To Take or Not To Take?

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1 To Take or Not To Take?

2 Assessment Question How do the terms adherence & compliance differ? 1. The terms are synonymous 2.Adherence assumes collaboration between patient & provider while compliance suggests obedience 3.Compliance applies to drug taking behavior while adherence refers to all medical advice

3 Pharmacoadherence The extent to which a patient follows a given therapeutic medication regimen as agreed on in partnership with a health care professional Am J Health Syst Pharm. 2008;65(7): 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

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

5 Assessment Question What is the typical nonadherence rate in long term regimens? 1. 20% 2.35% 3.50%

6 Patterns of Adherence to Once Daily BP Meds Examined data from 21 clinical studies with 4783 pt prescribed 1 once daily med for BP Adherence determined using electronic bottles At 1 yr, 50% stopped tx On any given day, 10% of doses were missed 95% missed single dose at least once yearly 50% missed single dose once monthly 50% took drug holidays for > 3 days at least once yearly BJM 2008May 17;336:1114.

7 Patterns of Adherence in Chronic Disease Management 1/6 come close to perfect adherence 1/6 take nearly all doses; some timing irregularity 1/6 occasionally miss single day s dose; some timing inconsistency 1/6 take drug holidays 3 4 times a year; occasional omissions 1/6 take drug holidays at least monthly; frequent omissions 1/6 take few to no doses N Eng J Med 2005;353:487 97

8 How Much is Enough? Adequate Adherence Drug & disease dependent Most researchers use 80%

9 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 Patients typically take about half the prescribed doses

10 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

11 Adherence Rates Among Patients with 7 Different Medical Conditions Determined medication possession ratio (MPR) during first year of drug therapy for 706,032 adults with at least 1 of 7 medical conditions HBP: 73.3% achieved adherence rates > 80% Hypothyroidism: 68.4% Type 2 DM: 65.4% Seizure disorders: 60.8% Hypercholesterolemia: 54.6% Osteoporosis: 51.2% Gout: 36.8% Pharmacotherapy 2008;28(4):

12 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 U.S. health care system $100 billion annually Annual indirect costs exceed $1.5 billion in lost patient earnings and $50 billion in lost productivity Am J Health Syst Pharm.2003;60:657 65

13 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

14 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

15 Nonadherence with Antiepileptic Drugs Retrospective evaluation of 33,658 adults with > 1 diagnosis of epilepsy & > 2 antiepileptic drugs Determined medication possession ratio (MPR) quarterly with MPR <0.80 considered nonadherent Nonaderence associated with: 3 fold increased risk of mortality Significantly greater incidence of ED visits, hospital admissions, motor vehicle accidents & fractures Neurology.2008,June 18 (Epub)

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

17 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

18 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

19 Medication Possession Ratio (MPR) (total day s supply / total # days evaluated) x 100 Deemed the preferred measure because: Fewest calculations Requires least amount of data Results identical to those achieved with the other refill adherence measures AnnPharmcother2006;40:

20 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

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

22 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

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

29 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

30 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

31 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

32 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

33 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

34 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

35 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

36 Assessment Question What is the most effective intervention to improve adherence? 1. Patient education 2.Pill boxes 3.None of the above

37 Strategies to Improve Adherence Therapy Related Interventions Patient Related Interventions

38 Patient Case: Mrs. Gotta Lower 67 yo postmenopausal female Problem list: none Meds: ASA daily calcium supplement Baseline labs: Total cholesterol = 270 mg/dl TG = 140 mg/dl (goal < 150 mg/dl) LDL C = 210 mg/dl (goal < 160 mg/dl) HDL C = 38 mg/dl (goal > 50 mg/dl) Plan: Diet changes & exercise

39 Follow up Visit Baseline TC (mg/dl) TG (mg/dl) Diet & Exercise LDL C (mg/dl) HDL C (mg/dl)

40 RX: Pravastatin 20mg I qd #30

41 Follow up Visits Baseline Diet & Exercise Pravastatin 20mg TC (mg/dl) TG (mg/dl) LDL C (mg/dl) HDL C (mg/dl)

42 A little dosage adjustment should get this under control.

43 Possible Reasons for Lack of Response Wrong diagnosis Inadequate dose Nonadherence with diet &/or exercise Erroneous lab result Drug interaction Nonadherence with medication

44 Nonadherence with Medication Determine degree of adherence Identify cause(s) of nonadherence Implement action plan

45 Determine Degree of Adherence Patient self report Lab results & physical assessment Pharmacy refill & appointment records

46 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?

47 Patient Case: Mrs. Gotta Lower I know I took it this morning & yesterday. Medication Possession Ratio (MPR) = 51% Lab results

48 Identify Causes of Nonadherence The good physician treats the disease; the great physician treats the patient who has the disease. Sir William Osler

49 Identify Causes of Nonadherence Readiness for behavioral change Support for behavioral change

50 Readiness for Behavioral Change Recognize there is a problem Believe the medical condition to be serious Believe the medication will help correct the problem Understand how to use the medication

51 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

52 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?

53 Elicit Patient s Thoughts Are you experiencing any problems taking your medication? Does your medication make you feel bad in any way?

54 Patient Case: Mrs. Gotta Lower My sister had trouble sleeping when she took this medication. I don t need that.

55 Assessment Question What % of patients reported not taking their medications due to concerns about ADRs? 1.10% 2.25% 3.45%

56 Minimize the 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

57 Patient Case: Mrs. Gotta Lower Determine if patient is actually experiencing symptom Evaluate likelihood of medication being the cause

58 Tools to Support Behavioral Change Patient specific education based on identified gaps in knowledge base

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

60 Tools to Support Behavioral Change Simplify the regimen Adherence declines significantly as the dosing frequency exceeds twice a day Ensure patient is on fewest medications possible Combination products reduce the number of doses per day as well as patient copayments

61 Tools to Support Behavioral Change Match administration times to patient s activities of daily living

62 Adherence to Once Daily BP Meds Examined data from 21 clinical studies with 4783 pt prescribed 1 once daily med for BP Missed doses were more common between April & Sept & on weekends Morning takers significantly more likely to adhere than evening takers BJM 2008May 17;336:1114.

63 Tell me about your daily routine When do you eat, when do you get up, and go to bed? What other activities you perform an a daily basis? How much variation is there in your routine from day to day? How does your weekday routine compare to your weekend routine? When do you think you are most likely to take your medications? What will work best for you?

64 Tools to Support Behavioral Change 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

65 Tools to Support Behavioral Change Vigilance effect

66 Tools to Support Behavioral Change Reinforcement and Rewards Routine reports on progress Ongoing reinforcement of the importance of adherence Praise

67 Elicit Patient s Thoughts Tell me your medication schedule. How do you remember to take your medication? How is this working for you?

68 Patient Case: Mrs. Gotta Lower I try to take it in the morning. Sometimes I can t remember if I took it or not.

69 Patient Case: Mrs. Gotta Lower Place in trigger location Use of pill box organizer

70 Implement Action Plan Patient education concerning ADRs Use of pill box organizer Place in trigger location Ongoing interaction & follow up

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72 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

73 Medical Science

74 FAME Trial Goal: effect of pharmacy intervention program on adherence among elderly with > 4 chronic meds Intervention: medication education, RPh follow up & customized blister packs Design: Run in phase: 2 months, baseline adherence, LDL & BP Phase 1: 6 months, intervention for all patients Phase 2: randomized to either continued intervention or return to usual care JAMA.2006;296:

75 FAME Trial Results: Run in phase: Mean adherence was 61.2% Phase 1: Adherence increased 35.5% over baseline 16 fold increase in patients > / = 80% adherent to all meds Mean SBP changed from mmhg to mmhg Mean DBP changed from 70.5 mmhg to 69.7 mmhg Mean LDL changed from 91.7 mg/dl to 86.9 mg/dl Phase 2: Mean adherence maintained in intervention arm Declined in usual care arm

76 Electronic Communications & Home BP Monitoring Goal: Determine if pt Web services, home BP monitoring & RPh assisted care improves BP control Intervention: Group 1 : usual care Group 2: home BP monitoring + Web services Group 3: home BP + Web services + RPh care via Web Results: Group 2 had nonsignificant increase in % pt with controlled BP Group 3 had 25% more pt with controlled BP JAMA 2008;299(24):

77 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%

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

79 Assessment Question How do the terms adherence & compliance differ? 1. The terms are synonymous 2.Adherence assumes collaboration between patient & provider while compliance suggests obedience 3.Compliance applies to drug taking behavior while adherence refers to all medical advice

80 Assessment Question What is the typical nonadherence rate in long term regimens? 1. 20% 2.35% 3.50%

81 Assessment Question What is the most effective intervention to improve adherence? 1. Patient education 2.Pill boxes 3.None of the above

82 Assessment Question What % of patients reported not taking their medications due to concerns about ADRs? 1.10% 2.25% 3.45%

83 Questions

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