4/26/2016. Disclosure. Institution. Objectives. Background. Background

Transcription

1 Pharmacist-led patient education: the impact of managing chemotherapy-induced nausea and vomiting (CINV) in ambulatory oncology patients Kristyn Gutowski, PharmD, RPh PGY1 Pharmacy Resident St. Vincent Healthcare Disclosure IRB Status: Approved Co-investigators: Sarah Hogue, PharmD Christopher Gilstrap, PharmD, BS Kristin Dimond, PharmD, BCPS Patrick Cobb, MD, FACP Conflicts of Interest: None Project Sponsorship: None Sisters of Charity of Leavenworth Health System, Inc. All rights reserved. 2 Institution Recognize the staffing difficulties associated with increased clinical responsibilities without supplementing distributive support in the ambulatory oncology setting Summarize the value pharmacist-led education can provide to patient care outcomes St. Vincent s Frontier Cancer Center (FCC) Billings, MT Serves an average of 115 infusion patients/week 340b facility Largely rural population 3 4 Study by Passik et al 1. Surveyed 255 chemotherapy-naïve patients and vomiting ranked among top 4 most-feared toxicities Despite antiemetic therapy, 30% of patients will suffer from breakthrough CINV events 1 Increased overall costs Uncontrolled CINV costs were $6,300/month in Guidelines to predict emetogenicity of chemotherapeutic agents National Comprehensive Cancer Network (NCCN) The American Society of Clinical Oncology (ASCO) Conducted drug utilization evaluation (DUE) Appropriateness of antiemetics 1. Passik SD et al. J Pain Symptom Manage. 2001;21(2): National Comprehensive Cancer Network. Antiemesis (Version ). 2. Carlotto A et al. Pharmacoeconomics. 2013;31(9):

2 Physician 4/26/2016 DUE Drug Utilization Evaluation Limitations Drug Utilization Evaluation Included 203 patients Prescribing practices met guideline recommendations: 49.2% Dr. A 43.2% Dr. B 48.3% Dr. D Dr. C 50.9% Dr. C Dr. D 53.4% Dr. B Dr. A Prescriber Guideline Adherence Adherence Nonadherence Patient CINV history Lack of differentiation between over/under prescribing Practice change in summer 2015 Push to use more oral agents Drug files entered by non-clinical staff (prior to July 2015) 0% 50% 100% Percentage of adherence 7 8 Pharmacist-led education Heart failure 1 Hyperlipidemia 2 Tuberculosis treatment 3 Diabetes mellitus, type 2 4 Determine the effect of pharmacist-led education regarding oncology patients breakthrough CINV Determine if patients are having breakthrough vomiting on the antiemetic regimen prescribed Determine the number of nauseous events patients have while receiving their chemotherapy regimen 1. Kalista T et al. J Am Pharm Assoc (2003). 2015;55(4): Ali F et al. Can J Clin Pharmacol. 2003;10(3): Clark PM, et al. Am J Health Syst Pharm. 2007;64(5): Al mazroui NR, et al. Br J Clin Pharmacol. 2009;67(5): Patient Eligibility Study Design Inclusion Criteria Receiving a single dose of the following agents in a single day of patient s cycle: Bendamustine Carboplatin Cisplatin Cyclophosphamide Doxorubicin Oxaliplatin 18 years of age Fluent in English Willingness to complete the MAT* Exclusion Criteria: Regimen beginning at a facility other than FCC < 18 years of age Unable to complete the MAT* Receiving a non-fda approved chemotherapeutic agent Five month prospective, randomized-controlled trial Simple randomization number generator Treatment 2 arms: Nurse-Led CINV education vs. Pharmacist-Led CINV education *MAT: Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool

3 Consent (n = 6) Randomization (n = 6) 4/26/2016 Study Design Nurse-led CINV education (n = 3) Patient completed MAT per chemotherapy regimen (n = 2) Patient withdrawals (n = 1) MAT returned to study investigators Treatment Education Checklist Pharmacist-led CINV education (n = 3) Patient completed MAT per chemotherapy regimen (n = 1) MAT returned to study investigators Patient withdrawals (n = 2) Management Directions for Taking Your Antiemetics Example: Endpoints MASCC Antiemesis Tool (MAT) Assessments Primary: 1. Number of breakthrough vomiting events Secondary: 1. Number of events in which a patient felt nauseous 2. Median rating of nausea experienced during first cycle of treatment Recruitment goals: Enroll 18 patients in each arm Need 6 patients per arm to meet power

4 MAT (con t) Assessments Nurse-Led CINV Education Arm ID # Y 1 0 N N 0 0 Y 2 Pharmacist-Led CINV Education Arm ID # ACUTE ACUTE DELAYED DELAYED Y 2 0 Y Discussion Discussion Power not met Statistical analysis inappropriate Type II error Only 6 patients enrolled 3 subjects withdrew: Emotional struggles Lost MAT Withdrew consent Strengths Standardized handouts based on regimen Consistent education process Consistent educator Increased visibility of pharmacist on infusion floor Strengthened relationships Limitations Geographical restriction Inability to blind Staffing limitations Limited access to records Low enrollment Inconsistent MAT return Inability to edit CINV regimen Off-site Conclusion Strengthened relationships Increased clinical presence Increased visibility Provided groundwork for pharmacist-patient interactions Conclusion Future Directions Increased pharmacist involvement with direct patient care Education Increased pharmacy staff Education of medical staff to improve guideline adherence Goal: collaborative practice agreement Allow pharmacists authority to change and/or prescribe antiemetics for all chemotherapy patients

5 Questions & Contact Information Recognize the staffing difficulties that are associated with increased clinical responsibilities without supplementing distributive support in the ambulatory oncology setting Summarize the value pharmacist-led education is able provide to patient care outcomes Kristyn Gutowski, PharmD (406)