Effect of A Pharmacovigilance Practice Training Course for Future Doctors of Korean Medicine on Knowledge, Attitudes and Self Efficacy

Mikyung Kim; Kim, Mikyung

doi:10.13048/jkm.20003

JKM > Volume 41(1); 2020 > Article

Kim: Effect of A Pharmacovigilance Practice Training Course for Future Doctors of Korean Medicine on Knowledge, Attitudes and Self Efficacy

Original Article

The Journal of Korean Medicine 2020; 41(1): 21-44.

Published online: March 9, 2020

DOI: https://doi.org/10.13048/jkm.20003

Effect of A Pharmacovigilance Practice Training Course for Future Doctors of Korean Medicine on Knowledge, Attitudes and Self Efficacy

Mikyung Kim^*

Department of Internal Medicine, College of Korean Medicine, Sangji University

Correspondence to: Mikyung Kim, Department of Internal Medicine, College of Korean Medicine, Sangji University, 83 Sangjidae-ro, Wonju, Gangwon-do, 26338, Republic of Korea, Tel: +82-33-741-9215, Fax: +82-33-732-2124, E-mail: 01mkkim@gmail.com

Received January 6, 2020 Revised February 3, 2020 Accepted February 5, 2020

Abstract

Objectives

This study was aimed to develop a pharmacovigilance practice training course for future doctors of Korean medicine, the graduate students of a college of Korean medicine, and to verify the educational effect of the curriculum.

Methods

Fifty-six students were given a training course designed as follows: 1) pre-class homework (basic theory self-study, online course, causality assessment, and adverse event reporting simulation); 2) in-class: homework submission and case discussion; 3) after-class: homework revision and resubmission. An online survey to assess the change of the level of basic knowledge and attitudes toward pharmacovigilance, the willingness to report adverse events, and self-efficacy for the causality assessment and adverse event reporting was conducted before and after education.

Results

The survey participation rate was 96.5% in pre-education and 64.3% in the post-education survey. After education, knowledge level was improved (mean score from 4.3±2.11 to 6.7±1.96 points, modal value from 3 to 8 points) and positive changes were observed in almost all questions on attitudes. In the post-education survey, more students felt that they could do causality assessment (from 13% to 80.5%), could report adverse events to the agency in charge (from 7.4% to 96.2%), and expressed their strong willingness to report adverse events in the future (from 77.8% to 88.9%) than in the pre-education survey.

Conclusions

More schools of Korean medicine need to adopt pharmacovigilance training courses in their curriculum to foster future doctors of Korean medicine with pharmacovigilance capabilities. Such efforts will be the basis for achieving an evidence-based, safe use of herbal medicine.

Keywords: pharmacovigilance, spontaneous reporting system, adverse event reporting, undergraduate education, clinical practice training, college of Korean medicine

Supplementary Material

Supplement 1

Questionnaire

jkm-41-1-21-suppl.pdf

Fig. 1

Changes in knowledge level before and after education (distribution of total score)

n=54 for pre-, and 36 for post-education

x-axis, total score (out of 10); y-axis, number of students

Fig. 2

Changes in expected responses in questions on attitudes toward pharmacovigilance and adverse event reporting before and after education

n=54 for pre-, and 36 for post-education

Abbreviations: KMD, Korean medicine doctor; PV, pharmacovigilance; AE, adverse event

Fig. 3

Changes in expected responses in questions on self-efficacy, willingness to report, and attitudes toward the need for PV course before and after education

n=54 for pre-, and 36 for post-education

Abbreviations: PV, pharmacovigilance; AE, adverse event; KM, Korean medicine

Table 1

Changes in knowledge level before and after education (percentage of the correct answer by each question)

Questions	Options	Pre-education	Post-education
Concept of pharmacovigilance		36(66.7)	27(75.0)
Concept of side effect		29 (53.7)	31 (86.1)
Concept of adverse drug reactions		10 (18.5)	18 (50.0)
Main methodology of PMS		32 (59.3)	34 (94.4)
Agency in charge of SRS in Korea		19 (35.2)	22 (61.1)
WHO CC for International Drug Monitoring		14 (25.9)	26 (72.2)

Potent reporters in SRS	Correct answer	11 (20.4)	20 (55.6)
	Doctors	47 (87.0)	35 (97.2)
	KMDs	46 (85.2)	34 (94.4)
	Dentists	45 (83.3)	35 (97.2)
	Pharmacists	35 (64.8)	30 (83.3)
	KOPs	21 (38.9)	27 (75.0)
	Nurses	20 (37.0)	27 (75.0)
	Patients	18 (33.3)	23 (63.9)
	Patients’ care-givers	13 (24.1)	22 (61.1)
	Do not know	10 (18.5)	2(5.6)

Targets of SRS	Correct answer	1 ( 1.9)	5(13.9)
	Nonprescription drugs	31 (57.4)	34 (94.4)
	Prescription drugs	29 (53.7)	32 (88.9)
	Vaccines	25 (46.3)	28 (77.8)
	Biologics	25 (46.3)	24 (66.7)
	HM (pharmaceutical preparations)	21 (38.9)	24 (66.7)
	HM (complex formulae prepared by individuals)	19 (35.2)	18 (50.0)
	HM (single drug)	16 (29.6)	27 (75.0)
	Do not know	22 (40.7)	3 (8.3)

Reporting criteria based on causality level		41 (75.9)	29 (80.6)
Disclosing of patient personal information in ICSRs		41 (75.9)	30 (83.3)

Results are presented as frequency (%). N=54 for pre-, and 36 for post-education.

Abbreviations: PMS, post-marketing surveillance; SRS, spontaneous reporting system; WHO, World Health Organization; CC, collaborating center; KMD, Korean Medicine Doctors; KOP, Korean Oriental Pharmacist; HM, herbal medicine; ICSR, individual case safety report

Table 2

Changes in attitudes toward pharmacovigilance and adverse event reporting before and after education (selection rate for each distractor)

Questions	Time point	Options
The role of the KMDs in PV is important		No		Do not know		Yes

	Pre	4 (7.4)		9 (16.7)		41 (75.9)
	Post	0 (0.0)		1 (2.8)		35 (97.2)

KMDs need to report AEs to agency in charge, when they experienced/witnessed AEs after HM therapy.		No	Do not know	Report only HM-related AEs	Report all except HM-related AEs	Yes

	Pre	0 (0.0)	4 (7.4)	3 (5.6)	0 (0.0)	47 (87.0)
	Post	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	36 (100.0)

AE reporting will result in the followings:		Unlikely	Less likely	Do not know	Likely	Very Likely

1) People learn lessons about drug risks	Pre	0 (0.0)	4 (7.4)	5 (9.3)	32 (59.3)	13 (24.1)
	Post	0 (0.0)	0 (0.0)	2 (5.6)	20 (55.6)	14 (38.9)

2) The reporter gains personal benefits	Pre	9 (16.7)	15 (27.8)	20 (37.0)	7 (13.0)	3 (5.6)
	Post	9 (25.0)	7 (19.4)	13 (36.1)	7 (19.4)	0 (0.0)

3) It contributes to improving patient safety.	Pre	1 (1.9)	1 (1.9)	5 (9.3)	32 (59.3)	15 (27.8)
	Post	0 (0.0)	0 (0.0)	2 (5.6)	15 (41.7)	19 (52.8)

4) It increases the risk of medication errors	Pre	11 (20.4)	22 (40.7)	10 (18.5)	9 (16.7)	2 (3.7)
	Post	13 (36.1)	15 (41.7)	7 (19.4)	0 (0.0)	1 (2.8)

5) It breaks trust with patients	Pre	6 (11.1)	16 (29.6)	15 (27.8)	15 (27.8)	2 (3.7)
	Post	8 (22.2)	13 (36.1)	12 (33.3)	2 (5.6)	1 (2.8)

6) It interferes with the normal workflow	Pre	4 (7.4)	23 (42.6)	18 (33.3)	7 (13.0)	2 (3.7)
	Post	12 (33.3)	11 (30.6)	10 (27.8)	2 (5.6)	1 (2.8)

7) The reporting process wastes time.	Pre	12 (22.2)	21 (38.9)	10 (18.5)	9 (16.7)	2 (3.7)
	Post	16 (44.4)	10 (27.8)	6 (16.7)	3 (8.3)	1 (2.8)

8) It leads to a decrease in medical income.	Pre	10 (18.5)	15 (27.8)	16 (29.6)	12 (22.2)	1 (1.9)
	Post	12 (33.3)	11 (30.6)	10 (27.8)	2 (5.6)	1 (2.8)

9) It causes legal disputes.	Pre	3 (5.6)	9 (16.7)	16 (29.6)	21 (38.9)	5 (9.3)
	Post	9 (25.0)	6 (16.7)	15 (41.7)	5 (13.9)	1 (2.8)

10) It contributes to the safe use of drugs.	Pre	0 (0.0)	2 (3.7)	5 (9.3)	28 (51.9)	19 (35.2)
	Post	1 (2.8)	0 (0.0)	3 (8.3)	12 (33.3)	20 (55.6)

Results are presented as frequency (%). N=54 for pre-, and 36 for post-education.

Abbreviations: KMD, Korean Medicine Doctors; PV, pharmacovigilance; pre, pre-education; post, post-education; HM, herbal medicine; AE, adverse event

Table 3

Changes in self-efficacy, willingness to report, and attitudes toward the need for pharmacovigilance course before and after education (selection rate for each distractor)

Questions	Time point	Options
I can assess the causal relationship between AEs and suspected drugs.		Not at all	Mostly no	Do not know	Mostly yes	Always yes

	Pre	3 (5.6)	11 (20.4)	33 (61.1)	5 (9.3)	2 (3.7)
	Post	1 (2.8)	1 (2.8)	5 (13.9)	25 (69.4)	4 (11.1)

I can report AEs to the agency in charge.		No		Yes

	Pre	50 (92.6)		4 (7.4)
	Post	1 (2.8)		35 (97.2)

I will report the AEs to the agency in charge.		Not at all	Mostly no	Do not know	Mostly yes	Always yes

	Pre	0 (0.0)	1 (1.9)	11 (20.4)	34 (63.0)	8 (14.8)
	Post	0 (0.0)	0 (0.0)	4 (11.1)	21 (58.3)	11 (30.6)

PV course should be included in the curriculum of college of KM.		Not agree		Do not know		Agree

	Pre	6 (11.1)		9 (16.7)		39 (72.2)
	Post	1 (2.8)		4 (11.1)		31 (86.1)

Results are presented as frequency (%). N=54 for pre-, and 36 for post-education.

Abbreviations: KMD, Korean Medicine Doctors; PV, pharmacovigilance; pre, pre-education; post, post-education; HM, herbal medicine; AE, adverse event; KM, Korean medicine

Table 4

Themes Emerging in the Survey

Question	Theme	Subtheme
Educational Effect of This Course	1. Instructive (n=9)	1-1. Learned new things not familiar with
		1-2. A chance to think about how to prepare in case of AEs

	2. Realized the need for PV (n=2)	2-1. PV will contribute to the improvement and development of KM
		2-2. I will actively participate in PV in the future.

Suggestions for Improvement of the PV System for HM	1. PV target expansion (n=4)	All types of HMs in circulation should be included in PV system in addition to pharmaceutical preparations

	2. Activation of PV participation in KM profession (n=3)	2-1. Activation of HM-related AE reporting by KMDs
		2-2. Promoting KMDs to report AEs
		2-3. Encouraging education and researches

Abbreviations: AE, adverse events; PV, pharmacovigilance; KM, Korean medicine; HM, herbal medicine; KMD, Korean medicine doctors

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