scholarly journals Population-scale patient safety data reveal inequalities in adverse events before and during COVID-19 pandemic

2021 ◽  
Author(s):  
Xiang Zhang ◽  
Marissa Sumathipala ◽  
Marinka Zitnik
Keyword(s):  
Public Health ◽  
Patient Safety ◽  
Adverse Events ◽  
Drug Safety ◽  
Gender Gap ◽  
Safety Data ◽  
Medication Use ◽  
Incidence Rates ◽  
Drug Interference ◽  
Demographic Groups

Adverse patient safety events were associated with 110 thousand deaths in the U.S. alone in 2019. The COVID-19 pandemic has further challenged the ability of healthcare systems to ensure medication safety, and its effects on patient safety remain unknown. Here, we investigate negative outcomes associated with medication use before and during the pandemic. Using a dataset of 10,443,476 reports involving 3,624 drugs and 19,193 adverse events, we develop an algorithmic approach to analyze the pandemic's impact on incidence of drug safety events by evaluating disproportional reporting relative to the pre-pandemic time, quantifying unexpected trends in clinical outcomes, and adjusting for drug interference. Among 64 adverse events identified by our analyses, we find 54 have increased incidence rates during the pandemic, even though reporting of adverse events has decreased by 4.4% overall. We find clinically relevant differences in drug safety outcomes between demographic groups. Comparing to male patients, women report 47.0% more distinct adverse events whose occurrence significantly increased during the pandemic relative to pre-pandemic levels. Out of 53 adverse events with the pre-pandemic gender gap, 33 have increased gap during the pandemic more than would have been expected had the pandemic not occurred. While musculoskeletal and metabolic side effects are disproportionately enriched in women during the pandemic, immune-related adverse events are enriched only in men. We also find the number of adverse events with a higher reporting ratio during the pandemic in adults is higher (16.8%) than in older patients (adjusted for population size). Our findings have implications for safe medication use and public health policy and highlight the role of variation in adverse events for improving patient safety during a public health emergency.

scholarly journals Population-scale identification of differential adverse events before and during a pandemic

2021 ◽  
Author(s):  
Xiang Zhang ◽  
Marissa Sumathipala ◽  
Marinka Zitnik
Keyword(s):  
Adverse Events ◽  
Gender Gap ◽  
Older Patients ◽  
Medication Use ◽  
The United States ◽  
Healthcare Systems ◽  
Safe Medication ◽  
Demographic Groups ◽  
Public Health Emergencies ◽  
Population Scale

AbstractAdverse patient safety events, unintended injuries resulting from medical therapy, were associated with 110,000 deaths in the United States in 2019. A nationwide pandemic (such as COVID-19) further challenges the ability of healthcare systems to ensure safe medication use and the pandemic’s effects on safety events remain poorly understood. Here, we investigate drug safety events across demographic groups before and during a pandemic using a dataset of 1,425,371 reports involving 2,821 drugs and 7,761 adverse events. Among 64 adverse events identified by our analyses, we find 54 increased in frequency during the pandemic, despite a 4.4% decrease in the total number of reports. Out of 53 adverse events with a pre-pandemic gender gap, 33 have seen their gap increase with the pandemic onset. We find that the number of adverse events with an increased reporting ratio is higher in adults (by 16.8%) than in older patients. Our findings have implications for safe medication use and preventable healthcare inequality in public health emergencies.

Promoting online drug safety: Using public–private partnerships to deter illicit online drug sales

1969 ◽  
Vol 17 (3) ◽  
Author(s):  
Timothy K Mackey ◽  
Bryan A Liang
Keyword(s):  
Public Health ◽  
Patient Safety ◽  
Global Health ◽  
Health Information ◽  
Drug Safety ◽  
Social Problem ◽  
The Internet ◽  
Critical Problem ◽  
Multiple Stakeholders ◽  
Counterfeit Drugs

Illicit online pharmacies selling counterfeit drugs in a global virtual marketplace remain a critical problem in global health. Yet they continue to operate with little regulation while growing numbers of consumers access the Internet for health information that may lead them to purchase dangerous drugs online. This global social problem requires immediate action to protect patient safety and public health. Public–private partnerships models represent a potentially effective way to address this issue through promoting mechanisms of collaboration and coordination of multiple stakeholders.

Is there a role for modified probiotics as beneficial microbes: a systematic review of the literature

2017 ◽  
Vol 8 (5) ◽  
pp. 739-754 ◽  
Author(s):  
L. Zorzela ◽  
S.K. Ardestani ◽  
L.V. McFarland ◽  
S. Vohra
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Safety Data ◽  
Probiotic Strain ◽  
Incidence Rates ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Treatment Trials ◽  
Probiotic Strains

Our objective was to conduct a systematic review and meta-analysis for the use of modified (heat-killed or sonicated) probiotics for the efficacy and safety to prevent and treat various diseases. Recent clinical research has focused on living strains of probiotics, but use in high-risk patients and potential adverse reactions including bacteremia has focused interest on alternatives to the use of live probiotics. We searched MEDLINE/PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL, Alt Health Watch, Web of Science, Scopus, PubMed, from inception to February 14, 2017 for randomised controlled trials involving modified probiotic strains. The primary outcome was efficacy to prevent or treat disease and the secondary outcome was incidence of adverse events. A total of 40 trials were included (n=3,913): 14 trials (15 arms with modified probiotics and 20 control arms) for the prevention of diseases and 26 trials (29 arms with modified probiotics and 32 control arms) for treatment of various diseases. Modified microbes were compared to either placebo (44%), or the same living probiotic strain (39%) or to only standard therapies (17%). Modified microbes were not significantly more or less effective than the living probiotic in 86% of the preventive trials and 69% of the treatment trials. Modified probiotic strains were significantly more effective in 15% of the treatment trials. Incidence rates of adverse events were similar for modified and living probiotics and other control groups, but many trials did not collect adequate safety data. Although several types of modified probiotics showed significant efficacy over living strains of probiotics, firm conclusions could not be reached due to the limited number of trials using the same type of modified microbe (strain, daily dose and duration) for a specific disease indication. Further research may illuminate other strains of modified probiotics that may have potential as clinical biotherapeutics.

scholarly journals Materiovigilance: Concept, Structure and Emerging Perspective for Patient’s Safety in India

Drug Research ◽  
2020 ◽  
Vol 70 (09) ◽  
pp. 429-436
Author(s):  
Farazul Hoda ◽  
Rishabh Verma ◽  
Mawrah Arshad ◽  
Ali Nasir Siddiqui ◽  
Mohammad Ahmed Khan ◽  
...  
Keyword(s):  
Patient Safety ◽  
Adverse Events ◽  
Medical Devices ◽  
Safety Data ◽  
Current Review ◽  
Ensure Patient Safety ◽  
Regulatory Perspective ◽  
Controller General ◽  
Ultimate Objective ◽  
Medical Device Regulation

AbstractThere has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of ‘how successful has it been so far’?

scholarly journals Socio-economic aspects of medical errors and their consequences in medical organizations

2019 ◽  
Vol 10 (1) ◽  
pp. 99-113 ◽  
Author(s):  
O. L. Zadvornaya ◽  
Yu. E. Voskanyan ◽  
I. B. Shikina ◽  
K. N. Borisov
Keyword(s):  
Public Health ◽  
Patient Safety ◽  
Adverse Events ◽  
Medical Care ◽  
Medical Errors ◽  
Quality Management System ◽  
The State ◽  
Risk Indicators ◽  
Economic Costs ◽  
Published Evidence

Medical errors and adverse events are a global problem of strategic importance, accompanied by economic costs that impose a burden on the health care system, the country's economy and society as a whole. The article presents the results of a review of world experience in developing approaches to assessing the safety of medical care in medical organizations, systematization and analysis of factors affecting the patient safety.Purpose: the purpose of the article is to study and assess the risks associated with medical errors and adverse events in the activities of medical organizations that affect the patient safety in order to reduce the loss of public health, improve the system of identification and monitoring of risk indicators that affect the safety of medical care.Methods: the method of rapid assessment and content analysis of published evidence, including who experience in safety of medical care, was used to highlight the issue. The methodology of functional benchmarking, which included the collection and analysis of the necessary information, the choice of individual functions, processes, methods of work of medical organizations working in similar conditions, was used in the study.Results: the approaches allowing to predict occurrence and development of risks in ensuring safety of medical care, reduction of losses of public health and social and economic costs of the state are considered and offered.Conclusions and Relevance: the materials presented in the article show that safety is a fundamental principle of providing medical services to patients and a critical component of the quality management system of medical care. To reduce the loss of public health, direct and indirect socio-economic costs of the state, comprehensive efforts are needed to reduce the risks that threaten the patient safety and improve the activities of medical organizations. 

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 Exploring patient safety outcomes for people with learning disabilities in acute hospital settings: a scoping review

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047102
Author(s):  
Gemma Louch ◽  
Abigail Albutt ◽  
Joanna Harlow-Trigg ◽  
Sally Moore ◽  
Kate Smyth ◽  
...  
Keyword(s):  
Learning Disabilities ◽  
Patient Safety ◽  
Adverse Events ◽  
Grey Literature ◽  
Good Practice ◽  
Hospital Setting ◽  
Eligibility Criteria ◽  
Infant Outcomes ◽  
Safety Outcomes

ObjectivesTo produce a narrative synthesis of published academic and grey literature focusing on patient safety outcomes for people with learning disabilities in an acute hospital setting.DesignScoping review with narrative synthesis.MethodsThe review followed the six stages of the Arksey and O’Malley framework. We searched four research databases from January 2000 to March 2021, in addition to handsearching and backwards searching using terms relating to our eligibility criteria—patient safety and adverse events, learning disability and hospital setting. Following stakeholder input, we searched grey literature databases and specific websites of known organisations until March 2020. Potentially relevant articles and grey literature materials were screened against the eligibility criteria. Findings were extracted and collated in data charting forms.Results45 academic articles and 33 grey literature materials were included, and we organised the findings around six concepts: (1) adverse events, patient safety and quality of care; (2) maternal and infant outcomes; (3) postoperative outcomes; (4) role of family and carers; (5) understanding needs in hospital and (6) supporting initiatives, recommendations and good practice examples. The findings suggest inequalities and inequities for a range of specific patient safety outcomes including adverse events, quality of care, maternal and infant outcomes and postoperative outcomes, in addition to potential protective factors, such as the roles of family and carers and the extent to which health professionals are able to understand the needs of people with learning disabilities.ConclusionPeople with learning disabilities appear to experience poorer patient safety outcomes in hospital. The involvement of family and carers, and understanding and effectively meeting the needs of people with learning disabilities may play a protective role. Promising interventions and examples of good practice exist, however many of these have not been implemented consistently and warrant further robust evaluation.

scholarly journals Longitudinal analysis of safety and medication adherence of patients in the Fingolimod patient support program: a real-world observational study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Aline Bourdin ◽  
Marie Paule Schneider ◽  
Isabella Locatelli ◽  
Myriam Schluep ◽  
Olivier Bugnon ◽  
...  
Keyword(s):  
Patient Safety ◽  
Medication Adherence ◽  
Real World ◽  
Safety Data ◽  
Support Program ◽  
Patient Support ◽  
Patient Support Program ◽  
Dose Monitoring ◽  
Real World Evidence ◽  
Patient Reported

AbstractThe Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence. This study aims to evaluate the safety and medication adherence of patients who joined the F-PSP between 2013 and 2016. Sociodemographic and medical characteristics, patient safety data (patient-reported symptoms, discontinuations due to adverse events (AEs), repeated first-dose monitoring), and medication adherence (implementation, persistence, reasons for discontinuation, influence of covariates, barriers and facilitators) were described. Sixty-seven patients joined the F-PSP. Patients reported a high frequency of symptoms. Due to AEs, 7 patients discontinued fingolimod, 3 took therapeutic breaks, and 1 reduced the regimen temporarily. Three patients repeated the first-dose monitoring. Patients had a high medication adherence over the 18-month analysis period: implementation decreased from 98.8 to 93.7%, and fingolimod persistence was 83.2% at 18 months. The patients’ level of education, professional situation, and living with child(ren) influenced implementation. Patients reported more facilitators of medication adherence than barriers. The F-PSP seems valuable for supporting individual patients (ensuring responsible use of fingolimod and inviting patients for shared-decision making) and public health (indirectly gathering real-world evidence).

Sign in / Sign up

Export Citation Format

Share Document