Evaluation of a decentralized investigational drug service pharmacist in a cancer clinical trial infusion unit

Author:

Baroody Christina1ORCID,Sandler Melissa1ORCID,Hong Christine1ORCID,Madanat Yazan F1ORCID,Conley Stefanie1ORCID

Affiliation:

1. University of Texas Southwestern Medical Center, Dallas, TX, USA

Abstract

Introduction Investigational drug service (IDS) oversees and manages use of investigational products. There is limited data on utility of pharmacy services in clinical trial conduct and outcomes, specifically on the value of a decentralized IDS pharmacist. Methods This is a quasi-experimental study conducted in an oncology clinical trial infusion unit. A retrospective chart review was done to reflect current practice from January through June 2022. A decentralized IDS pharmacist was piloted in December 2022. Data collected included number and types of consults, personnel requesting the consult, and intervention performed. A satisfaction questionnaire was conducted after the pilot program. Results A total of 16.3% (173 of 1062 patient visits) of pharmacy consults were completed in the centralized IDS pharmacy model, while 44.5% (81 of 182 patient visits) of pharmacy consults were completed during the decentralized IDS pharmacist pilot, p < .001. Decentralized IDS pharmacist completed 77% (62/81) of the consults during the pilot period. Most common types of consults were toxicity management (20%), electronic medical record issues (17%), and tubing and drug administration issues (16%). More than 80% of respondents to the satisfaction questionnaire responded that implementation of a decentralized IDS pharmacist is acceptable, appropriate, and feasible. Conclusion This pilot study demonstrated that a decentralized IDS pharmacist in an oncology clinical trial infusion unit improved accessibility to an IDS pharmacist, increased pharmacy consults relevant to patient care and optimized centralized pharmacists medication distribution workflow. Further studies are needed to evaluate patient benefits from implementing decentralized IDS pharmacist in direct patient care activities.

Publisher

SAGE Publications

Subject

Pharmacology (medical),Oncology

Reference14 articles.

1. American Society of Clinical Oncology Statement on Minimum Standards and Exemplary Attributes of Clinical Trial Sites

2. ASHP Guidelines for the Management of Investigational Drug Products

3. Amin S, Lee J, Avila J, et al. HOPA investigational drug service best practice standards, http://www.hoparx.org/images/hopa/resource-library/professional-tools/HOPA16_IDS_Guidelines.pdf (accessed 20 July 2023).

4. Effects of pharmacist interventions on reducing prescribing errors of investigational drugs in oncology clinical trials

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