의약품부작용보고 원시자료에서 소비자와 의료 전문가 간의 이상사례 보고 비교 연구

The Comparison of Spontaneous Adverse Event Reporting between Consumers and Healthcare Professionals using Korea Adverse Event Reporting System (KAERS) Database

BACKGROUNDS In reports of adverse drug reactions (ADRs), healthcare professionals including doctors, pharmacists and nurses make up the biggest roles whereas consumers were limited to spontaneous adverse event reporting. However, consumer reports have been gradually recognized as an important source of pharmacovigilance by providing unreported symptoms in traditional healthcare professional reports. OBJECTIVE To compare ADRs reported by consumers with ADRs reported by healthcare professionals, in terms of seriousness of event, types of symptoms and medications involved. METHODS ADRs reported to KAERS (Korea Adverse Event Reporting System) in 2014-2015 was analyzed according to source of report, seriousness of symptom, type of ADRs categorized by SOC (system organ class) and the majorly reported medications coded by ATC (anatomical therapeutic chemical). Odds ratio (OR) and 95% Confidence Interval (CI) for reporting serious ADRs by consumer was calculated as compared with healthcare professionals. RESULTS Consumer reports corresponded to 9.7% of ADR reports, among a total of 286,274 reports from 2014 to 2015. Consumer reports accounted for higher proportion in the reports of female (60.4%) and patients of aged between 28 days and 24 months (21.1%) as compared with healthcare professional reports. Consumers reported serious ADRs more than twice as compared with healthcare professionals (OR 2.30; 95% CI 2.19-2.42). In serious ADRs, significant difference was shown in the frequency of major symptoms and major medications involved between consumer reports and healthcare professional reports. CONCLUSION This study found significant difference between consumer and healthcare reports in its proportion of categories including gender, major symptoms and medications.