지역 약사의 자발적 부작용 보고에 대한 인식 및 태도와 영향요인 조사: 설문조사 결과를 중심으로 = Investigation on Perceptions, Attitudes, and Contributing Factors to Spontaneous Adverse Drug Reaction Reporting among Community Pharmacists: Results from a Web-based Survey

다국어 초록 (Multilingual 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.

참고문헌 (Reference)

1 Hazell L, "Under-reporting of adverse drug reactions" 29 (29): 385-396, 2006

2 Toklu HZ, "The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul" 30 (30): 556-562, 2008

3 Korean Pharmaceutical Association, "Strategies for improvement of Adverse Drug Reaction reporting and Drug Utilization Review monitoring system in Korean community pharmacies" Ministry of Food and Drug Safety 2017

4 Lee A, "Reporting of adverse drug reactions by hospital pharmacists: pilot scheme" 315 (315): 519-, 1997

5 Yu YM, "Predictive factors of spontaneous reporting of adverse drug reactions among community pharmacists" 11 (11): e0155517-, 2016

6 World Health Organization, "Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines"

7 Suyagh M, "Pharmacist’s knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process" 23 (23): 147-153, 2015

8 Granas AG, "Pharmacists’ attitudes towards the reporting of suspected adverse drug reactions in Norway" 16 (16): 429-434, 2007

9 Vessal G, "Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran" 31 (31): 183-187, 2009

10 Kongkaew C, "Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies" 42 (42): 1017-1025, 2008

11 Irujo M, "Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region" 30 (30): 1073-1082, 2007

12 Ortega A, "Efficacy of an adverse drug reaction electronic reporting system integrated into a hospital information system" 42 (42): 1491-1496, 2008

13 Lopez-Gonzalez E, "Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial" 38 (38): 189-196, 2015

14 Lopez-Gonzalez E, "Determinants of under-reporting of adverse drug reactions: a systematic review" 32 (32): 19-31, 2009

15 Mahmoud MA, "Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia" 22 (22): 411-418, 2014

16 Green CF, "Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting" 51 (51): 81-86, 2001

17 Kim J, "Analysis of characteristics about spontaneous reporting-reported in 2008" 3 : 23-31, 2010

18 Shamim S, "Adverse drug reactions (ADRS) reporting: awareness and reasons of under-reporting among health care professionals, a challenge for pharmacists" 5 (5): 1778-, 2016

19 Classen DC, "Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality" 277 (277): 301-306, 1997

20 Choi N, "A survey on attitudes and awareness of physicians and pharmacists regarding spontaneous reporting system and experience for adverse drug events in Goyangsi" 1 : 44-52, 2008