AbstractObjectivesThis 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.
MethodsFifty-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.
ResultsThe 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.
참고문헌1. Korea Institute of Drug Safety & Risk Management. Drug Safety Information. KIDS Webpage. [cited 2020 12 Jan]; Available from: https://www.drugsafe.or.kr/
2. Lopez-Gonzalez, E, Herdeiro, MT, & Figueiras, A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf, (2009). 32(1), 19-31.
3. Shetti, S, Kumar, CD, Sriwastava, NK, & Sharma, IP. Pharmacovigilance of herbal medicines: Current state and future directions. Pharmacogn Mag, (2011). 7(25), 69-73.
4. Inman, WH. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol, (1996). 41(5), 434-5.
5. Hartman, J, Härmark, L, & van Puijenbroek, E. A global view of undergraduate education in pharmacovigilance. Eur J Clin Pharmacol, (2017). 73(7), 891-9.
6. Beckmann, J, Hagemann, U, Bahri, P, Bate, A, Boyd, IW, & Dal Pan, GJ, et al. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf, (2014). 37(10), 743-59.
7. van Eekeren, R, Rolfes, L, Koster, AS, Magro, L, Parthasarathi, G, & Al Ramimmy, H, et al. What future healthcare professionals need to know about pharmacovigilance: introduction of the WHO PV core curriculum for university teaching with focus on clinical aspects. Drug Saf, (2018). 41(11), 1003-11.
8. Lareb . Pharmacovigilance Education for Universities. 2017. Available from: https://www.pv-education.org
9. Schutte, T, Tichelaar, J, Reumerman, MO, van Eekeren, R, Rolfes, L, & van Puijenbroek, EP, et al. Feasibility and educational value of a student-run pharmacovigilance programme: a prospective cohort study. Drug Saf, (2017). 40(5), 409-18.
10. Schutte, T, Tichelaar, J, Reumerman, MO, van Eekeren, R, Rissmann, R, & Kramers, C, et al. Pharmacovigilance skills, knowledge and attitudes in our future doctors–A nationwide study in the Netherlands. Basic Clin Pharmacol, (2017). 120(5), 475-81.
11. Choi, N-K, Kwon, H-B, Lee, A-Y, & Park, B-J. A Survey on Attitudes and Awareness of Physicians and Pharmacists Regarding Spontaneous Reporting System and Experience for Adverse Drug Events in Goyang-si. JPERM, (2008). 1, 44-52.
12. Teong, C-H, Jeong, J-S, Park, K-H, Lee, D-W, & Park, S-C. Medical Staff’s Attitude towards Adverse Drug Reaction in the Dongguk University Gyeongju Hospital. Korean J Fam Pract, (2015). 5(1), 25-33.
13. Braun, V, & Clarke, V. Using thematic analysis in psychology. Qual Res Psychol, (2006). 3(2), 77-101.
14. BIO, Biomedtracker, AMPLION. Clinical Development Success Rates 2006–2015. BIO Industry Analysis. Available from: https://www.bio.org/sites/default/files/legacy/bioorg/docs/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf
15. Jung, S-Y, Choi, N-K, Lee, J, & Park, B-J. Use of big data for drug safety monitoring and decision making. J Korean Med Assoc, (2014). 57(5), 391-7.
16. Alomar, MJ. Factors affecting the development of adverse drug reactions. Saudi Pharma J, (2014). 22(2), 83-94.
17. Uppsala Monitoring Center. UMC Web page. [cited 2020 12 Jan]; Available from: https://www.who-umc.org/
18. Park, B-J. Status and Improvement Plan of Patient Safety Management System Related to Pharmaceutical Products. HIRA Policy Trend, (2014). 8(5), 16-26.
19. Park, J-W. Past, Present, and Future of Korean Regional Drug Safety Center. JPERM, (2018). 10, 43-8.
20. Plöen M. Signal Detection in a Global Database. 2018. [cited 2020 12 Jan]; Available from: https://www.meddra.org/sites/default/files/page/documents_insert/signal_detection_in_a_global_database.pdf
21. APEC Harmonization Center. 2015 AHC Activity Report, (2016). 28-31.
22. Woo, Y-j, Chung, S-y, & Park, B-J. Current Status of Spontaneous Adverse Reactions Reporting System on Herbal Medicine in China, Japan, Korea and WHO. J Int Korean Med, (2014). 35(2), 111-8.
23. Woo, Y-j, Chung, S-y, & Park, B-J. Necessity of Reporting on Herbal Medicine Adverse Event and Introduction of Reporting Method. J Int Korean Med, (2014). Oct. 174-9.
24. Shaw, D, Graeme, L, Pierre, D, Elizabeth, W, & Kelvin, C. Pharmacovigilance of herbal medicine. J Ethnopharmacol, (2012). 140(3), 513-8.
25. World Health Organization. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. 2004. [cited 2020 12 Jan]; Available from: https://apps.who.int/iris/bitstream/handle/10665/43034/9241592214_eng.pdf
26. Wechwithan, S, Suwankesawong, W, Sornsrivichai, V, McNeil, EB, Jiraphongsa, C, & Chongsuvivatwong, V. Signal detection for Thai traditional medicine: examination of national pharmacovigilance data using reporting odds ratio and reported population attributable risk. Regul Toxicol Pharmacol, (2014). 70(1), 407-12.
27. Fahim, SM, Mishuk, AU, Cheng, N, Hansen, R, Calderon, AI, & Qian, J. Adverse event reporting patterns of concomitant botanical dietary supplements with CYP3A4 interactive & CYP3A4 non-interactive anticancer drugs in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Expert Opin Drug Saf, (2019). 18(2), 145-52.
28. Li, H, Deng, J, Yue, Z, Zhang, Y, & Sun, H. Detecting drug-herbal interaction using a spontaneous reporting system database: an example with benzylpenicillin and qingkailing injection. Eur J Clin Pharmacol, (2015). 71(9), 1139-45.
29. Kwon, Y-J, Jo, W-K, & Han, C-H. Status of Herbal-drug-associated Adverse Drug Reactions Voluntarily Reported by EMR. J Int Korean Med, (2012). 33(4), 485-97.
30. Kim, M, & Han, C-H. Analysis of Herbal-drug-associated Adverse Drug Reactions Using Data from Spontaneous Reporting System in Electronic Medical Records. J Korean Med, (2015). 36(1), 45-60.
31. Lee, SH, Song, BW, Choi, HJ, & Kim, EY. The Analysis of Herbal Medicine-Associated Adverse Drug Reactions Spontaneously Reported in a Korean Medicine Hospital. J Kor Soc Health-syst Pharm, (2017). 34(2), 183-99.
32. Cho, J-H, Oh, D-S, Hong, S-H, Ko, H, Lee, N-H, & Park, S-E, et al. A nationwide study of the incidence rate of herb-induced liver injury in Korea. Arch Toxicol, (2017). 91(12), 4009-15.
33. Kim, M, & Han, C-H. Adverse drug reactions in Korean herbal medicine: A prospective cohort study. Eur J Integr Med, (2017). 9, 103-9.
34. Woo, Y, & Hyun, MK. Safety of herbal medicine for elderly patients with chronic disease in the Republic of Korea. Eur J Integr Med, (2019). 30, 100934.
35. Elkalmi, RM, Hassali, MA, Ibrahim, MIM, Widodo, RT, Efan, QMA, & Hadi, MA. Pharmacy Students’ Knowledge and Perceptions About Pharmacovigilance in Malaysian Public Universities. Am J Pharm Educ, (2011). 75(5), 96.
36. Kim, HJ, & Hwang, SY. Impact of Safety Climate Perception and Barriers to Adverse Drug Reaction Reporting on Clinical Nurses’ Monitoring Practice for Adverse Drug Reactions. Korean J Adult Nurs, (2018). 30(2), 115-25.
37. Kyung, EJ, Rew, JH, Oh, M, & Kim, EY. A Survey on Attitude and Awareness of Health-Care Professionals Regarding Pharmacovigilance System and Experience for Adverse Drug Reaction (ADR) from a Single University Hospital. Korean K Clin Pharm, (2013). 23(3), 256-68.
38. De Smet, PA. An introduction to herbal pharmacoepidemiology. J Ethnopharmacol, (1993). 38(2–3), 189-95.
39. Farah M. Guidelines for herbal ATC classification. Uppsala Monitoring Centre;Uppsala. (2004.
40. Farah M. Herbal ATC index. Uppsala;Uppsala Monitoring Centre. (2004.
41. Uppsala Monitoring Center. What’s New in WHODrug. March. 1. 2018. [cited 202012 Jan]; Available from: https://www.who-umc.org/media/164170/whats-new-in-whodrug-2018.pdf
42. ISoP, Herbal and Traditional Medicine Group. Special Interest Group. 2017. [cited 2020 12 Jan]; Available from: https://isoponline.org/special-interest-groups/herbal-and-traditional-medicines-2
43. Ministry of Food and Drug Safety/Pusan University. Construction of Herbal Drug Code System for Pharmacovigilance. 2018. [cited 202012 Jan]; Available from: http://www.ndsl.kr/ndsl/search/detail/report/reportSearchResultDetail.do?cn=TRKO201900003538
44. Lesar, TS, Briceland, L, & Stein, DS. Factors Related to Errors in Medication Prescribing. JAMA, (1997). 277(4), 312-7.
45. Gavaza, P, & Bui, B. Pharmacy students’ attitudes toward reporting serious adverse drug events. Am J Pharm Educ, (2012). 76(10), 194.
46. Gerritsen, R, Faddegon, H, Dijkers, F, van Grootheest, K, & van Puijenbroek, E. Effectiveness of pharmacovigilance training of General Practitioners. Drug Saf, (2011). 34(9), 755-62.
47. Reumerman, M, Tichelaar, J, Piersma, B, Richir, MC, & van Agtmael, MA. Urgent need to modernize pharmacovigilance education in healthcare curricula: review of the literature. Eur J Clin Pharmacol, (2018). 74(10), 1235-48.
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