Sponsors of long-acting/extended release opioids are to submit their first assessment of prescribers’ understanding of the risks associated with the drugs by July 9, 2015, three years after Risk Evaluation and Mitigation Strategies for the products will have been operating and at a point when 25% of the drugs’ prescribers are expected to have received special training.
Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment
REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.
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