Vulnerabilities for Drug Diversion in the Handling, Data Entry, and Verification Tasks of 2 Inpatient Hospital Pharmacies: Clinical Observations and Healthcare Failure Mode and Effect Analysis

Abstract

Objectives: Inpatient hospital pharmacies have a central role in managing controlled substances (CS) throughout the hospital medication use process (MUP). Our objectives were to identify vulnerabilities for diversion in the MUPs of 2 inpatient pharmacies, explore differences between the sites, and characterize the types of vulnerabilities identified.

Methods: We conducted clinical observations in 2 pharmacies to map their MUPs and performed a healthcare failure mode and effect analysis to proactively identify (1) the critical failure modes (CFMs) that make them vulnerable to diversion and (2) the controls that prevent, mitigate, or enhance the detectability of CFMs.

Results: We conducted 99 hours of observations between May-June and September-October 2018. We observed 36 pharmacy technicians, 4 pharmacists, and 1 clerk as they conducted tasks involving 4 processes common to both sites: procuring CS, receiving CS deliveries to the pharmacy, unit-dose packaging CS oral solids, and distributing CS to hospital units. The tasks and subtasks we mapped in the process flow diagrams led to the identification of 220 failure modes. Of these, 34 were deemed CFMs and were categorized as related to handling CS, data entry, or verification tasks. Three of the CFMs were unique to one site, given that the other site had a control for the CFM.

Conclusions: Multiple vulnerabilities for diversion exist in inpatient pharmacy processes. Our results provide some much needed detail about how specific vulnerabilities in MUP tasks and subtasks lead to an increased risk of diversion.

FIGURE 1

Description of the study design showing the integration of the clinical observations and HFMEA. Arrows show where results from one informs or is informed by the other.