PGY2 Oncology Pharmacy Resident Froedtert & the Medical College of Wisconsin Wauwatosa, Wisconsin, United States
Poster Abstract:
Background: Pharmacists are an essential member of the clinical trial team and investigational drug services (IDS). IDS pharmacists hold expertise in the operational preparation, handling and storage requirements of research drugs, and clinical knowledge to support medication screening, and patient education. Screening for concomitant medications is a preliminary step in clinical trial enrollment. There is a gap in clinical decision support systems and drug information databases to alert healthcare providers about drug-drug interactions with investigational drugs, highlighting the need for pharmacist expertise. IDS pharmacists are uniquely poised to obtain a precise medication history and perform this review. The concomitant medication review service was implemented at Froedtert & the Medical College of Wisconsin in 2016. When pharmacists became involved in this process, they were able to proactively rectify situations where patients presented for their first study treatment and could not start because they were taking a prohibited medication. Recommendations made by pharmacists include identifying prohibited medications and those that may be used with caution, checking metabolism pathways of medications and herbal supplements, identifying when washout periods will be necessary before starting study.
Objectives: Primary: Evaluate investigational drug service pharmacist recommendations in the concomitant medication review process for oncology investigational trials. Secondary: Assess the number of recommendations provided for oral investigational agents, and those for non-oral routes of investigational agents. Quantify pharmacist time spent conducting concomitant medication review services. Determine cost generating potential for adding a line item for pharmacists concomitant medication review to clinical research budgets.
Methods: Single center, retrospective review with observational time evaluation. Patients were included if they had been actively enrolled and started on a phase I, II, I/II or III oncology clinical trial in 2021-2023 and have a documented investigational medication review by a pharmacist. Patients were excluded if they were enrolled in a study but did not start on treatment. Preliminary
Results: Since 2016, investigational drug pharmacists have performed over 1,391 concomitant medication reviews. Preliminary results of this study randomly selected 25 patients with an average of 12 medications on their list at screening. Pharmacists identified on average 1.7 prohibited medications and 1.1 medications to be used with caution per patient. Pharmacists made 43 total recommendations regarding medication therapy. For oral medications, The prohibited medication recommendations were accepted by physicians 100% of the time for oral medications.
Conclusions: Pharmacists provide an integral role to ensure that patients enrolled in clinical trials are not taking prohibited medications.
References (must also be included in final poster): 1. The drug development process, step 3: clinical research. U.S. Food & Drug Administration. Last updated January 4, 2018. Accessed August 1, 2023. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#Clinical_Research_Phase_Studies 2. American Society of Health-System Pharmacists. ASHP guidelines for the management of investigational drug products. Am J Health-Syst Pharm. 2018; 75:561–73. 3. Hemetology/Oncology Pharmacy Association. HOPA Investigational Drug Service Best Practice Standards. 2014. 4. Drug interactions relevant regulatory guidance and policy documents. U.S. Food & Drug Administration. Last updated June 23, 2022. Accessed August 1, 2023. https://www.fda.gov/drugs/drug-interactions-labeling/drug-interactions-relevant-regulatory-guidance-and-policy-documents 5. Borad MJ, Curtis KK, Babiker HM, et al. The impact of concomitant medication use on patient eligibility for phase I cancer clinical trials. J Cancer. 2012;3:345-353. doi:10.7150/jca.4714
