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Regs and Eggs - October 17, 2019


The Balancing Act: Addressing the Opioid Crisis vs. Exacerbating Drug Shortages

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As I mentioned previously, the Trump Administration has taken numerous actions to address the opioid crisis. While ACEP supports many of the efforts currently underway—including potentially having Medicare cover medication-assisted treatment (MAT) in the emergency department—others may have unintended consequences, including exacerbating America’s drug shortages problem.

Unfortunately, many of you undoubtably have experienced a drug shortage in your emergency department. In fact, a recent ACEP survey found that nine out of 10 emergency physicians had experienced a drug shortage sometime within the last month, and nearly 70 percent found that drug shortages in their emergency department significantly increased over the last year.

Some of the medications currently in shortage are injectable opioids. Despite these shortages, the administration has doubled down on its efforts to tackle the opioid epidemic by reducing the amount of opioids that can be manufactured. Recently, the Drug Enforcement Administration (DEA) issued a proposed reg reducing the amount of five Schedule II opioid controlled substances that can be manufactured in the US:

  • Oxymorphone: 55 percent cut
  • Fentanyl: 31 percent cut
  • Hydromorphone: 25 percent cut
  • Hydrocodone: 19 percent cut
  • Oxycodone: 9 percent cut

While we support the DEA’s ongoing effort to make sure opioids are used for their intended purposes, we need to ensure patients in serious need of injectable opioids can receive these medications going forward.

ACEP formally responded to the proposed reg, urging the DEA to maintain current manufacturing quotas until the Food and Drug Administration (FDA)’s Drug Shortage Task Force completes its work and submits a report to Congress outlining recommendations for how to address the root causes of drug shortages.

As you may know, the FDA created a Drug Shortages Task Force last year directly as a result of ACEP’s advocacy efforts. We worked with members of the U.S. House and Senate to draft letters to then-FDA Commissioner Scott Gottlieb encouraging him to collaborate with stakeholders to identify solutions to the drug shortages problem. The FDA Commissioner established the Task Force within weeks after receiving the Congressional letters. Since then, ACEP and other interested parties have participated in discussions with the FDA but are still awaiting the release of the report.

We must find the right balance between cracking down on overprescribing and the illicit use of opioids while ensuring your patients have the medications they need.

I don’t think we’re there yet, but ACEP will continue to work with the administration on this critical endeavor.

Until next week, this is Jeffrey saying, enjoy reading regs with your eggs!

jeff headshot.PNGIf you have any questions or want to weigh in on other regulatory items, feel free to email me: jdavis@acep.org.

Jeffrey Davis is the Director of Regulatory Affairs at the American College of Emergency Physicians (ACEP). He manages ACEP’s formal response to federal policies and works with federal agencies and other stakeholders to help advance ACEP’s federal affairs agenda. Prior to that, Jeffrey worked in the Budget Office at the U.S. Department of Health and Human Services for nearly eight years. Jeffrey came to the Government as a Presidential Management Fellow, and in his position in the Budget Office, he advised top level officials on major budgetary and policy considerations within Medicare and prepared detailed analyses of Medicare regulations and legislation. Jeffrey has a Masters of Science in Health Policy and Management from the Harvard T.H. Chan School of Public Health and a Bachelors of Arts degree from Duke University.

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