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.
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FDA tells sponsors to revise the indication for the ER/LA analgesics to highlight appropriate patient selection rather than severity of pain and orders post-marketing studies to identify a dose and duration-of-treatment associated with higher rates of abuse, misuse, addiction, overdose and death.
CME content must be developed without influence from drug companies, but FDA says it does not have the resources to write a blueprint for every risk management education program as it did for the opioid REMS.
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.