医薬品相互作用研究

Vol.43, No. 1（2019）17（17）

医薬品相互作用研究
一
般論
文
43（1） 17-23 （2019）

Questionnaire survey on knowledge and perceptions of generic medicines
for pharmacy students
Tomohiko TAIRABUNE1＊）, Takeshi CHIBA1）, Takashi TOMITA1）, Tomoya SAKURADA2）,
Eriko KOBAYASHI2）, Nobunori SATOH2）, Kenzo KUDO1）
Division of Clinical Pharmaceutics and Pharmacy Practice, Department of Clinical Pharmacy,
School of Pharmacy, Iwate Medical University
2）
Department of Social Pharmacy, Graduate School of Pharmaceutical Sciences, Chiba University
1）（Received May 11, 2018; Revised September 29, 2018; Accepted November 27, 2018）
In pharmaceutical education, students must be given basic knowledge of generic medicines and the needs ofpromoting their use. In this study, we compared the knowledge and perceptions of generic medicines among 3 rd to
6 th year students in the Faculty of Pharmaceutical Sciences. A total of 626 students completed the questionnaire(response rate of 98.6%), including 150 in 3 rd year, 162 in 4 th year, 162 in 5 th year, and 152 in 6 th year. Overall, very
few students in all years answered correctly “80 to 125%” when asked to give the acceptable tolerance range at a 90%
confidence interval of the mean blood concentration ratio of a generic medicine and a brand-name medicine inbioequivalence studies. The 4 th to 6 th year students were significantly more likely to answer “agree” to the questions“I have been introduced to issues on the bioequivalence of generic medicines during my pharmacy education” and “Generic medicines are less expensive than brand-name medicines” than the 3 rd year students. On the other
hand, compared to 3 rd year students, 4 th and 5 th year students were significantly more likely to answer “disagree” forquestions suggesting that generic medicines are of inferior quality, less effective, and produce more side effects thanbrand-name medicines. Based on these results, to promote the use of generic medicines, it is necessary for pharmacy
students to be educated about how to evaluate bioequivalence studies for generic medicines.
Key Words: generic medicines, questionnaire survey, pharmacy students, bioequivalence

Introduction

achieve this goal, the Ministry of Health, Labour

T h e J a p a n e s e g o ve r n m e n t h a s p r o m o t e d t h e

and Welfare created “the road map for further

use of generic medicines in order to minimize

promotion of use of the generic medicine,” which

the increase in national medical expenditure due

includes “improvement of the understanding of

to its ag ing populat ion and changes in medical

generic medicines in medical and pharmacy

technologies. As result, the rate of genericeducation” 3）. In other words, to promote of using

medicine use has increased over the past several

generic medicines, it is important to ensure thatyears, reaching 66.8% in 2016 . Despite thesep h a r m a c y s t u d e n t s h a ve s u f f i c i e n t k n o w l e d g eincreases, the Ministry of Health, Labour andand perceptions of generic medicines.

1）

Welfare in their "Basic policy 2015 of theGeneric medicines, containing the same amounteconomic financial administrat ion and reform"of active ingredients as their equivalent

set the target value of the quantity share as 80%

brand-name medicine, are given at the sameas early as possible unt il the end of fiscal year

dosages and route of administration, then overall

2020 . Therefore, further promotion of the use

have the same therapeutic effect. However, someof generic medicine is necessary in the future. To

studies have indicated that generic medicines do

2）

Division of Clinical Pharmaceutics and Pharmacy Practice, Department of Clinical Pharmacy, School of Pharmacy, Iwate Medical
University 2-1-1 Nishitokuta, Yahaba-cho, Shiwa-gun, Iwate 028-3603, Japan2）
Department of Social Pharmacy, Graduate School of Pharmaceutical Sciences, Chiba University 1-8-1 Inohana, Chuo-ku, Chiba-shi,
Chiba 260-8675, Japan*Corresponding author: tomohiko tairabune
E-mail: tomohiko.tairabune@j.iwate-med.ac.jp1）

18（18）

医薬品相互作用研究

Vol.43, No. 1（2019）differ from brand-name medicines in terms ofm e d i c i n e s v i a a q u e s t i o n n a i r e s u r v e y. T h e s eclinical effect and quality

results can then be utilized in planning. In response to these

4-6）

studies, the Ministry of Health, Labour andpharmacy education for generic medicine.

Welfare has begun publishing information on the

Methods

quality of generic medicines7） to ensure
reliability of their quality. Having an appropriate

1. Questionnaire survey

understanding of generic medicines is essential

Questionnaires were administered to 3 rd to 6 th

to carrying out further promotion of genericyear students of Faculty of Pharmaceutical

medicines in the future, so it is important to

Sciences, Chiba University and School ofenrich education on generic medicines for

Pharmacy, Iwate Medical University from April 1

u n d e r g r a d u a t e p h a r m a c y s t u d e n t s . C u r r e n t l y,

to June 30, 2015. Questionnaires were

however, pharmacy studentsʼ level of knowledge

distributed to students directly and collected

and actual perceptions of generic medicines are

immediately after completion. The purpose of

unclear.

this survey and the confident iality of personal

The aim of this study was to explore pharmacy
studentsʼ knowledge and perceptions of genericinformation were described in the questionnaires(Fig.1).

Fig.1 The questionnaire used in this study

The questionnaire comprised seven sections topharmaceutical sciences (Q4); knowledge of

elucidate pharmacy studentsʼ knowledge andbioequivalence (Q5); the tolerance range at aperceptions of generic medicine. The seven

90% confidence interval of the mean blood

sect ions included quest ions evaluat ing genderconcentration ratio of generic medicines and(Q1); year of study (Q2); age (Q3); educat ional

brand-name medicines in bioequivalence studies

backg round before admission in the faculty of(Q6); and know ledge of the difference between

医薬品相互作用研究

Vol.43, No. 1（2019）19（19）

generic and brand-name medicines andtest. Knowledge of the differences between

percept ions of educat ion on generic medicines

generic medicines and brand-name medicines, as(Q7a-n). These seven questions were developed

well as education of generic medicines, werebased on the questionnaire used by Hassali et al 8）.

assessed using theThis study was approved by the research ethics

Significant differences were followed up withcommittee of Graduate School of Pharmaceuticalp a i r- w i s e c o m p a r i s o n s u s i n g t h e S t e e l t e s t f o r

Sciences, Chiba University.

mult iple comparisons. A nominal alpha of 0.05

H-test.

was used for statistical tests. All statistical

2. Comparison the knowledge andanalyses were performed using SPSS Stat ist ics

perceptions of generic medicines by year

25.0 (IBM Corp., Armonk, NY, USA).

We compared responses to Q5 (know ledge of
bioequivalence) and Q6 (tolerance range at a

Results

90% confidence interval for mean blood

A total of 626 students completed theconcentration ratio of generic medicines andquestionnaire (response rate of 98.6%), including

brand-name medicines in bioequivalence studies)

150 in 3 r d year, 162 in 4 t h year, 162 in 5 t h year,by the participant year groups. We also

a n d 1 5 2 i n 6 t h y e a r. T h e r e w e r e n o s i g n i f i c a n t

compared mean scores for Q7 (knowledge of thedifferences in the proportions of each genderdifference between medicine types andand educational background by year of study.

perceptions of education of generic medicines)

The results for Q5 and Q6 are shown in Figureusing a 5-point Likert scale (1 = Strongly

2. Regarding Q5, the percentage of respondents

disag ree, 2 = Disag ree, 3 = Neutral, 4 = Ag ree,

who answered "I understand the meaning ofand 5 = Strongly agree) and between the 3rd

bioequivalence" was highest among 5th year

year and 4‒6 th year students.

students (67.3%), followed by 6 t h year (58.6%),
4 t h year (31.5%), and 3 r d year (14.0%) students.

3. Statistical analyses

As for Q6, the proportion of choosing the correct

We evaluated the proportions of each genderand educational background using the chi-squareanswer of "80‒125%" was less than 5%
regardless of year, which was extremely low.

Fig. 2 Recognition of bioequivalence20（20）

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Vol.43, No. 1（2019）

Table 1 displays the results for Q7a‒Q7d,“strong ly disag ree” that generic medicines arewhich ask about knowledge and perceptions

therapeutically equivalent to each other (P <about generic equivalence. Responses to0.01). Furthermore, 4 th to 6 th year students werequestions 7a and 7d did not significantly differ

significantly more likely to “agree” or “strongly

b y y e a r o f s t u d y. H o w e ve r, f o r Q 7 b, t h e m e a n

a g r e e” t h a t t h e y h a d b e e n i n t r o d u c e d t o t h eratings of 5

issues of bioequivalence for generic medicines

th

and 6

th

year students significantly

differed from those of 3rdyear students̶that is,(Q7c) compared to 3 rd year students (P < 0.01).

senior students were more likely to “disagree” orTable 1

Knowledge and perceptions about generic equivalence

Table 2 shows the results for Q7e‒Q7k, which

likely to "disag ree" or "strong ly disag ree" thatconcern percept ions of the dosage form, dose,g e n e r i c m e d i c i n e s a r e o f i n f e r i o r q u a l i t y, l e s squality, efficacy, side effects, prices, and safety

effective, and produce more side effects thano f g e n e r i c ve r s u s b r a n d - n a m e m e d i c i n e s . Po s tbrand-name medicines (P < 0.01). Students in the

hoc pair-wise comparisons indicated that,

4 th to 6 th years were also significantly more likely

compared to students in 3 rd year, students in 5 th

to “ag ree” or “strong ly ag ree” that generica n d 6 th y e a r w e r e s i g n i f i c a n t l y m o r e l i k e l y t omedicines are less expensive than are

ag ree that generic medicines must contain thebrand-name medicines compared to 3rd year

same dose as brand-name medicines (P < 0.01).

students (P < 0.01). Responses to Q7e and Q7k

In addition, compared to 3
and 5

th

rd

year students, 4th

did not significantly differ by year of study.

year students were significantly more

Table 2 Perceptions of the dosage form, dose, quality, efficacy, side effects, drug prices, and safety of generic medicines versus
brand-name medicines

医薬品相互作用研究

Vol.43, No. 1（2019）21（21）Ta b l e 3 s h o w s r e s p o n s e s t o Q 7 l ‒ Q 7 n , w h i c hrecall a therapeutic class of a drug using genericconcern perceptions about current pharmacy

names rather than brand-name medicines (P <education on generic medicines. We found that0.01). Furthermore, students in 4 t h to 6 t h years

perceptions regarding the need for more

were more likely to “ag ree” or “strong ly ag ree”

information on the safety and efficacy of genericthat they had received lectures and practical

medicines did not vary by year of study.

training about the burden of medical expenses

year,

between the self-pay and public insurance

students in 5th and 6th year reported asystem compared to 3 rd year students (P < 0.01).

However, compared to students in 3rdsignificantly greater tendency to find it easier toTable 3

Perceptions of current pharmacy education about generic medicines

Discussion

bioequivalence is related to studentsʼ subjective

This study examined the knowledge andu n d e r s t a n d i n g o f g e n e r i c m e d i c i n e 1 0 ）.

perceptions of generic medicine in 3 rd to 6 th year

Accordingly, students should be educated on how

students of the Faculty of Pharmaceuticalto interpret tolerance in bioequivalence studies

Sciences. There was an overall lack of knowledge

for generic medicines11） in order to obtain aamong part icipants, irrespect ive of the year of

proper understanding of generic medicines.

s t u d y. I n p a r t i c u l a r, t h e r e s u l t s o f Q 5 a n d Q 6

Properly trained students will, in the future, be

i n d i c a t e d t h a t s t u d e n t s d i d n o t h a ve s u f f i c i e n table to contribute to proper promotion of the use

knowledge of bioequivalence studies of genericof generic medicine.

medicines. Knowledge of bioequivalence isRegarding the results of the comparison

essential for interpreting the results of such

between 3rd and 4th to 6th year studentsʼ

studies, and the findings of this study indicate

knowledge and perceptions of genericthat education on bioequivalence should beequivalence, the latter group had a significantly

introduced earlier and covered more

better understanding than did the former of Q7b,comprehensively in pharmaceutical sciencebut there was no significant difference in Q7a

education. Indeed, being able to evaluate the(i.e., knowledge of the basic definition of genericbioequivalence of different formulations of

medicine). These results provide further evidenceprescription medicine (e.g., brand-name andof the need to strengthen education. As for Q7c,

generic medicine, changes in pharmaceutical

4 th to 6 th years were both significantly more likely

formulat ions during development) is one of theto answer “ag ree/strong ly ag ree” than were 3 r dspecific behavioral objectives (SBO) of the Model

year students, but there was no significant

Core Curriculum for Pharmaceut ical Educat ion

difference between the groups in Q7d. These(2015 version) 9）. A previous questionnaire survey

results suggest a gap: while students mentionedof pharmacy students receiving practical training

having a degree of knowledge of bioequivalence,on generic medicine (focusing on conveying

their reported understanding of it wasunderstanding of its characteristics and roles)

insufficient. Most participants had only received

showed that the degree of comprehension of

education on bioequivalence of generic medicines22（22）

医薬品相互作用研究

Vol.43, No. 1（2019）

in the form of lectures. It is therefore necessary

possible for pharmacists to switch genericto improve the educational curriculum to ensure

medicine and has allowed patients to requestthat students obtain a greater understanding ofgeneric medicines at the pharmacistʼs discretion.

bioequivalence, such as by incorporating new

For these reasons, education on generic

exercises to confirm the equivalence ofprescriptions remains necessary.

pharmacokinetics between generic andbrand-name medicines.

The SBO on generic medicines explicitly listed
in the Model Core Curriculum for PharmaceuticalIn the comparison of knowledge of the dosage

Education (2015 version) states that “the student

f o r m , d o s e , q u a l i t y, e f f i c a c y, s i d e e f f e c t s , d r u g

is able to evaluate the bioequivalence of different

prices, and safety of generic medicine, the mean

formulations of prescription medicine (e.g.,scores increased significantly with year of study

brand-name and generic medicine, changes infor Q7f and Q7j. This suggests that they gained

pharmaceutical formulations during

sufficient understanding of the definition ofdevelopment)” and “it is possible to compare andgeneric medicine and the economic effect ofevaluate the quality, safety, economic efficiency,

promot ing its use. On the other hand, althoughetc. of the brand-name and the generic medicine

years forb a s e d o n t h e d r u g i n f o r m a t i o n .” A l s o , t h e

Q7g, Q7h, and Q7i, there was no significant

outcomes of practical training are usuallydifference for the 6 year students. One possible

evaluated using rubrics, which ensures thatreason for this result is that during the practicalpharmacists and students can effect ively learn

training at hospitals and pharmacies conducted inwhile sharing goals 12）, and students are expected

the 5 year, participants might have encountered

to be able to deepen their understanding of thecases where there were evident differences in the

SBO. Therefore, education of generic medicines isquality, efficacy, and safety of generic medicinesconsidered more substantial.

knowledge increased in the 4

th

and 5

th

th

th

compared with brand-name medicines. Some

Based on the above findings, we might suggest

previous studies have found that the

an ideal future curriculum for education on

effectiveness and quality of certain genericgeneric medicines. First, early on in the course,

medicines are inferior to those of theirlectures on the benefits of promoting the use of. On the other hand,

generic medicines from the viewpoint of

the Ministry of Health, Labour and Welfare

pharmaceutical development and medical

regularly issues “generic medicine quality

economics should be held. By fourth year, wheni n f o r m a t i o n” w h i c h p r o v i d e s e v i d e n c e o f t h estudents begin preparing for practical training,

quality of generic medicines. Although the results

exercises could focus on providing students witho f t h i s s u r ve y i n d i c a t e t h a t s t u d e n t s g e n e r a l l ymore detailed knowledge of the adoption andhave sufficient knowledge of the quality, efficacy,

selection of generic medicines. This curriculumand side effects of generic medicines, it seems

will produce pharmacists who can contribute tonecessary to continue to educate them on thispromoting appropriate use of generic medicines.

topic through lectures and practical training toOverall, the results of this study suggest that

ensure further promot ion of the use of genericpharmacy students lack knowledge of

medicines.

bioequivalence. By enriching know ledge of thebrand-name counterparts

4-6）

Our results also indicate that students found it

evaluat ion of bioequivalence studies of genericeasier to recall a medicineʼs therapeutic classmedicines in undergraduate education, students

using generic rather than brand-names as they

will be better equipped to promote the use of

progressed through their education. Unlike

generic medicines. Although the current findings

pharmacists in the clinical setting, students

are compelling and important, the data wererecognized the names of medicines through their

obtained from a small sample of pharmacy

generic names rather than their brand-names. To

students at two facilities. Thus, the current

promote the prescription of generic nameresults may not be generalizable to othermedicines, the Japanese government has made it

pharmacy students. It is therefore important that

医薬品相互作用研究

Vol.43, No. 1（2019）23（23）

future studies recruit larger sample sizes witha/kenkou̲iryou/iyakuhin/kouhatsu̲iyakuhin/i

varying demographic characteristics and students

ndex.html, access 2018-08-3.

from other pharmaceutical training programs. In８）Hassali MA, Kong DC, Stewart K: A comparison

addit ion, it is also necessary to invest ig ate not

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generic medicines. Med Educ., 41(7), 703-710,

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Conflicts of interest: COI
The authors declare no conflicts of interest.

and Technology: Model Core Curriculum for
Pharmaceutical Education - 2015 version -,http://www.mext.go.jp/b̲menu/shingi/chousa/

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