FDA to Re-Evaluate Opioid Policies

| Feb 15, 2016
Evidence from the Centers for Disease Control and Prevention (CDC) has identified that between the years 2000 to 2014, nearly half a million people in the United States died from drug overdoses, with the vast majority of cases associated with opioid analgesics. In response to this ongoing opioid analgesic abuse epidemic in the United States, the Food and Drug Administration (FDA) announced that it will be undertaking a comprehensive review of their activities, reassessing their strategy, and taking new steps designed at making a positive difference. These efforts will be taken in conjunction with other agencies, including but not limited to, the Department of Health and Human Services (HHS) and the National Academy of Medicine (NAM). Several broad areas of focus have already been identified.

Issue Perspective
Balancing Individual and Societal Risk  Balancing the individual’s need for pain control with considerations for the consequences to public health 
Revisiting Opioid Analgesic Labeling and Post-marketing Study Requirements  Ensuring labeling and post-marketing requirements adequately address the risks of opioid analgesic therapy 
Deterring Abuse and Mitigating Harm from Overdose Continuing to support abuse-deterrent formulations, as well as encouraging development of more effective abuse-deterrent features, and supporting the development, marketing, and access to countermeasures that can reverse overdose 
Prioritizing the Development of Non-Opioid Alternatives for Pain Relief Developing additional alternative medications that can alleviate pain without the addictive properties of opioids beyond what is available today
Refining Guidelines for Opioid Use Make efforts to support other agencies, such as those of the Surgeon General’s office and the CDC’s Guidelines for Prescribing Opioids for Chronic Pain, to engage the medical community in an effort to curb inappropriate opioid prescribing 
Developing a Better Base for Chronic Pain Treatment  Further research on the risks and benefits of long-term treatment with opioid medications 
The use of opioid analgesics in the workers’ compensation industry is commonplace for treating acute and chronic pain resulting from a workplace injury or illness when other medications are ineffective. Studies have found that approximately 65-85 percent of injured workers who receive pain medication in the United States receive opioid analgesics. Similarly, in our own book of business, approximately 60% of injured workers receive opioid analgesics for the treatment of pain related to their injury.

Helios has worked with clients for decades to proactively manage medication utilization at every stage of the claim. Our comprehensive programs are deliberately built to proactively address the use of all medications, including opioid analgesics, to make sure injured workers receive the right medication at the right time. As a result, in 2015, opioid analgesic utilization was reduced by 2.9% and opioid analgesic prescriptions reduced by 3.8%, while the morphine equivalent dose (MED) per prescription declined 7.4%.

We support efforts by stakeholders throughout the system to ensure injured workers receive safe and efficacious medication therapy. As additional information regarding changes to FDA policies concerning opioid analgesics becomes available, we will continue to keep you informed.

If you have any questions or concerns regarding this Clinical Alert, please contact our Clinical Services Team at


  1. Centers for Disease Control and Prevention (CDC). Increases in Drug and Opioid Overdose Deaths-United States, 2000-2014. 2016 (
  2. Califf RM, Woodcock J, Ostroff S. A proactive response to prescription opioid abuse. N Engl J Med 2016;:160204151225004.
  3. Workers Compensation Research Institute (WCRI). Interstate Variations in Use of Narcotics, 2nd Edition. 2014 (
  4. Helios. 2015 Workers’ Compensation Drug Trends Report. 2015 (

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