Controlled substance diversion in health systems: A failure modes and effects analysis for prevention

The purpose of this study was to demonstrate the utility of failure modes and effects analysis (FMEA) for systematically identifying potential sources of controlled substance diversion and developing solutions in an academic health system.

The FMEA was conducted by an 18-member cross-functional team from the department of pharmacy. The team developed scoring criteria specifically for controlled substance diversion, outlined the controlled substance processes from procurement to administration or disposal, and identified ways in which each step of the medication supply process might fail (failure modes) and result in diversion of controlled substances. Failure modes with a vulnerability score of 48 or 64 were considered highest risk and were immediately intervened on by the FMEA team.

The FMEA outlined a total of 10 major steps and 30 substeps in the controlled substance supply process. From this, 103 potential failure modes were identified, with 24 modes (23%) receiving a vulnerability score of 48 or 64. Development of specific reports addressed 15 failure modes, while 9 involved pharmacy workflow alterations. Notable reports included controlled substance activity under temporary patients and discrepancy trends by user, medication, and patient care area. Notable workflow alterations included expanded use of cameras in high-risk areas and additional verification checks.

FMEA allowed for systematic identification of controlled substance diversion opportunities, prioritization by level of vulnerability, and the development of targeted strategies to reduce risk of diversion.