Abstract
Background: Governance of controlled drugs (CDs) in hospitals is resource intensive but important for patient safety and policy compliance. Objectives: To explore whether and how storing CDs in an automated dispensing cabinet (ADC) in a children's hospital intensive care unit (ICU) contributes to the effectiveness and efficiency of CD governance. Methods: We conducted a mixed-methods exploratory study, comprising observations, interviews and audits, 3 months after ADC implementation. We observed 54 hours of medications activities in the ICU medication room (with 42 hours of timed data); interviewed nurses (n=19), management (n=1) and pharmacy staff (n=3); reviewed 6 months of ICU incident reports pertaining to CD governance; audited 6 months of CD register data and extracted logs of all ADC transactions for the 3 months following implementation. Data analysis focused on four main CD governance activities: safekeeping/controlling access, documenting use, monitoring, and reporting/investigating. Results: Nurses and pharmacists perceived spending less time on CD governance tasks with the ADC. The ADC supported CD governance through automated documentation of CD transactions; 'blind counts'; automated count discrepancy checks; electronic alerts and reporting functionalities. It changed quality and distribution of governance tasks, such as removing the requirement for 'nurses with keys' to access CDs, and allowing pharmacists to generate reports remotely, rather than reviewing registers on the ward. For CDs in the ADC, auditing and monitoring appeared to be ongoing rather than periodic. Such changes appeared to create positive reinforcing loops. However, the ADC also created challenges for CD governance. Most importantly, it was not suitable for all CDs, leading to workarounds and parallel use of a safe plus paper registers. Conclusions: ADCs can significantly alter CDs governance in clinical areas. Effects of an ADC on efficiency and effectiveness of governance tasks appear to be complex, going beyond simple time savings or more stringent controls.