Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database

Soukavong, Mick; Kim, Jungmee; Park, Kyounghoon; Yang, Bo; Lee, Joongyub; Jin, Xueying; Park, Byung Joo

doi:10.3346/jkms.2016.31.9.1355

Cited by 20 publications

(12 citation statements)

References 35 publications

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“…A signal detection of adverse drug reaction identified by WHO-UMC reported a potential sub-group at risk which suggested that males may be at increased risk for drug induced aseptic meningitis with the use of amoxicillin and amoxicillin in combination with clavulanic acid 42 . Another 12 new signals were detected in Korea on the use of amoxicillin including ineffective amoxicillin 43 , however, the chirality factor was not reported to be associated with the new signals. In addition, a concern on safety of ceftriaxone has been reported for both adults and children 44,45 .…”

Section: Discussionmentioning

confidence: 94%

A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

Mwamwitwa

Kaibere

Fimbo³

et al. 2020

Sci Rep

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Medicines with a stereogenic center (asymmetric carbon) are mainly present as racemates with a mixture of equal amounts of enantiomers. One enantiomer may be active while the other inactive, alternatively one may produce side-effects and even toxicity. However, there is lack of information on the chirality status (either racemates, single active enantiomer or achiral) of medicines circulated on the market particularly in African countries. We established the chirality status of registered medicines in Tanzania by conducting a retrospective cross-sectional study. Registration data for the past 15 years from 2003 to 2018 were extracted from TMDA-IMIS database to Microsoft excel for review and analysis. A total of 3,573 human medicines had valid registration. Out of which 2,150 (60%) were chiral and 1,423 (40%) achiral. Out of the chiral medicines, 1,591 (74%) and 559 (26%) were racemates and single active enantiomers, respectively. The proportion of racemates within chiral medicines was considerably higher than single enantiomer medicines. The use of racemates may cause harm to the public and may contribute to antimicrobial resistance due to potential existence of inactive and toxic enantiomers. In order to protect public health, regulatory bodies need to strengthen control of chiral medicines by conducting analysis of enantiomeric impurity.

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Section: Discussionmentioning

confidence: 94%

A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

Mwamwitwa

Kaibere

Fimbo³

et al. 2020

Sci Rep

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“…The KAERS database was developed by KIDS in 2012 to manage AE reports effectively. This computerized AE reporting system includes voluntary reporting by healthcare workers and the general public, as well as mandatory reporting by manufacturers for serious and unexpected events, using a standardized form [11]. Reports from the Korean Regional Pharmacovigilance Centers accounted for 71.5% (163,676 reports) of the KAERS database, and among these, hospitals/clinics accounted for the majority.…”

Section: Methodsmentioning

confidence: 99%

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

Baek

Kim

et al. 2019

PLoS ONE

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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.

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“…Medical practices have proved that surveillance and learning from patient safety incidents can reduce the odds of making mistakes, and by doing so, improve patient safety. Given that, many countries have developed their reporting systems and have carried out a series of research works 8–10. In China, the National Patient Safety Incidents Reporting System (NPSIRS) was rolled out from early 2012.…”

Section: Introductionmentioning

confidence: 99%

<p>Implications from China patient safety incidents reporting system</p>

Gao

Yan

et al. 2019

TCRM

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ObjectiveWe aimed to explain the operational mechanism of China National Patient Safety Incidents Reporting System, analyze patterns and trends of incidents reporting, and discuss the implication of the incidents reporting to improve hospital patient safety.DesignA nationwide, registry-based, observational study design.Data sourceThe database of China National Patient Safety Incidents Reporting System.Outcome measuresOutcome measures of this study included the temporal, regional, and hospital distribution of the reports, as well as the incident type, location, parties, and possible reasons for frequently occurring incidents.ResultsDuring 2012–2017, 36,498 patient safety incidents were reported. By analyzing the time trends, we found that there was a significant upward trend on incidents reporting in China. The most common type of incidents was drug-related incidents, followed by nursing-related incidents and surgery-related incidents. The three most frequent locations of incident occurrence were Patient’s Room (65.4%), Ambulatory Care Unit (8.4%), and Intensive Care Unit (7.4%). The majority of the incidents involved nurses (40.7%), followed by physicians (29.5%) and medical technologist (13.6%). About 44.4% of the incidents were attributed to the junior staff (work experience ≤5 years). In addition, incidents triggered by the senior staff (work experience >5 years) were more often associated with severe patient harm.ConclusionTo strengthen the incidents reporting system and generate useful evidence through learning from incidents reporting will be important to China’s success in improving the nation’s patient safety status.

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Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database

Cited by 20 publications

References 35 publications

A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

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

<p>Implications from China patient safety incidents reporting system</p>

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