Christopher Fortier, Pharm.D., FASHP; Erasmo Mitrano, , M.S., B.S.Pharm.; Michelle McCrea, B.S.Pharm.; Dena Alioto, B.S.Pharm.; Kulwant Gill, Pharm.D.; Jean Elrick, M.D.
Massachusetts General Hospital, Boston, Massachusetts
Controlled substance diversion is an area of major concern and renewed focus for organizations following heightened scrutiny by external agencies. Statistics show that more than 100,000 doctors, nurses, medical technicians, and health-care aides abuse or are dependent on prescription drugs. In September 2015, the Massachusetts General Hospital (MGH) settled with the Department of Justice for $2.3 million stemming from multiple controlled substance diversions and lack of timely reporting. The purpose of this initiative was to launch a comprehensive controlled substance diversion program enhancing multidisciplinary collaboration, exceeding state and federal statutes, and creating new and innovative surveillance methods.
Led by the Department of Pharmacy, the Drug Diversion Task Force, with representatives from pharmacy, nursing, anesthesia, compliance, police & security, general counsel, and human resources, was recommissioned to identify gaps and implement new processes in the areas of surveillance, end-user education, reporting, and auditing, in part through the purchase of multiple technologies. Additionally, a Diversion Response Team and a Pharmacy Controlled Substance Oversight Team were established.
Starting in early 2014, gaps were addressed and multifaceted strategies were implemented. A Director of Controlled Substance Surveillance and Compliance position was created to provide program oversight. Anesthesia workstations, biometric capabilities, and a control substance surveillance software platform were purchased. Active surveillance methods and dashboards were created specific to nursing anomalous user report compliance, operating room post-case reconciliation, discrepancy checks, medication overrides, and monthly trend reports by location, drug, and provider. Clinical provider competencies to be completed annually were initiated for all pharmacy, nursing, and anesthesia staff along with targeted staff education. Controlled substance utilization records were reviewed by an independent auditor to identify potential discrepancies. Annual inventories resulted in 1 discrepancy out of 288,190 medications reviewed (0.0003%) in February 2015 and 3 discrepancies out of 248,340 medications audited (0.001%) in March 2016. Additionally, a restructured reporting process increased regulatory reporting that resulted in 121 Department of Public Health (DPH) and 5 Drug Enforcement Agency (DEA) reports in 2014, 56 DPH and 10 DEA reports in 2015, and 20 DPH and 4 DEA reports through July 2016.
Through these efforts, the MGH diversion program resulted in multidisciplinary collaboration, improved quality, regulatory compliance, the development of proactive surveillance strategies, and creation of a new organizational culture around drug diversion. Departments of Pharmacy must provide organizational leadership for establishing and sustaining comprehensive control substance diversion programs.