1. To Take or Not To Take?

2. Adherence vs. Compliance Adherence: “the degree to which a person’s behavior coincides with medical advice” Adherence requires the patient’s agreement with the recommendations Compliance may suggest a passive approach by the patient to health care

3. Persistence Overall duration of drug therapy The interval between date of first Rx and point where patient would have insufficient supply of drug to cover days between Rx refills NEEDED: Hybrid Term Defines patient’s medication-taking behavior in terms of both duration & intensity

4. What is the most common type of dosing error? 1. Dose omission 2. Extra dose taken 3. Misscheduled dose 4. Incorrect dosage

5. How Much is Enough? “Adequate Adherence” Drug & disease dependent Most researchers use 80%

6. Lets Look at the Numbers 14% of all written prescriptions are never filled 13% are filled but never taken Chronic diseases: Adherence drops most dramatically after first 6 months 50% drop out of treatment Of those who continue, typical rates of adherence are 50 to 60%

7. Patients with which of the following diseases or conditions are most likely to adhere to their medications? 1. Diabetes 2. HIV 3. Seizure disorders 4. Organ transplant

8. What are the Consequences? Causes 125,000 deaths annually 10% of hospital and 23% of nursing home admissions are linked to nonadherence Nonadherence directly costs the US health care system $100 billion annually Annual indirect costs exceed $1.5 billion in lost patient earnings and $50 billion in lost productivity

9. Adherence Post MI Hospitalization Evaluated 1521 patient’s use of ASA, beta blockers & statins one month post hospitalization Patients who discontinued use of all medications had lower 1 year survival (88.5% vs 97.7%) compared with those taking 1 or more of the medication

10. Adherence Rates & BP Control Retrospective evaluation of >10,000 pt with coronary disease, followed a mean of 4.6 years Investigated causes of treatment failures 1/3 of cases: failure to intensify treatment 1/3 of cases: medication nonadherence 67% did not fill Rx despite therapy intensification Conclusion: Importance of communication between clinician & pt Arch Intern Med.2008;168(3):271-76

11. Evaluating Adherence How accurate are physician’s estimates of their own patient’s adherence? 1. 80% 2. 75% 3. 60% 4. 50%

12. Evaluating Adherence: Pill Counts Counting the number of remaining dosage units at clinic visits Advantages: Easy Inexpensive Objective Disadvantages: Patient must bring in all medications at each visit Does not capture information such as timing of doses & patterns of missed doses Patients can scam the system

13. Evaluating Adherence: Monitoring Pharmacy Databases Check when prescriptions are initially filled, refilled over time & prematurely discontinued Advantages: Relatively easy Relatively inexpensive Objective Disadvantages: Obtaining a prescription does not ensure its proper use Information data base may be incomplete

14. Evaluating Adherence: Patient Self-Report Patients can be accurate in reporting whether they are adhering to their medication treatment if they are asked simply & directly Advantages: Practical, easy No cost Disadvantages All patients may not be forthcoming Susceptible to error with increasing time between visits

15. Which of the following questions is likely to elicit a honest response? 1. “You are taking all of your pills, aren’t you?” 2. “Many people have difficulty taking their medications as prescribed. Do you have any problems taking your meds?” 3. “I know it is very difficult to remember to take medications on a daily basis. How often did you forget to take your (specific drug name) last week?”

16. Evaluating Adherence: Surrogate Markers Appointment records Physical assessment & laboratory monitoring

17. This I Know… There is no gold standard for measuring adherence behavior Use a multi-method approach that combines self-reporting and reasonable objective measures

22. And the Winner is……

23. Five Dimensions of Adherence Health system Social/economic factors factors Condition related Therapy related factors Patient related factors

24. Social & Economic Factors Poor socioeconomic status Illiteracy Age Race Lack of effective social support networks Family dysfunction Culture & lay beliefs about illness & treatment Cost of medication & health care

25. Health Care Team & System Related Factors Patient-provider relationship Level of and accessibility to health services (convenience factors) Cost issues Level of knowledge & training for health care providers on chronic disease management Lack of knowledge on adherence & of effective interventions for improvement Lack of incentives & feedback on performance in this area

26. Medical Science

27. Condition Related Factors Rate of progression & severity of the disease Severity of symptoms Level of disability Availability of effective treatments Co-morbidities such as depression & alcohol abuse

28. Therapy Related Factors Complexity of the medication regimen Duration of treatment Previous treatment failures Frequent changes in treatment Immediacy of beneficial effects Adverse effects Cost

29. Patient Related Factors Knowledge about the disease and its management Confidence in diagnosis and ability to engage in illness-management behaviors Self-perceived need for treatment and consequences of poor adherence Psychosocial stress Expectations

30. This I Know… Patients have many barriers facing them when it comes to taking their medications as prescribed There are no definitive predictors of nonadherence Every patient should be viewed as a potential poor adherer

31. Based on self report, what is the most common reason patients gave for not taking their medications as prescribed? 1. Cost 2. Forgetfulness 3. Adverse side effects 4. Not convinced of the need & value of the therapy

32. Strategies to Improve Adherence The entire health care system as well as patients need to better understand the clinical value of medication adherence & persistence

33. Strategies to Improve Adherence Therapy Related Interventions Patient Related Interventions

34. Therapy Related Interventions Simplify the regimen Adherence declines significantly as the dosing frequency exceeds twice a day Combination products reduce the number of doses per day as well as patient copayments Help patient organize all medications and establish an administration schedule Match administration times to patient’s activities of daily living

35. Therapy Related Interventions Periodic medication profile review Systematic, ongoing review of all medications Ensure patient is on the fewest medications possible

36. Therapy Related Interventions Minimize the occurrence & impact of adverse effects Educate patients about the most common adverse effects associated with the medication Inform patients if adverse effects do occur it is usually possible to modify therapy to eliminate or avoid the unintended effects Ask patients if they are experiencing any possible adverse effects “Are you experiencing any problems taking your medications?” “Do your medications make you feel bad in any way?”

37. What % of patients reported not taking their medications due to concerns about ADRs? 1. 10% 2. 25% 3. 45% 4. 50%

38. Patient Related Interventions Major barriers: Lack of information & skills regarding self management Difficulty with motivation & self-efficacy Lack of support for behavioral changes

39. Impart Information Components of patient education Knowledge Skill Attitude

40. Patients typically forget what % of the info from a verbal explanation immediately after they heard it? 1. 10% 2. 25% 3. 50% 4. 75%

41. Physician Communication When Prescribing New Medications Goal: assess quality of physician communication with patients about newly prescribed medications Methods: observational study of transcribed audiotaped office visits from 185 outpatient encounters Results: % of times MD stated: Medication name = 74% Purpose of med = 87% ADRs = 35% How long to take med = 34% # of tablets to take = 55% Frequency or timing of dosing = 58% Arch Intern Med. 2006;166:1855-1862.

42. True or False? Once I tell my patients it is the right thing to do, they will adhere to their medications as prescribed.

43. Motivation & Self-Efficacy Directive method of communicating to enhance a person’s intrinsic motivation to change by exploring & resolving ambivalence & resistance Goal: increase the chance the patient will engage in healthy behaviors by uncovering the patient’s actual needs

44. Creating a Favorable Climate for Change The patient must: Recognize there is a problem (perceived susceptibility) Believe the medical condition to be serious (perceived severity) Believe that the prescribed medication will help correct the problem (perceived benefits) Understand how to use the medication & have confidence in their ability to do so (self-efficacy) Have realistic expectations about the outcomes (cure vs control)

45. The “Iceberg Effect” WHAT YOUR PATIENT TELLS YOU WHAT YOUR PATIENT DOESN’T TELL YOU Full extent of adverse effects Lifestyle concerns Confusion and memory problems Disabilities Doubts and fears

46. Elicit the Patient’s Thoughts Look for resistance “How confident are you that this medication will help you?” “What is your understanding of the consequences of not treating your (disease state)?” “What is your overall goal in using this medication?”

48. Support for Behavioral Changes Dosing Reminders Visual cues Place the vial in a “trigger” location Note on the refrigerator or bathroom mirror Pill boxes / organizers Mark the calendar or PDA Computer pop-ups or alarms Remindermed.com Rxnotify.com

49. Support for Behavioral Changes Reinforcement and Rewards Routine reports on progress Ongoing reinforcement of the importance of adherence Praise Vigilance effect

50. If a teacher gives a homework assignment but says you never have to turn it in and that he will never check it, what are the chances you will actually complete the assignment?

51. Adherence Related Research Most of the studies had small numbers of patients and lacked power to detect clinically important effects Most studies assessing complex interventions did not assess the separate effects of the components Often the interventions were not adequately described The follow-up period was relatively short-term Few studies examined major clinical end points

52. Evidence-Based Interventions Results: The following interventions were determined to positively impact adherence Use of fixed-dose combination drugs Once daily or once weekly dosing schedules Unit dose packaging Educational counseling by phone Case management by pharmacists Treatment in pharmacist or nurse operated disease management clinics Mailed refill reminders Self-monitoring Rewards Various combination strategies Int J Clin Pract. 2005;59(12): 1441-1451.

53. Evidence-Based Interventions Author conclusions: Personalized, patient-focused programs involving frequent contact with health professionals or combination interventions were the most effective Less intensive strategies such as combination products, once daily formulations, unit-dose packing & refill reminders: Yield small to moderate improvements May be implemented relatively efficiently to large populations May be the most cost effective interventions

54. Pillbox Organizers for HIV Pt Pop: HIV-positive individuals taking > 3 antiretroviral meds living in single-room hotels & homeless shelters Design: Pillbox organizers 12 month trial with unannounced pill counts conducted every 3-6 weeks @ patient’s residence Monthly assessment of HIV load Results: Pillboxes improved adherence by 4.1 to 4.5 % Improved viral suppression 14-16% higher probability of achieving a viral load < 400 copies/mL Clin Infec Dis 2007;45:908-15

55. This I Know… There is no single intervention strategy that is effective for all patients Most interventions have a positive effect in the short term, but to be successful in the long term, a sustained multifactoral approach is required Interventions must be tailored to the needs of the individual patient The gains in adherence achieved are typically < 20%

56. To reap the benefits of modern medical therapies, better, more effective, and more efficient interventions for helping people follow regimens are needed.