2013-40-4_17-30

Effect of Pharmacists Interventions on Glycemic Control in Diabetic Patients: A Systematic Review and Meta-analysis of Randomized Controlled TrialsNalinee Poolsup,1 Naeti Suksomboon,2* Methinee Intarates2 1 Department of Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon-Pathom, 73000, Thailand 2 Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, 10400, Thailand

Abstract Several clinical trials have evaluated the effect of pharmacists interventions. However, the results have been inconsistent. We performed a systematic review to evaluate the effect of pharmacists interventions on glycemic control in diabetes. Clinical trials of pharmacists interventions aimed at improving glycemic control in diabetes patients were identified through a systematic search of MEDLINE, CINAHL, Web of Science, the Cochrane Library, and THAILIS. The bibliographic databases were searched from their inceptions to the end of February 2012. The references lists of relevant articles were checked and experts were consulted. Studies were included if they were: i) randomized controlled trials of pharmacists interventions aimed at improving glycemic control in diabetes patients, ii) reporting HbA1c as an outcome measure, iii) published in English or Thai, and iv) clearly describing details of pharmacists intervention. Treatment effect was estimated with the mean difference in the change of HbA1c levels from baseline between the intervention and the control groups. Twenty-two trials involving 2,808 patients were included. Pharmacists interventions included an assessment and adjustment of anti-diabetic medications, identification of drug-related problems, co-operation with physicians and other members of the health care team, offering diabetes booklets and special medication containers, providing education concerning self-management of diabetes, and reinforcement of diabetes management with pharmacotherapy and non-pharmacotherapy. This meta-analysis showed that pharmacists interventions can improve glycemic control in diabetes patients (mean difference -0.68%, 95% CI -0.87% to -0.49%, p < 0.00001). Thus, pharmacists can play an important role in diabetes management.

Keyword: systematic review, pharmaceutical care, glycemic control, diabetes

INTRODUCTION Uncontrolled diabetes leads to micro-vascular complications, namely, retinopathy, nephropathy, and neuropathy, and macrovascular complications, namely, congestive heart failure (CHF), cerebrovascular disease (CVD), and peripheral arterial disease (PAD).1 Pharmacist has recently been involved in multidisciplinary team. The role of pharmacist in diabetes care, including discharged counseling and providing patient education regarding disease

and medication, especially, drug related problem (DRP) monitoring,2-4 is the most important responsibility of pharmacist to their patients for positive outcomes such as improving quality of life and keeping targeted goal of hemoglobin A1c (HbA1c). Evidence is clear that improving glycemic control and preventing complications result in significant cost saving and improved quality of life.5 There have been a large number of clinical trials evaluating pharmacists

*Corresponding author: Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand. E-mail: [email protected]

Original Article Mahidol University Journal of Pharmaceutical Sciences 2013; 40 (4), 17-30

N. Poolsup et al.18

interventions in diabetes mellitus (DM). However, the outcomes of these studies remain controversial. We conducted a systematic review and meta-analysis to assess the effect of pharmacists interventions on HbA1c level in diabetes patients.

METHODS Data sources

Reports of randomized controlled trials of pharmacists interventions aimed for good glycemic control in diabetes patients were identified through a systematic literature search of MEDLINE, CINAHL, the Cochrane Library, Web of Science, and the THAIland Library Integrated System (THAILIS). Literature searches were conducted from inception to the end of February 2012. The MeSH terms pharmaceutical services, pharmacists, and diabetes mellitus were used together with keywords pharmaceutical care and pharmacy counseling. Hand search was also performed on relevant journals in Thailand such as Journal of the Medical Association of Thailand, Thai Journal of Hospital Pharmacy. References of retrieved studies and reviews of the topic were hand searched and experts in the field were contacted for additional papers not captured by the search strategy.

Study selection

The studies were included in the review if they: 1) were randomized controlled trials of any pharmacists interventions compared with usual care in diabetes patients, including type 1, type 2, Gestational diabetes mellitus (GDM), or unspecified DM; 2) reported HbA1c as an outcome measure; 3) were published in English or Thai language; and 4) clearly described pharmacists intervention. Abstract presenta-tion was excluded.

Data extraction and quality assessment

Data extraction and study quality assessment were performed independently by two investigators using a standardized form. Disagreements were resolved by a third investigator. Data from individual studies were abstracted. Data recorded were

the year of publication, setting, country, duration of study, intervention frequency, number of visit, inclusion criteria and exclusion criteria of each trial, type of DM, concomitant drug and disease, sample size, age, duration of DM, details of pharmacists interventions and control intervention, and primary outcomes. Quality of randomized controlled trials included in this review was assessed using Maastricht-Amsterdam scale.6 The scale comprises 11 items to evaluate internal validity of the study results. Studies that met at least 6 of 11 quality criteria were of high quality. Those scoring less than 6 of the criteria were of low quality.

Statistical analysis

Treatment effect was estimated with a mean difference in the change of HbA1c level from baseline to final assessment between the intervention group and the control group. If the variances of change values were not provided, but the exact p-value of the mean difference between the intervention and the control groups was available, the p-value was used to impute the variance.7 If the variances of change values and the exact p-values of the mean difference were not provided, the pooled interstudy variances were imputed from studies reporting variances. The inverse variance-weighted method was used for the pooling of mean difference and the estimation of 95% confidence interval (CI).8 A random effects model was used when the Q-statistic for heterogeneity was significant at the level of 0.1,9 otherwise the fixed effects model was used.8 The degree of heterogeneity was quantified using the I2 statistic which is the percentage of total variation across studies due to heterogeneity.10 A funnel plot and Eggers method11 were performed to assess publication bias. Statistical analysis was undertaken with RevMan version 5.1 (Cochrane Collaboration, Oxford, UK). The significant level was set at p < 0.05.

RESULTS Study characteristics

The initial search of the computerized

19Effect of Pharmacists Interventions on Glycemic Control in Diabetic Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials

database and hand search identified a total of 1,160 articles (Figure 1). After the initial screening, 44 trials were attained in the selection process. Among the 44 trials, 16 trials were excluded because they did not report glycemic control/HbA1c. Five trials were further excluded because they did not state clearly the role of pharmacist in the intervention group. One trial reported results in terms of median and interquartile range

and was then excluded. Only 22 randomized controlled trials met inclusion criteria and were included in the systematic review and meta-analysis. Characteristics of these trials are presented in Table 1. In general, there were no significant differences between patients in the intervention group and those in the control group with respect to age and duration of diabetes.

Figure 1. Flow diagram of study selection for meta-analysis

Those trials, involved patients with type 1, type 2, GDM, or unspecified DM and were reported between 1996 and 2012. The setting of trials included primary care unit, home care, community pharmacy, primary care hospital, tertiary care hospital, a university-affiliated internal medicine outpatient clinic, endocrine clinic, military hospital, and veteran medical center in the USA, Canada, Australia, Sweden, Spain, UAE, and Thailand. The duration of trials varied from 3 months to 2 years. Pharmacists intervention was given at different frequency, for example, once a week and once every 6 months. Number of visit ranged between 1 and 24 times. Pharmacists involved included registered pharmacist,12,20,26,32 clinical pharmacist,14,16-18,21,23,25,27,29,30 community pharmacist,22,24,28,32 clinical pharmacist with multidisciplinary team,19,31 certified diabetes educator pharmacists,13 specially trained pharmacists.15 The methods of follow-up were

face-to-face encounter and/or by telephone. Details of pharmacist interventions differed from trial to trial (Table 2 and 3) and encompassed the followings: diabetes education and counseling about drug, disease, diet, exercise, life style modification, and self-management, assessment and adjustment of antidiabetic medications, identifying and solving drug-related problems, co-operating with physician and other diabetes health care team, providing materials, leaflet, diabetes booklet and special medication containers, and monthly newsletter that enforced patients to achieve a target goal, reminding about annual eye and foot examinations, and providing additional information about smoking cessation, stop drinking alcohol. For the usual care group, patients continued to receive standard medical care provided by their physicians, other health care team, and with/without pharmacists depending on each study design (Table 2).

N. Poolsup et al.20

No.

St

udy

Setti

ng

Cou

ntry

D

urat

ion

In

terv

entio

n In

clusio

n

of st

udy

frequ

ency

cr

iteria

1

Jabe

r LA

199

612

A U

nive

rsity

-affi

liate

d in

tern

al

US

4 m

o 2-

4 w

eeks

/tim

e T2

DM

m

edic

ine o

utpa

tient

clin

ic

2

Gui

rgui

s LM

200

113

Chai

n ph

arm

acy,

shop

pers

Ca

nada

; 6

mo

< 1

mon

th/ti

me

T2D

M fo

r Alb

erta

a m

inim

um

drug

mar

t Ed

mon

ton,

of

1 y

ear,

non-

insti

tutio

naliz

ed

3 Cl

iffor

d RM

200

214

Frem

entle

Hos

pita

l,

Austr

alia

6

mo

6 w

eeks

/tim

e A

ged

> 18

yea

rs w

ith ei

ther

T1D

M

diab

etes

out

patie

nt cl

inic

or T

2DM

and

was

hig

h-ris

k

for t

he d

evelo

pmen

t of d

iabe

tes

co

mpl

icat

ions

.

4 Sa

rkad

i A 2

0041

5 St

ockh

olm

Dia

bete

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tion

Swed

en

24 m

o 6

mon

ths/

time

T2D

M an

d, if

trea

ted

with

insu

lin,

on

ly fo

r 2 y

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ess

5

Cliff

ord

RM 2

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6 Fr

emen

tle H

ospi

tal,

Frem

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Au

stral

ia

12 m

o 6

wee

ks/ti

me

T2D

M

Dia

bete

s Stu

dy (F

DS)

6 Ch

oe H

M 2

0051

7 U

nive

rsity

-affi

liate

d pr

imar

y

US

24 m

o 1

mon

th/ti

me

T2D

M, H

bA1c

leve

ls >

8.0%

ca

re in

tern

al m

edic

ine c

linic

7 O

dega

rd P

S 20

0518

Th

e Uni

vers

ity o

f Was

hing

ton

US

6 m

o 1

wee

k/tim

e A

ged

18

yea

rs, T

2DM

, tak

ing

at

med

icin

e clin

ics

le

ast o

ne o

ral d

iabe

tes m

edic

atio

n,

with

an H

bA1c

9%

8

Suks

ombo

on N

2005

19

Prim

ary

care

uni

t, Sa

mut

sako

rn

Thai

land

3

mo

3 m

onth

s/tim

e T2

DM

, 18-

60 y

ears

old

, tak

e OA

D

Hos

pita

l

as m

etfo

rmin

, glip

izid

e and

/or

gl

iben

clam

ide,

HbA

1c >

7%

9

Supp

apiti

porn

S 2

0052

0 En

docr

ine c

linic

in K

ing

Th

aila

nd

6 m

o 3

mon

ths/

time

T2D

M, a

ged

> 40

yea

rs

Chul

alon

gkor

n M

emor

ial

H

ospi

tal (

out p

atie

nts)

10

Ro

thm

an R

L 20

0521

U

nive

rsity

of N

orth

Car

olin

a U

S 12

mo

2-4

wee

ks/ti

me

Age

d >1

8 ye

ars o

ld, T

2DM

, HbA

1c

Gen

eral

Inte

rnal

Med

icin

e

leve

l >8.

0%, l

ife ex

pect

ancy

>6

Pr

actic

e

mon

ths

11

Forn

os JA

200

622

Com

mun

ity p

harm

acie

s Sp

ain;

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mo

1 m

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/tim

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atm

ent w

ith o

ral a

ntid

iabe

tics

Pont

eved

ra

for m

ore t

han

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s

12

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623

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unity

Hea

lth

US

9 m

o 2

wee

ks/ti

me

T2D

M, a

ged

> 18

yea

rs

Cen

ter (

SCH

C)

Tabl

e 1. C

hara

cter

istic

s of t

he st

udie

s inc

lude

d in

the m

eta-

anal

ysis


No.

St

udy

Setti

ng

Cou

ntry

D

urat

ion

In

terv

entio

n In

clusio

n

of st

udy

frequ

ency

cr

iteria

13

Kr

ass I

200

724

Com

mun

ities

pha

rmac

ies

Au

stral

ia

6 m

o 1

mon

th/ti

me

T2D

M, H

bA1c

7

.5%

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ing

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ast

on

e ora

l glu

cose

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ring m

edica

tion

or

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lin, o

r HbA

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st

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ral g

luco

se lo

werin

g m

edic

atio

n

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, on

at le

ast o

ne an

ti-hy

per-

te

nsiv

e, an

gina

or l

ipid

-lowe

ring

drug

.

14

Elno

ur A

A 2

0082

5 A

l Ain

Hos

pita

l, gy

naec

olog

y

UAE

6 m

o 1

mon

th/ti

me

Patie

nt pr

ovid

ed w

ithin

the fi

rst 20

wee

ks

outp

atie

nt cl

inic

s

of g

esta

tion,

dia

gnos

is of

GD

M, a

nd

ag

ed 2

0- 3

9 ye

ars

15

Ph

umip

amor

n S

2008

26

Com

mun

ity h

ospi

tal i

n Kr

abi

Thai

land

10

mo

2 m

onth

s/tim

e M

uslim

dia

betic

pat

ient

s, ag

ed >

18

pr

ovin

ce

ye

ars,

and

HbA

1c >

7%

16

Pava

sudt

hipa

isit A

200

927 D

iabe

tes C

linic

, Out

-pat

ient

Th

aila

nd

12 m

o 6

mon

ths/

time

T2D

M, H

bA1c

leve

ls >

8.0%

with

out

de

part

men

t, N

ongb

uala

mph

u

mac

rova

scul

ar co

mpl

icat

ions

ho

spita

l

17

Dou

cette

WR

2009

28

Com

mun

ity p

harm

acy p

ract

ice si

te U

S; IO

WA

12

mo

3 m

onth

s/tim

e T2

DM

, HbA

1c >

7.0

%

18

Maz

roui

NRA

200

929

Zaye

d M

ilita

ry H

ospi

tal,

gene

ral

UAE

12 m

o 4

mon

ths/

time

T2D

M, r

ecei

ving

ora

l hyp

ogly

caem

ic

med

ical

war

ds an

d en

docr

inol

ogy

th

erap

y

& m

edic

al o

utpa

tient

clin

ics

19

Tave

ira T

H 2

0103

0 Ve

tera

ns H

ealth

Affa

irs

US

22 m

o 4

wee

ks/ti

me

T2DM

, age

d >

18 ye

ars,

or H

bA1c

7%-9

%

with

in th

e pre

viou

s 6 m

onth

s

20

Ed

elman

D 2

0103

1 Ve

tera

ns A

ffairs

Med

ical

Cen

ters

US;

Car

olin

a 12

.8 m

o 2

mon

ths/

time

Patie

nts h

ad b

oth

diab

etes

and

hype

r-

&

Virg

inia

te

nsio

n, r

ecei

ving

med

icat

ion

for

di

abet

es, a

nd H

bA1c

leve

l >7.

5% a

nd

hy

pert

ensio

n (S

BP >

140

mm

Hg

or

D

BP >

90 m

m H

g)

21

Meh

uys E

201

132

Com

mun

ity p

harm

acie

s Be

lgiu

m

6 m

o 6

wee

ks/ti

me

T2D

M, r

ecei

ving

ora

l hyp

ogly

caem

ic

m

edica

tion

for a

t lea

st 12

mon

ths,

aged

45

75

year

s, BM

I> 2

5 kg

/m2,

and

regu

lar v

isito

r of p

harm

acy

22

Srira

m S

201

133

A p

rivat

e ter

tiary

care

hos

pita

l S

outh

Indi

a 8

mo

3 m

onth

s/tim

e In

dian

, T2D

M, a

ged

> 18

yea

rs, w

ith

or w

ithou

t oth

er d

iseas

es

Tabl

e 1. C

hara

cter

istic

s of t

he st

udie

s inc

lude

d in

the m

eta-

anal

ysis

(con

t.)

N. Poolsup et al.22

No.

St

udy

Phar

mac

ist in

terv

entio

n U

sual

care

1 J

aber

LA

199

612

Dia

bete

s edu

catio

n, m

edic

atio

n co

unse

ling,

instr

uctio

ns o

n di

etar

y C

ontin

ued

to re

ceiv

e sta

ndar

d m

edic

al ca

re p

rovi

ded

by

regu

latio

n, ex

erci

se, a

nd h

ome b

lood

glu

cose

mon

itorin

g, an

d

thei

r phy

sicia

ns.

ev

alua

tion

and

adju

stmen

t of t

heir

hypo

glyc

emic

regi

men

.

2 G

uirg

uis L

M 20

0113

Usu

al ca

re p

lus s

ervi

ce p

rovi

de; d

iabe

tes a

nd it

s com

plic

atio

n,

Con

trol p

harm

acie

s pro

vide

d us

ual c

are,

phar

mac

ist

hypo

glyc

emia

, mon

itorin

g bl

ood

gluc

ose l

evel,

use

of

offer

ed p

atie

nts s

ome f

orm

of b

lood

glu

cose

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ood

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onito

r, nu

triti

on, e

xerc

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nsul

in u

se, i

nsul

in

met

er tr

aini

ng ,

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r tra

inin

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s man

agem

ent

de

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, med

icat

ion

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n co

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eval

uate

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ress

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artic

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view

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bA1c

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sure

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,

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este

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bum

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wed

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le, ad

vise

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non

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ysic

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Com

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plify

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Had

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ndar

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men

t by

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ary

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phy

sicia

n.

tele

phon

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essm

ents

and

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ther

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nal m

ater

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6 C

hoe H

M 20

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Ph

arm

acist

s pro

vide

d ev

alua

tion

and

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ifica

tion

of p

harm

acot

hera

py, K

ept a

s a n

atur

al co

ntro

l, th

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nly

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lar c

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anag

emen

t dia

bete

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catio

n, an

d re

info

rcem

ent o

f dia

bete

s in

cludi

ng re

gula

r fol

low

up

visit

s with

thei

r prim

ary

care

co

mpl

icatio

ns sc

reen

ing p

roce

sses t

hrou

gh cl

inic

visits

and

telep

hone

follo

w-up

. phy

sicia

ns, r

ecei

ved

no sp

ecia

l con

tact

dur

ing

the

in

terv

entio

n, d

id n

ot h

ave e

xit i

nter

view

s or p

roce

ss

mea

sure

men

ts at

the e

nd o

f the

stud

y.

Tabl

e 2. D

etai

ls of

pha

rmac

ists

inte

rven

tion

and

usua

l car

e of e

ach

tria

l


No.

St

udy

Phar

mac

ist in

terv

entio

n U

sual

care

7 O

dega

rd P

S 200

518

The p

harm

acist

inte

rven

tion

was

com

pose

d of

dev

elopm

ent o

f a

Patie

nts w

ere c

onstr

ucte

d to

cont

inue

nor

mal

care

di

abet

es ca

re p

lan

(DCP

), re

gula

r pha

rmac

ist-p

atie

nt co

mm

unic

atio

n on

with

thei

r prim

ary

care

pro

vide

r. D

iabe

tes e

duca

tion

di

abet

es ca

re p

rogr

ess,

phar

mac

ist-p

rovi

der c

omm

unica

tion

on th

e sub

jects

was

not

pro

vide

d du

ring t

he b

aseli

ne in

terv

iew to

avoi

d

diab

etes

care

pro

gres

s, an

d D

RP.

intro

ducin

g an

inter

vent

ion

for p

atien

ts in

the c

ontro

l gro

up.

8 S

ukso

mbo

on

Self-

effica

cy tr

aini

ng p

rogr

am b

y m

ultid

iscip

linar

y te

am in

cludi

ng

The c

ontro

l gro

up d

id n

ot en

ter p

erce

ived

self-

effica

cy

N

2005

19

phar

mac

ist, p

harm

acist

also

pro

vide

d ed

ucat

ion

on se

lf-ca

re b

ehav

iors

, tr

aini

ng p

rogr

am.

se

lf-m

onito

ring

of b

lood

glu

cose

, and

kno

wle

dge i

n di

abet

es.

9 S

uppa

pitip

orn

U

sual

care

plu

s dia

betic

dru

g co

unse

ling,

adde

d di

abet

es b

ookl

et, s

peci

al P

atie

nts w

ere i

nter

view

ed d

emog

raph

ic in

form

atio

n,

S

2005

20

med

icat

ion

cont

aine

rs.

bloo

d te

st, an

d m

edic

al re

cord

s. 1

0 Ro

thm

an

Inte

nsiv

e edu

catio

n se

ssio

ns, e

vide

nce-

base

d al

gorit

hm, p

roac

tive

Patie

nts r

ecei

ved

usua

l car

e fro

m th

eir p

rimar

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re

RL

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man

agem

ent.

prov

ider

and

had

no fu

rthe

r man

agem

ent f

rom

the

dise

ase m

anag

emen

t tea

m.

11

Forn

os

Usu

al ca

re p

lus p

harm

acot

hera

py fo

llow

up

prog

ram

(ind

ivid

ualiz

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Usu

al d

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sing

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harm

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.

JA

200

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m) w

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det

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n an

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solu

tion

of D

RPs

an

d di

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ucat

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lves

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thei

r ow

n ca

re in

ord

er to

obta

in m

axim

um b

enefi

t fro

m th

e med

icat

ion.

12

Scot

t Pa

tient

educ

atio

n ab

out d

iseas

e, te

sting

blo

od gl

ucos

e lev

els, d

rug t

hera

py,

Patie

nts r

ecei

ved

stand

ard

diab

etes

care

and

wer

e

D

M 2

0062

3 ps

ycho

logi

cal a

djus

tmen

t in

diab

etes

, sig

ns an

d sy

mpt

oms o

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er-

man

aged

by

a nur

se.

gl

ycem

ia, h

yper

glyc

emia

, and

dia

betic

ket

oaci

dosis

and

cour

se o

f act

ion.

13

Kras

s I 2

0072

4 Se

rvic

es fr

om p

harm

acist

s inc

lude

d of

revi

ew o

f self

mon

itorin

g of

Th

e con

trol p

atien

ts ha

d tw

o vi

sits w

ith th

e pha

rmac

ist,

bl

ood

gluc

ose;

dise

ase,

med

icat

ion,

and

lifes

tyle

educ

atio

n; ad

here

nce

one a

t the

beg

inni

ng an

d on

e at t

he en

d of

the s

tudy

.

supp

ort a

nd d

etec

tion

of d

rug-

rela

ted

prob

lem

s; an

d re

ferr

als t

o th

e D

urin

g the

inter

veni

ng 6

mon

ths,

they

rece

ived

usua

l car

e

patie

nts

GPs

whe

n ap

prop

riate

. (

i.e. n

o sp

ecia

lized

dia

bete

s ser

vice

in th

e pha

rmac

y).

14

Elno

ur

Ensu

red

that

inte

rven

tion

patie

nts r

ecei

ved

base

d tre

atm

ent a

nd

Patie

nts r

ecei

ved

trad

ition

al ca

re: m

onth

ly cl

inic

visi

ts

A

A 2

0082

5 tre

atm

ent f

or an

y ot

her c

onco

mita

nt il

lnes

s, ed

ucat

ed o

n G

DM

an

d se

lf-m

onito

ring

of p

lasm

a glu

cose

usin

g di

ary

card

s.

and

its m

anag

emen

t, ed

ucat

iona

l boo

klet

, Clin

ical

asse

ssm

ents.

Tabl

e 2. D

etai

ls of

pha

rmac

ists

inte

rven

tion

and

usua

l car

e of e

ach

tria

l (co

nt.)

N. Poolsup et al.24

No.

St

udy

Phar

mac

ist in

terv

entio

n U

sual

care

15

Phum

ipam

orn

U

sual

care

plu

s rem

inde

d th

e pat

ient

s, re

fille

d pr

escr

iptio

ns,

Patie

nts r

ecei

ved

usua

l sch

edul

e car

e by

prim

ary

care

S 20

0826

di

scus

sed

the u

ses o

f med

icat

ion,

chec

k th

e pill

coun

t, ed

ucat

ion

on

phys

icia

n ev

ery

4-8

wee

ks.,

disp

ensin

g by

pha

rmac

ist

diab

etes

abou

t app

ropr

iate l

ifesty

le, co

rrec

t diet

, and

pro

vide

d di

abet

ic fil

led

and

gave

gen

eral

advi

ce o

n m

edic

atio

n us

es o

ver

pa

mph

let; d

iabe

tic co

mpl

icat

ions

, tar

get o

f tre

atin

g di

abet

es, l

ife st

yle

the d

ispen

sary

coun

ter o

n a r

outin

e bas

is.

chan

ge, a

nd d

iabe

tic m

edic

atio

ns.

16

Pava

sudt

hipa

isit

Inte

rven

tion

grou

p re

ceiv

ed in

tens

ive m

anag

emen

t fro

m p

harm

acist

Pa

tient

s wer

e pro

vide

d ca

re b

y the

ir ph

ysici

ans o

f int

erns

.

A

200

927

prac

titio

ners

; rec

eived

an as

sess

men

t of m

edica

tion-

taki

ng ad

here

nce

an

d th

eir u

nder

stand

ing

of d

iabe

tes t

hen

appl

ied

algo

rithm

s for

m

anag

ing

gluc

ose c

ontro

l and

oth

er ca

rdio

vasc

ular

risk

fact

ors.

17

Dou

cette

D

iscus

sing m

edica

tions

, clin

ical g

oals,

self-

care

activ

ities

with

pat

ients

Patie

nts r

ecei

ved

usua

l dia

bete

s car

e fro

m th

eir p

rimar

y

W

R 20

0928

an

d re

com

men

ding

med

icatio

n ch

ange

s to

phys

ician

s whe

n ap

prop

riate

. ca

re p

rovi

der.

18

Maz

roui

Th

e res

earc

h ph

arm

acist

had

disc

ussio

ns w

ith th

eir p

hysic

ians r

egar

ding

Pa

tient

s rec

eive

d no

rmal

care

from

med

ical

and

nurs

ing

NRA

200

929

drug

ther

apy,

treat

men

t mod

ifica

tion,

educ

ated

for i

llnes

s and

sta

ff, d

id n

ot re

ceiv

e the

clin

ical

pha

rmac

y se

rvic

e.

med

icat

ion,

prin

ted

leafl

et, a

nd b

ehav

iora

l mod

ifica

tion.

19

Tave

ira

Usu

al ca

re p

lus t

reat

men

t of h

yper

glyc

emia

, hyp

erte

nsio

n,

Patie

nts r

ecei

ved

the s

tand

ard

care

pro

vide

d by

prim

ary

TH 2

0103

0 hy

perli

pide

mia

, and

ciga

rette

smok

ing.

ca

re p

rovi

ders

, fre

quen

cy av

erag

e 4 m

onth

s. 2

0 Ed

elman

Ph

arm

acist

revi

ewed

pat

ient

med

ical

reco

rds,

BP, a

nd h

ome b

lood

Pa

tient

s con

tinue

d to

rece

ive t

heir

usua

l prim

ary

care

,

D

201

031

gluc

ose r

eadi

ngs d

urin

g ea

ch se

ssio

n an

d de

velo

ped

indi

vidu

aliz

ed

no ac

tive i

nter

vent

ion.

pl

ans f

or m

edica

tion

or li

festy

le m

anag

emen

t. Ph

arm

acist

and

phys

ician

adju

sted

med

icat

ion

to m

anag

e eac

h pa

tient

HbA

1c le

vel a

nd B

P. 2

1 M

ehuy

s Ed

ucat

ion

abou

t T2D

M an

d co

mpl

icat

ions

, cor

rect

use

of o

ral

Patie

nts r

ecei

ved

usua

l pha

rmac

ist ca

re.

E 20

1132

hy

pogl

ycae

mic

agen

ts, fa

cilit

atio

n of

med

icat

ion

adhe

renc

e, he

alth

y

lifes

tyle

educ

atio

n, an

d re

min

ders

abou

t ann

ual e

ye an

d fo

ot

exam

inat

ions

. 2

2 Sr

iram

S 2

0113

3 Pa

tient

s rec

eived

pha

rmac

eutic

al ca

re; m

edica

tion

coun

selin

g ins

truct

ions

Pat

ient

s rec

eive

d us

ual d

iabe

tes c

are.

on

die

tary

regu

latio

n, ex

erci

se an

d ot

her l

ifesty

le m

odifi

catio

n.

Tabl

e 2. D

etai

ls of

pha

rmac

ists

inte

rven

tion

and

usua

l car

e of e

ach

tria

l (co

nt.)


Effect on HbA1c

Twenty two trials involving a total of 2,808 diabetes patients were pooled. HbA1c levels at baseline, final assessment are presented in Table 4. HbA1c levels were significantly reduced with pharmacists interventions

compared with usual care. The pooled mean difference in the change of HbA1c was -0.68% (95%CI, -0.87% to -0.49%; p< 0.00001) (Figure 2). No publication bias was detected (Egger bias -0.35; 95% CI -2.89 to 2.19, P= 0.7785).

Table 3. Component of pharmacists intervention in individual trials

Education Identifying and Study Materials provided and counseling resolving drug- related problems

Jaber LA 199612 - Guirguis LM 200113 glucose meter maintenance - Clifford RM 200214 - Sarkadi A 200415 video, booklet Clifford RM 200516 educational material Choe HM 200517 - Odegard PS 200518 - - Suksomboon N 200519 - - Suppapitiporn S 200520 booklet, containers - Rothman RL 200521 - - Fornos JA 200622 - Scott DM 200623 - Krass I 200724 monthly newsletter Elnour AA 200825 booklet Phumipamorn S 200826 pamphlet Pavasudthipaisit A 200927 - Doucette WR 200928 - Mazroui NRA 200929 leaflet - Taveira TH 201030 smoking cessation handout - Edelman D 201031 - Mehuys E 201132 educational material -

Sriram S 201133 leaflet, diabetic diet chart, diabetic diary

N. Poolsup et al.26

HbA1c (%)

Study Control Intervention

Baseline Final Baseline Final

Jaber LA 199612 11.52.9 12.13.3 12.23.5 9.22.1 Guirguis LM 200113 7.9* 7.1* 7.9* 6.9* Clifford RM 200214 8.51.6 8.11.6 8.41.4 8.21.5 Sarkadi A 200415 6.44* 6.60* 6.44* 6.09* Clifford RM 200516 7.1* 6.7* 7.5* 7.3* Choe HM 200517 10.21.7 9.32.1 10.11.8 8.01.4 Odegard PS 200518 10.61.4 9.2* 10.20.8 8.7* Suksomboon N 200519 9.731.88 10.232.59 9.031.67 8.691.82 Suppapitiporn S 200520 8.011.51 8.801.36 8.161.44 7.911.27 Rothman RL 200521 112 9.4* 113 8.5* Fornos JA 200622 7.81.7 8.51.9 8.41.8 7.91.7 Scott DM 200623 8.7* 8.0* 8.8* 7.08* Krass I 200724 8.31.3 8.01.2 8.91.4 7.91.2 Elnour AA 200825 6.87 6.55 6.85 6.38 (95%CI (95%CI (95%CI (95%CI 6.81, 6.93) 6.43, 6.67) 6.78, 6.90) 6.33, 6.42) Phumipamorn S 200826 8.71.6 8.11.9 8.71.5 7.91.4 Pavasudthipaisit A 201127 9.91.6 9.1* 9.81.4 7.8* Doucette WR 200928 7.911.91 8.03* 7.991.45 7.72* Mazroui NRA 200929 8.4 8.3 8.5 6.9 (95%CI (95%CI (95%CI (95%CI 8.6, 8.6) 8.1, 8.5) 8.3, 8.7) 6.7, 7.1) Taveira TH 201030 7.91.1 7.9* 8.11.5 7.2* Edelman D 201031 9.21.3 8.6* 9.21.5 8.3* Mehuys E 201132 7.3 1.2 7.2 1.0 7.7 1.7 7.1 1.1 Sriram S 201133 9.03 0.46 8.31 0.16 8.44 0.29 6.73 0.21

Data are meanSD, * mean value

Table 4. HbA1c levels at baseline and final assessment reported in individual trials


DISCUSSION

Pharmacist is part of a multidiscip-linary team. This team normally consists of pharmacist, physician, nurse, technician, nutritionist, and other health care professions. All of the members in multidisciplinary team have important roles in diabetes management in achieving the goal of treatment, improving quality of life, controlling disease and its complications, delaying complication, and decreasing mortality and morbidity. Pharma-cists interventions are an important factor to improve glycemic control in diabetic patients. Pharmacists interventions include diabetes education and counseling on drug, disease, diet, exercise, life style modification, and self-management, assessment and adjustment of anti-diabetic medications, identifying and solving drug-related problems, co-operation with physician and other diabetes health care team, providing materials that reinforce patients to achieve a target goal, providing additional information on smoking cessation. All of these interventions aimed at improving glycemic control. In our study, HbA1c levels significantly reduced with pharmacists interventions compared with usual care. The pooled mean

difference in the change of HbA1c was -0.68% (95%CI, -0.87% to -0.49%; p< 0.00001). This reduction is the same as the ability in reducing HbA1c by taking some oral anti-hyperglycemic drugs for example, DPP-4 inhibitors and alpha-glucosidase inhibitors. This would help patients meeting the target of their treatment. To ensure that the meta-analysis included quality study, the Maastricht Amsterdam scale was used to assess the quality of individual study. The majority of the studies12-13, 15-20, 22-31,33 were rated as low quality, only three studies14, 21, 32 were of high quality. Most of these studies were open (not blinded) in study design. Performance bias in both intervention and control groups was likely in these trials as patients may seek other interventions to help control their blood glucose. This was evident when only high quality studies14, 21, 32 were pooled, showing a slight reduction in the effect of pharmacists interventions on HbA1c (mean difference -0.39%, 95% CI -0.61% to -0.17%, p = 0.0005). There were limitations in individual studies included in this meta-analysis. In most of the trials, both pharmacists and patients were not blinded and therefore,

Figure 2. Mean difference (95% confidence interval) of HbA1c between pharmacist intervention group and usual care group

N. Poolsup et al.28

contamination between groups was possible. This may affect the final outcomes. Secondly, Hawthorne effect may occur when study participants improved because of the only fact that they were participating in a research study. The findings of our study suggest several practice implications. First, pharma-cists interventions effectively improve glycemic control when compared with usual care; and thus, pharmacist should be part of a diabetes care team. Second, the approprite components of intervention should include both pharmacotherapy and non-pharmaco-therapy. Interventions on pharmacotherapy are screening and solving drug-related problems; if necessary, pharmacists provide feedback to physician, deliver patient education and counseling on medication. Non-pharmacotherapy interventions include education and counseling on diet, exercise, disease, adherence, and life-style modification.

CONCLUSION The available evidence suggests that pharmacists interventions are more effective than usual care in decreasing HbA1c levels in diabetes patients. Pharmacists interventions included diabetes education and counseling on drug, disease, diet, exercise, life style modification, and self-management, an assessment and adjustment of anti-diabetic medications, identifying and solving drug-related problems, co-operation with physician and other diabetes health care team.

REFERENCES 1. American Diabetes Association. Standards of medical care in diabetes 2010. Diabetes Care 2010;33(1):S11 61. 2. Glasgow RE, Peeples M, Skovlund SE. Where is the patient in diabetes performance measures? The case for including patient-centered and self- management measures. Diabetes Care 2008;31:104650.

3. American Society of Health-System Pharmacists. ASHP statement on the pharmacists role in primary care. Am J Health-Syst Pharm 1999;56:1665-7. 4. Sisson E, Kuhn C. Pharmacist roles in the management of patients with type 2 diabetes. J Am Pharm Assoc 2009;49(1):S415. 5. Norris SL, Nichols PJ, Caspersen CJ, et al. The effectiveness of disease and case management for people with diabetes: a systematic review. Am J Prev Med 2002;22(4):1538. 6. van Tulder M, Furlan A, Bombardier C, et al. Updated method guidelines for systematic reviews in the Cochrane collaboration back review group. Spine 2003; 28(12):1209-9. 7. Higgins JPT, Deeks JJ. Selecting studies and collecting data. In: Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. United Kingdom: John Wiley & Sons, 2009;174-5. 8. Whitehead A, Whitehead J. A general parametric approach to the meta- analysis of randomized clinical trials. Stat Med 1991;10(11):1665-77. 9. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986;7(3):177-88. 10. Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta- analyses. BMJ 2003;327:55760. 11. Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 2003; 327(7414):557-60.12. Jaber LA, Halapy H, Fernet M, et al. Evaluation of a pharmaceutical care model on diabetes management. Ann Pharmacother 1996;3(3):238-43.13. Guirguis LM, Johnson JA, Farris KB, et al. A pilot study to evaluate the impact of pharmacists as certified diabetes educators on the clinical and humanistic outcomes of people with diabetes. Can J Diabetes 2001;25(4):266-76.


14. Clifford RM, Batty KT, Davis TME, et al. A randomized controlled trial of a pharmaceutical care programme in high-risk diabetic patients in an outpatient clinic. Int J Pharm Pract 2002; 10:85-9.15. Sarkadi A, Rosenqvist U. Experience- based group education in Type 2 diabetes: a randomised controlled trial. Patient Educ Couns 2004;53:291-8.16. Clifford RM, Batty KT, Davis WA, et al. Effect of a pharmaceutical care program on vascular risk factors in type 2 diabetes. Diabetes Care 2005;28:77 1-6.17. Choe HM, Mitrovich S, Dubay D, et al. Proactive case management of high- risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomized controlled trial. Am J Manag Care 2005; 11:253-60. 18. Odegard PS, Goo A, Hummel J, et al. Caring for poorly controlled diabetes mellitus: a randomized pharmacist intervention. Ann Pharmacother 2005; 39:433-40. 19. Suksomboon N, Luckanajantachote P, Poolsup N, et al. Effects of training programme on perceived self-efficacy, self-care behavior and diabetes know- ledge among type 2 diabetics. SWU J Pharm Sci 2005;10(2):145-53. 20. Suppapitiporn S, Chindavijak B, Onsanit S. Effect of diabetes drug counseling by pharmacist, diabetic disease booklet and special medication containers on glycemic control of type 2 diabetes mellitus: a randomized controlled trial. J Med Assoc Thai 2005;88(4):S134-41. 21. Rothman RL, Malone R, Bryant B, et al. A randomized trial of a primary care- based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes. Am J Med 2005;118:276- 83. 22. Fornos JA, Andres NF, Andres JC, et al. A pharmacotherapy follow-up program

in patients with type-2 diabetes in community pharmacies in Spain. Pharm World Sci 2006;28:65-72. 23. Scott DM, Boyd ST, Stephan M, et al. Outcomes of pharmacist-managed diabetes care services in a community health center. Am J Health-Syst Pharm 2006;63:2116-22. 24. Krass I, Armour CL, Mitchell B, et al. The Pharmacy Diabetes Care Program: assessment of a community pharmacy diabetes service model in Australia. Diabet Med 2007;24:67783. 25. Elnour AA, Mugammar ITE, Jaber T, et al. Pharmaceutical care of patients with gestational diabetes mellitus. J Eval Clin Pract 2008;14:131-40. 26. Phumipamorn S, Pongwecharak J, Soorapan S, et al. Effects of the pharmacists input on glycaemic control and cardiovascular risks in Muslim diabetes. Prim Care Diabetes 2008;2:31-7. 27. Pavasudthipaisit A, Awiphan R, Niwata- nanan K, et al. A randomized trial of a pharmacist practitioner model to improve glycemic control in type 2 diabetic patients. Faculty of Pharmacy, Chiang Mai University 2009. 28. Doucette WR, Witry MJ, Farris KB, et al. Community pharmacist-provided extended diabetes care. Ann Pharmacother 2009;4:882-9. 29. Mazroui NRA, Kamal MM, Ghabash NM, et al. Influence of pharmaceutical care on health outcomes in patients with type 2 diabetes mellitus. Br J Clin Pharmacol 2009;67(5):547-57. 30. Taveira TH, Friedmann PD, Cohen LB, et al. Pharmacist-led group medical in type 2 diabetes. Diabetes Educ 2010: 36(1):109-17. 31. Edelman D, Fredrickson SK, Melnyk SD, et al. Medical clinics versus usual care for patients with both diabetes and hypertension. Ann Intern Med 2010;152: 689-96. 32. Mehuys E, Bortel LV, Bolle LD, et al. Effectiveness of a community pharmacist

N. Poolsup et al.30

intervention in diabetes care: a randomized controlled trial. J Clin Pharm Ther 2011; 36:602-13. 33. Sriram S, Chack LN, Ramasamy R,

et al. Impact of pharmaceutical care on quality of life in patients with type 2 diabetes mellitus. JRMS 2011;16(Special Issue):412-8.

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