FDA Opens Opioid Education 'Blueprint' for Comment

Susan Jeffrey

November 04, 2011

November 4, 2011 — The US Food and Drug Administration (FDA) today released a draft "blueprint" to guide the development of prescriber training modules for the use of long-acting and extended-release opioid drugs.

The FDA is inviting stakeholder comment on the draft document, which will be incorporated into the final blueprint posted to the FDA site for ongoing use by continuing education (CE) providers in developing courses for the safe prescribing of opioids.

Developed by FDA with the input of other federal agencies, the blueprint "is a basic outline and the core messages that FDA believes should be conveyed to prescribers in a basic 2 to 3 hour educational module," the agency states in a Federal Register Notice.

Public Health Crisis

"Opioids are at the center of a major public health crisis of addiction, misuse, abuse, overdose and death," the notice, undersigned by Leslie Kux, Acting Assistant Commissioner for Policy at FDA, states. "FDA is taking action to protect patients from serious harm due to these drugs. This action represents a careful balance between continued access to these necessary medications and stronger measures to reduce their risks."

A new report released earlier this week by the Centers for Disease Control and Prevention states that the number of overdose deaths from opioid prescription pain relievers in the United States now outstrips those seen with heroin or cocaine combined.

The blueprint put forward today follows on an initiative that began in 2009, when the FDA sent letters to manufacturers of opioid drugs that a risk evaluation and mitigation strategy (REMS) would be required for certain of their products, the FDA notes. These included long-acting and extended-release brand-name and generic products formulated with the active ingredients buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol.

After informing the companies by letter, the agency held a series of meetings with stakeholders and convened an advisory committee to get input on what the appropriate elements of the REMS would be, the agency notes.

Then on April 19 this year, in conjunction with the Office of National Drug Control Policy release of the Obama Administration's comprehensive plan to address what is being called a national prescription drug abuse epidemic, the FDA sent letters to application holders directing them to submit a REMS within 120 days, as well as giving some direction on what to include.

"The central component of the Opioid REMS program is an education program for prescribers (e.g., physicians, nurse-practitioners, physician assistants) and patients," the FDA statement notes.

Specifically, they wanted to see information included on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. "In addition, the education must include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction."

The REMS notification letters stopped short of requiring prescribers to take these education courses as a prerequisite to continuing prescribing, but drug manufacturers will be required to provide unrestricted grants to accredited and independent CE providers to develop educational materials for prescribers that would be available at no cost to the healthcare providers.

"We believe having the training provided by CE organizations will be an incentive and will not create new burdens on prescribers because most healthcare professionals are routinely engaged in CE activity," the FDA statement notes.

Although prescribers are not obliged to take the training, "application holders will be required to establish goals for the number of prescribers who took the courses, collect the information about the number of prescribers who took the course, and report the information to FDA as part of periodic required assessments."

2- to 3-Hour Core

After the April REMS notification letter, an industry working group submitted potential topics to be covered, and this expanded outline would require 30 or more hours of education, the federal register statement notes. However, FDA's expects that the initial or basic REMS education would consist of a core content of about 2 to 3 hours.

"FDA has reviewed the industry submission and developed a basic outline and the core messages that FDA believes should be conveyed to prescribers in this basic educational module," the notice states.

After any feedback has been incorporated, the final document will be posted to the FDA's Web site for use by CE providers in developing these courses, and that's essentially where they will stop for now.

"Although FDA recognizes that additional training modules could be helpful, FDA's goal is to require basic education for all prescribers of long-acting and extended-release opioids, and at this time, FDA does not intend to develop or approve messages as part of the REMS beyond those approved in the basic core module," the agency states. Using this final blueprint, "CE providers can develop accredited CE in the manner they choose."


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