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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

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.

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
jkm-41-1-21f1.gif
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
jkm-41-1-21f2.gif
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
jkm-41-1-21f3.gif
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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