Abstract 1842P
Background
Information on drug-drug interactions (DDIs) from clinical trials is non-exhaustive and the risk to include patients with prohibited medications does exist. It was decided to conduct medication reconciliation (MR) by pharmacist during screening period or prior to the enrollment of patients, before starting investigational treatment. The objective of this study is to evaluate the impact of medication reconciliation.
Methods
All patients enrolled in early phase trial receiving MR by pharmacist between September 2015 and February 2020 were included. To conduct MR, a minimum of 3 sources were used to perform an exhaustive list of medications: patient’s medical record, patient interview and community pharmacy dispensing history, including over-the-counter medications, herbal drugs and food supplements. Protocols and investigator’s brochures provided by the sponsor were consulted to define prohibited or monitored drugs. DDIs of drugs commercialized were checked mainly using FDA or Geneva University Hospital drug interaction lists and interaction analysis websites.
Results
In this study, 501 MR were conducted in 469 patients. The median number of drugs per patient was 5 (range 0-17). A total of 1093 drugs (38%) were discovered by pharmacist in 380 patients (76%). Pharmaceutical analysis identified 350 DDIs (12%): 193 monitored drugs and 157 prohibited. More than half of the prohibited medications were herbal drugs, 12% alimentary tract and metabolism drugs, 11% cardiovascular system drugs, 9% nervous system drugs. Most prohibited drugs were stopped and 6% substituted. Among prohibited or monitored drugs, 53% were revealed by MR and unknown by oncologists.
Conclusions
MR reduces the risk of DDIs with the investigational drugs, limits protocol deviations by avoiding the co-administration of prohibited medications and helps secure patient care. Sponsors recognized benefits of MR and finance this activity in extra costs. MR takes place in multidisciplinary patient care through the collaboration between oncologists and pharmacists.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
N / A.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.