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ADA offers opioids prescribing recommendations in FDA comments

March 27, 2018

Washington — The Association March 16 filed comments with the U.S. Food and Drug Administration offering ways the agency can improve opioid prescribing for dentistry.

"Dentists are most often faced with managing acute pain following dental surgeries," wrote ADA President Joseph P. Crowley and Executive Director Kathleen T. O'Loughlin. "It would be valuable to have educational content geared toward safely managing acute pain, which would include the safe and effective use of immediate-release and short-acting opioid analgesics."

In 2017, the FDA established the Opioid Policy Steering Committee and tasked it with making recommendations about how the agency can use its resources and authorities to reduce cases of overdose, misuse and abuse of opioid pain relievers.

"Until the Centers for Disease Control and Prevention develops a guideline for prescribing opioids for acute pain, the ADA recommends that dentists review and follow the relevant portions of the CDC Guideline for Prescribing Opioids for Chronic Pain," Drs. Crowley and O'Loughlin wrote.

In 2007, FDA was given the authority to require a Risk Evaluation and Mitigation Strategy from manufacturers of certain medications with serious safety concerns. A REMS may include one or more elements, such as requiring that drug packaging include a patient medication guide or that the drugs be dispensed only in certain settings. 

The ADA is recommending that the FDA use its REMS authorities to:

  • Require covered drug manufacturers to offer free continuing education that is acceptable for both Drug Enforcement Administration registration and state licensure purposes.
  • Tailor the educational content to the practitioner's scope of practice and the nature of the type of pain managed (e.g., chronic vs. acute pain, dental pain vs. medical pain, etc.).
  • Require covered drug companies to enter a cooperative venture to develop effective Prescription Drug Monitoring Program quality measures and make such state programs interoperable.
  • Require covered drug manufactures and/or pharmacies develop convenient ways for patients to safely secure, monitor and dispose of unused medications.

The ADA noted that these recommendations are consistent with the Association's July 2017 comments in regarding revisions to FDA's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids.

"We are pleased that FDA is revisiting its risk management program to ensure opioid prescribing is better tailored to the medical indication. We would welcome the opportunity to work with you on a risk management program that addresses the nuances of managing acute pain in dental settings," Drs. Crowley and O'Loughlin said.

For more information on the ADA's advocacy efforts with opioids, visit ADA.org/opioids.