FDA Releases New REMS Proposal for Opioid Prescription Oversight

Allison Gandey

June 29, 2010

June 29, 2010 — The US Food and Drug Administration (FDA) has unveiled a new plan designed to curb the misuse of prescription opioids. The long-awaited and controversial Risk Evaluation and Mitigation Strategy (REMS) for long-acting and extended-release opioids includes mandatory prescriber and patient education.

"The misuse and abuse of long-acting and extended-release opioid drug products have resulted in a widespread and serious public health crisis of addiction, overdose, and death," Bob Rappaport, MD, from the FDA's office of drug evaluation, said in a recent letter to advisory committee members. In addition to the clear human costs, an estimated 60% of hospital costs related to opioid overdoses are paid for with public funds.

The burden of education will likely remain with drug manufacturers.

"It is critical we find ways to intervene," Dr. Rappaport noted, "while maintaining the necessary balance to assure continued access to these important analgesic drug products for people with chronic pain."

Regulators have released their new plan in advance of an advisory committee meeting scheduled for July 22 and 23. They are seeking input from stakeholders and the public.

The new proposal is advocating more oversight, but the FDA has dropped a number of earlier ideas such as prescriber accreditation and patient registration programs.

Prescriber education is in the plan, but the burden will be on drug manufacturers to offer training and demonstrate improvements in prescribing through surveys.

Regulators say they will not require any formal prescriber enrolment or real-time verification of training.

Regulations Dropped

FDA officials say that in the long term, linking education to the existing Drug Enforcement Administration registration system "would more efficiently ensure appropriate education of physicians, but would require legislation."

More than 1 million prescribers are registered with the Drug Enforcement Administration to prescribe opioids. Approximately 700,000 of these prescribe long-acting and extended-release opioids.

The current plan suggests that patient education be left primarily to physicians. Clinicians will be encouraged by regulators and manufacturers to hand out patient education sheets.

The idea of a patient registration program to monitor people taking prescription opioids was nixed after a public outcry that such a system would be overly burdensome and create a stigma for pain patients.

An estimated 4 million patients are prescribed opioids annually. "Enrolling this many patients in a registration system would be an enormous undertaking with unpredictable effects on patient access," officials state in their proposal.

The plan is also advocating a medication guide to inform people of the safe use, storage, and disposal of long-acting and extended-release opioids. The medication guide would be provided to patients each time a prescription is dispensed.

Regulators acknowledge they are proposing a more limited strategy than previously discussed, but they say they intend to monitor the effects of the program and "may consider further steps if the REMS does not prove effective in curbing serious adverse outcomes resulting from inappropriate prescribing, abuse, and misuse."

The proposal is available on the FDA's Web site.

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