The new federal government effort to limit unnecessary prescriptions of opioids has at least 2 prongs that will affect psychiatrists. The first is the FDA dictate that manufacturers of the drugs develop risk evaluation and mitigation strategies (REMS) for their individual products, which include methadone and buprenorphine. REMS are dictated when the FDA has worries about a drug’s adverse effects or other risks, such as diversion, with the latter being the main driver. One component of REMS is a physician education program, which the manufacturer offers to a physician but which the physician may volunteer to take. However, the FDA wants the companies to establish and meet targets for voluntary physician participation.
The potentially more important prong is the announcement by the White House Office of National Drug Control Policy that it will work with Congress to pass new legislation requiring all physicians with Drug Enforcement Administration (DEA) registrations to undergo mandatory education on the use of long-acting and extended-release opioids.
“It is important for all clinicians to recognize that we share a major professional responsibility to ensure that opioids and other abusable medications are prescribed only for appropriate indications, that patients are followed closely, and that both patients and their families understand the risks associated with these drugs,” said John Renner, MD, chair of the American Psychiatric Association’s (APA) Council on Addiction Psychiatry. “This plan recognizes that public education and, specifically, patient and clinician education are critical to this new approach.”
However, the APA’s Council on Addiction Psychiatry has not recommended nor has the APA Board of Trustees adopted a policy that addresses this federal initiative or the need for the “extra” mandatory education for psychiatrists. One APA staffer, speaking about all the recommendations in the Obama strategy (formerly called Epidemic: Responding to America’s Prescription Drug Crisis) said, “It is a big document, and we would probably express some reservations to some of the stuff in there.”
Concerns about unnecessary opioid prescriptions and their diversion were at the center of the Obama administration strategy released on April 19. At a press conference that day, Gil Kerlikowske, Director of the White House Office of National Drug Control Policy; Howard Koh, MD, Assistant Secretary for Health, US Department of Health and Human Services; Margaret A. Hamburg, MD, FDA Commissioner; and Michele M. Leonhart of the DEA released the Obama administration’s comprehensive action plan (ie, Epidemic). It focuses on several key areas, including:
• Supporting the expansion of state-based prescription drug monitoring programs
• Recommending more convenient and environmentally responsible disposal methods to remove unused medications from the home
• Supporting education for patients and health care providers
• Reducing the prevalence of pill mills and doctor shopping through enforcement efforts
One strand of the enhanced physician education effort will emerge from the FDA requirement that all long-acting and extended-release opioids have REMS. These products are methadone (Dolophine), morphine (MS Contin, Kadian, Avinza, Embeda, Oramorph), oxycodone (OxyContin), hydromorphone (Exalgo), transdermal fentanyl (Duragesic), transdermal buprenorphine (Butrans), and oxymorphone (Opana ER). Companies must produce these REMS for FDA approval within 120 days, and they are expected to go into effect in early 2012.
In the REMS, manufacturers must describe their goals for the percentage of prescribers who complete the program at specified times. The FDA expects manufacturers of the class of long-acting and extended-release opioids to work together to provide the educational materials as part of a class-wide, single shared system to reduce the burden of the REMS on the health care system.
Although the FDA imposed the REMS requirement on the entire class of opioids, it had previously demanded REMS from certain manufacturers. One of those is Mallinckrodt, a subsidiary of Covidien, which markets Exalgo (hydromorphone HCl).
Lynn Phillips, manager of media relations for Covidien Pharmaceuticals, says the FDA asked for and approved REMS for Exalgo extended-release tablets when the drug was introduced in 2010. The REMS materials for Exalgo are posted on a Covidien Web site (www.exalgorems.com) and include the prescribing guide, medication guide for patients, a package insert, and an Exalgo Essential Information Form to test a physician’s understanding of the material. Additional educational materials and enabling tools that are not specific to Exalgo or any other specific product are available through www.caresalliance.org, also sponsored by Covidien. It includes a current opioid misuse measure, numeric rating scale, opioid clinical management checklist, and pain management and documentation tool.
A physician voluntarily decides whether to complete the Exalgo online Essential Information form. According to Phillips, “Over a third of the prescriptions written for the product are written by prescribers who have studied the educational materials for Exalgo and completed the training verification form.” Phillips declined to say what percentage of Exalgo prescribers are psychiatrists. She added that the REMS Covidien has produced for Exalgo “is generally consistent” with the REMS the FDA is now dictating for the entire class of opioids.
The FDA said it would not require mandatory physician education as part of the REMS education program because the agency is concerned that such a system would be overly burdensome on the health care system and could negatively affect access to these necessary medications. The FDA will, however, work with other agencies, chiefly the DEA, to develop legislation that Congress would pass. That legislation would require physicians to complete some sort of opioid prescribing education test to obtain a DEA license to prescribe controlled substances.
Erica Chabot, spokeswoman for the Senate Judiciary Committee, which has the lead role on DEA issues, said no legislation had been sent up there yet by the Obama administration “but we will be speaking with the administration about its ideas and proposals,” she added.