Physicians' Views on Generic Medicines: A Narrative Review
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Journal of Generic Medicines: The Business
http://jgm.sagepub.com/content/7/1/30The online version of this article can be found at:
DOI: 10.1057/jgm.2009.32
2010 7: 30Journal of Generic Medicines: The Business Journal for the Generic Medicines SectorJamshed
Mohamed Azmi Hassali, Asrul Akmal Shafie, Ahmed Awaisu, Mohamed Izham Ibrahim, Chong Chee Ping and ShaziaPhysicians' Views on Generic Medicines: A Narrative Review
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Original Article
Physicians ’ views on generic medicines: A narrative review Received (in revised form): 27 th April 2009
Mohamed Azmi Hassali graduated with a pharmacy degree from the Universiti Sains Malaysia (USM), Malaysia in 1998. Following his pharmacy pre-registration training at Hospital Teluk Intan, Perak, he undertook his Master ’ s studies in the fi eld of clinical pharmacy at USM and graduated in 2000. In 2006, he was successfully awarded a PhD degree from the Victorian College of Pharmacy, Monash University, Melbourne in the fi eld of pharmacy practice. His current research interests are in the areas of clinical pharmacoeconomics, social pharmacy and the pharmacists ’ role in public health. Currently, Dr Azmi is attached to the Discipline of Social & Administrative Pharmacy, School of Pharmaceutical Sciences, USM.
Asrul Akmal Shafi e graduated with a pharmacy degree from the Universiti Sains Malaysia (USM), Malaysia in 2001 and was registered as a professional pharmacist in Malaysia in 2002. He was awarded USM fellowship in 2003 to pursue a doctorate degree in pharmacoeconomics, which he successfully completed at Cardiff University, United Kingdom in 2007. During this time, he also undertook a postgraduate diploma in Health Economics at the University of Glamorgan. His current research interests are in the area of health economics, and social and administrative pharmacy. Currently, Dr Shafi e is attached to the Discipline of Social & Administrative Pharmacy, School of Pharmaceutical Sciences, USM.
Ahmed Awaisu obtained a BPharm degree from Ahmadu Bello University Zaria, Nigeria in 1999 and a MPharm (Clin Pharm) degree from Universiti Sains Malaysia (USM) in 2004. He is an erstwhile lecturer in the Faculty of Pharmacy at the International Islamic University Malaysia and currently a doctoral degree candidate in the School of Pharmaceutical Sciences at USM. His research interests include clinical and outcomes research in cardiology and infectious diseases; evidence-based therapeutics; pharmacoepidemiology; health promotion and disease prevention; and pharmaceutical education. He has published extensively in the areas of clinical pharmacy, pharmacy practice and education in reputable international journals. He is also a recipient of a number of publication, research and scholarship awards.
Mohamed Izham Ibrahim is a professor of social and administrative pharmacy in the School of Pharmaceutical Sciences at Universiti Sains Malaysia. He obtained his BPharm degree from USM in 1991 and a PhD from University of Philadelphia in 1995. Izham has over 15 years of teaching experience and has successfully supervised more than 30 MSc and PhD students. His areas of research interest are pharmaceutical economics, drug policy & management, pharmacoepidemiology, social & behavioral aspects of pharmacy and health. He has published many books and research papers in international journals.
Chong Chee Ping is an academic staff training fellow and a PhD candidate in the Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM). He graduated with a BPharm degree and an MPharm (Clin Pharm) degree from USM in 2002 and 2005, respectively. He was awarded a USM fellowship to pursue a doctorate degree in 2006, which he is currently undertaking. His current PhD project involves a comparative study investigating the perceptions of various health-care professionals on generic medicines in Malaysia and Australia. He has published a number of papers in impact factor journals.
Correspondence: Mohamed A.A. Hassali Discipline of Social & Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia E-mail: azmihassali@usm.my
© 2010 Macmillan Publishers Ltd. 1741-1343 Journal of Generic Medicines Vol. 7, 1, 30–39
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Physicians’ views on generic medicines
31
INTRODUCTION Most nations demand similar things from their health-care systems: effective services that improve the health and quality of life of their citizens, equitable access to those services, and effi cient use of resources. 1,2 A recent trend common to most nations is the rapid growth in expenditure for prescription drugs. 1,3,4 Efforts to control health-care costs, a major priority in many countries, have produced some interesting shifts in strategy. 1,2 These paradigm shifts do not only focus on limiting government spending on health, but also include some measures to involve citizens and health-care professionals in cost-sharing and cost-reducing mechanisms. Within this policy environment, generic medicines play an important role as an alternative to branded innovator medicines in the treatment of diseases. The cost savings that result from generic medicines can be used to purchase
newer, more effective medicines where they exist. 5 Different countries have historically taken diverse approaches related to generic medicines. Some countries like Austria have drawn on supply-side policies related to pricing and reimbursement to develop their generic medicines market, whereas others such as Denmark, Germany and United Kingdom have chosen demand-side policies related to generic substitution by pharmacists, and physician budgets, respectively. 2 However, there is no single approach towards developing generic medicines market in a given country.
Drug prescribing around the world is the prerogative of a number of health-care professionals – from physicians to physician assistants to nurse practitioners, depending on prescribing rights available in respective countries. However, physicians are traditionally the dominant prescribing health
Shazia Jamshed is a doctoral research fellow in the Discipline of Social & Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Science Malaysia. She graduated with a BPharm, MPharm and MPhil (Pharmacology) degrees from the University of Karachi, Pakistan. She has over 10 years of teaching and research experience with a reasonable number of publications. For the PhD, she is currently working on generic medicines issues in Pakistan.
ABSTRACT Most countries are facing escalating health-care expenditures. A recent trend to control these staggering increases in costs is to encourage the use of generic medicines. Physicians are at the centerpiece of the medication use process as they are the dominant prescribers in all clinical settings. It is therefore prudent to examine what they perceive about generic medicines. The current study attempts to identify and review the literature on physicians ’ perceptions and practices on the use of generic medicines. Using subject-related keywords, an extensive literature search was undertaken through indexing services available in the authors ’ institution ’ s library. Full text papers written in English language between 1980 and 2008 were retrieved and reviewed. Fourteen studies, majority ( n = 5) from the United States were reviewed and included. Most of the studies used quantitative methodology. Generally, physicians were neutral to slightly supportive on the use of generic medications. Most of the studies reviewed highlighted the factors that can infl uence physicians ’ views as policy-related issues, patient-related variables, drug characteristics and physician-related variables. Although physicians accept generic substitution under policy and economic pressures, they still have concerns about the overall quality and reliability of generic drugs as well as generic interchange of certain drug categories. Journal of Generic Medicines (2010) 7, 30 – 39. doi: 10.1057/jgm.2009.32 ; published online 1 September 2009
Keywords: generic medicines ; generic prescribing ; generic substitution ; perceptions ; physicians ; review
© 2010 Macmillan Publishers Ltd. 1741-1343 Journal of Generic Medicines Vol. 7, 1, 30–39
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Hassali et al
32
professionals. 2 Therefore, physicians play a pivotal role in promoting and implementing the practice of generic prescribing and substitution. Prescribing lower costs generic medicines is recognized as a good prescribing practice and encouraged from an educational and cost-effectiveness point of view. 3,4,6
To the best of our knowledge, there is no published systematic or narrative review investigating the perceptions of physicians on generic medicines prescribing and substitution. Therefore, in order to get a better understanding on areas of agreement and disagreement held by physicians around the world on the concepts of generic prescribing and substitution, this narrative review was undertaken. In this article, we provide a chronological literature review on physicians ’ perceptions, experiences, and opinions towards generic medicines prescribing and use.
METHODS A literature search was performed from September to November 2008 to identify published studies on the views of physicians on generic medicines. The search strategy involved the use of Boolean connectors for combination of the terms ‘ generic ’ , ‘ brand ’ , ‘ multisource ’ , ‘ medications ’ , ‘ medicines ’ , ‘ drugs ’ , ‘ pharmaceuticals ’ and ‘ physicians ’ , ‘ general practitioners (GPs) ’ , and ‘ prescribers ’ . Equivalent terms in thesauruses or Medical Subject Headings browsers were used whenever possible. The search was limited to full text articles published in English language from 1980 until November 2008. Studies that measured physicians ’ perceptions on specifi c generic medicines or in specifi c disease conditions were excluded from this review. Studies that used aggregated data on prescribing were also excluded from this review. Electronic databases searched were those available in the authors ’ institution ’ s library and included: PubMed, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, Proquest, Ebsco Host and Google Scholar. This was supplemented by a
hand search of the reference lists of the retrieved articles and those that could be retrieved in full text were included. Identifi ed reports were sorted chronologically starting from 1980. The year 1980 was our starting point because we could not retrieve any full text papers before then.
Two hundred and nineteen titles and abstracts were identifi ed from the electronic search of all the eight databases and hand search. Subsequently, 159 titles and abstracts not related to physicians ’ views on generic medicines and duplicated citations were identifi ed and excluded. The full texts of 60 articles were retrieved for further evaluation. Lastly, 44 out of the 60 articles were excluded for further analysis as they only measured views on effi cacy of selected generic drugs used in specifi c disease conditions. The quorum fl ow chart for selection in this review is shown in Figure 1 .
Description of the studies included Eighteen studies were identifi ed, but fi ve studies 7 – 11 were excluded as they used aggregated data on prescribing rather than directly eliciting physicians ’ views. Subsequently, 14 published studies were included in the review (see Table 1 for more details). Of this, the majority ( n = 5) were from the United States, 12 – 16 and the rest from other countries of the world: one each from Australia, 17 Finland, 18 Malaysia, 19 Slovenia, 20 France, 21 Ireland, 22 United Kingdom 23 and Jamaica. 24 All the studies, except three 17 – 19 used quantitative methodology in exploring physicians ’ perceptions and experiences about generic medications. Further, all the studies, except two, 19,24 were conducted in developed nations. Six of the studies were directed to GPs, 17,20 – 23,25 one study involved family physicians, 13 and another study targeted resident physicians. 14 The rest of the studies 12,15,16,18,19,24 were directed to physicians, irrespective of their medical specialty. In addition, two studies, 12,21 reported their outcomes in the form of econometric models that explained factors affecting prescribing decisions by
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Physicians’ views on generic medicines
33
physicians, whereas most of the studies used descriptive and / or inferential statistics in reporting beliefs, knowledge and attitudes of physicians towards generic drugs 13 – 16,18 – 20,22 – 25 . The review also identifi ed two studies which utilized full qualitative methodology 17,18 and one study that used mixed methodology in reporting the results. 19
Methodological quality The retrieved literature was abstracted using a standardized data abstraction form in a table format containing most of the elements presented in Table 1 and our selection criteria. Each study was reviewed by all the six authors and a consensus meeting was convened to ensure quality assurance. The most prominent pitfall identifi ed was that the studies were restricted to certain geographical areas, provinces or states in which the results could not be generalized to the whole country of study. Three studies suffered
from inadequate sampling technique, 14,16,18 where convenience sampling and panel design, which might have an impact on generalization were used. Two studies suffered from self-report bias owing to dependence on physicians to report their recognition of drugs ’ names and dispensed drug data, respectively. 13,22 One study was supported by a brand name industry, which implied caution about its fi ndings. 15
RESULTS Generally, physicians were neutral to slightly supportive on the use of generic medications. However, the extent of their neutrality and acceptance varied substantially with several factors that can be summarized in the following main categories: policy-related issues, patient-related variables, drug characteristics and physician-related variable. Each of these categories is briefl y discussed in a narrative way below.
Titles and abstracts identified by electronic search of all nine databases and wherever possible review of the reference lists (n = 219)
Full text of articles retrieved for further assessment (n = 60)
Titles and abstracts not related to physicians’ views on generic medicines and duplications (n =159)
Studies related to physicians’ views on generic medicines which fulfill the selection criteria are included in the review (n = 14)
Articles not really assessing physicians’ views on generics, but targeting at the clinical efficacy and safety of generic medicines used in certain diseases or using aggregated data on prescribing (n = 46)
Figure 1 : Quorum fl ow chart of the review process.
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Hassali et al
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Tab
le 1
: A
sum
mar
y of
the
stu
dies
incl
uded
in t
he r
evie
w in
vest
igat
ing
phys
icia
ns ’ p
erce
ptio
n of
gen
eric
med
icin
es
Stud
y Co
untr
y M
etho
ds
Part
icipa
nts
Out
com
es
Lim
itatio
ns
Bear
den
and
Mas
on
(198
0)
USA
M
ail s
urve
y 41
8 ph
ysic
ians
R
esul
ts r
evea
led
that
con
fi den
ce in
reg
ulat
ion,
pot
entia
l sav
ings
, and
im
pact
s on
med
icin
e re
sear
ch r
epre
sent
rea
sona
ble
dete
rmin
ants
of
phy
sici
an p
refe
renc
e of
gen
eric
med
icin
es.
Stud
y w
as d
one
in o
nly
one
unsp
ecifi
ed
stat
e an
d th
e se
ttin
g w
as n
ot w
ell
desc
ribe
d.
Bow
er a
nd B
urke
tt
(198
7)
USA
M
ail s
urve
y 31
7 fa
mily
pr
actic
e ph
ysic
ians
The
maj
ority
(62
.5 %
) of
the
res
pond
ents
rep
orte
d th
at t
hey
had
enou
gh c
onfi d
ence
to
pres
crib
e ge
neri
c m
edic
ines
reg
ular
ly b
ut
only
26.
9 % in
dica
ted
that
the
y ac
tual
ly p
resc
ribe
d m
ostly
gen
eric
s.
The
gen
eric
pre
scri
bing
was
mor
e co
mm
on a
mon
g fa
mily
phy
sici
ans
who
wer
e re
side
ncy
trai
ned
and
who
rel
ied
leas
t on
dru
g co
mpa
ny
repr
esen
tativ
es fo
r in
form
atio
n on
new
med
icin
es, a
nd b
eing
a
read
er o
f the
New
Eng
land
Jour
nal o
f Med
icin
e.
Pres
ence
of d
iffer
ence
s be
twee
n re
spon
dent
s an
d no
n-re
spon
dent
s w
ith r
espe
ct t
o th
e va
riab
les
stud
ied.
The
stu
dy’s
dep
ende
nce
on r
espo
nden
ts t
o te
st t
heir
ow
n ab
ilitie
s to
rec
ogni
ze t
he n
ames
of
pres
crip
tion
drug
s.
Tily
ard
et a
l (19
90)
New
Zea
land
M
ail s
urve
y 20
0 G
Ps
Mos
t of
the
res
pond
ents
(67
% )
activ
ely
pres
crib
ed g
ener
ic m
edic
ines
. A
bout
52 %
of G
Ps w
ere
oppo
sed
to p
harm
acis
ts ’ g
ener
ic
subs
titut
ion
and
thei
r vi
ews
wer
e in
fl uen
ced
by t
he p
roof
of
gene
ric
bioe
quiv
alen
ce a
nd c
ost
savi
ng. A
nd 7
0 % in
dica
ted
that
pa
tient
s ’ g
ener
ic m
edic
ine
use
was
bec
ause
of t
he G
Ps c
hoic
e.
Smal
l sam
ple
size
and
sam
plin
g te
chni
que
was
not
wel
l des
crib
ed.
Shul
kin
et a
l (19
92)
USA
M
ail s
urve
y 63
res
iden
t ph
ysic
ians
M
ost
of t
he r
espo
nden
ts (
73 %
) be
lieve
d th
at g
ener
ic a
nd b
rand
nam
e m
edic
ines
wer
e eq
ually
effe
ctiv
e. S
ome
diffe
renc
es b
y sp
ecia
lty
wer
e se
en: f
or in
stan
ce, p
sych
iatr
y re
side
nts
wer
e m
ore
likel
y th
an
surg
ery
or in
tern
al m
edic
ines
res
iden
ts t
o pr
escr
ibe
bran
d na
me
med
icin
es.
Sam
plin
g te
chni
que
(con
veni
ence
sa
mpl
ing)
and
sm
all s
ampl
e si
ze.
Tur
nbul
l and
Pa
rson
s (1
993)
U
K
Res
earc
her
adm
inis
tere
d su
rvey
39 G
Ps
The
phy
sici
ans ’
att
itude
s to
war
ds g
ener
ic m
edic
ines
dep
ende
d on
va
riou
s pr
oduc
t fe
atur
es, n
amel
y, t
he t
hera
peut
ic c
ateg
ory
and
dosa
ge fo
rm c
ompl
exity
. The
att
itude
s al
so v
arie
d am
ong
diffe
rent
ph
ysic
ians
’ pra
ctic
e ch
arac
teri
stic
s. P
hysi
cian
s w
ho w
orke
d al
one
had
an a
vers
ion
to g
ener
ic p
resc
ribi
ng. T
he p
hysi
cian
s w
ith h
ighe
r nu
mbe
r of
yea
rs p
ract
isin
g in
gen
eric
pra
ctic
e w
ere
mor
e in
clin
ed
to p
resc
ribe
bra
nd n
ames
.
The
sam
plin
g po
pula
tion
rest
rict
ed t
o a
smal
l geo
grap
hic
area
, sam
plin
g te
chni
que
(con
veni
ence
sam
plin
g)
and
smal
l sam
ple
size
.
Bana
han
and
Kol
assa
(1
997)
U
SA
Mai
l sur
vey
396
phys
icia
ns
Phys
icia
ns w
ere
clas
sifi e
d in
to p
ro-s
ubst
itutio
n (4
3.2 %
) an
d an
ti-su
bstit
utio
n gr
oups
(56
.8 %
). T
he p
ro-s
ubst
itutio
n an
d an
ti-su
bstit
utio
n gr
oups
wer
e si
gnifi
cant
ly d
iffer
ent
with
res
pect
to
bel
iefs
abo
ut a
nd e
xper
ienc
es w
ith g
ener
ics
and
know
ledg
e of
th
e FD
A b
ioeq
uiva
lenc
y st
anda
rd. O
nly
17 %
of p
hysi
cian
s co
rrec
tly
iden
tifi e
d th
e FD
A s
tand
ards
for
bioe
quiv
alen
cy.
The
stu
dy w
as s
uppo
rted
by
gran
t fr
om a
bra
nd n
ame
indu
stry
.
© 2010 Macmillan Publishers Ltd. 1741-1343 Journal of Generic Medicines Vol. 7, 1, 30–39
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Physicians’ views on generic medicines
35
McG
ettig
an e
t al
(199
7)
Irel
and
Mai
l sur
vey
107
GPs
Se
vera
l fac
tors
con
trib
uted
to
low
gen
eric
pre
scri
bing
am
ong
the
Iris
h ph
ysic
ians
. The
phy
sici
ans
wer
e co
ncer
ned
abou
t th
e re
liabi
lity
or q
ualit
y of
gen
eric
pro
duct
s, p
ossi
ble
lega
l lia
bilit
ies
asso
ciat
ed
with
gen
eric
s us
e an
d th
e fa
ct t
hat
phar
mac
ists
may
dis
pens
e m
ore
expe
nsiv
e pr
opri
etar
y pr
epar
atio
ns in
the
cas
e of
pri
vate
pr
escr
iptio
ns w
ritt
en g
ener
ical
ly.
Sam
ple
size
was
sm
all a
nd m
ay n
ot b
e re
pres
enta
tive
of G
Ps in
the
cou
ntry
.
Para
pona
ris
et a
l (2
004)
Fr
ance
M
ail s
urve
y 60
0 G
Ps
Thi
s st
udy
eval
uate
d fa
ctor
s ex
plai
ning
GPs
’ will
ingn
ess
to p
resc
ribe
in
inte
rnat
iona
l non
-pro
prie
tary
nam
es (
INN
). N
earl
y 76
% o
f th
e re
spon
dent
s in
dica
ted
that
the
y w
ere
will
ing
to w
rite
the
ir
pres
crip
tions
usi
ng IN
N. T
he G
Ps w
ere
less
rel
ucta
nt t
o pr
escr
ibe
INN
w
hen
they
hav
e hi
gh w
orkl
oads
, reg
ular
ly u
se p
ract
ice
guid
elin
es, p
ay
for
med
ical
jour
nals
, hav
e a
pers
onal
com
pute
r to
get
dis
tant
ele
ctro
nic
mat
eria
ls o
r ha
ve s
ome
activ
ities
in a
hos
pita
l or
heal
th c
entr
e.
The
dat
a w
ere
colle
cted
from
one
pr
ovin
ce, t
hus
the
gene
raliz
abili
ty o
f th
e re
sults
is li
mite
d.
Barr
ett
(200
5)
USA
W
eb-b
ased
sur
vey
425
phys
icia
ns
The
maj
ority
of t
he p
hysic
ians
(95 %
) sup
port
the
use
of g
ener
ic s
ubst
itute
s fo
r br
and
nam
e m
edic
ines
whe
n th
ey a
re a
vaila
ble
and
appr
opria
te fo
r th
e pa
tient
s. Ph
ysic
ians
say
that
they
feel
pre
ssur
ed b
y pa
tient
s (6
9 % ),
heal
th-
care
pla
ns o
r in
sura
nce
com
pani
es (9
1 % ) t
o pr
escr
ibe
gene
ric d
rugs
.
Onl
ine
sam
ples
are
lim
ited
to o
nly
thos
e w
ho p
artic
ipat
ed in
the
re
sear
ch. H
ence
, the
re a
re p
oten
tials
fo
r no
n-re
spon
se e
rror
.
K
ersn
ik a
nd P
elka
r (2
006)
Sl
oven
ia
Mai
l sur
vey
117
GPs
A
bout
38 %
of t
he G
Ps d
id n
ot ta
ke p
rice
into
con
sider
atio
n w
hen
pres
crib
ing
med
icin
es. N
early
89 %
of t
he G
Ps p
erce
ived
gen
eric
s to
hav
e eq
ual e
ffect
iven
ess
as b
rand
nam
e m
edic
ines
. One
qua
rter
of t
he G
Ps
wou
ld p
resc
ribe
mor
e ge
neric
s if
addi
tiona
l clin
ical
tria
ls w
ere
avai
labl
e.
Abo
ut 1
6 % o
f the
res
pond
ents
thou
ght t
hat t
he p
harm
aceu
tical
indu
stry
ha
d a
huge
infl u
ence
on
thei
r pr
escr
ibin
g pa
tter
ns.
Ran
dom
izat
ion
met
hod
not
wel
l el
ucid
ated
.
De
Run
and
Fel
ix
(200
6)
Mal
aysi
a In
-dep
th in
terv
iew
s an
d se
lf-ad
min
iste
red
surv
ey
15 h
ospi
tal-b
ased
ph
ysic
ians
(in
terv
iew
ed in
th
e fi r
st p
hase
) an
d 62
phy
sici
ans
from
the
sam
e in
stitu
tion
answ
ered
a
ques
tionn
aire
Thi
s st
udy
dete
rmin
ed p
erce
ptio
ns o
f phy
sici
ans
in a
pub
lic h
ospi
tal
tow
ards
pat
ente
d an
d ge
neri
c m
edic
ines
. The
res
pond
ents
vie
wed
pa
tent
ed m
edic
ines
as
supe
rior
in q
ualit
y, e
ffi ca
cy a
nd s
afet
y.
Gen
eric
med
icin
es w
ere
perc
eive
d as
mor
e af
ford
able
, but
lack
of
qual
ity c
ontr
ol a
nd u
ncer
tain
effi
cacy
. Fac
tors
tha
t af
fect
phy
sici
ans ’
pr
escr
ibin
g de
cisi
ons
incl
ude
thei
r ow
n ex
peri
ence
, lite
ratu
res,
pa
tient
affo
rdab
ility
and
hos
pita
l pol
icy.
Dat
a w
ere
colle
cted
from
one
pr
ovin
ce, t
hus
the
gene
raliz
abili
ty
of t
he r
esul
ts is
lim
ited.
Bia
ses
from
ex
peri
ence
of r
espo
nden
ts c
ould
ha
ve a
ffect
ed t
he r
elia
bilit
y of
the
fi n
ding
s.
Has
sali
et a
l (20
06)
Aus
tral
ia
Sem
i-str
uctu
red
qual
itativ
e in
terv
iew
10 G
Ps
The
res
pond
ing
GPs
hav
e m
ixed
att
itude
s to
war
d ge
neri
cs p
resc
ribi
ng.
The
re w
ere
GPs
who
vie
wed
gen
eric
s as
equ
ally
effe
ctiv
e as
the
in
nova
tor
bran
ds. S
ome
GPs
wer
e di
ssat
isfi e
d w
ith t
he g
ener
ic
subs
titut
ion
polic
y be
caus
e th
eir
pers
onal
rol
e as
pre
scri
ber
is b
eing
th
reat
ened
by
the
phar
mac
ists
. The
re w
ere
conc
erns
abo
ut p
atie
nt
conf
usio
n ar
isin
g fr
om s
ubst
itutio
n. N
one
of t
he G
Ps k
new
the
bi
oequ
ival
ence
acc
epta
bilit
y cr
iteri
a fo
r ge
neri
c m
edic
ines
.
Stud
y w
as c
onfi n
ed t
o on
e st
ate
only
, so
the
fi nd
ings
can
not
be
extr
apol
ated
.
© 2010 Macmillan Publishers Ltd. 1741-1343 Journal of Generic Medicines Vol. 7, 1, 30–39
at Universiti Sains Malaysia on December 13, 2011jgm.sagepub.comDownloaded from
Hassali et al
36
Policy-related issues One of the factors related to the policy is knowledge of regulatory requirements imposed on generic drugs by regulatory authorities. In this context, the available data, 15,17 shows that physicians lack the knowledge of these requirements. Another factor is physicians ’ confi dence in regulatory authorities in ensuring the quality, safety and effi cacy of generic drugs. Although this confi dence was seen as an important determinant for supporting generics by physicians, 12 it differed across countries, 15,17 and within the same country over time.
Besides requirements imposed by regulatory authorities, physicians also found that specifi c provision of health-care fi nancing plan do have an impact on the utilization pattern for generic by physicians. 16
Patient-related factors Physicians ’ prescribing decision was seen to be the result from essentially their own decision-making process. However, a certain proportion of this decision can be explained by patient-related variables. These variables include feelings that they can contribute to consumers ’ saving on drugs by prescribing generically. 12,15 – 19,24
Drug-related factors Being cheaper than their branded counterparts raised the concerns of the physicians about their quality, safety and effectiveness, especially in the presence of heavy and successful promotional activities from brand name industry. 16,19,20 These concerns faded in many drug classes, but strengthen in a few classes which are considered by physicians to be critical dose drugs. 15,18 The issues also stem from the exceptional situation of prescription drugs, where drug companies know more about their drugs than the professionals who prescribe them. Another issue that deserves mention is the source of information about drugs that is available to physicians. Most studies found that physicians are exposed to biased and unbalanced T
able
1 C
ontin
ued
Stud
y Co
untr
y M
etho
ds
Part
icipa
nts
Out
com
es
Lim
itatio
ns
Hei
kkila
et a
l (20
06)
Finl
and
Stru
ctur
ed
qual
itativ
e in
terv
iew
s
49 p
hysi
cian
s T
he m
ajor
ity o
f phy
sici
ans
(86 %
) w
ere
satis
fi ed
with
gen
eric
su
bstit
utio
n po
licy.
The
mai
n re
ason
men
tione
d fo
r su
bstit
utio
n w
as
cost
sav
ing.
Aro
und
half
of t
he p
hysi
cian
s th
ough
t in
terc
hang
eabl
e m
edic
ines
in c
erta
in m
edic
ine
grou
ps a
re n
ot e
qual
ly e
ffect
ive
and
safe
.
Con
veni
ent
sam
plin
g te
chni
que,
thu
s th
e re
sults
can
not
be g
ener
aliz
ed t
o al
l Fin
nish
phy
sici
ans.
Gos
sell-
Will
iam
s (2
007)
Ja
mai
ca
Surv
ey a
dmin
iste
red
via
mul
ti ch
anne
ls
(e-m
ails
, fax
, fac
e-to
-face
inte
rvie
ws
and
by p
hone
)
60 p
hysi
cian
s A
roun
d 49
% o
f the
res
pond
ing
phys
icia
ns w
ere
mos
tly p
resc
ribi
ng
gene
ric
will
ingl
y. T
here
wer
e do
ubts
abo
ut w
heth
er b
ioeq
uiva
lenc
e of
a g
ener
ic w
as e
quita
ble
to t
hera
peut
ic e
quiv
alen
ce t
o in
nova
tor
med
icin
e. A
bout
33 %
of t
he p
hysi
cian
s ha
d ex
peri
ence
d cl
inic
al
prob
lem
s w
ith g
ener
ic s
ubst
itute
s th
at t
hey
perc
eive
d w
ould
not
ha
ve o
ccur
red
with
the
inno
vato
r.
Phys
icia
ns s
elec
ted
to p
artic
ipat
e in
th
e su
rvey
is li
mite
d to
the
ir li
stin
g in
loca
l dir
ecto
ry, h
ence
thi
s w
ill
incr
ease
the
pot
entia
l of
non-
resp
onse
bia
s.
© 2010 Macmillan Publishers Ltd. 1741-1343 Journal of Generic Medicines Vol. 7, 1, 30–39
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Physicians’ views on generic medicines
37
information about drugs from brand name companies, 19,20 and at the same time weak promotional activities from generic companies. 16
Physician-related factors Factors found to be related to physicians and their generic versus branded drugs prescribing decisions are socio-demographic factors, unobservable characteristics of physicians and the concern of legal liabilities in case of prescribing generic medicines. Socio-demographic characteristics of physicians studied include age, training level and type, time since graduation, specialty, fi eld experience, practice setting and caseload. Although some studies found some of these socio-demographic variables to be associated with prescribing generically, 13,19 one study found them to explain only a small percentage of prescribing decisions. 20
DISCUSSION Generally, the review suggests that physicians will resist generic practices at the beginning of introducing them, but this resistance will wane in the face of policy measures and economic pressures, but not to the extent of regular generic prescribing. The study has managed to contribute to the existing literature related to physicians ’ view on generic prescribing and substitution and what infl uences their decision making. However, there are a few limitations to the review. Notable among these is that the review was limited to studies published in English language only, which might have prevented us from including the work done in other languages. Another limitation is that the review was limited to full text papers retrieved from databases subscribed by our institution ’ s library.
In the late 1980s in the US drug market which is one of the earliest markets to introduce the concept of generic drugs, researchers and policy-makers were concerned about the acceptance of new legislations enacted to increase generics market share,
because health professionals showed substantial reluctance to generic prescribing and substitution. The view that was dominant was that generic drugs produced by small and unknown companies were less satisfactory than branded ones produced by well-known companies. 12 With time, regulatory measures taken in response to economic pressures and experience with generics have revolutionalized the resistance. These views and resistances therefore have changed and more physicians looked to generics as equivalents to branded drugs and started to accept generic alternatives and prescribed them willingly. 24 However, concerns and doubts persisted about this equivalency in certain drug categories 24 and prescribing by brand names continued to be the most prevalent practice. 12 – 15 In Britain, GPs showed a great deal of resistance to prescribing generics voluntarily until when policy measures were taken (introduction of black list which is not available through National Health Services fund-holding scheme), which forced GPs to prescribe by generic names. 23 Physicians from the rest of the countries reviewed here held similar opinions about generic prescribing and substitution to those held by their colleagues in countries where generic substitution was introduced earlier as narrated above. The most common opinions held by physicians from these countries are their concerns about the quality of generic drugs in comparison with branded ones and about the switchability of certain drug classes considered critical to these physicians. 17 – 22
CONCLUSION Although physicians accepted generic substitution under policy and economic pressures, they still have concerns about overall generic drugs ’ quality and reliability, and switchability of certain drug categories which differ from country to country. These concerns prevent the full adoption of generic drugs prescribing and substitution by physicians, which can lead to escalation in
© 2010 Macmillan Publishers Ltd. 1741-1343 Journal of Generic Medicines Vol. 7, 1, 30–39
at Universiti Sains Malaysia on December 13, 2011jgm.sagepub.comDownloaded from
Hassali et al
38
health-care costs either on the governments, insurers or consumers directly. In order to eliminate these concerns, there should be full cooperation between governments, educators, professional organizations and consumers associations: regulatory authorities through assuring that generics are produced and kept according to the required standards; educators through teaching the concepts and values of generic medicines and disseminating knowledge on the standards required to register generics; professional bodies through declaring their views from generic practices in their policy statements; and consumers ’ associations through demanding to be informed about the drugs they will pay for, especially in cases of out-of-pocket payments.
ACKNOWLEDGEMENTS This article is dedicated to late Mr Nabil Abdo Al-Gedadi who passed away peacefully earlier last year. Nabil was instrumental in devising the fi rst version of this manuscript and his sudden demise is a great loss to all the authors. This study received no specifi c grant from any funding agency in the public, commercial or not-for profi t sectors.
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