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Hypertension: Leading cause of global disease burden
Yet.......Despite the availability of effective therapy
we are not doing well !!!
One key reason could be non-adherence
Challenges in hypertension treatment
“Drugs don't work in patients who don't take them”
C Everett Koop: US Surgeon General 1981-89
1) What is the definition
of medication
non-adherence?
2) Who
is at risk?
3) How should
patients at risk
be screened and
identified?
4) What are
the negative impacts
of non-adherence?
5) What is the
practical approach
for improving adherence?
Five
Questions
Definition of
Medication Non-adherence
WHO definition of non-adherence
The extent to which a person’s behaviour:
•taking medication
•following a diet
•and/or executing lifestyle changes
corresponds with agreed recommendations from a health care provider
An arbitrary non-evidence-based cutoff of 80% is frequently
used in the literature to define medication adherence
Patients are generally considered adherent to their medication
if their medication adherence percentage, defined as the number of pills absent in a
given time period (“X”) divided by the number of pills prescribed by the physician in that
same time period, is greater than 80%
European Society for Patient Adherence, COMpliance and Persistence
ESPACOMP
Founded 2009 The ABC taxonomy for medication adherence
The new taxonomy of adherence to medications
according to the ABC European Consensus project
3 components
1
Drug therapy starts with the initiation, i.e., when the patient takes the first dose of the prescribed medication. It is a yes or no
phenomenon. Thereafter, the implementation is the extent to which the patient’s actual dosing is in accordance with the prescribed
dosing regimen between the initiation and the last dose. It is measured over a period of time and generally reported as a percentage. At
last, discontinuation occurs when the patient stops taking the prescribed medication for whatever reason.
Clinically, the most important measure of drug utilization in chronic diseases is certainly persistence which represents the time between
initiation and the last dose before sustained discontinuation (persistence is also reported as a dichotomous variable patients being
“persistent” or “non-persistent” ).
2
3
The more scientific definition of medication adherence
is the process by which patients take their medication as prescribed,
which is further divided into 3 quantifiable components:
initiation , implementation , and discontinuation
Non-initiation Poor implementation Non-persistence
There are 2 types of medication-taking behaviors.
Intentional non-adherence
is an active decision
Motivation→Perceptions
Unintentional non-adherence
is a passive process
Ability→Practicalities
Risk Factors Associated With
Medication Non-adherence
(Multifactorial )
Factors affecting medication adherence
(based on WHO recommendation)
Non-adherence
is a multifactorial
phenomenon:
The five
dimensions
of non-adherence
The 5
dimensions
of non-adherence
Screening and Identification
of Patients with
Medication Non-adherence
Do you think it is difficult to
measure adherence ? And if so, why?
Yes
 Non-adherence is a multifactorial phenomenon
(5 barriers to medication adherence)
 Medication adherence is a dynamic process
that change overtime.
Sequential barriers to adherence with antihypertensive therapy
Adherence (3 components: initiation, implementation, and Persistence ) is a marathon , not a sprint.
Patients can become non-adherent at any time (3 types) i.e. non-initiation, poor implementation and short persistence
Methods for the detection of
poor medication adherence in hypertension
( To measure initiation, implementation and persistence )
There are direct and indirect methods,
each with respective advantages and disadvantages
Assessment of medication adherence is
complex, expensive, and difficult to
implement in routine clinical practice.
There is no one gold
standard method of
measuring adherence
Indirect simple, cheap, and readily available
methods, but with low reliability and
validity—4 Ps
• Patient questionnaire and self-reporting
• Patient interview
• Pill count
• Prescription refill data
Questionnaire→ MMAS-4, 8, four-item and eight-item Morisky Medication Adherence Scales
Interview→Clinical estimation
Pill count→ manual
Refill Data→ MPR, medication possession ratio; PDC, proportion of days covered.
The 8-items Morisky Medication Adherence Scale (MMAS-8)
Characteristics Response
1. Do you sometimes forget to take your medication? Yes/No
2. People sometimes miss taking their medications for reasons other than forgetting.
Over the past 2 weeks, where there any days when you did not take your medication?
Yes/No
3. Have you ever cut back or stopped taking your medication without telling your
doctor because you felt worse when you took it?
Yes/No
4. When you travel or leave home, do you sometimes forget to bring your medication? Yes/No
5. Did you take all your medication yesterday? Yes/No
6. When you fell like your symptoms are under control, do you sometimes stop taking
your medication?
Yes/No
7. Taking medication every day is a real inconvenience for some people. Do you ever
feel hassled about sticking to your treatment plan?
Yes/No
8. How often do you have difficulty remembering to take all your medication?
Never/Rarely
Once in a while
Sometimes
Usually
All the time
The MMAS-8 can range from 0 to 8, with scores of <6, 6 to <8 and 8
reflecting low, medium and high adherence, respectively.
Quantitative direct objective methods with
high reliability and validity, but costly—4 Ms
• Medication intake under observation (DOT)
• Medication event monitoring system
(MEMS) (Electronic monitoring)
• Medication level measurement in body
fluids (Therapeutic drug monitoring :TDM)
• Digital medicine
DOT ( Directly observed therapy) →Witnessed drug intake
MEMS→Smart pill containers (Smart packaging):Digital monitoring .
TDM :Drug assay → LC/MS, liquid chromatography coupled to mass spectrometry
Digital medicine→Ingestable Sensor (Proteus system).
Evolution of the MEMS® Cap from version 1 in 1977 to version 8 in 2017
Electronic medication monitoring or medication event monitoring system (MEMS) is accurate but
limited to tracking of one single medication. It requires incorporation of an expensive microcircuit
into packages such that each pill removal is recorded in real time
The first electronic monitor for medication adherence, known as the Medication
Event Monitoring System (MEMS®), was initially tested in 1977.
The process of biochemical screening for non-adherence to antihypertensive treatment
(a high performance liquid chromatography-tandem mass spectrometry “LC-MS/MS” instrument)
The instrument is expensive (around £200,000–250,000). This makes biochemical
testing for non-adherence unlikely to be available across the world.
Digital medicine
This illustration shows the ingestion
of the ingestible sensor and its
detection by the wearable sensor .
Data received from the wearable
sensor will be processed and
displayed on a compatible computing
device (e.g., tablet computer) paired
with the wearable sensor
The latest technique to monitor
drug adherence and identify poor
adherence in various clinical
settings was designed by Proteus
Digital Health
Health Impacts of
Medication Non-adherence
Non-adherence consequences
Treatment "Rx"→ Adherence → Outcomes
Impact of non-adherence to antihypertensive medications
Economic
• Increased healthcare costs
• Reduce quality of life
• Disability
Cerebrovascular
• Stroke
• Cognitive dysfunction
• Dementia
Renal
• Microalbuminuria
• Chronic kidney disease
• End-stage renal disease
Cardiovascular
• Hypertensive crisis
• Left ventricular hypertrophy
• Vascular stiffness
• Myocardial infarction
• Chronic heart failure
• Death
Patient Consequences & Healthcare system Consequences
Did you know
that it’s estimated that
between 20% to 50% of
patients are non-adherent ?
Medication Adherence Stats
Non-adherence also leads to
a lot of monetary loss for all stakeholders
$300 Bn
The approx. annual avoidable healthcare cost due to
non-adherence in the US (which is 10% of total
healthcare spendings in the US)
As a result, hospital admissions and readmissions
take a giant leap.
1 in 3
Medicine-related hospital admissions that are due to non-adherence
66%
Hospital readmissions that occur annually due to non-adherence.
No wonder, non-adherence is termed as
‘the silent killer’
125,000
Number of people that die every year in the US
as they either fail to take medication or
take it improperly.
Rest In Peace
Medication
Non-adherence
“Modifiable
Risk Factor”
Future Vital Signs ?
Medication Adherence → low, medium and high adherence
Practical Approach
to Improve
Medication Adherence
A 360-degree approach to patient adherence
The approach to improve medication adherence
should address as much as possible
all of the potential detectable barriers listed under the five WHO categories.
Five Barriers to Medication Adherence
Social &
economic
Patient-
related
Healthcare-
related
Therapy-
related
Condition-
related
Physicians
01
Patients
02
Drug treatment
03
Health systems
.
04
Level of
Intervention
Interventions that may improve
drug adherence in hypertension
( 2018 ESC/ESH Guidelines )
Physician level
Provide information on the risks of hypertension and the benefits of
treatment, as well as agreeing a treatment strategy to achieve and
maintain BP control using lifestyle measures and a single-pill-based
treatment strategy when possible
(information material, programmed learning, and computer-aided counselling)
Empowerment of the patient
Feedback on behavioural and clinical improvements
Assessment and resolution of individual barriers to adherence
Collaboration with other healthcare providers, especially nurses and
pharmacists
Patient level
Self-monitoring of BP (including telemonitoring)
Group sessions
Instruction combined with motivational strategies
Self-management with simple patient-guided systems
Use of reminders
Obtain family, social, or nurse support
Provision of drugs at worksite
Health system level
Supporting the development of monitoring systems
(telephone follow-up, home visits, and telemonitoring of home BP)
Financially supporting the collaboration between healthcare
providers (e.g. pharmacists and nurses)
Reimbursement of SPC pills
Development of national databases, including prescription data,
available for physicians and pharmacists
Accessibility to drugs
Drug treatment level
Simplification of the drug regimen favouring the use of SPC therapy
Reminder packaging
Consider easy to use
technology-based solutions
A smartphone app
improves medication adherence
Smart pill bottles
 Every patient should be considered as potentially
non-adherent.
 Rule out non-adherence routinely
 It’s not just if a patient is non-adherent,but why ?
“Understanding the key drivers of non- adherence”
 Here are ways to improve hypertension
medication adherence to improve BP control.
 Prescribe fixed-dose combinations
 Switch to less expensive “generic” drugs
 Adopt standardized clinical guidelines
Adherence →High Adherence→Low
Finger-pointing connotation
“You will comply or
there will be consequences”
Warm , friendly sounding
“We would like you to adhere to the
prescribed regimen”
I should be spending more time on my patients , not on paperwork
Antihypertensive treatment strategies and adherence:
can we decrease risk?

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Strategies to improve adherence to antihypertensive medication

  • 1.
  • 2. Hypertension: Leading cause of global disease burden Yet.......Despite the availability of effective therapy we are not doing well !!! One key reason could be non-adherence Challenges in hypertension treatment “Drugs don't work in patients who don't take them” C Everett Koop: US Surgeon General 1981-89
  • 3. 1) What is the definition of medication non-adherence? 2) Who is at risk? 3) How should patients at risk be screened and identified? 4) What are the negative impacts of non-adherence? 5) What is the practical approach for improving adherence? Five Questions
  • 5. WHO definition of non-adherence The extent to which a person’s behaviour: •taking medication •following a diet •and/or executing lifestyle changes corresponds with agreed recommendations from a health care provider An arbitrary non-evidence-based cutoff of 80% is frequently used in the literature to define medication adherence Patients are generally considered adherent to their medication if their medication adherence percentage, defined as the number of pills absent in a given time period (“X”) divided by the number of pills prescribed by the physician in that same time period, is greater than 80%
  • 6. European Society for Patient Adherence, COMpliance and Persistence ESPACOMP Founded 2009 The ABC taxonomy for medication adherence
  • 7. The new taxonomy of adherence to medications according to the ABC European Consensus project 3 components 1 Drug therapy starts with the initiation, i.e., when the patient takes the first dose of the prescribed medication. It is a yes or no phenomenon. Thereafter, the implementation is the extent to which the patient’s actual dosing is in accordance with the prescribed dosing regimen between the initiation and the last dose. It is measured over a period of time and generally reported as a percentage. At last, discontinuation occurs when the patient stops taking the prescribed medication for whatever reason. Clinically, the most important measure of drug utilization in chronic diseases is certainly persistence which represents the time between initiation and the last dose before sustained discontinuation (persistence is also reported as a dichotomous variable patients being “persistent” or “non-persistent” ). 2 3
  • 8. The more scientific definition of medication adherence is the process by which patients take their medication as prescribed, which is further divided into 3 quantifiable components: initiation , implementation , and discontinuation Non-initiation Poor implementation Non-persistence
  • 9. There are 2 types of medication-taking behaviors. Intentional non-adherence is an active decision Motivation→Perceptions Unintentional non-adherence is a passive process Ability→Practicalities
  • 10. Risk Factors Associated With Medication Non-adherence (Multifactorial )
  • 11. Factors affecting medication adherence (based on WHO recommendation) Non-adherence is a multifactorial phenomenon: The five dimensions of non-adherence
  • 13. Screening and Identification of Patients with Medication Non-adherence
  • 14. Do you think it is difficult to measure adherence ? And if so, why? Yes  Non-adherence is a multifactorial phenomenon (5 barriers to medication adherence)  Medication adherence is a dynamic process that change overtime. Sequential barriers to adherence with antihypertensive therapy Adherence (3 components: initiation, implementation, and Persistence ) is a marathon , not a sprint. Patients can become non-adherent at any time (3 types) i.e. non-initiation, poor implementation and short persistence
  • 15. Methods for the detection of poor medication adherence in hypertension ( To measure initiation, implementation and persistence ) There are direct and indirect methods, each with respective advantages and disadvantages Assessment of medication adherence is complex, expensive, and difficult to implement in routine clinical practice. There is no one gold standard method of measuring adherence
  • 16. Indirect simple, cheap, and readily available methods, but with low reliability and validity—4 Ps • Patient questionnaire and self-reporting • Patient interview • Pill count • Prescription refill data Questionnaire→ MMAS-4, 8, four-item and eight-item Morisky Medication Adherence Scales Interview→Clinical estimation Pill count→ manual Refill Data→ MPR, medication possession ratio; PDC, proportion of days covered.
  • 17. The 8-items Morisky Medication Adherence Scale (MMAS-8) Characteristics Response 1. Do you sometimes forget to take your medication? Yes/No 2. People sometimes miss taking their medications for reasons other than forgetting. Over the past 2 weeks, where there any days when you did not take your medication? Yes/No 3. Have you ever cut back or stopped taking your medication without telling your doctor because you felt worse when you took it? Yes/No 4. When you travel or leave home, do you sometimes forget to bring your medication? Yes/No 5. Did you take all your medication yesterday? Yes/No 6. When you fell like your symptoms are under control, do you sometimes stop taking your medication? Yes/No 7. Taking medication every day is a real inconvenience for some people. Do you ever feel hassled about sticking to your treatment plan? Yes/No 8. How often do you have difficulty remembering to take all your medication? Never/Rarely Once in a while Sometimes Usually All the time The MMAS-8 can range from 0 to 8, with scores of <6, 6 to <8 and 8 reflecting low, medium and high adherence, respectively.
  • 18. Quantitative direct objective methods with high reliability and validity, but costly—4 Ms • Medication intake under observation (DOT) • Medication event monitoring system (MEMS) (Electronic monitoring) • Medication level measurement in body fluids (Therapeutic drug monitoring :TDM) • Digital medicine DOT ( Directly observed therapy) →Witnessed drug intake MEMS→Smart pill containers (Smart packaging):Digital monitoring . TDM :Drug assay → LC/MS, liquid chromatography coupled to mass spectrometry Digital medicine→Ingestable Sensor (Proteus system).
  • 19. Evolution of the MEMS® Cap from version 1 in 1977 to version 8 in 2017 Electronic medication monitoring or medication event monitoring system (MEMS) is accurate but limited to tracking of one single medication. It requires incorporation of an expensive microcircuit into packages such that each pill removal is recorded in real time The first electronic monitor for medication adherence, known as the Medication Event Monitoring System (MEMS®), was initially tested in 1977.
  • 20. The process of biochemical screening for non-adherence to antihypertensive treatment (a high performance liquid chromatography-tandem mass spectrometry “LC-MS/MS” instrument) The instrument is expensive (around £200,000–250,000). This makes biochemical testing for non-adherence unlikely to be available across the world.
  • 21. Digital medicine This illustration shows the ingestion of the ingestible sensor and its detection by the wearable sensor . Data received from the wearable sensor will be processed and displayed on a compatible computing device (e.g., tablet computer) paired with the wearable sensor The latest technique to monitor drug adherence and identify poor adherence in various clinical settings was designed by Proteus Digital Health
  • 24. Impact of non-adherence to antihypertensive medications Economic • Increased healthcare costs • Reduce quality of life • Disability Cerebrovascular • Stroke • Cognitive dysfunction • Dementia Renal • Microalbuminuria • Chronic kidney disease • End-stage renal disease Cardiovascular • Hypertensive crisis • Left ventricular hypertrophy • Vascular stiffness • Myocardial infarction • Chronic heart failure • Death Patient Consequences & Healthcare system Consequences
  • 25. Did you know that it’s estimated that between 20% to 50% of patients are non-adherent ? Medication Adherence Stats Non-adherence also leads to a lot of monetary loss for all stakeholders $300 Bn The approx. annual avoidable healthcare cost due to non-adherence in the US (which is 10% of total healthcare spendings in the US)
  • 26. As a result, hospital admissions and readmissions take a giant leap. 1 in 3 Medicine-related hospital admissions that are due to non-adherence 66% Hospital readmissions that occur annually due to non-adherence.
  • 27. No wonder, non-adherence is termed as ‘the silent killer’ 125,000 Number of people that die every year in the US as they either fail to take medication or take it improperly. Rest In Peace
  • 29. Future Vital Signs ? Medication Adherence → low, medium and high adherence
  • 31. A 360-degree approach to patient adherence The approach to improve medication adherence should address as much as possible all of the potential detectable barriers listed under the five WHO categories. Five Barriers to Medication Adherence Social & economic Patient- related Healthcare- related Therapy- related Condition- related
  • 32. Physicians 01 Patients 02 Drug treatment 03 Health systems . 04 Level of Intervention Interventions that may improve drug adherence in hypertension ( 2018 ESC/ESH Guidelines )
  • 33. Physician level Provide information on the risks of hypertension and the benefits of treatment, as well as agreeing a treatment strategy to achieve and maintain BP control using lifestyle measures and a single-pill-based treatment strategy when possible (information material, programmed learning, and computer-aided counselling) Empowerment of the patient Feedback on behavioural and clinical improvements Assessment and resolution of individual barriers to adherence Collaboration with other healthcare providers, especially nurses and pharmacists
  • 34. Patient level Self-monitoring of BP (including telemonitoring) Group sessions Instruction combined with motivational strategies Self-management with simple patient-guided systems Use of reminders Obtain family, social, or nurse support Provision of drugs at worksite
  • 35. Health system level Supporting the development of monitoring systems (telephone follow-up, home visits, and telemonitoring of home BP) Financially supporting the collaboration between healthcare providers (e.g. pharmacists and nurses) Reimbursement of SPC pills Development of national databases, including prescription data, available for physicians and pharmacists Accessibility to drugs
  • 36. Drug treatment level Simplification of the drug regimen favouring the use of SPC therapy Reminder packaging
  • 37. Consider easy to use technology-based solutions A smartphone app improves medication adherence Smart pill bottles
  • 38.
  • 39.  Every patient should be considered as potentially non-adherent.  Rule out non-adherence routinely  It’s not just if a patient is non-adherent,but why ? “Understanding the key drivers of non- adherence”  Here are ways to improve hypertension medication adherence to improve BP control.  Prescribe fixed-dose combinations  Switch to less expensive “generic” drugs  Adopt standardized clinical guidelines
  • 40. Adherence →High Adherence→Low Finger-pointing connotation “You will comply or there will be consequences” Warm , friendly sounding “We would like you to adhere to the prescribed regimen”
  • 41. I should be spending more time on my patients , not on paperwork
  • 42. Antihypertensive treatment strategies and adherence: can we decrease risk?