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.
At a public meeting held by the Food and Drug Administration, the working group presented those and other options as part of an initiative to develop a class-wide risk evaluation and mitigation strategy (REMS) for long-acting opioid drugs.
In February 2009, the FDA 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 abuse, misuse, overdose, and addiction associated with the use of the products, and to ensure that their benefits outweigh their risks.
Under one element of the plan under consideration, clinicians seeking Drug Enforcement Agency registration to prescribe schedule II controlled substances would be required to certify that they were trained to safely prescribe and choose the appropriate patients for the drugs. Currently, a physician can obtain DEA registration without a training requirement. Giving the DEA such authority would require an act of Congress, according to one of the industry working group representatives.
Voluntary programs could be developed, possibly with medical specialty societies, while legislative efforts are underway, the working group noted.
Requiring such training raises the concern that some physicians would opt out of training—thus reducing access to the drugs for patients who need them, said Dr. John Jenkins, director of the Office of New Drugs, in the FDA's Center for Drug Evaluation and Research.
The REMS program's goals are to ensure that the drugs' benefits exceed their risks, while providing 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. Among the problems associated with those products include their use in patients who are nonopioid tolerant or otherwise inappropriately selected, as well as misuse and abuse of the drugs.
Dr. Jenkins cited the example of pain treatment with methadone—which, when taken too frequently, can result rapidly in an overdose.
Short-acting opioid products were not discussed, but meeting participants expressed concern that an effective REMS for long-acting products could shift misuse and abuse to shorter-acting agents.
The working group also proposed these ideas:
▸ A patient-prescriber agreement. This would serve as a tool to facilitate discussion between the physician and patient.
▸ A medication information sheet.
▸ Metrics to assess the impact of the REMS. There should be a measure to determine whether the REMS impedes patients' access to appropriate medication, the working group noted.
The working group made no definitive conclusions at the meeting and has not developed 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 product in this drug class.
My Take
Pain Treatment Could Be Restricted
Requiring physicians to undergo training in order to prescribe opioids would be a major impediment to the care of patients. Most of the physicians I have spoken to say they would not take such training and would instead simply stop prescribing the related drugs. The problem is that most of us have a few patients requiring long-term narcotics, but just a few, and most narcotic use in rheumatology is short term or limited long-term use (e.g., 20 tablets for 3-6 months).
The patient-prescriber agreement is important but is really only needed for patients using continuous long-term narcotics. The medication information sheet is a good idea, but what is the role of the pharmacist? In many states, the pharmacist has access to electronic records of narcotic prescriptions. Shouldn't they have the responsibility of notifying physicians of misuse?
It seems to me that the imposition of training and compulsory use of forms would not reduce the risk of addiction or improve detection of abuse, but it would add another layer of rules and make it more difficult to practice medicine and provide appropriate patient care.
ROY ALTMAN, M.D., is professor of rheumatology and immunology at the University of California Los Angeles. Dr. Altman reported having financial relationships with numerous pharmaceutical companies.