Learn Connect Succeed. JCAHPO Regional Meetings 2016

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1 Learn Connect Succeed JCAHPO Regional Meetings 16

2 Number of patients Number of eyes 1/18/16 Medication Adherence in Glaucoma: An Update Financial Disclosure The speaker has the following relevant financial relationships: Consultant: Aerie Pharmaceuticals; Inotek Pharmaceuticals James C. Tsai, M.D., M.B.A. President New York Eye and Ear Infirmary of Mount Sinai Delafield Rodgers Professor of Ophthalmology Chair of Ophthalmology, Mount Sinai Health System Key Points Role of IOP in Glaucoma Glaucoma Rx: inherent risk of non-adherence Multiple barriers to medication adherence Effective health communication and awareness can improve glaucoma adherence Empowered patient self-education Individualized approach targeting each patient s unique set of barriers Glaucoma is a multifactorial disease, but elevated IOP is still the major risk factor Decreasing IOP is the only proven Rx at this time (it is the main therapeutic effect of all current meds, lasers, surgeries) Paradox of IOP: 9% of pts with IOP may never have damage % of pts with glaucoma do not have IOP Low IOP Decreases Risk of POAG Progression Target Pressures < 15 mm Hg Often Needed in Advanced Glaucoma Mean IOP (mm Hg) Stable Progressed Mean IOP over 15 years Stable eyes Eyes that progressed Mao et al. Am J Ophthalmol. 1991;111: Shirakashi et al. Ophthalmlogica. 199;7:1-5. 1

3 Mean change in visual defect Patients (%) Mean VF Scores (db ± SE) 1/18/16 Sustained IOP Reduction < 18 mm Hg Reduces Risk of Vision Loss CIGTS: Medical vs. Surgical Therapy as Initial Glaucoma Therapy Advanced Glaucoma Intervention Study (AGIS) to 5% of visits < 18 5 to 75% of visits < to 1% of visits < 18 all visits < Follow-up month Mean IOP. mm Hg 16.9 mm Hg 1.7 mm Hg 1. mm Hg Medicine IOP approximately 8% Surgery IOP approximately 5% Time (mo) AGIS. Am J Ophthalmol. ;1:9-. Lichter PR, et al, and the CIGTS Study Group. Ophthalmology. 1;18: EMGT: Treatment Prevents Progression Risk Factors for Progression of Established Glaucoma (AGIS, EMGT) Risk of Progression of Glaucoma in Early Manifest Glaucoma Trial (EMGT) 1, Heijl A et al. Arch Ophthalmol ; 1: Untreated 5% risk reduction in treated patients 5 In treated patients Note: Treatment may have been suboptimal since no target IOP was established as a goal of therapy Risk Factors Older age Higher IOP (baseline) Higher IOP (over follow-up)? IOP fluctuation Race Disk hemorrhage Pseudoexfoliation The AGIS Investigators. Am J Ophthalmol. ;1:99-51; Leske et al. Arch Ophthalmol. ;11:8-56; Lichter et al. Ophthalmology. 1;18:19-195; Bergeå et al. Ophthalmology. 1999;16:997-15; Drance et al. Am J Ophthalmol. 1;11: Target IOP: Summary Perspective Challenges in Glaucoma Abundance of evidence that lowering IOP is beneficial to optic nerve and visual field Setting target IOP range consistent with evidence-based medicine Target IOP is dynamic concept, requiring constant reevaluation Preliminary guidelines for target IOP ranges Insidious, poorly perceived visual loss Therapy with more immediate side-effects Rx prevents (but does not reverse) visual loss Costs of chronic therapy and follow-up Average patient has other chronic diseases for which he/she takes additional medications Disparities in medical care / community outreach Damji KF et al, Can J Ophthalmol 1 Tsai JC. Medication adherence in glaucoma: approaches for optimizing patient compliance. Curr Opin Ophthalmol 6. 17(): p Tsai JC. A Comprehensive Perspective on Patient Adherence to Topical Glaucoma Therapy. Ophthalmology (11): p. S-S6.

4 1/18/16 Patient Concerns & Issues Concomitant Therapy in the Medical Management of Glaucoma Doctor, why me? Doctor, what can I do? Doctor, will I go blind? Doctor, will this drop work? Doctor, will I tolerate the drop? Doctor, can I take the drops correctly? Doctor, can I afford the drop? 5% % % % 1% % Compliance with IOP - Lowering Medication 9% Compliant % Compliant One Medication Multiple Medications (N = 1) (N = 1) in the long run, single drugs that do the work of more than one drug likely would enhance compliance. - George L. Spaeth, M.D. 1 1 Patel SC, Spaeth GL. Ophthalmic Surg. 1995;6():-6. Barriers to Adherence with Medical Rx Major Categories Affecting Glaucoma Drug Adherence Glaucoma patients at risk for non-compliance Taxonomy: classification of adherence barriers Identify situational obstacles to adherence Systematic interview of 8 patients 71 distinct situational obstacles abstracted Grouped obstacles into major categories Tsai JC et al, J Glaucoma Regimen factors (%) Provider factors (%) Patient factors (16%) Situational/environmental factors (9%) Accountability/lack of support Major life events Travel/away from home Competing activities Change in routine 16 Tsai JC, et al. Compliance barriers in glaucoma: a systematic classification. J Glaucoma,. 1(5): p Risk Factors: Follow-up Non-compliance Glaucoma Severity: Direct Costs (U.S.) Computer records of patients in residents eye clinic (random sample of glaucoma & glaucoma suspect) Compliant ( 6 mo.) vs. non-compliant (> 6 mo.) Telephone interview (196 non-comp., compliant) Knowledge of glaucoma & blindness (85.%, 88.%) Risk factors for visit non-compliance - Less severe disease (e.g. suspects) - Dissatisfied with waiting time (p <.5) - Non-adherence to prescribed Rx (p <.) Kosoko O, et al. Ophthalmology. 1998; 15: Stage Staging System (Bascom Palmer HAP system) Visits, surgeries, medications Avg. costs (pt/yr) ranged from $6 for glaucoma suspects to $511 for end-stage disease Meds: 61% of total costs Resource use & direct costs increase with worsening severity Lee PP, Arch Ophthalmol 6; 1: 1-19.

5 1/18/16 Social & Health Maintenance Costs Health Literacy & Adherence Estimated costs & QOL of late-stage glaucoma patients in European countries (France, Denmark, Germany, UK) Avg. maintenance costs of 8; x higher home help costs QOL positively correlated with level of visual acuity in best eye Thygesen J, et al. Curr Med Res Opin 8; : Patient survey / chart review & pharmacy refill data 8% read at/above 9 th grade level; 1% read at/below rd grade Positive relationship between health literacy & number of refills obtained Interventions targeting low literacy may improve medication adherence Muir KW, et al. Am J Ophthalmol 6; 1: -6. Screening for Barriers to Adherence: Five Determinants of Adherence 1. Importance and threat of the illness. Benefit of the treatment. Burden of the treatment. Knowing what to do and how to do it 5. Social and instrumental support and resources Reducing Medication Nonadherence Alert technician staff to patient comments Provide illustrated fact/dosing sheet Train patients to administer drops correctly Enlist others (e.g., caregiver) to assist patient Link dosing schedule to activities of daily living Address work-related issues Choose treatment that enhances adhererence Adapted from World Health Organization. Adherence to Long-term Therapies: Evidence for Action..Geneva, Switzerland. Tsai JC. Curr Opin Ophthalmol 6;17: Recent Adherence Literature (1) Recent Adherence Literature () Electronic dose monitors show low adherence in a significant number of participants 1 Effective health communication and awareness can improve glaucoma adherence Patients with severe glaucoma more likely to adhere to IOP-lowering regimen than those with milder disease Risk factors for non-adherence: Younger age, Black race, Worse general health status, Shorter duration of therapy, Lower self-reported adherence, Admitting to not following doctors orders Provider education about how to administer glaucoma drops and patient glaucoma medication adherence self-efficacy are associated positively with adherence 1 Patients with lower health literacy are less likely to express problems with side effects and eye drop administration Barriers associated with higher odds of non-adherence Forgetfulness (OR, 5.6; p.1) Decreased self-efficacy (OR,.7; p.1) Difficulties with medication schedule (OR,.9; p =.6) Difficulty instilling drops (OR,.; p =.) * For each additional barrier cited as important, there was a 1% increased odds of being non-adherent (OR, 1.1; p =.1). 1. Dreer LE, et al. J Glaucoma. 1; 1: -.. Glanz K, et al. Arch Ophthalmol. 1; Jun 11: Ung C, et al. Ophthalmology. 1; 1: Chang DS, et al. Ophthalmology. 1; 1: Sleath B, et al. Ophthalmology. 15; 1: Slota C, et al. Optom Vis Sci. 15; 9: Newman-Casey PA, et al. Ophthalmology. 15; 1:

6 1/18/16 Recent Adherence Literature () Real Benefits of Improved Adherence Electronic dose monitors (MEMS) show 79% adherence and self-report 9%; self-efficacy, motivation, dose frequency, and nonminority race/ethnicity predicted 5% of variance in MEMS 1 Glaucoma Treatment Compliance Assessment Tool: - Mean adherence percentage 79.9% - Health Belief Model statements, white race, older age, married marital status assoc. with higher adherence Physician understanding of patient medication use based solely on bottle cap color is frequent incorrect, particularly in patients with glaucoma who have color vision deficiency 1. Cook PF, et al. Ann Behav Med. 15; 9: Barker GT, et al. Am J Ophthalmol. 15; 159: Dave P, et al. Ophthalmology. 15 Aug 7 (Epub ahead of print). 6 Shared decision making about adherence - Action: active change in behavior - Maintenance: identify barriers & create solutions - Episodic relapses: reenergize behavior change Implementation of stage-specific interventions - Focus on patient psychology & readiness for change - Patient-centered solutions (individual responsibility) Support patient confidence / self-efficacy Hahn SR. Ophthalmology 9; 116: S7-S. Budenz DL. Ophthalmology 9; 116: S-S7. Patterns of Med Adherence ( yr. FU) The Patient s Individual Journey Retrospective, longitudinal cohort analysis US managed care plan: Age yrs enrolled for 7 yrs; newly diagnosed & treated for open angle glaucoma Medication possession ratio & group-based trajectory modeling (GBTM): Identify patterns of adherence Best adherence characteristics: white, older, earn > $6K, have more eye care visits (p<.5 for all comparisons) Those with higher initial copayment cost had lower adherence rates (β=-.6/dollar, p=.) Proactive approach embracing life & disease Empowered self-education and contemplation Every patient is a doctor after his cure (Irish proverb) Hope for the future / confidence in one s own abilities and help of physician partners in care 7 Newman-Casey PA, et al. Ophthalmology 15; 1(1): Hartmann CW, Rhee DJ. The patient's journey: glaucoma. BMJ 6. (7571): p Key Points Glaucoma Rx: inherent risk of non-adherence Multiple barriers to medication adherence Effective health communication and awareness can improve glaucoma adherence Empowered patient self-education Individualized approach targeting each patient s unique set of barriers 9 5