Implementation of an Investigational Pharmacy-Led Process in a Pediatric Hospital Improves Investigational Drug Documentation on the Electronic Health Record Medication List

Background: During hospital admission and discharge, investigational drugs administered due to participation in clinical trials are at risk for medication errors if not accurately documented. Objective: The primary objective of this study is to assess whether investigational drug service (IDS) pharmacy-led investigational medication reconciliation during outpatient investigational drug dispensing improves the rate and accuracy of investigational drug documentation in the electronic health record (EHR) medication list. Methods: This retrospective study was conducted at Rady Children’s Hospital Orange County and compared investigational drug dispensing encounters in the pre-IDS period (August 1, 2022-July 31, 2023) to the IDS period (November 1, 2023-October 31, 2024). Differences between periods were estimated using binomial generalized estimating equations to obtain absolute risk differences, with robust standard errors to account for multiple prescriptions within patients. Results: Of 174 dispensed prescriptions, the investigational drug was documented on the EHR medication list for 27 of 90 drugs in the pre-IDS period (30.0%) and 80 of 84 drugs in the IDS period (95.2%; P < .001). Complete and accurate documentation increased from 6.7% to 95.2% for formulation, 21.1% to 94.0% for dose, 28.9% to 95.2% for route, 27.8% to 94% for frequency, and 7.8% to 95.2% for investigational drug alert (all P < .001). Conclusions: Baseline documentation of investigational drugs on the EHR medication list was low. Investigational drug service pharmacy-led documentation was associated with significant improvement in documentation rate and accuracy.