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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2019-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0212336 |
| _version_ | 1819115139252617216 |
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| author | In-Sun Oh Yeon-Hee Baek Hye-Jun Kim Mose Lee Ju-Young Shin |
| author_facet | In-Sun Oh Yeon-Hee Baek Hye-Jun Kim Mose Lee Ju-Young Shin |
| author_sort | In-Sun Oh |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-22T04:56:26Z |
| format | Article |
| id | doaj.art-d4d9984a8a9548db9d02b832297f62c7 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-22T04:56:26Z |
| publishDate | 2019-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-d4d9984a8a9548db9d02b832297f62c72022-12-21T18:38:22ZengPublic Library of Science (PLoS)PLoS ONE1932-62032019-01-01142e021233610.1371/journal.pone.0212336Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea.In-Sun OhYeon-Hee BaekHye-Jun KimMose LeeJu-Young ShinThe 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.https://doi.org/10.1371/journal.pone.0212336 |
| spellingShingle | In-Sun Oh Yeon-Hee Baek Hye-Jun Kim Mose Lee Ju-Young Shin Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea. PLoS ONE |
| title | Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea. |
| title_full | Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea. |
| title_fullStr | Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea. |
| title_full_unstemmed | Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea. |
| title_short | Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea. |
| title_sort | differential completeness of spontaneous adverse event reports among hospitals clinics pharmacies consumers and pharmaceutical companies in south korea |
| url | https://doi.org/10.1371/journal.pone.0212336 |
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