Presenting Author: Clarissa Wilkins, PharmD, BCOP, CHRISTUS Health, Irving, TX
Co-Author: Alexandra Ritenour, PharmD, CSP, CHRISTUS Health, Irving, TX
BACKGROUND: Oral oncolytic therapy offers benefits such as ease of administration, fewer clinic visits, and enhanced quality of life. However, the monitoring of adverse drug reactions largely relies on patient self-reporting, which may result in undetected issues. The revised Edmonton Symptom Assessment System (ESAS-r), a validated tool used in outpatient cancer care, serves as a patient-reported outcomes measure to assess symptoms and therapy-related side effects. The implementation of the tool at the health-system specialty pharmacy (HSSP) level has yet to be extensively explored. Given their frequent patient outreach, specialty pharmacists may be ideally positioned to complete the ESAS-r for patients to assist with bridging care, proactively monitor medication safety, and provide patient education.
OBJECTIVE: To evaluate the implementation of a specialty pharmacist–led oral oncolytic monitoring program in an HSSP. The program utilizes the ESAS-r to capture, assess, and prompt interventions by specialty pharmacists aimed at addressing gaps in current oral oncolytic monitoring practices.
METHODS: This quality improvement project is a prospective descriptive study designed to evaluate a specialty pharmacist–led oral oncolytic monitoring program within an HSSP. Patients receiving an oral oncolytic drug from September 24, 2024, to November 23, 2024, from the CHRISTUS Specialty Pharmacy (CSP) were included in the pilot study. To integrate the ESAS-r into the CSP workflow, a flowsheet was developed for use in conjunction with routine clinical assessments. Based on the ESAS-r score, the pharmacists’ interventions were implemented, including patient counseling or provider outreach, as clinically appropriate. The primary end points used descriptive statistics to evaluate the type and quantity of the pharmacist interventions. The secondary end points examined the frequency of symptom severity, average symptom scores, and the average time spent by the specialty pharmacist completing the oral oncolytic monitoring program.
RESULTS: A total of 76 patients were enrolled in the oral oncolytic monitoring program. The most common cancer types were breast cancer (20%), followed by chronic lymphocytic leukemia (16%) and prostate cancer (14%). Palbociclib (10.5%) and venetoclax (10.5%) were the most frequently received treatments. Of the total patients, 72% required an intervention, with patient counseling (42%) being the most common type. Among all reported symptoms and side effects, tiredness was the most frequent and severe.
CONCLUSION: The high number of pharmacist interventions required highlights a potential unmet need in patients receiving oral oncolytics. Implementing an oral oncolytic monitoring program that incorporates the ESAS-r allows for the HSSP to capture and proactively address patient-reported side effects. This pilot study suggests that specialty pharmacists could be an optimal stakeholder to address the gaps in current oral oncolytic monitoring practices.
- Moreira A, Bernardo C, Ramos C, et al. National trends in the use of oral chemotherapy over 13 years. Front Pharmacol. 2022;13:909948.
- Muluneh B, Deal A, Alexander MD, et al. Patient perspectives on the barriers associated with medication adherence to oral chemotherapy. J Oncol Pharm Pract. 2018;24:98-109.
- Fromme EK, Eilers KM, Mori M, et al. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the quality-of-life questionnaire C30. J Clin Oncol. 2004;22:3485-3490.
- Basch E, Deal AM, Kris MG, et al. Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol. 2016;34:557-565. Errata in: J Clin Oncol. 2016;34:2198; J Clin Oncol. 2019;37:528.
- Bruera E, Kuehn N, Miller MJ, et al. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991;7:6-9.
- Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000;88:2164-2171.
- Hannon B, Dyck M, Pope A, et al. Modified Edmonton Symptom Assessment System including constipation and sleep: validation in outpatients with cancer. J Pain Symptom Manage. 2015;49:945-952.
- Mackler E, Peterson L, Severson J, et al. Implementing a method for evaluating patient-reported outcomes associated with oral oncolytic therapy. J Oncol Pract. 2017;13:e395-e400.
- McNamara E, Redoutey L, Mackler E, et al. Improving oral oncolytic patient self-management. J Oncol Pract. 2016;12:e864-e869.
- Signorelli J, Bell C, Monaco S. Oral oncolytic monitoring pilot with patient-reported outcomes and adherence assessments. J Oncol Pharm Pract. 2022 Sep 16. Epub ahead of print.