Dataset Information

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.

SUBMITTER: Oh IS

PROVIDER: S-EPMC6375612 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Oh In-Sun IS Baek Yeon-Hee YH Kim Hye-Jun HJ Lee Mose M Shin Ju-Young JY

PloS one 20190214 2

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 complet ...[more]

PMID: 30763386

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Project description:Importance:Understanding the profitability of pharmaceutical companies is essential to formulating evidence-based policies to reduce drug costs while maintaining the industry's ability to innovate and provide essential medicines. Objective:To compare the profitability of large pharmaceutical companies with other large companies. Design, Setting, and Participants:This cross-sectional study compared the annual profits of 35 large pharmaceutical companies with 357 companies in the S&P 500 Index from 2000 to 2018 using information from annual financial reports. A statistically significant differential profit margin favoring pharmaceutical companies was evidence of greater profitability. Exposures:Large pharmaceutical vs nonpharmaceutical companies. Main Outcomes and Measures:The main outcomes were revenue and 3 measures of annual profit: gross profit (revenue minus the cost of goods sold); earnings before interest, taxes, depreciation, and amortization (EBITDA; pretax profit from core business activities); and net income, also referred to as earnings (difference between all revenues and expenses). Profit measures are described as cumulative for all companies from 2000 to 2018 or annual profit as a fraction of revenue (margin). Results:From 2000 to 2018, 35 large pharmaceutical companies reported cumulative revenue of $11.5 trillion, gross profit of $8.6 trillion, EBITDA of $3.7 trillion, and net income of $1.9 trillion, while 357 S&P 500 companies reported cumulative revenue of $130.5 trillion, gross profit of $42.1 trillion, EBITDA of $22.8 trillion, and net income of $9.4 trillion. In bivariable regression models, the median annual profit margins of pharmaceutical companies were significantly greater than those of S&P 500 companies (gross profit margin: 76.5% vs 37.4%; difference, 39.1% [95% CI, 32.5%-45.7%]; P?<?.001; EBITDA margin: 29.4% vs 19%; difference, 10.4% [95% CI, 7.1%-13.7%]; P?<?.001; net income margin: 13.8% vs 7.7%; difference, 6.1% [95% CI, 2.5%-9.7%]; P?<?.001). The differences were smaller in regression models controlling for company size and year and when considering only companies reporting research and development expense (gross profit margin: difference, 30.5% [95% CI, 20.9%-40.1%]; P?<?.001; EBITDA margin: difference, 9.2% [95% CI, 5.2%-13.2%]; P?<?.001; net income margin: difference, 3.6% [95% CI, 0.011%-7.2%]; P?=?.05). Conclusions and Relevance:From 2000 to 2018, the profitability of large pharmaceutical companies was significantly greater than other large, public companies, but the difference was less pronounced when considering company size, year, or research and development expense. Data on the profitability of large pharmaceutical companies may be relevant to formulating evidence-based policies to make medicines more affordable.

Project description:IntroductionAdverse drug events (ADEs) are a leading cause of unplanned hospital visits. We designed ActionADE, an online ADE reporting platform, and integrated it with PharmaNet, British Columbia's (BC's) provincial medication dispensing system, to overcome identified barriers in ADE reporting and communicate ADEs to community pharmacies. Our objectives were to characterise ADEs reported in ActionADE, explore associations between patients' age, sex and ADE characteristics, and estimate the re-dispensation rate of culprit medications in community pharmacies.MethodsWe conducted a prospective observational study of ADE reporting in four BC hospitals between April 1, 2020 and October 31, 2022. We described the characteristics of ADEs reported into ActionADE, used logistic regression modelling to examine associations between age and sex and ADE characteristics, and calculated rates of avoided culprit drug re-dispensations using community pharmacists' responses to ActionADE alerts.ResultsIn total, 3591 ADE reports were initiated by hospital clinicians, 3174 of which were included in this analysis. Serious or life-threatening ADEs resulting in permanent disability, hospitalisation, extended hospitalisation, and/or death accounted for 28.5% (906/3174; 95% CI 27.0-30.1%) of reports. Males were more likely to have non-adherence reported compared to females and experienced life threatening ADEs at a younger age than females. Of 592 patients who had ≥ 1 adverse drug reaction or allergy report (a subset of ADEs) transmitted to community pharmacies, 200 subsequently attempted to re-fill the culprit or a same class drug. Community pharmacists responded to preventative alerts by avoiding re-dispensation in 33.0% (66/200; 95% CI 26.5-39.5%).InterpretationActionADE is the first interoperable system that communicates ADEs via a central medication database to community pharmacies. Every 10th ADE reported in ActionADE and shared to PharmaNet resulted in community pharmacists' avoiding one culprit or same class drug re-exposure. Further research is needed to understand ActionADE's impact on patient and health system outcomes.

Dataset Information

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

Publications

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

Similar Datasets

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