Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea

Abstract

The differential pattern and characteristics of completeness in adverse event (AE) reports generated by hospitals/clinics, pharmacies, consumer and pharmaceutical companies remain unknown. Thus, we identified the characteristics of complete AE reports, compared with those of incomplete AE reports, using a completeness score. We used Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) between January 1, 2016 and December 31, 2016. The completeness score was determined out of a total of 100 points, based on the presence of information on temporal relationships, age and sex of patients, AE progress, name of reported medication, reporting group by profession, causality assessment, and informational text. AE reports were organized into four groups based on affiliation: hospitals/clinics, pharmacies, consumers, and pharmaceutical companies. Affiliations that had median completeness scores greater than 80 points were classified as ‘well-documented’ and these reports were further analyzed by logistic regression to estimate the adjusted odds ratios and 95% confidence intervals. We examined 228,848 individual reports and 735,745 drug-AE combinations. The median values of the completeness scores were the highest for hospitals/clinics (95 points), followed by those for consumers (85), pharmacies (75), and manufacturers (72). Reports with causality assessment of ‘certain’, ‘probable’, or ‘possible’ were more likely to be ‘well-documented’ than reports that had causality assessments of ‘unlikely’. Serious reports of AEs were positively associated with ‘well-documented’ reports and negatively associated with hospitals/clinics.

Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST

“…In contrast, reports from PRHs and other HCPs (including regulatory affairs officers, clinical trial associates, nurses, and medical assistants) were flagged as the key features negatively associated with Malaysian report completeness ( Figure 2 B). These findings are consistent with the features observed in the United States [ 15 ], Brazil [ 16 ], Spain [ 17 ], South Korea [ 18 ], and Japan [ 19 , 20 ]. Of note, the NPRA classified the reports from PRHs as reported by other HCPs when the primary reporter was unknown.…”

Comparative Safety Profiles of Sedatives Commonly Used in Clinical Practice: A 10-Year Nationwide Pharmacovigilance Study in Korea

“…In addition, potential reporting bias might exist, which could result in selective over-reporting of some ADEs and under-reporting of others [31]. Nevertheless, the majority of ADE cases, particularly those induced by sedatives, were reported by healthcare professionals (Table 2) [50], suggesting adequate reliability and appropriateness of the recorded ADE data. Furthermore, the number of ADE reports for a specific medication can be influenced by the prevalence of using the medication in clinical practice.…”

Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports

“…However, the quality of reports made by consumers is of concern. For example, when introducing consumer reporting programs in the EU, an argument was made that patient reports tended to be easily influenced by mass media, which might result in increased reports with trivial or well‐known ADRs . Recent studies showed that ADRs reported by patients overlap with ADRs reported by healthcare professionals (HCPs), but the ADRs are reported in different ways.…”

“…Although the quality of ADR reports from patients and HCPs is comparable in many ways, it is possible that reporting behaviours may be different between consumers and HCPs because of obvious differences in professional expertise, motivation and practical restrictions related to submission of ADR reports. Given the growing number of direct ADR reports from patients in the United States, the EU and other jurisdictions, increased heterogeneity caused by diverse reporters and clinical environments would be a critical issue in monitoring drug safety with pharmacovigilance databases …”