Transcript Patient and Provider Non-Adherence to Therapy in

Patient and Provider Non-Adherence
to Therapy in Prevention and
Treatment of Disease:
Problems and Solutions
Ned Ferguson, M.D.
Professor of Medicine
Preventive Cardiology
Section of Cardiovascular Medicine
Definitions
The extent to which a person’s
behavior corresponds with agreed
recommendations from a healthcare provider;
also called compliance
Adherence:
Persistence:
The duration of treatment (ie, the
length of time a patient fills his/her prescriptions)
Benner JS et al. JAMA. 2002;288:255-261.
Insull W. J Intern Med. 1997;241:317-325.
World Health Organization. World Health Organization; Geneva,
Switzerland. 2003.
Nonadherence to Therapy:
A Major Challenge
Nonadherence
(aka noncompliance,
nonpersistence, etc) is a major problem
Within 1 year, ~50% of patients overall
discontinue use of drugs
An additional ~35% discontinue treatment
within
2 years
National Council on Patient Information and Education, 1997.
Adherence to Chronic Therapy
100
90
80
Patients (%)
70
60
50
40
30
20
10
0
1
2
3
4
5
6
7
8
9
Month
ACE-Inhibitor
Statin
Courtesy: Ockene IS; Source: IMS Health data, 1996.
10
11
12
Combining 2 Antihypertensive Agents
In 1 Pill Enhances Persistence
Persistence (%)
100
90
80
70
69%
19%*
60
58%
50
0
1
2
3
4
5
6
7
Months
Lisinopril/HCTZ combination pill (n=1644)
*P<0.05 vs. fixed-dose combination
Dezii C. Managed Care. 2000;(Suppl 2):6-10.
8
9
10
11
12
Lisinopril and diuretic in separate pills (n=624)
Persistence* with Diabetes Therapy Declines
When Patients Are Prescribed 2 Pills Instead of 1
Persistence (%)
100
75
58%
55%
50
29%**
25
0
1
2
3
4
5
6
7
8
9
10
11
12
Months
Metformin alone
Sulfonylurea alone
Metformin and sulfonylurea in separate pills
*Defined as continuous months of drug use. **P<0.05 vs. monotherapies.
Data on file. Bristol-Myers Squibb Company.
Adherence Lowest When Therapy Was
Preventive
0%
0%
0%
0%
0%
0%
Patients taking statins (%)
0%
100
Post-event
90
Evidence of disease progression
80
Prevention
70
60
50
40
0%
30
0%
20
0%
10
0%
0
0
3
6
9
12
15
Months since statin initiation
18
21
Cohort study using linked population-based administration data from Ontario, Canada (N=143,505).
Jackevicius CA et al. JAMA. 2002;288:462-467.
24
Initial Therapy Choice Influenced
Long-term Persistence
Patients continuing therapy at 48-month
follow-up (%)
60
50
40
30
20
10
0
ARB
ACE inhibitor
CCB
b-Blocker
Retrospective, records-based, cohort study of patients on antihypertensive medication using
the Merck-Medco Managed Care LLC Research Convenience Sample database (N=15,175).
Conlin PR et al. Clin Ther. 2001;23:1999-2010.
Thiazide diuretic
Patient Reasons for Nonadherence
Don’t think it’s necessary all the time
55%
Just forget
14%
Don’t think it’s necessary all the time
Hate taking
7%
Don’t like being dependent
7%
Drugs give me side effects
Don’t think drugs are working
Too expensive
6%
3%
2%
Don’t like being told
what to take
1%
Supply will last longer
1%
Other
4%
Prospective, open-label, interview-based study in metropolitan New York area pharmacies (N=821).
Cheng JWM et al. Pharmacotherapy. 2001;21:828-841.
What Research Shows About Patterns
of Adherence
Remember,
nonadherence begins early and
persists
Patients must actively decide to adhere
Many factors influence adherence
More Frequent Physician Visits
Improved Adherence
2.60
Adherence ≥80% (OR)
2.40
2.20
2.00
1.80
1.60
1.40
1.20
1.00
0.80
1-3
4-7
8+
Physician visits in last 120 days
Retrospective study of elderly (aged 65 to 99 years) members of the New
Jersey Medicaid and Medicare populations (N=8643).
Monane M et al. Am J Hypertens. 1997;10:697-704.
Number of Concurrent Medications
Influenced Adherence
Adherence ≥80% (OR)
3.00
P<.0001
2.50
P<.0001
2.00
P<.0001
P<.0002
1.50
1.00
0.50
0.00
0
1
2
3-5
6+
Number of other prescription medications
Retrospective cohort study in a large managed care population (N=8406).
Data on file. Pfizer Inc., New York, NY.
Concurrently Starting 2 Medications
Improved Adherence
1.70
Adherence ≥80% (OR)
1.60
1.50
1.40
1.30
1.20
1.10
1.00
0.90
0.80
1-30 days
31-60 days
61-90 days
Time between start of antihypertensive and lipid-lowering therapies
Retrospective cohort study in a large managed care population (N=8406).
Data on file. Pfizer Inc., New York, NY.
Using Multiple Pharmacies Negatively
Affected Adherence
Adherence ≥80% (OR)
1.10
1.00
0.90
0.80
0.70
0.60
0.50
0.40
0.30
1
>1
Pharmacies used in last 120 days
Retrospective study of elderly (aged 65 to 99 years) members of the
New Jersey Medicaid and Medicare populations (N=8643).
Monane M et al. Am J Hypertens. 1997;10:697-704.
The Case for Improving Adherence
Improved




adherence can lead to:
Higher rates of treatment success
Fewer diagnostic procedures
Fewer hospitalizations
Lower mortality rates
Benner JS et al. JAMA. 2002;288:255-261.
Insull W. J Intern Med. 1997;241:317-325.
World Health Organization. World Health Organization; Geneva,
Switzerland. 2003.
Strategies for Success
Adherence: A Multilevel Problem
The
Individual/Patient
The Healthcare Provider
The Healthcare System
The Social-Environmental Context
Adapted from: Miller NH, Hill M, Kottke T, Ockene IS. Circulation. 1997;95:1085-1090.
Summary of Implications for
Adherence Intervention Programs
Intervene
EARLY in therapy
Interact OFTEN
KNOW your patient
TARGET interventions
EDUCATE patients
PRESCRIBE regimens with a high probability
of adherence
ENCOURAGE close relationships
Adherence: Patient Factors
Knowledge,
attitudes, skills
Organic factors (memory, cognitive-information
processing)
Self-efficacy
Decision-making processes – discounting
Co-morbidities/complexity of therapeutic regimen
Individual resources
Recommended Strategies From
Several Studies: Prescribing Practices
1
Prescribe:





Regimens with the lowest appropriate pill burden
Drugs with reduced dose frequencies
Drugs with favorable side-effect profiles
Drugs with a lower cost
Before hospital discharge
Remind
patients by letter and/or phone to refill
prescriptions
Aronow HD et al. Arch Intern Med. 2003;163:2576-2582.
Avorn J et al. JAMA. 1998;279:1458-1462.
Bloom BS. Clin Ther. 1998;20:671-681.
Dezii CM. Manag Care. 2000;9(suppl):S2-S6.
Monane M et al. Am J Hypertens. 1997;10:697-704.
Newell SA et al. Prev Med. 1999;29:535-548.
2
Reach
Medicaid Study: Time Interventions
to the Advantage of Adherence
patients within the first 3 months of
therapy
or sooner, if possible
After 6 months, attitudes about therapy are
formed
Retrospective claims analysis of elderly members of the New Jersey Medicaid
and Pharmaceutical Assistance to the Aged and Disabled programs (N=34,501).
Benner JS et al. JAMA. 2002;288:255-261.
Adherence: Provider Factors
Counseling
skills
Involvement of patients in decision-making/plan
of care
Time constraints
Knowledge, awareness, adherence to clinical
practice guidelines
Individual vs. team-provider approach
Provider Level – Problems
Problem-solving
skills
Self-monitoring
Relapse
prevention strategies
Prompts/reminder systems
 Mail/telephone
 Medication
Social
containers
support
Realistic/appropriate goals
Reward system
Provider Level – Problems
Number
of daily doses
Number
of medications
Occurrence
and severity of side effects
Incompatibility
Inadequate
with patient’s daily routine
physician-patient communication
Cost
Russell M. Behavioral Counseling in Medicine: Strategies for Modifying At-Risk Behavior.
New York, NY: Oxford Press; 1986.
Provider Level – Problems
Studies
show clinicians generally cannot reliably
predict which patients will be adherent
Clinicians
consistently overestimate patient
adherence
Physicians
tend to believe adherence is solely
the patient’s responsibility
Adherence: Societal Factors
Example: Obesity
Food used to be expensive – now it’s cheap
Physical activity used to be cheap – now it’s
expensive
Social Learning Theory: Albert Bandura
Behavior
is learned and can be unlearned
People learn best by active participation
People need to believe they can change
(self-efficacy)
Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory.
Englewood Cliffs, NJ: Prentice Hall; 1986.
Health Belief Model
People
are more likely to take action if
they believe:
 They’re
vulnerable or susceptible to consequence of a
behavior
 They’re capable of change
 Benefits of change will outweigh costs
Rosenstock I, in Glanz K et al, eds. Health Behavior and Education: Theory, Research and
Practice. San Francisco: Jossey-Bass; 1990.
Stages of Change
Precontemplation
Contemplation
Action
Relapse
Maintenance
Adapted from: Prochaska J, DiClemente CC. J Consulting Clin Psych. 1983;51:390.
Summary of Principles from
Theories and Models of Change
Individuals
need to have adequate information
Individuals
need to believe in their ability to make
changes and have positive expected outcomes
Individuals
need skills, support, resources
Interventions
need to be tailored to the individual
or organization and its social context
Patient Level – Solutions
Counseling
Use
questions related to 5 content areas:
 Desire
 Past
and motivation to change behavior
experiences with the behavioral change
 Factors
that inhibit the change (barriers)
 Resources
 Plan
for change (strengths)
for change and follow-up
Courtesy: Ockene IS.
Ockene IS, et al. J Am Coll Cardiol; 2002;40:630-638.
Provider Level – Solutions
 Simplify
the regimen
 Ask about adherence at every visit
 Look at the refill dates!!
 Tailor regimen to patient’s lifestyle
and needs, and to patient’s
willingness/desire to be challenged
 Involve patient as partner in treatment
 Provide clear written and oral instructions
 Use behavioral strategies (reminder systems,
cues, self-monitoring, feedback, reinforcement)
Courtesy: Ockene IS.
Ockene IS, et al. J Am Coll Cardiol; 2002;40:630-638.
Physician Adherence Management
Clinician uses problem-solving approach based on
questioning the patient in a nonjudgmental manner
 “How
do you remember to take your medicine?”
 “As is the case with many patients, do you ever
miss or forget a dose?”
 “How do you remember to take your medication
on weekends or while traveling?”
 “What do you think you could do to avoid
missing doses?”
 “Might any future events interfere with taking
your medication?”
Insull W. J Intern Med. 1997;241:317.
Self-reported Adherence
Level
of adherence reported by patient, in
interview or questionnaire
Frequently overstated
Sample questions:




Do you ever forget to take your medicine?
Are you careless at times about taking your
medicine?
When you feel better, do you sometimes stop taking
your medicine?
Sometimes if you feel worse when you take the
medicine,
do you stop taking it?
Choo PW et al. Med Care. 1999;37:846-857.
Morisky DE et al. Med Care. 1986;24:67-74.
Wang PS et al. Pharmacoepidemiol Drug Saf. 2004;13:11-19.
Adherence: System-Based Factors
Extent
to which the healthcare system facilitates
or impedes provider’s adherence-related
activities
 Organizational
structures and processes
 Organizational priorities
 Need to extend financial horizon –
5-year vs. 6-12 month outlook
Systems Level – Solutions
 Create
an environment/office system supportive
of preventive interventions
 Establish
tracking and reporting systems
 Optimize
multidisciplinary team approach
 Implement
education, training programs
for provider
 Establish
appropriate reimbursement for
providers
Courtesy: Ockene IS.
Ockene IS, et al. J Am Coll Cardiol. 2002;40:630-638.
Midwest Heart Specialists’ Experience
 Cardiology
practice in Naperville, Illinois started
physician-directed, nurse-managed lipid clinic in 1985
 All new patients see medical director, then lipid nurse
 Lipid nurse reviews lab results, educates patient
on NCEP lipid goals and step II diet
 After diet trial, patient has repeat lipid profile and
appointment with lipid physician for individualized
treatment plan
 Electronic medical record tracks patients
 Nurses provide ongoing education, phone consultation
 Intense compliance effort through phone calls, postcards
Brown AS, et al. Am J Cardiol. 2000;85:18A-22A.
Midwest Heart Specialists’ Experience
97%
of patients have LDL-C level in their charts
71% are at their LDL-C goal
29% not at goal have average LDL-C of 105
mg/dL
Brown AS, et al. Am J Cardiol. 2000;85:18A-22A.
Easily Implemented Steps
for All Practices
 Have
nurse flag date of last lipid measurement on Post-It atop
patient’s chart
 Measure
lipids upon diagnosing a patient with hypertension,
diabetes, other conditions
 Designate
1 nurse or other staffer to handle basic lipid and
hypertension education and phone calls, clearly defining what
issues warrant notifying physician
 Use
paper or electronic methods for quick calculation of
Framingham 10-year risk
 Use
preprinted index cards or other form to provide each patient
with his or her lipid and blood pressure levels and goals
Specific Challenges in Adherence to
Long-Term Medication Regimens

Most effective interventions are complex
and labor intensive:



Usually require multiple approaches and
follow-up supervision
Even effective interventions may have only
modest effects
Full benefits of long-term medications cannot
be realized at currently achievable levels
of adherence:

More innovative approaches are needed
McDonald HP, et al. JAMA. 2002;288:2868-2879.
In-Hospital Initiation of Lipid-Lowering Therapy
for Patients CHD: The Time is NOW



Therapy more likely to be

Initiated by physician

Continued by physician long term
Patients

Less likely to be concerned about side effects
and monitoring

More likely to view therapy as essential (heart medication)

More likely to adhere (lower discontinuation rates)

More likely to achieve LDL-C<100 mg/dL
Early event reduction in ACS patients not missed
Fonarow GC, et al. Circulation. 2001;103:2768-2770.
In-Hospital Prescribing of Statin
Improves Long-Term Compliance
3-year follow-up
Taking statin at follow-up (%)
100
P<0.0001
75
77%
50
40%
25
0
No (n=278)
Yes (n=65)
Prescribed statin at discharge
Muhlestein JB, et al. Am J Cardiol. 2001;87:257-261.
Change at Follow-up
from Baseline
Prevention Clinic Approach Improves
Lipid Profiles
20
0
-20
-40
-60
-80
-100
-120
-140
Total Cholesterol
Low Density Lipoprotein
†
†
1
0
-44 -48
-54
* *


-51
-59
*
*
-54
-67 -70
* * *
-108
†
CHD

Triglyceride
High Density Lipoprotein
†
0
Diabetes
Thomas HD, et al. NC Med J. 2003;6:263-266.
-41
-51
‡
*
-110
†
High Risk
All drugs/combinations: >80% success to reach goal ATP III
Success rate with statins: 97%
Success rate with statin and niacin: 100%
*P<0.001; †P=NS; ‡P=0.001.
†
1
Low Risk
Other Successful Prevention Clinic Models
Collaborative care




417 patients (66% CHD)
Baseline: 45% no therapy, 29% on statins
3d year: 41% on monotherapy, 56% on
combination therapy
62%-74% reached singular lipid goals
Pharmacist-managed

LDL-C goals at enrollment vs 12 mo:
 <100 mg/dL (ASCVD or DM): 24% vs 63%
 <130 mg/dL (>2 RF): 42% vs 79%
 <160 mg/dL (<2 RF): 59% vs 93%
Physician-directed,
nurse-managed

National average vs clinic:
 Lipid-lowering meds: 39% vs 100%
 LDL-C documentation: 44% vs 97%
 LDL-C goals reached: 11% vs 71%
Ryan MJ Jr, et al. Am J Cardiol. 2003;91:1427-1431; Cording MA, et al. Ann Pharmacother.
2002;36:892-904; Brown AS, Cofer LA. Am J Cardiol. 2000;85:18A-22A; Sueta CA, et al.
Am J Cardiol. 1999;83:1303-1307.
A Prevention Clinic Offers:

Enhanced patient compliance with therapy

Aggressive treatment and follow-up, including combination
therapy

Aggressive lifestyle and risk factor modification
A Prevention Clinic’s Keys to Success Are:

Multifaceted team approach (diet, exercise, medication)

Continuous patient education (handouts, tapes, classes)

Constant reinforcement (frequent visits, calls, mailers)
Summary
Patient Barriers to Adherence with
Treatment Recommendations











Lack of access to care
Psychological dysfunction, such as depression, alcohol
abuse
Cognitive impairment
Societal issues (lack of education, cultural beliefs and
habits)
Failure to recognize severity of condition
Failure to recognize the need for chronic therapy
Distrust of long-term medication safety
Lack of understanding goals and benefits of therapy
Asymptomatic nature of dyslipidemia
Lack of immediate benefits from medication regimen
Polypharmacy (costs, complexity, fear of side effects)
Strategies for Improving Patient
Adherence







Seeking continuing education of health care professionals on
principles and implementation of evidence-based guidelines
Implement a team approach to preventive care
Ask about patient adherence at every visit
Be aware of pharmacy refill dates
Simplify the regimen if possible (fewest number of pills and
simplest dosing schedule, tailored to the patient’s lifestyle)
Involve patient as active partner in treatment goals and
regimen
Use proven behavioral modification tools (reminder systems,
prompts for health care professionals; in-office and home
educational tools for patients; clear verbal and written
instructions)
Physician Barriers to Adherence with
Guidelines
Time pressure/constraints
 Reimbursement issues
 Overestimation of patient adherence
 Underestimation of the consequences of
undertreatment
 Belief that adherence is solely the patient’s
responsibility
 Discomfort in discussing risk factors with patients
 Lack of knowledge of evidence-based practice
guidelines (awareness differs by physician type:
primary care, OB/GYN, cardiologists)
 Delay in rapid and effective dissemination of new
clinical trial results to health care professionals

Physician Barriers to Adherence with
Guidelines (cont’d)







Focus on single risk factors, not the global picture
Gender issues (risk prevention is driven by
misperceived lower risk in women even though
calculated risk is equivalent to men)
Underdeveloped counseling skills
Failing to involve patients in decision-making and care
plan
Lack of perceived effectiveness of attempts to change
lifestyle
Individual vs. team-provider care
Lack of referral to specialty care, eg, preventive
cardiology clinic, cardiac rehabilitation program,
diabetes nurse educator, smoking cessation program
References
1.
Jackevicius CA, Mamdani M, Tu JV. Adherence with statin
therapy in elderly patients with and without acute coronary
syndromes. JAMA. 2002;288:462-467.
2.
Ellis JJ, Erickson SR, Stevenson JG, et al. Suboptimal
statin adherence and discontinuation in primary and
secondary care populations. Should we target patients
with the most to gain? J Gen Intern Med. 2004;19:638645.
3.
Ockene IS, Hayman LL, Pasternek RC, et al. Task Force
#4—Adherence issues and behavior changes: achieving a
long-term solution. J Am Coll Cardiol. 2002;40:630-640.
References (cont’d)
4.
Roter DL, Hall JA, Kern DE, et al. Improving physicians’
interviewing skills and reducing patients’ emotional
distress: a randomized clinical trial. Arch Intern Med.
1995;155:1877-1884.
5.
Fonarow GC, Gawlinski A, Moughrabi S, et al. Improved
treatment of coronary heart disease by implementation of
a Cardiac Hospitalization Atherosclerosis Management
Program (CHAMP). Am J Cardiol. 2001;87:819-822.
6.
Smaha LA. The American Heart Association Get with the
Guidelines program. Am Heart J. 2004;148:S46-S48.
References (cont’d)
7.
Mason CM. The nurse practitioner’s role in helping
patients achieve lipid goals with statin therapy. J Am
Acad Nurse Pract. 2005;17:256-262.
8.
Osterberg L, Blaschke T. Adherence to Medication. N
Engl J Med 2005;353:487-97.
9.
Ferguson EE. Physician and Patient Nonadherence:
How to Improve Therapy and Outcomes. Lipid Letter
2005;5:1-8 (available at www.eslm.org).