scholarly journals An Analysis of The Hospital Bylaws Policies to Protect Healthcare Workers Against Indictments of Adverse Events

2017 ◽  
Vol 2 (1) ◽  
Author(s):  
Ade Leana ◽  
Adang Bachtiar
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Research Design ◽  
Healthcare Workers ◽  
Qualitative Method ◽  
Legal Protection ◽  
Hospital Staff ◽  
Staff Members ◽  
Operational Policies

One of the functions of hospital bylaws are a means to provide legal protection for all all parties that are related to the hospital. Legal protection is essential for prosecuted hospital staff members. One of the reasons for indictments is adverse events. The goal of this research is to discover how the hospital by-laws protects the hospital staff in the event of an indictment based on an adverse event and how the by-laws adhere to the guidelines in a comprehensive way. The research design used the qualitative method. The results of this research indicates that the hospital by-laws of RSKO Jakarta, although it has served as a protective method, it still needs further technical-operational policies as a supplement, and there are still discrepancies compared to the guidelines. We suggest that the by-laws of RSKO Jakarta are amended to adhere to the governmental guidelines and to establish supplementing technical-operational policies.

scholarly journals Presumed adverse events in health care are a frequent indication for medico-legal autopsy in Finland

2019 ◽  
Vol 16 (1) ◽  
pp. 65-70
Author(s):  
Lasse Pakanen ◽  
Noora Keinänen ◽  
Paula Kuvaja
Keyword(s):  
Health Care ◽  
Risk Management ◽  
Adverse Event ◽  
Adverse Events ◽  
Gastrointestinal Surgery ◽  
Legal Protection ◽  
Clinical Risk Management ◽  
Data Set ◽  
Manner Of Death ◽  
Clinical Risk

AbstractThe medico-legal autopsy is an essential tool in investigating deaths caused by an adverse event in health care, for both clinical risk management and for professional liability issues. However, there are no statistics available regarding the frequency of autopsies performed due to suspected adverse events. This study aimed to determine the number of medico-legal autopsies done because of presumed adverse events, whether these events were unintentional, medical errors or cases in which malpractice was suspected. Furthermore, differences in treatment types, causes and manner of death were analyzed. The data was obtained from all medico-legal autopsies performed in Northern Finland and Lapland during 2014–2015 (n = 2027). Adverse events were suspected in 181 (8.9%) cases. The suspicions of an adverse event occurring were most often related to medication, gastrointestinal surgery and orthopedic surgery. The manner of death was classified as medical (or surgical) treatment or investigative procedure in 22 (12.2%) cases. The causes of death were completely unrelated to the suspected adverse event in 41 (22.7%) cases. In conclusion, the frequency of presumed adverse events was quite high in this data set, but in the majority of the cases, the suspicion of an adverse event causing death was disproved by an autopsy. Nonetheless, proper investigation of these cases is essential to ensure legal protection of the deceased, next of kin and health care personnel, as well as to support clinical risk management.

scholarly journals The New Normal of ENT OPD - Adapting Safe Practices.

2020 ◽  
Author(s):  
Aditya Yeolekar ◽  
Sudhir Bhalerao ◽  
Maya Bhalerao
Keyword(s):  
Healthcare Workers ◽  
High Viral Load ◽  
Hospital Staff ◽  
Staff Members ◽  
Contingency Plans ◽  
Practice Plan ◽  
Cross Transmission ◽  
Small Set ◽  
Set Up ◽  
Transmission Of Disease

Abstract The COVID-19 epidemic originating in China has spread rapidly worldwide and converted to pandemic proportions in March 2020. In India and densely populated countries like Brazil and USA the numbers are still rising. Clinicians all over the world are trying to contain it by minimizing the cross-transmission of disease among hospital staff members. In the field of Otorhinolaryngology (ENT) the doctors are exposed to high viral load while examining the patients. Therefore contingency plans are required for dealing with patients in outpatient clinics, and while performing diagnostic endoscopies, minor procedures in OPD and surgeries in operating rooms. Infected patients may shed severe acute respiratory syndrome coronavirus-2 (SARS-CoV- 2) particles into their environment via body secretions. Therefore, Otolaryngologists should be vigilant. In this submission, we share our experience of an innovative practice plan in redesigning the ENT OPD setup, endoscopy set up and OT so as to reduce the risk of transmission of virus not only to doctors but other healthcare workers. We hope that our modifications will serve as a guide for every Otolaryngologist throughout India towards performing their clinical duties confidently without any apprehension and ensuring adequate safety during this testing times in their small set-up/ clinical establishments.

scholarly journals HyPE study: hydroxychloroquine prophylaxis-related adverse events’ analysis among healthcare workers during COVID-19 pandemic: a rising public health concern

2020 ◽  
Vol 42 (3) ◽  
pp. 493-503 ◽  
Author(s):  
Bada Sharanappa Nagaraja ◽  
Kalhalli Narayanaswamy Ramesh ◽  
Debjyoti Dhar ◽  
Mahammad Samim Mondal ◽  
Treshita Dey ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Adverse Event ◽  
Adverse Events ◽  
Healthcare Workers ◽  
Cross Sectional Study ◽  
Health Concern ◽  
Cross Sectional ◽  
Web Based ◽  
Logistic Regression Models ◽  
Younger Age

Abstract Background The rising burden of Coronavirus disease (COVID-19) has led to the mass use of hydroxychloroquine by healthcare workers (HCWs). Adverse event profile of this drug when used as prophylaxis is not well known in the literature. Methods A retrospective, cross-sectional study was conducted across the country using semi-structured web-based questionnaire among COVID-19 negative and asymptomatic healthcare workers, taking hydroxychloroquine prophylaxis. Descriptive and multivariate logistic-regression models were applied for analysis. Results Of the 166 participants, at least one adverse event was experienced by 37.9% participants, gastrointestinal being the most common (30.7%). Risk was higher in participants <40 years age (odd’s ratio (OR): 2.44, 95% confidence interval (CI): 1.18–5.05) and after first dose of hydroxychloroquine (51.2%, OR: 2.38, 95%CI: 1.17–4.84). Hydroxychloroquine prophylaxis was initiated without electrocardiography by 80.1% of HCWs. Only 21.6% of those with cardiovascular disease could get prior ECG. Conclusions A higher incidence of adverse events was observed when results were compared with studies involving patients on long-term hydroxychloroquine therapy. Younger age and first dose were associated with greater incidence of adverse events though all were self-limiting. Monitoring prior and during prophylaxis was inadequate even among those with cardiovascular disease and risk-factors. However, no serious cardiovascular events were reported.

scholarly journals The need and availability of support systems for physicians involved in a serious adverse event

2018 ◽  
Vol 7 (2) ◽  
pp. 23 ◽  
Author(s):  
Esther H.M. Leferink ◽  
Aline Bos ◽  
Martijn P. Heringa ◽  
Elizabeth L.J. van Rensen ◽  
Dorien L.M. Zwart
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Healthcare Professionals ◽  
Well Being ◽  
Working Environment ◽  
Support Needs ◽  
Quality And Safety ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
Staff Members

Objective: Serious adverse events occur in healthcare, and do not solely have consequences for patients (first victims), but also affect physicians involved (second victims). These second victims experience diminished emotional well-being and less professional performance. An increasing number of hospitals organize support for second victims, although scientific evidence on the kind of support that is expected and needed is poor. This study therefore investigates support needs after serious adverse events from both personal (physicians) and organizational (quality and safety staff members) perspectives.Methods: We conducted semi-structured interviews in a Dutch university medical center. Physicians (N = 19) who had been directly involved in a serious adverse event participated. In addition, quality and safety staff members (N = 3) reflected on the support needs as expressed by physicians. Verbatim transcripts were three-fold coded, which led to several themes for our inductive thematic analysis.Results: Contrary to recent developments in healthcare organizations, participants did not plea for a hospital-wide support team. Acceptance of the emotional and professional impact of an adverse event by direct colleagues and supervisors is more important. Where such a cultural context is provided, physicians prefer support of a close and reliable colleague to cope with emotions and doubts, a supervisor who monitors recovery, and a healthcare organization that provides information about required procedures to learn from the events. However, this ideal was seldom found in the competitive working environment. This underlines the need for a shift from a competitive professional culture into a more supportive one.Conclusions: Ideally, direct colleagues support each other after an adverse event. This form of collegial support can only be successful if there is general acceptance of healthcare professionals’ vulnerability and their support needs within the direct working environment. To create the right circumstances to meet these support needs, both healthcare professionals and hospital organizations have to recognize and take their responsibilities.

scholarly journals Demographic and occupational determinants of anti-SARS-CoV-2 IgG seropositivity in hospital staff

2020 ◽  
Author(s):  
Christopher A Martin ◽  
Prashanth Patel ◽  
Charles Goss ◽  
David R Jenkins ◽  
Arthur Price ◽  
...  
Keyword(s):  
South Asian ◽  
Healthcare Workers ◽  
Hospital Staff ◽  
Front Line ◽  
University Hospitals ◽  
Cross Sectional ◽  
Acute Medicine ◽  
Occupational Factors ◽  
Factors Associated ◽  
Staff Members

Abstract Background Although evidence suggests that demographic characteristics including minority ethnicity increase the risk of infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), it is unclear whether these characteristics, together with occupational factors, influence anti-SARS-CoV-2 IgG seroprevalence in hospital staff. Methods We conducted cross-sectional surveillance examining seroprevalence of anti-SARS-CoV-2 IgG amongst staff at University Hospitals of Leicester (UHL) NHS Trust. We quantified seroprevalence stratified by ethnicity, occupation and seniority of practitioner and used logistic regression to examine demographic and occupational factors associated with seropositivity. Results A total of 1148/10662 (10.8%) hospital staff members were seropositive. Compared to White staff (seroprevalence 9.1%), seroprevalence was higher in South Asian (12.3%) and Black (21.2%) staff. The occupations and department with the highest seroprevalence were nurses/healthcare assistants (13.7%) and the Emergency Department (ED)/Acute Medicine (17.5%), respectively. Seroprevalence decreased with seniority in medical/nursing practitioners. Minority ethnicity was associated with seropositivity on an adjusted analysis (South Asian: aOR 1.26; 95%CI: 1.07–1.49 and Black: 2.42; 1.90–3.09). Anaesthetics/ICU staff members were less likely to be seropositive than ED/Acute medicine staff (0.41; 0.27–0.61). Conclusions Ethnicity and occupational factors, including specialty and seniority, are associated with seropositivity for anti-SARS-Cov-2 IgG. These findings could be used to inform occupational risk assessments for front-line healthcare workers.

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.

Adverse Effects of Natural Products: A Brief Pre-Systematic Review

2020 ◽  
Vol 01 ◽  
Author(s):  
Carla Pires ◽  
Ana Fernandes
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Natural Products ◽  
Adverse Events ◽  
In Vitro Study ◽  
Google Scholar ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Meta Analyses

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.

viewpoint TIME TO RESTART: PROTOCOL OF RESUMPTION OF ACTIVITIES OF A DERMATOLOGICAL CLINIC OF A LEVEL II HOSPITAL IN THE COVID-19 ERA. (Preprint)

2020 ◽  
Author(s):  
Federico Diotallevi ◽  
Anna Campanati ◽  
Giulia Radi ◽  
Oriana Simonetti ◽  
Emanuela Martina ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
World Health ◽  
New Wave ◽  
Staff Members ◽  
Level Ii ◽  
The World ◽  
Health Organization ◽  
Spread Of Infection ◽  
Hospital Wards ◽  
Medical And Healthcare

UNSTRUCTURED Two months have passed since the World Health Organization (WHO) declared the pandemic of the Coronavirus Disease 19 (COVID-19), caused by the SARS CoV-2 virus, on March 11, 2020. Medical and healthcare workers have continued to be on the frontline to defeat this disease, however, continual changes are being made to their working habits which are proving to be difficult. Since the beginning of the pandemic, a major reorganisation of all hospital wards, including dermatological wards, has been carried out in order to make medical and nursing staff available in COVID wards and to prevent the spread of infection. These strategies, which were also adopted in our clinic, proved to be effective, as no staff members or patients were infected by the virus. Now, thanks to the global decrease in SARS-CovV2 infections, it is necessary to make dermatological wards accessible to patients again, but it is also essential to adopt specific protocols to avoid a new wave of infections.

scholarly journals Adverse Events in Home-Care Nursing Agencies and Related Factors: A Nationwide Survey in Japan

2021 ◽  
Vol 18 (5) ◽  
pp. 2546
Author(s):  
Noriko Morioka ◽  
Masayo Kashiwagi
Keyword(s):  
Adverse Event ◽  
Patient Safety ◽  
Adverse Events ◽  
Home Care ◽  
Process Of Care ◽  
Related Factors ◽  
Cross Sectional ◽  
Home Care Nursing ◽  
Number Of Patients ◽  
Care Nursing

Despite the importance of patient safety in home-care nursing provided by licensed nurses in patients’ homes, little is known about the nationwide incidence of adverse events in Japan. This article describes the incidence of adverse events among home-care nursing agencies in Japan and investigates the characteristics of agencies that were associated with adverse events. A cross-sectional nationwide self-administrative questionnaire survey was conducted in March 2020. The questionnaire included the number of adverse event occurrences in three months, the process of care for patient safety, and other agency characteristics. Of 9979 agencies, 580 questionnaires were returned and 400 were included in the analysis. The number of adverse events in each agency ranged from 0 to 47, and 26.5% of the agencies did not report any adverse event cases. The median occurrence of adverse events was three. In total, 1937 adverse events occurred over three months, of which pressure ulcers were the most frequent (80.5%). Adjusting for the number of patients in a month, the percentage of patients with care-need level 3 or higher was statistically significant. Adverse events occurring in home-care nursing agencies were rare and varied widely across agencies. The patients’ higher care-need levels affected the higher number of adverse events in home-care nursing agencies.

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.

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