Comprehensive pharmacist-managed oral chemotherapy monitoring, education, and adherence program Becky Fahrenbruch, Pharm D, BCOP Fairview Maple Grove Medical Center Oncology Infusion Pharmacy Maple Grove, Minnesota Faculty Disclosures Becky has participated on advisory boards for Genetech, Lilly and Taiho. She is a speaker for Grifols. Objectives Explain the steps in developing a comprehensive oral chemotherapy program Discuss the pharmacist involvement and function in managing patients on oral chemotherapy Describe technician workflow in assisting patients on oral chemotherapy Summarize result of a retrospective review conducted at a large health system regarding pharmacist management of oral chemotherapy Why a Pharmacy Driven Program? Oncology Medical Director sought a system-wide pharmacist managed program Pharmacist group was developed to define new process Retrospective internal review (MD managed patient monitoring): 54% (cycle 1) 39.2% (cycle 2) 35.4% (cycle 3) Developing a Comprehensive Oral Program EPIC protocol development for oral regimens Patient educational materials Drug information sheets (including ASCO QOPI measures) Adherence calendars Guidelines for monitoring oral chemotherapy (drug specific) Workflow process for pharmacists and technicians Education of health care staff Patient Education Materials Patient Education Packet Fairview drug education Coping with. (diarrhea, n/v, neutropenia etc) Safe Handling of Oral Chemotherapy Medication Oral Chemotherapy Management Program Overview Cancer Clinic Pharmacy Liaison Services Overview and contact information Medication calendar if needed Patient satisfaction survey 1
Which of the following is helpful when developing an oral chemotherapy program?(objective 1) a)patient educational materials b)drug specific monitoring guidelines c)workflow for pharmacy staff d)all of the above Professional Education Pharmacist: Oral Chemo Process Modules 1:How to Verify/Check an Oral Chemo Order 2: How to Teach the Patient About Oral Chemotherapy 3: Monitoring the Patient 4: Plan for Monitoring Patient Adherence Technician Liaison Training Provider Oral Chemotherapy Management Program Workflow Overview Oral Chemotherapy Management Program Intro for Providers Provider 2
Pharmacist Management Pharmacist Patient Education Pharmacist Monitoring Pharmacist Monitoring Drug information & Monitoring Therapy Ends 3
Which of the following steps was included in the pharmacist managed oral oncology program? (Objective 2) a) Documentation done by lab technician b) Nurse in the exam room during education c) Oncologist education on oral chemotherapy d) Call back to patient after 3-5 days Financial Issue Financial burden of oral chemotherapies 1 in 10 patients abandoned their first prescription for an oral chemotherapy agent One quarter of patients were not able to receive their first oral chemotherapy and followed up with a second, potentially causing an unnecessary delay in treatment 1 in 4 patients filling prescriptions with cost-sharing amounts over $500 abandoned the prescription and did not receive another within 90 days Streeter SB, et al. Am J Manage Care. 2011;17(Suppl 5):38-44. Pharmacy Technician Pharmacy Technician Workflow Meet patient and discuss role Release e-scribe prescription to retail pharmacy to determine coverage and additional information: Participating pharmacy as determined by insurance Prior Authorization Coverage appeals Pharmacy Technician Workflow Determine if financial assistance is needed Discussion with patient Research options for financial assistance Private vs. Public Insurance Private Insurance or No Insurance Manufacturer sponsored assistance programs Public Insurance Co-pay assistance programs through various private foundations Obtain medication Sent to patient s home Available for pick up Pharmacy Technician Workflow Financial Assistance Where to start*? Criteria to be eligible Completion and submission of application Obtaining funds *Resources for pharmacist 4
Financial Assistance Foundations* Which of the following is a financial assistance foundation? (Objective 3) a) NeedyMeds b) Fairview c) Healthwell d) Preferred One *Resources for pharmacist Fairview Program Our program began system wide within Fairview in March 2013 Multi-site analysis designed to assess the impact of a pharmacist-managed oral chemotherapy program Primary outcome is adherence to recommended monitoring parameters Secondary outcomes including appropriate patient education, medication regimen adherence, and patient satisfaction. Design 238 ambulatory cancer patients receiving treatment at an outpatient cancer clinic Retrospective data was collected for 119 patients in a historical group (pre-implementation of a pharmacistmanaged oral chemotherapy program) 119 patients in an intervention group (post-implementation) Exclusion concomitant intravenous therapy counseling not done by a pharmacist enrollment on a study insufficient data for collection Medication # included # excluded Capecitabine 62 153 Sorafenib 27 8 Imatinib 16 55 Everolimus 26 11 Sunitinib 19 25 Temozolomide 13 18 Abiraterone 19 15 Erlotinib 19 16 Nilotinib 5 3 Vemurafenib 4 1 Pazopanib 28 20 Exclusion reasons: Concurrent IV therapy, RPh intervention (historical), not a new start to therapy (intervention), pt never started, incomplete records, study patient Results Adherence to Monitoring Parameters for Historical and Intervention Groups 90 Percentage 80 70 60 50 40 30 20 10 0 Cycle 1 Cycle 2 Cycle 3 -P value < 0.001 for all cycles MD Driven RPh Driven 5
Results Patient Education for Historic and Intervention Groups Education Physician Pharmacist P-value Parameter Documented Documented Name of Agent 94.12% 100.00% 0.0143 Dose 73.95% 100.00% <0.0001 Indication 92.44% 100.00% 0.0033 Schedule 77.31% 100.00% <0.0001 Lab/Toxicity 31.09% 100.00% <0.0001 Monitoring Frequency of 55.46% 99.16% <0.0001 Office Visits Safe Handling 0% 96.64% <0.0001 Missed Dose 0.84% 95.80% <0.0001 Food/Drug 4.20% 100.00% <0.0001 Interactions Side Effects 73.95% 99.16% <0.0001 Contact 10.92% 99.16% <0.0001 Information Adherence Based on patient report and assessed in the intervention group Each encounter following the initiation of therapy, patients were asked How many doses have you missed in the past two weeks? Adherence was reported as a percentage of doses taken during each two week interval Adherence will be compared with the commonly accepted definition of adherence, which is greater than or equal to 80%. Results Reported medication adherence as 99.59% (cycle 1), 99.86% (cycle 2), and 99.49% (cycle 3). Average overall 99.6% Patient Survey Nine 4-point Likert scale questions (strongly agree, agree, disagree, and strongly disagree) online or paper 1) I know when to take my medicine (ex: when and how many times a day) 2) I know how to take my medicine (ex: with or without food) 3) I know what to do if I miss a dose 4) I know about some of my medicine s possible side effects 5) I know who to call if I have questions about my medicine 6) The pharmacist listened to my concerns 7) The clinic pharmacist answered my questions 8) I was happy with the amount of time the pharmacist spent with me 9) I was happy with the amount of information the pharmacist gave me Survey Results Overall program scored 3.78 out of a possible 4.0 points 100% of respondents also agree the pharmacists listened to their concerns and were happy with the time the pharmacist spent with them and the information provided Patients who returned surveys, all agreed they know: When and how to take their medication What to do if they miss a dose Understand possible side effects Know who to call if they have questions Program Success In 2015 to date more than 4 million dollars in financial assistance has been obtained for Fairview patients Plan for publication Limitations Retrospective review, which introduces the possibility of observer bias Did not reaching adequate power due to the small number of patients collected in the historic group Patient self-report for medication adherence 6
Which of the following medications were included in analysis of the program discussed? (Objective 4) a) Capecitabine b) Thalidomide c) Afatinib d) Regorafenib Conclusion A variety of resources are needed when developing a comprehensive oral chemotherapy pharmacy management program Pharmacist and technician can have specific roles in managing oral chemotherapy patients Medication assistance programs exist to cover high outof-pocket costs for oral chemotherapy agents After implementing the program, adherence to monitoring for the first three cycles was statistically significant at 75.2%, 77.1%, and 75.3% References Aisner J. Overview of the changing paradigm in cancer treatment: oral chemotherapy. Am J Health-Syst Pharm. 2007; 64: S4-S7. Schwartz RN, Eng KJ, Frieze DA, et al. NCCN Task force report: specialty pharmacy. J Natl Compr Canc Netw. 2010; 8(suppl 4): S1-S12. Mosely WG, Nystrom JS. Dispensing oral medications: why now and how? Community Oncology. 2009; 6: 358-6. Hansen LA. Best practices in maximizing adherence to cancer therapy. The Oncology Pharmacist. http://www.theoncologypharmacist.com/article/best-practices-maximizing-adherence-cancer-therapy. Accessed June 3, 2012. Weingart S, Flug J, Brouillard D, et al. Oral chemotherapy safety practices at US cancer centres: questionnaire survey. BMJ. 2007; 334: 407. Simchowitz, B, Shiman L, Spencer J, et al. Perceptions and Experiences of Patients Receiving Oral Chemotherapy. Clinical Journal of Oncology Nursing. 2010; 14: 447-453. Regnier-Denois V, Poirson J, Nourissat A, et al. Adherence with Oral Chemotherapy: Results from a Qualitative Study of the Behaviour and Representations of Patients and Oncologists. European Journal of Cancer Care. 2011; 20: 520-527. Mancini R, Kaster L, Vu B, Modlin J, Wilson D. Implementation of a pharmacist-managed interdisciplinary oral chemotherapy program in a community cancer center. J Hematol Oncol Pharm. 2011; 1(2): 23-30. Simons S, Ringsdorf S, Braun M, et al. Enhancing adherence to capecitabine chemotherapy by means of multidisciplinary care. Support Care Cancer. 2011; 19: 1009-1018. Resources for Pharmacists www.needymeds.org www.panfoundation.org http://cancercarecopay.org rarediseases.org www.healthwellfoundation.org American Society of Clinical Oncology. The Quality Oncology Practice Initiative. http://qopi.asco.org/documents/qopispring2012measuressummary_000.pdf. Accessed June 15th, 2015.. 7