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War on Opioid-Abuse

February 5, 2016
New FDA Action Plan and call for more pain management education in medical schools.
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As the headlines continue to report, the opioid abuse epidemic shows no signs of easing. Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States—surpassing motor vehicle crashes.1

The government is increasingly taking multi-prong steps to try to address the epidemic—from a beefed-up action plan to evaluate and approve new pain medications to a resolution for more pain management education to be taught in medical schools.

Robert Califf, MD, the US Food and Drug Administration’s Deputy Commissioner for Medical Products and Tobacco, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. “The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief,” noted a press release from the agency.2

The FDA has committed to:

  • Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects
  • Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties
  • Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved
  • Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required    
  • Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements
  • Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products
  • Improve access to naloxone and medication-assisted treatment options for patients with opioid use disorders
  • Support better pain management options, including alternative treatments.3

As one of the cornerstones of this plan, the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. For example, the FDA has already asked the National Academy of Medicine to help develop a framework for opioid review, approval, and monitoring that balances individual need for pain control with considerations of the broader public health consequences of opioid misuse and abuse, noted the agency.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Califf. “This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis.”

In addition, the FDA will convene independent advisory committees made up of physicians and other experts when considering for approval any new opioid drugs that do not contain abuse-deterrent properties. The agency was widely criticized for the initial approval of Zohydro, a hydrocodone-only product for the treatment of moderate to severe pain that did not contain any abuse-deterrent properties.4 The product was later reformulated and contains technology that makes it harder to manipulate and abuse.5

The FDA is also strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. This requirement is key for researchers to examine the real risk of addiction related to these products. The agency expects this to result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. “The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose, and death,” noted the agency.2

 “Agencies from across the Department of Health and Human Services [HHS] and throughout the federal government are united in aggressively addressing this public health crisis,” said HHS Secretary Sylvia M. Burwell. “The FDA is a vital component to combating this epidemic, and the innovation and modernization they have committed to undertaking is an important part of the overall efforts at HHS.”2

Medical School Pain Education Lacking

For years, pain specialists have been calling for medical schools to add a pain management curriculum to their programs—and now Congress is taking notice. In a Senate meeting in February, Nora Volkow, MD, director of that National Institute on Drug Abuse (NIDA) in Bethesda, MD, highlighted the sad state of pain education. “If you're a veterinarian, you get much more training on how to address pain than if you're a medical student," she said.6

Veterinarians spend five times as many education hours focused on pain management as students in medical schools, she said. By contrast, U.S. medical schools allot a median of 9 teaching hours on pain and its management, compared to a median of 19.5 hours in Canada. In the U.S., that's approximately 0.03% of the total curriculum hours.6 According to the authors of the study, “in short, pain education was limited and fragmentary. Innovative and integrated pain education in primary medical education is needed.”7

One postgraduate program that has taken the lead in this area is the Pain Research, Education, and Policy (PREP) program at Tufts University School of Medicine, in Boston. In an interview with Practical Pain Management, founding director of the PREP program Daniel B. Carr, MD, said: “The PREP program is the first and only interprofessional postgraduate pain curriculum of its kind in the United States. Started in 1999, the program emphasizes pain as a public health issue and pain education as a public health imperative.”8

These also are emphasized in the National Pain Strategy prepared by the National Institutes of Health for HHS.  The strategy includes 6 areas of pain care, including: population research, prevention and care, disparities, service delivery and reimbursement, professional education and training, and public awareness.9

Silver Lining

This renewed effort falls within the context of a broad national campaign that includes a major initiative led by HHS. The initiative focuses on three promising areas: informing opioid prescribing practices; increasing the use of naloxone, building on the FDA’s recent approvals of injectable and intranasal naloxone; and using medication-assisted treatment to move people out of opioid addiction.

 “Things are getting worse, not better, with the epidemic of opioid misuse, abuse, and dependence,” added Dr. Califf. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Last updated on: March 1, 2016
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