FDA Expands Safe Prescribing Program for Opioids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration will require that educational training in pain management and safe opioid prescribing be offered to all healthcare providers under a major expansion of the agency’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program.

REMS is also being expanded to include immediate-release (IR) opioids such as hydrocodone, oxycodone and morphine. Until now, REMS regulations only applied to extended-release and long-acting (ER/LA) opioid analgesics, such as OxyContin and Exalgo. Warning labels will be updated for all IR opioids, which account for about 90 percent of opioid pain medications.

“Many people who become addicted to opioids will have their first exposure in the medical setting,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements.”

The REMS program was first established in 2012. It required manufacturers of ER/LA opioids to pay for continuing education programs for prescribers only. Updated educational content must now also be provided to nurses, pharmacists and other healthcare providers who seek it. The training will cover broader information about pain management, including alternatives to opioids for the treatment of pain.

The training is not mandatory, but the FDA is considering whether to require continuing educational programs in pain management and safe prescribing.


“The agency believes that all health care providers 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 these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight,” the agency said.

“I think these changes to the REMS are very good and long overdue,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. “We know that the IR opioids are much more highly sought-after, versus ER/LA opioids, for purposes of abuse, and there is absolutely no reason why they (and their manufacturers) should be exempt from this requirement.  

“I’m not concerned, at this stage, about this change causing primary care providers to back off on prescribing, given that participation in the program is still completely voluntary for healthcare providers. If this voluntary status changes, and FDA finds a way to make REMS education mandatory, I will be concerned that some providers will opt out of prescribing opioids altogether.”

The FDA’s action greatly expands the number of opioid products covered by REMS from 62 to 347 opioid analgesics. The updated warning labels will strongly encourage providers to complete a REMS education program, and to counsel patients and caregivers on the safe use of opioid medication.

“Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines,” said Gottlieb.

Opioid prescriptions in the United States fell sharply during the first half of 2018 and now stand at their lowest levels since 2003, according to data released last month by the FDA. The trend appears to be accelerating as many doctors lower doses, write fewer prescriptions or simply discharge pain patients.

While opioid prescriptions decline, overdoses continue to rise. According to preliminary data from the CDC, nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl, heroin and counterfeit drugs, not prescription opioids.