(150) Implementation of Pharmacy Medication Counseling Services for Phase I Investigational Agents

Poster Abstract:

Introduction: As of December 20, 2023, there are 31 active phase 1 studies at Roswell Park Comprehensive Cancer Center. Phase 1 clinical trials often involve increasing complexity due to the multi-part study design and unknown safety, tolerability, pharmacokinetic and pharmacodynamic properties of the investigational agent.(1) To ensure the clinical trial is conducted in a safe and effective manner, investigational drug service (IDS) pharmacists traditionally focus on logistical operations such as protocol management, regulatory compliance, drug accountability and ensuring safe preparation and dispensing of an investigational drug. A National Survey in 2017 demonstrated that medication counseling is one of the biggest performance gaps in clinical trials surveyed by pharmacists from multi-centers, which is an area that an IDS clinical pharmacist may be able to assist in bridging the gaps.(2)

Objectives: To examine the clinical impact and feasibility of an IDS clinical pharmacist-led counseling in the early phase research clinic on patient satisfaction and comprehension of a clinical trial. The initial a will assessment conducted after MD counseling, but prior to pharmacy counseling to establish a baseline and to evaluate the added value of pharmacist counseling.

Methods: This single-center, prospective survey was conducted at Roswell Park Comprehensive Cancer Center from September 1, 2023 to February 29, 2024. An eight-question knowledge assessment was provided to patients at three time-points: 1) prior to pharmacist counseling on the first day of treatment of cycle 1, 2) after pharmacist counseling during the first follow-up visit within cycle 1, and 3) on day 1 of cycle 2. The assessment response will be given raw value scores of 0 if they answer incorrectly, or 1 if they answer correctly for analysis. A satisfaction survey using a five-point Likert scale with values “strongly agree”, “agree”, “neutral”, “disagree”, and “strongly disagree” was also provided on the patient’s first follow-up visit within cycle 1. Baseline characteristics including age, race/ethnicity, language, diagnosis, IV/oral treatment, number of counseling performed, time spent preparing for counseling, and type of interventions will be collected, analyzed, and reviewed. Descriptive statistics will be utilized to analyze the results of the surveys and baseline characteristics. Thirty patients will be collected to reach the probability of McNemar’s test of 85%.

Results: Results pending and will be presented at the 2023 HOPA Annual Conference.
Discussion/

Conclusions: Conclusion/discussion pending and will be presented at the 2023 HOPA Annual Conference.

References (must also be included in final poster): 1. Brown JN, Britnell SR, Stivers AP, Cruz JL. Medication safety in clinical trials: role of the pharmacist in optimizing practice, collaboration, and education to reduce errors. Yale J Biol Med. 2017;90:125-133.
2. Khandoobhai A, et al. National survey of comprehensive pharmacy services provided in cancer clinical trials. Am J Health-syst Pharm. 2017; 74(Supplement 2): S35-S41.