DEA-Mandated Opioid Training Allows Dispensing To Be Unencumbered By REMS
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The prescriber education mandate envisioned as part of the Obama administration’s plan to curb prescription drug abuse could plunge the Drug Enforcement Administration into unfamiliar territory, although the agency seems eager to stay away from it. Legislation requiring prescribers to complete training on the safe use of long-acting and extended-release opioids as a condition of DEA registration was included in the plan. No bill has been introduced yet, but the plan sets April 2013 as the goal for passage (Also see "Implementation Timeline For Opioid REMS And National Rx Abuse Plan" - Pink Sheet, 25 Apr, 2011.). DEA, as mandated in the Controlled Substances Act, requires physicians to register if they want to prescribe those drugs, but does not actively determine whether they are fit to practice medicine. The agency relies on state licensing boards to enforce medical practice standards and registration is pulled if a prescriber loses their state license. Spokeswoman Barbara Carreno said DEA likely would not change that policy if the mandate is passed. “We’re cops. We’re not health professionals,” Carreno said. “Our role would be to decide what kind of evidence we’ll accept” as proof of completing the training. Over One Million Providers Impacted The plan, announced April 19, includes the DEA proposal as well as a new Risk Evaluation and Mitigation Strategy for the long-acting and extended release class of opioids. An education portion for prescribers was included in the REMS as part of its Elements to Assure Safe Use, but currently is considered voluntary. The administration said the training should be mandated, which would require legislation. Getting that bill passed without any changes is uncertain, however, since one member of Congress has already called the plan weak (Also see "Does Mandatory Opioid Prescriber Education Go Far Enough? Congress Might Say No" - Pink Sheet, 25 Apr, 2011.). FDA directed the opioid manufactures to come up with the training course, which will be done through the continuing medical education system. It is expected to include information on patient selection and counseling and addiction recognition. The training would be a massive effort, assuming all DEA registrants eventually take the course. There were nearly 1.1 million practitioners listed in the agency database as of March, which includes physicians and dentists. Approximately another 186,000 registrants were considered mid-level practitioners, meaning they were nurse practitioners, physician assistants and others authorized to prescribe or dispense controlled substances. Registrations must be renewed every three years. Assuming the legislation requires all practitioners and mid-level practitioners to be trained, more than 428,000 registrants would need to take the course each year, on average, before their licenses expire. The Accreditation Council for Continuing Medical Education has told FDA it believes providing the training would be possible. It has 17 million registrants each year for courses offered (Also see "Opioid REMS: Sponsors Share Implementation, But Also Give Up Some Control" - Pink Sheet, 25 Apr, 2011.). Separate Verification Steps Not Required CDER Director Janet Woodcock said during a call for stakeholders on April 20 that she expected a registration system that eventually would seamlessly incorporate the CME verification into the DEA registration process. That likely would not change the dispensing process at the pharmacy, Woodcock said. “We expect if the legislation goes through this would be linked to the DEA registration and so the pharmacist only needs to do what they do now, which is confirm the DEA registration, depending on what the state laws are around prescribing controlled substances,” she said. Marcie Bough, senior director of government affairs for the American Pharmacists Association, said in an interview that an extra verification step would have caused a major problem for the pharmacy community. “One of the differences with this opioid REMS [and other risk management programs] is the very large number of prescribers and patients and pharmacies that it involves,” Bough said. “Requiring verification in a separate process would be a logistical challenge just because of the sheer number of prescriptions and patients and health care providers involved. “If they did it a different way, it could be a bigger burden on the health care system and potentially impact patient access,” she said. The education component of the risk management plan is directed at prescribers, but Woodcock also said pharmacists could help educate patients. “I believe that the pharmacist is the most trained now in maybe not the diagnosis of the pain states and so forth, but certainly in the use of the medication,” she said. “… They are generally the most knowledgeable about the characteristics of the medication.” |