Impact of Medication Reconciliation in Oncology Early Phase Studies: A Drug-Drug Interaction Retrospective Study

Abstract

PURPOSE This study aims to investigate the impact of medication reconciliation (MR) conducted by pharmacists before patient enrollment and the initiation of investigational treatments. By implementing MR, the primary objective is to evaluate the extent to which the inclusion of patients with prohibited or not recommended concomitant medications in clinical trials can be significantly reduced. MATERIALS AND METHODS The study included all patients who participated in clinical trials and underwent MR between September 1, 2015, and September 1, 2020. To identify prohibited or monitored drugs, protocols and investigator’s brochures provided by the sponsor were meticulously reviewed and taken into consideration. RESULTS MR was performed for 501 patients, uncovering 35% of the medications they were currently taking. Through the pharmaceutical analysis, a total of 346 drug-drug interactions (DDIs) were identified, of which 188 required monitoring and 158 were strictly prohibited. More than half of the prohibited medications were herbal drugs. A significant portion of these prohibited drugs were discontinued, with only 6% being replaced by suitable alternatives. The implementation of MR played a crucial role in the identification of 51% of the prohibited or monitored drugs that were initially overlooked by oncologists. CONCLUSION MR is a highly effective measure aimed at reducing the risk of DDIs with investigational drugs, thereby minimizing protocol deviations and enhancing patient care. Sponsors of clinical trials value its implementation and recognize the substantial benefits it brings to the entire trial process. Consequently, many sponsors willingly provide funding to investigational sites that adopt MR as part of their standard practice, acknowledging its critical role in ensuring patient safety and maintaining data integrity throughout the course of clinical research studies.