An investigation of learning motivation for pharmaceutical laws among pharmacy students

抄録

薬事関係法規に対する薬学生の学習意欲と興味のある職種との関係性を明らかにすることを目的として，北里大学薬学部の6年制課程と4年制課程の4年次生を対象にアンケート調査を行った．246名の有効回答を用いて因子分析を行い，さらに回答者ごとに算出した因子得点を用いてクラスター分析を行った．また，現時点で興味のある職種に関する自由記載データを用いて計量テキスト分析を行い，学科別に興味のある職種と学習意欲との関係性について対応分析を行った．その結果，4年制課程の学生は6年制課程の学生に比べて学習意欲が低く，薬事関係法規の知識習得の必要性を感じていないことが示唆された．また，6年制課程の学生では，病院や薬局の薬剤師に興味のある学生の学習意欲が高く，4年制課程の学生では，研究職や開発職に興味のある学生は，薬事関係法規の知識習得の必要性を感じていないことが示唆された．

Abstract

This study sought to clarify the relationship between the learning motivation of pharmacy students to study pharmaceutical laws and their occupations of interest. A questionnaire was administered to fourth-year students in the six-year and four-year programs at the Kitasato University School of Pharmacy. A factor analysis used 246 valid responses, and factor scores calculated for each respondent were used for cluster analysis. A quantitative textual analysis was also conducted using data from a free-response question on the occupations that respondents were interested in at the time of the investigation. The results suggested that students in the four-year program had lower learning motivation than students in the six-year program did and that they did not feel the need to acquire knowledge on pharmaceutical laws. It was suggested that, among students in the six-year program, students interested in becoming a pharmacist at a hospital or a community pharmacy had higher learning motivation. Furthermore, it was suggested that among students in the four-year program, those interested in research and development jobs did not feel the need to acquire knowledge on pharmaceutical laws.

Introduction

Until the 2005 academic year, Japanese pharmaceutical education adhered to a four-year program. However, from the April of 2006, two separate undergraduate programs were introduced: a six-year program aimed primarily at training pharmacists and a four-year program intended to train specialists involved in the research and development of drugs as well as various talents in other areas¹⁾. With the introduction of the new six-year program, a Model Core Curriculum for Pharmacy Education (MCC) was compiled to provide a set of guidelines on educational content; a second revised version of which is in use since April 2015²⁾. The MCC outlines competencies that pharmacy students must acquire by the time of graduation, and the learning objective covers the acquisition of knowledge on the key laws and regulations governing their work. Although, until recently, there were no curriculum guidelines for four-year programs in Japanese pharmacy schools, in August 2017, a set of reference criteria³⁾ was published, and students are now required to acquire basic knowledge of laws and regulations governing the development and supply of drugs, medical instruments, et al. Thus far, the authors have analyzed the effects of learner characteristics on outcomes of learning pharmaceutical laws⁴⁾ and conducted research related to teaching materials designing⁵⁾, which has yet to lead to an improvement in learning results. We have therefore investigated learning motivation in students in the six-year and four-year programs at the Kitasato University School of Pharmacy and identified its relationship with occupations they are interested in so as to gain valuable insights toward designing education in pharmaceutical laws.

Method

1.  Course overview

The fourth-year course “Pharmaceutical Affairs Law and Related Laws” of the Kitasato University School of Pharmacy is conducted via weekly 90-minute lectures over the course of 10 weeks. There is no separate group work, but generally, a quiz is taken every class. Fourth-year students on the six- and four-year programs take the same classes together on this course. The lectures were held in the second period every Tuesday from April 10, 2018 to June 19, 2018. The contents of this class address SBOs No. 1–9 in the revised version of the MCC, Section B. Pharmaceutical Sciences in Society, (2) Laws and Regulations Governing Pharmacists and Pharmaceuticals, ② Laws and Regulations Ensuring the Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, as well as items No. 1–3 of the SBOs in ③ Laws and Regulations Governing Supervised Pharmaceuticals and Substances. Specifically, lectures proceed through the regulations in the following order: Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices; Act on Securing a Stable Supply of Safe Blood Products; Narcotics and Psychotropics Control Act; Opium Control Act; Cannabis Control Act; and Poisonous and Deleterious Substances Control Act.

2.  Respondents

The study targeted 300 fourth-year students in the School of Pharmacy, Kitasato University; who were enrolled in the Faculty of Pharmacy (six-year program: 254 students) and the Department of Pharmaceutical Life Sciences (four-year program: 46 students), that took a course titled “Pharmaceutical Affairs Law and Related Laws” in the 2018 academic year. At the Kitasato University School of Pharmacy, “Pharmaceutical Affairs Law and Related Laws” was previously offered as a compulsory course for students in the six-year program, and as an elective course for students in the four-year program. However, from the 2018 academic year, this course became compulsory for both programs.

3.  Questionnaire content and method

The questionnaire was developed with reference to the ARCS model^6,7) to measure pharmacy student’s learning motivation for studying pharmaceutical laws (Table 1). The ARCS model is an approach that synthesizes research on learning motivation to describe motivational factors across four categories: attention (A), relevance (R), confidence (C), and satisfaction (S). In addition, space was provided to freely describe “Occupations you are currently interested in (multiple answers accepted)” to widely explore what type of occupations the students were currently interested in. The questionnaire was distributed to the students on the final day of the course and the students were informed of the purpose of the study. They were also informed that participation was voluntary—they would not suffer any disadvantage if they declined to participate—and steps would be taken to ensure their confidentiality if the results were published at an academic conference or in a journal. All consenting students placed their completed questionnaires in a collection box near the entrance of the lecture hall.

Table 1 Questionnaire on learning motivation

		←	Strongly agree		Cannot say either way	Strongly disagree		→
Q1	It made me sleepy.		1	2	3	4	5		It did not make me sleepy.
Q2	It did not make me curious.		1	2	3	4	5		It made me curious.
Q3	It was tedious.		1	2	3	4	5		There was a lot of variety.
Q4	It had nothing to do with me.		1	2	3	4	5		It was relevant to me.
Q5	I did not care about the content.		1	2	3	4	5		I wanted to acquire the content.
Q6	The learning process was not fun.		1	2	3	4	5		The learning process was fun.
Q7	The learning goals were ambiguous.		1	2	3	4	5		The learning goals were clear.
Q8	I gradually got lost as the learning progressed.		1	2	3	4	5		The learning progressed steadily, one step at a time.
Q9	I was not able to put my own effort into it.		1	2	3	4	5		I was able to put my own effort into it.
Q10	There were no chances to use the knowledge I acquired.		1	2	3	4	5		There were chances to use the knowledge I acquired.
Q11	I was not recognized despite doing well.		1	2	3	4	5		I was recognized when I did well.
Q12	Grades weren’t evaluated fairly.		1	2	3	4	5		Grades were evaluated fairly.

4.  Analysis method

Factor analysis was performed on the aggregate data that was collected from the questionnaire and the number of factors was determined by choosing components with eigenvalues greater than 1.0. Items with a final communality lower than 0.2 were eliminated along with items with a factor loading of less than 0.4 with respect to all the other factors. The factor analysis used maximum likelihood estimation with the varimax rotation method. Next, hierarchical cluster analysis (Ward’s method) was performed using the factor scores obtained for each respondent, and the mean factor scores along with the distribution of students was computed for each group. These analysis methods and criteria settings were determined based on reports previously published Japanese research findings on pharmaceutical education^8–12). In addition, a quantitative textual analysis was performed on the responses to the free-form question on the types of occupation that respondents were interested in at the time of the investigation, and the occupation types that appeared in the responses more than five times were extracted. Of the extracted occupation types, Contract research organization (CRO), Site management organization (SMO), Clinical research coordinator (CRC), and Clinical research associate (CRA) were placed in the “Clinical Trials” category. Meanwhile, Civil Servant, Ministry Narcotics Agent, National Civil Servant, Prefectural Narcotics Agent, Pharmaceutical Affairs Inspector, and Local Civil Servant were placed in the “Civil Servant” category. A correspondence analysis was also performed to clarify the relationship between respondents’ occupations of interest at the time of the investigation and their motivation to learn. IBM SPSS Version 23 and KH Coder 3¹³⁾ were used for this data analysis. The data of respondents who did not answer the item regarding their motivation to learn were excluded from the statistical analysis.

5.  Ethical considerations

The study was approved by the Research Ethics Committee of Kitasato Institute Hospital (approval number: 18022).

Results

Table 2 shows the analyzed results of 246 responses (valid response rate: 82.0%). The factor analysis generated four factors, with a cumulative contribution ratio of 52.5% (Table 3). Based on their constituent items, the factors were as follows:

Table 2 Aggregated results

	Six-year Program (n = 215)					Mean	Four-year Program (n = 31)					Mean	Total (n = 246)					Mean
	1	2	3	4	5		1	2	3	4	5		1	2	3	4	5
Q1	6	32	74	62	41	3.47	0	8	13	6	4	3.19	6	40	87	68	45	3.43
Q2	5	21	74	89	26	3.51	2	4	19	5	1	2.97	7	25	93	94	27	3.44
Q3	3	20	97	73	22	3.42	1	5	16	9	0	3.06	4	25	113	82	22	3.38
Q4	3	9	63	94	46	3.80	2	2	16	11	0	3.16	5	11	79	105	46	3.72
Q5	0	10	30	111	64	4.07	0	5	14	9	3	3.32	0	15	44	120	67	3.97
Q6	2	18	77	79	39	3.63	1	4	15	9	2	3.23	3	22	92	88	41	3.58
Q7	0	11	56	92	56	3.90	0	3	15	10	3	3.42	0	14	71	102	59	3.84
Q8	2	26	78	78	31	3.51	1	4	19	6	1	3.06	3	30	97	84	32	3.46
Q9	10	52	104	39	10	2.94	3	8	17	3	0	2.65	13	60	121	42	10	2.90
Q10	7	26	92	65	25	3.35	3	6	17	4	1	2.81	10	32	109	69	26	3.28
Q11	0	8	129	62	16	3.40	1	1	25	4	0	3.03	1	9	154	66	16	3.35
Q12	1	4	94	52	64	3.81	0	0	20	8	3	3.45	1	4	114	60	67	3.76

Table 3 Results of the factor analysis

Factor	Name	Question	Communality	Factor 1	Factor 2	Factor 3	Factor 4
Factor 1	How interesting were the classes	Q6	0.556	0.667	0.208	0.206	0.162
		Q2	0.569	0.646	0.001	0.208	0.328
		Q3	0.512	0.599	0.321	0.051	0.217
		Q1	0.254	0.458	0.153	0.069	0.126
Factor 2	Clarity of goals and assessment	Q12	0.415	0.116	0.629	0.054	0.050
		Q11	0.546	0.127	0.617	–0.012	0.385
		Q7	0.525	0.350	0.586	0.243	0.030
Factor 3	How essential is the knowledge acquired	Q4	0.999	0.138	0.043	0.966	0.212
		Q5	0.419	0.375	0.211	0.468	0.119
Factor 4	Sense of actually acquiring and using knowledge	Q9	0.536	0.286	0.072	0.112	0.661
		Q10	0.415	0.197	0.211	0.275	0.506
		Q8	0.557	0.423	0.413	0.133	0.435
		Contribution ratio		17.0	13.0	11.8	10.7
		Cumulative contribution ratio		17.0	30.0	41.8	52.5

Factor 1: How interesting the classes are

Factor 2: Clarity of learning goals and assessment

Factor 3: How essential is the knowledge being acquired

Factor 4: Sense that knowledge is being acquired and used

In addition, hierarchical cluster analysis was performed using individual respondents’ factor scores. The respondent were then divided into three groups (Group A, Group B, and Group C) based on the shape of the dendrogram (Fig. 1, Table 4). The characteristics of each group indicated by the mean factor scores were as follows:

Fig. 1

Tree diagram of cluster analysis.

Table 4 Factor scores and distribution of students in each group

Group	Factor 1	Factor 2	Factor 3	Factor 4	Six-year program (n = 215)		Four-year Program (n = 31)		Total (n = 246)
					n	%	n	%	n	%
A	–0.48	–0.18	0.61	–0.29	84	39.1	12	38.7	96	39.0
B	0.72	0.43	0.33	0.62	70	32.6	3	9.7	73	29.7
C	–0.08	–0.19	–1.08	–0.23	61	28.4	16	51.6	77	31.3

The mean score is displayed for each factor.

Group A: Respondents who recognize the need to acquire knowledge but whose scores for the other factors are below the mean

Group B: Respondents who scored above the mean for all factors and who had an overall high level of motivation to learn

Group C: Respondents who scored below the mean for all factors and who felt no particular need to acquire knowledge

The total students were divided as: Group A (n = 96, 39.0%), Group B (n = 73, 29.7%), and Group C (n = 77, 31.3%); with six-year and four-year program contributing to Group A (n = 84, 39.1%), Group B (n = 70, 32.6%), Group C (n = 61, 28.4%); and Group A (n = 12, 38.7%), Group B (n = 3, 9.7%), Group C (n = 16, 51.6%), respectively.

In addition, 163 of the 246 students answered the free-response question on the types of occupation they were interested in at the time of the investigation. The quantitative textual analysis generated the following eleven categories of occupations that occurred in more than five responses: Pharmacist, Hospital, Community pharmacy, Clinical trials, Medical representative (MR), Research, Civil servant, Development, Pharmaceutical industry, Cosmetics, and Drugstore (Table 5). Among students on the six-year program, “Pharmacist” (95 responses) was the most common, followed by “Hospital” (44 responses) and “Community pharmacy” (41 responses). Among the students on the four-year program, “Research” (12 responses) was the most common, followed by “Development” (7 responses) and “Cosmetics” (5 responses). Next, correspondence analysis (results shown in Fig. 2) was used to determine the relationships between the three groups (Group A, Group B, and Group C) in terms of trends in relation to students’ learning motivation and the occupations that respondents were interested in on each program. For students on the six-year program who were in Group B, the responses “Hospital,” “Pharmacist,” and “Community pharmacy” tended to appear more often than other occupations; the responses “Pharmaceutical industry” and “Development” tended to appear more often in the answers of Group A; “MR” tended to appear more often in the answers of both Group A and Group C; and “Cosmetics” appeared in the answers of both Group B and Group C. Meanwhile, with regard to students on the four-year program, the responses “Research” and “Development” tended to appear more often in Group C, while the responses “Clinical trials,” “Pharmaceutical industry,” “MR,” and “Cosmetics,” showed a slight tendency to appear more often in Group A.

Table 5 Results of textual analysis of the occupations that students were interested in at the time of the investigation

No.	Category	Extracted words	Six-year program (n = 139)		Four-year program (n = 24)		Total frequency
			Frequency	%a)	Frequency	%a)
1	Pharmacist	Pharmacist	95	63.3b)	0	0	95
2	Hospital	Hospital	44	31.7	0	0	44
3	Community Pharmacy	Community Pharmacy	41	29.5	0	0	41
4	Clinical Trials	CRO	15	10.8	4	16.7	25c)
		SMO	3	2.2	0	0
		CRC	2	1.4	0	0
		CRA	1	0.7	0	0
5	MR	MR	20	14.4	3	12.5	23
6	Research	Research	3	2.2	12	45.8d)	15
7	Civil Servant	Civil Servant	4	2.9	0	0	14
		Ministry Narcotics Agents	4	2.9	0	0
		National Civil Servant	3	2.2	0	0
		Prefectural Narcotics Agents	1	0.7	0	0
		Pharmaceutical Affairs Inspectors	1	0.7	0	0
		Local Civil Servant	1	0.7	0	0
8	Development	Development	4	2.9	7	29.2	11
9	Pharmaceutical Industry	Pharmaceutical Industry	5	3.6	3	12.5	8
10	Cosmetics	Cosmetics	2	1.4	5	20.8	7
11	Drugstore	Drugstore	6	4.3	0	0	6

^a) This indicates the percentage of respondents whose words extracted from the questionnaire were included. ^b) Seven respondents answered “Pharmacist” twice in the questionnaire, and therefore, the percentage of respondents was calculated based on 88 respondents. ^c) Two respondents from the six-year program responded to the questionnaire with “CRO” and “SMO” in the same answer. ^d) One respondent answered “Research” twice in the questionnaire, and therefore, the percentage of respondents was calculated based on 11 respondents.

Fig. 2

Results of the correspondence analysis.

Discussion

With regard to students’ motivation to learn, 39.1% of students on the six-year program were in Group A, 32.6% were in Group B, and 28.4% were in Group C. Meanwhile, for the students on the four-year program, 38.7% of students were in Group A, 9.7% were in Group B, and 51.6% were in Group C. This indicates a difference in the distribution tendencies between the two programs (Table 4). In particular, among the students on the four-year program, there were few who were in Group B, and there were many who were in Group C. This may have been because the pharmaceutical laws course targeted in the present study was based on the revised MCC, and thus, there was no motivation for students on the four-year program to study CBT or the national examinations for pharmacists.

The correspondence analysis revealed that among students on the six-year program, the responses “Hospital,” “Pharmacist,” and “Community pharmacy” tended to appear more often than other occupations in Group B, which comprised the students with a higher level of motivation to learn (Fig. 2). A study of students on a six-year program at the Hoshi University has indicated that the learning effects of sixth-year students may be influenced by factors such as whether the students want to work in an occupation for which a pharmacist license is required¹⁴⁾. Although the present study investigated fourth-year students, it is possible that student’s interest in occupations that required a pharmacist license was related to their motivation to learn about pharmaceutical laws, even while students were in the fourth year of a six-year program. In addition, responses for “Pharmaceutical industry” and “Development” tended to appear more often in Group A, while “MR” tended to appear more often in both Group A and Group C responses; this suggests that in addition to the factors noted above, there may have been a lack of information to motivate students who were interested in these occupations. “Cosmetics” responses were plotted at a position distant from the origin in an intermediate direction between Group B and Group C; this may have been because this response was only featured in two answers, and therefore, it appears in a distinct position in the calculation. Meanwhile, among students on the four-year program, those in Group A showed a slight tendency toward responses mentioning “Clinical trials,” “Pharmaceutical industry,” “MR,” and “Cosmetics,” whereas “Research” and “Development” tended to appear more often in the responses of students who were in Group C. This may have been because students who were interested in careers in research and development felt little need to acquire knowledge on this particular course, as the lectures were based on the revised MCC, which does not include much content that is of relevance to research and development roles.

By way of example, one potential way of improving lesson design based on the findings of the present research is to invite guest speakers who work in occupations that are of interest to students on both the four- and six-year programs to give lectures on the relationship between business and pharmaceutical laws. This may help stimulate curiosity among students who are not motivated to learn in lecture-based classes conducted solely by university faculty members, as well as prompting such students to feel the need to acquire knowledge. It may also be possible to increase students’ motivation to learn about pharmaceutical laws by taking advantage of the extant course structure in which students on both the four- and six-year programs take classes together, by introducing active learning classes in which students can engage in discussion and exchange opinions. Although the course examined in the present study did not include content on regulatory science, which is highly relevant to the research and development of pharmaceutical products, recent studies of practical examples of regulatory science education^15–17) indicate that such education may be useful for improving the learning motivation of pharmacy students who are interested in careers in research and development.

One limitation of the present study is that it focused on the fourth-year students of the six- and four-year programs at the Kitasato University School of Pharmacy who learn about pharmaceutical laws only through lectures. Therefore, the effects of classes conducted via other than lectures or those for students at grades other than fourth year may be different. Future research will be necessary to explore the structure of the motivation to learn about pharmaceutical laws among pharmacy students and strive to design lessons that contribute to improving learning motivation.

Acknowledgments

We are deeply grateful to Dr. Masako Kiyono, professor at Kitasato University School of Pharmacy, and Dr. Daisuke Kuroda, lecturer at the Faculty of Engineering, The University of Tokyo, for their invaluable advice during the course of this study.

Conflicts of interest

There is no conflict of interest to be disclosed in relation to the contents of this paper.

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