FDA to require manufacturers to train providers who prescribe immediate release opioids
September 28, 2017
Silver Spring, Md. — The Food and Drug Administration announced Sept. 28 that it will begin requiring manufacturers to train health care providers who prescribe immediate release opioids medications as part of the agency’s efforts to address the nation’s opioids crisis.
Immediate release opioids are used to treat acute pain and are often used in dental settings. They account for about 90 percent of all opioid pain medications prescribed, some 160 million prescriptions a year, FDA said. In July, the ADA 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." Previously FDA focused on extended release opioids used to manage chronic pain.
"FDA believes that all health care professionals involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving an opioid analgesic, they can help ensure that the product is properly indicated for the patient and used under appropriate clinical care," FDA Commissioner Scott Gottlieb, M.D., said in prepared remarks.
"In July of this year, we asked the Food and Drug Administration to expand its blueprint for dealing with opioid abuse to include looking at the ways dentists manage acute pain associated with dental disease and treatment," said Dr. Gary L. Roberts, ADA president. "Long-acting opioids used to treat chronic pain are not prevalently used in dentistry, nor are they particularly helpful for the kind of pain management issues dentists deal with. We are gratified that the agency took our comments to heart."
The FDA sent letters to the 74 manufacturers of immediate release opioid analgesics and said the drugs will “now be subject to the same regulatory requirements as the ER/LA opioid analgesic formulations.” The agency also said the manufacturers would “be subject to a more stringent set of requirements under a Risk Evaluation and Mitigation Strategy,” which will include mandates that training be made available to health care providers who prescribe immediate release opioids, including training on safe prescribing practices and consideration of non-opioid alternatives.
The July ADA comments were part of the FDA's request for public comment on "FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain." That document 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).
For more information about the ADA's advocacy efforts with opioids education, visit ADA.org/opioids.