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User acceptance and performance assessment of an opioid REMS system: a pilot study
N. Katz, E. Adams, K. Flynn, G. Strickler, J. Franco, S. Tikku, R. Edwards, T. Brown, R. Sage, A. McDonald, A. Sabo
The Journal of Pain, Volume 11, Issue 4, Supplement, April 2010, pS23
FDA is considering a class-wide REMS for extended-release (ER) opioids and methadone, but given that this would become the largest REMS (>20 million Rx's/year), successful implementation requires a new model that minimizes undue burden on healthcare providers, ensures appropriate access to patients, and documents relevant measures. Current enrollment verification systems that employ website lookup or interactive voice response (IVR) are viewed as cumbersome and not scalable. New systems must accommodate large volumes of prescriptions quickly and accurately and be integrated into the pharmacist's workflow to ensure compliance.