FDA's Guide To Mitigating Risks Of Long-Acting Opioids

Executive Summary

Because registries could have an adverse impact on patient access to long-acting and extended-release opioids, FDA is proposing a Risk Evaluation and Mitigation Strategy for the drugs that focuses on educating prescribers and patients about proper prescribing and use of the painkillers. The goal for the REMS is to reduce addiction, unintentional overdose and death resulting from inappropriate prescribing, misuse and abuse of the LA/ER products. If that does not occur with the education programs, FDA leaves the door open for a more vigorous risk management program. Below is a summary of FDA's proposal.