ADA asks FDA to expand opioids efforts to include managing dental pain
July 18, 2017
Silver Spring, Md. — The ADA is asking the Food and Drug Administration to better address the nuances of managing dental pain in its opioid prescriber education and training programs.
In May, FDA requested public comment on the “FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain,” which broadens the current blueprint to include information on pain management, including the principles of acute and chronic pain management; nonpharmacologic treatments for pain; and pharmacologic treatments for pain (both nonopioid analgesic and opioid analgesic).
In comments filed July 17, ADA President Gary L. Roberts and Executive Director Kathleen T. O’Loughlin urged FDA to expand its efforts to include the “nuances of managing acute, short-term pain following a one-time outpatient surgical procedure, particularly in dental settings.”
In the letter, Drs. Roberts and O’Loughlin said that while the revised blueprint outlines core messages to be communicated to prescribers of extended release/long-acting opioids for chronic pain, the document is not “particularly relevant” to dentistry and urged the agency to develop a blueprint for educating prescribers of immediate release and short-acting opioid analgesics.
They also recommended FDA to expand its risk evaluation and mitigation strategy to include educating prescribers of immediate release and short acting opioid analgesics, noting that both recommendations are consistent with those developed at the May 2016 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.
“When indicated, a dentist may prescribe an immediate release and short-acting opioid to help manage acute pain following a one-time dental procedure (e.g., wisdom tooth extraction, etc.). But there is rarely, if ever, a need to manage chronic pain after dental surgery, much less to prescribe an extended release or long-acting opioid,” Drs. Roberts and O’Loughlin wrote.
Drs. Roberts and O’Loughlin also noted that many federal programs and activities have not sufficiently addressed the nuances of prescribing immediate release and short-acting opioids for acute pain versus extended release and long-acting opioids for chronic pain.
“We were pleased by a recent statement from FDA Commissioner Scott Gottlieb suggesting that the agency will be revisiting its risk management program to ensure opioid prescribing is better tailored to the medical indication,” Drs. Roberts and O’Loughlin wrote. “We are ready and willing to help you develop a risk management program that addresses the nuances of managing acute pain in dental settings.”
For more information about the ADA’s advocacy efforts with opioids education, visit ADA.org/opioids. The ADA is hosting a free webinar Aug. 9 from 2-3 p.m. Central time on Peer Assistance for the Dental Team Member with Opioid Dependency. To register, visit the website.