A physician-based voluntary reporting system for adverse events and medical errors

2001 ◽  
Vol 16 (12) ◽  
pp. 809-814 ◽  
Author(s):  
Saul N. Weingart ◽  
Lawrence D. Callanan ◽  
Amy N. Ship ◽  
Mark D. Aronson
Keyword(s):  
Adverse Events ◽  
Medical Errors ◽  
Reporting System ◽  
Voluntary Reporting

Adverse Events and Medical Errors in Greece

2012 ◽  
pp. 95-101 ◽  
Author(s):  
Athanassios Vozikis
Keyword(s):  
Quality Assurance ◽  
Knowledge Management ◽  
Adverse Events ◽  
Medical Errors ◽  
Healthcare Quality ◽  
Mandatory Reporting ◽  
Performance Data ◽  
Voluntary Reporting ◽  
Related Data ◽  
Over Time

For years, experts have recognized that medical errors exist and compromise healthcare quality. Much has been written worldwide about medical errors and improvements in their reporting and handling, with the proposals ranging from the implementation of nationwide mandatory reporting with public release of performance data to voluntary reporting and quality-assurance efforts that protect the confidentiality of error-related data. In the present chapter, the author first points out the lack of standardized nomenclature and a universal taxonomy-classification for adverse events and medical errors, which complicates the development of a response to these issues. The chapter also reviews a number of methods of and adverse events’ and medical errors’ knowledge management, each of which has evolved over time and been adapted to different contexts. Finally, the author assesses each of these methods, unveiling their particular strengths and advantages, and also weaknesses and limitations.

Adverse Events Reporting System as Experienced by Critical-Care Nurses in KwaZulu-Natal, South Africa

2018 ◽  
Vol 20 (1) ◽  
Author(s):  
Thusile Mabel Gqaleni ◽  
Busisiwe Rosemary Bhengu
Keyword(s):  
South Africa ◽  
Critical Care ◽  
Adverse Events ◽  
Patient Care ◽  
Family Involvement ◽  
Reporting System ◽  
Legal Framework ◽  
Critical Care Nurses ◽  
Kwazulu Natal ◽  
Life Threatening

Critically ill patients admitted to critical-care units (CCUs) might have life-threatening or potentially life-threatening problems. Adverse events (AEs) occur frequently in CCUs, resulting in compromised quality of patient care. This study explores the experiences of critical-care nurses (CCNs) in relation to how the reported AEs were analysed and handled in CCUs. The study was conducted in the CCUs of five purposively selected hospitals in KwaZulu-Natal, South Africa. A descriptive qualitative design was used to obtain data through in-depth interviews from a purposive sample of five unit managers working in the CCUs to provide a deeper meaning of their experiences. This study was a part of a bigger study using a mixed-methods approach. The recorded qualitative data were analysed using Tesch’s content analysis. The main categories of information that emerged during the data analysis were (i) the existence of an AE reporting system, (ii) the occurrence of AEs, (iii) the promotion of and barriers to AE reporting, and (iv) the handling of AEs. The findings demonstrated that there were major gaps that affected the maximum utilisation of the reporting system. In addition, even though the system existed in other institutions, it was not utilised at all, hence affecting quality patient care. The following are recommended: (1) a non-punitive and non-confrontational system should be promoted, and (2) an organisational culture should be encouraged where support structures are formed within institutions, which consist of a legal framework, patient and family involvement, effective AE feedback, and education and training of staff.

Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

2019 ◽  
Vol 14 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Viswam Subeesh ◽  
Eswaran Maheswari ◽  
Hemendra Singh ◽  
Thomas Elsa Beulah ◽  
Ann Mary Swaroop
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Disproportionality Analysis ◽  
Positive Signal ◽  
Data Mining Algorithms ◽  
Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

scholarly journals The Association between Ranitidine Use and Gastrointestinal Cancers

Cancers ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 24
Author(s):  
Gerald McGwin
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Large Body ◽  
Science Research ◽  
Gastrointestinal System ◽  
Gastrointestinal Cancers ◽  
H2 Antagonists ◽  
Study Results ◽  
Risk Of Cancer

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

Vaccine ◽  
2019 ◽  
Vol 37 (44) ◽  
pp. 6760-6767 ◽  
Author(s):  
Michael M. McNeil ◽  
Iwona Paradowska-Stankiewicz ◽  
Elaine R. Miller ◽  
Paige L. Marquez ◽  
Srihari Seshadri ◽  
...  
Keyword(s):  
United States ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adenovirus Type ◽  
Adverse Event Reporting ◽  
Event Reporting

scholarly journals Just culture: “Evidence”, power and algorithms

2013 ◽  
Vol 2 (3) ◽  
pp. 73 ◽  
Author(s):  
Sidney W. A. Dekker ◽  
James M. Nyce
Keyword(s):  
Adverse Events ◽  
Organizational Justice ◽  
Medical Errors ◽  
Just Culture ◽  
Iatrogenic Harm ◽  
The Creation ◽  
Power Play

Background: The notion of “just culture” has become a way for hospital administrations to determine employee accountability for medical errors and adverse events. Method: In this paper, we question whether organizational justice can be achieved through algorithmic determination of the intention, volition and repetition of employee actions. Results and conclusion: The analysis in our paper suggests that the construction of evidence and use of power play important roles in the creation of “justice” after iatrogenic harm. 

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