Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지
DOI QR코드

DOI QR Code

Investigation on Perceptions, Attitudes, and Contributing Factors to Spontaneous Adverse Drug Reaction Reporting among Community Pharmacists: Results from a Web-based Survey

지역 약사의 자발적 부작용 보고에 대한 인식 및 태도와 영향요인 조사: 설문조사 결과를 중심으로

  • Lee, Mo-Se (Regional pharmacovigilance center, The Korea Pharmaceutical Association) ;
  • Choi, Ah-Hyung (School of pharmacy, Sungkyunkwan University) ;
  • Jang, Bo-Hyun (Regional pharmacovigilance center, The Korea Pharmaceutical Association) ;
  • Kim, Na-Young (Regional pharmacovigilance center, The Korea Pharmaceutical Association) ;
  • Lee, Jung-Min (Regional pharmacovigilance center, The Korea Pharmaceutical Association) ;
  • Shin, Ju-Young (School of pharmacy, Sungkyunkwan University) ;
  • Jeon, Ha-Lim (School of pharmacy, Sungkyunkwan University)
  • 이모세 (대한약사회 지역의약품 안전센터) ;
  • 최아형 (성균관대학교 약학대학) ;
  • 장보현 (대한약사회 지역의약품 안전센터) ;
  • 김나영 (대한약사회 지역의약품 안전센터) ;
  • 이정민 (대한약사회 지역의약품 안전센터) ;
  • 신주영 (성균관대학교 약학대학) ;
  • 전하림 (성균관대학교 약학대학)
  • Received : 2019.05.03
  • Accepted : 2019.06.18
  • Published : 2019.06.30
Download PDF
⟨ Previous Next ⟩

Abstract

Objective: To examine the perceptions and attitudes toward spontaneous adverse drug reaction (ADR) reporting system among community pharmacists and identify factors that influence reporting, by implementing a survey. Methods: A structured questionnaire was developed and distributed online. Request for the survey was posted on the website of pharmacy's billing program, and the survey was conducted for 8 days. We collected the participants' response on their work environment, experience of ADR reporting, and their perception and attitude on the reporting system. Multivariate logistic regression was used to evaluate factors influencing ADR reporting. Results: A total of 382 pharmacists participated in the survey. Significant contributing factors for reporting level were age (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.84-0.96), knowledge of reporting method (OR, 53.56; 95% CI, 9.10-315.41), installation of reporting program (OR, 31.92; 95% CI, 4.16-244.75), and encouragement from the Korean pharmaceutical association (OR, 4.13; 95% CI, 1.11-15.35). Regarding the attitude toward spontaneous ADR reporting system, 'lack of time for reporting' (OR, 0.29; 95% CI, 0.15-0.53) and 'complexity of reporting procedure' (OR, 0.51; 95% CI, 0.31-0.84), were associated with a low likelihood of reporting. Conclusion: Our results indicated that the knowledge of ADR reporting method, installation of the reporting program, and encouragement from the Korean Pharmaceutical Association contribute to active reporting. It is necessary to simplify the reporting method, make the ADR reporting program user-friendly, and provide educational interventions to increase participation in spontaneous reporting by the community pharmacists.

Keywords

References

  1. Kim J, Ha J-H, Kim B-R, et al. Analysis of characteristics about spontaneous reporting-reported in 2008. JPERM 2010;3:23-31.
  2. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality. JAMA 1997;277(4):301-6. https://doi.org/10.1001/jama.1997.03540280039031
  3. Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother 2008;42(7-8):1017-25. https://doi.org/10.1345/aph.1L037
  4. Hazell L and Shakir SA. Under-reporting of adverse drug reactions. Drug saf 2006;29(5):385-96. https://doi.org/10.2165/00002018-200629050-00003
  5. Korean Pharmaceutical Association. Strategies for improvement of Adverse Drug Reaction reporting and Drug Utilization Review monitoring system in Korean community pharmacies. Republic of Korea: Ministry of Food and Drug Safety; 2017.
  6. Choi N, Kwon H, Lee A, Park B. A survey on attitudes and awareness of physicians and pharmacists regarding spontaneous reporting system and experience for adverse drug events in Goyangsi. JPERM 2008;1:44-52.
  7. 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
  8. Irujo M, Beitia G, Bes-Rastrollo M, Figueiras A, Hernandez-Diaz S, Lasheras B. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug saf 2007;30(11):1073-82. https://doi.org/10.2165/00002018-200730110-00006
  9. Granas AG, Buajordet M, Stenberg-Nilsen H, Harg P, Horn AM. Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf 2007;16(4):429-34. https://doi.org/10.1002/pds.1298
  10. Lee A, Bateman DN, Edwards C, Smith JM, Rawlins MD. Reporting of adverse drug reactions by hospital pharmacists: pilot scheme. BMJ 1997;315(7107):519. https://doi.org/10.1136/bmj.315.7107.519
  11. World Health Organization (WHO). Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines, Geneva, Switzerland; 2004. Available from: http://whqlibdoc.who.int/hq/2004/WHO_EDM_2004.8.pdf. Accessed Apr 8th, 2019.
  12. Yu YM, Lee E, Koo BS, et al. Predictive factors of spontaneous reporting of adverse drug reactions among community pharmacists. PloS One 2016;11(5):e0155517. https://doi.org/10.1371/journal.pone.0155517
  13. Toklu HZ and Uysal MK. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci 2008;30(5):556-62. https://doi.org/10.1007/s11096-008-9209-4
  14. Mahmoud MA, Alswaida Y, Alshammari T, et al. Community pharmacists' knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia. Saudi Pharm J 2014;22(5):411-8. https://doi.org/10.1016/j.jsps.2013.07.005
  15. Suyagh M, Farah D, Farha RA. Pharmacist's knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process. Saudi Pharm J 2015;23(2):147-53. https://doi.org/10.1016/j.jsps.2014.07.001
  16. Lopez-Gonzalez E, Herdeiro MT, Pineiro-Lamas M, Figueiras A. Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial. Drug saf 2015;38(2):189-96. https://doi.org/10.1007/s40264-014-0256-6
  17. Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001;51(1):81-6. https://doi.org/10.1046/j.1365-2125.2001.01306.x
  18. Shamim S, Sharib SM, Malhi SM, et al. Adverse drug reactions (ADRS) reporting: awareness and reasons of under-reporting among health care professionals, a challenge for pharmacists. Springerplus 2016;5(1):1778. https://doi.org/10.1186/s40064-016-3337-4
  19. Vessal G, Mardani Z, Mollai M. Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran. Pharm World Sci 2009;31(2):183-7. https://doi.org/10.1007/s11096-008-9276-6
  20. Ortega A, Aguinagalde A, Lacasa C, Aquerreta I, Fernandez-Benítez M, Fernandez LM. Efficacy of an adverse drug reaction electronic reporting system integrated into a hospital information system. Ann Pharmacother 2008;42(10):1491-6. https://doi.org/10.1345/aph.1L130

Cited by

  1. Educating Healthcare Professionals in Pharmacovigilance: Global Trends and Korea's Status vol.22, pp.1, 2019, https://doi.org/10.17496/kmer.2020.22.1.32