Download Non-compliance

Compliance / non-compliance
Which factors play a key role in
adhering to a treatment?
Monica C. Fliedner, ANP, MSN
Bern, Switzerland
[email protected]
Overview
Background - how big is the problem?
What do we mean with the phrase compliance ?
How can we measure compliance - methodological flaws?
What can we do - which interventions are useful - what is
our job?
Discussion - questions
Non-compliance: an important problem in
today's health care that can not be ignored
Poor adherence in treatment of chronic diseases is a
worldwide problem with growing magnitude
Impact grows as the burden of chronic illness grows
Poor adherence = poor health outcomes (including death)
and increased medical and health care costs
WHO (2003) Adherence to long-term therapies: Evidence for Action
http://www.emro.who.int/ncd/Publications/adherence_report.pdf
Non-compliance: a significant
problem in haematology
Oral therapies are increasingly used in the haematology setting
Immuno-suppressants
Supportive care (eg. oral morphine and antibiotics)
Targeted therapies (e.g. imatinib, nilotinib, dasatinib, lenalidomide, ...)
Difficult to define exact scope of treatment non-compliance
Estimated rates vary considerably
Difficult to measure
Estimates of non-compliance to oral anti-cancer agents is extremely
variable (reported adherence rates of 20-100%)
Many clinicians lack awareness about the scope of the problem and basic
compliance management principles
National Council on Patient Information and Education Report (2007) Enhancing
prescription medicine adherence: a national action plan (http://www.talkaboutrx.org
Adherence to Imatinib may decline over time
Patients taking recommended dose of Imatinib
3500
Patients
3000
2921
2500
2000
1500
1000
500
685
0
0 1 1 2
2 3
3 4
4 5
5 6
6 7
7 8
8 9
9 10 10 11 11 12 12 13 13+
Months
In this US study, persistency* was near 100% at month 4
Persistency declined from 94% at month 5, to 23% at month 14
Imatinib plasma level testing may help identify patients who
become less adherent
*time on therapy without any significant gaps of refills
Tsang J-P, Rudychev I, Pescatore SL. Poster presented at ASCO 2006.
Non-compliance: a problem in CML
Retrospective analysis of healthcare claims of 267 CML patients taking
Imatinib in a US-based managed care setting
Medication possession ratio (MPR) for Imatinib was 77.7%
20% had a MPR of <50%
31% of patients had a treatment interruption of at least 30 days
Factors contributing to lower MPR levels
Gender (women > men)
Concomitant medications
High starting dose of Imatinib ( 600mgs)
High cancer complexity
Patients with a lower MPR had higher healthcare costs
Darkow T et al. Treatment interruptions and non-adherence with imatinib and
associated healthcare costs. Pharmacoeconomics 2007, 25(6): 481-496
Other possible factors for non-adherence
Evaluation of 52 patients with CML in CP
Calculation of IM-taking-compliance: total doses of IM
obtained at pharmacy / total doses of IM prescribed at the
hospital during study period (1 year) as a percentage
No statistical difference between gender, prior therapeutic
history, duration on IM
Overall good compliance
Possible impact: co-morbidities
Kiguchi T et al. (2009) Leukemia Research, 33: 506-508
Challenges in the oral treatment of CML
Starting out on Imatinib
How to take the medication correctly
Development of a routine in taking the medication
Interactions with other medications / food / drinks (e.g. grapefruit
juice, fat-rich food)
Management of treatment-related side effects at home
Taking a drug every single day in the long run
Taking a long-term treatment without any visible sign or symptom of
the disease
Resistance / intolerance to Imatinib (only a small % patients)
Coping with a change to another TKI-treatment with a different
administration schedule, interactions and side effects
Change of one TKI-Schedule to another can be
confusing
IMATINIB administration schedule
5am
7am
6am
8am+
4pm
5pm
6pm
7pm+
Take IMATINIB with FOOD and a large glass of water
NILOTINIB administration schedule
8am
9am
FAST
10am
11am
12noon
6pm
7pm
FAST
Take NILOTINIB while FASTING
8pm
9pm
FAST
FAST
10pm
11pm
FAST
How often was a dose missed
Don t know / can t remember
Never miss a dose
10%
5%
Less than once every 6 months
55%
Once every 4-5 months
5%
Once every 2-3 months
5%
Once a moth
10%
Once a week
5%
More than once a week
5%
0%
20%
40%
60%
Synovate Market Research 2005. BASE: All respondents (n=30) / All who have ever missed a dose of imatinib (n=20)
Who is that patient really, what does he
really need?
Questions
Remember a patient that you considered as noncompliant ?
In what way was the patient non-compliant?
How did you find out that the patient was non-compliant?
How did the team talk about the patient?
What did you do?
There is some confusion in the jungle of terms...
Compliance / non-compliance
Adherence / non-adherence
Concordance / non-concordance
Motivation to follow a treatment
Non-intentional / intentional
Clinical / non-clinical
Self-care management abilities
clinically relevant
relevant definition
definition
clinically
World Health Organization (WHO)
Paradigm Shift:
Non-compliance is a failure of the healthcare system
WHO:Global Report on Innovative Care for Chronic Conditions: Building Blocks for Action 2002
World Health Organization (WHO)
Paradigm Shift:
Patients need to be supported, and not blamed
Sabaté Adherence to long-term therapies: evidence for action. WHO 2003
Multi-dimensional concept of non-adherence
WHO (2003) Adherence to long-term therapies: Evidence for Action
http://www.emro.who.int/ncd/Publications/adherence_report.pdf
Determinants (Hematology)
Favorable prognosis (Behnke et al 1994)
Believe in therapy (Pederson & Perran 1999)
Socio-economic status (
Educational level (
Levine et al 1987)
Levine et al 1987)
Characteristics of the personality (Pederson & Perran 1999)
(Expectations towards) side effects of medications (Levine et al
1987; Richardson et al 1988)
Complexity of treatment (Levine et al 1987; Richardson et al 1988)
Methodological problems
Measurement of
of non-compliance
non-compliance
Measurement
Direct
Direct
Indirect
Indirect
Observation
Observation
Assay(blood,
(blood,urine,
urine,stool,
stool,
Assay
Self-Report
Self-Report
Collateral Report
Report
Collateral
saliva)
saliva)
Counttablet/medications
tablet/medicationsor
or
Count
monitoringof
ofprescriptions
prescriptions
monitoring
Successof
oftreatment
treatment
Success
Electronic Event
EventMonitoring
Monitoring
Electronic
Interventions
Screening of risk factors
Educational strategies
Behavioral strategies
Interventions using the social network
All five dimensions should be considered when
target the intervention
social and economic factors
health care team and systems-related factors
therapy-related factors
condition-related factors
patient-related factors
WHO 2003
Interventions
State-of-the art interventions target the patient, the provider
and the health-care system in a multi-level team approach
Most promising is the use of a combination of:
Patient education
Behavioral skills
Self-rewards
Social support
Telephone follow-up
It increases adherence and improves treatment outcomes
WHO 2003
Patient interventions
Most effective
aim to enhance selfregulation or selfmanagement
capabilities.
These include:
self-monitoring
goal-setting
corrective feedback
behavioral contracting
commitment
enhancement
creating social support
reinforcement
relapse prevention
stimulus control
behavioral rehearsal
WHO 2003
Multifacets / interdisciplinary interventions are
necessary
Patient - intervention programs should be...
...based on a thorough assessment, identifying risk factors e.g.
Lack of knowledge
Depression
Suffering by symptoms / side effects
Lack of social support
Financial restraints
...tailored to the individual patient
...continuous
Haynes RB et al (2005) Cochrane Database of Systematic Reviews.
http://www.cochrane.org/reviews/en/ab000011.html
Interventions directed to providers
Interventions that might have an effect
Training in patient-centered methods of care may be effective
(patient satisfaction with treatment)
Training in adherence interventions based on behavioral
principles
Training to use goal-setting, feedback and ongoing education
reveal better patient outcomes
WHO 2003
Interventions in the health-care system
Organization and financing of care and quality of care
programmes.
One example is the creation and adoption of chronic care
models of service delivery, which, at least in patients with
diabetes and asthma, have been shown to result in better
patient outcomes
WHO 2003
Educational strategies
Ask patients about the challenges they face in taking
medication over the long-term
Education of patient / relatives
Oral and written information of patient and family according
to the learning type of the patient
Help patients establish a routine for taking the drug
Recognize and support coping-mechanisms
Counseling
Automatic monitoring / coaching through phone
Support of the family
Try not to be judgemental
Behavioral strategies
Medications under control of patient a.s.a.p.
Evaluation of complexity of treatment and adjust if possible
/ necessary
Simplify the treatment
Adjust treatment schedule to the lifestyle of the patient
Multifacets / interdisciplinary interventions are
necessary
Development of different strategies including:
Patient education
Utilization of support devices / reminders
Strategies that enhance memory
Measures to change behavior
Motivational interviewing
Involve the social network of the patient
Linking patients to share their experiences, e.g.
www.cmlalliance.com
www.cmlsupport.org.uk
www.leukaemie-hilfe.de
Haynes RB et al (2005) Cochrane Database of Systematic Reviews.
http://www.cochrane.org/reviews/en/ab000011.html
Interventions through social network
Evaluation of social network
Stimulate partner or other key persons of the patient to
support the patient
Therapeutic contract between patient and...
Partner
Family members
Friends
Professionals
Tackle the compliance-crisis :
which way to go?
Consider non-compliance as a serious health problem of
all chronically ill patients
Make sure that you and your colleagues receive excellent
training in managing compliance
Share best practice strategies in management strategies
Increase / seek for financial resources, to built up /
increase research knowledge
National Council on Patient Information and Education report (2007) Enhancing
prescription medicine adherence: a national action plan (http://www.talkaboutrx.org)
Future
Prevalence, determinants and consequences of noncompliance
Qualitative and quantitative studies, to understand the
dynamic behind non-compliance
Test the effectiveness of different interventions
Conclusions
Non-compliance in long-term oral therapies is a serious public problem
Bad compliance in oral therapies can have a negative influence on
outcome of the treatment
Several different factors can be the reason that a patient can not follow
the therapy / is non-compliant
Health care workers have to...
...play a key role in identifying patients at risk for non-compliance
...develop effective strategies to support patients to adhere to longterm therapies