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

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, u...

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Bibliographic Details
Published in:PloS one 2019-02, Vol.14 (2), p.e0212336-e0212336
Main Authors: Oh, In-Sun, Baek, Yeon-Hee, Kim, Hye-Jun, Lee, Mose, Shin, Ju-Young
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems
Age
Causality
Completeness
Confidence intervals
Consumers
Data base management systems
Databases, Factual
Drug Industry
Drug stores
Drug-Related Side Effects and Adverse Reactions - epidemiology
Drugstores
Evaluation
Health care industry
Hospitals
Humans
Incident reporting (Medical care)
Logistic Models
Medical errors
Medicine and Health Sciences
Methods
Nurses
Odds Ratio
Patient safety
People and Places
Pharmaceutical industry
Pharmaceuticals
Pharmacies
Pharmacovigilance
Pharmacy
Quality management
Regression analysis
Republic of Korea - epidemiology
Research and Analysis Methods
Risk management
Safety management
Software
Statistical analysis
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Summary: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.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0212336