Defining Value in a Nontraditional Investigative Drug Service Pharmacy Model.

BACKGROUND: The current models for conducting clinical trials involve a multidisciplinary research team working collectively to deliver patient care. The investigational drug service (IDS) plays a central role in effectively conducting clinical trials involving investigational drugs. Traditional IDS pharmacists' responsibilities, as defined by the authors, may include medication management, site initiation visits, and the development of procedures that detail the IDS workflow. Nontraditional activities include patient counseling, providing supportive-care management, investigational drug and standard-of-care dose modifications, medication adherence assessments, and other clinical tasks. OBJECTIVE: To define the value of nontraditional IDS pharmacy practice through the evaluation of traditional and nontraditional IDS pharmacy metrics to expand the pharmacy IDS practice. METHODS: This multisite residency project was a retrospective data review conducted every October and November from 2018 to 2021 at a regional cancer center and its health system network locations. The data were collected for patients who were screened or enrolled in a clinical trial and received research-related services or investigational drugs. Throughout the study, a variety of IDS-related metrics were tracked longitudinally. The pharmacists' interventions were categorized as drug-drug interaction reviews, investigational drug counseling, dose modification/adverse event management, and miscellaneous interventions. RESULTS: Overall, there was an approximately 45% increase in the total number of studies open during the 4-year study duration. During the evaluated time period, the number of studies with the highest complexity level also increased, by 125%. Despite an increase in the number of open studies, the total number of dispensations decreased during the study period from 58 in 2018 to 42 in 2021, which occurred during the COVID-19 pandemic. After the implementation of standardized tracking for pharmacy interventions, a baseline for nontraditional IDS pharmacy activities was established at the institution. CONCLUSION: Based on the results of this study, nontraditional IDS activities provide a unique opportunity for the expansion of the IDS pharmacy staff's responsibilities beyond their traditional roles. Nontraditional IDS activities also provide potential opportunities for multidisciplinary clinical team integration and increased opportunities for direct patient care. [ABSTRACT FROM AUTHOR]