1. Jacqueline Dunbar-Jacob, PhD, RN, FAAN Dean, School of Nursing University of Pittsburgh School of Nursing Center for Research in Chronic Disorders

2. “On Several Occasions I Have Been With My Brother Herodicus Or Some Other Physician To See One of His Patients, Who Would Not Allow The Physician To Give Him Medicine, Or Apply the Knife or Hot Iron To Him” - Plato (427? - 347 B. C.)

3. What is Poor Adherence? t Deviation from Optimal Prescription

4. Extent of the Problem

5. 50% of Patients Fail to Adhere t To Pharmacotherapy t To Diet t To Exercise Programs

6. t Decline in health status t Increase in disease complications t Relapse t Unnecessary hospitalizations t Loss of transplanted organs t Development of disease resistant organisms t Death Clinical Impact of Poor Compliance

7. Impact of Poor Compliance on Research t Lack of Study Power t Increased Sample Size Needs t Overestimate of Safety t Underestimate of Risks, Adverse Effects t Underestimate of Effectiveness t Increased Cost

8. Costs of Non-Compliance $ BILLIONS Hospital Admissions 25 Lost Productivity 50+ Nursing Home Admissions 5 Premature Deaths ?? Treatment Costs In Ambulatory Patients ?? TOTAL COSTS100+ Emerging Issues In Pharmaceutical Cost Containment 6/92

9. Why Do Patients Fail to Adhere Effectively?

10. Why Prescriptions Are Not Filled Task Force on Compliance (1994). Noncompliance with medications. Reproduced by permission of the Task Force for Compliance via the Copyright Clearance Center, Inc. 5% Not Available in Store 51% Did not need the medication 10.5% Other 10.5% Cost 21.7% Did Not Want to Take 2.8% Lost or Forgot It 22% Concerned about Side Effects 21% Thought medication Would Not Help 14% Cost 20% Condition Improved Upjohn SurveyAARP Survey

11. Cognitions/Beliefs t Readiness (TTM) t Beliefs about Disorders and Treatments (CSM)

12. Reasons for Poor Adherence Patient Perspective t Forgetting t Symptom Management t Schedule Disruptions t Adequacy or Completeness of Instructions t Multiple or Complex Regimens t Concerned About Side Effects t Condition Improved t Thought Medication Wouldn’t Help t Did Not Need Medication t Did Not Want to Take It t Lost Medication t Cost t Not Available In Stores

13. Relationship of Regularity of Routine and Medication Adherence ACT (Days Compliant): Once a Day Medication Taken At Bedtime Regularity of Bedtime Hours x 2 = 3.866 d  = 2p =.145 Regularity of Bedtime Routine x 2 = 5.996 d  = 2p =.050

14. Most of These Reasons Have Been Identified by Self-Report with Adherence Also Evaluated by Self-Report

15. What Does Poor Adherence Look Like?

16. Poor Adherence is a Variable Event Poor Adherence is a Variable Event

17. Once a Day Dosing Prescription 12 pm 10 pm x 8 pm x 6 pm 4 pm 2 pm Noon x 10 am x x x x x 8 am x x x x x x x x x x x x 4 am x    1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Days of Observation Actual Time   Extra Doses  Missed Doses

18. Twice a Day Dosing Prescription 5am 6am 7am 8am x 9am x 10am 11am 12N 1pm x 2pm x 3pm x 4pm x 5pm 6pm x 7pm x 8pm 9pm 10pm x x x 11pm x x x x x x x x x 12M x x x x x x x x x x x x x 1am x x x x 2am 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 Days of Observation Actual Time   Extra Doses  Missed Doses

19. Three Times a Day Dosing Prescription 5am x 6am 7am x x x x 8am x x x x x x x 9amx x x x x 10amx x x x 11am x 12N x 1pm 2pm 3pmx 4pmx x 5pm x x x x x x x x x x x 6pmx 7pm x 8pm 9pm x x x x x 10pm x x x x x x x x 11pm x x x x x 12Mx x x x x x x 1am x x 2am 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 Days of Observation Actual Time   Extra Doses  Missed Doses

20. Adherence Rates Smoking Medication ExerciseDietSmokersRelapse 1970’s50%50% 50%34.4%70-80% 2000’s50%50% 50%22.7%70-80%

21. Adherence Refers to Multiple Behavioral Errors

22. Types of Behavioral “Errors” t Failure to Adopt the Regimen t Early Stoppage of Treatment t Reduction in Levels of treatment t Over Treatment t Variability in the Conduct of Treatment t Dosage Interval Errors t Performance Errors

23. How Much of a Behavioral Deviation or Error Constitutes Poor Adherence? t Standard in the Field t Loss of Therapeutic Effectiveness

24. Is This Likely to be Influenced By Measurement Method?

25. Relationship of Adherence to Cholesterol Change %  Total Adherence Cholesterol p-value EEM 1.26.043 EEM 2.18NS 7-Day EEM 1.34.009 7-Day EEM 2.26.050 Pill Count.12NS 7-Day Recall 1.20NS 7-Day Recall 2.00NS 1 # pills 2 #pills in correct dosing interval

26. Correlation (r s ) Between Days Adherent and Clinical Outcomes Diary EEM Pain FSI-.091.265* MPI.151.120 Diary-.104-.108 Difficulty FSI-.091.172 Assistance FSI-.029.108 Symptom Rating Diary-.111.017 *p <.05 (two-tailed) RAC-1

27. MEMs Cap and Monitor MEMs ELECTRONIC MEDICATION CAP ADHERENCE

28. Thus, Poor Adherence Refers to Multiple Behavioral Errors at Varying Levels Occurring in Varying Patterns Due to Varying Reasons

29. Most of the Adherence Research Treated Poor Adherence as a Single Behavior with a Stable Pattern That is Primarily Due to a Motivational Deficit