Development of oral oncolytic nonadherence estimator (ORACLE): A pretreatment nonadherence risk assessment for oral oncolytics.

INTRODUCTION: To date, there is no adherence estimator to identify risk of nonadherence prior to initiating oral oncolytics. METHODS: A workgroup was assembled through the National Community Oncology Dispensing Association and tasked with creating a tool to meet this need. Tool constructs were defined after a review of the literature identifying top barriers to adherence. A second literature search was conducted to identify questions targeting specific barriers from validated adherence questionnaires. Once a finalized draft was complete, the risk assessment tool was built into an electronic survey where a risk category can be automatically calculated for the patient. RESULTS: The six most impactful factors affecting compliance to oral oncolytics were identified as patient's confidence, health literacy, perception of treatment, quality of life, social support, and complexity of chemotherapy regimen. A six-item questionnaire was created with five patient-directed questions and one clinician-directed question. Examples and descriptions were provided for clinicians to consider when categorizing complexity of a regimen. The tool was designed for responses to each question to be indexed into categories through a 10-point system. Results will be stratified into low, moderate, or high risk for nonadherence. CONCLUSION: The creation of a tool to predict nonadherence prior to starting therapy is an unmet need for patients initiating oral oncolytics. The aim of this tool is to meet those needs and better guide clinicians to provide patients with strategies to better manage nonadherence. Next steps include tool validation and piloting in clinical practice.

Oral Antineoplastics in Acute Myeloid Leukemia: A Comprehensive Review.

AML is a biologically and clinically heterogeneous disease that is associated with poor overall long-term survival. The expanding knowledge of genomic landscape in AML as well as advancements in molecular and chemical biology over the pathway in AML. After 40 years of stagnancy, the recent approval of numerous novel oral anti-leukemic agents for the treatment of AML has changed both the armamentarium of medications and treatment paradigms. These agents have unique clinical considerations in terms of administration, adverse effects, and monitoring parameters which may differ from clinician's historical expectations. Understanding the data, indication and clinical considerations for such novel oral anti-leukemic agents is paramount for clinicians caring patients with AML.

Financial Impact of Medically Integrated Pharmacy Interventions on Oral Oncolytic Prescriptions.

PURPOSE: As the utilization of oral cancer medications rises, it is vital that cancer centers track costs associated with these expensive medications. This research seeks to report the cost interventions associated with medically integrated pharmacies (MIPs) and mail-order pharmacies. METHODS: Data collection occurred from October 2016 through May 2021. Volunteers input data from their oncology practice into NCODA's Cost Avoidance and Waste Tracker tool, an innovative easy-to use tool that allows practices to document any cost saving interventions or waste occurrences. RESULTS: The Cost Avoidance and Waste Tracker tool was used by nearly 50 MIPs across the country. Specifically, 26 practices submitted cost avoidance data, and 37 practices tracked waste associated with oral oncolytic therapy. Among the 26 practices, 677 cost avoidance events led to a total cost avoidance of $7,057,053.73 US dollars (USD). The net cost avoidance for the MIP's was $6,510,971.28 USD compared with $546,082.45 USD for the external mail-order pharmacies. Among the 37 practices that reported waste, 768 events were reported, leading to a total drug waste of $11,275,642.16 USD. Of that, $8,935,612.15 USD was attributed waste from external mail-order pharmacies, whereas $2,429,592.01 USD worth of drug waste was reported from MIPs. CONCLUSION: Medically integrated dispensing of oral oncolytic therapies allows for increased pharmacy oversight, leading to increased cost avoidance and reduced waste for patients and third-party payers. Although these data are difficult to compare because of the complexity of workflows at different dispensing sites, the real-world financial differences between medically integrated dispensing and mail-order pharmacies appear to be significant.

Management of Adverse Events Associated with Cabozantinib Treatment in Patients with Advanced Hepatocellular Carcinoma.

Cabozantinib is an oral multikinase inhibitor whose targets include vascular endothelial growth factor receptors, MET, and the TAM family of kinases (TYRO3, AXL, MER). Cabozantinib is approved for patients with advanced hepatocellular carcinoma who have been previously treated with sorafenib, based on improved overall survival and progression-free survival relative to placebo in the phase III CELESTIAL study. During CELESTIAL, the most common adverse events (AEs) experienced by patients receiving cabozantinib included palmar-plantar erythrodysesthesia, fatigue, gastrointestinal-related events, and hypertension. These AEs can significantly impact treatment tolerability and patient quality of life. However, AEs can be effectively managed with supportive care and dose modifications. During CELESTIAL, more than half of the patients receiving cabozantinib required a dose reduction, while the rate of treatment discontinuation due to AEs was low. Here, we review the safety profile of cabozantinib and provide guidance on the prevention and management of the more common AEs, based on current evidence from the literature as well as our clinical experience. We consider the specific challenges faced by clinicians in treating this patient population and discuss factors that may affect exposure and tolerability to cabozantinib.

Evaluation of a Pharmacist Led Oral Chemotherapy Clinic: A Pilot Program in the Gastrointestinal Oncology Clinic at an Academic Medical Center.

Oral chemotherapy represents a major patient-centric advancement in therapy convenience. However, ownership of safe and correct administration of these agents requires significant patient education. To address this challenge, an in-person pharmacist-led oral chemotherapy education clinic in gastrointestinal oncology patients within an academic medical center was created and assessed. In this pilot program, a medication-specific quiz was administered to patients before and after education performed by a pharmacist to assess patient understanding of their new oral chemotherapy. A five-question satisfaction survey was also administered at the conclusion of the pharmacist clinic visit. Primary outcome was the percentage difference between pre-and post-education quiz scores. Secondary outcomes included patient satisfaction, time to treatment initiation, and number of pharmacist interventions. Frequencies and medians were used to describe categorical and continuous variables, respectively. Of the 18 patients analyzed, 50% were male and median age was 59.5 years. Approximately 28% had colon cancer, and 61% were treated with capecitabine. The median post-education scores improved from a pre-education score of 75% to 100%. Overall, seventeen of the eighteen patients responded with "strongly agree" to all satisfaction survey statements. An in-person oncology pharmacist-led oral chemotherapy education session demonstrated an improvement in patients' understanding of their new oral chemotherapy treatment.