The Journal of Korean Medicine (대한한의학회지)

The Society of Korean Medicine (대한한의학회)
권호 표지
DOI QR코드

DOI QR Code

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

약물감시 실습 교육이 한의과대학 학부생의 지식, 태도 및 자가 효능감에 미치는 효과

  • Kim, Mikyung (Department of Internal Medicine, College of Korean Medicine, Sangji University)
  • 김미경 (상지대학교한의과대학 내과학교실)
  • Received : 2020.01.06
  • Accepted : 2020.02.05
  • Published : 2020.03.01
Download PDF
⟨ Previous Next ⟩

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

References

  1. Korea Institute of Drug Safety & Risk Management, Drug Safety Information. In: 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. https://doi.org/10.2165/00002018-200932010-00002
  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. https://doi.org/10.4103/0973-1296.75905
  4. Inman WH. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol. 1996;41(5):434-5. https://doi.org/10.1111/j.1365-2125.1996.tb00040.x
  5. Hartman J, Harmark L, van Puijenbroek E. A global view of undergraduate education in pharmacovigilance. Eur J Clin Pharmacol. 2017;73(7):891-9. https://doi.org/10.1007/s00228-017-2237-z
  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. https://doi.org/10.1007/s40264-014-0216-1
  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. https://doi.org/10.1007/s40264-018-0681-z
  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. https://doi.org/10.1007/s40264-016-0502-1
  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. https://doi.org/10.1111/bcpt.12712
  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. https://doi.org/10.1191/1478088706qp063oa
  14. BIO, Biomedtracker, AMPLION. Clinical Development Success Rates 2006-2015. In: 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. https://doi.org/10.5124/jkma.2014.57.5.391
  16. Alomar MJ, Factors affecting the development of adverse drug reactions. Saudi Pharma J. 2014;22(2):83-94. https://doi.org/10.1016/j.jsps.2013.02.003
  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. Ploen 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. https://doi.org/10.1016/j.jep.2012.01.051
  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. https://doi.org/10.1016/j.yrtph.2014.06.007
  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. https://doi.org/10.1080/14740338.2019.1562546
  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. https://doi.org/10.1007/s00228-015-1898-8
  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. https://doi.org/10.13048/jkm.15005
  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. https://doi.org/10.1007/s00204-017-2007-9
  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. https://doi.org/10.1016/j.eujim.2016.11.016
  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. https://doi.org/10.1016/j.eujim.2019.100934
  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. https://doi.org/10.5688/ajpe75596
  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. https://doi.org/10.7475/kjan.2018.30.2.115
  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. https://doi.org/10.1016/0378-8741(93)90016-X
  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 2020 12 Jan]; Available from: https://www.who-umc.org/media/164170/whats-new-in-whodrug-2018.pdf.
  42. ISoP, Herbal and Traditional Medicine Group. In: 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 2020 12 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. https://doi.org/10.1001/jama.1997.03540280050033
  45. Gavaza P, Bui B. Pharmacy students' attitudes toward reporting serious adverse drug events. Am J Pharm Educ. 2012;76(10):194. https://doi.org/10.5688/ajpe7610194
  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. https://doi.org/10.2165/11592800-000000000-00000
  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. https://doi.org/10.1007/s00228-018-2500-y

Cited by

  1. Facilitators and barriers of herbal medicine use in diabetic patients: A qualitative study vol.10, pp.1, 2021, https://doi.org/10.4103/jehp.jehp_1451_20