Medication Adherence and Medication Adherence and Chronic Disease ManagementChronic Disease ManagementChronic Disease ManagementChronic Disease Management

Cynthia Jackevicius, BScPhm, PharmD, MSc, FCSHP, BCPSCynthia Jackevicius, BScPhm, PharmD, MSc, FCSHP, BCPS

Associate Professor, Pharmacy Practice, Western University of Health SciencesAssociate Professor, Pharmacy Practice, Western University of Health SciencesClinical Pharmacy Specialist, Cardiology, VA West LA Healthcare CenterClinical Pharmacy Specialist, Cardiology, VA West LA Healthcare Center

Assistant Professor, Faculty of Medicine, University of TorontoAssistant Professor, Faculty of Medicine, University of TorontoAdjunct Scientist, Institute for Clinical Evaluative SciencesAdjunct Scientist, Institute for Clinical Evaluative Sciences

National Conference of State LegislaturesNational Conference of State LegislaturesDecember 2009December 2009

ObjectivesObjectivesObjectivesObjectives

Identify the patient role in chronic diseaseIdentify the patient role in chronic diseaseIdentify the patient role in chronic disease Identify the patient role in chronic disease management focusing on adherence and management focusing on adherence and cardiovascular diseasecardiovascular diseasecardiovascular diseasecardiovascular diseaseProvide examples of where adherence Provide examples of where adherence and health policy potentially intersect withand health policy potentially intersect withand health policy potentially intersect with and health policy potentially intersect with respect to chronic disease managementrespect to chronic disease management

QuestionQuestionQuestion....Question....

33

Adherence DefinitionAdherence DefinitionAdherence Definition Adherence Definition

““The extent to which a person’s behaviorThe extent to which a person’s behavior --The extent to which a person s behavior The extent to which a person s behavior --taking medications, following diet, and/or taking medications, following diet, and/or executing lifestyle changes executing lifestyle changes -- corresponds corresponds g y gg y g pp

with agreed recommendations from with agreed recommendations from a health care provider.”a health care provider.”

Adherence to Long-term Therapies: Evidence for Action. World Health Organization Press; 2003.

Rule of 6Rule of 6Rule of 6Rule of 6

1/6 take meds nearly perfectly1/6 take meds nearly perfectly1/6 take meds nearly perfectly1/6 take meds nearly perfectly1/6 take nearly all doses, but irregular timing1/6 take nearly all doses, but irregular timing1/6 miss an occasional single day’s dose and1/6 miss an occasional single day’s dose and1/6 miss an occasional single day s dose and 1/6 miss an occasional single day s dose and have irregular timinghave irregular timing1/6 take "drug holidays" 31/6 take "drug holidays" 3--4 times a year with4 times a year with1/6 take drug holidays 31/6 take drug holidays 3 4 times a year, with 4 times a year, with occasional missed dosesoccasional missed doses1/6 take "drug holidays" monthly or more often 1/6 take "drug holidays" monthly or more often /6 ta e d ug o days o t y o o e o te/6 ta e d ug o days o t y o o e o tewith frequent omissionswith frequent omissions1/6 take few or no doses1/6 take few or no doses

Urquhart J. Br J Clin Pharmacol 2002;54:212-20.

Some patients do not fill their initial Some patients do not fill their initial i ti f ll ii ti f ll i h t tt kh t tt kprescription following prescription following a heart attacka heart attack

25

20

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Not filled-Day 7

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0

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ins

Jackevicius, et al. Circulation . 2008;117: 1028-36.

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Those who don’t fill their first prescriptions have a Those who don’t fill their first prescriptions have a hi h h f d i ft h t tt khi h h f d i ft h t tt khigher chance of dying after a heart attackhigher chance of dying after a heart attack

Filled some instead of all prescriptionsFilled some instead of all prescriptions44% hi h h f d i ithi 144% hi h h f d i ithi 1–– 44% higher chance of dying within 1 year44% higher chance of dying within 1 year

Filled none instead of all prescriptionsFilled none instead of all prescriptions–– 80% higher chance of dying within 1 year80% higher chance of dying within 1 yearg y g yg y g y

Jackevicius, et al. Circulation . 2008;117: 1028-36.

Medication discontinuation occurs Medication discontinuation occurs l ft h it l di hl ft h it l di h

Discharge 1-month 6-month 12-month

early after hospital dischargeearly after hospital discharge

8090

100

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Discharge 1-month 6-month 12-month

~18% ~15% 16%

50607080

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~23%15% ~16%

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*Acetylsalicylic AcidHo PM. et al. Arch Intern Med. 2006

Statin Statin Adherence by Adherence by GroupGroup

100

120

0.5 y72.9%70 4%

1 y57.5%54 1%

1.5 y47.6%43 7%

2 y40.1%36 1%

80

100

ing

on S

tatin

s

70.4%56.1%

54.1%39.4%

43.7%30.9%

36.1%25.4%

60

of P

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emai

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ACS

20

40

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CAD

Primary

0

20

0 3 7 10 13 16 20 23 26 30 33 36 39 43 46 49 53 56 59 62 66 69 72 76 79 82 85 89 92 95 99 02

Primary Prevention

1 1 1 2 2 2 3 3 3 3 4 4 4 5 5 5 6 6 6 7 7 7 8 8 8 9 9 9 10

Follow-up (Weeks)

Jackevicius C, et al. JAMA 2002;288:462ACS= Acute Coronary SyndromeCAD= Coronary Artery Disease

The Heart and Soul StudyThe Heart and Soul StudyThe Heart and Soul StudyThe Heart and Soul Study1015 outpatients with 1015 outpatients with ppheart diseaseheart diseaseVA and community health VA and community health li ili i

P=0.03

clinicsclinics“In the past month, how “In the past month, how often did you take youroften did you take youroften did you take your often did you take your medications as the doctor medications as the doctor prescribed?”prescribed?”C di E t diC di E t diCardiac Events: cardiac Cardiac Events: cardiac death, heart attack, death, heart attack, strokestroke

Gehi NK ,et al. Arch Intern Med 2007;167:1798-1803.

Poor adherence is associated with Poor adherence is associated with higher higher costs: hypertension examplecosts: hypertension example

Adherence Adherence level (%)level (%)

Medical Medical cost ($)cost ($)

Drug Drug cost ($)cost ($)

Total Total cost ($)cost ($)

Hospitalization Hospitalization risk (%)risk (%)

11--1919 48474847 3131 48784878 282811--1919 48474847 3131 48784878 2828

2020--3939 59735973 8989 60626062 2424

4040--5959 51135113 184184 52975297 2424

6060 7979 49774977 285285 52625262 20206060--7979 49774977 285285 52625262 2020

8080--100100 43834383 489489 48714871 1919

Sokol MC. Med Care. 2005.

Solutions?Solutions?

Prevent & IntervenePrevent & Intervene

World Health Organization’s World Health Organization’s 5 Di i f Adh5 Di i f Adh5 Dimensions of Adherence5 Dimensions of Adherence

ComplexComplexComplex Complex behaviouralbehavioural processprocessMany interacting Many interacting y gy gfactorsfactorsNo single model or No single model or theory to integratetheory to integratetheory to integrate theory to integrate different studies or different studies or findingsfindings

WHO 2003

Determinants of NonadherenceDeterminants of NonadherenceDeterminants of NonadherenceDeterminants of Nonadherence

Since ~1975, more than 200 variables haveSince ~1975, more than 200 variables haveSince 1975, more than 200 variables have Since 1975, more than 200 variables have been studied, but none solely predicts been studied, but none solely predicts nonadherencenonadherenceSociodemographicSociodemographic and health status indicators and health status indicators are not generally good predictors of adherenceare not generally good predictors of adherenceMajor determinants: Major determinants: –– PolypharmacyPolypharmacy–– Poor patientPoor patient--provider relationships/multiple providersprovider relationships/multiple providers

Little consensus on other variablesLittle consensus on other variables

Vik SA, et al. Ann Pharmacother 2004;38:303-12.

Barriers to Barriers to Medication AdherenceMedication Adherence

Patients Provider

HealthcareHealthcare System

Osterberg L, et al. NEJM 2005

Most Common Most Common PatientPatient SelfSelf--Reported Reported R f N dhR f N dhReasons for NonadherenceReasons for Nonadherence

Taking too Many Rx

Rx Ran Out, Drug N/A,CostCost

AsymptomaticPatient Feels Not NeededPatient ForgetsUnclear about Use

Asymptomatic

WHO 2003; Vik SA, et al Ann Pharmacother 2004;38:303-12.

Unclear about Use

Patient’s RolePatient’s RolePatient s RolePatient s Role

Become responsible for your own healthBecome responsible for your own healthBecome responsible for your own healthBecome responsible for your own healthBecome informed & empoweredBecome informed & empowered

A k tiA k ti–– Ask questionsAsk questionsWork with your health care providersWork with your health care providersCommunicate with providers Communicate with providers honestlyhonestly

Improving AdherenceImproving AdherenceSingle strategies have small effectSingle strategies have small effectNot surprising since there are many reasons forNot surprising since there are many reasons forNot surprising since there are many reasons for Not surprising since there are many reasons for nonadherencenonadherenceIntentional nonadherence targets:Intentional nonadherence targets:Intentional nonadherence targets:Intentional nonadherence targets:–– Information Information -- perceived value (costperceived value (cost--benefit analysis)benefit analysis)–– Beliefs/preferences Beliefs/preferences pp–– Confidence/selfConfidence/self--efficacyefficacy

NonintentionalNonintentional nonadherence targets:nonadherence targets:–– Process orientedProcess oriented

Information Information –– skills, techniquesskills, techniquesOrgani ationOrgani ationOrganizationOrganizationStructureStructure

EvidenceEvidence--Based Strategies Based Strategies to Impro e Adherenceto Impro e Adherenceto Improve Adherenceto Improve Adherence

COMBINATIONSCOMBINATIONS of:of:–– Instruction and instructional materialsInstruction and instructional materials–– Counseling about the regimenCounseling about the regimen Information

B li f–– Involving family membersInvolving family members–– Support group sessionsSupport group sessions

Reinforcements and rewardsReinforcements and rewards

Beliefs

–– Reinforcements and rewardsReinforcements and rewards–– SelfSelf--monitoring with regular MD review monitoring with regular MD review

and reinforcementand reinforcement

Confidence

–– RemindersReminders–– Cuing medications to daily eventsCuing medications to daily events Nonintentional

Process–– Simplifying the regimenSimplifying the regimen

Haynes RB, et al. JAMA 2002;288:2868-79.

Process

Start Medications in HospitalStart Medications in HospitalStart Medications in HospitalStart Medications in HospitalAronowAronow also found trend to also found trend to

d d t litd d t litreduced mortalityreduced mortality–– 5.7% 5.7% vsvs 11.7% (p=0.06 in 11.7% (p=0.06 in

adjusted model)adjusted model)Linking initiation of secondary Linking initiation of secondary prevention Rx with cardiac prevention Rx with cardiac admission conveys message admission conveys message f i t f th &f i t f th &of importance of therapy & of importance of therapy &

relation to cardiac eventrelation to cardiac eventTargets beliefs & information Targets beliefs & information

t tt tconstructsconstructsTargets processTargets process–– System to start Rx in System to start Rx in

hospitalhospital

AJC 2001;87:257-61. ArIM 2003;163:2576-82.

Policy BarriersPolicy Barriers

Medication CostsMedication CostsMedication PoliciesMedication Policies–– Cost Sharing/Cost Sharing/CopaysCopaysgg p yp y–– Restrictions that present barriers/delaysRestrictions that present barriers/delays

E.g., Prior authorization E.g., Prior authorization

R t i ti f l iR t i ti f l i–– Restrictive formulariesRestrictive formulariesSwitching therapies, especially during care transitionsSwitching therapies, especially during care transitions

Medication CostsMedication CostsRelated to Related to socioeconomic statussocioeconomic status, policies and , policies and trusttrusttrusttrustSelfSelf--reported costreported cost--related medication related medication nonadherencenonadherencenonadherence nonadherence –– 9.9% in US, 5.1% in Canada9.9% in US, 5.1% in Canada–– Rising to 28.2% in uninsured AmericansRising to 28.2% in uninsured AmericansRising to 28.2% in uninsured AmericansRising to 28.2% in uninsured Americans–– 23% in US didn’t fill Rx or missed doses due to cost23% in US didn’t fill Rx or missed doses due to cost

Trust between patient and provider is a modifierTrust between patient and provider is a modifierp pp p–– costcost--related underuse related underuse 3X more with low trust 3X more with low trust

relationship with their providerrelationship with their provider

Clin Ther 2006;28:1217-24. Health Affairs 2007:26:w717-734. Piette et al. ArIM 2005;165:1749-55.

Cost Sharing PoliciesCost Sharing PoliciesCost Sharing PoliciesCost Sharing PoliciesFor every 10% increase in cost sharing, prescription For every 10% increase in cost sharing, prescription y g, p py g, p pdrug spending (surrogate for drug use) decreases by drug spending (surrogate for drug use) decreases by 2% 2% -- 6%, varying by drug class & condition6%, varying by drug class & conditionF l if f $5 t $10 th dF l if f $5 t $10 th dFor example, if copay goes from $5 to $10, then drug For example, if copay goes from $5 to $10, then drug spending (& use) will decrease by 10% spending (& use) will decrease by 10% -- 30%30%For some chronic conditions, higher cost sharing isFor some chronic conditions, higher cost sharing isFor some chronic conditions, higher cost sharing is For some chronic conditions, higher cost sharing is associated with more use of medical servicesassociated with more use of medical services–– Heart failure, lipid disorders, diabetes, schizophreniaHeart failure, lipid disorders, diabetes, schizophrenia

C i t d d t d f “l i t t”C i t d d t d f “l i t t”Copays are intended to reduce use of “less important” Copays are intended to reduce use of “less important” medications by making patients responsible for part of medications by making patients responsible for part of the cost also adversely affect the use of “important” the cost also adversely affect the use of “important” y py ptherapiestherapies

Goldman DP, et al. JAMA 2007;298;61-9.

Decreasing CopaymentsDecreasing CopaymentsDecreasing CopaymentsDecreasing CopaymentsIntervention employer reduced copays for 5 Intervention employer reduced copays for 5 chronic medication classes within a disease chronic medication classes within a disease management (DM) programmanagement (DM) program

G i $5 t $0 B d $25 t $12 50 ( f d)G i $5 t $0 B d $25 t $12 50 ( f d)–– Generics: $5 to $0, Brand: $25 to $12.50 (preferred) Generics: $5 to $0, Brand: $25 to $12.50 (preferred) and $45 to $22.50 (nonpreferred)and $45 to $22.50 (nonpreferred)

Control employer only did DM programControl employer only did DM programControl employer only did DM programControl employer only did DM programNonadherence was reduced by 7%Nonadherence was reduced by 7%--14%14%–– A lower effect than instituting a copay would have onA lower effect than instituting a copay would have on–– A lower effect than instituting a copay would have on A lower effect than instituting a copay would have on

increasing nonadherence by 10%increasing nonadherence by 10%--30%30%–– Decreasing a copay is less effective than increasing a Decreasing a copay is less effective than increasing a

copay on drug usecopay on drug useChernew ME, et al. Health Affairs 2008;27:103-12.

Prior Authorization & OutcomesPrior Authorization & OutcomesPrior Authorization & OutcomesPrior Authorization & OutcomesTo evaluate the population level effect on cardiovascular To evaluate the population level effect on cardiovascular p pp poutcomes of a change from a PA policy to a limited use outcomes of a change from a PA policy to a limited use (LU) policy for clopidogrel in patients undergoing stent (LU) policy for clopidogrel in patients undergoing stent implantation postimplantation post acute myocardial infarction (AMI)acute myocardial infarction (AMI)implantation postimplantation post--acute myocardial infarction (AMI).acute myocardial infarction (AMI).

Jackevicius C, et al. NEJM 2008;359:1802-10.

Policy Barriers Policy Barriers –– Prior Authorization & OutcomesPrior Authorization & Outcomes

PA policy associated with:PA policy associated with:–– Delay in filling Rx (9d) vs. special limited use form (0d)Delay in filling Rx (9d) vs. special limited use form (0d)

Fewer prescriptions filled through government prescriptionFewer prescriptions filled through government prescription–– Fewer prescriptions filled through government prescription Fewer prescriptions filled through government prescription planplan

Jackevicius C, et al. NEJM 2008;359:1802-10.

Preferred Drug Lists/Drug Limits & Preferred Drug Lists/Drug Limits & N dhN dhNonadherenceNonadherence

Alabama Medicaid changedAlabama Medicaid changedAlabama Medicaid changed Alabama Medicaid changed to a preferred drug list for to a preferred drug list for statins in 2004 + a limit of 4 statins in 2004 + a limit of 4 b d di ti & 10b d di ti & 10

Increased Chance of

NonadherenceOverall

Furtherbrand medications & 10 brand medications & 10 total medications/ patient/ total medications/ patient/ monthmonth

80%

Further NonadherenceFor Restricted Statins

North Carolina was the North Carolina was the control (no change)control (no change)Nonadherence in AL preNonadherence in AL pre

40%

Nonadherence in AL pre Nonadherence in AL pre and post policy change:and post policy change:–– 39% vs 51%39% vs 51%

Ridley et al. Pharmacoeconomics 2006;24(Suppl 3);65-78.

Drugs don’t work in patients Drugs don’t work in patients g pg pwho don’t take them. who don’t take them.

C Everett Koop M DC Everett Koop M DC. Everett Koop M.D.C. Everett Koop M.D.

Effect of Doubling Copayment on Medication UseEffect of Doubling Copayment on Medication Usei Ch i ll Ill P ti ti Ch i ll Ill P ti tin Chronically Ill Patientsin Chronically Ill Patients

Goldman DP, et al. JAMA 2004;291:2344-50.

Copay Effect on StatinsCopay Effect on Statinsb Th ti N db Th ti N dby Therapeutic Needby Therapeutic Need

Full compliance impact:Full compliance impact:

High risk:High risk:–– 357 fewer hospitalizations 357 fewer hospitalizations

/y/1000 pts/y/1000 pts/y/1000 pts/y/1000 pts

Low riskLow risk–– 42 fewer hospitalizations 42 fewer hospitalizations

/ /1000 t/ /1000 t/y/1000 pts/y/1000 pts

Goldman DP, et al. AJMC 2006;12:21-8.

SummarySummarySummarySummary

Medication nonadherence is a commonMedication nonadherence is a commonMedication nonadherence is a common Medication nonadherence is a common problem that results in poor patient problem that results in poor patient outcomes & economic consequencesoutcomes & economic consequencesoutcomes & economic consequencesoutcomes & economic consequencesMedication adherence may be affected by Medication adherence may be affected by actions from the patient the provider andactions from the patient the provider andactions from the patient, the provider and actions from the patient, the provider and the healthcare systemthe healthcare systemD li i d i t di tiD li i d i t di tiDrug policies do impact medication use Drug policies do impact medication use and need to be considered carefullyand need to be considered carefully