Evaluation and Enhancement of a Comprehensive Controlled Substances Management Process at an Academic Medical Center.

Purpose: Controlled substances management is highly regulated, and requires institutions to have processes in place to maintain a closed-loop. This study was conducted to comprehensively evaluate the current state of controlled substances management, propose optimization opportunities, and implement steps to align the medication use process (MUP) to a defined desired state.

Methods: This evaluation was conducted in 2 phases. In phase 1, the current state of controlled substances management was assessed in order to develop a gap analysis tool and failure mode and effects analysis (FMEA). In phase 2, a work group was assembled to address opportunities within the FMEA. The work group prioritized opportunities using the risk priority number (RPN), and formulated action steps to align processes with the defined desired state.

Results: Through the literature evaluation, a desired state, consisting of 86 segments, was defined and compared with a gap analysis tool. Direct observation of the MUP allowed for development of 13 process maps depicting current state. Of the 86 segments, it was determined the study institution had a compliance rate of 62%. The remaining 38% correlated with 55 actionable process opportunities that were included in the FMEA. To date, 31 of the 55 (56%) opportunities have been successfully addressed by the work group.

Conclusion: Use of direct observation to formulate a gap analysis tool and FMEA is an effective modality to evaluate controlled substances processes. These tools allow for pharmacy departments to identify and prioritize opportunities to optimize controlled substances management within an academic medication center.