Long-Acting Opioid Prescribing Might Require Mandatory Training

COLLEGE PARK, MD. — Special training in safe prescription of long-acting opioid drugs, as well as the use of patient-prescriber agreements, could be required to earn federal approval to prescribe such products, under proposals discussed by an industry working group.

The working group presented those and other options at a public meeting held Dec. 4 by the Food and Drug Administration. The meeting was part of an initiative to develop a class-wide risk evaluation and mitigation strategy (REMS) for long-acting opioid drugs.

The FDA last February informed manufacturers of long-acting opioid products that they would have to develop a single REMS for the drug class. The FDA wants to reduce the potential for abuse, misuse, overdose, and addiction associated with the products.

In one scenario, clinicians seeking Drug Enforcement Agency registration to prescribe schedule II controlled substances would beed to certify that they were trained to choose appropriate patients. Currently, no physician training is required for DEA registration. Giving the DEA such authority would require an act of Congress, according to one of the industry working group representatives.

“If some physicians would opt out of training, access to the drugs would be reduced for patients who need them,” said Dr. John Jenkins, director of the FDA's Office of New Drugs. The REMS program's goals are to assure that the drugs' risks don't exceed their benefits, while ensuring access for patients who need them, Dr. Jenkins noted during a press briefing after the meeting.

The drugs to be included in the REMS are brand name and generic products that contain fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.

The problems associated with those products include their use in patients who are nonopioid tolerant or otherwise inappropriately selected, as well as the drugs' misuse and abuse.

Short-acting opioid products are not included in the discussion. But meeting participants expressed concern that an effective REMS for the long-acting products could shift misuse and abuse to the shorter-acting agents.

Other ideas proposed by the group for the REMS included:

▸ A patient-prescriber agreement to facilitate discussion about the drugs.

▸ A medication-information sheet.

▸ Metrics to assess whether the REMS impedes patients' access to appropriate medication,

The working group made no conclusions at the meeting toward a final plan for the REMS.

Dr. Jenkins said he couldn't predict when the REMS would be finalized. But an FDA advisory panel will meet in the spring to discuss the elements of the proposed REMS, to solicit advice from experts, and to hear public comment, he added. Until a final REMS is approved, Dr. Jenkins said, the FDA will require an interim REMS for any other products in the drug class.