DOI QR코드

DOI QR Code

Awareness of Adverse Drug Reaction Reporting System in General Population

일반인에서의 의약품 부작용보고제도 인식도

  • Received : 2014.03.24
  • Accepted : 2014.06.09
  • Published : 2014.06.30

Abstract

Background: Safety of drugs has become a major issue in public healthcare. Spontaneous reporting of adverse drug reaction (ADR) is the cornerstone in management of drug safety. We aimed to investigate the awareness and knowledge of spontaneous ADR reporting in general public of Korea. Methods: A total of 1,500 study subjects aged 19-69 years were interviewed with a questionnaire for their awareness and knowledge related to spontaneous ADR reporting. Computer assisted telephone interview was performed from 27th February 2013 to 4th March 2013. Target population was selected with quota sampling, using age, sex, and residence area. Healthcare professionals such as physicians, pharmacists, and nurses were excluded. The survey questions included awareness of spontaneous ADR reporting, opinions on ways to activate ADR reporting, and sociodemographic characteristics. Results: Overall awareness of spontaneous ADR reporting system was 8.3% (${\pm}2.53%$) among general population of Korea. Major source from which people got the information regarding ADR reporting was television/radio (69.9%), followed by internet (19.3%), and poster/brochure (6.1%). Awareness level differed between age groups (p<0.0001) and education levels (p<0.0001). Upon learning about the ADR reporting system, 88.5% of study subjects agreed on the necessity of ADR reporting system, while 46.6% thought promotion through internet and mass media as an effective way to activate ADR reporting. Conclusion: The overall awareness of spontaneous ADR reporting should be enhanced in order to establish a firm national system for drug safety. Adequate promotions should be performed targeting lower awareness groups, as well as various publicity activities via effective channels for the general population.

Keywords

References

  1. ICH Expert Working Group. Post-approval safety data management: definitions and standards for expedited reporting E2D. ICH Harmonised Tripartite Guideline. Geneva: ICH Expert Working Group; 2003.
  2. Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, et al. Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess 2011;15(20): 1-234. https://doi.org/10.3310/hta15200
  3. U.S. Food and Drug Administration. FAERS reporting by healthcare providers and consumers by year [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2013 [cited 2013 Nov 6]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070456.htm.
  4. Health Canada Marketed Health Products Directorate. Canadian adverse reaction newsletter [Internet]. Ottawa (ON): Health Canada Marketed Health Products Directorate; 2013 [cited 2013 Jul 9]. Available from: http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v23n3-eng.php.
  5. Choi NK, Park BJ. Adverse drug reaction surveillance system in Korea. J Prev Med Public Health 2007;40(4):278-284. https://doi.org/10.3961/jpmph.2007.40.4.278
  6. Korea Institute of Drug Safety and Risk Management. Drug safety information reporting status [Internet]. Seoul: Korea Institute of Drug Safety and Risk Management; 2013 [cited 2013 Nov 13]. Available from: http://drugsafe.or.kr/iwt/ds/ko/bbs/EgovBbs.do?bbsId=BBSMSTR_0000000 00021.
  7. The Medicine and Society Forum. Drug policy proposal for enhancing national health rights. Proceedings of Seminar for The Medicine and Society Forum; 2007 Nov 6; Seoul, Korea.
  8. Kim KR; Korea Consumer Agency. Survey on drug side effects. Seoul: Korea Consumer Agency; 2008 [cited 2008 Nov]. Available from: http:// www.kca.go.kr/brd/m_46/down.do?itm_seq_1=1&brd_id=R001&seq= 1300&data_tp=A&file_seq=1.
  9. Park S, Song HJ, Jin XM, Rhee CW, Seo JY, Oh JW, et al. Awareness of spontaneous adverse drug events reporting system among general population. J Pharmacoepidemiol Risk Manag 2012;5:130-136.
  10. Billings J, Zeitel L, Lukomnik J, Carey TS, Blank AE, Newman L. Impact of socioeconomic status on hospital use in New York City. Health Aff (Millwood) 1993;12(1):162-173.
  11. Mehta RH, O'Shea JC, Stebbins AL, Granger CB, Armstrong PW, White HD, et al. Association of mortality with years of education in patients with ST-segment elevation myocardial infarction treated with fibrinolysis. J Am Coll Cardiol 2011;57(2):138-146. https://doi.org/10.1016/j.jacc.2010.09.021
  12. Korea Internet & Security Agency. Study on internet usage in 2013. Seoul: Korea Internet Security Agency; 2013.
  13. Ministry of Food and Drug Safety. Provision of safety information management regulation of drugs. MFDS notice no. 2014-97. Cheongwon: Ministry of Food and Drug Safety; 2014.
  14. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol 2007;63(2):148-156. https://doi.org/10.1111/j.1365-2125.2006.02746.x
  15. Aagaard L, Nielsen LH, Hansen EH. Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006. Drug Saf 2009;32(11):1067-1074. https://doi.org/10.2165/11316680-000000000-00000
  16. Aagaard L, Hansen EH. Consumers' reports of suspected adverse drug reactions volunteered to a consumer magazine. Br J Clin Pharmacol 2010;69(3):317-318. https://doi.org/10.1111/j.1365-2125.2009.03584.x
  17. Office of the Safety and Quality Council. Consumer Update (November 2004) [Internet]. Canberra: Australian Council for Safety and Quality in Health Care; 2004 [cited 2004 Nov 20]. Available from: http://www.safetyandquality.gov.au/wp-content/uploads/2012/01/newsnov04.pdf.

Cited by

  1. Signal Detection for Cardiovascular Adverse Events of DPP-4 Inhibitors Using the Korea Adverse Event Reporting System Database, 2008–2016 vol.60, pp.2, 2019, https://doi.org/10.3349/ymj.2019.60.2.200