opiates. It also provides education resources for patients who want information on their medications and offers a list of questions patients can ask their physicians about the drugs they are prescribed. The three primary questions are:

  • Why do I need this medication? Is it right for me?
  • How long should I take this medication? (Under this question, the FDA suggests patients ask about addiction, interactions, storage, and disposal of unused portions.)
  • Can I have a prescription for naloxone? (This medication is used to treat overdose by blocking the effects of opiates.)

On the provider side, the agency offers a link to the site “Search and Rescue,” which offers resources for prescribers to learn how to address drug misuse and abuse in their practices. The site, funded through an FDA grant to A Partnership for Drug-Free Kids, includes links to the state Prescription Drug Monitoring Program; videos on spotting drug abuse, using PDMPs, and case studies; and access to continuing medical education specific to prescribing ER/LA opioid analgesics.

One big push for the FDA is finding medications for pain that do not lend themselves to abuse. For example, in January of this year, the agency approved its eighth ER opiate analgesic with labeling describing its abuse-deterrent properties. In this case, the medication is Arymo ER, which has physicochemical properties that make abuse by injection difficult.

The efforts of the FDA, along with those of various other agencies and organizations, seem to be having the intended effects. According to a fact sheet put out by the American Medical Association in 2016, opioid prescribing in the United States fell 10.6 percent in 2015. Prescriptions to treat opioid use disorders rose by 11 percent from 2014 to 2015, according to the fact sheet. The number of physicians certified to treat substance use disorders has ballooned to 33,000—an 81 percent increase since 2012. Physicians have also greatly increased their use of prescription drug monitoring programs and sought education about opioid prescribing, pain management, and other related issues in greater numbers. There was also a more than tenfold increase in prescriptions for naloxone.


The ICD-10-CM codes for opioid abuse, dependence, and use fall under category code F11. Drug/substance abuse is characterized by recurring, excessive misuse of a drug accompanied by harmful and dysfunctional behaviors and negative consequences for health, psychosocial state, and employment. The use must have persisted for at least one month or occurred repeatedly within a 12-month period.

The provider must state the pattern of harmful usage (i.e., dependence, abuse, or use) and the current clinical state (e.g., uncomplicated, intoxication, remission, etc.) in the medical note. The relationship to any mental, behavioral, or physical disorder or the patient’s status or encounter must also be described. Documentation must identify the specific opiate and, for legal substances, indicate whether it had been prescribed.

For more information on the FDA’s action plan, visit https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm


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