1. Identify how oral chemotherapy marks a fundamental. 2. Are cancer patients adherent to oral therapy? A review of

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1 2. Are cancer patients adherent to oral therapy? A review of the published literature 3. Review the factors that influence patient adherence to oral chemotherapy 4. Discuss the challenges with respect to improving adherence to oral chemotherapy Rick Abbott, BSc.Pharm Regional Pharmacy Manager, Systemic Therapy St. John s, NL Rick.abbott@easternhealth.ca 1 5. Discuss how pharmacists can improve patient adherence to oral chemotherapy and how to incorporate this into your existing practice 2 Preventing Errors! To prevent medication errors: Oral Chemotherapy Challenges Chemotherapy Gone Wrong! 1. Physician must prescribe correctly 2. Pharmacist must understand and dispense the order correctly 3. The Nurse must administer the drug correctly We know that our systems sometimes fail! Taylor, J.A., Winter, L.; Cancer, Sept 15, 2006, Volume 107, Number year year-old woman with brain cancer died as a result of a lomustine overdose Physician had written a poorly legible prescription; 190 mg q 6 wks Pharmacist misunderstood the directions as daily for 6 weeks Patient s physician had not explained how to take the medication Hospitalized with severe bone marrow suppression and acute bleeding and died a month later 4 Oral Chemotherapy [2003] Advantages: Oral vs. IV Chemotherapy Accounts for less than 5% of all drugs used for cancer treatment They are expected to represent up to 25% in the next decade Nearly one quarter of the 200 anti-neoplastic neoplastic drugs in development are oral agents : 2009: 13/25 (52%) of drugs reviewed by JODR have been oral agents (Cancer Drug Access for Canadians, Can. Cancer Society, Aug 2009) Birner A. Safe administration of oral chemotherapy. Clin J Oncol Nurs. 2003;7: Patient convenience / preference Flexibility in dosing and scheduling Prolonging drug exposure Decreased resource utilization Altered toxicities Improved quality of life Am J Health-Syst Pharm Vol 64 May 1, 2007 Suppl 5 6 1

2 Oncologists Preference: Oral vs IV Efficacy with no increase in toxicities especially N-V and diarrhea Concerns Bioavailability of oral agents Compliance was also cited as a concern Patient Preference: Oral vs IV Reasons: treatment at home 57% avoidance of venepunctures 55% greater sense of control over t eir tx 33% > 80% of pts prefer oral chemotherapy NOT at the expense of efficacy Communication between health provider and patient. REVIEW: Oral Cancer Treatment: developments in chemotherapy and beyond 7 O Neill, VJ., Twelves, CJ., British Journal of Cancer, 2002, REVIEW: Oral Cancer Treatment: developments in chemotherapy and beyond O Neill, VJ., Twelves, CJ., British Journal of Cancer, 2002, Are cancer patients adherent to oral therapy? A review of the published literature 3. Review the factors that influence patient adherence to oral chemotherapy Compliance/Adherence What is Adherence? Extent to which a patient s behaviour corresponds with agreed upon recommendations from a healthcare provider 4. Discuss the challenges with respect to improving adherence to oral chemotherapy 5. Discuss how pharmacists can improve patient adherence to oral chemotherapy and how to incorporate this into your existing practice 9 Often referred to as compliance. Am J Health-Syst Pharm. 2007; 64(Suppl 5):S Compliance/Adherence The ADAGIO study aimed to Assess prevalence of Imatinib nonadherence in CML patients Non-Adherence: Adj Hormonal Tx 2414 women, 2005 to 2008 Examine relationship between treatment response and adherence levels Results: One-third of patients were considered to be non-adherent Only 14.2% of patients were perfectly adherent Patients with suboptimal response had significantly higher mean percentages of Imatinib not taken Noens et al. Blood.2009; 0: blood v1 11 Methods - refill history Non-adherence - < 80% of days covered with a prescription Tamoxifen and AI s Median age 64 yrs (40-98) Chan, A., Speers, C., O Reilly, S., Pickering, R., Adherence of adjuvant hormonal therapies Abstract #36, 32 nd San Antonio Breast Cancer Symposium, Dec

3 Non-Adherence: Adj Hormonal Tx Results: Non-adherence rate: - 40% Tamoxifen 42% & AI s 37% CANCER Studies of Adult Adherence to Oral Chemotherapy NO. Hematology 108 ORAL TX Prednisone Allopurinol Breast Cancer 51 Cyclophosphamide MEASURE RATE TIME FRAME Serum metabolites 20% 6 mon STUDY Levine 1987 Richardson 1988 Self Report 53% 6 mon Lebovits 1990 Factors Associated with non-adherence Older age Smaller Tumor size Lower Grade of Tumor Lower Rate of Adj Chemotherapy Lymphoma 21 Chlorambucil Prednisolone Dexamethasone Breast Cancer 53 Tamoxifen Breast Cancer 2378 Tamoxifen Breast Cancer 2816 Tamoxifen MEMS 100% 852 days Waterhouse 1993 Self Report 76% 6 mon Murthy 2002 Rx Refill Records Rx Refill Records 77% Rx filled 1 st yr 50% Rx filled 4 th yr 78% Rx filled 1 st yr 65% Rx filled 3.5 yr 4 yrs Patridge yrs Barron 2007 Non-Adherence Rates by Physician Grp Medical Onc 34% Breast Cancer 1633 Tamoxifen Breast Cancer 12,391 Anastrazole Clinical Notes; Audit Records; Cancer Registry Data; Rx Refill Records Rx Refill Records 93% 2.4 yr Thompson % 86% 1 st year 62-79% 3 rd year 3 yrs Patridge 2008 Radiation Onc 47% Breast Cancer 161 Capecitabine MEMS 76% took 80% doses 6 cycles Patridge 2008 Chan, A., Speers, C., O Reilly, S., Pickering, R., Adherence of adjuvant hormonal therapies Abstract #36, 32 nd San Antonio Breast Cancer Symposium, Dec Ruddy, K. et al, 2009; 59; pp Studies of Pediatric Adherence to Oral Chemotherapy CANCER NO. ORAL TX Leukemia or NHL 52 Prednisone ALL 31 Prednisone MEASURE Urinary metabolites RATE Overall 67% Adolescent 41% TIME FRAME STUDY NA Smith 1979 Urinary metabolites 58% NA Lansky 1983 Concerns One of the biggest areas of concern: Patient Adherence ALL MP ALL MP Variety 46 Variety Two metabolites in RBC s Two metabolites in RBC s Self report of missed > 1 dose 90% > 7 days Lennard % NA Lancaster % 50 wks Tebbi 1986 Drugs don t work in patients who don t take them! ALL and HL 50 Prednisone or prophylactic penicillin Serum dehydroepiandrosterone sulfate suppression 50% NA Tamaroff Ruddy, K. et al, 2009; 59; pp Journal of the National Cancer Institute, 2002, Vol 94, No Are cancer patients adherent to oral therapy? A review of the published literature 3. Review the factors that influence patient adherence to oral chemotherapy Case Study Adherence Example G.W. is a 63 year old male diagnosed with Stage III rectal cancer. Currently taking Capecitabine 825 mg/m2 = 1500 mg po bid x 6 weeks with radiation. 4. Discuss the challenges with respect to improving adherence to oral chemotherapy 5. Discuss how pharmacists can improve patient adherence to oral chemotherapy and how to incorporate this into your existing practice 17 During the weekly toxicity assessment clinic on week 5, he complains of diarrhea over the past week. He decided 4 days ago to stop the drug himself due to this adverse event. 18 3

4 Adherence Challenges Model of Adherence Which patients will not adhere to therapy? Over adherence is a concern, pts often have the misconception more is better. Toxicities and drug related problems can be a deterrent to adherence. Personal Factors emotional state health benefits social supports feelings about disease, self-efficacy & outcome expectations socioeconomic status Treatment Factors reason for therapy dosing schedule immediacy of benefit side effects costs Treatment Outcomes Bonadonna and Valagussa (1981, N Eng J Med), Pts who received < 85% of their prescribed adjuvant therapy had a shorter relapse free survival and overall survival times Journal of the National Cancer Institute, 2002, Vol 94, No 9 Patridge, A. et al 19 Interaction With Systems relationship with providers satisfaction with care insurance coverage convenience of clinics Ruddy, K. et al, 2009; 59; pp Interventions for Adherence Cochrane review by Beney et al revealed improved pt outcomes in 10 of 13 studies Due to Pt education by physicians, nurses and pharmacists Continuous dose observation is the most precise way to monitor adherence. Eg. IV therapy Adherence should never be assumed, even in oncology; every pt is at risk for non- adherence Every pt is at risk for non-adherence Ruddy, K. et al, 2009; 59; pp Are cancer patients adherent to oral therapy? A review of the published literature 3. Review the factors that influence patient adherence to oral chemotherapy 4. Discuss the challenges with respect to improving adherence to oral chemotherapy 5. Discuss how pharmacists can improve patient adherence to oral chemotherapy and how to incorporate this into your existing practice 22 Methods for Monitoring Adherence Direct Methods Directly Observe Therapy Pharmacokinetic Measurement Indirect Methods Patient Self Report Patient Diaries Pill Counts Pt. Refill History Electronic Medication Monitoring Authors of the NCCN report write Regardless for the method used to assess adherence, clinicians must realize that lack of adherence typically reflects the complexity of the regimen rather than willful or manipulative behaviour from the patient. Two types of non-adherent behaviours 1. Unintentional non-adherence due to forgetfulness or inability to follow directions poor understanding, regimen complexity, or physical problems. 2. Intentional or intelligent non-adherence the patient decides not to take the medication as instructed, due to adverse events and perceptions about the risks and benefits. Health beliefs, experiences and behaviour are associated with non-adherence in patients with chronic conditions. American Society of Clinical Oncology JULY 2008 jop.ascopubs.org Weingart SN, Brown E, Bach PB, et al: NCCN task force report: Oral chemotherapy. J NCCN 6:S1-S15, THE AUSTRALIAN JOURNAL OF PHARMACY VOL.88 OCTOBER 2007 Adherence assessment tools: Drugs don t work when they re not taken Debbie Rigby* 24 4

5 Signs and Predictors of Poor Adherence Missed Appointments, Inadequate Follow-up Poor Patient-Provider Provider Relationship Unfilled Prescriptions Adverse Effects from Medication, Medication Cost Lack of belief in Treatment Psychologic Problems, Particularly Depression Interventions for Improving Adherence Increased Accessibility to Healthcare More convenient follow up appointments Access to Pharmacists and Nurses Improved Dosing Plan Simplified schedule Supply dose dispensers or blister packs Reminders to take medications Education: Increase Pts Understanding Disease Characteristics Risks and benefits of treatment Proper use of medication Physician Initiatives Simplify oral regimen Increase the pts understanding of disease Listen to the patient Learn about drug cost Reinforce adherent behaviors 25 Ruddy, K. et al, 2009; 59; pp Technology Angela DeMichele: Interventions to boost adherence Technology cell phone programs & computerized pill boxes, remains an untapped resource 2008 study, found that adolescents who played a video game called "Re-Mission were more adherent to their oral chemotherapy Angela DeMichele, Compliance And Cost: Bitter Pills To Swallow In The Age Of Oral Chemotherapy. Science Daily, June 1 st, Assessing Adherence Morisky scale Assessing Adherence Morisky scale been used in research on adherence for more than two decades. four simple close-ended questions with binary response options (yes/no) The theory: non-adherence can occur because of forgetfulness, carelessness, stopping the drug when feeling better or when experiencing an adverse event. THE AUSTRALIAN JOURNAL OF PHARMACY VOL.88 OCTOBER 2007 Adherence assessment tools: Drugs don t work when they re not taken Debbie Rigby* 27 THE AUSTRALIAN JOURNAL OF PHARMACY VOL.88 OCTOBER 2007 Adherence assessment tools: Drugs don t work when they re not taken Debbie Rigby* 28 Adherence Monitoring 1. Tell me how you take your medications (i.e. what time of day and how many pills per dose?) 2. Do you ever forget to take your medications? (What do you do when you forget to take your medications?) 3. How many doses, if any, were missed last cycle? When you feel better, do you sometimes stop taking your medications? If you feel worse when you take your medications, do you stop taking them? 29 MASCC teaching tool Tool kit includes: 4 Key Elements 1. Key assessment questions 2. Generic education discussion points 3. Drug specific education 4. Evaluation questions to help ensure pt understanding Support Cancer Care; Sultan, K., Schulmeister, L., et al Published online: 10 July

6 31 32 Survey: Community Pharmacists Good News Bad News! Pt Counselling by Community PhC s Initial fill: 47% of respondents counsel pts Upon refill: 5.9% of respondents counsel pts Only 25% of respondents felt comfortable counselling pts on oral chemotherapy Good News Bad News Top Two topics discussed with patients Medication Directions & Compliance 33 The Future: What s Needed? The success of a home service depends on the communication between the team and the patient An effective home chemotherapy program will require increased resources and stronger linkages to the community. Pt selection is crucial for regimens that are planned for home delivery 34 Ruddy, K. et al, 2009; 59; pp A Field of Dreams! Policies / Guidelines Home Infusion Programs Learning Agreements Patients are taught the following Broad Selection Criteria Assessment for Patient Eligibility Mini Mental Status Examinations Consent to Home Chemotherapy Patient Learning Agreement Patient Teaching Guide Checklist for Eligibility 35 Drug information and SE Monitoring of Medication Administration Safe Handling and disposal Home Chemotherapy Precautions Contact numbers if problems arise This document is reviewed and signed by both the Health Care Provider and the Learner 36 6

7 The IDEAL Oral Chemo Pt. Possess good communication skills or have a reasonable committed care giver Can demonstrate a willingness and ability to comply with instructions Intellectual discipline and emotional wherewithal to commit to the oral chemo treatment program Barefoot, J., Blecher, C., Emery, R. Oncology Issues, May/June The IDEAL Oral Chemo Pt. Pts should be assessed with regards to: understanding of the importance of tx side effects of the tx how they will integrate the therapy into their schedule whether they can swallow the tablets or liquid the number of medication doses normally missed on a weekly basis where they obtain & how they pay for their Rx Barefoot, J., Blecher, C., Emery, 38 R. Oncology Issues, May/June 2009 Keeping Pace with Oral Chemo Need to develop new infrastructures that include: a system for patient selection a robust educational component to address safety and adherence pt follow-up to ensure toxicity management, adherence and treatment efficacy Barefoot, J., Blecher, C., Emery, R. Oncology Issues, May/June Are cancer patients adherent to oral therapy? A review of the published literature 3. Review the factors that influence patient adherence to oral chemotherapy 4. Discuss the challenges with respect to improving adherence to oral chemotherapy 5. Discuss how pharmacists can improve patient adherence to oral chemotherapy and how to incorporate this into your existing practice 40 Which statement best describes the practice at your center pertaining to patient safety and toxicity management in regards to IV and Oral therapy? 1. Patients receiving IV chemotherapy have a better standard of care. 2. Patients receiving oral chemotherapy have a better standard of care. Do you have Pharmacists in your chemotherapy suite doing toxicity assessments and teaching for patients receiving IV therapy? 1. Yes 2. No 3. Patients receiving IV and Oral chemotherapy are both getting the same standard of care

8 Are the patients you see in your chemotherapy suite being assessed by the oncology nurse with respect to toxicities? Questions / Comments / Experiences 1. Yes 2. No 43 rick.abbott@easternhealth.ca