Sound Medication Therapy Management Programs · SOUND MEDICATION THERAPY MANAGEMENT PROGRAMS 3 There are cases of self-insured employers and state Medicaid programs turning to MTM

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Sound Medication TherapyManagement Programs

This document is endorsed or supported by the following organizations:

n AARP

n Academy of Managed Care Pharmacy

n American College of Clinical Pharmacy

n American Geriatrics Society

n American Pharmacists Association

n American Society of Consultant Pharmacists

n Case Management Society of America

n College of Psychiatric and NeurologicPharmacists

n Department of Veterans Affairs

Copyright © 2006, Academy of Managed Care Pharmacy. All rights reserved.

S O U N D M E D I C A T I O N T H E R A P Y M A N A G E M E N T P R O G R A M S

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PrefaceSpurred by the Medicare Modernization Act’s (MMA’s) inclusion of the medication therapymanagement (MTM) requirement, the Academy of Managed Care Pharmacy (AMCP) andother organizations recognized that there was a lack of clear definition of what specific elements would comprise a quality MTM program. In order to fill that gap, the Academyassembled a variety of stakeholder organizations that were willing to work to build a consensus document that would define those elements.

The stakeholder group used interactive discussion through both face-to-face meetings and e-mail correspondence in the drafting of the document. AMCP was responsible forassembling the work group and for the drafting and dissemination of the document. This initiative was funded through a restricted grant from Merck/Schering-Plough (MSP).

The stakeholder work group consisted of:

n AARP

n Academy of Managed Care Pharmacy

n American Academy of Family Physicians

n American Geriatrics Society

n American Pharmacists Association

n American Society of Consultant Pharmacists

n Case Management Society of America

n Department of Veterans Affairs

n National Business Coalition on Health

In order to gain insight from health care professionals who had built MTM programs,AMCP identified and recruited a resource panel of 15 representatives from health plans,pharmacy benefit management companies and integrated health care systems. The individualsbrought expertise in medication therapy improvement and served as a resource for the stake-holder group while the consensus paper was being developed.

The project facilitator used an interview instrument developed by the stakeholder workgroup to solicit input from the resource panel. The resource panel input ensured that the con-sensus paper had applicability in real-world health care practice. These resource organizationsalso had the opportunity to review and comment on a draft of the consensus document.

Additionally, other pharmacy organizations provided input on drafts of the document. We are pleased to have received comments from the American Association of Colleges ofPharmacy, the American Society of Health-Systems Pharmacists, the College of Psychiatricand Neurologic Pharmacists and the National Association of Chain Drug Stores.

The project began in September 2005; the draft document was completed by February2006. AMCP contracted with Pete Penna, PharmD, to facilitate the stakeholder meetings,conduct interviews with the resource panel and draft the document.


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IntroductionThe purpose of this document is to help guide designers of medication therapy management(MTM) programs to identify the critical elements that support an effective, quality MTMprogram and allow them to be constructive in encouraging positive patient outcomes. Thisguide also can help purchasers of MTM programs evaluate the quality of those programs andprovide a basis for assessing programs established by Medicare Part D plan sponsors andother MTM program sponsors.

MTM programs are developed by health plans or other health care entities focused onoptimizing patient therapeutic outcomes. MTM services are components of MTM programsand are delivered by health care professionals.

This document is not intended to be a prescriptive document, to imply oversight or in anyway to impinge creativity or innovation. MTM programs by their nature should be evolving,flexible and responsive to patient and health care system needs.

BackgroundFor modern prescription medication therapies to be most effective, several things must occur:

n The right medication must be prescribed at the correct dose and for the proper duration.

n The medication must be accessible to the patient. The patient must get the prescriptionfilled and must be adherent to the therapy.

n Patients must be monitored to ensure that best outcomes are achieved, that the objectivesof therapy are being met and that adverse events are minimized.

n Patients and caregivers must be properly educated and counseled and their medicationtherapy properly managed.

This is particularly true for patients who are at high risk as a result of chronic medical condi-tions and/or complex medication regimens. MTM programs that implement effective MTMservices greatly enhance patient care, leading to improved overall health, while at the sametime decreasing overall health care system costs by reducing improper medication use, pre-venting adverse drug events and other undesirable outcomes and supporting achievement oftherapeutic goals (see Appendix B for examples).

The Medicare Modernization Act (MMA) recognizes the value of medication therapymanagement. The Act requires prescription drug plans (PDPs) and Medicare Advantageplans (MA-PDs) that offer prescription drug coverage to have a medication therapy manage-ment program for those beneficiaries who meet high-risk eligibility criteria. As defined in theMedicare prescription drug benefit regulations issued by the Centers for Medicare andMedicaid Services (CMS), MTM programs are defined as programs of drug therapy manage-ment whose goal is to ensure that medications provided to the eligible beneficiaries areappropriately used to (a) optimize therapeutic outcomes through improved medication useand (b) reduce the risk of adverse events.


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There are cases of self-insured employers and state Medicaid programs turning to MTMservices as well, in order to ensure that medications are being used to optimize outcomes.1,2

While such activities are not yet widespread, they are increasing and are an indication ofthings to come. In addition, there are well-documented activities that fit the MTM definitionthat have been introduced in such diverse settings as the Veterans Administration, healthplans, integrated health systems, hospitals and community pharmacies. Examples include:

n Drug therapy management clinics, such as anticoagulation clinics; transplant programs;and HIV, hepatitis C, psychiatric and lipid management clinics. These programs are set upto ensure that patients are taking their medications correctly and that drug-related prob-lems are identified and managed. For example, anticoagulation clinics are typically run byan integrated health system or hospital to manage patients who require anticoagulationtherapy. Such clinics have been documented to reduce hospitalizations, morbidity andmortality in patients who must use these medications.

n Comprehensive medication reviews conducted by pharmacists (e.g., “brown-bag” pro-grams). These are programs in which a patient brings all the medications they are taking(prescription, nonprescription and dietary supplements) to their pharmacist, physician orother health care provider to review the appropriateness of each medication and ensurethat the patient is taking them correctly, to avoid drug-related problems.

n Drug utilization review projects and other programs dealing with appropriate medicationtherapy or patient safety. Managed care organizations and providers often run computerprograms to identify patients at risk for specific medication problems. Examples includescreening to identify asthmatics or congestive heart failure patients not using appropriatemedications and patients prescribed antidepressants who have discontinued their medica-tions early.

n Prescription drug adherence clinics and case management adherence programs. These areprograms set up to identify patients who have been prescribed a medication for a chroniccondition (e.g., diabetes, lipid disorders, asthma, psychiatric problems, hypertension) whoare no longer taking their medication against medical advice. The goal of the program isto increase the number of patients who are adherent with their medication therapy, there-by achieving positive clinical outcomes.

Medication therapy management programs are of significant interest to several health profes-sions since it is anticipated and expected that they would play key roles in such programs. Asthese professions come together to determine how best to deliver such programs and servic-es, they are searching for guidance as to how these programs might be structured. The needfor consensus on the essential components of an MTM program springs from two currentfactors:

n First, experience shows that the Medicare program establishes precedents in coverage deci-sions that are often replicated in both state-based health care programs and the privatesector. Based on this history, it can be anticipated that MTM programs may become aroutine part of health care in this country. Since there are costs associated with providingthese services, it will be important to define successful business models, including incen-tives, that are based on a widely accepted understanding of what comprises an appropriateMTM program.


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n Second, to date, CMS has chosen not to issue a strict definition of what constitutes anacceptable MTM program. Although there are some experiences with medication therapymanagement, there is not one universally accepted set of parameters that can adequatelydefine MTM services. CMS encourages the multiple Part D sponsors to be innovative inthe approaches used to meet the Medicare requirement for offering an MTM program.These innovations will target a variety of patients with a broad array of diagnoses thatdepend on appropriate medication therapy to generate positive patient outcomes. It isexpected that once CMS has data from two or more years of implementation of MTMprograms, the agency will be able to identify those programs that work most effectivelyand that these approaches will be the basis for future regulatory oversight and guidance inthis area.

Spurred by the MMA’s inclusion of the MTM program requirement, numerous initiativeshave been undertaken to define medication therapy management services. In 2004, a groupof 11 national pharmacy organizations developed a consensus document on the service andprogram components of medication therapy management.3 In 2005, the AmericanPharmacists Association and the National Association of Chain Drug Stores Foundationdeveloped a model guide for community pharmacists to use in effectively delivering MTMservices in the community setting.4 Additionally in 2005, the Academy of Managed CarePharmacy and the American Society of Health-System Pharmacists published the results of anexecutive session convened to discuss the implementation of medication therapy managementunder the Medicare Part D benefit.5

What is lacking today is a clear identification of what elements would constitute a qualitymedication therapy management program. From a programmatic standpoint, MTM pro-grams are in a formative stage with no specific “best practices” or quality assurance standardshaving been fully articulated or evaluated. Although definitions and frameworks for MTMservices have been drafted, no detailed guidelines have been established for MTM programs.This consensus document addresses that gap by outlining the critical elements for an MTMprogram to be considered high quality. The members of the organizations represented onthis consensus panel are in the best position to help define these elements. The settings theyrepresent find value in the interdisciplinary systematic approach to quality care delivery that isan essential piece of organized patient care both at the population and individual patientlevel. Included in the consensus is input from additional organizations dedicated to establish-ing sound MTM programs.


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Important Features of a Quality MTM Program

The safe, effective, appropriate and economical use of medications is the overarching goal ofMTM programs. In order to achieve these objectives, MTM designers should consider sever-al elements. The following list comprises features, principles and approaches to MTM thatthe consensus group believes are important elements of a quality MTM program:

n Patient-centered approach. Effective management of a patient should consider suchaspects of that patient’s environmental, social and medical status that may be factors. Apatient-centered approach to managing and implementing MTM programs will helpensure that the correct medication, including dose and dosing regimen, is prescribed. It isinherent in such an approach that decisions will be made based on current and accuratemedical information.

n Interdisciplinary, team-based approach. Services offered by MTM programs should bedelivered by an interdisciplinary MTM team led by a qualified pharmacist or other healthcare professional; team members should have expertise in the specifics of the medicationsin question. The inclusion of different perspectives will often highlight problems that maybe unforeseen when only the prescriber and patient are involved. Ineffective use of med-ications is a multifactorial problem. Effective MTM programs address these factors as wellas the root causes of suboptimal use of medications and the fundamental changes that willbe necessary. No single health care professional has all of the answers to all of these prob-lems for all patients. Therefore, MTM programs may involve representatives of a variety ofprofessions so that more effective programs can be delivered.

n Communication. Effective communication and sharing of pertinent care informationbetween those parties involved in the prescribing, dispensing, monitoring and educationalcomponents are vital to the successful use of medications.

n Population and individual patient perspective. MTM programs are developed for targetpatient populations so that services can be individually delivered to patients.

n Flexibility for broad applications. Programs can be designed and implemented toaddress the needs of additional at-risk patient populations.

n Evidence-based medicine. The adoption and application of evidence-based medicine is agrowing force in health care. There should be recognition that best practices predicated onrigorously applied evidence-based medicine should be incorporated into MTM programs.

n Promotion of MTM services. Mutual promotion of MTM by health plans and healthcare professionals can help enhance adoption.


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Operational Aspects of Quality MTM Programs

The following list consists of specific operational elements that the consensus group identi-fied as components of quality MTM programs. This list is not meant to be prescriptive:

1. Patient identification and recruitment. There should be a process to identify andthen to enroll the pool of patients at risk for adverse events and those likely to suffer pooroutcomes. Programs should identify both the process and accountability for identification ofsuch patients. Lists of eligible patients should be updated frequently. Patients at risk couldinclude those who

n are over- or under-utilizers of medications;

n visit multiple physicians;

n routinely are not adherent to or persistent with medication regimens;

n do not understand how to use their medications and do not have a support system/network in place to guide their utilization;

n have financial barriers to obtaining their prescriptions, including those who use veryexpensive medications or have very high total drug expenses; and

n need multiple medications to treat complex comorbidities.

Patients could be identified by an MTM program, a health plan or other health care entity, aprovider and/or patient self-referral.

2. Services to meet the needs of individual patients. There are a number ofpotential activities that might be undertaken by quality MTM programs, targeted to theneeds of individual patients. While not an all-inclusive list, there is a catalogue of nine serviceactivities identified by a group of 11 national pharmacy organizations in a July 2004 consen-sus statement (see Appendix A for this report). This is not intended to be a definitive list,and it is not suggested that any given program must contain all of these elements. The itemslisted are offered as examples of the types of activities that quality MTM programs mightemploy. In addition, it is recognized that interdisciplinary care should be encouraged, appro-priately utilizing skill sets of different health care providers. Qualified pharmacists are in aunique position to manage MTM programs.


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3. Services tailored for setting, cultural differences. Programs should use methodsappropriate to meet the needs of the targeted patient population. Patient demographics and health conditions to be considered include such elements as the patient’s residence (institutional, multiple, undefined), cultural diversity, health literacy and language barriers.Appropriate methods of delivering information to and communicating with patients shouldaccount for such factors in the design.

4. Coordination of care. An emphasis on coordination of care rather than perpetuationof fragmented care can improve patient outcomes. This may be accomplished by

n establishing processes that allow appropriate sharing and communication of patient information among health care providers who have a need to know (such processes shouldbe able to identify those practitioners who need to have access to this information),

n maximizing the productivity of MTM providers through appropriate use of informationtechnology as well as other communication tools and

n providing a capability that allows one provider to refer patients to another.

It is noted that the technology of e-prescribing and electronic medical records may promote efforts to coordinate care.

5. Appropriate documentation and measurement. MTM programs will need toidentify and perform a variety of measurements and document program results in order todetermine overall program effectiveness and achievements. Examples include:

n Patient satisfaction

n Services that are provided and by whom (type of health care professional or other person)

n Desired treatment outcomes and results achieved (economic, clinical or humanistic)

6. Quality assurance. Given concerns about the quality of health care, MTM programswill need to address the issue of quality assurance. Longitudinal assessment of program quali-ty should be incorporated into program design to ensure that program goals are met. Specificareas that could be addressed include:

n Achievement of quality targets measured by both internal and external metrics

n Identification and appropriate use of best practices

n Application of evidence-based medicine, as appropriate

7. Communications by the MTM program. Effective communications with planmembers and providers will be integral to the success of MTM programs. Considerations forsuch communications should include that they are

n regular and ongoing;

n descriptive of the benefits and limitations, including opt-in and opt-out opportunities; and

n descriptive of how long patients remain enrolled once they enter the program.

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8. Practitioners who can coordinate and provide MTM. Programs may bedeli’vered by and involve a variety of health care professionals. The list of potential providersmight include:

n Pharmacists employed by a pharmacy, health plan, PBM, hospital, other health care entityor as an independent provider of care

n Other qualified health care professionals

Continuing education and training of MTM providers on services, access to care and interventions will be necessary for success.

9. Adoption of standardized documentation, billing and payment systems.Programs should include standardized documentation, billing and payment systems forMTM services.

References1. Cranor CW, Bunting BA, Christensen DB. The Asheville project: long-term clinical and

economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc.2003;43:173-90.

2. Chrischilles EA, Carter BL, Lund BC, et al . Evaluation of the Iowa Medicaid pharmaceu-tical case management program. J Am Pharm Assoc. 2004;44:337-49.

3. Bluml B. Definition of medication therapy management: development of profession-wideconsensus. J Am Pharm Assoc. 2005;45:566-72.

4. American Pharmacists Association and National Association of Chain Drug StoresFoundation. Medication therapy management in community pharmacy services: core ele-ments of an MTM service (I version 1.0). Am Pharm Assoc. 2005;45:573-79. Available at:http://www.aphanet.org/AM/Template.cfm?Template=/CM/ContentDisplay.cfm&ContentID=3303. Accessed July 5, 2005.

5. Summary of the executive sessions on medication therapy management programs,Bethesda, Maryland, June 14 and August 18, 2004. Medication therapy management pro-grams: to optimize pharmacy outcomes [letter]. J Manag Care Pharm. 2004;11(2):179-86. Available at: http://www.amcp.org/data/jmcp/Letters-179-186.pdf. Accessed February10, 2006.


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Appendix AMedication Therapy Management Services

Definition and Program Criteria

Approved: July 27, 2004,by the Academy of Managed Care Pharmacy, American Association of Colleges of Pharmacy,

American College of Apothecaries, American College of Clinical Pharmacy,American Society of Consultant Pharmacists, American Pharmacists Association,

American Society of Health-System Pharmacists, National Association of Boards of Pharmacy,**National Association of Chain Drug Stores, National Community Pharmacists Association

and National Council of State Pharmacy Association Executives

Medication Therapy Management is a distinct service or group of services that optimize ther-apeutic outcomes for individual patients. Medication Therapy Management services are inde-pendent of, but can occur in conjunction with, the provision of a medication product.Medication Therapy Management encompasses a broad range of professional activities andresponsibilities within the licensed pharmacist’s, or other qualified health care provider’s,scope of practice. These services include but are not limited to the following, according tothe individual needs of the patient:

a. Performing or obtaining necessary assessments of the patient’s health status

b. Formulating a medication treatment plan

c. Selecting, initiating, modifying, or administering medication therapy

d. Monitoring and evaluating the patient’s response to therapy, including safety and effectiveness

e. Performing a comprehensive medication review to identify, resolve, and prevent medication-related problems, including adverse drug events

f. Documenting the care delivered and communicating essential information to the patient’s other primary care providers

g. Providing verbal education and training designed to enhance patient understanding and appropriate use of his/her medications

h. Providing information, support services, and resources designed to enhance patient adherence with his/her therapeutic regimens

i. Coordinating and integrating medication therapy management services within the broader health care management services being provided to the patient

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A program that provides coverage for Medication Therapy Management services shallinclude:

a. Patient-specific and individualized services or sets of services provided directly by a pharmacist to the patient.* These services are distinct from formulary development and use, generalized patient education and information activities, and other population-focused quality assurance measures for medication use.

b. Face-to-face interaction between the patient* and the pharmacist as the preferred methodof delivery. When patient-specific barriers to face-to-face communication exist, patientsshall have equal access to appropriate alternative delivery methods. Medication TherapyManagement programs shall include structures supporting the establishment and maintenance of the patient*–pharmacist relationship.

c. Opportunities for pharmacists and other qualified health care providers to identify patients who should receive Medication Therapy Management services.

d. Payment for Medication Therapy Management services consistent with contemporaryprovider payment rates that are based on the time, clinical intensity, and resourcesrequired to provide services (e.g., Medicare Part A and/or Part B for Current ProceduralTerminology [CPT] and Resource-Based Relative Value Scale [RBRVS]).

e. Processes to improve continuity of care, outcomes, and outcome measures.

* In some situations, Medication Therapy Management services may be provided to the caregiver or other persons involved in the care of the patient.

**Organizational policy does not allow NABP to take a position on payment issues.


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Appendix BEvidence of the Pharmacists’ Value:

An Overview of Several Landmark Studies

Reprinted from:

Medication Therapy Management Services:A Critical Review

Prepared for the American Pharmacists Association byThe Lewin Group

May 17, 2005

Note: The Executive Summary of this report is available at www.aphanet.org.

To obtain a copy of the complete report, contact the American Pharmacists Association at 202-429-7559.

2 0 0 6 C O N S E N S U S D O C U M E N T — A P P E N D I X B

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ogni

tive

serv

ices

pro

vide

din

res

pons

e to

a fi

nanc

ial

ince

ntiv

e. J

Am

Pha

rm A

ssoc

,40

: 609

–617

.

Pros

pect

ive

ran-

dom

ized

tria

l 11

0 st

udy

phar

mac

ies

(fin

anci

al in

terv

entio

n);

90 c

ontr

ol p

harm

acie

s

Stud

y ph

arm

acist

s do

cum

ente

d an

aver

age

of 1

.59

CS

inte

rven

tions

per

100

pres

crip

tions

ver

sus

con-

trol

s do

cum

entin

g an

ave

rage

of

0.69

CS

inte

rven

tions

per

100

pre

-sc

riptio

ns. T

he a

vera

ge s

elf-

repo

rted

time

to p

erfo

rm C

S w

as 7

.5 m

in-

utes

, with

75%

last

ing

few

er t

han

6m

inut

es. F

inan

cial

ince

ntiv

e as

soci

-at

ed w

ith s

igni

fican

tly m

ore

and

dif-

fere

nt t

ypes

of C

S pe

rfor

med

by

phar

mac

ists.

Num

ber

of c

ogni

tive

serv

ice

(CS)

inte

rven

-tio

ns p

er 1

00 p

resc

rip-

tions

ove

r 20

-mon

thpe

riod

Man

asse

HR

. (19

89).

Med

icat

ion

use

in a

n im

per-

fect

wor

ld: D

rug

misa

dven

tur-

ing

as a

n iss

ue o

f pub

lic p

oli-

cy. P

art

1. A

m J

Hos

p Ph

arm

,46

: 929

–944

.

Rev

iew

T

wel

ve t

hous

and

deat

hs a

nd 1

5,00

0ho

spita

lizat

ions

wer

e re

port

ed t

oth

e FD

A, b

ut t

he n

umbe

r of

adve

rse

drug

rea

ctio

ns m

ight

be

asm

all f

ract

ion—

perh

aps

only

10%

of

the

true

num

ber.

Dea

ths

and

hosp

italiz

a-tio

ns d

ue t

o ad

vers

edr

ug r

eact

ions

Boo

tman

JL

, Har

rison

DL

,C

ox E

. (19

97).

The

hea

lthca

re c

ost

of d

rug-

rela

ted

mor

-bi

dity

and

mor

talit

y in

nur

s-in

g fa

cilit

ies.

Arc

h In

t M

ed,

157:

208

9–20

96.

Dec

ision

ana

lysis

B

asel

ine

estim

ates

indi

cate

tha

t th

eco

st o

f dru

g-re

late

d m

orbi

dity

and

mor

talit

y w

ith t

he s

ervi

ces

of c

on-

sulta

nt p

harm

acist

s w

as $

4.0

billi

onve

rsus

$7.

6 bi

llion

with

out

the

serv

-ic

es o

f con

sulta

nt p

harm

acist

s.

Cos

t of

dru

g-re

late

dm

orbi

dity

in n

ursin

gfa

cilit

ies

Cit

atio

nSa

mpl

e Po

pula

tion

Stud

y T

ype

Res

ults

(Con

clus

ions

)O

utco

me

Vari

able

s

14


App

endi

x B

: Evi

denc

e of

the

Pha

rmac

ists

’ Val

ue

John

ston

AM

, Doa

ne K

,Ph

ipps

K, B

ell A

. (Ja

n 19

96).

Out

com

es o

f pha

rmac

ists’

cogn

itive

ser

vice

s in

the

long

-te

rm c

are

sett

ing.

Con

sPh

arm

, 11(

1): 4

1–50

.

Cha

rt r

evie

w10

,207

res

iden

t ch

art

revi

ews

of d

rug

regi

-m

en c

olle

cted

ove

r 1-

mon

th p

erio

d of

122

long

-ter

m c

are

faci

li-tie

s; c

hart

rev

iew

ove

r3-

mon

th m

onito

ring

perio

d

Phar

mac

ists

mad

e 3,

464

inte

rven

-tio

ns. R

espo

nse

rate

for

inte

rven

-tio

ns r

eque

stin

g a

resp

onse

was

85.7

%, w

ith a

68%

acc

epta

nce

rate

.A

ccep

ted

reco

mm

enda

tions

res

ulte

din

a t

otal

cos

t sa

ving

s of

$15

,111

.38

for

the

1-m

onth

per

iod.

Acc

epte

dre

com

men

datio

ns r

esul

ted

in fa

vor-

able

hea

lth o

utco

mes

99.

5% o

f the

time.

Num

ber

and

type

of

inte

rven

tions

, cha

nge

in d

rug

ther

apy,

cha

nge

in m

edic

atio

n co

st,

chan

ge in

pat

ient

heal

th

McM

ullin

ST

, Hen

nenf

ent

JA, R

itchi

e D

, Hue

y W

Y,L

oner

gan

T, S

chai

ff R

, Ton

nM

, Bai

ley

TC

. (19

99).

Apr

ospe

ctiv

e ra

ndom

ized

tria

lto

ass

ess

the

cost

impa

ct o

fph

arm

acist

-initi

ated

inte

rven

-tio

ns. A

rch

Int

Med

, 159

:23

06–2

309.

Pros

pect

ive

ran-

dom

ized

con

-tr

olle

d tr

ial

1,22

6 in

terv

entio

ns b

ysix

pha

rmac

ists

at la

rge

univ

ersit

y ho

spita

l

Cos

t-sa

ving

inte

rven

tions

invo

lved

stre

amlin

ing

ther

apy

to le

ss-e

xpen

-siv

e ag

ents

(39

%),

disc

ontin

uing

an

unne

cess

ary

med

icat

ion

(25%

), a

ndm

odify

ing

rout

e of

adm

inist

ratio

n(2

4%).

Int

erve

ntio

n gr

oup

had

drug

cost

s 41

% lo

wer

tha

n co

ntro

l gro

up(P

< .0

01).

Mea

n $4

3.40

ver

sus

$73.

75.

Dru

g co

sts

Cit

atio

nSa

mpl

e Po

pula

tion

Stud

y T

ype

Res

ults

(Con

clus

ions

)O

utco

me

Vari

able

s

15


App

endi

x B

: Evi

denc

e of

the

Pha

rmac

ists

’ Val

ue

Schm

ader

KE

, Han

lon

JT,

Piep

er C

F, S

loan

e R

, Rub

yC

M, T

wer

sky

J, F

ranc

is M

A,

Wei

nber

ger

M, F

euss

ner

J,C

ohen

HJ.

(20

04).

Eff

ects

of

geria

tric

eva

luat

ion

and

man

-ag

emen

t on

adv

erse

dru

gre

actio

ns a

nd s

ubop

timal

pre

-sc

ribin

g in

the

frai

l eld

erly

.A

m J

Med

, 116

: 394

– 40

1.

Ran

dom

ized

2x2

fact

oria

lco

ntro

lled

stud

y

834

patie

nts

in 1

1 V

Aho

spita

ls ov

er a

ge 6

5w

ho m

et c

riter

ia fo

rfr

ail f

ollo

wed

for

12m

onth

s—bl

inde

dph

ysic

ian-

phar

mac

istpa

irs

Out

patie

nt g

eria

tric

clin

ic c

are

resu

lted

in 3

5% r

educ

tion

in t

he r

iskof

ser

ious

dru

g re

actio

n (a

djus

ted

rela

tive

risk,

0.6

5; 9

5% C

I, 0

.45-

0.93

). I

npat

ient

ger

iatr

ic u

nit

care

redu

ced

unne

cess

ary

and

inap

pro-

pria

te d

rug

use

and

unde

ruse

sig

nif-

ican

tly (

P <

.05)

. Out

patie

nt g

eri-

atric

car

e re

duce

d th

e nu

mbe

r of

omitt

ed d

rugs

(P

< .0

5).

Risk

of s

erio

us a

dver

sedr

ug r

eact

ions

, unn

ec-

essa

ry a

nd in

appr

opri-

ate

drug

use

and

unde

ruse

Bro

oks

JM, M

cDon

ough

RP,

Dou

cett

e W

R. (

Jun

2000

).C

ost

anal

ysis:

Pha

rmac

istre

imbu

rsem

ent

for

phar

ma-

ceut

ical

car

e se

rvic

es: W

hyin

sure

rs m

ay fl

inch

. Dru

gB

enef

it T

rend

s, 4

5–62

.

Eco

nom

ic c

ost

anal

ysis

Res

earc

hers

dev

elop

ed c

ompl

ex e

co-

nom

ic m

odel

des

crib

ing

mor

al h

az-

ard,

pro

ving

tha

t en

rolli

ng h

igh-

risk

patie

nts

into

pha

rmac

eutic

al c

are

prog

ram

s ca

n be

of v

alue

to

insu

rers

if th

e sa

ving

s in

curr

ed is

mor

e th

anth

e pr

ogra

m e

xpen

se. B

ased

on

the

mod

el, a

utho

rs c

oncl

ude

that

rei

m-

burs

ing

phar

mac

ists

to p

rovi

deph

arm

aceu

tical

car

e is

optim

al if

are

lativ

ely

inex

pens

ive

patie

nt s

cree

n-in

g m

etho

d is

avai

labl

e th

at e

nabl

esin

sure

rs t

o lim

it vi

sits

to t

hose

patie

nts

who

off

er c

ost

savi

ngs

toth

e in

sure

r.

Cit

atio

nSa

mpl

e Po

pula

tion

Stud

y T

ype

Res

ults

(Con

clus

ions

)O

utco

me

Vari

able

s

16


App

endi

x B

: Evi

denc

e of

the

Pha

rmac

ists

’ Val

ue

Chr

isten

sen

D, T

rygs

tad

T,

Sulli

van

R, G

arm

ise J

, Weg

ner

S. (

Dec

200

4). A

pha

rmac

ym

anag

emen

t in

terv

entio

n fo

rop

timiz

ing

drug

the

rapy

for

nurs

ing

hom

e pa

tient

s. A

m J

Ger

iatr

Pha

rmac

othe

r, 2(

4):

248–

256.

Bef

ore-

afte

rde

sign

Doc

umen

ted

DR

R fo

r9,

208

resid

ents

in 2

53nu

rsin

g ho

mes

rec

eiv-

ing

18 o

r m

ore

pre-

scrip

tion

refil

ls in

90

days

Bas

elin

e m

ean

was

9.5

2 pr

escr

ip-

tions

per

mon

th, w

ith m

ean

drug

cost

of $

502.

96 t

o N

orth

Car

olin

aM

edic

aid

prog

ram

. Aft

er in

terv

en-

tion,

mea

n re

duct

ion

of 0

.21

occu

rred

in n

umbe

r of

pre

scrip

tions

per

mon

th, w

ith m

ean

redu

ctio

n in

drug

cos

t of

$30

.33

per

patie

nt p

erm

onth

.

Num

ber

of p

resc

rip-

tions

per

mon

th, d

rug

cost

s

Lip

ton

HL

, Ber

o L

A, B

ird

JA,

McP

hee

SJ. (

Jul 1

992)

. The

impa

ct o

f clin

ical

pha

rmac

ists’

cons

ulta

tions

on

phys

icia

ns’

geria

tric

dru

g pr

escr

ibin

g.M

ed C

are,

30(

7): 6

46–6

58.

Pros

pect

ive

ran-

dom

ized

con

-tr

olle

d tr

ial

236

patie

nts

age

65+

with

thr

ee +

med

ica-

tions

, 123

exp

erim

en-

tal,

113

cont

rols

from

a 45

0-be

d ho

spita

l

Exp

erim

enta

ls w

ere

less

like

ly t

oha

ve o

ne o

r m

ore

pres

crib

ing

prob

-le

ms

(P <

.05)

; exp

erim

enta

l dru

gre

gim

ens

wer

e m

ore

appr

opria

teth

an t

hose

of c

ontr

ols

(P <

.01)

.

Dru

g th

erap

y pr

ob-

lem

s, r

egim

en a

ppro

-pr

iate

ness

Cra

nor

CW

, Bun

ting

BA

,C

hrist

ense

n D

B. (

Mar

/A

pr20

03).

The

Ash

evill

e pr

ojec

t:L

ong-

term

clin

ical

and

eco

-no

mic

out

com

es o

f a c

omm

u-ni

ty p

harm

acy

diab

etes

car

epr

ogra

m. J

Am

Pha

rm A

ssoc

,43

(2):

173

–190

.

Qua

si-ex

peri-

men

tal l

ongi

tu-

dina

l pre

-pos

tco

hort

stu

dy

136

empl

oyee

s ha

ving

diab

etes

follo

wed

for

5ye

ars—

inte

rven

tion

ofed

ucat

ion,

con

sulta

-tio

ns, c

linic

al a

sses

s-m

ent,

goal

set

ting,

col

-la

bora

tive

drug

the

rapy

man

agem

ent

with

phys

icia

ns

Mea

n A

1c d

ecre

ased

at

all f

ollo

w-

ups,

mor

e th

an 5

0% o

f pat

ient

sde

mon

stra

ted

impr

ovem

ents

at

each

follo

w-u

p, n

umbe

r of

pat

ient

s w

ithop

timal

A1c

incr

ease

d at

eac

h fo

l-lo

w-u

p, a

nd >

50%

impr

oved

in li

pid

leve

ls. C

osts

shi

fted

from

inpa

tient

and

out-

patie

nt s

ervi

ces

from

phy

si-

Cha

nges

in g

lyco

syla

t-ed

hem

oglo

bin

(A1c

)an

d se

rum

lipi

d co

n-ce

ntra

tions

, cha

nges

indi

abet

es-r

elat

ed a

ndto

tal m

edic

al u

se, c

osts

over

tim

e

Cit

atio

nSa

mpl

e Po

pula

tion

Stud

y T

ype

Res

ults

(Con

clus

ions

)O

utco

me

Vari

able

s

cont

inue

d

17


App

endi

x B

: Evi

denc

e of

the

Pha

rmac

ists

’ Val

ue

Cra

nor

CW

, Bun

ting

BA

,C

hrist

ense

n D

B. (

Mar

/A

pr20

03).

cian

s to

pre

scrip

tions

, mea

n di

rect

m

edic

al c

osts

dec

reas

ed b

y$1

,200

.00

to $

1,87

2.00

per

pat

ient

per

year

, and

sic

k da

ys d

ecre

ased

for

one

empl

oyer

gro

up, w

ith in

crea

ses

in p

rodu

ctiv

ity e

stim

ated

at

$18,

000.

00 a

nnua

lly.

Wal

ker

S, W

illey

CW

. (20

04).

Impa

ct o

n dr

ug c

osts

and

uti-

lizat

ion

of a

clin

ical

pha

rma-

cist

in a

mul

tisite

prim

ary

care

med

ical

gro

up. J

Man

ag C

are

Phar

m, 1

0(4)

: 345

–354

.

Ret

rosp

ectiv

epr

etes

t po

stte

stst

udy

Inde

pend

ent,

nona

cad-

emic

, am

bula

tory

, pri-

mar

y ca

re m

edic

alpr

actic

e of

65

phys

i-ci

ans

Dru

g co

sts

per

patie

nt p

er y

ear

incr

ease

d 1.

7% v

ersu

s na

tiona

lin

crea

se o

f 31.

2%. P

resc

riptio

ns p

erpa

tient

per

yea

r in

crea

sed

4% v

ersu

sun

chan

ged

natio

nal r

ate.

Cos

t pe

rpr

escr

iptio

n de

crea

sed

2.1%

ver

sus

natio

nal i

ncre

ase

of 3

1.2%

. Res

ults

due

to in

crea

se in

use

of g

ener

ics.

Net

med

ical

gro

updr

ug c

ost

per

enro

lled

mem

ber

per

year

ove

r2-

year

per

iod

Wei

nber

ger M

, Mur

ray

M,

Mar

rero

D, B

rew

er N

, Lyk

ens

M, H

arris

LE,

Ses

hadr

i R,

Caf

frey

H, R

oesn

er J

F, S

mith

F,

New

ell A

J, C

ollin

s JC

, McD

on-

ald C

J, T

iern

ey W

M. (

2002

).Ef

fect

iven

ess o

f pha

rmac

ist c

are

for p

atie

nts w

ith re

activ

e air

way

sdi

seas

e. J

AM

A, 2

88: 1

594–

1602

.

Ran

dom

ized

cont

rolle

d tr

ial

1,11

3 pa

rtic

ipan

ts w

ithac

tive

CO

PD o

r as

th-

ma.

Out

com

es w

ere

asse

ssed

in 9

47 (

85.1

%)

part

icip

ants

at

6m

onth

s an

d 89

8(8

0.7%

) at

12

mon

ths.

At

12 m

onth

s, p

atie

nts

rece

ivin

gph

arm

aceu

tical

car

e ha

d sig

nific

antly

high

er p

eak

flow

rat

es t

han

the

usua

l car

e gr

oup

(P =

.02)

but

not

than

PE

FR m

onito

ring

cont

rols

(P=

.28)

. No

signi

fican

t be

twee

n-gr

oup

diff

eren

ces

occu

rred

in m

ed-

Peak

exp

irato

ry fl

owra

tes,

bre

athi

ng-r

elat

edE

D o

r ho

spita

l visi

ts,

heal

th-r

elat

ed q

ualit

y of

life

(HR

QO

L),

med

ica-

tion

com

plia

nce,

and

patie

nt s

atisf

actio

n.

Cit

atio

nSa

mpl

e Po

pula

tion

Stud

y T

ype

Res

ults

(Con

clus

ions

)O

utco

me

Vari

able

s

cont

inue

d

18


App

endi

x B

: Evi

denc

e of

the

Pha

rmac

ists

’ Val

ue

Wei

nber

ger

M, M

urra

y M

,M

arre

ro D

, Bre

wer

N, L

yken

sM

, Har

ris L

E, S

esha

dri R

,C

affr

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, Roe

sner

JF,

Sm

ithF,

New

ell A

J, C

ollin

s JC

,M

cDon

ald

CJ,

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rney

WM

.(2

002)

.

icat

ion

com

plia

nce

or H

RQ

OL

.A

sthm

a pa

tient

s re

ceiv

ing

phar

ma-

ceut

ical

car

e ha

d sig

nific

antly

mor

ebr

eath

ing-

rela

ted

ED

or

hosp

ital

visit

s th

an t

he u

sual

car

e gr

oup

(OR

, 2.1

6; 9

5% C

I, 1

.76-

2.63

; P <

.001

). P

atie

nts

rece

ivin

g ph

arm

a-ce

utic

al c

are

wer

e m

ore

satis

fied

with

the

ir ph

arm

acist

tha

n th

e us

ual

care

gro

up (

P =

.03)

and

the

PE

FRm

onito

ring

grou

p (P

= .0

01)

and

wer

e m

ore

satis

fied

with

the

ir he

alth

care

tha

n th

e us

ual c

are

grou

p at

6m

onth

s on

ly (

P =

.01)

. Des

pite

ampl

e op

port

uniti

es t

o im

plem

ent

the

prog

ram

, pha

rmac

ists

acce

ssed

patie

nt-s

peci

fic d

ata

only

abo

ut h

alf

of t

he t

ime

and

docu

men

ted

actio

nsab

out

half

of t

he t

ime

that

rec

ords

wer

e ac

cess

ed.

Cit

atio

nSa

mpl

e Po

pula

tion

Stud

y T

ype

Res

ults

(Con

clus

ions

)O

utco

me

Vari

able

s

19


App

endi

x B

: Evi

denc

e of

the

Pha

rmac

ists

’ Val

ue

Goo

de J

K, S

wig

er K

, Blu

ml

BM

. (M

ar/

Apr

200

4).

Reg

iona

l ost

eopo

rosis

scr

een-

ing,

ref

erra

l, an

d m

onito

ring

prog

ram

in c

omm

unity

pha

r-m

acie

s: F

indi

ngs

from

Pro

ject

ImPA

CT

: Ost

eopo

rosis

. J A

mPh

arm

Ass

oc, 4

4(2)

:15

2–16

0.

Sing

le c

ohor

tob

serv

atio

nal

stud

y

Con

sum

ers

with

one

or

mor

e kn

own

risk

fac-

tors

for

oste

opor

osis

The

pha

rmac

ists

scre

ened

532

patie

nts

and

wer

e ab

le t

o co

ntac

t 30

5of

the

se p

atie

nts

for

follo

w-u

p in

ter-

view

s 3

mon

ths

to 6

mon

ths

late

r.T

he s

trat

ifica

tion

for

risk

of fr

actu

rew

as 3

7%, h

igh

risk;

33%

, mod

erat

eris

k; a

nd 3

0%, l

ow r

isk. A

tot

al o

f78

% o

f pat

ient

s in

dica

ted

that

the

yha

d no

prio

r kn

owle

dge

of t

heir

risk

for

futu

re fr

actu

re. I

n th

e m

oder

ate-

and

high

-risk

cat

egor

ies,

37%

of

patie

nts

sche

dule

d an

d co

mpl

eted

aph

ysic

ian

visit

, 19%

had

a d

iagn

ostic

scan

, and

24%

of t

hose

pat

ient

s w

ere

initi

ated

on

oste

opor

osis

ther

apy

sub-

sequ

ent

to t

he s

cree

ning

.Pa

rtic

ipat

ing

phar

mac

ies

rece

ived

paym

ent

for

both

the

ost

eopo

rosis

scre

enin

g an

d th

e co

llabo

rativ

e he

alth

man

agem

ent

serv

ices

.

Res

ults

of s

cree

ning

s,re

spon

ses

of p

atie

nts

and

phys

icia

ns t

o no

ti-fic

atio

ns, a

nd lo

ng-

term

res

ults

dur

ing

col-

labo

rativ

e ca

re

Han

lon

JT, A

rtz

MB,

Pie

per C

F,Li

ndbl

ad C

I, Sl

oane

RJ,

Rub

yC

M, S

chna

der K

E. (2

004)

.In

appr

opria

te m

edica

tion

use

amon

g fra

il el

derly

inpa

tient

s.A

nn P

harm

acot

her,

38(1

): 9–

14.

Obs

erva

tiona

l39

7 fr

ail,

elde

rly in

pa-

tient

s in

ele

ven

VA

faci

litie

s

Thr

ee h

undr

ed s

ixty

-fiv

e (9

1.9%

)pa

tient

s ha

d =1

med

icat

ion

with

=1

MA

I cr

iteria

rat

ed a

s in

appr

opria

te.

The

mos

t co

mm

on p

robl

ems

invo

lved

exp

ensiv

e dr

ugs

(70.

0%),

Prev

alen

ce o

f ina

ppro

-pr

iate

pre

scrib

ing

for

hosp

italiz

ed fr

ail,

elde

r-ly

pat

ient

s

Cit

atio

nSa

mpl

e Po

pula

tion

Stud

y T

ype

Res

ults

(Con

clus

ions

)O

utco

me

Vari

able

s

cont

inue

d

20


App

endi

x B

: Evi

denc

e of

the

Pha

rmac

ists

’ Val

ue

Han

lon

JT, A

rtz

MB,

Pie

per C

F,Li

ndbl

ad C

I, Sl

oane

RJ,

Rub

yC

M, S

chna

der K

E. (2

004)

.

CI

= co

nfid

ence

inte

rval

; CO

PD =

chr

onic

obs

truc

tive

pul

mon

ary

dise

ase;

DR

R =

dru

g re

gim

en r

evie

w; E

D =

em

erge

ncy

depa

rtm

ent;

FDA

= F

ood

and

Dru

g A

dmin

istra

tion

; MA

I =

Med

icat

ion

App

ropr

iate

ness

Inde

x; N

CE

P =

Nat

iona

l Cho

leste

rol E

duca

tion

Pro

gram

; O

R =

odd

s rat

io; P

EFR

= p

eak

expi

rato

ry fl

ow r

ate.

impr

actic

al d

irec

tions

(55

.2%

), a

ndin

corr

ect

dosa

ges

(50.

9%).

The

mos

t co

mm

on d

rug

clas

ses

with

appr

opria

tene

ss p

robl

ems

wer

e ga

s-tr

ic (

50.6

%),

car

diov

ascu

lar

(47.

6%),

and

cent

ral n

ervo

us s

yste

m (

23.9

%).

The

mea

n ±

SD M

AI

scor

e pe

r pe

r-so

n w

as 8

.9 ±

7.6.

Ste

pwise

ord

inal

logi

stic

reg

ress

ion

anal

yses

rev

eale

dth

at b

oth

the

num

ber

of p

resc

rip-

tion

(adj

uste

d O

R, 1

.28;

95%

CI,

1.21

-1.3

6) a

nd n

on-p

resc

riptio

ndr

ugs

(adj

uste

d O

R, 1

.17;

95%

CI,

1.06

-1.2

9) w

ere

rela

ted

to h

ighe

rM

AI

scor

es. A

naly

ses

excl

udin

g th

enu

mbe

r of

dru

gs r

evea

led

that

the

Cha

rlson

inde

x (a

djus

ted

OR

, 1.6

2;95

% C

I, 1

.12-

2.35

) an

d fa

ir/po

orse

lf-ra

ted

heal

th (

adju

sted

OR

,1.

15; 9

5% C

I, 1

.05-

1.26

) w

ere

rela

ted

to h

ighe

r M

AI

scor

es.

Cit

atio

nSa

mpl

e Po

pula

tion

Stud

y T

ype

Res

ults

(Con

clus

ions

)O

utco

me

Vari

able

s

21

2 0 0 6 C O N S E N S U S D O C U M E N T — A P P E N D I X C

Appendix CGlossary

Access A patient’s ability to obtain medical care determined by the availability of medical servic-es, their acceptability to the patient, the location of health care facilities, transportation, hours ofoperation and cost of care.

Adherent; adherence Also referred to as compliance. The ability of a patient to take a med-ication or follow a treatment protocol according to the directions for which it was prescribed; apatient taking the prescribed dose of medication at the prescribed frequency for the prescribedlength of time.

Adverse event Any harm a patient suffers that is caused by factors other than the patient’sunderlying condition.

Best practices Actual practices, in use by qualified providers following the latest treatmentmodalities, which produce the best measurable results on a given dimension.

Case management A collaborative process of assessment, planning, facilitation and advocacyfor options and services to meet an individual’s health needs through communication and avail-able resources to promote quality cost-effective outcomes.

Centers for Medicare and Medicaid Services (CMS) Formerly known as the HealthCare Financing Administration (HCFA), the federal agency responsible for administeringMedicare and overseeing states’ administration of Medicaid and the State Children’s HealthInsurance Program.

Drug utilization review (DUR) A system of drug use review that can detect potential adversedrug interactions, drug-pregnancy conflicts, therapeutic duplication, drug-age conflicts, etc.There are three forms of DUR: prospective (before dispensing), concurrent (at the time of pre-scription dispensing) and retrospective (after the therapy has been completed). Appropriate use ofan integrated DUR program can curb drug misuse and abuse and monitor quality of care. DURcan reduce hospitalization and other costs related to inappropriate drug use.

Medicare Advantage plans (MA-PDs) Health plan coverage that is offered under a man-aged care policy or plan that has been approved by CMS and provides both prescription drug andcomprehensive health care coverage.

Medicare Modernization Act (MMA) The Medicare Prescription Drug, Improvement, andModernization Act of 2003, referred to as the Medicare Modernization Act, was enacted inDecember 2003. Title I of MMA established a new Part D of Medicare, which provides anoptional outpatient prescription drug benefit effective January 2006.

Prescription drug plan (PDP) Medicare Part D prescription drug coverage that is offeredunder a policy or plan that has been approved by CMS and is offered by a PDP sponsor that hasa contract with CMS.

Self-insured employers Employers who choose to accept the financial risk for the health carecosts of their employees. Typically, employers “hire” a health plan or insurance company to pro-vide for the health care needs of their employees (and often their family members), and theemployers accept the financial risk for the services provided. This allows employers to retain sav-ings if the costs of health care provided are effectively managed. Self-insured employers will use ahealth plan or insurance company to provide administrative services such as claims processing.Self-insured employers commonly purchase stop-loss insurance to cover catastrophic cases.

22


Appendix DConsensus Document Work Group Participants:

AARPN. Lee Rucker, MSPHSenior Policy AdvisorPublic Policy Institute

Academy of Managed Care PharmacyJudith A. Cahill, CEBSExecutive Director

American Academy of Family PhysiciansDonnie Batie, MDPhysician in private practice

American Geriatrics SocietySunny A. Linnebur, PharmD, FASCP, BCPS, CGPHealth Care Systems Committee MemberAssistant Professor, Department of Clinical PharmacyUniversity of Colorado Health Sciences Center

American Pharmacists AssociationAnne Burns, RPhGroup Director, Practice Development and Research

American Society of ConsultantPharmacistsCarla Saxton, RPh, CGPAssistant Director, Policy and Advocacy

Case Management Society of AmericaJeanne Boling, MSN, CRRN, CDMS, CCMAssociate Executive Director

Department of Veterans AffairsVirginia Torrise, PharmDDeputy Chief ConsultantPharmacy Benefits Management SHG

National Business Coalition on HealthAndrew WebberPresident and CEO

23

2 0 0 6 C O N S E N S U S D O C U M E N T — A P P E N D I X D

Resource Group:15 health plans, pharmacy benefit management companies, integrated health care systemsand medication therapy management programs, including:

Community Care Rx

Coventry Health Care, Inc.

Humana

Independent Health

Intermountain Health Care

Kaiser Permanente

Medicine Shoppe International

Outcomes Pharmaceutical Health Care

Ovations: Pharmacy Solutions, UnitedHealth Group

Premier Pharmacists Network

Prescription Solutions

Scott & White Health Plan

Walgreens Health Initiatives

Pharmacy Organizations Serving as Reviewers:

American Association of Colleges of Pharmacy

American Society of Health-System Pharmacists

College of Psychiatric and Neurologic Pharmacists

National Association of Chain Drug Stores

24

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This project and the printing of this document was funded through a restricted grant from Merck/Schering-Plough (MSP).

Sound Medication Therapy Management Programs · SOUND MEDICATION THERAPY MANAGEMENT PROGRAMS 3 There are cases of self-insured employers and state Medicaid programs turning to MTM

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