Enhancing Prescription Medicine Adherence

7/29/2019 Enhancing Prescription Medicine Adherence

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Enhancin Prescriptin

Medicine Adherence:A Natinal Actin Plan

National Council on Patient Inormation and Education

Ast 2007


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Cpyi 2007 by Naina Cunci n Paien Inmain and Educain.

A is eseved. N pa is ep may be epduced uiized in any m by any means, eecnic mecanica, incudinpcpyin, ecdin, by any inmain sae eeiva sysem, wiu pemissin in wiin m e pubise. Inquiies sud be

addessed :

Pined in e Unied Saes Ameica.

National Council on Patient Information and Education

200-A Monroe Street

Suite 212

Rockville, MD 20850-4448

301-340-3940


3/38E N h A N C I N g P r E S C r I P t I o N M E D I C I N E A D h E r E N C E : A N A t I o N A l A C t I o N P l A N

Preace

In the United States and around the world, there is compelling evidence that patients are not taking theirmedicines as prescribed, resulting in signicant consequences. Lack o medication adherence isAmericasother drug problem and leads to unnecessary disease progression, disease complications, reduced unctionalabilities, a lower quality o lie, and even death.

Contributing toAmericas other drug problem are numerous behavioral, social, economic, medical, andpolicy-related actors that must be addressed i medication adherence rates are to improve. This includeslack o awareness among clinicians about basic adherence management principles, poor communicationbetween patients and clinicians, operational aspects o pharmacy and medical practice, and proessionalbarriers. Moreover, adherence improvement is aected by ederal policies that provide insucient undingor adherence-related research and ederal and state laws and regulations that impact the availability ocompliance assistance programs. All o these problems contribute to a rising tide o poor medication

adherence and all must be addressed.

The ramications o poor prescription medicine adherence aect virtually every aspect o the health caresystem. Addressing this persistent and pervasive problem cannot wait. Today, extensive research data existthat point to actions that can be taken now to improve adherence education and medication management.Accordingly, the National Council on Patient Inormation and Education (NCPIE) -- a non-prot coalitiono more than 00 organizations that are working to stimulate and improve communication on theappropriate use o medicines -- convened a group o advisors rom leading proessional societies, voluntaryhealth organizations, and patient advocacy groups to assess the extent and nature o poor medicineadherence, its health and economic costs, and its underlying actors. These advisors also examined thecurrent state o research unding and educational initiatives around patient adherence to determine wheremajor gaps still exist.

What ollows is the result o this review, which ocuses specically on identiying those action steps thatcan signicantly impact medication adherence and can be readily implemented. As such, this reportserves as a leprint r actin by all stakeholders. To achieve the awareness, behavior changes, andadditional resources or research and education that will improve patient medication adherence requiresan ongoing partnership through which policymakers, regulators, the public health community, clinicians,the pharmaceutical industry, and patient advocates can share research, resources, and good ideas, whileworking toward a common goal. It is intended that this report will be a catalyst or this necessary andimportant collaborative eort.


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American Academ Phsician AssistantsMichael Ellwood, MBA, PA-CDirector, Special Projects

American Cancer ScietLen Lichteneld, M.D.

Deputy Chie Medical Ocer

American Cllee Phsicians FndatinRuth M. Parker, M.D.

Special Advisor in Health Literacy to the EVP and CEO

American Diaetes AssciatinDiane Tuncer

National Director, External Communications

American Heart AssciatinPenelope Solis, J.D.

Regulatory Relations Manager, Oce o Legislative Aairs

Asthma and Aller Netwr / Mthers AsthmaticsSandra J. Fusco-Walker

Director Government Aairs

Natinal Assciatin Chain Dr Stres FndatinPhillip Schneider, M.A.

Vice President, External Relations & Program Development

Natinal Cnsmers LeaeRebecca Burkholder

Director o Health Policy

Natinal Cncil n Patient Inrmatin and EdcatinWm. Ray Bullman

Executive Vice President

Derah DaidsnMembership Director

Natinal Wmens Health Resrce Center, Inc.Heidi Rosvold-Brenholtz

Editorial Director and Managing Editor

Prect Adisr Team



Eectie Smmar

At the same time that medical science has madepossible new therapies or treating AIDS, cancer,and other once atal diseases, poor adherence withmedication regimens has reached crisis proportionsin the United States and around the world.

On a worldwide basis, the World HealthOrganization (WHO) projects that only about 50percent o patients typically take their medicinesas prescribed. In the U.S., non-adherence aectsAmericans o all ages, both genders and is just aslikely to involve higher-income, well-educated

people as those at lower socioeconomic levels.Furthermore, since lack o medication adherenceleads to unnecessary disease progression, diseasecomplications, reduced unctional abilities, a lowerquality o lie, and even premature death, pooradherence has been estimated to cost approximately$77 billion annually in total direct and indirecthealth care costs.

Although the challenge o poor medicationadherence has been discussed and debated orat least three decades, these problems havegenerally been overlooked as a serious publichealth issue and, as a result, have received littledirect, systematic, or sustained intervention.As a consequence, Americans have inadequateknowledge about the signicance o medicationadherence as a critical element o their improvedhealth. Further, adherence rates suer rom theragmented approach by which hospitals, healthcare providers, and other parts o the healthdelivery system intervene with patients andcaregivers to encourage adherence. Consequently,

many leading medical societies are now advocatinga multidisciplinary approach through coordinatedaction by health proessionals, researchers, healthplanners and policymakers.

Over a decade ago, the National Council on PatientInormation and Education (NCPIE) recognizedthe need or such a coordinated approach toimproved medication adherence and issued a report

-- Prescription Medicine Compliance: A Review of theBaseline Knowledge -- which dened the key actorscontributing to poor adherence. Since that time, theNational Institutes o Health (NIH) and a numbero voluntary health organizations in the U.S. haveweighed in with new ndings on the importanceo adherence or successul treatment. Furtherelevating the need or action is the WHO, which hascalled or an initiative to improve worldwide rates oadherence to therapies commonly used in treatingchronic conditions, including asthma, diabetes, andhypertension.

Unortunately, however, these calls or action haveyet to be heeded and rates o medicine adherencehave not improved. Thus, action is needed nowto reduce the adverse health and economicconsequences associated with this pervasiveproblem. While no single strategy will guaranteethat patients will ll their prescriptions and taketheir medicines as prescribed, elevating adherenceas a priority issue and promoting best practices,behaviors, and technologies may signicantlyimprove medication adherence in the U.S.

Towards this end, NCPIE convened a panelo experts to create consensus on ten nationalpriorities that may have the greatest impact onimproving the state o patient adherence in theU.S. These recommendations serve as a catalystor action across the continuum o care -- romdiagnosis through treatment and ollow-uppatient care and monitoring. Ultimately involvingthe support and active participation o manystakeholders -- the ederal government, state and

local government agencies, proessional societiesand health care practitioners, health educators, andpatient advocates -- this platorm calls or action inthe ollowing areas:

Eleate patient adherence as a criticalhealth care isse.Medication non-adherence is a problemthat applies to all chronic disease states;

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aects all demographic and socio-economicstrata; diminishes the ability to treatdiabetes, heart disease, cancer, asthma,and many other diseases; and results insuering, sub-optimal utilization o healthcare resources, and even death. Despite

this impact, patient adherence is not on theradar screen o policy makers and manyhealth proessionals, which has meantinconsistent government policies and alack o resources or research, education,and proessional development. Until healthcare policy makers, practitioners and otherstakeholders recognize the extent o non-adherence, its cost, and its contribution tonegative health outcomes, this problem willnot be solved.

Aree n a cmmn adherenceterminl that will nite allstaehlders.Today, a number o common terms -- compliance, adherence, persistence,and concordance -- are used to denethe act o seeking medical attention,lling prescriptions and taking medicinesappropriately. Because these terms refectdierent views about the relationshipbetween the patient and the health care

provider, conusion about the languageused to describe a patients medication-taking behavior impedes an inormeddiscussion about compliance issues.Thereore, the public health communityshould endeavor to reach agreementon standard terminology that will unitestakeholders around the common goalo improving the sel-administrationo treatments to promote better healthoutcomes.

Create a plic/priate partnershipt mnt a nifed natinal edcatincampain t mae patient adherence anatinal health pririt.To motivate patients and practitionersto take steps to improve medicationadherence, compelling, actionable messagesmust be communicated as part o a uniedand sustained public education campaign.

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A oremost priority is creating the means bywhich government agencies, proessionalsocieties, non-prot consumer groups,and other aected stakeholders can worktogether to reach public and proessionalaudiences on a sustained basis. Even as

NCPIE and various government agencies,proessional societies, and voluntary healthorganizations work to provide inormationabout medication adherence, there needsto be a national clearinghouse, servingas the catalyst and convener so that allstakeholders can speak with one voiceabout the need or improving patientadherence. NCPIE, a proessional society,or academic institution could manage thisclearinghouse eectively.

Estalish a mltidisciplinar apprach tadherence edcatin and manaement.There is a growing recognition that amultidisciplinary approach to medicationtaking behavior is necessary or patientadherence to be sustained. This has ledNCPIE to promote a new model -- theMedicine Education Team -- in which thepatient and all members o the health careteam work together to treat the patientscondition, while recognizing the patients

key role at the center o the process.Looking to the uture, this approach haspotential to improve adherence ratessignicantly by changing the interactionbetween patients and clinicians andby engaging all parties throughout thecontinuum o care.

Immediatel implement pressinaltrainin and increase the ndin rpressinal edcatin n patientmedicatin adherence.

Todays practitioners need hands-oninormation about adherence managementto use in real-world settings. This needcomes at a time when a solid baseo research already exists about thesteps physicians and other prescribers,pharmacists, nurses, and other health carepractitioners can take to help patientsimprove their medication taking behavior.

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Proessional societies and recognizedmedical sub-specialty organizations shouldimmediately apply these research ndingsinto proessional education throughcontinuing education courses as well aslecture series on patient adherence issues.

Address the arriers t patientadherence r patients with lw healthliterac.Low health literacy and limited Englishprociency are major barriers to adherenceand deserve special consideration. Thus,an important target or patient-tailoredinterventions is the 90 million Americanswho have diculty reading, understandingand acting upon health inormation.Accordingly, advocates recommend

widespread adoption o existing tools,such as the Rapid Estimate o AdultLiteracy in Medicine Revised (REALM-R),validated pictograms designed to conveymedicine instructions and specic patienteducation programs that promote andvalidate eective oral communicationbetween health care providers and patientssupported by provision o adjunctive,useul inormation in its most useulormat to address the patients individual

capabilities.Create the means t share inrmatinat est practices in adherenceedcatin and manaement.Today, stakeholders have access to morethan 0 years o research measuringthe outcomes and value o adherenceinterventions. Building on this oundation,a critical next step is or the ederalgovernment -- through the AdherenceResearch Network -- to begin collecting

data on best practices in the assessment opatient readiness, medication managementand adherence interventions, incentivesthat produce quality outcomes romadherence interventions, and measurementtools so that this inormation can bequantied and shared across specialtiesand health care acilities. Just as ederal andstate registries collect and share necessary

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data on dierent disease states, a sharedknowledge base regarding systems change,new technologies, and model programsor evaluating and educating patientsabout adherence will signicantly improvethe standard o adherence education and

management.

Deelp a crriclm n medicatinadherence r se in medical schls andallied health care instittins.Lack o awareness among clinicians aboutbasic adherence management principlesand their eective application remainsa major reason that adherence has notadvanced in this country. Changing thissituation will require institutionalizingcurricula at medical, nursing, pharmacy,

and dental schools as well as courses oraculty members that ocus on adherenceadvancement and execution o medication-related problem solving. Moreover, oncethese courses are developed, it will beimportant or academic centers to elevatepatient adherence as a core competency bymandating that course work in this area bea requirement or graduation.

See relatr chanes t remerad-lcs r adherence assistance

prrams.Improved adherence to medicationregimens is predicated in part onsupportive government policies.Unortunately, a number o ederaland state laws and policies now limitthe availability o adherence assistanceprograms. Accordingly, limitations topatient communication about medicineadherence in ederal and state laws must beidentied or lawmakers and regulators to

resolve. Key issues to be addressed includeclariying that education and rell remindercommunications all within the scope o theederal anti-kickback statute, and ensuringthat ederal and state laws related topatient privacy and the use o prescriptiondata are in balance such that they do notunduly limit the ability o pharmaciesto communicate with patients about the

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importance o adhering to their prescribedtherapy.

Increase the ederal det and stimlaterirs research n medicatinadherence.

Although the National Institutes o Healthcreated the Adherence Research Networkto identiy research opportunities at its8 Institutes and Centers, the Networkhas been inactive since 00. Moreover,in 000, when the Network was undingadherence research, the actual NIH dollarsearmarked or testing interventions toimprove medication-taking behavior wasonly $ million in a budget o nearly $8billion. Thus, it will be important orstakeholders to advocate or the Adherence

Research Network to be re-invigoratedand or NIH to signicantly increase theproportion o its research unding to testadherence interventions and measure theireectiveness. Even i NIH triples its 000commitment, the small amount spent onpatient adherence will still signal that theissue is a critical area or new researcheorts.

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Everyone in the health care system rom patientsand caregivers to health care providers, patientadvocates and payors has a signicant role to playin improving prescription medicine adherence.Thus, an agenda that removes the barriers andadvances education and inormation sharing is acritical step to improving the health status o allAmericans. Clearly, the time or action is now.

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Intrdctin

There is much to celebrate about the improvedhealth status o many Americans. Smoking rateshave dropped signicantly, inant mortality hasdeclined and there have been major advancementsin treatments or serious diseases that oncedevastated the lives o millions. This includesmore than 00 new drugs, biologics andvaccines approved by the U.S. Food and DrugAdministration (FDA) since 99 to prevent andtreat over 50 medical conditions.()

While we recognize such progress, now is the

time to be even more mindul o the publichealth problems we have yet to solve. One othese persistent challenges is improving patientcompliance (or adherence) dened as theextent to which patients take medications asprescribed by their health care providers.() At thesame time that medical science has made possiblenew therapies or treating AIDS, cancer, and otheronce atal diseases, poor adherence with medicationregimens has reached crisis proportions in theUnited States and around the world. According tothe World Health Organization (WHO), only about50 percent o patients typically take their medicinesas prescribed.() For this reason, WHO calls pooradherence rates a worldwide problem o strikingmagnitude() and has published an evidence-based guide or health care providers, health caremanagers, and policymakers to improve strategieso medication adherence.()

Looking specically at lack o medication adherencein the U.S., a recent survey reported that nearlythree out o every our American consumers report

not always taking their prescription medicineas directed.() Commissioned by the NationalCommunity Pharmacists Association (NCPA), thissurvey also ound a major disconnect betweenconsumers belies and their behaviors when itcomes to taking medicines correctly. Some o thendings o the survey include:

Almost hal o those polled (9 percent)said they had orgotten to take a prescribedmedicine;

Nearly one-third ( percent) had not lleda prescription they were given;

Nearly three out o 0 (9 percent) hadstopped taking a medicine beore thesupply ran out; and

Almost one-quarter ( percent) had takenless than the recommended dosage.

While disturbing, these statistics only begin todemonstrate the magnitude and scope o pooradherence in the U.S. Lack o adherence aectsAmericans o all ages and both genders, but is oparticular concern among those aged 5 and overwho, because they have more long-term, chronicillnesses, now buy 0 percent o all prescriptionmedicines(5) and oten combine multiplemedications over the course o a day. Regardless oage and sex, poor medication adherence is also justas likely to involve higher-income, well-educated

people as those at lower socioeconomic levels.()As a result, poor medication adherence has beenestimated to cost approximately $77 billionannually in total direct and indirect health carecosts.()

Adherence rates are typically higher in patientswith acute conditions, as compared to those withchronic conditions, with adherence droppingmost dramatically ater the rst six months otherapy.() The problem is especially grave or suchpatients with chronic conditions requiring long-term or lielong therapy, because poor medicationadherence leads to unnecessary disease progression,disease complications, reduced unctional abilities,a lower quality o lie, and premature death. () Lacko adherence also increases the risk o developing aresistance to needed therapies (e.g., with antibiotictherapy), more intense relapses, and withdrawal(e.g., with thyroid hormone replacement therapy)



and rebound eects (e.g., with hypertensionand depression therapy) when medication isinterrupted.() Because o this impact, adherencehas been called the key mediator between medicalpractice and patient outcomes.(7)

A TIME FoR ACTIoN

Although the challenge o poor medicationadherence has been discussed and debated or atleast three decades, these problems have generallybeen overlooked as a major health care priority.Compounding the situation, adherence problemshave been exacerbated by the ragmented approachby which hospitals, health care providers, and otherparts o the health delivery system intervene withpatients and caregivers to encourage adherence.

Consequently, many leading medical societiesare now advocating a multidisciplinary approachthrough coordinated action by health proessionals,researchers, health planners and policymakers.

Over a decade ago, the National Council on PatientInormation and Education (NCPIE) recognizedthe need or such a coordinated approach toimproved medication adherence and issued a report-- Prescription Medicine Compliance: A Review of theBaseline Knowledge(8) -- which dened the key actorscontributing to poor adherence. The report urtheroutlined strategies that could be implemented byhealth care proessionals, patients and caregiversand health care systems, including these keystrategies recommended or health care providers:

Using a verbal discussion reinorced withappropriately designed written materialsto help the patient understand the medicalcondition, the need or the treatment, andthe value o the treatment;

Oering verbal counseling rom both the

prescribing health care provider and thepharmacist that the prescription shouldbe lled and taken as prescribed. Whilewritten instruction sheets can reinorcethese instructions, they should never beused as a substitute or counseling;

Providing useul written inormation inpatient language that clearly explains

how the patient can correctly managehis/her medications. This inormationincludes details on how to administer themedication, the exact time the medicineshould be taken and why, how long to takethe medicine, recognition and management

steps or common side eects, specialprecautions, and how to monitor theprogress o the therapy;

Making patients aware o the variousmedication adherence aids and devicesavailable, such as dosing reminders, pillboxes and rell reminder programs;

Monitoring patient adherence with everyvisit to the prescribing health care provideror pharmacist; and

Instructing patients and caregivers on homemonitoring activities (such as home bloodpressure monitoring) and home monitoringrecords that should be maintained or useduring uture medical and pharmacy visits.

Since the NCPIE report was published, theNational Institutes o Health (NIH) and a numbero voluntary health organizations ocusing onthe major chronic diseases aecting Americanstoday -- asthma, cancer, cardiovascular disease,diabetes and mental illness -- have weighed in withnew ndings on the importance o adherence orsuccessul treatment. The consensus o these groupsis that interventions that improve patient adherenceimprove health status and reduce health care costs.As stated in The Multilevel Compliance Challenge, apaper by the American Heart Association:

Maximum use o strategies to enhancecompliance must be made. Application othese strategies is particularly importantnow, when there is great pressure to

decrease costs and improve quality andpatient outcomes.(9)

Further elevating the need or action is the WorldHealth Organization (WHO), which has calledor an initiative to improve worldwide rates oadherence to therapies commonly used in treatingchronic conditions, including asthma, diabetes, andhypertension. In a 00 report entitledAdherence



to Long-Term Therapies: Evidence for Action, WHOdened poor medication adherence as a criticalissue or global public health, and identiedve broad dimensions aecting adherence thatneed to be addressed by health managers andpolicymakers:()

social and economic actors;

health system and health care team-relatedactors;

therapy-related actors;

condition-related actors; and

patient-related actors.

To bring about needed change, the WHO

report called or a multidisciplinary approachtoward adherence that includes patient-tailored interventions and training in adherencemanagement or health proessionals. This approachwas also addressed in a 005 review article byresearchers Lars Osterberg, M.D., and TerrenceBlaschke, M.D. published in the New England

Journal of Medicine where the authors identied major predictors associated with poor adherence-- rom the side eects o treatment to the patientsbelie in the benet o the medicine.() (See Table ;page 9) Noting that race, sex, and socioeconomic

status have not been consistently associated withlevels o adherence,() the authors conclude thatpoor adherence should always be consideredwhen a patients condition is not responding totherapy. Accordingly, the authors recommendthat physicians ask a series o non-judgmentalquestions o their patients designed to acilitatethe identication o poor adherence and enlistancillary health care providers, such as pharmacists,behavioral specialists, and nursing sta to improveadherence.()

Another major development since the publicationo NCPIEs report is new technology that makesavailable a number o useul mechanisms orostering adherence. For example, patients canreceive pharmaceutical inormation and rellreminders via letter, ax, telephone, e-mail andpager messages. There are also electronic reminderdevices, which can be programmed or multiple

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daily alarms and may permit the user to recordbrie dosing instructions. Moreover, a number omedication organizers now incorporate electronicalarms to alert patients when doses are due.

Despite such developments, adherence rates have

not changed signicantly since NCPIE issued itsrecommendations over a decade ago, demonstratingthat an intensied, sustained ocus on adherenceimprovement among all stakeholders is essentialto reduce the adverse health and economicconsequences associated with this pervasiveproblem. While no single strategy will guaranteethat patients will ll their prescriptions and taketheir medicines as prescribed, elevating adherenceas a priority issue and promoting best practices,behaviors, and technologies may signicantly

improve medication adherence in the U.S.

This report, therefore, is intended as a renewednationwide call to action. Based on an analysis oresearch to date, it examines the current state opatient adherence and trends that may lead toimproved medication use. This report also oersrealistic goals or improving medication adherencethrough patient inormation and education,health proessional intervention, and supportivegovernment policies.


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Even as the issue o taking medicines as prescribedis getting increased attention within the publichealth community, the multi-aceted nature o pooradherence has signicantly clouded the debate. Theollowing is a look at the current state o patientadherence and the actors contributing to thiscomplex problem.

LACk oF A STANDARDDEFINITIoN AND CoNSISTENTTERMINoLogy LIMITS

CoNSENSuS

Even though there is a growing recognitionabout the need or improvements in medicationadherence, progress has been hampered by a lacko consistent terminology. Today, a number ocommon terms are used to dene the act o seekingmedical attention, lling prescriptions, and takingmedicines appropriately. All have their supportersand detractors and all refect dierent views aboutthe relationship between the patient and the health

care provider.

In its 995 report, NCPIE dened adherence asollowing a medicine treatment plan developedand agreed on by the patient and his/her healthproessional(s). Originally, NCPIE used theterm compliance because historically, it is theterm most widely used in medical indices. Firstappearing in the medical literature in the 950s, theterm compliance came into popular use ollowingthe 97 publication o the proceedings o the rstmajor academic symposium on the subject.(0) As

originally dened, compliance was intended todescribe the extent to which patients behaviorscoincide with the health care providers medical orhealth advice.

Yet to many researchers, compliance connotes apassive role or the patient and appears to blameand stigmatizes the patients independent judgment

as deviant behavior. Thus, many stakeholderspreer the term adherence, which implies a morecollaborative relationship between patients andclinicians and is more respectul o the role thatpatients can play in their own treatment decisions.Thus, the NCPIE denition proposed in 995 wasintended to encompass the concept o adherence,including two-way communication, patient-centered treatment planning, and agreement uponthe medication and dosing requirements.

The term persistence has also entered the

lexicon and is intended to address the treatmentcontinuum, beginning with having the prescriptionlled and continuing with taking and relling themedicine or as long as necessary. However, in theview o some researchers, the term adherence ismore comprehensive and refects both taking themedicine as directed (compliance) and continuingto take the medication or the duration required(persistence).

Another term now being used is concordance,which is intended to convey an activepartnership between the patient and the healthcare proessional. Developed by the RoyalPharmaceutical Society o Great Britain, the conceptsuggests that the clinician and patient nd areas ohealth belie that are shared and then build on thesebelies to improve patient outcomes.() However,this term has also been challenged as being moreinspirational than what is possible in promotingbetter medication taking by patients.

Despite the increased use o persistence, and

concordance, many researchers now use the termscompliance and adherence interchangeably.However, since concordance is being increasinglyused in Europe, an important priority or the globalpublic health community is to agree on a standarddenition that will unite all stakeholders around thecommon goal o improving the sel-administrationo treatments to promote better health outcomes.For the purposes o this report, NCPIE has adopted

Prescriptin Medicine Adherence:A Fresh L at a Persistent and Cmple Prlem



the term adherence because the term supportsa patient-centered approach to improving howpatients seek inormation, ll their prescriptionsand take their medicines as prescribed.

THE ExTENT oF THE PRobLEMAgreeing on a standard denition or patientadherence also requires an up-to-date assessment othe problem, which today rivals many disease statesin terms o prevalence, human suering, and healthcare costs. From a public health perspective, pooradherence is nothing short o a crisis.

Although the problem varies by condition and thetypes o drugs prescribed, it is signicant, not onlyin the U.S. but around the world. According to

research ndings:

Between percent and 0 percent opatients take other peoples medicines;()

In developed countries like the U.S.,adherence among patients with chronicconditions averages only 50 percent;()

Other studies show that about one-third opatients ully comply with recommendedtreatment while another third sometimescomply and one-third never comply;()

The World Health Organization reportsthat only about percent o patients indeveloped nations take their medicines asprescribed to treat asthma and between 0percent and 70 percent ollow the doctorsorders to treat depression;()

Although hypertension increases the risko ischemic heart disease three- to our-oldand increases the overall cardiovascular riskby two- to three-old, just 5 percent o

patients take their prescribed doses o drugsto manage this condition;()

Among 7,000 U.S. patients prescribedbeta blocker drugs ollowing a heartattack, a major study conducted by DukeUniversity Medical Center reported thatonly 5 percent regularly took thesemedications during the rst year ater

leaving the hospital, with the biggest dropin adherence occurring during the initialmonths ater hospital discharge;()

Less than percent o adults withdiabetes perorm the ull level o care,

which includes sel-monitoring o bloodglucose and dietary restrictions as well asmedication use, that is recommended bythe American Diabetes Association;()

Although adherence with short-termtherapy is generally considered to behigher than or long-term treatments, rapiddeclines occur even in the rst ten days ouse;(5) and

Even among health care proessionals,sel-reported adherence with prescribed

therapies averaged only 79 percent in onestudy.()

Researchers have ound that even the potentialor serious harm may not be enough to motivatepatients to take their medicines appropriately. Inone study, only percent o glaucoma patients metminimal criteria or adherence ater having beentold they would go blind i they did not comply.Among patients who already had gone blind inone eye, adherence rates rose only to 58 percent.(7)Another study o renal transplant patients acingorgan rejection or even death rom poor adherencewith immunosuppressant therapy ound that 8percent o patients were not taking their medicineas prescribed.(8)

SPECIAL PoPuLATIoNS AT RISk

O special concern to the public health communityis poor adherence among people aged 5 and over,who tend to have more long-term, chronic illnesses--such as arthritis, diabetes, high blood pressure, and

heart disease-- and thereore, take more dierentmedications as they age. According to one study,people aged 75 years and older take an average o7.9 drugs per day.() Other studies have shown thatbetween 0 percent and 75 percent o older people donot take their medications at the right time or in theright amount(9) due to such complicating actors ashaving multiple health problems requiring treatment,



needing multiple medications, being seen by multipleprescribers, and having physical and cognitivechallenges that may impact medication use.

The impact o poor adherence is also a seriousproblem among the medically underserved -- those

Americans o all ethnic backgrounds who are poor,lack health insurance, or otherwise have inadequateaccess to high-quality health care. According tothe third National Healthcare Disparities Report(NHDR) issued in 005 by the Agency or HealthcareResearch and Quality (AHRQ), health care disparitiesby race and ethnicity remain prevalent in the U.S.and are signicantly correlated with health literacy-- the ability o an individual to access, understandand use health-related inormation and services tomake appropriate health decisions -- among the

underserved. The Oce o the U.S. Surgeon Generalestimates that more than 90 million Americans cannotunderstand basic health inormation,(0) which coststhe health system billions o dollars each year due tomisdirected or misunderstood medical advice.

Children and teenagers are also an at-risk group,especially when it comes to adherence to treatmentsor asthma, one o the most common chronic diseaseso childhood.() Research shows that adherence toprescribed pulmonary medication may be as low as0 percent in adolescents,() leading to uncontrolled

asthma. A number o actors related to childrensexperiences taking medicines during their ormativeyears aect uture rates o compliance. These actorsinclude parents not adequately monitoring theirchildrens use o medicines, poor parental adherenceto treatment regimens, and lack o school educationabout medicine use.

PAyINg THE PRICE FoR PooRADHERENCE

Who is paying the price or the epidemic o poormedication adherence? We all are -- and the costsare substantial. Researchers have calculated thatnon-adherence costs the U.S. health care systemabout $00 billion annually,(, , ) includingapproximately $7 billion each year or drug-relatedhospitalizations.(5) Moreover, not taking medicinesas prescribed has been associated with as many as 0

percent o admissions to nursing homes() and with anadditional $,000 a year per patient in medical costsor visits to physicians oces.() The total direct andindirect costs to U.S. society rom prescription drugnon-adherence are about $77 billion annually.(7)

Employers also pay a high price or employees non-adherence to prescribed medical treatments, bothin terms o reduced productivity and absenteeism,and in higher costs or private or managed carehealth insurance benets. With prescription drugsrepresenting the astest-growing cost component ormost health plans (climbing at more than 7 percentannually),(8) employers are increasingly requiring thatcovered members and their amilies assume a greaterpercent o their cost.

Although the economic cost associated with pooradherence is already staggeringly high, the WorldHealth Organization predicts that this problemwill only grow as the burden o chronic diseasesincreases worldwide.() As policymakers considerways to address the escalating costs o health carein the U.S., it is critical that the agenda include thepressing issue o improving patient adherence withmedication regimens. Mounting evidence shows thatbetter adherence leads to improved clinical outcomesand reduced costs.(9) Based on a meta-analysis o studies involving more than 9,000 patients, higher

adherence was ound to reduce the risk or a poortreatment outcome by percent.(0) Other dataassociate patient sel-management and adherenceprograms with a reduction in the number o patientsbeing hospitalized, days in the hospital, and outpatientvisits. The data suggest a cost to savings ratio oapproximately :0 in some cases, with the resultscontinuing over several years.()

As Americans age, an increasing number areprescribed multiple medications or multiple chronicconditions. As a result, new strategies to enhanceprescription medicine adherence are needed. Whilenew interventions are not cost-ree, improvingadherence is likely to increase the cost eectiveness ohealth interventions, thereby reducing the burden ochronic illness. The investment o time and resourcesto improve patient adherence will likely more than payor itsel through improved health status and reducedutilization and costs.



What Is behind Pr Adherence:Factrs That Cntrite t the Prlem

Poor adherence encompasses much more thanpatients not taking their medicines as directed.Numerous behavioral, social, economic, medical,and policy-related actors contribute to the problemand must be addressed i adherence rates are toimprove.()

To understand the interplay o these issues, theresearch community has categorized the actorsunderlying non-adherence as medication-related,patient-related, prescriber-related, and pharmacy-related. Additionally, ederal and state government

policies can also serve as impediments to adherenceimprovement. The ollowing describes these actorsand the challenges they represent.

MEDICATIoN-RELATED FACToRS

For many patients, one o the biggest stumblingblocks to taking their medicines is the complexityo the regimen. Studies nd that patients on once-daily regimens are much more likely to comply thanpatients who are required to take their medicine(s)

multiple times each day.()

Conversely, the number o medications a persontakes has a negative impact on adherence. In anygiven week, our out o ve U.S. adults will useprescription medicines, over-the-counter (OTC)drugs, or dietary and herbal supplements andnearly one-third will take ve or more dierentmedications.() O special concern are adults aged5 and older, who take more prescription and OTCmedicines than any other age group.() Accordingto a 00 survey o older Americans conducted by

the American Society o Health-System Pharmacists(ASHP), 8 percent o patients over age 5 take atleast one prescription medicine, more than hal (5percent) take three or our prescription medicines,and as many as a third ( percent) take eight ormore prescription medicines to treat their healthconditions.(5) Adherence also decreases whenpatients are asked to master a specic technique in

order to take their medication, such as using devicesto test blood levels as part o a treatment protocol,using inhalers, or sel-administering injections.()

Compounding the problem, many patients -- andespecially older adults -- are being seen by morethan one physician or other prescriber, and eachmay be prescribing medications or a speciccondition. Unless there is a primary care providerwho coordinates these medication regimens, thenumber o dierent medicines the patient takeseach day may limit adherence while also increasing

the risk o medication errors and harmul druginteractions.

Beyond the complexity o the regimen, concernabout medication side eects remains a powerulbarrier to patient adherence. In a 005 survey o,507 adults conducted by Harris Interactive, nearlyhal o the respondents (5 percent) reported nottaking their medicines due to concerns about sideeects.(7) Conversely, when medications such asantidepressants and corticosteroids are slow toproduce intended eects, patients may believe themedication is not working and discontinue use.(8)

Addressing these medication-related actors willrequire better communication between the patientand his/her prescriber about what to expect romtreatment and about the patients medicationchallenges (including the number o medicinesbeing taken, worries about side eects and how toadminister and monitor the medicine). Throughhigh-quality, two-way discussions, clinicians willbe able to identiy and discontinue unnecessary

medications, simpliy dosing regimens, andaddress other medication-related issues that makeadherence dicult.

PATIENT-RELATED FACToRS

Patients ultimately are in control o whether,how saely and how appropriately they take their



medicines. For example, a common reason whypatients dont take their medicines is simplyorgetulness.(9) Another signicant barrier is theinability to understand and act on instructions ortaking the medication. In act, a study ound that0 percent or more o patients being ollowed could

not correctly report what their physicians toldthem about medication use 0 to 80 minutes aterreceiving the inormation.(0)

While problems such as these are signicant,public health ocials are increasingly concernedabout patients and especially those with chronicconditions requiring long-term therapy, such asasthma, diabetes, and hypertension, who make aconscious choice not to ll the prescription, not totake their medicine as prescribed, or to discontinue

therapy. Infuencing these decisions are a numbero actors related to the patients experiences,perceptions, and understanding about his or herdisease. These include:()

Perceptions about the nature and severity otheir illness;

Denial o illness and the need to takemedicines;

The assumption that once the symptomsimprove or the person eels better, he or

she can discontinue use o the medication;

Limited appreciation about the value omedicines when properly used;

Belies about the eectiveness o thetreatment;

Acceptance o taking medications orpreventive purposes and or symptomlessconditions (e.g. statins to lower bloodcholesterol levels);

Worries about the social stigma associatedwith taking medicines;

Fear o side eects or concern aboutbecoming drug dependent;

Fear o needles and the need or sel-injections;

.

.

.

.

5.

.

7.

8.

9.

Lack o condence in the ability to ollowthe medication regimen;

Media infuence regarding saety or riskissues associated with particular medicines;and

Lack o positive motivations and incentivesto make necessary changes in behavior.

Along with these attitudes and belies, the durationo the course o therapy also contributes to whetherand how patients take their medicines.() Adherencerates have been ound to decline over time whenpatients are treated or chronic conditions.(9)

Moreover, or many Americans, the high cost omedications is a barrier to medication use.() In a

00 study o nearly ,000 Medicare enrollees,9 percent o disabled people and percent oseniors reported skipping doses or not lling aprescription because o cost.() Limited access tohealth care services, lack o nancial resources, andburdensome work schedules are also associatedwith poor adherence to medication regimens.()

Compounding these problems is the impact olow health literacy and limited English languageprociency, which greatly aect the ability opatients to read, understand, and act on health

inormation about medication use. Accordingto published studies, 5 percent o the adultpopulation (90 million people) have literacy skillsat or below the eighth grade reading level, makingit dicult or these individuals to read healthinormation, understand basic medical instructionsand adhere to medication regimens.() In one studyinvolving patients over age 0 who were treated attwo public hospitals, 8 percent could not read orunderstand basic materials, such as prescriptionlabels.() A 00 study, published in theAnnals ofInternal Medicine ound that low-literacy patientshave diculty understanding basic inormationregarding medication dosage. While over 70 percento the respondents correctly stated instructionsabout taking two pills twice a day, only one-third(.7 percent) could demonstrate the correctnumber o pills to be taken daily.()

0.

.

.



Further, studies have ound that people withlow health literacy or limited English languageprociency are oten ashamed to get help withmedical instructions,(5) which increases thelikelihood that they will not be able to ollow theirtreatment regimens. As a result, the U.S. Surgeon

General, the National Quality Forum, and otherstakeholders have called or immediate action toimprove adherence among these sizeable vulnerablepopulations.

PRESCRIbER-RELATED FACToRS

In 995, NCPIE identied the lack o awarenesso basic compliance management principlesamong some clinicians as a major causal actor orprescription non-adherence. More than a decade

later, this appears to remain the case. According toa 00 telephone survey conducted by the Foodand Drug Administration (FDA), only percento consumers polled reported receiving instructionsrom their physician about how oten to take a newmedication and only percent were told howmuch to take.() The survey also examined thereceipt o medicine inormation at the pharmacy.Here, the gures dropped considerably, to percent (how oten to take) and 9 percent (howmuch to take) respectively.()

Why is this the case? One reason is that clinicianstend to overestimate the extent o their patientsability to adhere to a medication regimen and thepatients actual adherence level. In one study o 0amily physicians who had known many o theirpatients or more than ve years, researchers oundthat only 0 percent o the physicians estimateso adherence with digoxin therapy were accuratewhen compared with inormation rom a pill countand serum digoxin concentration measurements.(9)Earlier studies reported that health proessionals

overstate the adherence o their patients by as muchas 50 percent.(7)

At the same time, the WHO report attributeslack o adequate medication counseling to theoutdated belie that adherence is solely the patientsresponsibility.() Practical issues such as lack o timeand lack o nancial reimbursement or education

and counseling also represent persistent barriers tohealth care provider adherence interventions.(8)

Besides these practical issues is the actor o trustbetween the clinician and the patient. Accordingto a study recently reported in theArchives of

Internal Medicine, when physician trust levels arelow, patients are more likely to orego the use omedications.(9) This study suggests that cliniciansneed to encourage adherence through behaviorsdesigned to improve patient trust. Further, ameta-analysis o studies assessing the quality ophysician-patient communication ound that thequality o communication both in the history-takingsegment o the visit and during discussion o themanagement plan signicantly improved patienthealth outcomes.(50)

Finally, there is the pervasive problem opoor communication between the clinicianand the patient. Because this lack o eectivecommunication can lead to medication errors andnon-adherence, the Institute o Medicine (IOM)in its landmark 999 report To Err is Human;Building a Safer Health System called on cliniciansto educate their patients about the medicationsthey are taking, why they are taking them, whatthe medications look like, what time patientsshould take their medicines, potential side eects,

what to do i a patient experiences side eects, andwhat regular testing is necessary.(5) Osterberg andBlaschke also present a range o communications-based strategies or improving medicationadherence in their review article,Adherence toMedication, published in the August , 005 issue othe New England Journal of Medicine.() (See Table ;page 0 o this report).

PHARMACy-RELATED FACToRS

Because pharmacists have direct and requentcontact both with prescribers and patients, researchsuggests that community-based pharmacistscan play a unique role in promoting medicationadherence.(, ) For example, a study examiningthe interaction o 78 ambulatory care clinicalpharmacists with 5 patients treated at selectedVeterans Aairs medical centers over the courseo a year ound that pharmacists were responsible



or adjusting patients drug regimens as well asidentiying and preventing drug-related problems.(5)

Also demonstrating the ability o community-basedpharmacists to increase medication adherence is therecent Federal Study o Adherence to Medications

in the Elderly (FAME) conducted among militaryhealth care beneciaries aged 5 years or olderwho were prescribed at least our chronicmedications a day. Designed to assess the ecacyo a comprehensive pharmacy care program,this multi-phase study examined the impact opatient education and the use o an adherence aid(medications custom packaged in blister packs),nding that the program increased medicationadherence and persistence, whereas discontinuationo the program was associated with decreased

medication adherence and persistence.(5)

Findingsrom the FAME study call or greater emphasiswithin health care delivery systems and policyorganizations on the development and promotion oclinical programs to enhance medication adherenceparticularly among the at-risk elderly population.

Despite these research ndings, however, ourcategories o pharmacy-related barriers to improvedpatient adherence remain and must be addressed.Broadly dened, these categories are: the attitudeso patients and pharmacists, the knowledge level

o pharmacists, the operational aspects o thepharmacy practice, and proessional barriers.()

In its 995 report, NCPIE identied manyattitudinal barriers that contribute to the pooradherence, including the perceptions o patients,caregivers, and other health care providers aboutthe expertise o pharmacists and the pharmacistswillingness to tailor education and counseling to theneeds o the patient. Moreover, pharmacists ownviews about their role in medication adherence canbe a actor. Many pharmacists are accustomed to apaternalistic relationship where the pharmacist tellsthe patient what to do and the patient is expectedto ollow those instructions.() Further complicatingthe situation or pharmacists is identiying potentialadherence problems when medication regimens canbe complex and then applying complex technicalinormation to practice situations.()

Beyond these issues, NCPIE has noted unctionaland proessional barriers that can signicantlyimpact the ability o pharmacists to engage inadherence education and counseling. Functionalbarriers can include space limitations, timeconstraints, the lack o resources, and the lack

o management support to counsel patients onmedication adherence.(55) Moreover, thousandso pharmacies must divert time and cannoteciently ll prescriptions because inormationneeded to obtain reimbursement requently doesnot appear on a patients drug benet card. As aconsequence, thousands o hours are occupiedcalling employers or insurance companies to obtainthis inormation.(5) Reimbursement or counselingpatients has not kept pace with the pharmacyproessions attempts to obtain this payment,

although the Medicare prescription drug benetplan aords opportunities due to requirements ormedication therapy management programs (MTMP)or specic enrollees.

Proessional barriers also arise rom a lack oconsensus within the pharmacy community aboutthe role o pharmacists in health care delivery.To gain this consensus, national pharmacyorganizations have endorsed the concept opharmaceutical care,(57) a maturation o pharmacyas a clinical proession, with pharmacists

cooperating directly with other proessionalsand the patient in designing, implementing andmonitoring a therapeutic plan. This approachrequires a knowledgeable rontline sta supportedby managers, other pharmacists and eective worksystems.

govERNMENT IMPEDIMENTS

The pharmaceutical care model advanced by thepharmacy community is predicated on supportive

government policies. However, a number o ederaland state laws, as currently interpreted, may actuallyimpede the availability o adherence assistanceprograms.

One such impediment is the ederal anti-kickbackstatute containing rules that cover businessesreimbursed by Medicare, Medicaid or other ederallyunded health care programs. This statute is so



broadly written that many types o health carepractices and business relationships designed toincrease patient adherence may theoretically besubject to criminal prosecution under the statute.

To help address this problem, the Oce o the

Inspector General (OIG) within the Department oHealth and Human Services (HHS) issued regulationsgranting sae harbor protections to certain typeso health care practices and business arrangements.However, because OIGs regulations dont specicallycover patient education, medication rell reminderprograms and other pharmacy-based adherencemessaging programs, the result has been a reduceduse o adherence messaging programs. In anabundance o caution, some rell reminder programsnow exclude any patients who participate in any

ederal health care program (e.g., Medicare, Medicaid,TRICARE).

Another impediment to pharmacy adherenceassistance programs involves ederal and state medicalprivacy requirements. At the ederal level, there isthe Privacy Rule, a set o ederal medical privacyregulations issued to implement the Health InsurancePortability and Accountability Act o 99 (HIPAA).Although these rules permit health care providersto carry out treatment unctions, includingrell reminders and other adherence messaging

programs, without rst obtaining the patients writtenpermission, some privacy advocates object to theseprovisions.

With these concerns in mind, the NationalConsumers League (NCL) created voluntaryperormance-based Best Practice Principles thatbuild on the requirements contained in the HIPAAprivacy rule.(58) Developed by a Working Groupo representatives rom public interest groups,health proessional societies, the consumer/privacy movement, pharmacy industry tradegroups, pharmacy vendors, retail chains, andthe pharmaceutical industry, the Best Practices

Principles are intended to bridge the gap between theprotections aorded by HIPAA and air inormationpractices that dene the degree o control thatconsumers should have over the ways their healthinormation is used. Accordingly, the Best PracticesPrinciples include:(58)

Ensuring that a pharmacys Notice o PrivacyPractices can be easily understood;

Providing patients with a description opharmacy messaging programs;

Providing an opportunity to opt out o thepharmacy messaging programs;

Ensuring that opt-out mechanisms unctionproperly;

Identiying sponsorship;

Disclosing limitations o materials as a sourceo health care inormation;

Providing inormation that is clear andreliable;

Endeavoring to use discretion incommunicating about sensitive subjects;

Ensuring that persistence and adherencemessages are written in a manner consistentwith available data about the characteristicso eective messaging; and

Engaging in messaging about alternativeand/or adjunctive therapies only when thereis a clear potential benet to patients.

Even with these voluntary principles, however,HIPAA does not preempt state law, which is why anumber o states have enacted, or are considering,legislation to restrict the ability o pharmacies toconduct adherence messaging programs. As withthe ederal anti-kickback statute, the unintended

consequence o some o these state laws is uncertaintyabout which types o medical inormation requirepatient authorization and which do not. For example,

42 C.f.r. Pa 1001.

t e exen a e anikickback saue discuaes ei emindes and e cmpiance pams, is eec is smewa a dds wi e Medicae Mdenizain Ac,

wic equied a, evey Pa D benei pan impemen medicain manaemen eapy pams (MtMPs). MtMPs ae desined pimize e eapeuic ucme dueamen ceain beneiciaies u educain and manaemen pams. Impved medicain cmpiance and adeence is a key pa a successu MtMP.

Pub. l. N. 104-191.

45 C.f.r. 164.506(a) and (c).



the Caliornia Condentiality o Medical InormationAct (CMIA) provides (in relevant part):

Except to the extent expressly authorizedby the patient . . . no provider o health care. . . shall intentionally share, sell, use or

marketing, or otherwise use any medicalinormationfor any purpose not necessary to

provide health care services to the patient.5

When read literally, the CMIA seems to prohibitadherence-messaging programs without specicauthorization, when in act, the Act views theseprograms as necessary to provide health careservices and exempts this requirement. The CMIAalso exempts the authorization requirement oradherence communications that address a chronicand seriously debilitating or lie-threateningcondition i certain conditions are satised. Butsince there is uncertainty as to how state regulatorscould interpret these provisions, many pharmaciesand pharmaceutical manuacturers have opted not torun adherence programs in Caliornia, or run themon a limited basis. The consequence is that adherencecommunications or medications or diabetes,osteoporosis, asthma, hypertension and heart attackand stroke prevention now being provided in otherstates are, in some cases, being withheld romCaliornians. The same situation could result i a

number o state bodies enact legislation that broadlyprohibit the use o prescription drug inormation orcommercial purposes, including pharmacy-basedprograms unded through third parties.

LIMITED FEDERAL SuPPoRT FoRADHERENCE RESEARCH

Besides ederal and state laws and policies that impactthe availability o adherence assistance programs,insucient ederal unding or adherence research is

another impediment to improving medication use.Although created the Adherence Research Network toidentiy research opportunities at its 8 Institutes andCenters, the Network has been inactive since 00.Moreover, in 000, when the Network was undingadherence research, the actual NIH dollars earmarked

or testing interventions to improve medication-taking behavior was only $ million in a budget onearly $8 billion.(59) The overall NIH budget in 000was $7.8 billion.

Such paucity in adherence research unding has

implications or public policy, as policymakers lookto researchers to help determine priorities or themedical community. While NIH dollars are beingspent on patient adherence as it applies to treatingspecic disease states, very little is actually goinginto testing interventions and measuring theireectiveness. Thus, a key goal will be to re-invigoratethe Adherence Research Network while increasingsubstantially the level o NIH unding or researchto test adherence interventions and measure theireectiveness.

Kripalani, Yao, and Haynes (Interventions toEnhance Medication Adherence in Chronic MedicalConditions) point out key limitations and challengesor uture adherence research, noting that becausemost o the available literature does not separateout the eects o the individual components omultiaceted interventions, it is not possible todraw denitive conclusions about which eatureso combined interventions are most benecial.(0)Additional research, the authors note, is neededto clariy which eatures are most responsible or

changes in adherence and clinical outcomes, withthe caveat that individual components may not provepowerul enough to show important eects.

Future studies should also examine the eect ovarying the intensity o interventions to determinedose response relationships. Such ndings wouldhave important implications or health systemsconsidering the implementation o patient adherenceprograms on a large scale. Investigations should beconducted with clinically meaningul outcomes as theprimary end points and be suciently powered todetect a dierence in these measures. Most important,uture research should seek to understand thedeterminants o adherence behavior and to developand test innovative ways to help people adhereto prescribed medication regimens, rather thanpersisting with existing approaches.(0)

Ca. Civ. Cde 56.10(d), as amended by A.B. 715.

Ca. Civ. Cde 56.05()(3).



How do we change behavior? How can wemotivate patients with chronic illnesses to take stepsthat will keep their diseases rom progressing? Howcan we engage health proessionals to intervenewith patients and their caregivers about theneed to take medicines as directed -- sometimesor lie? And how can we elevate the subject oprescription medicine adherence, an issue to whichAmericans have been largely indierent, to one thatis both compelling and actionable by all aectedstakeholders?

These are the challenges acing the U.S. healthsystem at a time when lack o patient adherence tomedication regimens, especially or the treatmento chronic conditions, leads to unnecessary diseaseprogression, disease complications, reducedunctional abilities, a lower quality o lie, and evendeath. To address this serious problem, a range ostrategies must be used to target the underlyingcauses o poor adherence and to make the relevanceo taking medicines as prescribed meaningul toall stakeholders -- patients, caregivers, clinicians,payors, public health advocates, and policymakers.But this does not mean starting rom scratch:extensive research exists that provides insightsinto eective approaches to improve adherence totherapeutic regimens.

RECogNIzINg THE DISEASECHARACTERISTICS oFNoNCoMPLIANCE

The 99 report Noncompliance With Medications:

An Economic Tragedy With Important Implicationsfor Health Care Reform introduced the concept thatnon-adherence is a disease because the problemshares many eatures o a medical disorder,including:()

Non-adherence can lead to increasedmorbidity and mortality;

The problem can be assessed andmonitored;

Eective interventions have been identied;

Triage is needed to identiy those patients atgreatest risk o non-adherence; and

Non-adherence is a public health problemor which prevention is an important goal.

In light o these similarities, approaching non-adherence as a disease could be an important step

towards increasing the extent to which patients taketheir medications as prescribed by their health careprovider(s). With implications or research, healthpolicy, and the day-to-day practice o medicine andpharmacy, widespread recognition o the diseasecharacteristics o non-compliance would put theissue into a new perspective that would help gainthe attention, ocus and sustained commitment thatthis problem deserves.

INCREASINg PubLIC AWARENESS

THRougH EDuCATIoNTo motivate patients to adhere to their medicationregimens, the American public must rstrecognize the role each person plays in takingtheir medications as prescribed or in makingsure that a loved one does so. Simply put, theAmerican public needs increased education aboutmedication adherence that captures their attention,increases their understanding, and enhances theirmotivation to take their prescribed medication inthe recommended way.

To achieve these goals, specialists in medicationuse advocate mounting a sustained, nationalpublic education campaign to provide patientsand caregivers with meaningul inormation aboutadherence that they can incorporate into theirdaily lives. Ultimately, enlisting the support andparticipation o many stakeholders -- includingthe public health community, physicians and other

Strateies r Imprin Patient Adherence



prescribers, nurses, pharmacists, the pharmaceuticalindustry, government, private payors, and consumerorganizations such a campaign must elevateadherence as a health priority and utilize multipleinormation channels to engage the public on asustained basis. Only by making the public aware o

the role individuals play in the management o theirown health conditions will we empower peopleto ask questions about their medicines, ll theirprescriptions, and ollow their treatment regimensas recommended.

PATIENT INFoRMATIoNSTRATEgIES

As noted by the American Heart Association, therationale or enhancing adherence is based on the

premise that the patient will get well or stay welli the physician, other health care providers, andthe health care organization make appropriaterecommendations, providing the patient hasthe requisite knowledge, motivation, skills,and resources to ollow the recommendations.Specically, the American Society o ConsultantPharmacists states that patients need to know: ()

What condition the medicine wasprescribed to treat.

What the medicine is, why it is needed andhow it works in the body.

Why the medicine was selected.

The dosage schedule and relatedinstructions about how to take the medicine(beore eating, with ood, etc).

Whether the medicine will work saelywith other medicines being taken(both prescription and nonprescriptionmedicines).

What to do i doses are missed or delayed.

The common adverse eects that may occurand what to do about them.

How to monitor whether the medicine ishaving its intended eect (are lab tests orblood work necessary; i so, how oten).

Serious adverse eects to look out or andwhat to do i they occur.

What action to take when the prescriptionis about to run out.

In the outpatient setting, the primary opportunitiesor providing this inormation to the patientoccur in discussions when the prescriber writesthe prescription and when the patient lls theprescription at the pharmacy. Visiting nurses in thehome setting also have an opportunity or suchdialogue with patients. During these discussions,research has ound that relaying the most importantinormation rst, repeating key points, andhaving patients restate key instructions increasepatient understanding.() Moreover, data showthat providing patients with inormation about

possible adverse eects does not appear to decreaseadherence.()

Besides providing basic inormation about howto take the medication correctly, an importantreason or clinicians to educate patients abouttheir medication regimens is to address commonmisperceptions that lead to non-adherence. Thismay include the perception that the medication canbe stopped when the condition improves or that themedicine is only needed when there are symptoms.Moreover, studies demonstrate the benets oimproved adherence when patients are encouragedto ask questions and share inormation. Thisprocess is built upon the Health Belie Model, oneo the most widely used conceptual rameworks inhealth behavior, which suggests that peoples beliesguide their understanding o and response to theirdiseases.()

However, since studies nd patients orgetmore than hal o the inormation rom a verbalexplanation immediately ater they hear it,(7) health

care providers should welcome patients who bringa partner or caregiver as a second set o ears,and should ask patients to repeat instructions andencourage note taking during the oral discussion.Complementing these actions, providing writteninormation about the medication has been shownto improve patients knowledge and decreasemedication errors. A 007 study conductedby researchers at the Arnold &Marie Schwartz



College o Pharmacy and Health Sciences, LongIsland University, ound that approximately two-thirds o surveyed patients reported reading thenon-manuacturer developed consumer medicineinormation (CMI) leafets about new medicationsprovided by pharmacies.() Accordingly, the study

recommends that pharmacists should encouragepatients to read the CMI leafet and promote it as auseul resource, although this inormation shouldbe used in conjunction with, but not as a substituteor, oral discussions.(0)

In the case o teaching complex medication-takingtechniques, such as using a metered dose inhaleror administering an injection, oral and writteninormation will not suce. Here, patients needa health care provider to walk them through the

process in easy steps and to observe while thepatient repeats the procedures. The health careprovider is then able to answer questions, point outany problems with the patients technique and workwith the patient to repeat the procedure until theproblems are resolved.

While all these strategies are helpul in promotingpatient adherence, how the inormation is conveyedalso matters greatly to how patients ultimatelyrespond. For example, a 00 study conductedor the American College o Physicians (ACP)

Foundation and reported in theAnnals of InternalMedicine(5) ound that a major barrier to patientadherence is patient understanding o prescriptiondrug labels, including the ormat, content, and useo medical jargon. Because this problem is especiallyacute among those with lower literacy (eighthgrade level or below) and patients taking multipleprescription drugs, the ACP Foundation haslaunched a Prescription Medication Labeling projectto address the problems associated with poor healthcommunication.

A key strategy o the Prescription MedicationLabeling project is the use o patient-centeredcounseling, an approach that ocuses not only onthe content o the inormation but also on the toneused by health proessionals. As detailed in the995 NCPIE report, patient adherence improveswhen proessionals:()

Are warm and caring and respect thepatients concerns,

Talk to patients directly about the need oradherence,

Probe patients about their medicine taking

habits and health belies,

Obtain agreement rom the patient on thespecics o the regimen, including themedical treatment goals,

Communicate the benets and risks otreatment in an understandable way thatosters the perception that the patient hasmade an inormed choice about his or hercare, and

Probe or and help resolve patient concernsupront so they do not become hiddenreasons or non-adherence.

bEHAvIoRAL REINFoRCEMENTAND PATIENT SuPPoRT

Especially in chronic disease management, wheremedication is required on a continuing basis,adherence with medication regimens involves achange in behavior on the part o the patient. ()In some cases, patients may need to take specic

medications every day at a set time. Adherencealso requires that patients remember to get theirprescriptions relled and to incorporate theirmedication taking into their daily schedules andliestyle.

Because these actions require diligence, adherencecan be viewed as a continuum, with most patientsstarting as very diligent and declining over time.Adherence has also been shown to decline betweenvisits to the physician/clinic.() That is why regular

interaction between patients and health providers isso important or improving medication use.

Recognizing these challenges, adherence researchersstress the importance o tailoring the medicationregimen to the patients daily schedule and liestyle,such as:


24/38



proessionals, studies nd that lack o medicationadherence is a problem.()

To ll this troubling education gap will requiredeveloping a curriculum that will allow medical,nursing and pharmacy students to conceptualize

and execute responsible medication-relatedproblem-solving on behal o individual patients.Curricula should be designed to produce graduateswith sucient knowledge and skills to providepatients with adherence education and counselingcompetency. Expanding the core competencies oclinicians also requires a signicant investment inexpanding proessional education through coursesprovided by recognized medical sub-specialty andallied health organizations as well as lecture serieson patient adherence.

At the same time, improving the ability o patientsto adhere to their therapy regimens necessitatesan expanded role or pharmacists, who are amongthe most accessible members o the health careteam once medication therapy is initiated.() Thereis also growing evidence that pharmacy-basedinterventions are eective in improving drugtherapy results. For example, in a study wherepharmacists provided adherence counseling topatients with high blood cholesterol, medicationadherence improved rom a national average o 0

percent to 90 percent.(9)

To capitalize on the role o pharmacists as thenexus or conducting adherence interventions,the pharmacy community has been working toimplement collaborative drug therapy management(CDTM) through which pharmacists and physiciansvoluntarily enter into agreements to jointly managea patients drug therapy.(70) Currently, 0 stateshave specic laws that allow CDTM and othersare developing or reviewing proposed legislationto enable CDTM or improved disease and drugtherapy management.(5)

At the same time, more initiatives like theAsheville Project, the longest-running test usingpharmacist interventions to improve patientadherence with diabetes and asthma regimens,are needed to improve health outcomes.(7)Featuring patient counseling, the Asheville Project

provides pharmacists with intensive training inmanaging the target disease and then pays themor monthly consultations with patients, duringwhich they encourage those patients to adhere tothe recommended liestyle changes and prescribedmedication regimen. Currently, the American

Pharmacists Association (APhA) Foundation haslaunched the Diabetes Ten City Challenge modeledater the Asheville Project to improve medicationadherence among people with diabetes.(7) Thisdemonstrates that matching patients with speciallytrained pharmacists is a useul strategy to helppatients learn how to manage their disease moreeectively while lowering the costs o health care.

Pharmacists should also take advantage o advanceswithin the practice that make patient adherence

eorts more eective. This includes designatingareas within the pharmacy that are conducive topatient counseling and undertaking such activitiesas monitoring blood pressure, blood glucose levelsand other patient screening activities. Further,adherence technologies now make it possible orpharmacists to conduct direct-to-patient counselingprograms tailored to the needs o patients whohave been prescribed medication in virtuallyevery therapeutic class. These programs can beimplemented in various orms, including educationand reminder letters, e-mail messages, newsletters,

brochures, and phone calls.

THE NEED FoR AMuLTIDISCIPLINARy APPRoACHTo IMPRovE ADHERENCE

I the goal o medication adherence is to improvethe outcome or each patient through the correctuse o prescribed medicines, then what is ultimatelyneeded is a multidisciplinary approach to adherencemanagement whereby the patient and all members

o the health care team work together to cure thepatients illness, provide symptom relie, or arrestthe disease process. This approach is intended toconvey a respect or the goals o both the patientand the health proessional, and envisions patientsand clinicians engaging in a productive discussionabout medication regimens.



The idea o a multidisciplinary team is the conceptbehind the term concordance advanced by theRoyal Pharmaceutical Society o Great Britain()and other European bodies, and behind theterm pharmaceutical care,(57) which has gainedtraction within the U.S. Regardless o the term,

the underlying premise is what NCPIE calls theMedication Education Team, a model o opencommunication and shared responsibilities inwhich physicians and other prescribers, nurses,pharmacists and other providers communicate withpatients at every teachable medicine moment,making communication a two-way street, listeningto the patients as well as talking to them abouttheir medicine use. Since the 980s, NCPIEhas advocated or the ormation o a MedicineEducation Team or every patient, so each

individual is ully inormed about each medicine he/she is taking, has the instructions or taking thesemedicines properly, and knows the medication risksto avoid.

Recognizing that many interventions have beenshown to be eective in improving adherencerates, the World Health Organization (WHO)report specically calls on health proessionals,researchers, health planners and policymakersto implement a multidisciplinary approach toadherence education and management.() This

has led to the creation o a special Task Force onMedicines Partnership in the United Kingdom.(7)In the United States, pharmacy researchers are alsoexamining ways to demonstrate the benets opharmacy-based adherence intervention services.What is needed now is or leading physician,nursing, and pharmacy organizations to embraceNCPIEs concept o the Medicine Education Team,resulting in its widespread adoption in clinicalsettings.

THE NEED FoR SuPPoRTIvEgovERNMENT PoLICIES

At a time when the number o prescriptionsdispensed in the U.S. is expected to grow to .5billion by 00,(7) enabling pharmacists to use themost modern technologies to conduct adherenceassistance programs would seem obvious.

However, as noted previously, there are a variety oimpediments, including limitations by a numbero ederal and state laws. An immediate need isto resolve ambiguities about whether sponsoredprograms all within the scope o the ederalanti-kickback statute, and to ensure that ederal

and state medical privacy laws make clear thatpharmacies may communicate with patients aboutthe importance o adherence to prescribed courseso therapy, as long as such compliance programsaddress privacy-related concerns.

THE NEED FoR RESEARCHSuPPoRT AND RESEARCH RIgoR

With the astonishing advances in medicaltherapeutics during the past two decades, one

would think that studies about the nature o non-adherence and the eectiveness o strategies tohelp patients overcome it would fourish. On thecontrary, the literature concerning interventions toimprove adherence with medications remains arrom robust. Compared with the many thousandso trials or individual drugs and treatments,only a ew relatively rigorous trials o adherenceinterventions exist and these studies provide limitedinormation about how medication adherencecan be improved consistently using the resources

usually available in the clinical settings.(75)

At the same time, there has been inadequateunding rom the NIH or research on the causeso non-adherence and the interventions neededto improve adherence across types o health-careproessions, settings, interventions, and personso varying educational, economic, and ethnicbackgrounds. Policymakers must re-examinehow research on patient adherence is addressedwithin NIH with the goal o signicantly increasingunding or research on interventions to improve

adherence. While the creation o the AdherenceResearch Network is a good start, now is the time toinvest in adherence research to identiy behaviorallysound multi-ocal interventions across diseases andin dierent service delivery environments.



Adancin Adherence:A Natinal Actin Aenda

10 PRIoRITIES FoR ACTIoN

Mounting evidence shows that poor medicationadherence is pervasive and costly. The problemaects all ages, both genders and people o allsocioeconomic levels. Non-adherence is particularlyimportant or patients with chronic conditions as itleads to unnecessary disease complications, reducedunctional abilities, a lower quality o lie and toooten, premature death.

Because o the nature and extent o this

challenge, NCPIE has described non-adherenceas Americas other drug problem. NCPIE, alongwith NIH, WHO, and numerous voluntaryhealth and proessional societies around theworld, has contributed a new understandingabout the importance o adherence or successultreatment. The consensus o all stakeholders isthat interventions that improve patient adherenceenhance health status and reduce health care costs.

But this consensus is only the beginning o what

is needed to address the problem o patientnonadherence. Adherence problems have beengenerally overlooked as a serious public healthissue and, as a result, have received little direct,systematic, or sustained intervention. Moreover,Americans have inadequate knowledge about thesignicance o medication adherence as a criticalelement o their improved health. Thus, a major,sustained public education eort is requiredto educate people beore they become ill, toprepare them to respond positively to adherenceinormation when aced with a condition requiring

medication.

Because the stakes are so high, NCPIE has becomea convener and catalyst or promoting a dialogue onnew ways to advance patient medication adherenceacross the continuum o care -- rom diagnosisthrough treatment and ollow-up patient care andmonitoring. Accordingly, NCPIE convened a panel

o experts to create consensus on ten nationalpriorities that may have the greatest impact onimproving the state o patient adherence in theU.S. Ultimately involving the support and activeparticipation o many stakeholders -- the ederalgovernment, state and local government agencies,proessional societies and health care practitioners,health educators, and patient advocates -- thisplatorm calls or action in the ollowing areas:

Eleate patient adherence as a criticalhealth care isse.

Medication non-adherence is a problemthat applies to all chronic disease states;aects all demographic and socio-economicstrata; diminishes the ability to treatdiabetes, heart disease, cancer, asthma,and many other diseases; and results insuering, death, and sub-optimal utilizationo health care resources. Despite thisimpact, patient adherence is not on theradar screen o policy makers and manyhealth proessionals, which has meantinconsistent government policies and alack o resources or research, education,and proessional development. Until healthcare policy makers, practitioners and otherstakeholders recognize the extent o non-adherence, its cost, and its contribution tonegative health outcomes, this problem willnot be solved.

Aree n a cmmn adherenceterminl that will nite allstaehlders.Today, a number o common terms -- compliance, adherence, persistence,and concordance -- are used to denethe act o seeking medical attention,lling prescriptions and taking medicinesappropriately. Because these terms refectdierent views about the relationshipbetween the patient and the health careprovider, conusion about the language

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ormat to address the patients individualcapabilities.

Create the means t share inrmatinat est practices in adherenceedcatin and manaement.

Today, stakeholders have access to morethan 0 years o research measurin

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Enhancing Prescription Medicine Adherence