Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

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

약물감시사업과 약물유해반응에 대한 인식도 조사

  • Kyung, Eun Jung (College of Pharmacy, Chungnam National University) ;
  • Rew, Ji Hyun (College of Pharmacy, Chungnam National University) ;
  • Oh, Mina (Department of Pharmacy, St. Mary's Hospital) ;
  • Kim, Eun Young (College of Pharmacy, Chung-Ang University)
  • Received : 2013.02.07
  • Accepted : 2013.09.05
  • Published : 2013.09.30
Download PDF
⟨ Previous Next ⟩

Abstract

Objective: To study the attitudes and awareness of healthcare professionals (physicians, pharmacists, nurses and others) toward the Pharmacovigilance system and experience for adverse drug reactions (ADRs) from a Single University Hospital in Deajeon. Methods: A survey was performed using a structured questionnaire involving 360 health-care professionals at the hospital between $1^{st}$ November and $16^{th}$ November, 2012. Results: Sixty-five percent (n=235) of all respondents were experienced incidences of ADRs for their patients and 55.8% (n=201) knew the ADR Spontaneous Reporting System in the hospital. However, three-fourths (n=273, 75.8%) of respondents did not know the existence of the Korean Association of Regional Pharmacovigilance Centers (KARP) and 61.7% (n=222) were unaware of the obligation of ADR report from KFDA in cases of serious ADRs. About 83% (n=299) answered that the electronic ADR report system of the hospital was helpful while their work and most (n=336, 93.3%) agreed on the necessaries of the promotion and education about ADR. Conclusion: Seventy-five percent (n=271) of respondents wanted to continue the work for evaluation and feedback for ADRs reported in the hospital. However, the barriers to reporting ADR were; inconvenient ADR reporting system and the lack of time to report ADRs. This study showed that the easier ADR reporting system and education and promotion about ADRs for health-care providers are needed to improve the ADR reporting.

Keywords

References

  1. World Health Organization: Safety of Medicines: A guide to detecting and reporting adverse drug reactions. WHO, EDM, QSM, 2002.
  2. Davies EC, Green CF, Taylor S, et al., Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS One. 2009; 4: e4439. https://doi.org/10.1371/journal.pone.0004439
  3. Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: updating the cost-of-illness model. J Am Pharm Assoc (Wash) 2001; 41(2): 192-9.
  4. Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, EQUUS: Safety Monitoring of Medicinal Products Guidelines for setting up and running a Pharmacovigilance Centre. London, 2000.
  5. Bennett CL, Nebeker JR, Yarnold PR, et al., Evaluation of serious adverse drug reaction. Arch Intern Med 2007; 167: 1041-49. https://doi.org/10.1001/archinte.167.10.1041
  6. Moore TJ, Cohen MR, Furberg CD. Serious adverse events reported to the Food and Drug Administration, 1995-2005. Arch Intern Med 2007; 167: 1752-59. https://doi.org/10.1001/archinte.167.16.1752
  7. Website. Available at http://www.nso.go.kr.
  8. DICKSON, M. & JACOBZONE, S. Pharmaceutical use and expenditure for cardiovascular disease and stroke: A study of 12 OECD countries. Paris, Organisation for Economic Co-operation and Development. 2003.
  9. KUIJPERS, M. A. J., VAN MARUM, R. J., et al., Relationship between polypharmacy and underprescribing. British Journal of Clinical Pharmacology 2007; 65: 130-3.
  10. WIEDENMAYER, K. Rational use of medicines. IN ANDERSON, S., HUSS, R., SUMMERS, R. & WIEDENMAYER, K.(Eds.) Managing pharmaceuticals in international health. Basel, Birkhauser 2004; 141-52.
  11. WINDMEIJER, F., DE LAAT, E., DOUVEN, R, et al., Pharmaceutical promotion and GP prescription behaviour. Heath Economics 2006; 15: 5-18. https://doi.org/10.1002/hec.1007
  12. Roughead E, Pratt N, Peck R, et al., Improving medication safety: influence of a patient-specific prescriber feedback program on rate of medication reviews performed by Australian general medical practitioners. Pharmacoepidemiol Drug Saf 2007; 16: 797-803. https://doi.org/10.1002/pds.1393
  13. Korea Food and Drug Administration[internet]. Announcement of drug safety information surveillance. [cited 2008 Jun 30] Available from: http://kfda.go.kr [accessed 2012 Nov 27]
  14. Kim HK, Kim YS, Pak YG. A Survey on introduction of pharmacovigilance specialist certification system. Journal of pharmacoepidemiology and risk management 2010; 3: 36-45.
  15. Figuerias A, Herdeiro MT, Polonia J, et al., An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA 2006; 296: 1086-93. https://doi.org/10.1001/jama.296.9.1086
  16. Kelly M, Kaye KI, Davis SR, et al., Factors influencing adverse drug reaction reporting in New South Wlaes teaching hospitals. Drug Saf 2004; 22: 161-8.
  17. Nissen SE, K W. Rosiglitazone Revisited: An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality. Arch Intern Med 2010; 170: 1191-201.
  18. Rhew KY, Lee S. Analysis of the Korea Food and Drug Administration Adverse Drug Reaction Reports. Kor J Clin Pharm 2011; 21(2): 138-44.
  19. Choi YH, Sohn UD. The Surveillance of Adverse Drug Reaction (ADR) Reported. Kor J Clin Pharm 2003; 13(2): 72-81.
  20. Lim HR, Park EH. Analysis of ADR Reporting Types in Yonsei University Healthcare System. J. Kor. Soc. Health- Syst. Pharm 2011; 28(2): 127-35.
  21. Rhew KY, Cho HK, Lee S. Characteristics of Cardiovascular Adverse Drug Reactions Reported to KFDA. Kor J Clin Pharm 2012; 22(1): 41-6.