FDA's CME Expectations For Opioid Prescribers Keep Sponsors At A Distance
Manufacturers of long-acting/extended-release opioids must develop a blueprint for physician education in pain management with their products, but otherwise will be involved only at arms’ length in the doctor training portion of the Risk Evaluation and Mitigation Strategies.
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Opioid Physician Training Options Remain Limited After Initial Launch
FDA encourages physicians to take advantage of an educational program funded by sponsors of the analgesics as part of the REMS for extended-release opioid products, but only three programs were identified by the March 1 launch date, with Boston University taking the lead.
Opioid Training Syllabus Increases Emphasis On Patient Monitoring In Final REMS Blueprint
Prescriber training courses to be provided through continuing medical education venues are to be available by March 1, 2013. Changes from the draft are subtle, but indicate FDA’s focus on preventing incorrect use of the high-dosage narcotics and protecting patients.
Opioid REMS Requires Sponsors To Launch Prescriber Training CME Within 9 Months
By the third year of continuing medical education efforts, FDA expects 60% of those who wrote a prescription for a long-acting/extended-release opioid in 2011 to receive training.