User acceptance and performance assessment of an opioid REMS system: a pilot study

Abstract

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. The objective of this study was to evaluate user acceptance and system performance of a REMS system comprising prescriber and patient education, stakeholder enrollment, and point-of-dispensing verification of safe-use conditions in patients receiving opioids. Four prescribers completed baseline assessments of risk knowledge, self-efficacy in managing opioid risks, and adherence to safe use guidelines. They also completed a 30-minute educational program on safe opioid prescribing and attested, using an online enrollment form, to following safe use guidelines. Patients completed similar baseline assessments (knowledge, self-efficacy, adherence) prior to their office visits and received education on general and product-specific safe use guidelines. Basic patient demographic information was entered into the REMS database. Eight patients and two prescribers were manually “de-enrolled” to test the ability of the system to discriminate “valid” (enrolled) from “invalid” (unenrolled) stakeholders. Prescriptions were filled at 1 of 2 study pharmacies, and as a part of the normal electronic adjudication process, the pharmacy claim was routed to the REMS database to verify enrollment. Prescribers and patients completed post-interventional surveys on risk knowledge, self-efficacy, and adherence to safe use guidelines, and all study participants, including pharmacists, completed a system usability survey. Enrollment is ongoing (target n = 16). Survey and performance data will be presented, and policy/public health implications will be discussed.