ArticlePDF Available

Perceptions of generic medication in the general population, doctors and pharmacists: A systematic review

Authors:

Abstract

Objective To investigate negative perceptions about generic medicines and evaluate the proportions of lay people, doctors and pharmacists who hold these perceptions. Design A systematic review of observational studies. Data sources MEDLINE, EMBASE, PsycInfo and Scopus. Eligibility criteria Quantitative data from cross-sectional and prospective studies published in English after 1980, using self-report measures to evaluate perceptions about generic medicines, presented as percentages of the total sample assessed. Results After screening 2737 articles, 52 articles were included in the final analysis. A high proportion of doctors, pharmacists and lay people had negative perceptions of generics. Lay people were significantly more likely to view generics as less effective than branded medication (35.6%, 95% CI 34.8% to 36.4%) compared to doctors (28.7%, 27.5% to 29.9%) and pharmacists (23.6%, 21.2% to 26.2%), p<0.0001. Pharmacists (33.4%, 31.0% to 35.9%) were significantly more likely to believe generics were of inferior quality compared to branded medication than were doctors (28.0%, 26.3% to 29.9%), p=0.0006, and lay people (25.1%, 24.2% to 26.0%), p<0.0001. Doctors believed generics caused more side effects than branded medication (24.4%, 22.2% to 26.9%), compared to pharmacists (17.6%, 15.3% to 20.1%) and lay people (18.8%, 17.8% to 19.8%), p<0.0001. Doctors (28.5%, 26.9% to 30.2%) and pharmacists (25.4%, 21.4% to 29.9%) had significantly more safety concerns about generics than did lay people (18.0%, 17.0% to 19.0%), p≤0.0002. A greater proportion of lay people felt negatively about generic substitution (34.0%, 33.2% to 34.9%), compared to doctors (24.1%, 22.0% to 26.4%) and pharmacists (11.0%, 9.6% to 12.7%), p<0.0001. Rates of negative perceptions of generics do not appear to have changed substantially over time in the general population or among physician groups, p≥0.431, but such negative beliefs show a decreasing trend in pharmacists over the study period, p=0.034. Conclusions A significant proportion of doctors, pharmacists and lay people hold negative perceptions of generic medicines. It is likely these attitudes present barriers to the wider use of generics.
Perceptions of generic medication in the
general population, doctors and
pharmacists: a systematic review
Sarah Colgan,
1
Kate Faasse,
1
Leslie R Martin,
2
Melika H Stephens,
1
Andrew Grey,
3
Keith J Petrie
1
To cite: Colgan S, Faasse K,
Martin LR, et al. Perceptions
of generic medication in the
general population, doctors
and pharmacists: a
systematic review. BMJ Open
2015;5:e008915.
doi:10.1136/bmjopen-2015-
008915
Prepublication history and
additional material is
available. To view please visit
the journal (http://dx.doi.org/
10.1136/bmjopen-2015-
008915).
Received 27 May 2015
Revised 10 November 2015
Accepted 12 November 2015
1
Department of Psychological
Medicine, University of
Auckland, Auckland, New
Zealand
2
Department of Psychology,
La Sierra University,
Riverside, California, USA
3
Department of Medicine,
University of Auckland,
Auckland, New Zealand
Correspondence to
Professor Keith J Petrie;
kj.petrie@auckland.ac.nz
ABSTRACT
Objective: To investigate negative perceptions about
generic medicines and evaluate the proportions of lay
people, doctors and pharmacists who hold these
perceptions.
Design: A systematic review of observational studies.
Data sources: MEDLINE, EMBASE, PsycInfo and
Scopus.
Eligibility criteria: Quantitative data from cross-
sectional and prospective studies published in English
after 1980, using self-report measures to evaluate
perceptions about generic medicines, presented as
percentages of the total sample assessed.
Results: After screening 2737 articles, 52 articles
were included in the final analysis. A high proportion
of doctors, pharmacists and lay people had negative
perceptions of generics. Lay people were significantly
more likely to view generics as less effective than
branded medication (35.6%, 95% CI 34.8% to 36.4%)
compared to doctors (28.7%, 27.5% to 29.9%) and
pharmacists (23.6%, 21.2% to 26.2%), p<0.0001.
Pharmacists (33.4%, 31.0% to 35.9%) were
significantly more likely to believe generics were of
inferior quality compared to branded medication than
were doctors (28.0%, 26.3% to 29.9%), p=0.0006,
and lay people (25.1%, 24.2% to 26.0%), p<0.0001.
Doctors believed generics caused more side effects
than branded medication (24.4%, 22.2% to 26.9%),
compared to pharmacists (17.6%, 15.3% to 20.1%)
and lay people (18.8%, 17.8% to 19.8%), p<0.0001.
Doctors (28.5%, 26.9% to 30.2%) and pharmacists
(25.4%, 21.4% to 29.9%) had significantly more safety
concerns about generics than did lay people (18.0%,
17.0% to 19.0%), p0.0002. A greater proportion of
lay people felt negatively about generic substitution
(34.0%, 33.2% to 34.9%), compared to doctors
(24.1%, 22.0% to 26.4%) and pharmacists (11.0%,
9.6% to 12.7%), p<0.0001. Rates of negative
perceptions of generics do not appear to have changed
substantially over time in the general population or
among physician groups, p0.431, but such negative
beliefs show a decreasing trend in pharmacists over
the study period, p=0.034.
Conclusions: A significant proportion of doctors,
pharmacists and lay people hold negative perceptions
of generic medicines. It is likely these attitudes present
barriers to the wider use of generics.
INTRODUCTION
Generic medicines have been available for
many years and are routinely used to treat a
wide range of acute and chronic illnesses. In
order to be approved for use, a generic
medicine must be bioequivalent to the ori-
ginator product, and must be the same in
terms of strength, safety and quality.
1
While
generic medicines are permitted to differ
from their equivalent branded medicine in
terms of colour, size, shape and excipient
ingredients, they must be able to demon-
strate bioequivalence to the originator
product in terms of the rate and extent of
absorption.
23
Generic formulations provide
the same therapeutic effect as branded medi-
cines at a much more economical price.
4
For
this reason, generic drugs have been increas-
ingly popular as a method to reduce pressure
on drug budgets, and they now make up an
increasing percentage of dispensed drugs.
5
Strengths and limitations of this study
This review is a comprehensive amalgamation of
current research investigating perceptions of
generic medicines among physicians, pharma-
cists and lay people.
Our review used widely accepted methodology to
evaluate the literature, and identified that a sig-
nificant proportion of medical professionals and
lay people hold negative perceptions of generic
medicines.
The review may have increased the risk of publi-
cation bias by only including studies that were
published and available through the four data-
bases we accessed, and hand searching was not
performed.
While there are a range of studies looking at atti-
tudes of the general population and of doctors
towards generics, there were only nine studies
examining those views of pharmacists, which
may have reduced the accuracy of the estimates
in this group.
Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915 1
Open Access Research
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
Although generic medicine use has become more
widespread, there is evidence that many doctors and
pharmacists hold negative views of generics and resist
prescribing generic medicines.
67
Many doctors oppose
brand substitution, believing generic medicines to be
inferior to their branded counterparts.
7
In the UK,
there was strong opposition when plans were proposed
to introduce generic substitution into UK primary care,
8
as well as controversy about using generic antiepileptic
drugs
9
and generic pregabalin for pain control.
10
A number of surveys have also shown sizable propor-
tions of patients reporting negative views about generics,
believing them to be less effective, of lower quality and
unsuitable for treatment of major illnesses, as compared
to their branded equivalents.
1114
Such negative views of
generic medicines are important because they are likely
to be associated with poorer health outcomes due to an
association with higher side effect reporting and lower
adherence.
14 15
If a substantial proportion of doctors,
pharmacists and the general population hold negative
views of generic drugs, it could represent an impedi-
ment to the widespread adoption of generic medication.
We conducted a systematic review to examine the atti-
tudes towards generic drugs held by lay people, doctors
and pharmacists. We extracted from the literature the
proportion of participants who held negative views
about how generics were perceived compared to their
branded equivalent for the following ve perceptions:
drug effectiveness, drug quality, the likelihood of
causing side effects, drug safety and attitude towards
generic substitution or the process of replacing a
branded medication with its generic equivalent.
METHODS
Inclusion criteria
To be eligible for inclusion in the review, studies had to
include quantitative data presented as proportion of par-
ticipants holding perceptions about generic medicines
along any of the relevant dimensions. Studies could be
either cross-sectional, mixed method or prospective in
design. They also had to be in English, published in or
after 1980, and had to include self-report measures to
evaluate general perceptions about generic medicines,
presented as percentages of the total sample assessed.
Data sources and searches
A systematic search of databases (MEDLINE, EMBASE,
PsycINFO, Scopus) was conducted on 6 September
2015, to retrieve relevant peer reviewed articles. The
search strategy (see online supplementary appendix 1)
employed for this review drew on common phrases and
terms used in the literature concerning generic medi-
cines, and included input from a specialist librarian.
Keywords (appropriately truncated to allow a wide
search) were combined with medical subject headings
(MeSH) to comprehensively search four databases. The
strategy was modied for Scopus due to a different
search platform. Hand searching was not performed,
but reference lists of identied systematic reviews and
narrative reviews were reviewed to identify further
studies.
Data collection
One author (SC) reviewed the titles and available
abstracts for all identied citations, to determine rele-
vance. Following the initial review, two of the authors
(SC and MHS) independently reviewed full-text publica-
tions to make a nal selection of included studies.
A structured Excel spreadsheet was used to record rele-
vant information and ensure uniformity of evaluation
for each study. Extracted data included study character-
istics including country of origin, sample type (doctor,
pharmacist or lay population), sample size and propor-
tions of participants with negative perceptions of generic
medicines. The primary outcomes of this review were
the proportions of participants reporting perceptions
about generic medicines in terms of generic substitu-
tion, effectiveness, quality, side effects and safety.
Quality assessment
Two reviewers (KF and LRM) independently examined
the full-text publications to complete a quality assess-
ment. Raters independently categorised the articles as
high, acceptable or poor quality, based on an evaluation
of study design, participants (N, and type), demograph-
ics, recruitment method (random or other), exclusion-
ary criteria, method of assessing perceptions (interview,
questionnaire) and question quality (clarity, appropriate
response options) (see online supplementary appendix 2).
Consensus between the two reviewers was used to resolve
any disagreement. Studies that were classied as being
of poor quality were subsequently excluded. In line with
Cochrane recommendations, we chose not to use a stan-
dardised scoring system to assess study quality.
Calculating a summary score was not carried out so as to
avoid assigning weightsto items on the scale that were
unlikely to accurately reect their relevance and that
may have changed across different studies.
16
Statistical analyses
From the full text of each paper, the total number of
participants who took part in each study and the per-
centage who held perceptions of generic medicines
across the ve domains were extracted. These data were
used to calculate the proportion of participants who
reported negative views of generics compared to those
who reported more accurate or positive views. These
gures were summed to yield a total proportion of nega-
tive to neutral/positive views for each of the three popu-
lation samples under investigation (general population,
physician and pharmacist) for perceptions of effective-
ness, quality, side effects, safety and substitution of
generic medicines. Within each perception, the propor-
tion of negative to neutral perceptions was compared
across the three participant groups using χ
2
tests of
2Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915
Open Access
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
contingency tables with a Yates correction using
GraphPad QuickCalcs software (http://graphpad.com/
quickcalcs/). As this approach required multiple compari-
sons, a conservative Bonferroni correction with an
adjusted αlevel of p=0.0033 (0.05/15 tests) was used.
For additional clarity and ease of interpretation in the
presentation of the results, the extracted data were also
used to calculate a weighted percentage (equivalent to
the number of participants reporting negative views of
generics out of the total number of respondents in each
sample for each perception) of people holding negative
perceptions across the relevant studies in each domain,
assessed by generating a total sum of the number of par-
ticipants with negative views, and calculating a percent-
age based on the total number of respondents in each
group. Following this, modied Wald 95% CIs were cal-
culated for each weighted percentage value.
17
The
weighted percentages and 95% CIs were calculated
using Microsoft Excel 2010 software.
Finally, Spearmans correlations were utilised in order to
assess whether there had been a systematic change in per-
ceptions of generic medicines over time. Correlations
between publication year and the percentage of partici-
pants reporting negative perceptions were conducted to
assess relationships between (1) the percentage of partici-
pants holding negative perceptions (across all participants
and all ve domains) and publication year, (2) the per-
centage of negative perceptions in each domain (across all
participants) and publication year and (3) the percentage
of negative perceptions across all domains within each of
the three participant groups. Spearmans correlations
were used because publication year was not normally dis-
tributed (almost 80% of the papers were published in the
past 10 years), and were carried out using SPSS V.22 soft-
ware. As this approach required multiple comparisons, a
conservative Bonferroni correction with an adjusted α
level of p=0.0055 (0.05/9 tests) was used.
RESULTS
Search results
The systematic search process identied 2737 potentially
relevant publications. The initial review eliminated 2582
of these publications, including duplicates, leaving 155
articles for full-text review. Of these, 73 articles were put
forward for quality assessment. During this process, 21
studies were eliminated (gure 1). The publication
dates for these studies ranged from 1987 through 2015,
and included data from 27 countries. Additional
characteristics of the studies included in the review are
presented in table 1 for the general population, and in
table 2 for doctors and pharmacists.
Study quality
The two raters initially made identical assessments in 48
of the 58 eligible papers, yielding a Cohensκinter-rater
reliability of 0.70, p<0.001, which indicates substantial
agreement.
18
Subsequently, each of the 10 cases on
which raters disagreed was re-evaluated. For these
studies, one rater had indicated acceptable and the
other, either high or poor quality, but in no case was
there a highpoor pairing. Discussion of rationale for
the non-identical ratings was completed, and the raters
came to a nal agreement on each of the 10 cases. Of
58 studies, 29 were classied as high-quality, 23 were clas-
sied as acceptable and 6 were rated as being of poor
quality. The six studies rated as poor quality were
removed from the analysis.
PERCEPTIONS OF GENERIC MEDICINES
Effectiveness
A signicantly greater proportion of the general popula-
tion held the view that generic drugs were less effective
than their brand name equivalents (5274/14 817;
35.59% (95% CI (34.83% to 36.37%)), compared to
doctors (1450/5056; 28.68% (95% CI (27.45% to
29.94%)), χ
2
(1)=80.22, p<0.0001) and pharmacists
(264/1119; 23.60% (95% CI (21.20% to 26.18%)), χ
2
(1)=65.57, p<0.0001). The proportion of physicians who
held these negative views was signicantly greater than
pharmacists, χ
2
(1)=11.57, p=0.0007 (see gure 2 for
graphical representation of results).
Quality
At least 25% from each group reported the belief that
the quality of generic medications is lower than that of
branded drugs. Pharmacists reported the highest
Figure 1 Flow chart of studies assessing perceptions of
generics.
Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915 3
Open Access
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
Table 1 Selected studies assessing layperson perceptions of generic medicines
Authors, date Country Sample N Substitution, % Effectiveness, % Quality, % Side effects, % Safety
Al-Gedadi et al, 2008
21
Malaysia Lay 396 38.80 38.90 31.20
Babar et al, 2011
5
New Zealand Lay 441 22.90 34.20
Bertoldi et al, 2005
23
Brazil Lay 3182 30
Bradley et al, 1998
24
UK Lay 2276 43.90
Costa-Font et al, 2014
25
Spain Lay 2244 13.20
Dunne et al, 2014
26
Ireland Lay 42 18 24 5
Figueiras et al, 2009
27
Portugal Lay 819 40
Heikkilä et al, 2011
28
Finland Lay 1844 19.10 15.50
Himmel et al, 2005
13
Germany Lay 804 36.70
Ibrahim et al, 2012
29
Australia Lay 503 13 13 5 15
Iosifescu et al, 2008
30
USA Lay 315 15.60 11.60 20.10
Keenum et al, 2012
31
USA Lay 172 23.30 13.40
Kobayashi et al, 2011
32
Japan Lay 1215 46
Kohli and Buller, 2013
33
USA Lay 160 17 28 9
Lebanova et al, 2012
34
Bulgaria Lay 216 94 94 94
Lira et al, 2014
35
Brazil Lay 278 20.9 14.4
Nardi et al, 2015
36
Brazil Lay 5000 30.4
Omojasola et al, 2012
37
USA Lay 525 6 7 29.60 3
Palagyi and Lassanova, 2008
38
Slovakia Lay 1777 64 16.70
Perri et al, 1990
39
USA Lay 326 13.50 11.40 6.70
Piette et al, 2010
40
USA Lay 806 31.60 28.50
Rathe et al, 2013
41
Denmark Lay 2476 14.50
Sansgiry and Bhosle, 2004
42
USA Lay 505 10.92 7.40 5.08 6.08
Shrank et al, 2009
43
USA Lay 1047 26.10 9.50
Sicras-Mainar and Navarro-Artieda, 2012
44
Spain Lay (and physician) 203 33.20 42.30
Wong et al, 2014
45
Malaysia Lay 202 23.8 23.3 23.8
Yousefi et al, 2015
46
Iran Lay 1309 81 86 21.4
N reporting negative perceptions 3874 5274 2290 1054 942
Total N sampled 11 386 14 817 9119 5618 5242
Overall percentage 34.03 35.59 25.11 18.76 17.97
4Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915
Open Access
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
Table 2 Selected studies assessing physician and pharmacist perceptions of generic medicines
Authors, date Country Sample N Substitution, % Effectiveness, % Quality, %
Side
effects, % Safety, %
Andersson et al, 2006
47
Sweden Physicians 892 16.70
Bower and Burkett, 1987
48
USA Physicians 317 37.50
Brust et al, 1990
49
USA Physicians 145 45
Chua et al, 2010
50
Malaysia Physicians 87 33 41.40 52.90
Dosedel et al, 2014
51
Czech
Republic
Physicians 263 39.1 46 37.3
Dunne et al, 2014
52
Ireland Physicians 34 11.8 8.8 11.8
Fabiano et al, 2012
53
Italy Physicians 303 17.50 17.80
Friedman et al, 1987
54
USA Physicians 245 43.20
Gossell-Williams, 2007
55
Jamaica Physicians 60 13 60
Jamshed et al, 2012
56
Pakistan Physicians 206 24.30 39.30 26.70 41.26
Kersnik and Peklar, 2006
57
Slovenia Physicians 117 11.10
Kumar et al, 2015
58
Malaysia Physicians 263 51.7 19.8
Lewek et al, 2014
59
Poland Physicians 170 28.8 12.1
Shrank et al, 2011
7
USA Physicians 506 23.50 50
Sicras-Mainar and Navarro-Artieda, 2012
44
Spain Physician (and
lay)
201 40.80
Theodorou et al, 2009
60
Greece Physicians 1204 14.09 16.83 15.37
Cyprus 193 5.70 7.25 5.70
Tsiantou et al, 2009
61
Greece Physicians 1204 40.70 41.90
N reporting negative perceptions 341 1450 675 316 836
Total N sampled 1414 5056 2406 1292 2928
Overall percentage 24.11 28.68 28.04 24.43 28.54
Allenet and Barry, 2003
62
France Pharmacists 1000 10
Auta et al, 2014
63
Nigeria Pharmacists 154 7.10 54.50
Awaisu et al, 2014
64
Qatar Pharmacists 108 27.70
Babar et al, 2011
5
New Zealand Pharmacists 360 10.60 50 65 28
Chong et al, 2010
65
Australia Pharmacists 157 13.40
Chong et al, 2011
6
Malaysia Pharmacists 219 21.40 38.40
Dunne et al, 2014
66
Ireland Pharmacists 44 2.3 2.3 4.5
Gupta, 1996
67
USA Pharmacists 100 40
Maly et al, 2013
68
Czech Rep Pharmacists 615 7 16.10 11.20
N reporting negative perceptions 179 264 465 174 103
Total N sampled 1622 1119 1392 991 404
Overall percentage 11.04 23.60 33.39 17.56 25.44
Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915 5
Open Access
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
proportion of negative perceptions about quality (465/
1392; 33.39% (95% CI (30.96% to 35.91%)), a signi-
cantly greater proportion of negative perceptions than
in either the physician sample (625/2406; 28.04% (95%
CI (26.28% to 29.87%)), χ
2
(1)=11.76, p=0.0006) or the
general population (2290/9119; 25.11% (95% CI
(24.23% to 26.01%)), χ
2
(1)=42.51, p<0.0001).
Physicians and general population participants did not
differ signicantly from one another (after applying the
Bonferroni correction), χ
2
(1)=8.47, p=0.0036.
Safety
A greater proportion of doctors (836/2928, 28.54%,
95% CI (26.93% to 30.20%)) and pharmacists (103/
404; 25.44%, 95% CI (21.43% to 29.91%)) held the per-
ception that generic medicines were less safe to use than
branded drugs than did the general population (942/
5242; 17.97%, 95% CI (16.96% to 19.04%)), χ
2
(1)
=122.93 and 13.59, respectively, p<0.0001 and 0.0002.
Physicians and pharmacists did not differ from one
another with regard to negative perceptions of safety of
generic drugs, χ
2
(1)=1.49, p=0.22.
Side effects
Physicians were the most likely to hold negative beliefs
that side effects are more frequently caused by generic
drugs in comparison to brand name alternatives, with
one in four (316/1292; 24.43%, 95% CI (22.17% to
26.85%)) endorsing these views. Physicians held signi-
cantly more inaccurate beliefs about side effects than
did the general population groups (1054/5618; 18.76%,
95% CI (17.76% to 19.80%)), χ
2
(1)=21.09, p<0.0001,
and pharmacists (174/991; 17.56% (95% CI (15.31% to
20.06%)), χ
2
(1)=15.43, p<0.0001. There was no signi-
cant difference between the proportions of members of
the general population and pharmacists reporting the
perception that the side effects of generic drugs are
higher than branded, χ
2
(1)=0.73, p=0.3934.
Drug substitution
Pharmacists had the lowest rates of negative perceptions
about substitution of generic drugs for their brand
name alternatives (179/1622; 11.04%, 95% CI (9.60% to
12.66%)). The general population were most likely to
report unfavourable attitudes towards substituting a
branded medication with its generic equivalent (3874/
11 386; 34.03%, 95% CI (33.16% to 34.90%)), followed
by physicians (341/1414; 24.11%, 95% CI (21.95% to
26.41%)). Pharmacists had signicantly lower rates of
negative perceptions about generic drug substitution
than both, members of the general population and
doctors, χ
2
(1)=348.72 and 90.14, respectively, p<0.0001.
The general population samples held more negative per-
ceptions of drug substitution than did physicians, χ
2
(1)
=55.46, p<0.0001.
Perceptions of generic medicines over time
There was no signicant overall relationship between
publication year and the percentage of participants
reporting negative perceptions of generic medicines
across all participant groups and perception domains,
r=0.04, n=115, p=0.641. Similarly, the percentage of
negative perceptions held across the ve domains did
not demonstrate a signicant correlation with publica-
tion year for beliefs about effectiveness, r=0.03, n=37,
p=0.853; quality, r=0.02, n=25, p=0.919; safety, r=0.20,
n=18, p=0.424; side effects, r=0.08, n=20, p=0.742; or
appropriateness of substitution, r=0.11, n=15, p=0.693.
Finally, the change in the percentage of negative percep-
tions over time was assessed separately across the three
participant groups. There was no signicant correlation
between negative perceptions and publication year for
Figure 2 Bar graph showing the
percentage (95% CI) of
participants (general population,
physicians and pharmacists)
reporting negative perceptions
across the domains of
effectiveness, quality, safety, side
effects and substitution.
6Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915
Open Access
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
general population samples, r=0.10, n=60, p=0.431; or
physicians, r=0.04, n=37, p=0.794. There was a trend
(after applying the Bonferroni correction) towards a sig-
nicant correlation in pharmacistsoverall negative per-
ceptions and publication year, r=0.50, n=18, p=0.034.
Although the result is not statistically signicant, it indi-
cates a possible reduction in overall reported negative
perceptions in pharmacists over time.
DISCUSSION
Key findings
Our systematic review identied that a signicant pro-
portion of lay people, doctors and pharmacists hold
negative perceptions of generic medicines, perceiving
generics as less effective, less safe, inferior in quality and
more likely to cause side effects compared to their
branded equivalents. More than a quarter of doctors
and the general population believed that generic drugs
are less effective and of poorer quality than branded
medication. A similar proportion of doctors and phar-
macists had safety concerns about generics. While we
did not identify any reduction in negative views of gener-
ics in doctors or lay people over the course of the review
period, there was some evidence that the percentage of
negative views of pharmacists had decreased.
These ndings are important, as previous work has
suggested that negative perceptions about generic medi-
cines are major barriers to their acceptance and wide-
spread usage.
2
Furthermore, these ndings have
important implications for clinical practice, as pharma-
cists and medical practitioners are in a position where
they can easily transmit their expectations about the
effectiveness and side effects of generic medication to
the patients under their care.
19 20
Research suggests that
the majority of consumers learn about generic medi-
cines from a physician or pharmacist, and this medical
advice is critical to consumersdecision to take a
generic medication.
11 21
Implications
Generic medicines provide cost-effective alternatives to
branded medicines, resulting in considerable savings to
healthcare budgets. However, if consumers are poorly
informed about their equivalence to branded medica-
tion, it is highly unlikely that generic medicines will be
preferred over their branded equivalents.
22
This review
has identied that a signicant proportion of health pro-
fessionals and consumers have negative perceptions of
generic medicines. There is clearly a need for interven-
tions aimed at the general population and health profes-
sionals to target misperceptions of inferior quality, safety
and efcacyas well as to explain the reasons why
generic medicines are cheaper than brand-name equiva-
lents, the meaning of bioequivalence, and the testing
and regulatory processes involved in approving a generic
medicine for general use.
2
Currently, there is a lack of
research regarding what type of intervention may be
effective in improving perceptions of generic medicines.
Strengths and limitations
This review is a comprehensive amalgamation of current
research investigating perceptions of generic medicines
among physicians, pharmacists and laypeople. The
methods used to search and evaluate the literature are
widely accepted. However, it is important to note that we
may have increased the risk of publication bias by only
including studies that were published and available
through one of the four databases we accessed, and
hand searching was not performed. In addition, we only
reviewed studies that were published in English and we
did not include qualitative studies, as we needed to
compute the proportion of participant between physi-
cians, pharmacists and lay groups. While there are a
range of studies looking at the attitudes of the general
population and doctors towards generics, there were
only nine studies examining the views of pharmacists,
and ve of these studies had fewer than 200 participants.
This may have reduced the accuracy of the estimates in
this group.
CONCLUSIONS
These results suggest that there are a signicant number
of laypeople, doctors and pharmacists with concerns
about the efcacy, safety and quality of generic medi-
cines. The negative perceptions of doctors and pharma-
cists are likely to be barriers to a wider acceptance of
generics, as health professionals have a strong inuence
on patientsdecisions to take generic medicine. Further
work is needed on how interventions for medical profes-
sionals and for the public can reduce negative attitudes
about efcacy, safety and side effects, in order to
increase the acceptability of generic prescribing and
substitution.
Twitter Follow Keith Petrie at @KeithPetrie and Leslie Martin at
@LeslieRMartin1
Contributors SC and KJP designed the study. SC and MHS searched the
literature and extracted the data. KF and LRM conducted the quality analysis,
and analysed and interpreted the data. SC, KF and KJP drafted the
manuscript. AG, MHS and LRM contributed to the critical revision of the
manuscript. SC and KJP are the guarantors.
Funding This research was funded by the Auckland Medical Research
Foundation and Pharmac (the New Zealand Governments Pharmaceutical
Management Agency).
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
Open Access This is an Open Access article distributed in accordance with
the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,
which permits others to distribute, remix, adapt, build upon this work non-
commercially, and license their derivative works on different terms, provided
the original work is properly cited and the use is non-commercial. See: http://
creativecommons.org/licenses/by-nc/4.0/
Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915 7
Open Access
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
REFERENCES
1. World Health Organisation. Trade, foreign policy, diplomacy and
health: generic drugs. http://www.who.int/trade/glossary/story034/en/
(accessed 18 Mar 2014).
2. Alrasheedy AA, Hassali MA, Stewart K, et al. Patient knowledge,
perceptions, and acceptance of generic medicines: a comprehensive
review of the current literature. Patient Intell 2014;6:129.
3. Dunne S, Shannon B, Dunne C, et al. A review of the differences
and similarities between generic drugs and their originator
counterparts, including economic benefits associated with usage of
generic medicines, using Ireland as a case study. BMC Pharmacol
Toxicol 2013;14:1.
4. Howland RH. What makes a generic medication generic?
J Psychosoc Nurs Ment Health Serv 2009;47:1720.
5. Babar ZU, Grover P, Stewart J, et al. Evaluating pharmacistsviews,
knowledge, and perception regarding generic medicines in New
Zealand. Res Social Adm Pharm 2011;7:294305.
6. Chong CP, Hassali MA, Bahari MB, et al. Exploring community
pharmacistsviews on generic medicines: a nationwide study from
Malaysia. Int J Clin Pharm 2011;33:12431.
7. Shrank WH, Liberman JN, Fischer MA, et al. Physician perceptions
about generic drugs. Ann Pharmacother 2011;45:318.
8. Ferner R, Lenney W, Marriott J, et al. Controversy over generic
substitution. BMJ 2010;340:c13413.
9. Shaw SJ, Hartman AL. The controversy over generic antiepileptic
drugs. J Pediatr Pharmacol Ther 2010;15:8193.
10. Wise J. Doctors are warned not to prescribe generic pregabalin for
pain control. BMJ 2015;350:h1724.
11. Babar ZU, Stewart J, Reddy S, et al. An evaluation of consumers
knowledge, perceptions and attitudes regarding generic medicines in
Auckland. Pharm World Sci 2010;32:4408.
12. Al Ameri MN, Whittaker C, Tucker A, et al. A survey to determine the
views of renal transplant patients on generic substitution in the UK.
Transpl Int 2011;24:7709.
13. Himmel W, Simmenroth-Nayda A, Niebling W, et al. What do primary
care patients think about generic drugs? Int J Clin Pharmacol Ther
2005;43:4729.
14. Faasse K, Cundy T, Gamble G, et al. The effect of an apparent
change to a branded or generic medication on drug effectiveness
and side effects. Psychosom Med 2013;75:906.
15. Håkonsen H, Eilertsen M, Borge H, et al. Generic substitution:
additional challenge for adherence in hypertensive patients? Curr
Med Res Opin 2009;25:251521.
16. Higgins JPT, Green S. Cochrane handbook for systematic reviews of
interventions. Version 5.1.0. Cochrane Collaboration, 2009.
17. Agresti A, Coull BA. Approximate is better than exactfor interval
estimation of binomial proportions. Am Statistician 1998;52:11926.
18. Landis JR, Koch GG. The measurement of observer agreement for
categorical data. Biometrics 1977;33:15974.
19. Faasse K, Petrie KJ. The nocebo effect: Patient expectations and
medication side effects. Postgrad Med J 2013;89:5406.
20. Bingel U, Wanigasekera V, Wiech K, et al. The effect of treatment
expectation on drug efficacy: imaging the analgesic benefit of the
opioid remifentanil. Sci Transl Med 2011;3:70ra14.
21. Al-Gedadi NA, Hassali MA, Shafie AA, et al. A pilot survey on
perceptions and knowledge of generic medicines among consumers
in Penang, Malaysia. Pharm Prac 2008;6:937.
22. Hassali MA, Shafie AA, Jamshed S, et al. Consumersviews on
generic medicines: a review of the literature. Int J Pharm Pract
2009;17:7988.
23. Bertoldi AD, Barros AJ, Hallal PC. Generic drugs in Brazil: known by
many, used by few. Cad Saude Publica 2005;21:180815.
24. Bradley CP, Riaz A, Tobias RS, et al. Patient attitudes to
over-the-counter drugs and possible professional responses to
self-medication. Fam Pract 1998;15:4450.
25. Costa-Font J, Rudisill C, Tan S, et al. Brand loyalty, patients
and limited generic medicines uptake. Health Policy
2014;116:22433.
26. Dunne S, Shannon B, Dunne C, et al. Patient perceptions of generic
medicines: a mixed-methods study.Patient 2014;7:17785.
27. Figueiras MJ, Alves NC, Marcelino D, et al. Assessing lay beliefs
about generic medicines: development of the generic medicines
scale. Psychol Health Med 2009;14:31121.
28. Heikkilä R, Mäntyselkä P, Ahonen R, et al. Do people regard
cheaper medicines effective? Population survey on public opinion of
generic substitution in Finland. Pharmacoepidemiol Drug Saf
2011;20:18591.
29. Ibrahim R, McKinnon RA, Ngo SN, et al. Knowledge and
perceptions of community patients about generic medicines. JPPR
2012;42:2836.
30. Iosifescu A, Halm EA, McGinn T, et al. Beliefs about generic drugs
among elderly adults in hospital-based primary care practices.
Patient Educ Couns 2008;73:37783.
31. Keenum AJ, Devoe JE, Chisolm DJ, et al. Generic medications for
you, but brand-name medications for me. Res Social Adm Pharm
2012;8:5748.
32. Kobayashi E, Karigome H, Sakurada T, et al. Patientsattitudes
towards generic drug substitution in Japan. Health Policy
2011;99:605.
33. Kohli E, Buller A. Factors influencing consumer purchasing patterns
of generic versus brand name over-the-counter drugs. South Med J
2013;106:15560.
34. Lebanova H, Manolov D, Getov I, et al. Patientsattitude about
generics-Bulgarian perspective. Marmara Pharm J 2012;1:3640.
35. Lira CA, Oliceira JN, Adrade Mdos S, et al. Knowledge, perceptions
and use of generic drugs: a cross sectional study. Einstein (São
Paulo) 2014;12:26773.
36. Nardi EP, Ferraz MB, Pinheiro GR, et al. Perceptions of the
population regarding generic drugs in Brazil: a nationwide survey.
BMC Public Health 2015;15:117.
37. Omojasola A, Hernandez M, Sansgiry S, et al. Perception of generic
prescription drugs and utilization of generic drug discount programs.
Ethn Dis 2012;22:47985.
38. Palagyi M, Lassanova M. Patients attitudes towards experience with
use of generics in Slovakia, performance of generic substitution.
Bratisl Lek Listy 2008;109:3248.
39. Perri M,III, Wolfgang AP, Jankel CA, et al. Georgia consumers
awareness and perceptions of generic drugs after the scandals. Am
Pharm 1990;NS30:336.
40. Piette JD, Heisler M, Harand A, et al. Beliefs about prescription
medications among patients with diabetes: Variation across racial
groups and influences on cost-related medication underuse.
J Health Care Poor Underserved 2010;21:34961.
41. Rathe J, Larsen P, Andersen M, et al.Associations between generic
substitution and patientsattitudes, beliefs and experiences. Eur J
Clin Pharmacol 2013;69:182736.
42. Sansgiry SS, Bhosle MJ. Consumer perceptions of generic drug
substitution practices in the USA. JPPR 2004;34:2626.
43. Shrank WH, Cox ER, Fischer MA, et al. Patientsperceptions of
generic medications. Health Aff 2009;28:54656.
44. Sicras-Mainar A, Navarro-Artieda R. Physiciansand patients
opinions on the use of generic drugs. J Pharmacol Pharmacother
2012;3:26870.
45. Wong ZY, Hassali MA, Alrasheedy AA, et al. Patientsbeliefs about
generic medicines in Malaysia. Age 2014;12:474.
46. Yousefi N, Mehralian G, Peiravian F, et al. Consumersperception of
generic substitution in Iran.Int J Clin Pharm 2015;37:497503.
47. Andersson K, Jörgensen T, Carlsten A, et al. Physiciansopinions
and experiences of the pharmaceutical benefits reform. Scand J
Public Health 2006;34:6549.
48. Bower AD, Burkett GL. Family physicians and generic drugs: a study
of recognition, information sources, prescribing attitudes, and
practices. J Fam Pract 1987;24:61216.
49. Brust M, Hawkins CF, Grayson D, et al. Physiciansattitudes toward
generic drug substitution by pharmacists. Tex Med 1990;86:459.
50. Chua GN, Hassali MA, Shafie AA, et al. A survey exploring
knowledge and perceptions of general practitioners towards the use
of generic medicines in the northern state of Malaysia. Health Policy
2010;95:22935.
51. Dosedel M, Maly J, Kubena A, et al. Opinions of Czech general
practitioners on generic drugs and substitution. Cent Eur J Med
2014;9:8308.
52. Dunne SS, Shannon B, Cullen W, et al. Beliefs, perceptions and
behaviours of GPs towards generic medicines.Fam Prac t
2014;31:46774.
53. Fabiano V, Mameli C, Cattaneo D, et al. Perceptions and patterns of
use of generic drugs among Italian family pediatricians: first round
results of a web survey. Health Policy 2012;104:24752.
54. Friedman D, Jaffe A, Steinhardt S. Physiciansattitudes toward and
knowledge about generic drug substitution. N Y State J Med
1987;87:53942.
55. Gossell-Williams M. Generic substitutions: a 2005 survey of the
acceptance and perceptions of physicians in Jamaica. West Indian
Med J 2007;56:45863.
56. Jamshed SQ, Ibrahim MI, Hassali MA, et al. Perception and attitude
of general practitioners regarding generic medicines in Karachi,
Pakistan: a questionnaire based study. South Med Rev
2012;5:2230.
57. Kersnik J, Peklar J. Attitudes of Slovene general practitioners
towards generic drug prescribing and comparison with international
studies. J Clin Pharm Ther 2006;31:57783.
8Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915
Open Access
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
58. Kumar R, Hassali MA, Saleem F, et al. Knowledge and perceptions
of physicians from private medical centres towards generic
medicines: a nationwide survey from Malaysia.J Pharm Policy Pract
2015;8:11.
59. Lewek P, Smigielski J, Kardas P, et al. Factors affecting the opinions
of family physicians regarding generic drugsa questionnaire based
study.Bosn J Basic Med Sci 2014;15:4550.
60. Theodorou M, Tsiantou V, Pavlakis A, et al. Factors influencing
prescribing behaviour of physicians in Greece and Cyprus: results from
a questionnaire based survey. BMC Health Serv Res 2009;9:150.
61. Tsiantou V, Zavras D, Kousoulakou H, et al. Generic medicines:
Greek physiciansperceptions and prescribing practices. J Clin
Pharm Ther 2009;34:54754.
62. Allenet B, Barry H. Opinion and behaviour of pharmacists towards
the substitution of branded drugs by generic drugs: Survey of 1,000
French community pharmacists. Pharm World Sci 2003;25:197202.
63. Auta A, Bala ET, Shalkur D, et al. Generic medicine substitution:
a cross-sectional survey of the perception of pharmacists
in north-central, Nigeria. Med Prin Pract
2014;23:538.
64. Awaisu A, Kheir N, Ibrahim MI, et al. Knowledge, attitudes, and
practices of community pharmacists on generic medicines in Qatar.
Int J Clin Pharm 2014:36:394404.
65. Chong CP, Hassali MA, Bahari MB, et al. Evaluating community
pharmacistsperceptions of future generic substitution policy
implementation: a national survey from Malaysia. Health Policy
2010;94:6875.
66. Dunne SS, Shannon B, Cullen W, et al. Perceptions and attitudes of
community pharmacists towards generic medicines. J Manag Care
Pharm 2014;20:113846.
67. Gupta PB. Survey of pharmacists: impact of the generic drug
scandal and implications for marketing generic drugs. Health Mark Q
1996;13:10920.
68. Maly J, Dosedel M, Kubena A, et al. Analysis of pharmacists
opinions, attitudes and experiences with generic drugs and generic
substitution in the Czech Republic. Acta Pol Pharm 2013;70:92331.
Colgan S, et al.BMJ Open 2015;5:e008915. doi:10.1136/bmjopen-2015-008915 9
Open Access
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
a systematic review pharmacists:general population, doctors and
Perceptions of generic medication in the
Grey and Keith J Petrie
Sarah Colgan, Kate Faasse, Leslie R Martin, Melika H Stephens, Andrew
doi: 10.1136/bmjopen-2015-008915
2015 5: BMJ Open
http://bmjopen.bmj.com/content/5/12/e008915
Updated information and services can be found at:
These include:
Material
Supplementary
915.DC1.html
http://bmjopen.bmj.com/content/suppl/2015/12/15/bmjopen-2015-008
Supplementary material can be found at:
References #BIBLhttp://bmjopen.bmj.com/content/5/12/e008915
This article cites 66 articles, 10 of which you can access for free at:
Open Access
http://creativecommons.org/licenses/by-nc/4.0/non-commercial. See:
provided the original work is properly cited and the use is
non-commercially, and license their derivative works on different terms,
permits others to distribute, remix, adapt, build upon this work
Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
This is an Open Access article distributed in accordance with the Creative
service
Email alerting box at the top right corner of the online article.
Receive free email alerts when new articles cite this article. Sign up in the
Collections
Topic Articles on similar topics can be found in the following collections
(314)Pharmacology and therapeutics
(408)Evidence based practice
Notes
http://group.bmj.com/group/rights-licensing/permissions
To request permissions go to:
http://journals.bmj.com/cgi/reprintform
To order reprints go to:
http://group.bmj.com/subscribe/
To subscribe to BMJ go to:
group.bmj.com on December 16, 2015 - Published by http://bmjopen.bmj.com/Downloaded from
... However, because generic drugs can be approved by confirming their bioequivalence without undergoing clinical trials, whether their clinical effects are equivalent to those of the original drug when administered in clinical settings remains controversial [6,7]. In a systematic review and meta-analysis comparing the safety and efficacy of original and generic cardiovascular drugs in 30 randomized controlled trials and 42 non-randomized clinical trials or observational studies, 60% of the studies identified no difference in effectiveness between original and generic administration, 26% found the original to be more efficacious and safer than the generic version, and 1% found the generic to be more effective than the original drug [8]. ...
... Generics are approved because they are considered as effective as the original (brand-name) drug; therefore, these drugs can be used interchangeably. In real-world clinical practice, the perception of original and generic drugs has yet to converge [6,7] despite frequent medication changes between brand names and generics or between generic and generic drugs [25]. In the present study, 25% of the patients (401 out of 1,588) switched within approximately two years. ...
Article
Full-text available
Background Although generic drugs have been approved with the assurance of interchangeable applications with original drugs, some physicians, and patients still view their efficacy and interchangeability negatively. Using real-world data, we aimed to determine factors that impact switching between drugs that contain the same active ingredient, i.e., atorvastatin, and, in turn, whether this ‘switch’ could alter clinical outcomes. Methods Using the National Health Insurance Service senior cohort, a retrospective cohort study was conducted to assess patients who had newly started atorvastatin 10 mg and had at least two records of national health examinations from 2010 to 2014. Drug switching, which was defined as a change in the atorvastatin product administered 90 days before the first and second examinations, was assessed. Greedy propensity score matching (1:2) was performed between switchers and non-switchers to control for potential confounders. Factors influencing switching were analyzed using multivariate logistic regression to estimate odds ratios and 95% confidence intervals (CIs). Changes in low-density lipoprotein-cholesterol (LDL-C) levels attributable to drug switching were evaluated using difference-in-differences regression. Results A total of 1,588 patients were included, of whom 25.3% switched drugs (1,187 non-switchers and 401 switchers). Compared to patients taking generics before the first examination, those taking the original drugs had a lower odds ratio (0.31; 95% CI [0.21, 0.46]) for subsequent drug switching. A change in medical institution was associated with a significantly higher odds ratio (6.83; 95% CI [4.66, 10.02]). There were no significant differences in LDL-C alterations between switchers and non-switchers (0.42 mg/dL; 95% CI [-2.29, 3.13]). Conclusion The type of first-time drug administered and changes in medical institution can influence drug switching. No significant changes in LDL-C values were observed in the various switching scenarios between the original and generic drugs, suggesting their interchangeable application in real-world clinical practice.
... A bioequivalence study is a test that compares the bioavailability profile between a test drug and a comparator drug [1]. Even though they have passed bioequivalence tests, some surveys show that most patients believe a copy drug's effectiveness is not equivalent to the innovator drug [6]. ...
Article
Full-text available
Metformin is the first line in type 2 Diabetes Mellitus (DM). Metformin is available as an innovator drug and copy drug. The high price of innovator drugs makes it difficult for patients to obtain the required drugs. Therefore, many pharmaceutical industries have developed a copy of the innovator drug. To obtain .a distribution license, the pharmaceutical industry must conduct a bioequivalence test on metformin copy tablets to ensure that the copy drug has the same efficacy, safety, and quality as the innovator drug. However, several surveys show that most patients believe that the effectiveness of copy drugs is not equivalent to the innovator drug. This study aims to determine the bioavailability profile and bioequivalence profile of Metformin copy tablets to Glucophage® (Merck) innovator tablets so that it can provide an overview of the effectiveness of copy drugs with innovator drugs and the public no longer hesitate to use copy drugs. Metformin copy tablets are declared bioequivalent to the innovator drug if they provide a Confidence Interval (CI) value of 90% in the 80-125% range. All 500 mg, 850 mg, and 1000 mg doses of metformin copy tablets, both fasting and eating conditions, gave bioequivalent results to the innovator Glucophage® based on 90% CI.
... They can also include the likelihood that the medication can cure or control disease (Leventhal et al., 2003). Medication beliefs can also encompass general themes such as the nature of pharmaceuticals and whether they are overused , beliefs about the manufacture of medications, efficacy of generic versus branded medication (Colgan et al., 2015;Keenum et al., 2012), and the trustworthiness of the pharmaceutical industry (Goff et al., 2008). Beliefs can also involve broader domains such as cultural beliefs and beliefs related to one's control over the disease. ...
... Negative media coverage can contribute to increased rates of reported side effects [21]. Generic medication is perceived by patients and doctors alike as inherently less potent, limiting their use [22]. Even apparently frivolous characteristic, such as the price or the colour of the drug can prove to have profound impact on its perceived efficacy [23,24]. ...
Article
The placebo and nocebo effects are commonly understood as the patients’ responses to treatment in accordance with their positive or negative expectations, respectively, regarding their health. Such treatments involve substances or interventions with no known inherent effects on the studied condition, but which nonetheless may have a discernible effect on the condition’s presentation and evolution. Their influence on clinical outcomes confront practitioners with often underestimated therapeutic tools and challenges whose applicability are subject to ethical debate. Furthermore, placebos play a crucial part in our current understanding of therapeutic efficacy and in the development of novel interventions. This narrative review aims to present a brief exposition of the roles that placebo and nocebo effects play in psychiatric clinical practice and research.
... Meskipun sudah dilakukan uji ekivalensi, banyak masyarakat yang menganggap obat copy tidak setara dengan obat inovator. Menurut Colgan, et al (2), orang awam memandang obat copy tidak setara dengan obat inovator dalam hal efektivitas. ...
Article
Drugs are available in the form of innovator and copy drugs. The high cost of innovator drugs makes it difficult for patients to obtain the drugs they need. Therefore, many pharmaceutical industries have developed copy drugs from their innovator drugs. To get a distribution license, the pharmaceutical industry must conduct an equivalence study on copy drugs to ensure that the copy drug has the same efficacy, safety and quality as the innovator drug. However, several surveys show that most patients believe that the effectiveness of copy drugs is not equivalent to the innovator drug. This study aims to determine the role of in vitro equivalence and in vivo equivalence studies in determining drug quality. This study is expected to provide benefits for the public so they are no longer hesitant to use copy drugs. The equivalence study has an important role in ensuring that the quality of the copy drug is equivalent to the innovator drug in terms of efficacy, safety and quality of the copy drug. Abstrak. Obat tersedia dalam bentuk obat inovator dan obat copy. Tingginya harga obat inovator membuat pasien sulit untuk memperoleh obat yang dibutuhkan. Sehingga banyak industri farmasi yang mengembangkan obat copy dari obat inovatornya. Untuk mendapatkan izin edar, industri farmasi harus melakukan uji ekivalensi terhadap obat copy guna menjamin obat copy memiliki khasiat, keamanan dan mutu yang setara dengan obat inovatornya. Namun, beberapa survei menunjukkan sebagian besar pasien percaya bahwa efektivitas obat copy tidak setara dengan obat inovatornya. Penelitian ini bertujuan untuk mengetahui peranan uji ekivalensi in vitro dan ekivalensi in vivo dalam penentuan kualitas obat. Sehingga penelitian ini diharapkan memberikan manfaat bagi masyarakat agar tidak lagi ragu menggunakan obat copy. Uji ekivalensi memiliki peran penting dalam menjamin kualitas dari obat copy setara dengan obat inovator dalam hal khasiat, keamanan serta mutu obat copy.
... These perceptions are in line with some research 30,31 but contradict those from other studies conducted in New Zealand and in Ethiopia, in which pharmacists had safety and quality concerns about generics. 28,32 More than half of our study participants revealed that locally manufactured generics are equivalent in quality and safety to imported generics. This finding emphasizes the importance of supporting local firms since the same regulations are applied for both local and imported generic drugs. ...
Article
Full-text available
Background Pharmacists are crucial in lowering pharmaceutical expenditures by substituting brand-name drugs for generic drugs. They are expected to understand the principles and practices of generic drug substitution for high-quality patient care. Some key areas of knowledge include bioequivalence and therapeutic equivalence, regulatory requirements, drug interchangeability, and adequate patient counseling. Objectives This study aims to assess the knowledge, perception, and practice of generic drug substitution among pharmacists in Lebanon following the crises and the factors affecting the prescription and selection of generic drugs. Methods A pilot descriptive cross-sectional study targeting 80 Lebanese pharmacists was conducted over 2 months (September-October 2022), in which data were collected using a uniform survey. Results Overall, pharmacists had a good knowledge of generic drugs in terms of active ingredients (97.5%), pharmaceutical form (85.0%), lower cost (88.7%), bioequivalence to the brand before (95.0%), and therapeutic equivalence. Nevertheless, 22.5% reported that generic drugs are less safe than brands, and 22.5% said they cause side effects or did not know. Among the possible factors that influence the prescription of generic drugs, 35.0% of pharmacists reported that the financial situation of the patient is among the least important factors, while the lack of possible alternatives (45.0%) and the difference in prices (40.0%) were the most important ones. The price of different generics on the market was among the most important factors (36.3%) affecting the selection of generic drugs, followed by the patient’s. preference (26.3%). Only 11.2% considered the information given by pharmaceutical firms could affect their choice, and 10.0% considered the presence or not of excipients with known effects in the formulation. Conclusion Most pharmacists in Lebanon were familiar with generic drugs and supported generic drug substitution. Factors affecting generic drug use and prescription should be further explored to clarify misconceptions and reduce possible adverse events.
... Previous studies have compared generic and originator formulations of different drug classes, in which pharmacokinetic properties [ 9 , 16 ], microbiological activity [17] and clinical efficacy and safety [18][19][20][21][22] were found to be similar. Nevertheless, patients and healthcare professionals still express considerable concerns about the efficacy and safety of generic medicines [2][3][4][5][6] . This perception, however, may antagonize several benefits of prescribing generic drugs, such as cost reduction, which makes health care more accessible to a broader group of patients. ...
Article
Full-text available
Objectives: Although generic medicinal products are required to have the same qualitative and quantitative composition of the active substance as their reference originator product, patients and health care professionals express concerns about their interchangeability and safety. Therefore, the present study investigated the antimicrobial activity and pathogen mutation prevention of original and generic cefepime, linezolid and piperacillin/tazobactam against Staphylococcus aureus. Methods: Two generic formulations of cefepime, linezolid and piperacillin/tazobactam were tested against their respective originator products. Susceptibility testing was performed with twenty-one clinical isolates of S. aureus and ATCC-29213 using broth microdilution. Time kill curves (TKC) were performed with ATCC-29213 at drug concentrations above and below the respective minimum inhibitory concentrations (MIC). Mutation prevention concentration was determined for each drug formulation against ATCC-29213. All experiments were performed in triplicate. Mutant colonies from mutation prevention concentration (MPC) experiments were genotypically tested by sequence analysis. Results: MIC ratios between contiguous originator and generic drugs were similar for each isolate. No visual differences were observed in TKCs between originator and generic substances. The MPC did not differ between different formulations of the same substance. Although sequence analysis of mutant colonies revealed genomic differences compared to the original ATCC-29213, no differences in mutation frequencies were observed between clinical isolates and ATCC-29213 treated with originator or generic substances. Conclusions: Similar antimicrobial activity and pathogen mutation prevention was observed between contiguous substances. These results support the interchangeability of generic and originator drug formulations with the same active ingredient.
... 10 Even though replacing brand-name medicines with less expensive generic equivalents is practiced globally and many studies have demonstrated no difference in outcomes between cardiovascular (CV) generics and their brand-name counterparts, [13][14][15][16] many professionals and the general public have negative opinions on the effectiveness and/or safety of generic medications. 17 Therefore, this study aimed to examine the efficacy and safety of patients receiving a generic clopidogrel versus brand-name clopidogrel after AMI. ...
Article
Full-text available
Skepticism exists among healthcare workers and patients regarding the efficacy and safety of generic medication, despite their potential to lower healthcare costs. This study aimed to compare the outcomes of a generic clopidogrel and its brand-name counterpart for secondary prevention of patients with acute myocardial infarction (AMI). Using the Taiwan National Health Insurance Research Database, we identified 49,325 patients who were hospitalized for AMI between January 1, 2008 and December 31, 2013 and prescribed either generic or brand-name clopidogrel. Among them, 2419 (4.9%) were prescribed the generic clopidogrel. After propensity score matching, both the generic and brand-name groups consisted of 2382 patients. The primary efficacy outcome was a composite of myocardial infarction, coronary revascularization, ischemic stroke, and all-cause death. The primary safety outcome was major bleeding requiring hospitalization. At a mean follow-up of 2.5 years, the generic and brand-name clopidogrel groups had comparable risks of primary efficacy outcome (41.9% vs. 42%; hazard ratio [HR] 0.96; 95% confidence interval [CI] 0.88-1.04), and the risks of the individual components were also similar. There were no significant differences between the two groups in major bleeding (7.9% vs. 7.9%; HR 0.99; 95% CI 0.81-1.21). Subgroup analyses also revealed no statistically significant interactions between the treatment effect and various subgroups. In this retrospective database analysis, the generic clopidogrel was comparable to its brand-name counterpart regarding cardiovascular and bleeding outcomes for the treatment of patients with AMI.
Article
Full-text available
Objectives Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. Methods This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians’ knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. Results A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41–50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they ‘always’ write their prescriptions using originator product name whereas 50.2% do it ‘usually’. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. Conclusions The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic medicines with regard to their bioequivalence, quality, efficacy and safety. Apart from the policy on generic substitution, it would also be recommended to have a national medicine pricing policy, which controls drug prices, in both the public and private sector. These efforts are worthwhile to reduce the drug expenditure and improve the medicine affordability in Malaysia.
Article
Full-text available
A range of factors are believed to exert a negative influence on opinions of physicians about generic drugs.The aim of this study was to survey the opinions of primary care doctors on generics, and determine the factors which may affect them. A questionnaire comprising thirty eight questions was distributed among primary care doctors working in seventy out-patient clinics of the Lodzkie province, Poland, during the period of January 1, 2010 - December 31, 2010. A total of170 of 183 participants completed the survey (average age 48.5; 70.0% women): a 92.9%response rate. While 38.8% of physicians claimed that generics were worse than brand name drugs, 54.1% considered them to be better. However, 36.5% of the doctors did not choose generics for their own use. Two key opinions were identified among the responses concerning the effectiveness of generic drugs: use of generic drugs by the physician (p<0.001), and their opinion that pharmacists do inform patients about generic drugs (p<0.05). Although existing evidence confirms that generic and brand name drugs are equally effective, many physicians doubt this, which prevents them from being used as cost effective drug therapy. In order to increase healthcare savings through the use of generics, these factors should be addressed: for example, convincing a physician to adopt generics for personal use may be an efficient way to support more cost effective treatment of his patients.
Article
Background: To improve the uptake of generic drugs, understanding consumer perceptions is important. Increased use of generic drugs may help contain escalating healthcare costs. Aim: To evaluate consumer perceptions of generic drug substitution practices by pharmacists in the USA and predict the effect of health and social factors on the use of generic drugs. Method: Surveys were administered to consumers filling prescriptions at 10 community pharmacies in metropolitan Houston, Texas. A 12‐item, 5‐point scale was used to evaluate consumer perceptions. Information on current drugs, purchase behaviour and sociodemographic factors was also requested. Results: 505 surveys were completed (61% response rate). Participants had a slightly positive attitude toward generic drug substitution practices (mean 3.59, SD 1.13). Although participants perceived generic drugs to be safe (68%) and effective (62%), 50% did not consider them to be identical to brand equivalents. Attitude towards generic drugs was the most important predictor of consumer perceptions towards generic drug substitution practices by pharmacists. Conclusion: To improve consumer perceptions of generic drug substitution practices, it is imperative to develop strategies to increase positive attitudes towards generic drugs. Pharmacists can improve consumer perceptions of generic drugs, enhance consumer awareness of potential savings, and help reduce the overall healthcare costs. J Pharm Pract Res 2004; 34: 262–6.
Article
Background Patients' knowledge and perceptions about generic medicines are extremely important for promoting generic substitution. Few studies have investigated patients' acceptance or understanding of generic medicines.AimTo explore knowledge and perceptions of community patients about generic medicines.MethodA self-administered anonymous survey was completed by patients presenting at 1 of 18 community pharmacies in Adelaide, South Australia. The questionnaire comprised items on: demographics (age, gender, ethnicity, education, income, self-rated health status), safety, efficacy, cost and value of generic medicines, and patients' willingness to use these.Results503 patients completed the survey − 51% females and 49% males. 60% of patients were on more than one prescription medication. 67% of patients rarely asked for a generic medicine when their prescriptions were being filled. Around 47% of patients believed that they needed more information on the difference between generic and brand-name medicines. Around 81% of patients knew that generic medicines were less expensive than brand-name medicines; and 51% believed generic medicines offered better value. When asked whether 'they would rather take generic medicines than brand-name medicines' - about 30% indicated they would, 25%) would not, 40% were neutral and 5% did not provide an answer Younger patients (55 years or less) asked for generic medicines more often than older patients (over 55 years) (p < 0.05). There were no other significant differences.Conclusion Most patients had some knowledge about generic medicines. However, many were unsure if they preferred generic to brand-name medicines or brand-name to generic medicines.
Article
Doctors have been warned against prescribing generic pregabalin for pain control and instead told to prescribe Lyrica (Pfizer, New York) by brand. Failing to do so may leave them open to litigation, both the BMA and NHS England have warned.The patent for Lyrica that expired in July 2014 only related to its use for epilepsy and generalised anxiety disorder. The manufacturer, Warner-Lambert (a subsidiary of Pfizer), still holds a “second medical use” patent for the use of pregabalin in the treatment of peripheral and central neuropathic pain, which expires in July 2017. A second medical use patent is one that relates to a new medical use for a known compound.So despite being the same as the branded version, generic versions of pregabalin have been approved for use only in epilepsy and generalised anxiety disorder. Pfizer is in dispute with a number of generic drug suppliers and has indicated that it will contest any challenges to the patent for pain.Earlier this year Pfizer sent a letter to pharmacists and hospital administrators stating that pharmacists and others in the supply chain may infringe the patent, even potentially unwittingly, if they supply generic pregabalin for the pain indication and that this would be an unlawful act.After a High Court ruling on 2 March the NHS was told it must not promote generic pregabalin for pain. As a result NHS England issued guidance to GPs and pharmacists saying that “so far as reasonably possible” pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica. Pharmacists have been told to confirm the indications for generic prescriptions of pregabalin. If the indication is for neuropathic pain then pharmacists have been told to return the prescription for amendment to Lyrica.NHS England has also told clinical commissioning groups to ensure that any electronic prescription system is amended to include a notice or advice box saying, “If treating neuropathic pain, prescribe Lyrica due to patent protection. For all other indications, prescribe generically.”The BMA’s General Practitioners Committee has advised GPs to prescribe Lyrica by brand when used for pain control for the time being. Andrew Green, chair of the BMA’s GP clinical and prescribing subcommittee, said, “The BMA was made aware of attempts by Pfizer to enforce use of their brand when pregabalin is prescribed for long term pain, even though the brand is much more expensive and no more effective than the generic version. Accordingly, we issued pragmatic guidance designed to protect doctors from personal legal challenge as well as from being distracted from patient care by pharmacists anxious about the intended use of a generic prescription.” He added, “There would be considerable savings for the NHS if generic pregabalin was available for long term pain relief.”A spokesperson for Pfizer said in a statement, “Pfizer does not wish to take legal action against any individuals or organisations in relation to this matter. We recognise this is a relatively unusual situation and have therefore been engaging with stakeholders across the NHS for over six months to ensure essential guidance is available. We are confident that the central guidance and FAQs recently issued by NHS England will provide much needed clarity and also help to protect pharmacists from unwittingly infringing the patent.”The spokesperson said that the current situation was unprecedented. But they added that second medical use patents are likely to become increasingly common and so similar situations could occur more frequently in the future. “We hope the work we have been doing with stakeholders across the NHS will help provide clarity around the Lyrica (pregabalin) pain patent specifically but, more importantly, also help ensure the right policy, infrastructure, and guidance is in place to support and protect future medical innovation.”NotesCite this as: BMJ 2015;350:h1724
Article
For interval estimation of a proportion, coverage probabilities tend to be too large for "exact" confidence intervals based on inverting the binomial test and too small for the interval based on inverting the Wald large-sample normal test (i.e., sample proportion ± z-score × estimated standard error). Wilson's suggestion of inverting the related score test with null rather than estimated standard error yields coverage probabilities close to nominal confidence levels, even for very small sample sizes. The 95% score interval has similar behavior as the adjusted Wald interval obtained after adding two "successes" and two "failures" to the sample. In elementary courses, with the score and adjusted Wald methods it is unnecessary to provide students with awkward sample size guidelines.
Article
Background: The growth of pharmaceutical expenditure and patients' out of pocket has motivated policy makers to encourage patients to substitution of brands medicines with their generic alternatives called generic substitution. Objectives: As the patients are final decision makers to accept generic substitution, the aim of this study is to evaluate the patient perception about generic medicines and underlying factors which can promote the generic acceptance. Setting: The study was done in community pharmacies in Tehran, the capital city of Iran. Method: A cross-sectional descriptive study inviting people purchasing their drug at community pharmacies were per-formed using a self-administrated anonymous questionnaire (N=1309). Main outcomes measures: Besides the demographic section, 16 items of developed questionnaire were categorized to five main factors including: patients' perception about efficiency, safety and cost of generic medicines, patient trust on physicians and pharmacists' advice. Results: Findings of completed questionnaires showed among the aforementioned factors the physician has the first priority to encourage patients to use of generics medicines which followed respectively by pharmacist's role, cost of medicines, efficacy, and safety concerns. Conclusion: In conclusion, the trust of Iranian's society on the physicians and pharmacists advice would create a credible opportunity to reduce pharmaceutical expenditures as well as patients' out of pocket by promotion of generic substitution.