Facilitated Nurse Medication-Related Event Reporting to Improve Medication Management Quality and Safety in Intensive Care Units.

PubMed

Xu, Jie; Reale, Carrie; Slagle, Jason M; Anders, Shilo; Shotwell, Matthew S; Dresselhaus, Timothy; Weinger, Matthew B

Medication safety presents an ongoing challenge for nurses working in complex, fast-paced, intensive care unit (ICU) environments. Studying ICU nurse's medication management-especially medication-related events (MREs)-provides an approach to analyze and improve medication safety and quality. The goal of this study was to explore the utility of facilitated MRE reporting in identifying system deficiencies and the relationship between MREs and nurses' work in the ICUs. We conducted 124 structured 4-hour observations of nurses in three different ICUs. Each observation included measurement of nurse's moment-to-moment activity and self-reports of workload and negative mood. The observer then obtained MRE reports from the nurse using a structured tool. The MREs were analyzed by three experts. MREs were reported in 35% of observations. The 60 total MREs included four medication errors and seven adverse drug events. Of the 49 remaining MREs, 65% were associated with negative patient impact. Task/process deficiencies were the most common contributory factor for MREs. MRE occurrence was correlated with increased total task volume. MREs also correlated with increased workload, especially during night shifts. Most of these MREs would not be captured by traditional event reporting systems. Facilitated MRE reporting provides a robust information source about potential breakdowns in medication management safety and opportunities for system improvement.

Integrating natural language processing expertise with patient safety event review committees to improve the analysis of medication events.

PubMed

Fong, Allan; Harriott, Nicole; Walters, Donna M; Foley, Hanan; Morrissey, Richard; Ratwani, Raj R

2017-08-01

Many healthcare providers have implemented patient safety event reporting systems to better understand and improve patient safety. Reviewing and analyzing these reports is often time consuming and resource intensive because of both the quantity of reports and length of free-text descriptions in the reports. Natural language processing (NLP) experts collaborated with clinical experts on a patient safety committee to assist in the identification and analysis of medication related patient safety events. Different NLP algorithmic approaches were developed to identify four types of medication related patient safety events and the models were compared. Well performing NLP models were generated to categorize medication related events into pharmacy delivery delays, dispensing errors, Pyxis discrepancies, and prescriber errors with receiver operating characteristic areas under the curve of 0.96, 0.87, 0.96, and 0.81 respectively. We also found that modeling the brief without the resolution text generally improved model performance. These models were integrated into a dashboard visualization to support the patient safety committee review process. We demonstrate the capabilities of various NLP models and the use of two text inclusion strategies at categorizing medication related patient safety events. The NLP models and visualization could be used to improve the efficiency of patient safety event data review and analysis. Copyright © 2017 Elsevier B.V. All rights reserved.

On Building an Ontological Knowledge Base for Managing Patient Safety Events.

PubMed

Liang, Chen; Gong, Yang

2015-01-01

Over the past decade, improving healthcare quality and safety through patient safety event reporting systems has drawn much attention. Unfortunately, such systems are suffering from low data quality, inefficient data entry and ineffective information retrieval. For improving the systems, we develop a semantic web ontology based on the WHO International Classification for Patient Safety (ICPS) and AHRQ Common Formats for patient safety event reporting. The ontology holds potential in enhancing knowledge management and information retrieval, as well as providing flexible data entry and case analysis for both reporters and reviewers of patient safety events. In this paper, we detailed our efforts in data acquisition, transformation, implementation and initial evaluation of the ontology.

Using Active Learning to Identify Health Information Technology Related Patient Safety Events.

PubMed

Fong, Allan; Howe, Jessica L; Adams, Katharine T; Ratwani, Raj M

2017-01-18

The widespread adoption of health information technology (HIT) has led to new patient safety hazards that are often difficult to identify. Patient safety event reports, which are self-reported descriptions of safety hazards, provide one view of potential HIT-related safety events. However, identifying HIT-related reports can be challenging as they are often categorized under other more predominate clinical categories. This challenge of identifying HIT-related reports is exacerbated by the increasing number and complexity of reports which pose challenges to human annotators that must manually review reports. In this paper, we apply active learning techniques to support classification of patient safety event reports as HIT-related. We evaluated different strategies and demonstrated a 30% increase in average precision of a confirmatory sampling strategy over a baseline no active learning approach after 10 learning iterations.

Event Reports Promoting Root Cause Analysis.

PubMed

Pandit, Swananda; Gong, Yang

2016-01-01

Improving health is the sole objective of medical care. Unfortunately, mishaps or patient safety events happen during the care. If the safety events were collected effectively, they would help identify patterns, underlying causes, and ultimately generate proactive and remedial solutions for prevention of recurrence. Based on the AHRQ Common Formats, we examine the quality of patient safety incident reports and describe the initial data requirement that can support and accelerate effective root cause analysis. The ultimate goal is to develop a knowledge base of patient safety events and their common solutions which can be readily available for sharing and learning.

Safety evaluation of laninamivir octanoate hydrate through analysis of adverse events reported during early post-marketing phase vigilance.

PubMed

Nakano, Takashi; Okumura, Akihisa; Tanabe, Takuya; Niwa, Shimpei; Fukushima, Masato; Yonemochi, Rie; Eda, Hisano; Tsutsumi, Hiroyuki

2013-06-01

Abnormal behavior and delirium are common in children with influenza. While abnormal behavior and delirium are considered to be associated with influenza encephalopathy, an increased risk of such neuropsychiatric symptoms in patients receiving neuraminidase inhibitor treatment is suspected. Laninamivir octanoate hydrate, recently approved in Japan, is a long-acting neuraminidase inhibitor. It is important to establish a safety profile for laninamivir early, based on post-marketing experiences. Spontaneous safety reports collected in the early post-marketing phase vigilance were analyzed. Adverse events of interest such as abnormal behavior/delirium, dizziness/vertigo, respiratory disorders, shock/syncope, and any other serious events were intensively reviewed by the Safety Evaluation Committee. Abnormal behavior/delirium was a frequently reported event. Almost all the reported cases were considered to be due to influenza and not laninamivir. There were 32 cases of abnormal behavior/delirium that could lead to dangerous accidents, and these were observed more frequently in males and teenagers. Syncope probably related to the act of inhalation per se of laninamivir was reported during this survey. This safety review revealed that the safety profile of laninamivir for abnormal behavior/delirium and syncope was similar to that of other neuraminidase inhibitors. As stated in the labeling, teenage patients inhaling laninamivir should remain under constant parental supervision for at least 2 days and should be closely monitored for behavioral changes to prevent serious accidents associated with abnormal behavior/delirium. Furthermore, to avoid syncope because of inhalation, patients should be instructed to inhale in a relaxed sitting position.

Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

PubMed

Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

2018-05-15

Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems.

PubMed

Pham, Julius Cuong; Williams, Tamara L; Sparnon, Erin M; Cillie, Tam K; Scharen, Hilda F; Marella, William M

2016-05-01

In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of events reported in each database were related

The reasons for Chinese nursing staff to report adverse events: a questionnaire survey.

PubMed

Hong, Su; Li, QiuJie

2017-04-01

To investigate the impact of nurses' perception of patient safety culture and adverse event reporting, and demographic factors on adverse event reporting in Chinese hospitals. Accurate and timely adverse event reporting is integral in promoting patient safety and professional learning around the incident. In a cross-sectional survey, a sample of 919 nurses completed a structured questionnaire composed of two validated instruments measuring nurses' perception of patient safety culture and adverse event reporting. Associations between the variables were examined using multiple linear regression analysis. The positive response rates of five dimensions of the Patient Safety Culture Assessment Scale varied from 47.55% to 80.62%. The accuracy rate of Adverse Event Reporting Perception Scale was 63.16%. Five hundred and thirty-one (58.03%) nurses did not report adverse event in past 12 months. Six variables were found to be associated with nurses' adverse event reporting: total work experience (P = 0.003), overall patient safety culture score (P < 0.001), safety climate (P < 0.001), teamwork climate (P < 0.001), overall the adverse event reporting perception scale score (P = 0.003) and importance or reporting (P = 0.002). The results confirmed that improvements in the patient safety culture and nurses' perception of adverse event reporting were related to an increase in voluntary adverse event reporting. The knowledge of adverse event reporting should be integrated into the patient safety curriculum. Interventions that target a specific domain are necessary to improve the safety culture. © 2017 John Wiley & Sons Ltd.

Preparation for global introduction of inactivated poliovirus vaccine: safety evidence from the US Vaccine Adverse Event Reporting System, 2000-12.

PubMed

Iqbal, Shahed; Shi, Jing; Seib, Katherine; Lewis, Paige; Moro, Pedro L; Woo, Emily J; Shimabukuro, Tom; Orenstein, Walter A

2015-10-01

Safety data from countries with experience in the use of inactivated poliovirus vaccine (IPV) are important for the global polio eradication strategy to introduce IPV into the immunisation schedules of all countries. In the USA, IPV has been included in the routine immunisation schedule since 1997. We aimed to analyse adverse events after IPV administration reported to the US Vaccine Adverse Event Reporting System (VAERS). We analysed all VAERS data associated with IPV submitted between Jan 1, 2000, and Dec 31, 2012, either as individual or as combination vaccines, for all age and sex groups. We analysed the number and event type (non-serious, non-fatal serious, and death reports) of individual reports, and explored the most commonly coded event terms to describe the adverse event. We classified death reports according to previously published body-system categories (respiratory, cardiovascular, neurological, gastrointestinal, other infectious, and other non-infectious) and reviewed death reports to identify the cause of death. We classified sudden infant death syndrome as a separate cause of death considering previous concerns about sudden infant syndrome after vaccines. We used empirical Bayesian data mining methods to identify disproportionate reporting of adverse events for IPV compared with other vaccines. Additional VAERS data from 1991 to 2000 were analysed to compare the safety profiles of IPV and oral poliovirus vaccine (OPV). Of the 41,792 adverse event reports submitted, 39,568 (95%) were for children younger than 7 years. 38,381 of the reports for children in this age group (97%) were for simultaneous vaccination with IPV and other vaccines (most commonly pneumococcal and acellular pertussis vaccines), whereas standalone IPV vaccines accounted for 0·5% of all reports. 34,880 reports were for non-serious events (88%), 3905 reports were for non-fatal serious events (10%), and 783 reports were death reports (2%). Injection-site erythema was the most

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1979-01-01

The human factors frequency considered a cause of or contributor to hazardous events onboard air carriers are examined with emphasis on distractions. Safety reports that have been analyzed, processed, and entered into the aviation safety reporting system data base are discussed. A sampling of alert bulletins and responses to them is also presented.

Review of Safety Reports Involving Electronic Flight Bags.

DOT National Transportation Integrated Search

2010-04-01

Safety events in which Electronic Flight Bags (EFBs) were a factor are reviewed. Relevant reports were obtained from the public Aviation Safety Reporting System (ASRS) database and the National Transportation Safety Board (NTSB) accident report datab...

Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015.

PubMed

Myers, Tanya R; McNeil, Michael M; Ng, Carmen S; Li, Rongxia; Lewis, Paige W; Cano, Maria V

2017-03-27

Limited data are available describing the post-licensure safety of meningococcal vaccines, including Menveo®. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in all age groups. VAERS is a national spontaneous vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. We searched the VAERS database for US reports of adverse events in persons who received Menveo from 1 January 2010 through 31 December 2015. We clinically reviewed reports and available medical records for serious AEs, selected pre-specified outcomes, and vaccination during pregnancy. We used empirical Bayesian data mining to identify AEs that were disproportionately reported after receipt of Menveo. During the study period, VAERS received 2614 US reports after receipt of Menveo. Of these, 67 were classified as serious, including 1 report of death. Adolescents (aged 11-18years) accounted for 74% of reports. Most of the reported AEs were non-serious and described AEs consistent with data from pre-licensure studies. Anaphylaxis and syncope were the two most common events in the serious reports. We did not identify any new safety concerns after review of AEs that exceeded the data mining threshold, although we did observe disproportionate reporting for terms that were not associated with an adverse event (e.g., "incorrect drug dosage form administered", "wrong technique in drug usage process"). Although reports were limited, we did not find any evidence for concern regarding the use of Menveo during pregnancy. In our review of VAERS reports, findings of AEs were consistent with the data from pre-licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine. Copyright © 2017 Elsevier Ltd. All rights reserved.

The attributes of medical event-reporting systems: experience with a prototype medical event-reporting system for transfusion medicine.

PubMed

Battles, J B; Kaplan, H S; Van der Schaaf, T W; Shea, C E

1998-03-01

To design, develop, and implement a prototype medical event-reporting system for use in transfusion medicine to improve transfusion safety by studying incidents and errors. The IDEALS concept of design was used to identify specifications for the event-reporting system, and a Delphi and subsequent nominal group technique meetings were used to reach consensus on the development of the system. An interdisciplinary panel of experts from aviation safety, nuclear power, cognitive psychology, artificial intelligence, and education and representatives of major transfusion medicine organizations participated in the development process. Setting.- Three blood centers and three hospital transfusion services implemented the reporting system. A working prototype event-reporting system was recommended and implemented. The system has seven components: detection, selection, description, classification, computation, interpretation, and local evaluation. Its unique features include no-fault reporting initiated by the individual discovering the event, who submits a report that is investigated by local quality assurance personnel and forwarded to a nonregulatory central system for computation and interpretation. An event-reporting system incorporated into present quality assurance and risk management efforts can help organizations address system structural and procedural weakness where the potential for errors can adversely affect health care outcomes. Input from the end users of the system as well as from external experts should enable this reporting system to serve as a useful model for others who may develop event-reporting systems in other medical domains.

Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.

PubMed

Miller, Elaine R; Moro, Pedro L; Cano, Maria; Lewis, Paige; Bryant-Genevier, Marthe; Shimabukuro, Tom T

2016-05-27

23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. Published by Elsevier Ltd.

The relationship between organizational leadership for safety and learning from patient safety events.

PubMed

Ginsburg, Liane R; Chuang, You-Ta; Berta, Whitney Blair; Norton, Peter G; Ng, Peggy; Tregunno, Deborah; Richardson, Julia

2010-06-01

To examine the relationship between organizational leadership for patient safety and five types of learning from patient safety events (PSEs). Forty-nine general acute care hospitals in Ontario, Canada. A nonexperimental design using cross-sectional surveys of hospital patient safety officers (PSOs) and patient care managers (PCMs). PSOs provided data on organization-level learning from (a) minor events, (b) moderate events, (c) major near misses, (d) major event analysis, and (e) major event dissemination/communication. PCMs provided data on organizational leadership (formal and informal) for patient safety. Hospitals were the unit of analysis. Seemingly unrelated regression was used to examine the influence of formal and informal leadership for safety on the five types of learning from PSEs. The interaction between leadership and hospital size was also examined. Formal organizational leadership for patient safety is an important predictor of learning from minor, moderate, and major near-miss events, and major event dissemination. This relationship is significantly stronger for small hospitals (<100 beds). We find support for the relationship between patient safety leadership and patient safety behaviors such as learning from safety events. Formal leadership support for safety is of particular importance in small organizations where the economic burden of safety programs is disproportionately large and formal leadership is closer to the front lines.

Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.

PubMed

Arana, Jorge E; Harrington, Theresa; Cano, Maria; Lewis, Paige; Mba-Jonas, Adamma; Rongxia, Li; Stewart, Brock; Markowitz, Lauri E; Shimabukuro, Tom T

2018-03-20

The Food and Drug Administration (FDA) approved quadrivalent human papillomavirus vaccine (4vHPV) for use in females and males aged 9-26 years, since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS), a US spontaneous reporting system, in females and males who received 4vHPV vaccination. We searched VAERS for US reports of adverse events (AEs) following 4vHPV from January 2009 through December 2015. Signs and symptoms were coded using Medical Dictionary for Regulatory Activities (MedDRA). We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reports. Clinicians reviewed available information, including medical records, and reports of selected pre-specified conditions. VAERS received 19,760 reports following 4vHPV; 60.2% in females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports were non-serious; dizziness, syncope and injection site reactions were commonly reported in both males and females. Headache, fatigue and nausea were commonly reported serious AEs. More than 60 million 4vHPV doses were distributed during the study period. Crude AE reporting rates were 327 reports per million 4vHPV doses distributed for all reports, and 19 per million for serious reports. Among 29 verified reports of death, there was no pattern of clustering of deaths by diagnosis, co-morbidities, age, or interval from vaccination to death. No new or unexpected safety concerns or reporting patterns of 4vHPV with clinically important AEs were detected. Safety profile of 4vHPV is consistent with data from pre-licensure trials and postmarketing safety data. Published by Elsevier Ltd.

Applied Use of Safety Event Occurrence Control Charts of Harm and Non-Harm Events: A Case Study.

PubMed

Robinson, Susan N; Neyens, David M; Diller, Thomas

Most hospitals use occurrence reporting systems that facilitate identifying serious events that lead to root cause investigations. Thus, the events catalyze improvement efforts to mitigate patient harm. A serious limitation is that only a few of the occurrences are investigated. A challenge is leveraging the data to generate knowledge. The goal is to present a methodology to supplement these incident assessment efforts. The framework affords an enhanced understanding of patient safety through the use of control charts to monitor non-harm and harm incidents simultaneously. This approach can identify harm and non-harm reporting rates and also can facilitate monitoring occurrence trends. This method also can expedite identifying changes in workflow, processes, or safety culture. Although unable to identify root causes, this approach can identify changes in near real time. This approach also supports evaluating safety or policy interventions that may not be observable in annual safety climate surveys.

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda

2011-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 900,000 reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 5,500 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides de-identified report information through the online ASRS Database at http://asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation \\vill discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda J.

2017-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

Consumer reporting of adverse events following immunization.

PubMed

Clothier, Hazel J; Selvaraj, Gowri; Easton, Mee Lee; Lewis, Georgina; Crawford, Nigel W; Buttery, Jim P

2014-01-01

Surveillance of adverse events following immunisation (AEFI) is an essential component of vaccine safety monitoring. The most commonly utilized passive surveillance systems rely predominantly on reporting by health care providers (HCP). We reviewed adverse event reports received in Victoria, Australia since surveillance commencement in July 2007, to June 2013 (6 years) to ascertain the contribution of consumer (vaccinee or their parent/guardian) reporting to vaccine safety monitoring and to inform future surveillance system development directions. Categorical data included were: reporter type; serious and non-serious AEFI category; and, vaccinee age group. Chi-square test and 2-sample test of proportions were used to compare categories; trend changes were assessed using linear regression. Consumer reporting increased over the 6 years, reaching 21% of reports received in 2013 (P<0.001), most commonly for children aged less than 7 years. Consumer reports were 5% more likely to describe serious AEFI than HCP (P=0.018) and 10% more likely to result in specialist clinic attendance (P<0.001). Although online reporting increased to 32% of all report since its introduction in 2010, 85% of consumers continued to report by phone. Consumer reporting of AEFI is a valuable component of vaccine safety surveillance in addition to HCP reporting. Changes are required to AEFI reporting systems to implement efficient consumer AEFI reporting, but may be justified for their potential impact on signal detection sensitivity.

Lessons learnt from Dental Patient Safety Case Reports

PubMed Central

Obadan, Enihomo M.; Ramoni, Rachel B.; Kalenderian, Elsbeth

2015-01-01

Background Errors are commonplace in dentistry, it is therefore our imperative as dental professionals to intercept them before they lead to an adverse event, and/or mitigate their effects when an adverse event occurs. This requires a systematic approach at both the profession-level, encapsulated in the Agency for Healthcare Research and Quality’s Patient Safety Initiative structure, as well as at the practice-level, where Crew Resource Management is a tested paradigm. Supporting patient safety at both the dental practice and profession levels relies on understanding the types and causes of errors, an area in which little is known. Methods A retrospective review of dental adverse events reported in the literature was performed. Electronic bibliographic databases were searched and data were extracted on background characteristics, incident description, case characteristics, clinic setting where adverse event originated, phase of patient care that adverse event was detected, proximal cause, type of patient harm, degree of harm and recovery actions. Results 182 publications (containing 270 cases) were identified through our search. Delayed and unnecessary treatment/disease progression after misdiagnosis was the largest type of harm reported. 24.4% of reviewed cases were reported to have experienced permanent harm. One of every ten case reports reviewed (11.1%) reported that the adverse event resulted in the death of the affected patient. Conclusions Published case reports provide a window into understanding the nature and extent of dental adverse events, but for as much as the findings revealed about adverse events, they also identified the need for more broad-based contributions to our collective body of knowledge about adverse events in the dental office and their causes. Practical Implications Siloed and incomplete contributions to our understanding of adverse events in the dental office are threats to dental patients’ safety. PMID:25925524

Prevalence and test characteristics of national health safety network ventilator-associated events.

PubMed

Lilly, Craig M; Landry, Karen E; Sood, Rahul N; Dunnington, Cheryl H; Ellison, Richard T; Bagley, Peter H; Baker, Stephen P; Cody, Shawn; Irwin, Richard S

2014-09-01

The primary aim of the study was to measure the test characteristics of the National Health Safety Network ventilator-associated event/ventilator-associated condition constructs for detecting ventilator-associated pneumonia. Its secondary aims were to report the clinical features of patients with National Health Safety Network ventilator-associated event/ventilator-associated condition, measure costs of surveillance, and its susceptibility to manipulation. Prospective cohort study. Two inpatient campuses of an academic medical center. Eight thousand four hundred eight mechanically ventilated adults discharged from an ICU. None. The National Health Safety Network ventilator-associated event/ventilator-associated condition constructs detected less than a third of ventilator-associated pneumonia cases with a sensitivity of 0.325 and a positive predictive value of 0.07. Most National Health Safety Network ventilator-associated event/ventilator-associated condition cases (93%) did not have ventilator-associated pneumonia or other hospital-acquired complications; 71% met the definition for acute respiratory distress syndrome. Similarly, most patients with National Health Safety Network probable ventilator-associated pneumonia did not have ventilator-associated pneumonia because radiographic criteria were not met. National Health Safety Network ventilator-associated event/ventilator-associated condition rates were reduced 93% by an unsophisticated manipulation of ventilator management protocols. The National Health Safety Network ventilator-associated event/ventilator-associated condition constructs failed to detect many patients who had ventilator-associated pneumonia, detected many cases that did not have a hospital complication, and were susceptible to manipulation. National Health Safety Network ventilator-associated event/ventilator-associated condition surveillance did not perform as well as ventilator-associated pneumonia surveillance and had several undesirable

Defining and classifying medical error: lessons for patient safety reporting systems.

PubMed

Tamuz, M; Thomas, E J; Franchois, K E

2004-02-01

It is important for healthcare providers to report safety related events, but little attention has been paid to how the definition and classification of events affects a hospital's ability to learn from its experience. To examine how the definition and classification of safety related events influences key organizational routines for gathering information, allocating incentives, and analyzing event reporting data. In semi-structured interviews, professional staff and administrators in a tertiary care teaching hospital and its pharmacy were asked to describe the existing programs designed to monitor medication safety, including the reporting systems. With a focus primarily on the pharmacy staff, interviews were audio recorded, transcribed, and analyzed using qualitative research methods. Eighty six interviews were conducted, including 36 in the hospital pharmacy. Examples are presented which show that: (1) the definition of an event could lead to under-reporting; (2) the classification of a medication error into alternative categories can influence the perceived incentives and disincentives for incident reporting; (3) event classification can enhance or impede organizational routines for data analysis and learning; and (4) routines that promote organizational learning within the pharmacy can reduce the flow of medication error data to the hospital. These findings from one hospital raise important practical and research questions about how reporting systems are influenced by the definition and classification of safety related events. By understanding more clearly how hospitals define and classify their experience, we may improve our capacity to learn and ultimately improve patient safety.

77 FR 22322 - Common Formats for Patient Safety Data Collection and Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... Safety Databases (NPSD). The Common Formats include two general types of formats, generic and event... Common Formats. The inventory includes many systems from the private sector, including prominent academic...

The complexity of patient safety reporting systems in UK dentistry.

PubMed

Renton, T; Master, S

2016-10-21

Since the 'Francis Report', UK regulation focusing on patient safety has significantly changed. Healthcare workers are increasingly involved in NHS England patient safety initiatives aimed at improving reporting and learning from patient safety incidents (PSIs). Unfortunately, dentistry remains 'isolated' from these main events and continues to have a poor record for reporting and learning from PSIs and other events, thus limiting improvement of patient safety in dentistry. The reasons for this situation are complex.This paper provides a review of the complexities of the existing systems and procedures in relation to patient safety in dentistry. It highlights the conflicting advice which is available and which further complicates an overly burdensome process. Recommendations are made to address these problems with systems and procedures supporting patient safety development in dentistry.

Incidence of patient safety events and process-related human failures during intra-hospital transportation of patients: retrospective exploration from the institutional incident reporting system.

PubMed

Yang, Shu-Hui; Jerng, Jih-Shuin; Chen, Li-Chin; Li, Yu-Tsu; Huang, Hsiao-Fang; Wu, Chao-Ling; Chan, Jing-Yuan; Huang, Szu-Fen; Liang, Huey-Wen; Sun, Jui-Sheng

2017-11-03

Intra-hospital transportation (IHT) might compromise patient safety because of different care settings and higher demand on the human operation. Reports regarding the incidence of IHT-related patient safety events and human failures remain limited. To perform a retrospective analysis of IHT-related events, human failures and unsafe acts. A hospital-wide process for the IHT and database from the incident reporting system in a medical centre in Taiwan. All eligible IHT-related patient safety events between January 2010 to December 2015 were included. Incidence rate of IHT-related patient safety events, human failure modes, and types of unsafe acts. There were 206 patient safety events in 2 009 013 IHT sessions (102.5 per 1 000 000 sessions). Most events (n=148, 71.8%) did not involve patient harm, and process events (n=146, 70.9%) were most common. Events at the location of arrival (n=101, 49.0%) were most frequent; this location accounted for 61.0% and 44.2% of events with patient harm and those without harm, respectively (p<0.001). Of the events with human failures (n=186), the most common related process step was the preparation of the transportation team (n=91, 48.9%). Contributing unsafe acts included perceptual errors (n=14, 7.5%), decision errors (n=56, 30.1%), skill-based errors (n=48, 25.8%), and non-compliance (n=68, 36.6%). Multivariate analysis showed that human failure found in the arrival and hand-off sub-process (OR 4.84, p<0.001) was associated with increased patient harm, whereas the presence of omission (OR 0.12, p<0.001) was associated with less patient harm. This study shows a need to reduce human failures to prevent patient harm during intra-hospital transportation. We suggest that the transportation team pay specific attention to the sub-process at the location of arrival and prevent errors other than omissions. Long-term monitoring of IHT-related events is also warranted. © Article author(s) (or their employer(s) unless otherwise stated in the

A signal detection method for temporal variation of adverse effect with vaccine adverse event reporting system data.

PubMed

Cai, Yi; Du, Jingcheng; Huang, Jing; Ellenberg, Susan S; Hennessy, Sean; Tao, Cui; Chen, Yong

2017-07-05

To identify safety signals by manual review of individual report in large surveillance databases is time consuming; such an approach is very unlikely to reveal complex relationships between medications and adverse events. Since the late 1990s, efforts have been made to develop data mining tools to systematically and automatically search for safety signals in surveillance databases. Influenza vaccines present special challenges to safety surveillance because the vaccine changes every year in response to the influenza strains predicted to be prevalent that year. Therefore, it may be expected that reporting rates of adverse events following flu vaccines (number of reports for a specific vaccine-event combination/number of reports for all vaccine-event combinations) may vary substantially across reporting years. Current surveillance methods seldom consider these variations in signal detection, and reports from different years are typically collapsed together to conduct safety analyses. However, merging reports from different years ignores the potential heterogeneity of reporting rates across years and may miss important safety signals. Reports of adverse events between years 1990 to 2013 were extracted from the Vaccine Adverse Event Reporting System (VAERS) database and formatted into a three-dimensional data array with types of vaccine, groups of adverse events and reporting time as the three dimensions. We propose a random effects model to test the heterogeneity of reporting rates for a given vaccine-event combination across reporting years. The proposed method provides a rigorous statistical procedure to detect differences of reporting rates among years. We also introduce a new visualization tool to summarize the result of the proposed method when applied to multiple vaccine-adverse event combinations. We applied the proposed method to detect safety signals of FLU3, an influenza vaccine containing three flu strains, in the VAERS database. We showed that it had high

A novel approach to increase residents' involvement in reporting adverse events.

PubMed

Scott, David R; Weimer, Melissa; English, Clea; Shaker, Lynn; Ward, William; Choi, Dongseok; Cedfeldt, Andrea; Girard, Donald

2011-06-01

In the wake of the Patient Safety and Quality Improvement Act of 2005, national attention has increasingly focused on adverse-event reporting as a means of identifying systems changes to improve patient safety. However, physicians and residents have demonstrated meager involvement in this effort. In 2008-2009, the authors measured participation in adverse-event reporting by 680 residents at Oregon Health & Science University before and after implementing a quality improvement initiative, which consisted of a financial incentive and multifaceted educational campaign. The primary measure of success was an increase in the average monthly adverse-event reports submitted by residents to greater than 5% of the institution's overall report submissions. The average number of adverse events reported by residents increased from 1.6% to 9.0% of the institution's overall event reports, representing a 5.6-fold increase during the initiative (P < .001). The relative percentage of resident-submitted reports defined as "near-misses" increased from 6% to 27% during the initiative (P < .001). The novel approach of integrating a retirement benefit and educational campaign to increase residents' involvement in adverse-event reporting was successful. In addition to increasing residents' contributions to adverse-event reporting to levels higher than any documented in the current literature, there was also a remarkable increase in the relative frequency of near-miss reporting by residents.

Implementation and evaluation of a prototype consumer reporting system for patient safety events.

PubMed

Weingart, Saul N; Weissman, Joel S; Zimmer, Karen P; Giannini, Robert C; Quigley, Denise D; Hunter, Lauren E; Ridgely, M Susan; Schneider, Eric C

2017-08-01

No methodologically robust system exists for capturing consumer-generated patient safety reports. To address this challenge, we developed and pilot-tested a prototype consumer reporting system for patient safety, the Health Care Safety Hotline. Mixed methods evaluation. The Hotline was implemented in two US healthcare systems from 1 February 2014 through 30 June 2015. Patients, family members and caregivers associated with two US healthcare systems. A consumer-oriented incident reporting system for telephone or web-based administration was developed to elicit medical mistakes and care-related injuries. Key informant interviews, measurement of website traffic and analysis of completed reports. Key informants indicated that Hotline participation was motivated by senior leaders' support and alignment with existing quality and safety initiatives. During the measurement period from 1 October 2014 through 30 June 2015, the home page had 1530 visitors with a unique IP address. During its 17 months of operation, the Hotline received 37 completed reports including 20 mistakes without harm and 15 mistakes with injury. The largest category of mistake concerned problems with diagnosis or advice from a health practitioner. Hotline reports prompted quality reviews, an education intervention, and patient follow-ups. While generating fewer reports than its capacity to manage, the Health Care Safety Hotline demonstrated the feasibility of consumer-oriented patient safety reporting. Further research is needed to understand how to increase consumers' use of these systems. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Prospective data mining of six products in the US FDA Adverse Event Reporting System: disposition of events identified and impact on product safety profiles.

PubMed

Bailey, Steven; Singh, Ajay; Azadian, Robert; Huber, Peter; Blum, Michael

2010-02-01

The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not been elucidated. To analyse the number and types of disproportionately reported product-event combinations (DRPECs), as well as the final disposition of each, in order to understand the potential utility and resource implications of routinely conducting data mining in the US FDA Adverse Event Reporting System (AERS). We generated DRPECs from AERS for six of Wyeth's products, prospectively tracked their dispositions and evaluated the appropriate DRPECs in the company's safety database. We chose EB05 (the lower bound of the 90% confidence interval around the Empirical Bayes Geometric Mean) > or =2 as the appropriate metric, employing stratification based on age, sex and year of report. A total of 861 DRPECs were identified - the average number of DRPECs was 144 per product. The proportion of unique preferred terms (PTs) in AERS for each drug with an EB05 > or =2 was similar across the six products (5.1-8.5%). Overall, 64.0% (551) of the DRPECs were closed after the initial screening (44.8% labelled, 14.3% indication related, 4.9% non-interpretable). An additional 9.9% (85) had been reviewed within the prior year and were not further reviewed. The remaining 26.1% (225) required full case review. After review of all pertinent reports and additional data, it was determined which of the DRPECs necessitated a formal review by the company's ongoing Safety Review Team (SRT) process. In total, 3.6% (31/861) of the DRPECs, yielding 16 medical concepts, were reviewed by the SRT, leading to seven labelling changes. These labelling changes involved 1.9% of all DRPECs generated. Four of the six compounds reviewed as part of this pilot had an identified labelling change. The

Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015.

PubMed

Miller, Elaine R; Lewis, Paige; Shimabukuro, Tom T; Su, John; Moro, Pedro; Woo, Emily Jane; Jankosky, Christopher; Cano, Maria

2018-03-26

Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged ≥50 years and recommended by the CDC for persons ≥60 years. We analyzed U.S. reports of adverse events (AEs) following ZVL submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system to monitor vaccine safety, for persons vaccinated May 1, 2006, through January 31, 2015. We conducted descriptive analysis, clinical reviews of reports with selected pre-specified conditions, and empirical Bayesian data mining. VAERS received 23,092 reports following ZVL, of which 22,120 (96%) were classified as non-serious. Of reports where age was documented (n = 18,817), 83% were in persons aged ≥60 years. Reporting rates of AEs were 106 and 4.4 per 100,000 ZVL doses distributed for all reports and serious reports, respectively. When ZVL was administered alone among persons aged ≥50 years, injection site erythema (27%), HZ (17%), injection site swelling (17%), and rash (14%) were the most commonly reported symptoms among non-serious reports; HZ (29%), pain (18%), and rash (16%) were the most commonly reported symptoms among serious reports. Six reports included laboratory evidence of vaccine-strain varicella-zoster virus (Oka/Merck strain) infection; AEs included HZ, HZ- or varicella-like illness, and local reaction with vesicles. In our review of reports of death with sufficient information to determine cause (n = 46, median age 75 years), the most common causes were heart disease (n = 28), sepsis (n = 4), and stroke (n = 3). Empirical Bayesian data mining did not detect new or unexpected safety signals. Findings from our safety review of ZVL are consistent with those from pre-licensure clinical trials and other post-licensure assessments. Transient injection-site reactions, HZ, and rashes were most frequently

Review of safety reports involving electronic flight bags

DOT National Transportation Integrated Search

2009-04-27

Electronic Flight Bags (EFBs) are a relatively new device used by pilots. Even so, 37 safety-related events involving EFBs were identified from the public online Aviation Safety Reporting System (ASRS) database as of June 2008. In addition, two accid...

Bisphosphonates and Nonhealing Femoral Fractures: Analysis of the FDA Adverse Event Reporting System (FAERS) and International Safety Efforts

PubMed Central

Edwards, Beatrice J.; Bunta, Andrew D.; Lane, Joseph; Odvina, Clarita; Rao, D. Sudhaker; Raisch, Dennis W.; McKoy, June M.; Omar, Imran; Belknap, Steven M.; Garg, Vishvas; Hahr, Allison J.; Samaras, Athena T.; Fisher, Matthew J.; West, Dennis P.; Langman, Craig B.; Stern, Paula H.

2013-01-01

Background: In the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts. Methods: We analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012). Results: The analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures. Conclusions: Nonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing. PMID:23426763

From the school of nursing quality and safety officer: nursing students' use of safety reporting tools and their perception of safety issues in clinical settings.

PubMed

Cooper, Elizabeth

2013-01-01

Improved patient safety and quality are priority goals for nurses and schools of nursing. This article describes the innovative new role of quality and safety officer (QSO) developed by one university in response to the Quality and Safety Education for Nurses challenge to increase quality and safety education for prelicensure nursing students. The article also describes the results of a study conducted by the QSO, obtaining information from prelicensure nursing students about the use of safety tools and identifying the students' perceptions of safety issues, communication, and safety reporting in the clinical setting. Responses of 145 prelicensure nursing students suggest that it is difficult to get all errors and near-miss events reported. Barriers for nursing students are similar to the barriers nurses and physicians identify in reporting errors and near-miss events. The survey reveals that safety for the patient is the primary concern of the student nurse. Copyright © 2013 Elsevier Inc. All rights reserved.

Development of an automated assessment tool for MedWatch reports in the FDA adverse event reporting system.

PubMed

Han, Lichy; Ball, Robert; Pamer, Carol A; Altman, Russ B; Proestel, Scott

2017-09-01

As the US Food and Drug Administration (FDA) receives over a million adverse event reports associated with medication use every year, a system is needed to aid FDA safety evaluators in identifying reports most likely to demonstrate causal relationships to the suspect medications. We combined text mining with machine learning to construct and evaluate such a system to identify medication-related adverse event reports. FDA safety evaluators assessed 326 reports for medication-related causality. We engineered features from these reports and constructed random forest, L1 regularized logistic regression, and support vector machine models. We evaluated model accuracy and further assessed utility by generating report rankings that represented a prioritized report review process. Our random forest model showed the best performance in report ranking and accuracy, with an area under the receiver operating characteristic curve of 0.66. The generated report ordering assigns reports with a higher probability of medication-related causality a higher rank and is significantly correlated to a perfect report ordering, with a Kendall's tau of 0.24 ( P  = .002). Our models produced prioritized report orderings that enable FDA safety evaluators to focus on reports that are more likely to contain valuable medication-related adverse event information. Applying our models to all FDA adverse event reports has the potential to streamline the manual review process and greatly reduce reviewer workload. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the United States.

Impact of High-Reliability Education on Adverse Event Reporting by Registered Nurses.

PubMed

McFarland, Diane M; Doucette, Jeffrey N

Adverse event reporting is one strategy to identify risks and improve patient safety, but, historically, adverse events are underreported by registered nurses (RNs) because of fear of retribution and blame. A program was provided on high reliability to examine whether education would impact RNs' willingness to report adverse events. Although the findings were not statistically significant, they demonstrated a positive impact on adverse event reporting and support the need to create a culture of high reliability.

Identification of serious and reportable events in home care: a Delphi survey to develop consensus.

PubMed

Doran, Diane M; Baker, G Ross; Szabo, Cathy; McShane, Julie; Carryer, Jennifer

2014-04-01

To assess which client events should be considered reportable and preventable in home care (HC) settings in the opinion of HC safety experts. Patient safety in acute care settings has been well documented; however, there are limited data about this issue in HC. While many organizations collect information about 'incidents', there are no standards for reporting and it is challenging to compare incident rates among organizations. A 29-item electronic survey that included potential HC safety issues was used in a two-round Delphi study. Twenty-four pan-Canadian HC safety experts participated in an electronic survey. Perceived reportability and preventability of patient safety events, HC. The events that were perceived as being most reportable and preventable included the following: a serious injury related to inappropriate client service plan (e.g. incomplete/inaccurate assessments, poor care plan design, flawed implementation); an adverse reaction requiring emergency room visit or hospitalization related to a medication-related event; a catheter-site infection (e.g. a new peritoneal dialysis infection or peritonitis); any serious event related to care or services that are contrary to current professional or other practice standards (e.g. incorrect treatment regimen, theft, retention of a foreign object in a wound, individual practicing outside scope or competence). These data represent an important step in the development and validation of standard metrics about client safety in HC. The results address an expanding area of health services where there is a need to improve standardization and reporting.

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

2017-12-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

Parental perspectives of vaccine safety and experience of adverse events following immunisation.

PubMed

Parrella, Adriana; Gold, Michael; Marshall, Helen; Braunack-Mayer, Annette; Baghurst, Peter

2013-04-12

We aimed to determine demographic predictors of parental vaccine safety and risk perceptions, and assess the relationship between the occurrence of children's perceived adverse events following immunisation (AEFI) on parents' opinions. Computer-assisted telephone interviews (CATI) were conducted in 2011 with a cross-sectional, random general population sample of rural and metropolitan residents in South Australia. Multivariate ordinal logistic regression analyses examined associations between parental vaccine safety attitudes and socio-demographic factors, adjusting for whether children had ever experienced a previous suspected AEFI. Of 469 parents interviewed, 95% were confident in vaccine safety in general, but almost half expressed concern for pre-licensure testing of vaccines. Of all parents, 41% responded that at least one of their children had experienced an AEFI. Almost one third of the AEFI parent group indicated they reported their children's symptoms to either a healthcare professional or the Department of Health. Parental acceptability of the risks of febrile convulsion and anaphylaxis were 73% and 76% respectively. Ordinal logistic regression analyses showed parents of children who had experienced a suspected AEFI were associated with greater concern for vaccine safety (OR:0.53, p≤0.01) and more were likely to expect either a mild or a serious AEFI. After adjusting for demographics, parental confidence in vaccine safety was significantly associated with higher levels of education (OR:2.58, p=0.01) and being born in Australia OR:2.30, p=0.004. Mothers, when compared with fathers, were less accepting of the two vaccine risks presented: febrile convulsion (OR:0.57, p=0.04) and anaphylaxis, (OR:0.55, p=0.04). Parents commonly perceive and report that their child has experienced an AEFI. In this group of parents the subsequent expectation of an AEFI and vaccine safety concerns may be heightened. Further research should investigate parental understandings

A new safety event reporting system improves physician reporting in the surgical intensive care unit.

PubMed

Schuerer, Douglas J E; Nast, Patricia A; Harris, Carolyn B; Krauss, Melissa J; Jones, Rebecca M; Boyle, Walter A; Buchman, Timothy G; Coopersmith, Craig M; Dunagan, W Claiborne; Fraser, Victoria J

2006-06-01

Medical errors are common, and physicians have notably been poor medical error reporters. In the SICU, reporting was generally poor and reporting by physicians was virtually nonexistent. This study was designed to observe changes in error reporting in an SICU when a new card-based system (SAFE) was introduced. Before implementation of the SAFE reporting system, education was given to all SICU healthcare providers. The SAFE system was introduced into the SICU for a 9-month period from March 2003 through November 2003, to replace an underused online system. Data were collected from the SAFE card reports and the online reporting systems during introduction, removal, and reimplementation of these cards. Reporting rates were calculated as number of reported events per 1,000 patient days. Reporting rates increased from 19 to 51 reports per 1,000 patient days after the SAFE cards were introduced into the ICU (preporting increased most, rising from 0.3 to 5.8 reports per 1,000 patient days; nursing reporting also increased from 18 to 39 reports per 1,000 patient days (both preporting declined to 0 reports per 1,000 patient days (p=0.01) and rose to 8.1 (p=0.001) when the cards were returned, similar to nursing results. A higher proportion of physician reports were events that caused harm compared with no effect (p < 0.05). A card reporting system, combined with appropriate education, improved overall reporting in the SICU, especially among physician providers. Nurses were more likely to use reporting systems than were physicians. Physician reports were more likely to be of events that caused harm.

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

PubMed

Crowe, Brenda J; Xia, H Amy; Berlin, Jesse A; Watson, Douglas J; Shi, Hongliang; Lin, Stephen L; Kuebler, Juergen; Schriver, Robert C; Santanello, Nancy C; Rochester, George; Porter, Jane B; Oster, Manfred; Mehrotra, Devan V; Li, Zhengqing; King, Eileen C; Harpur, Ernest S; Hall, David B

2009-10-01

The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period. SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions. An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission. We recognize that there may be other valid approaches. The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond.

Screening Electronic Health Record-Related Patient Safety Reports Using Machine Learning.

PubMed

Marella, William M; Sparnon, Erin; Finley, Edward

2017-03-01

The objective of this study was to develop a semiautomated approach to screening cases that describe hazards associated with the electronic health record (EHR) from a mandatory, population-based patient safety reporting system. Potentially relevant cases were identified through a query of the Pennsylvania Patient Safety Reporting System. A random sample of cases were manually screened for relevance and divided into training, testing, and validation data sets to develop a machine learning model. This model was used to automate screening of remaining potentially relevant cases. Of the 4 algorithms tested, a naive Bayes kernel performed best, with an area under the receiver operating characteristic curve of 0.927 ± 0.023, accuracy of 0.855 ± 0.033, and F score of 0.877 ± 0.027. The machine learning model and text mining approach described here are useful tools for identifying and analyzing adverse event and near-miss reports. Although reporting systems are beginning to incorporate structured fields on health information technology and the EHR, these methods can identify related events that reporters classify in other ways. These methods can facilitate analysis of legacy safety reports by retrieving health information technology-related and EHR-related events from databases without fields and controlled values focused on this subject and distinguishing them from reports in which the EHR is mentioned only in passing. Machine learning and text mining are useful additions to the patient safety toolkit and can be used to semiautomate screening and analysis of unstructured text in safety reports from frontline staff.

Knowledge is power: averting safety-compromising events in the OR.

PubMed

Catalano, Kathleen

2008-12-01

Surgical procedures can be unpredictable, and safety-compromising events can jeopardize patient safety. Perioperative nurses should be watchful for factors that can contribute to safety-compromising events, as well as the errors that can follow, and know how to avert them if possible. Knowledge is power and increased awareness of patient safety issues and the resources that are available to both health care practitioners and consumers can help perioperative nurses ward off patient safety problems before they occur.

Effects of organizational safety practices and perceived safety climate on PPE usage, engineering controls, and adverse events involving liquid antineoplastic drugs among nurses.

PubMed

DeJoy, David M; Smith, Todd D; Woldu, Henok; Dyal, Mari-Amanda; Steege, Andrea L; Boiano, James M

2017-07-01

Antineoplastic drugs pose risks to the healthcare workers who handle them. This fact notwithstanding, adherence to safe handling guidelines remains inconsistent and often poor. This study examined the effects of pertinent organizational safety practices and perceived safety climate on the use of personal protective equipment, engineering controls, and adverse events (spill/leak or skin contact) involving liquid antineoplastic drugs. Data for this study came from the 2011 National Institute for Occupational Safety and Health (NIOSH) Health and Safety Practices Survey of Healthcare Workers which included a sample of approximately 1,800 nurses who had administered liquid antineoplastic drugs during the past seven days. Regression modeling was used to examine predictors of personal protective equipment use, engineering controls, and adverse events involving antineoplastic drugs. Approximately 14% of nurses reported experiencing an adverse event while administering antineoplastic drugs during the previous week. Usage of recommended engineering controls and personal protective equipment was quite variable. Usage of both was better in non-profit and government settings, when workers were more familiar with safe handling guidelines, and when perceived management commitment to safety was higher. Usage was poorer in the absence of specific safety handling procedures. The odds of adverse events increased with number of antineoplastic drugs treatments and when antineoplastic drugs were administered more days of the week. The odds of such events were significantly lower when the use of engineering controls and personal protective equipment was greater and when more precautionary measures were in place. Greater levels of management commitment to safety and perceived risk were also related to lower odds of adverse events. These results point to the value of implementing a comprehensive health and safety program that utilizes available hazard controls and effectively communicates

Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

PubMed

Hohl, Corinne M; Small, Serena S; Peddie, David; Badke, Katherin; Bailey, Chantelle; Balka, Ellen

2018-02-27

Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care. ©Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka. Originally published in JMIR

Using naturalistic driving data to explore the association between traffic safety-related events and crash risk at driver level.

PubMed

Wu, Kun-Feng; Aguero-Valverde, Jonathan; Jovanis, Paul P

2014-11-01

There has been considerable research conducted over the last 40 years using traffic safety-related events to support road safety analyses. Dating back to traffic conflict studies from the 1960s these observational studies of driver behavior have been criticized due to: poor quality data; lack of available and useful exposure measures linked to the observations; the incomparability of self-reported safety-related events; and, the difficulty in assessing culpability for safety-related events. This study seeks to explore the relationships between driver characteristics and traffic safety-related events, and between traffic safety-related events and crash involvement while mitigating some of those limitations. The Virginia Tech Transportation Institute 100-Car Naturalistic Driving Study dataset, in which the participants' vehicles were instrumented with various cameras and sensors during the study period, was used for this study. The study data set includes 90 drivers observed for 12-13 months driving. This study focuses on single vehicle run-off-road safety-related events only, including 14 crashes and 182 safety-related events (30 near crashes, and 152 crash-relevant incidents). Among the findings are: (1) drivers under age 25 are significantly more likely to be involved in safety-related events and crashes; and (2) significantly positive correlations exist between crashes, near crashes, and crash-relevant incidents. Although there is still much to learn about the factors affecting the positive correlation between safety-related events and crashes, a Bayesian multivariate Poisson log-normal model is shown to be useful to quantify the associations between safety-related events and crash risk while controlling for driver characteristics. Copyright © 2014 Elsevier Ltd. All rights reserved.

Design a Learning-Oriented Fall Event Reporting System Based on Kirkpatrick Model.

PubMed

Zhou, Sicheng; Kang, Hong; Gong, Yang

2017-01-01

Patient fall has been a severe problem in healthcare facilities around the world due to its prevalence and cost. Routine fall prevention training programs are not as effective as expected. Using event reporting systems is the trend for reducing patient safety events such as falls, although some limitations of the systems exist at current stage. We summarized these limitations through literature review, and developed an improved web-based fall event reporting system. The Kirkpatrick model, widely used in the business area for training program evaluation, has been integrated during the design of our system. Different from traditional event reporting systems that only collect and store the reports, our system automatically annotates and analyzes the reported events, and provides users with timely knowledge support specific to the reported event. The paper illustrates the design of our system and how its features are intended to reduce patient falls by learning from previous errors.

Event (error and near-miss) reporting and learning system for process improvement in radiation oncology.

PubMed

Mutic, Sasa; Brame, R Scott; Oddiraju, Swetha; Parikh, Parag; Westfall, Melisa A; Hopkins, Merilee L; Medina, Angel D; Danieley, Jonathan C; Michalski, Jeff M; El Naqa, Issam M; Low, Daniel A; Wu, Bin

2010-09-01

The value of near-miss and error reporting processes in many industries is well appreciated and typically can be supported with data that have been collected over time. While it is generally accepted that such processes are important in the radiation therapy (RT) setting, studies analyzing the effects of organized reporting and process improvement systems on operation and patient safety in individual clinics remain scarce. The purpose of this work is to report on the design and long-term use of an electronic reporting system in a RT department and compare it to the paper-based reporting system it replaced. A specifically designed web-based system was designed for reporting of individual events in RT and clinically implemented in 2007. An event was defined as any occurrence that could have, or had, resulted in a deviation in the delivery of patient care. The aim of the system was to support process improvement in patient care and safety. The reporting tool was designed so individual events could be quickly and easily reported without disrupting clinical work. This was very important because the system use was voluntary. The spectrum of reported deviations extended from minor workflow issues (e.g., scheduling) to errors in treatment delivery. Reports were categorized based on functional area, type, and severity of an event. The events were processed and analyzed by a formal process improvement group that used the data and the statistics collected through the web-based tool for guidance in reengineering clinical processes. The reporting trends for the first 24 months with the electronic system were compared to the events that were reported in the same clinic with a paper-based system over a seven-year period. The reporting system and the process improvement structure resulted in increased event reporting, improved event communication, and improved identification of clinical areas which needed process and safety improvements. The reported data were also useful for the

21 CFR 312.32 - IND safety reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... safety reports. (a) Definitions. The following definitions of terms apply to this section:- Associated... intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include... example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if...

Leveraging Event Reporting Through Knowledge Support: A Knowledge-Based Approach to Promoting Patient Fall Prevention.

PubMed

Yao, Bin; Kang, Hong; Miao, Qi; Zhou, Sicheng; Liang, Chen; Gong, Yang

2017-01-01

Patient falls are a common safety event type that impairs the healthcare quality. Strategies including solution tools and reporting systems for preventing patient falls have been developed and implemented in the U.S. However, the current strategies do not include timely knowledge support, which is in great need in bridging the gap between reporting and learning. In this study, we constructed a knowledge base of fall events by combining expert-reviewed fall prevention solutions and then integrating them into a reporting system. The knowledge base enables timely and tailored knowledge support and thus will serve as a prevailing fall prevention tool. This effort holds promise in making knowledge acquisition and management a routine process for enhancing the reporting and understanding of patient safety events.

Reporting of adverse events following immunizations in Ghana - Using disproportionality analysis reporting ratios.

PubMed

Ankrah, Daniel N A; Darko, Delese M; Sabblah, George; Mantel-Teeuwisse, Aukje; Leufkens, Hubert M G

2018-01-02

Timely reporting of safety information post vaccination is pivotal for the success of any vaccination program. Reports of adverse events following immunization (AEFI) of 6 different vaccinations from Ghana were analysed for signals. De-identified data from active surveillance for AEFIs after 2009 AH1N1 influenza, yellow fever, meningitis, measles-rubella, pneumococcal-rotavirus and human papilloma virus vaccinations were used. All vaccinations occurred between January 2010 and December 2013. The ten most occurring events for each vaccination were captured and arranged using Medical Dictionary for Regulatory Authorities (MedDRA) Preferred Term (PT) and System Organ Classification (SOC) codes. Adverse event incidence rates were calculated for each vaccine type, and signals were generated using proportional reporting ratios (PRR). A total number of 5,141 reports were analysed ranging from 33 (human papilloma virus) to 1958 (measles-rubella). Between 22% and 55% of all AEFIs per vaccine type were collected on the day of vaccination. For each vaccine type, at least 87% of all reported AEFIs occurred in the first 7 days post-vaccination. Multiple reports were received per vaccine type. For the MR vaccine, urticarial recorded the highest attack rate of 6.6 (95% CI 6.2, 7.1) per 100,000 vaccines. The AEFI with the highest PRR for both human papilloma and measles-rubella vaccines was abdominal pain, recording a PRR of 8.15 (95% CI 3.46, 19.23) and 43.75 (95% CI 17.81, 107.45) respectively. These results underscore the competency of public health systems in sub-Saharan African countries (like Ghana) to identify most frequently occurring and important vaccine related safety issues.

Development of an adverse events reporting form for Korean folk medicine.

PubMed

Park, Jeong Hwan; Choi, Sun-Mi; Moon, Sujeong; Kim, Sungha; Kim, Boyoung; Kim, Min-Kyeoung; Lee, Sanghun

2017-05-01

We developed an adverse events (AEs) reporting form for Korean folk medicine. The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Implementation of a Data-Based Medical Event Reporting System in the U.S. Department of Defense

DTIC Science & Technology

2005-05-01

where patient safety events warrant further investigation. Introduction Department of Defense Instruction 6025.17 established the Military Health ...Administration (VHA) Patient Safety Reporting Program for error tracking and reporting within all military health care facilities. 5 On August 16, 2001...DoD Instruction number 6025.17 “established a Military Health System Patient Safety Center (MHSPSC), including a MHS Patient Safety Registry (MHSPSR

When bad things happen: adverse event reporting and disclosure as patient safety and risk management tools in the neonatal intensive care unit.

PubMed

Donn, Steven M; McDonnell, William M

2012-01-01

The Institute of Medicine has recommended a change in culture from "name and blame" to patient safety. This will require system redesign to identify and address errors, establish performance standards, and set safety expectations. This approach, however, is at odds with the present medical malpractice (tort) system. The current system is outcomes-based, meaning that health care providers and institutions are often sued despite providing appropriate care. Nevertheless, the focus should remain to provide the safest patient care. Effective peer review may be hindered by the present tort system. Reporting of medical errors is a key piece of peer review and education, and both anonymous reporting and confidential reporting of errors have potential disadvantages. Diagnostic and treatment errors continue to be the leading sources of allegations of malpractice in pediatrics, and the neonatal intensive care unit is uniquely vulnerable. Most errors result from systems failures rather than human error. Risk management can be an effective process to identify, evaluate, and address problems that may injure patients, lead to malpractice claims, and result in financial losses. Risk management identifies risk or potential risk, calculates the probability of an adverse event arising from a risk, estimates the impact of the adverse event, and attempts to control the risk. Implementation of a successful risk management program requires a positive attitude, sufficient knowledge base, and a commitment to improvement. Transparency in the disclosure of medical errors and a strategy of prospective risk management in dealing with medical errors may result in a substantial reduction in medical malpractice lawsuits, lower litigation costs, and a more safety-conscious environment. Thieme Medical Publishers, Inc.

Learning from Taiwan patient-safety reporting system.

PubMed

Lin, Chung-Chih; Shih, Chung-Liang; Liao, Hsun-Hsiang; Wung, Cathy H Y

2012-12-01

The aim of this study is to create a national database to record incidents that endanger patient safety. We try to identify systemic problems in hospitals in order to avoid safety incidents in the future and improve the quality of healthcare. The Taiwan Patient Safety Reporting System employs a voluntary notification model. We define 13 types of patient safety incidents, and the reports of different types of incidents are recorded using common terminology. Statistical analysis is used to identify the incident type, time of occurrence, location, person who reported the incident, and possible reasons for frequently occurring incidents. There were 340 hospitals that joined this program from 2005 to 2010. Over 128,271 incident events were reported and analyzed. The three most common incidents were drug-related incidents, falls, and endo tube related incidents. By analyzing the time of occurrence of incidents, we found that drug-related incidents usually occurred between 8 and 10 am. Falls and endo tube incidents usually occurred between 4 and 6 am. The most common location was wards (57.6%), followed by intensive care areas (13.5%), and pharmacies (9.1%). Among hospital staff, nurses reported the highest number of incidents (68.9%), followed by pharmacists (14.5%) and administrative staff (5.5%). The number of incidents reported by doctors was much lower (1.2%). Most staff members who reported incidents had been working for less than five years (58.1%). The unified reporting system was found to improve the recording and analysis of patient safety incidents. To encourage hospital staff to report incidents, hospitals need to be assisted in establishing an internal report and management system for safety incidents. Hospitals also need a protection mechanism to allow staff members to report incidents without the fear of punishment. By identifying the root causes of safety incidents and sharing the lessons learned across hospitals is the only way such incidents can be

General in-situation safety behaviors are uniquely associated with post-event processing.

PubMed

Mitchell, Melissa A; Schmidt, Norman B

2014-06-01

Research suggests that state anxiety and in-situation safety behaviors are associated with post-event processing (PEP) in social anxiety. Past research has obtained mixed results on whether one or both factors contribute to PEP. The current investigation evaluated state anxiety and in-situation safety behaviors (including subtypes of in-situation safety behaviors) simultaneously to determine their relative contributions to PEP. A prospective study assessed social anxiety, state anxiety, in-situation safety behaviors, PEP, and depression in the context of a speech stressor. Consistent with theory, in-situation safety behaviors were uniquely associated with greater PEP. State anxiety was not uniquely associated with PEP. Furthermore, restricting and active subtypes of in-situation safety behaviors showed specificity to PEP. Limitations of the present study include the use of a nonclinical analog sample and retrospective reporting of PEP. These findings highlight the importance of research on in-situation safety behaviors as a potential contributor to PEP. Published by Elsevier Ltd.

Reporting of Perioperative Adverse Events by Pediatric Anesthesiologists at a Tertiary Children's Hospital: Targeted Interventions to Increase the Rate of Reporting.

PubMed

Williams, Glyn D; Muffly, Matthew K; Mendoza, Julianne M; Wixson, Nina; Leong, Kit; Claure, Rebecca E

2017-11-01

Incident reporting systems (IRSs) are important patient safety tools for identifying risks and opportunities for improvement. A major IRS limitation is underreporting of incidents. Perioperative anesthesia IRSs have been established at multiple pediatric institutions and a national pediatric anesthesia IRS for perioperative serious adverse events (SAEs) is maintained by Wake Up Safe (WUS), a patient safety organization dedicated to pediatric anesthesia quality improvement. A confidential, electronic, perioperative IRS was instituted at our tertiary children's hospital, which is a WUS member. The primary study aim was to increase the rate of incident reporting by anesthesiologists at our institution through a series of interventions. The secondary aim was to characterize our reporting behavior relative to national practice by referencing SAE data from WUS. Perioperative adverse events reported over a 71-month period (November 2010 to September 2016) were categorized and the monthly reporting rates determined. Effects of 6 interventions targeted to increase the reporting rate were analyzed using control charts. Intervention 5 involved interviewing pediatric anesthesiologists to ascertain incident reporting barriers and motivators. A key driver diagram was developed and used to guide an improvement initiative. Incidents that fulfilled WUS criteria for SAEs were identified and categorized. SAE reporting rates over a 27-month period for 12 WUS member institutions were determined. 2689 perioperative adverse events were noted in 1980 of 72,384 anesthetics. Mean monthly adverse event case rate was 273 (95% confidence interval, 250-297) per 10,000 anesthetics. A subgroup involving 54,469 cases had 529 SAEs in 440 anesthetics; a mean monthly SAE case rate of 80 (95% confidence interval, 69-91) per 10,000 anesthetics. Cardiac, respiratory, and airway events predominated. Relative to WUS peer members, our institution is a high-reporting outlier. The rate of incident reporting

Why System Safety Professionals Should Read Accident Reports

NASA Technical Reports Server (NTRS)

Holloway, C. M.; Johnson, C. W.

2006-01-01

System safety professionals, both researchers and practitioners, who regularly read accident reports reap important benefits. These benefits include an improved ability to separate myths from reality, including both myths about specific accidents and ones concerning accidents in general; an increased understanding of the consequences of unlikely events, which can help inform future designs; a greater recognition of the limits of mathematical models; and guidance on potentially relevant research directions that may contribute to safety improvements in future systems.

Creating the Web-based Intensive Care Unit Safety Reporting System

PubMed Central

Holzmueller, Christine G.; Pronovost, Peter J.; Dickman, Fern; Thompson, David A.; Wu, Albert W.; Lubomski, Lisa H.; Fahey, Maureen; Steinwachs, Donald M.; Engineer, Lilly; Jaffrey, Ali; Morlock, Laura L.; Dorman, Todd

2005-01-01

In an effort to improve patient safety, researchers at the Johns Hopkins University designed and implemented a comprehensive Web-based Intensive Care Unit Safety Reporting System (ICUSRS). The ICUSRS collects data about adverse events and near misses from all staff in the ICU. This report reflects data on 854 reports from 18 diverse ICUs across the United States. Reporting is voluntary, and data collected is confidential, with patient, provider, and reporter information deidentified. Preliminary data include system factors reported, degree of patient harm, reporting times, and evaluations of the system. Qualitative and quantitative data are reported back to the ICU site study teams and frontline staff through monthly reports, case discussions, and a quarterly newsletter. PMID:15561794

Vaccine Adverse Events

MedlinePlus

... use in the primary immunization series in infants Report Adverse Event Report a Vaccine Adverse Event Contact FDA (800) 835- ... back to top Popular Content Home Latest Recalls Report an Adverse Event MedWatch Safety Alerts News Releases ...

Implementation of a patient safety program at a tertiary health system: A longitudinal analysis of interventions and serious safety events.

PubMed

Cropper, Douglas P; Harb, Nidal H; Said, Patricia A; Lemke, Jon H; Shammas, Nicolas W

2018-04-01

We hypothesize that implementation of a safety program based on high reliability organization principles will reduce serious safety events (SSE). The safety program focused on 7 essential elements: (a) safety rounding, (b) safety oversight teams, (c) safety huddles, (d) safety coaches, (e) good catches/safety heroes, (f) safety education, and (g) red rule. An educational curriculum was implemented focusing on changing high-risk behaviors and implementing critical safety policies. All unusual occurrences were captured in the Midas system and investigated by risk specialists, the safety officer, and the chief medical officer. A multidepartmental committee evaluated these events, and a root cause analysis (RCA) was performed. Events were tabulated and serious safety event (SSE) recorded and plotted over time. Safety success stories (SSSs) were also evaluated over time. A steady drop in SSEs was seen over 9 years. Also a rise in SSSs was evident, reflecting on staff engagement in the program. The parallel change in SSEs, SSSs, and the implementation of various safety interventions highly suggest that the program was successful in achieving its goals. A safety program based on high-reliability organization principles and made a core value of the institution can have a significant positive impact on reducing SSEs. © 2018 American Society for Healthcare Risk Management of the American Hospital Association.

An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials

PubMed Central

2011-01-01

Background Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Methods Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. Results Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting. For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). Conclusions An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement. PMID

[Validation of an adverse event reporting system in primary care].

PubMed

de Lourdes Rojas-Armadillo, María; Jiménez-Báez, María Valeria; Chávez-Hernández, María Margarita; González-Fondón, Araceli

2016-01-01

Patient safety is a priority issue in health systems, due to the damage costs, institutional weakening, lack of credibility, and frustration on those who committed an error that resulted in an adverse event. There is no standardized instrument for recording, reporting, and analyzing sentinel or adverse events (AE) in primary care. Our aim was to design and validate a surveillance system for recording sentinel events, adverse events and near miss incidents in primary care. We made a review of systems for recording and reporting adverse events in primary care. Then, we proposed an instrument to record these events, and register faults in the structure and process, in primary health care units in the Instituto Mexicano del Seguro Social. We showed VENCER-MF format to 35 subjects. Out of them, 100% identified a failure in care process, 90% recorded a sentinel event, 85% identified the cause of this event, 75% of them suggested some measures for avoiding the recurrence of adverse events. We used a Cronbach's alpha of 0.6, p=0.03. The instrument VENCER-MF has a good consistency for the identification of adverse events.

The Hidden Cost of Regulation: The Administrative Cost of Reporting Serious Reportable Events.

PubMed

Blanchfield, Bonnie B; Acharya, Bijay; Mort, Elizabeth

2018-04-01

More than half of the 50 states (27) and the District of Columbia require reporting of Serous Reportable Events (SREs). The goal is to hold providers accountable and improve patient safety, but there is little information about the administrative cost of this reporting requirement. This study was conducted to identify costs associated with investigating and reporting SREs. This qualitative study used case study methods that included interviewing staff and review of data and documents to investigate each SRE occurring at one academic medical center during fiscal year 2013. A framework of tasks and a model to categorize costs was created. Time was summarized and costs were estimated for each SRE. The administrative cost to process 44 SREs was estimated at $353,291, an average cost of $8,029 per SRE, ranging $6,653 for an environmental-related SRE to $21,276 for a device-related SRE. Care management SREs occurred most frequently, costing an average $7,201 per SRE. Surgical SREs, the most expensive on average, cost $9,123 per SRE. Investigation of events accounted for 64.5% of total cost; public reporting, 17.2%; internal reporting, 10.2%; finance and administration, 6.0%; and 2.1%, other. Even with 26 states mandating reporting, the 17.2% incremental cost of public reporting is substantial. Policy makers should consider the opportunity costs of these resources, averaging $8,029 per SRE, when mandating reporting. The benefits of public reporting should be collectively reviewed to ensure that the incremental costs in this resource-constrained environment continue to improve patient safety and that trade-offs are acknowledged. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

Avant, Debbie; Baer, Gerri; Moore, Jason; Zheng, Panli; Sorbello, Alfred; Ariagno, Ron; Yao, Lynne; Burckart, Gilbert J.; Wang, Jian

2017-01-01

Background Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. Methods FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. Results The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. Conclusions Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal

Recognising safety critical events: can automatic video processing improve naturalistic data analyses?

PubMed

Dozza, Marco; González, Nieves Pañeda

2013-11-01

New trends in research on traffic accidents include Naturalistic Driving Studies (NDS). NDS are based on large scale data collection of driver, vehicle, and environment information in real world. NDS data sets have proven to be extremely valuable for the analysis of safety critical events such as crashes and near crashes. However, finding safety critical events in NDS data is often difficult and time consuming. Safety critical events are currently identified using kinematic triggers, for instance searching for deceleration below a certain threshold signifying harsh braking. Due to the low sensitivity and specificity of this filtering procedure, manual review of video data is currently necessary to decide whether the events identified by the triggers are actually safety critical. Such reviewing procedure is based on subjective decisions, is expensive and time consuming, and often tedious for the analysts. Furthermore, since NDS data is exponentially growing over time, this reviewing procedure may not be viable anymore in the very near future. This study tested the hypothesis that automatic processing of driver video information could increase the correct classification of safety critical events from kinematic triggers in naturalistic driving data. Review of about 400 video sequences recorded from the events, collected by 100 Volvo cars in the euroFOT project, suggested that drivers' individual reaction may be the key to recognize safety critical events. In fact, whether an event is safety critical or not often depends on the individual driver. A few algorithms, able to automatically classify driver reaction from video data, have been compared. The results presented in this paper show that the state of the art subjective review procedures to identify safety critical events from NDS can benefit from automated objective video processing. In addition, this paper discusses the major challenges in making such video analysis viable for future NDS and new potential

Patients' identification and reporting of unsafe events at six hospitals in Japan.

PubMed

Hasegawa, Tomonori; Fujita, Shigeru; Seto, Kanako; Kitazawa, Takefumi; Matsumoto, Kunichika

2011-11-01

Hospitals and other health care organizations have increasingly recognized the need to engage patients as participants in patient safety. A study was conducted to compare patients' and health care staff's identification and reporting of such events. A questionnaire was administered at six hospitals in Japan to outpatients and inpatients from November 2004 through February 2007. Patients were asked to respond to questions about experiences of possibly unsafe events. Patients experiencing such events were then asked about the events and whether they had reported their experience to health care staff. A specialist panel classified reported events as "uneasy-dissatisfying" or "unsafe." The response rates of outpatients and inpatients were 85.4% (1,506/1,764) and 54.3% (1,738/3,198), respectively. Among the respondents (> or = 20 years of age), 125 (8.7%) of the outpatients and 185 (10.9%) of the inpatients experienced uneasy-dissatisfying or unsafe events; 35 (2.4%) of the outpatients and 67 (4.0%) of the inpatients experienced unsafe events, the percent increasing with hospital stay. Only 38 (30.4%) of the outpatients and 62 (33.5%) of the inpatients reported the unsafe events to health care staff Only 17.1% of unsafe events reported by inpatients were identified by the in-house reporting systems of adverse events and near misses. For the uneasy-dissatisfying or unsafe events that patients did not think necessary to report, the patients often felt they were self-evident or easily identifiable by health care staff, had difficulty evaluating the event, did not expect their report to bring any improvement, or even felt that reporting it would create some disadvantage in their medical treatment. Patient reporting programs and in-house reporting systems, among other detection methods, should be regarded as complementary sources of information.

What Do We Really Know About the Safety of Tai Chi?: A Systematic Review of Adverse Event Reports in Randomized Trials

PubMed Central

Wayne, Peter M.; Berkowitz, Danielle L.; Litrownik, Daniel E.; Buring, Julie E.; Yeh, Gloria Y.

2014-01-01

Objective Systematically review frequency and quality of adverse event (AE) reports in randomized clinical trials (RCTs) of Tai Chi (TC). Data Sources Electronic searches of PubMed/MEDLINE and additional databases from inception through March 2013 of English-language RCTs. Search terms were tai chi, taiji, tai chi chuan. Data were independently extracted by two investigators. Study Selection We included all available randomized controlled trials (RCTs) that were published in English and used Tai Chi as an intervention. Inclusion and exclusion of studies were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data Extraction Eligible RCTs were categorized with respect to AE reporting: 1) No mention of protocols for monitoring AEs or reports of AEs; 2) Reports of AEs either with or without explicit protocols for monitoring AEs. Data Synthesis 153 eligible RCTs were identified, most targeting older adults. Only 50 eligible trials (33%) included reporting of AEs, and of these, only 18 trials (12% overall) also reported an explicit AE monitoring protocol. Protocols varied with respect to rigor of systematic monitoring in both Tai Chi and comparison groups. Reported AEs were typically minor and expected, and primarily musculoskeletal related (e.g., knee and back pain); no intervention-related serious AEs were reported. Conclusions Tai Chi is unlikely to result in serious adverse events, but may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of Tai Chi. PMID:24878398

Surface Movement Incidents Reported to the NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

Connell, Linda J.; Hubener, Simone

1997-01-01

Increasing numbers of aircraft are operating on the surface of airports throughout the world. Airport operations are forecast to grow by more that 50%, by the year 2005. Airport surface movement traffic would therefore be expected to become increasingly congested. Safety of these surface operations will become a focus as airport capacity planning efforts proceed toward the future. Several past events highlight the prevailing risks experienced while moving aircraft during ground operations on runways, taxiways, and other areas at terminal, gates, and ramps. The 1994 St. Louis accident between a taxiing Cessna crossing an active runway and colliding with a landing MD-80 emphasizes the importance of a fail-safe system for airport operations. The following study explores reports of incidents occurring on an airport surface that did not escalate to an accident event. The Aviation Safety Reporting System has collected data on surface movement incidents since 1976. This study sampled the reporting data from June, 1993 through June, 1994. The coding of the data was accomplished in several categories. The categories include location of airport, phase of ground operation, weather /lighting conditions, ground conflicts, flight crew characteristics, human factor considerations, and airport environment. These comparisons and distributions of variables contributing to surface movement incidents can be invaluable to future airport planning, accident prevention efforts, and system-wide improvements.

Simulating adverse event spontaneous reporting systems as preferential attachment networks: application to the Vaccine Adverse Event Reporting System.

PubMed

Scott, J; Botsis, T; Ball, R

2014-01-01

Spontaneous Reporting Systems [SRS] are critical tools in the post-licensure evaluation of medical product safety. Regulatory authorities use a variety of data mining techniques to detect potential safety signals in SRS databases. Assessing the performance of such signal detection procedures requires simulated SRS databases, but simulation strategies proposed to date each have limitations. We sought to develop a novel SRS simulation strategy based on plausible mechanisms for the growth of databases over time. We developed a simulation strategy based on the network principle of preferential attachment. We demonstrated how this strategy can be used to create simulations based on specific databases of interest, and provided an example of using such simulations to compare signal detection thresholds for a popular data mining algorithm. The preferential attachment simulations were generally structurally similar to our targeted SRS database, although they had fewer nodes of very high degree. The approach was able to generate signal-free SRS simulations, as well as mimicking specific known true signals. Explorations of different reporting thresholds for the FDA Vaccine Adverse Event Reporting System suggested that using proportional reporting ratio [PRR] > 3.0 may yield better signal detection operating characteristics than the more commonly used PRR > 2.0 threshold. The network analytic approach to SRS simulation based on the principle of preferential attachment provides an attractive framework for exploring the performance of safety signal detection algorithms. This approach is potentially more principled and versatile than existing simulation approaches. The utility of network-based SRS simulations needs to be further explored by evaluating other types of simulated signals with a broader range of data mining approaches, and comparing network-based simulations with other simulation strategies where applicable.

Vaccine adverse event text mining system for extracting features from vaccine safety reports.

PubMed

Botsis, Taxiarchis; Buttolph, Thomas; Nguyen, Michael D; Winiecki, Scott; Woo, Emily Jane; Ball, Robert

2012-01-01

To develop and evaluate a text mining system for extracting key clinical features from vaccine adverse event reporting system (VAERS) narratives to aid in the automated review of adverse event reports. Based upon clinical significance to VAERS reviewing physicians, we defined the primary (diagnosis and cause of death) and secondary features (eg, symptoms) for extraction. We built a novel vaccine adverse event text mining (VaeTM) system based on a semantic text mining strategy. The performance of VaeTM was evaluated using a total of 300 VAERS reports in three sequential evaluations of 100 reports each. Moreover, we evaluated the VaeTM contribution to case classification; an information retrieval-based approach was used for the identification of anaphylaxis cases in a set of reports and was compared with two other methods: a dedicated text classifier and an online tool. The performance metrics of VaeTM were text mining metrics: recall, precision and F-measure. We also conducted a qualitative difference analysis and calculated sensitivity and specificity for classification of anaphylaxis cases based on the above three approaches. VaeTM performed best in extracting diagnosis, second level diagnosis, drug, vaccine, and lot number features (lenient F-measure in the third evaluation: 0.897, 0.817, 0.858, 0.874, and 0.914, respectively). In terms of case classification, high sensitivity was achieved (83.1%); this was equal and better compared to the text classifier (83.1%) and the online tool (40.7%), respectively. Our VaeTM implementation of a semantic text mining strategy shows promise in providing accurate and efficient extraction of key features from VAERS narratives.

Mobile physician reporting of clinically significant events-a novel way to improve handoff communication and supervision of resident on call activities.

PubMed

Nabors, Christopher; Peterson, Stephen J; Aronow, Wilbert S; Sule, Sachin; Mumtaz, Arif; Shah, Tushar; Eskridge, Etta; Wold, Eric; Stallings, Gary W; Burak, Kathleen Kelly; Goldberg, Randy; Guo, Gary; Sekhri, Arunabh; Mathew, George; Khera, Sahil; Montoya, Jessica; Sharma, Mala; Paudel, Rajiv; Frishman, William H

2014-12-01

Reporting of clinically significant events represents an important mechanism by which patient safety problems may be identified and corrected. However, time pressure and cumbersome report entry procedures have discouraged the full participation of physicians. To improve the process, our internal medicine training program developed an easy-to-use mobile platform that combines the reporting process with patient sign-out. Between August 25, 2011, and January 25, 2012, our trainees entered clinically significant events into i-touch/i-phone/i-pad based devices functioning in wireless-synchrony with our desktop application. Events were collected into daily reports that were sent from the handoff system to program leaders and attending physicians to plan for rounds and to correct safety problems. Using the mobile module, residents entered 31 reportable events per month versus the 12 events per month that were reported via desktop during a previous 6-month study period. Advances in information technology now permit clinically significant events that take place during "off hours" to be identified and reported (via handoff) to next providers and to supervisors via collated reports. This information permits hospital leaders to correct safety issues quickly and effectively, while attending physicians are able to use information gleaned from the reports to optimize rounding plans and to provide additional oversight of trainee on call patient management decisions.

NASA Range Safety Annual Report 2007

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2007-01-01

As always, Range Safety has been involved in a number of exciting and challenging activities and events. Throughout the year, we have strived to meet our goal of protecting the public, the workforce, and property during range operations. During the past year, Range Safety was involved in the development, implementation, and support of range safety policy. Range Safety training curriculum development was completed this year and several courses were presented. Tailoring exercises concerning the Constellation Program were undertaken with representatives from the Constellation Program, the 45th Space Wing, and the Launch Constellation Range Safety Panel. Range Safety actively supported the Range Commanders Council and it subgroups and remained involved in updating policy related to flight safety systems and flight safety analysis. In addition, Range Safety supported the Space Shuttle Range Safety Panel and addressed policy concerning unmanned aircraft systems. Launch operations at Kennedy Space Center, the Eastern and Western ranges, Dryden Flight Research Center, and Wallops Flight Facility were addressed. Range Safety was also involved in the evaluation of a number of research and development efforts, including the space-based range (formerly STARS), the autonomous flight safety system, the enhanced flight termination system, and the joint advanced range safety system. Flight safety system challenges were evaluated. Range Safety's role in the Space Florida Customer Assistance Service Program for the Eastern Range was covered along with our support for the Space Florida Educational Balloon Release Program. We hope you have found the web-based format both accessible and easy to use. Anyone having questions or wishing to have an article included in the 2008 Range Safety Annual Report should contact Alan Dumont, the NASA Range Safety Program Manager located at the Kennedy Space Center, or Michael Dook at NASA Headquarters.

Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems.

PubMed

Raschi, Emanuel; Girardi, Anna; Poluzzi, Elisabetta; Forcesi, Emanuele; Menniti-Ippolito, Francesca; Mazzanti, Gabriela; De Ponti, Fabrizio

2018-03-26

Food supplements containing red yeast rice (RYR) are proposed as an alternative in statin-intolerant patients, although they actually contain natural statin(s) and their safety in clinical practice is still incompletely characterized. We described and compared adverse events (AEs) associated with RYR products submitted to reporting systems maintained by the Food and Drug Administration (FDA), with a focus on liver and muscular events. We extracted RYR-related AEs from the FDA Adverse Event Reporting System (FAERS) [first quarter (Q1)-2004 to Q2-2016], a drug-based archive, and the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) (Q1-2004 to Q1-2017). Disproportionality via reporting odds ratio (ROR) with 95% confidence interval (CI) calculation and case-by-case inspection were performed, with a focus on muscular and hepatic AEs. One thousand three hundred AEs were extracted from FAERS (RYR mainly reported as a concomitant agent), whereas only 159 AEs were found in CAERS (RYR recorded mainly as a suspect agent). In FAERS, a large number of reports emerged for "general disorders and administration site conditions," whereas CAERS received also a high number of reports for "investigations" and "musculoskeletal and connective tissue disorders". Disproportionality analyses confirmed higher reporting of serious muscular and liver injuries: in FAERS, five cases of hepatic disorders (ROR = 13.71; 95% CI 5.44-34.57); in CAERS, 27 cases of rhabdomyolysis/myopathy (8.44; 5.44-13.10). Notwithstanding recognized limitations, these findings strengthen the importance of exploring multiple databases in safety assessment of RYR products, which should be monitored by clinicians for muscular and hepatic safety, and call for urgent review by policymakers to harmonize their regulatory status.

Completeness of Methicillin-Resistant Staphylococcus aureus Bloodstream Infection Reporting From Outpatient Hemodialysis Facilities to the National Healthcare Safety Network, 2013.

PubMed

Nguyen, Duc B; See, Isaac; Gualandi, Nicole; Shugart, Alicia; Lines, Christi; Bamberg, Wendy; Dumyati, Ghinwa; Harrison, Lee H; Lesher, Lindsey; Nadle, Joelle; Petit, Susan; Ray, Susan M; Schaffner, William; Townes, John; Njord, Levi; Sievert, Dawn; Thompson, Nicola D; Patel, Priti R

2016-02-01

Reports of bloodstream infections caused by methicillin-resistant Staphylococcus aureus among chronic hemodialysis patients to 2 Centers for Disease Control and Prevention surveillance systems (National Healthcare Safety Network Dialysis Event and Emerging Infections Program) were compared to evaluate completeness of reporting. Many methicillin-resistant S. aureus bloodstream infections identified in hospitals were not reported to National Healthcare Safety Network Dialysis Event.

Making Residents Part of the Safety Culture: Improving Error Reporting and Reducing Harms.

PubMed

Fox, Michael D; Bump, Gregory M; Butler, Gabriella A; Chen, Ling-Wan; Buchert, Andrew R

2017-01-30

Reporting medical errors is a focus of the patient safety movement. As frontline physicians, residents are optimally positioned to recognize errors and flaws in systems of care. Previous work highlights the difficulty of engaging residents in identification and/or reduction of medical errors and in integrating these trainees into their institutions' cultures of safety. The authors describe the implementation of a longitudinal, discipline-based, multifaceted curriculum to enhance the reporting of errors by pediatric residents at Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center. The key elements of this curriculum included providing the necessary education to identify medical errors with an emphasis on systems-based causes, modeling of error reporting by faculty, and integrating error reporting and discussion into the residents' daily activities. The authors tracked monthly error reporting rates by residents and other health care professionals, in addition to serious harm event rates at the institution. The interventions resulted in significant increases in error reports filed by residents, from 3.6 to 37.8 per month over 4 years (P < 0.0001). This increase in resident error reporting correlated with a decline in serious harm events, from 15.0 to 8.1 per month over 4 years (P = 0.01). Integrating patient safety into the everyday resident responsibilities encourages frequent reporting and discussion of medical errors and leads to improvements in patient care. Multiple simultaneous interventions are essential to making residents part of the safety culture of their training hospitals.

Mitigating adverse event reporting bias in spine surgery.

PubMed

Auerbach, Joshua D; McGowan, Kevin B; Halevi, Marci; Gerling, Michael C; Sharan, Alok D; Whang, Peter G; Maislin, Greg

2013-08-21

Recent articles in the lay press and literature have raised concerns about the ability to report honest adverse event data from industry-sponsored spine surgery studies. To address this, clinical trials may utilize an independent Clinical Events Committee (CEC) to review adverse events and readjudicate the severity and relatedness accordingly. We are aware of no prior study that has quantified either the degree to which investigator bias is present in adverse event reporting or the effect that an independent CEC has on mitigating this potential bias. The coflex Investigational Device Exemption study is a prospective randomized controlled trial comparing coflex (Paradigm Spine) stabilization with lumbar spinal fusion to treat spinal stenosis and spondylolisthesis. Investigators classified the severity of adverse events (mild, moderate, or severe) and their relationship to the surgery and device (unrelated, unlikely, possibly, probably, or definitely). An independent CEC, composed of three spine surgeons without affiliation to the study sponsor, reviewed and reclassified all adverse event reports submitted by the investigators. The CEC reclassified the level of severity, relation to the surgery, and/or relation to the device in 394 (37.3%) of 1055 reported adverse events. The proportion of adverse events that underwent reclassification was similar in the coflex and fusion groups (37.9% compared with 36.0%, p = 0.56). The CEC was 5.3 (95% confidence interval [CI], 2.6 to 10.7) times more likely to upgrade than downgrade the adverse event. The CEC was 7.3 (95% CI, 5.1 to 10.6) times more likely to upgrade than downgrade the relationship to the surgery and 11.6 (95% CI, 7.5 to 18.8) times more likely to upgrade than downgrade the relationship to the device. The status of the investigator's financial interest in the company had little effect on the reclassification of adverse events. Thirty-seven percent of adverse events were reclassified by the CEC; the large majority

A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus.

PubMed

Tamminga, Cindy; Kavanaugh, Michael; Fedders, Charlotte; Maiolatesi, Santina; Abraham, Neethu; Bonhoeffer, Jan; Heininger, Ulrich; Vasquez, Carlos S; Moorthy, Vasee S; Epstein, Judith E; Richie, Thomas L

2013-08-02

Malaria, tuberculosis (TB) and human immunodeficiency virus (HIV) are diseases with devastating effects on global public health, especially in the developing world. Clinical trials of candidate vaccines for these diseases are being conducted at an accelerating rate, and require accurate and consistent methods for safety data collection and reporting. We performed a systematic review of publications describing the safety results from clinical trials of malaria, TB and HIV vaccines, to ascertain the nature and consistency of safety data collection and reporting. The target for the review was pre-licensure trials for malaria, TB and HIV vaccines published in English from 2000 to 2009. Search strategies were customized for each of the databases utilized (MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and the Database of Reviews and Effects). Data extracted included age of trial participants, vaccine platform, route and method of vaccine administration, duration of participant follow-up, reporting of laboratory abnormalities, and the type, case definitions, severity, reporting methods and internal reporting consistency of adverse events. Of 2278 publications screened, 124 were eligible for inclusion (malaria: 66, TB: 9, HIV: 49). Safety data reporting was found to be highly variable among publications and often incomplete: overall, 269 overlapping terms were used to describe specific adverse events. 17% of publications did not mention fever. Descriptions of severity or degree of relatedness to immunization of adverse events were frequently omitted. 26% (32/124) of publications failed to report data on serious adverse events. The review demonstrated lack of standardized safety data reporting in trials for vaccines against malaria, TB and HIV. Standardization of safety data collection and reporting should be encouraged to improve data quality and comparability. The search strategy missed studies published in languages other than English and excluded studies

Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Advisory Committee on Causality Assessment.

PubMed Central

Collet, J. P.; MacDonald, N.; Cashman, N.; Pless, R.

2000-01-01

Monitoring vaccine safety is a complex and shared responsibility. It can be carried out in many ways, one of which is the reporting of individual cases of adverse reactions thought to be due to vaccination. The task is difficult because ascribing causality to an individual case report is fraught with challenges. A standardized evaluation instrument--known as the causality assessment form--was therefore developed for use by an expert advisory committee to facilitate the process. By following the several sections in this form, the members of the committee are taken through a series of points to establish causality. These points include the basic criteria for causation such as biological plausibility, the time elapsed between the vaccine administration and the onset of the adverse event, and whether other factors (drugs, chemicals or underlying disease) could account for the adverse symptoms. The form concludes with a consensus assessment of causality, a commentary about the assessment, and advice for further study or follow-up. This method of assessing the more serious cases of adverse reaction reported to vaccination has proven useful in evaluating ongoing safety of vaccines in Canada. Through analyses such as this, new signals can be identified and investigated further. PMID:10743282

Adverse event reports following yellow fever vaccination, 2007-13.

PubMed

Lindsey, Nicole P; Rabe, Ingrid B; Miller, Elaine R; Fischer, Marc; Staples, J Erin

2016-05-01

Yellow fever (YF) vaccines have been available since the 1930s and are generally considered safe and effective. However, rare reports of serious adverse events (SAE) following vaccination have prompted the Advisory Committee for Immunization Practices to periodically expand the list of conditions considered contraindications and precautions to vaccination. We describe adverse events following YF vaccination reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2007 through 2013 and calculate age- and sex-specific reporting rates of all SAE, anaphylaxis, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). There were 938 adverse events following YF vaccination reported to VAERS from 2007 through 2013. Of these, 84 (9%) were classified as SAEs for a rate of 3.8 per 100 000 doses distributed. Reporting rates of SAEs increased with increasing age with a rate of 6.5 per 100 000 in persons aged 60-69 years and 10.3 for ≥70 years. The reporting rate for anaphylaxis was 1.3 per 100 000 doses distributed and was highest in persons ≤18 years (2.7 per 100 000). Reporting rates of YEL-AND and YEL-AVD were 0.8 and 0.3 per 100 000 doses distributed, respectively; both rates increased with increasing age. These findings reinforce the generally acceptable safety profile of YF vaccine, but highlight the importance of continued physician and traveller education regarding the risks and benefits of YF vaccination, particularly for older travellers. Published by Oxford University Press on behalf of the International Society of Travel Medicine, 2016. This work is written by US Government employees and is in the public domain in the United States.

Association rule mining in the US Vaccine Adverse Event Reporting System (VAERS).

PubMed

Wei, Lai; Scott, John

2015-09-01

Spontaneous adverse event reporting systems are critical tools for monitoring the safety of licensed medical products. Commonly used signal detection algorithms identify disproportionate product-adverse event pairs and may not be sensitive to more complex potential signals. We sought to develop a computationally tractable multivariate data-mining approach to identify product-multiple adverse event associations. We describe an application of stepwise association rule mining (Step-ARM) to detect potential vaccine-symptom group associations in the US Vaccine Adverse Event Reporting System. Step-ARM identifies strong associations between one vaccine and one or more adverse events. To reduce the number of redundant association rules found by Step-ARM, we also propose a clustering method for the post-processing of association rules. In sample applications to a trivalent intradermal inactivated influenza virus vaccine and to measles, mumps, rubella, and varicella (MMRV) vaccine and in simulation studies, we find that Step-ARM can detect a variety of medically coherent potential vaccine-symptom group signals efficiently. In the MMRV example, Step-ARM appears to outperform univariate methods in detecting a known safety signal. Our approach is sensitive to potentially complex signals, which may be particularly important when monitoring novel medical countermeasure products such as pandemic influenza vaccines. The post-processing clustering algorithm improves the applicability of the approach as a screening method to identify patterns that may merit further investigation. Copyright © 2015 John Wiley & Sons, Ltd.

33 CFR 165.T01-1057 - Safety Zones; Marine Events in Northern New England.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Safety Zones; Marine Events in... § 165.T01-1057 Safety Zones; Marine Events in Northern New England. (a) Regulations. The general regulations contained in 33 CFR 165.23 as well as the following regulations apply to the events listed in the...

Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

PubMed

Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

2017-05-01

Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

Adverse drug event reporting systems: a systematic review

PubMed Central

Peddie, David; Wickham, Maeve E.; Badke, Katherin; Small, Serena S.; Doyle‐Waters, Mary M.; Balka, Ellen; Hohl, Corinne M.

2016-01-01

Aim Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. Methods We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full‐texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. Results We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). Conclusion We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance. PMID:27016266

Adverse drug event reporting systems: a systematic review.

PubMed

Bailey, Chantelle; Peddie, David; Wickham, Maeve E; Badke, Katherin; Small, Serena S; Doyle-Waters, Mary M; Balka, Ellen; Hohl, Corinne M

2016-07-01

Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance. © 2016 The British Pharmacological Society.

Meeting Report: 2013 PDA Virus & TSE Safety Forum.

PubMed

Willkommen, Hannelore; Blümel, Johannes; Brorson, Kurt; Chen, Dayue; Chen, Qi; Gröner, Albrecht; Hubbard, Brian R; Kreil, Thomas R; Ruffing, Michel; Ruiz, Sol; Scott, Dorothy; Silvester, Glenda

2014-01-01

The report provides a summary of the presentations and discussions at the Virus & TSE Safety Forum 2013 organized by the Parenteral Drug Association (PDA) and held in Berlin, Germany, from June 4 to 6, 2013. The conference was accompanied by a workshop, "Virus Spike Preparations and Virus Removal by Filtration: New Trends and Developments". The presentations and the discussion at the workshop are summarized in a separate report that will be published in this issue of the journal as well. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2013 provided again an excellent opportunity to exchange information and opinions between the industry, research organizations, and regulatory bodies. Updates on regulatory considerations related to virus and transmissible spongiform encephalopathy (TSE) safety of biopharmaceuticals were provided by agencies of the European Union (EU), the United States (US), and Singapore. The epidemiology and detection methods of new emerging pathogens like hepatitis E virus and parvovirus (PARV 4) were exemplified, and the risk of contamination of animal-derived raw materials like trypsin was considered in particular. The benefit of using new sequence-based virus detection methods was discussed. Events of bioreactor contaminations in the past drew the attention to root cause investigations and preventive actions, which were illustrated by several examples. Virus clearance data of specific unit operations were provided; the discussion focused on the mechanism of virus clearance and on the strategic concept of viral clearance integration. As in previous years, the virus safety section was followed by a TSE section that covered recent scientific findings that may influence the risk assessment of blood and cell substrates. These included the realization that interspecies transmission of TSE by blood components in sheep is greater than predicted by assays in transgenic mice. Also, the pathogenesis and possibility of

Serious adverse events in randomized psychosocial treatment studies: Safety or Arbitrary Edicts?

PubMed Central

Petry, Nancy M.; Roll, John M.; Rounsaville, Bruce J.; Ball, Samuel A.; Stitzer, Maxine; Peirce, Jessica M.; Blaine, Jack; Kirby, Kimberly C.; McCarty, Dennis; Carroll, Kathleen M.

2009-01-01

Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance abusing participants (N=1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced one or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the Data Safety Monitoring Board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates. These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials. PMID:19045975

Bovine thrombin safety reporting: an example of study design and publication bias.

PubMed

Crean, Sheila; Michels, Shannon L; Moschella, Kevin; Reynolds, Matthew W

2010-01-01

Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials. A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed. In 38 studies, about half were case reports and 31.5% were interventional trials. In case reports, 41% of authors reported severe coagulopathic adverse events. In contrast, whereas blood complications were common in large trials, no association of harm was established for bovine thrombin product exposure and/or immunization. In this review, later clinical trials failed to reproduce the common and severe coagulopathy predicted by earlier observational studies in bovine exposed patients. This example illustrates that perceptions of safety can change as a function of study design, even for a widely adopted, well established biologic such as thrombin. Caution must be exercised in interpreting evidence from observational studies alone.

Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine administered to adults 65 years of age and older reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010.

PubMed

Moro, Pedro L; Yue, Xin; Lewis, Paige; Haber, Penina; Broder, Karen

2011-11-21

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine was not licensed for use in adults aged ≥65 years due to lack of sufficient efficacy and safety data. To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged ≥65 years who received Tdap vaccine 'off-label' to assess for potential vaccine safety concerns. We searched VAERS for US reports of adverse events (AEs) in subjects aged ≥65 years who received Tdap vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports coded as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening-illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after Tdap compared with Td reports in subjects aged ≥65 years. VAERS received 243 reports following Tdap administered to persons aged ≥65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after Tdap compared with Td. Six of seven Tdap reports containing the term 'Cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Our VAERS review of the 'off-label' use of Tdap vaccine in adults ≥65 years did not find any safety concerns that warrant further study. These data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted. Published by Elsevier Ltd.

Adverse events and comparison of systematic and voluntary reporting from a paediatric intensive care unit.

PubMed

Silas, Reshma; Tibballs, James

2010-12-01

Little is known of the incidence of adverse events in the paediatric intensive care unit (PICU). Perceived incidence may be dependent on data-collection methods. To determine the incidence of adverse events by voluntary reporting and systematic enquiry. Adverse events in PICU were recorded contemporaneously by systematic enquiry with bedside nurses and attending doctors, and compared with data submitted voluntarily to the hospital's quality and safety unit. Events were classified as insignificant, minor, moderate, major and catastrophic or lethal, and assigned origins as medical/surgical diagnosis or management, medical/surgical procedures, medication or miscellaneous. Among 740 patients, 524 adverse events (mean 0.71 per patient) occurred in 193 patients (26.1%). Systematic enquiry detected 405 (80%) among 165 patients and were classified by one investigator as insignificant 30 (7%); minor 100 (25%); moderate 160 (37%); major 103(25%) and catastrophic 12 (3%). The coefficient of agreement (kappa) of severity between the two investigators was 0.82 (95% CI 0.78-0.87). Voluntary reporting detected 166 (32%) adverse events among 100 patients, of which 119 were undetected by systematic reporting. Forty-nine events (9%) were detected by both methods. The number and severity of events reported by the two methods were significantly different (p<0.0001). Voluntary reporting, mainly by nurses, did not capture major, severe or catastrophic events related to medical/surgical diagnosis or management. Neither voluntary reporting nor systematic enquiry captures all adverse events. While the two methods both capture some events, systematic reporting captures serious events, while voluntary reporting captures mainly insignificant and minor events.

Nurses' systems thinking competency, medical error reporting, and the occurrence of adverse events: a cross-sectional study.

PubMed

Hwang, Jee-In; Park, Hyeoun-Ae

2017-12-01

Healthcare professionals' systems thinking is emphasized for patient safety. To report nurses' systems thinking competency, and its relationship with medical error reporting and the occurrence of adverse events. A cross-sectional survey using a previously validated Systems Thinking Scale (STS), was conducted. Nurses from two teaching hospitals were invited to participate in the survey. There were 407 (60.3%) completed surveys. The mean STS score was 54.5 (SD 7.3) out of 80. Nurses with higher STS scores were more likely to report medical errors (odds ratio (OR) = 1.05; 95% confidence interval (CI) = 1.02-1.08) and were less likely to be involved in the occurrence of adverse events (OR = 0.96; 95% CI = 0.93-0.98). Nurses showed moderate systems thinking competency. Systems thinking was a significant factor associated with patient safety. Impact Statement: The findings of this study highlight the importance of enhancing nurses' systems thinking capacity to promote patient safety.

[Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database].

PubMed

Sasaoka, Sayaka; Hatahira, Haruna; Hasegawa, Shiori; Motooka, Yumi; Fukuda, Akiho; Naganuma, Misa; Umetsu, Ryogo; Nakao, Satoshi; Shimauchi, Akari; Ueda, Natsumi; Hirade, Kouseki; Iguchi, Kazuhiro; Nakamura, Mitsuhiro

2018-01-01

 OTC combination cold remedies are widely used in Japan. In the present study, we aimed to evaluate the adverse event profiles of OTC combination cold remedy based on the components using the Japanese Adverse Drug Event Report (JADER) database. The JADER database contained 430587 reports between April 2004 and November 2016. 1084 adverse events associated with the use of OTC combination cold remedy were reported. Reporting odds ratio (ROR) was used to detect safety signals. The ROR values for "skin and subcutaneous tissue disorders", "hepatobiliary disorders", and "immune system disorders" stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 9.82 (8.71-11.06), 2.63 (2.25-3.07), and 3.13 (2.63-3.74), respectively. OTC combination cold remedy containing acetaminophen exhibited a significantly higher reporting ratio for "hepatobiliary disorders" than OTC combination cold remedy without acetaminophen. We demonstrated the potential risk of OTC combination cold remedy in a real-life setting. Our results suggested that the monitoring of individuals using OTC combination cold remedy is important.

Analysis of adverse events as a contribution to safety culture in the context of practice development

PubMed

Hoffmann, Susanne; Frei, Irena Anna

2017-01-01

Background: Analysing adverse events is an effective patient safety measure. Aim: We show, how clinical nurse specialists have been enabled to analyse adverse events with the „Learning from Defects-Tool“ (LFD-Tool). Method: Our multi-component implementation strategy addressed both, the safety knowledge of clinical nurse specialists and their attitude towards patient safety. The culture of practice development was taken into account. Results: Clinical nurse specialists relate competency building on patient safety due to the application of the LFD-tool. Applying the tool, fosters the reflection of adverse events in care teams. Conclusion: Applying the „Learning from Defects-Tool“ promotes work-based learning. Analysing adverse events with the „Learning from Defects-Tool“ contributes to the safety culture in a hospital.

Factor analysis of safety for visitors to a mega-event.

PubMed

Kwon, Young Guk; Park, Hyun Jee

2002-01-01

This paper investigated the safety factors considered by visitors to the Kwangju Biennale 2000 and analyzed the correlation between the safety factors and the demographic characteristics of the visitors. Global tourism increased throughout the 1990s, with the biggest surge occurring in the Asia-Pacific region. Long-distance travel is also increasing, and at a rate faster than the global average. The opportunities for event tourism appear to be strong almost everywhere, even though recessions may have an impact on these destinations. Along with this upward trend, competition for more desirable tourists is also surging (Getz, 1997). Therefore event tourism is appearing as a powerful method in the fierce competition around the tourism industry.

Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.

PubMed

Haber, Penina; Moro, Pedro L; Ng, Carmen; Lewis, Paige W; Hibbs, Beth; Schillie, Sarah F; Nelson, Noele P; Li, Rongxia; Stewart, Brock; Cano, Maria V

2018-01-25

Currently four recombinant hepatitis B (HepB) vaccines are in use in the United States. HepB vaccines are recommended for infants, children and adults. We assessed adverse events (AEs) following HepB vaccines reported to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. We searched VAERS for reports of AEs following single antigen HepB vaccine and HepB-containing vaccines (either given alone or with other vaccines), from January 2005 - December 2015. We conducted descriptive analyses and performed empirical Bayesian data mining to assess disproportionate reporting. We reviewed serious reports including reports of special interest. VAERS received 20,231 reports following HepB or HepB-containing vaccines: 10,291 (51%) in persons <2 years of age; 2588 (13%) in persons 2-18 years and 5867 (29%) in persons >18 years; for 1485 (7.3%) age was missing. Dizziness and nausea (8.4% each) were the most frequently reported AEs following a single antigen HepB vaccine: fever (23%) and injection site erythema (11%) were most frequent following Hep-containing vaccines. Of the 4444 (22%) reports after single antigen HepB vaccine, 303 (6.8%) were serious, including 45 deaths. Most commonly reported cause of death was Sudden Infant Death Syndrome (197). Most common non-death serious reports following single antigen HepB vaccines among infants aged <1 month, were nervous system disorders (15) among children aged 1-23 months; infections and infestation (8) among persons age 2-18 years blood and lymphatic systemic disorders; and general disorders and administration site conditions among persons age >18 years. Most common vaccination error following single antigen HepB was incorrect product storage. Review current U.S.-licensed HepB vaccines administered alone or in combination with other vaccines did not reveal new or unexpected safety concerns. Vaccination errors were identified which indicate the need for training and education

Development of an adverse events reporting form for Korean folk medicine

PubMed Central

Park, Jeong Hwan; Choi, Sun‐Mi; Moon, Sujeong; Kim, Sungha; Kim, Boyoung; Kim, Min‐Kyeoung

2016-01-01

Abstract Purpose We developed an adverse events (AEs) reporting form for Korean folk medicine. Methods The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. Results We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. Conclusions This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. PMID:27501410

Dietary Supplements: Knowledge and Adverse Event Reporting Among American Medical Society for Sports Medicine Physicians.

PubMed

Pascale, Blaise; Steele, Clay; Attipoe, Selasi; OʼConnor, Francis G; Deuster, Patricia A

2016-03-01

Certain dietary supplements (DSs) used by military populations pose a threat to overall readiness. This study assessed members of the American Medical Society for Sports Medicine (AMSSM) regarding their knowledge of DS use among their patients and reporting of suspected adverse events. A thirteen-question retrospective, cross-sectional, Web-based survey sought data on practices regarding DSs and adverse event reporting. Anonymous Web-based survey. Military and civilian sports medicine physicians. The primary finding of the study was how frequently practitioners report adverse events associated with DS use. A total of 311 physicians responded to the survey. Only 51% of respondents had a reliable source for information on DS safety and 58% routinely discussed DS use with their patients. Although a majority (71%) of respondents had encountered adverse events associated with DS use, few of those (10%) confirmed reporting such events. Reasons that physicians did not report adverse events were lack of knowledge regarding where to report (68%), how to report (61%), and availability of time (9%). Our results indicate that some AMSSM physicians are familiar with DSs and have encountered adverse events associated with their use. However, reporting of these adverse events to the appropriate agency is minimal at best. The significant gaps in physician knowledge regarding how and where to report such events indicate a need to educate physicians on this subject. The findings of this survey indicate the need for provider education on reporting adverse events associated with DS use. Although reporting of adverse events is essential for removing harmful DSs from the market, a majority of physicians have limited knowledge on this issue. Moreover, the survey provides insight into the barriers to physician reporting of adverse events.

The association between EMS workplace safety culture and safety outcomes.

PubMed

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

Westinghouse Small Modular Reactor passive safety system response to postulated events

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, M. C.; Wright, R. F.

2012-07-01

The Westinghouse Small Modular Reactor (SMR) is an 800 MWt (>225 MWe) integral pressurized water reactor. This paper is part of a series of four describing the design and safety features of the Westinghouse SMR. This paper focuses in particular upon the passive safety features and the safety system response of the Westinghouse SMR. The Westinghouse SMR design incorporates many features to minimize the effects of, and in some cases eliminates the possibility of postulated accidents. The small size of the reactor and the low power density limits the potential consequences of an accident relative to a large plant. Themore » integral design eliminates large loop piping, which significantly reduces the flow area of postulated loss of coolant accidents (LOCAs). The Westinghouse SMR containment is a high-pressure, compact design that normally operates at a partial vacuum. This facilitates heat removal from the containment during LOCA events. The containment is submerged in water which also aides the heat removal and provides an additional radionuclide filter. The Westinghouse SMR safety system design is passive, is based largely on the passive safety systems used in the AP1000{sup R} reactor, and provides mitigation of all design basis accidents without the need for AC electrical power for a period of seven days. Frequent faults, such as reactivity insertion events and loss of power events, are protected by first shutting down the nuclear reaction by inserting control rods, then providing cold, borated water through a passive, buoyancy-driven flow. Decay heat removal is provided using a layered approach that includes the passive removal of heat by the steam drum and independent passive heat removal system that transfers heat from the primary system to the environment. Less frequent faults such as loss of coolant accidents are mitigated by passive injection of a large quantity of water that is readily available inside containment. An automatic depressurization system is

ED accreditation update. Physicians, medical staff may report safety concerns without fear of disciplinary action.

PubMed

2007-11-01

Educating your staff about The Joint Commission's requirements for concerns about hospital safety and quality of care requires the ED manager to set a tone of openness and cooperation, while at the same time emphasizing your department's role in addressing such concerns: * The ED should be the first place that staff members communicate quality and safety concerns. It is only when a problem is not addressed that they should take the issue to hospital administration and, if necessary, The Joint Commission. * A single event should not trigger a report to The Joint Commission, unless it is unusually serious. Otherwise, only a series of events should trigger a report. * Reassure your staff that you care about what is reported and will act quickly on it. Educate your staff about the reporting forms, and follow up with random audits to ensure compliance.

International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

PubMed

2016-06-23

The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

77 FR 64411 - Safety Zone; Cooper T. Smith Fireworks Event; Mobile River; Mobile, AL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... 1625-AA00 Safety Zone; Cooper T. Smith Fireworks Event; Mobile River; Mobile, AL AGENCY: Coast Guard.... Smith Fireworks Event. Entry into, transiting or anchoring in this zone is prohibited to all vessels... safety hazards associated with a fireworks display. B. Basis and Purpose Cooper T. Smith Corp. has hired...

76 FR 63565 - Event Reporting Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-13

...-2011-0237] Event Reporting Guidelines AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG... comments on Draft NUREG-1022, Revision 3, ``Event Reporting Guidelines: 10 CFR 50.72 and 50.73''. The NUREG-1022 contains guidelines that the NRC staff considers acceptable for use in meeting the event reporting...

Comparing two safety culture surveys: safety attitudes questionnaire and hospital survey on patient safety.

PubMed

Etchegaray, Jason M; Thomas, Eric J

2012-06-01

To examine the reliability and predictive validity of two patient safety culture surveys-Safety Attitudes Questionnaire (SAQ) and Hospital Survey on Patient Safety Culture (HSOPS)-when administered to the same participants. Also to determine the ability to convert HSOPS scores to SAQ scores. Employees working in intensive care units in 12 hospitals within a large hospital system in the southern United States were invited to anonymously complete both safety culture surveys electronically. All safety culture dimensions from both surveys (with the exception of HSOPS's Staffing) had adequate levels of reliability. Three of HSOPS's outcomes-frequency of event reporting, overall perceptions of patient safety, and overall patient safety grade-were significantly correlated with SAQ and HSOPS dimensions of culture at the individual level, with correlations ranging from r=0.41 to 0.65 for the SAQ dimensions and from r=0.22 to 0.72 for the HSOPS dimensions. Neither the SAQ dimensions nor the HSOPS dimensions predicted the fourth HSOPS outcome-number of events reported within the last 12 months. Regression analyses indicated that HSOPS safety culture dimensions were the best predictors of frequency of event reporting and overall perceptions of patient safety while SAQ and HSOPS dimensions both predicted patient safety grade. Unit-level analyses were not conducted because indices did not indicate that aggregation was appropriate. Scores were converted between the surveys, although much variance remained unexplained. Given that the SAQ and HSOPS had similar reliability and predictive validity, investigators and quality and safety leaders should consider survey length, content, sensitivity to change and the ability to benchmark when selecting a patient safety culture survey.

Pharmacy student perceptions of adverse event reporting.

PubMed

Kalari, Sirisha; Dormarunno, Matthew; Zvenigorodsky, Oleg; Mohan, Aparna

2011-09-10

To assess US pharmacy students' knowledge and perceptions of adverse event reporting. To gauge pharmacy students' impressions of adverse event reporting, a 10-question survey instrument was administered that addressed student perceptions of the reporting procedures of the Food and Drug Administration (FDA) and pharmaceutical manufacturers, as well as student understanding of the Health Insurance Portability and Accountability Act (HIPAA) and its relationship to adverse event reporting. Two hundred twenty-eight pharmacy students responded to the survey. The majority of respondents believed that the FDA is more likely than a pharmaceutical company to take action regarding an adverse event. There were misconceptions relating to the way adverse event reports are handled and the influence of HIPAA regulations on reporting. Communication between the FDA and pharmaceutical manufacturers regarding adverse event reports is not well understood by pharmacy students. Education about adverse event reporting should evolve so that by the time pharmacy students become practitioners, they are well acquainted with the relevance and importance of adverse event reporting.

Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

PubMed

Pohlman, Katherine A; Carroll, Linda; Tsuyuki, Ross T; Hartling, Lisa; Vohra, Sunita

2017-12-01

Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Current status of proactive risk assessment, reactive analysis of events, and reporting and learning systems in Europe.

PubMed

Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Prieto Martin, Carlos; Przybylska, Kamila; Skrobała, Agnieszka; Valero, Marc; Jarvinen, Hannu

2017-04-01

To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. The original data were collected as part of the ACCIRAD project through two online surveys. Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons. Copyright © 2017 Elsevier B.V. All rights reserved.

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

33 CFR 165.T11-0551 - Safety Zone; America's Cup Sailing Events.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Sailing Events. 165.T11-0551 Section 165.T11-0551 Navigation and Navigable Waters COAST GUARD, DEPARTMENT... § 165.T11-0551 Safety Zone; America's Cup Sailing Events. (a) Definitions—(1) America's Cup Racing... 34th America's Cup sailing events. (2) Patrol Commander. As used in this section, “Patrol Commander” or...

Safety climate and attitude toward medication error reporting after hospital accreditation in South Korea.

PubMed

Lee, Eunjoo

2016-09-01

This study compared registered nurses' perceptions of safety climate and attitude toward medication error reporting before and after completing a hospital accreditation program. Medication errors are the most prevalent adverse events threatening patient safety; reducing underreporting of medication errors significantly improves patient safety. Safety climate in hospitals may affect medication error reporting. This study employed a longitudinal, descriptive design. Data were collected using questionnaires. A tertiary acute hospital in South Korea undergoing a hospital accreditation program. Nurses, pre- and post-accreditation (217 and 373); response rate: 58% and 87%, respectively. Hospital accreditation program. Perceived safety climate and attitude toward medication error reporting. The level of safety climate and attitude toward medication error reporting increased significantly following accreditation; however, measures of institutional leadership and management did not improve significantly. Participants' perception of safety climate was positively correlated with their attitude toward medication error reporting; this correlation strengthened following completion of the program. Improving hospitals' safety climate increased nurses' medication error reporting; interventions that help hospital administration and managers to provide more supportive leadership may facilitate safety climate improvement. Hospitals and their units should develop more friendly and intimate working environments that remove nurses' fear of penalties. Administration and managers should support nurses who report their own errors. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Identifying and Synchronizing Health Information Technology (HIT) Events from FDA Medical Device Reports.

PubMed

Kang, Hong; Wang, Frank; Zhou, Sicheng; Miao, Qi; Gong, Yang

2017-01-01

Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. It is crucial to gain a better understanding of the nature of the errors and adverse events caused by current HIT systems. The scarcity of HIT event-exclusive databases and event reporting systems indicates the challenge of identifying the HIT events from existing resources. FDA Manufacturer and User Facility Device Experience (MAUDE) database is a potential resource for HIT events. However, the low proportion and the rapid evolvement of HIT-related events present challenges for distinguishing them from other equipment failures and hazards. We proposed a strategy to identify and synchronize HIT events from MAUDE by using a filter based on structured features and classifiers based on unstructured features. The strategy will help us develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.

10-Year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors.

PubMed

Lowe, Gregory; Costabile, Raymond A

2012-01-01

To ensure public safety all Food and Drug Administration (FDA)-approved medications undergo postapproval safety analysis. Phosphodiesterase type-5 inhibitors (PDE5-i) are generally regarded as safe and effective. We performed a nonindustry-sponsored analysis of FDA reports for sildenafil, tadalafil, and vardenafil to evaluate the reported cardiovascular and mortality events over the past 10 years. Summarized reports of adverse events (AEs) for each PDE5-i were requested from the Center for Drug Evaluation and Research within the FDA. These data are available under the Freedom of Information Act and document industry and nonindustry reports of AEs entered into the computerized system maintained by the Office of Surveillance and Epidemiology. The data were analyzed for the number of AE reports, number of objective cardiovascular events, and reported deaths. Overall, 14,818 AEs were reported for sildenafil. There were 1,824 (12.3%) reported deaths, and reports of cardiovascular AEs numbered 2,406 (16.2%). Tadalafil was associated with 5,548 AEs and 236 deaths were reported. Vardenafil was associated with 6,085 AEs and 121 reports of deaths. The percentage of reported severe cardiovascular disorders has stabilized at 10% to 15% of all AE reports for sildenafil and tadalafil and 5% to 10% for vardenafil. Only 10% of AE reports sent to the FDA for PDE5-i were from pharmaceutical manufacturers. Reports of deaths associated with PDE5-i remain around 5% of total reported events. Despite inherent limitations from evaluating FDA reports of AEs, it is important that these reports be reviewed outside pharmaceutical industry support in order to provide due diligence and transparency. Lowe G and Costabile RA. 10-year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors. J Sex Med 2012;9:265-270. © 2011 International Society for Sexual Medicine.

[EuCliD 5TM Clinic Variance Report: a means to improve the safety of patients and staff].

PubMed

Oggero, Anna Rita; Palmieri, Veronica; Cerreto, Maria; Manna, Luisa; Lettieri, Iolanda; Napoli, Antonio; Ravone, Virginia; Pelliccia, Francesco; Moretti, Manuela; Parisotto, Maria Teresa

2010-01-01

The collection of information about events in the healthcare sector has been documented internationally for more than 25 years. Incident reporting is used for the structured acquisition of information about adverse events to improve patient and healthcare staff safety, prepare corrective action, and prevent event recurrence in the future. The establishment of an incident reporting system requires that the staff involved should be capable of recognizing events which require reporting. The aim of this work was to encourage operators to use the incident reporting system and gradually achieve 100% compliance in the reporting of adverse events and corrective and preventive actions taken. The project was carried out by the staff of one NephroCare dialysis center. The parameters observed were how many times the Variance Report was used, how problems were analyzed, and how many times and by what means the medical and nursing staff took action to correct problems. Ten months from the start of the project 100% reporting was achieved. All selected adverse advents were correctly reported and corrective or preventive action was taken to improve patient care and dialysis center organization. Only effective feedback on the results achieved in terms of safety and tangible improvements by staff will allow the number of reports to be kept high, and maintain participants' compliance with the incident reporting system over the long term.

78 FR 20454 - Safety Zones; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... written--Celebrate Americafest/Fire over the Fox. This event has historically involved both a fireworks... day of the event. To ensure the safety of the Celebrate Americafest/Fire over the Fox event in its... 7 p.m. (2) Michigan Aerospace Challenge Sport Rocket Launch; Muskegon, MI--(i) Location. All waters...

The association between EMS workplace safety culture and safety outcomes

PubMed Central

Weaver, Matthew D.; Wang, Henry E.; Fairbanks, Rollin J.; Patterson, Daniel

2012-01-01

Objective Prior studies have highlighted wide variation in EMS workplace safety culture across agencies. We sought to determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. Methods We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, perceptions of working conditions, stress recognition, and job satisfaction. A panel of medical directors, paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Results Sixteen percent of all respondents reported experiencing an injury in the past 3 months, four of every 10 respondents reported an error or adverse event (AE), and 90% reported safety-compromising behaviors. Respondents reporting injury scored lower on 5 of the 6 domains of safety culture. Respondents reporting an error or AE scored lower for 4 of the 6 domains, while respondents reporting safety-compromising behavior had lower safety culture scores for 5 of 6 domains. Conclusions Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes. PMID:21950463

2012 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2012-01-01

This report provides a NASA Range Safety (NRS) overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various NASA Range Safety Program (RSP) activities performed during the past year, links to past reports, and information on several projects that may have a profound impact on the way business will be conducted in the future. Specific topics discussed in the 2012 NASA Range Safety Annual Report include a program overview and 2012 highlights; Range Safety Training; Independent Assessments; Support to Program Operations at all ranges conducting NASA launch/flight operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities.

Healthcare providers’ knowledge, experience and challenges of reporting adverse events following immunisation: a qualitative study

PubMed Central

2013-01-01

Background Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to surveillance systems. The aim of this study was explore the knowledge, experience and attitudes of medical and nursing professionals towards detecting and reporting AEFI. Methods We conducted a qualitative study, using semi-structured, face to face interviews with 13 Paediatric Emergency Department consultants from a tertiary paediatric hospital, 10 General Practitioners, 2 local council immunisation and 4 General Practice nurses, recruited using purposive sampling in Adelaide, South Australia, between December 2010 and September 2011. We identified emergent themes related to previous experience of an AEFI in practice, awareness and experience of AEFI reporting, factors that would facilitate or impede reporting and previous training in vaccine safety. Thematic analysis was used to analyse the data. Results AEFI reporting was infrequent across all groups, despite most participants having reviewed an AEFI. We found confusion about how to report an AEFI and variability, according to the provider group, as to the type of events that would constitute a reportable AEFI. Participants’ interpretation of a “serious” or “unexpected” AEFI varied across the three groups. Common barriers to reporting included time constraints and unsatisfactory reporting processes. Nurses were more likely to have received formal training in vaccine safety and reporting than medical practitioners. Conclusions This study provides an overview of experience and beliefs of three healthcare professional groups in relation to identifying and reporting AEFI. The qualitative assessment reveals differences in experience and awareness of AEFI reporting across the three professional groups. Most participants appreciated the importance of their role in

Mines Systems Safety Improvement Using an Integrated Event Tree and Fault Tree Analysis

NASA Astrophysics Data System (ADS)

Kumar, Ranjan; Ghosh, Achyuta Krishna

2017-04-01

Mines systems such as ventilation system, strata support system, flame proof safety equipment, are exposed to dynamic operational conditions such as stress, humidity, dust, temperature, etc., and safety improvement of such systems can be done preferably during planning and design stage. However, the existing safety analysis methods do not handle the accident initiation and progression of mine systems explicitly. To bridge this gap, this paper presents an integrated Event Tree (ET) and Fault Tree (FT) approach for safety analysis and improvement of mine systems design. This approach includes ET and FT modeling coupled with redundancy allocation technique. In this method, a concept of top hazard probability is introduced for identifying system failure probability and redundancy is allocated to the system either at component or system level. A case study on mine methane explosion safety with two initiating events is performed. The results demonstrate that the presented method can reveal the accident scenarios and improve the safety of complex mine systems simultaneously.

Adverse Event Reporting for Herbal Medicines: A Result of Market Forces

PubMed Central

Walji, Rishma; Boon, Heather; Barnes, Joanne; Austin, Zubin; Baker, G. Ross; Welsh, Sandy

2009-01-01

Herbal products are readily available over the counter in health food stores and are often perceived to be without risk. The current Canadian adverse event reporting system suffers from severe underreporting, resulting in a scarcity of safety data on herbal products. Twelve health food store personnel in the Greater Toronto Area were interviewed about their responses to herbal product–related adverse reactions. They generally fostered customer loyalty by offering generous return policies, which included collecting contact information to be sent to the manufacturers with the returned product. Thus, despite the public's lack of knowledge about the formal reporting system, adverse reaction information was directed to manufacturers whenever it resulted in a product return. The relationship between health food stores, industry and Health Canada provides a new opportunity to facilitate adverse event reporting. Additional information could be collected during the return process, and educational initiatives could be implemented to augment current post-market surveillance procedures for herbal products. PMID:20436811

Designing Adverse Event Forms for Real-World Reporting: Participatory Research in Uganda

PubMed Central

Innocent, Simeon H. S.; Kalumuna, Charles; Terlouw, Dianne J.; Lalloo, David G.; Staedke, Sarah G.; Haaland, Ane

2012-01-01

The wide-scale roll-out of artemisinin combination therapies (ACTs) for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV) relies on adverse event (AE) reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs. Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form. The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users. We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings to improve

Designing adverse event forms for real-world reporting: participatory research in Uganda.

PubMed

Davies, Emma C; Chandler, Clare I R; Innocent, Simeon H S; Kalumuna, Charles; Terlouw, Dianne J; Lalloo, David G; Staedke, Sarah G; Haaland, Ane

2012-01-01

The wide-scale roll-out of artemisinin combination therapies (ACTs) for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV) relies on adverse event (AE) reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings to improve quality

2010 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2010-01-01

this report provides a NASA Range Safety overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various NASA Range Safety Program activities conducted during the past year, links to past reports, and information on several projects that may have a profound impact on the way business will be done in the future. Specific topics discussed in the 2010 NASA Range Safety Annual Report include a program overview and 2010 highlights; Range Safety Training; Range Safety Policy revision; Independent Assessments; Support to Program Operations at all ranges conducting NASA launch/flight operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. Once again, the web-based format was used to present the annual report.

77 FR 30245 - Safety Zones; Annual Fireworks Events in the Captain of the Port Detroit Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-22

...-AA00 Safety Zones; Annual Fireworks Events in the Captain of the Port Detroit Zone AGENCY: Coast Guard... by adding three permanent safety zones within the Captain of the Port Detroit Zone. This action is necessary to provide for the safety of life and property on navigable waters during each event. This action...

Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting.

PubMed

Baker, Meghan A; Kaelber, David C; Bar-Shain, David S; Moro, Pedro L; Zambarano, Bob; Mazza, Megan; Garcia, Crystal; Henry, Adam; Platt, Richard; Klompas, Michael

2015-09-15

Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values, and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the MetroHealth System, an integrated healthcare system in Ohio. We queried the VAERS database to determine MetroHealth's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2%) messages, responded to 209 (15.1%), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95% confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants.

PubMed

Cornell, Erika; Kwa, Michael; Paller, Amy S; Xu, Shuai

2018-03-01

Despite their ubiquitous use and several recent health controversies involving cosmetics and personal care products for children, the Food and Drug Administration has little oversight of these products and relies on consumer-submitted adverse event reports. We assessed the recently released Center for Food Safety and Applied Nutrition's Adverse Event Reporting System database for adverse event reports submitted to the Food and Drug Administration for baby personal care products and to determine whether useful insights can be derived. We extracted the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System data file from 2004 to 2016 and examined the subset classified according to the Food and Drug Administration-designated product class as a baby product. Events were manually categorized into product type and symptom type to assess for trends. Only 166 total adverse events were reported to the Food and Drug Administration for baby products from 2004 to 2016. The majority of reports indicated rash or other skin reaction; 46% of reported events led to a health care visit. Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health. © 2018 Wiley Periodicals, Inc.

Are measurements of patient safety culture and adverse events valid and reliable? Results from a cross sectional study.

PubMed

Farup, Per G

2015-05-02

The association between measurements of the patient safety culture and the "true" patient safety has been insufficiently documented, and the validity of the tools used for the measurements has been questioned. This study explored associations between the patient safety culture and adverse events, and evaluated the validity of the tools. In 2008/2009, a survey on patient safety culture was performed with Hospital Survey on Patient Safety Culture (HSOPSC) in two medical departments in two geographically separated hospitals of Innlandet Hospital Trust. Later, a retrospective analysis of adverse events during the same period was performed with the Global Trigger Tool (GTT). The safety culture and adverse events were compared between the departments. 185 employees participated in the study, and 272 patient records were analysed. The HSOPSC scores were lower and adverse events less prevalent in department 1 than in department 2. In departments 1 and 2 the mean HSOPSC scores (SD) were at the unit level 3.62 (0.42) and 3.90 (0.37) (p < 0.001), and at the hospital level 3.35 (1.53) and 3.67 (0.53) (ns, p = 0.19) respectively. The proportion of records with adverse events were 10/135 (7%) and 28/137 (20%) (p = 0.003) respectively. There was an inverse association between the patient safety culture and adverse events. Until the criterion validity of the tools for measuring patient safety culture and tracking of adverse events have been further evaluated, measurement of patient safety culture could not be used as a proxy for the "true" safety.

Investigating the potential benefits of on-site food safety training for Folklorama, a temporary food service event.

PubMed

Mancini, Roberto; Murray, Leigh; Chapman, Benjamin J; Powell, Douglas A

2012-10-01

Folklorama in Winnipeg, Manitoba, Canada, is a 14-day temporary food service event that explores the many different cultural realms of food, food preparation, and entertainment. In 2010, the Russian pavilion at Folklorama was implicated in a foodborne outbreak of Escherichia coli O157 that caused 37 illnesses and 18 hospitalizations. The ethnic nature and diversity of foods prepared within each pavilion presents a unique problem for food inspectors, as each culture prepares food in their own very unique way. The Manitoba Department of Health and Folklorama Board of Directors realized a need to implement a food safety information delivery program that would be more effective than a 2-h food safety course delivered via PowerPoint slides. The food operators and event coordinators of five randomly chosen pavilions selling potentially hazardous food were trained on-site, in their work environment, focusing on critical control points specific to their menu. A control group (five pavilions) did not receive on-site food safety training and were assessed concurrently. Public health inspections for all 10 pavilions were performed by Certified Public Health Inspectors employed with Manitoba Health. Critical infractions were assessed by means of standardized food protection inspection reports. The results suggest no statistically significant difference in food inspection scores between the trained and control groups. However, it was found that inspection report results increased for both the control and trained groups from the first inspection to the second, implying that public health inspections are necessary in correcting unsafe food safety practices. The results further show that in this case, the 2-h food safety course delivered via slides was sufficient to pass public health inspections. Further evaluations of alternative food safety training approaches are warranted.

Analysis of event data recorder data for vehicle safety improvement

DOT National Transportation Integrated Search

2008-04-01

The Volpe Center performed a comprehensive engineering analysis of Event Data Recorder (EDR) data supplied by the National Highway Traffic Safety Administration (NHTSA) to assess its accuracy and usefulness in crash reconstruction and improvement of ...

Meeting Report: 2015 PDA Virus & TSE Safety Forum.

PubMed

Willkommen, Hannelore; Blümel, Johannes; Brorson, Kurt; Chen, Dayue; Chen, Qi; Gröner, Albrecht; Kreil, Thomas R; Ruffing, Michel; Ruiz, Sol; Scott, Dorothy; Silvester, Glenda

2016-01-01

The report provides a summary of the presentations at the Virus & TSE Safety Forum 2015 organized by the Parenteral Drug Association (PDA) and held in Cascais, Portugal, from 9 to 11 June, 2015. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2015 provided an excellent forum for the exchange of information and opinions between the industry, research organizations, and regulatory bodies. Regulatory updates on virus and TSE safety aspects illustrating current topics of discussion at regulatory agencies in Europe and the United States were provided; the conference covered emerging viruses and new virus detection systems that may be used for the investigation of human pathogenic viruses as well as the virus safety of cell substrates and of raw material of ovine/caprine or human origin. Progress of development and use of next-generation sequencing methods was shown by several examples. Virus clearance data illustrating the effectiveness of inactivation or removal methods were presented and data provided giving insight into the mechanism of action of these technologies. In the transmissible spongiform encephalopathy (TSE) part of the conference, the epidemiology of variant Creutzfeldt-Jakob disease was reviewed and an overview about diagnostic tests provided; current thinking about the spread and propagation of prions was presented and the inactivation of prions by disinfection (equipment) and in production of bovine-derived reagents (heparin) shown. The current report provides an overview about the outcomes of the 2015 PDA Virus & TSE Safety Forum, a unique event in this field. © PDA, Inc. 2016.

Root Cause Analysis: Learning from Adverse Safety Events.

PubMed

Brook, Olga R; Kruskal, Jonathan B; Eisenberg, Ronald L; Larson, David B

2015-10-01

Serious adverse events continue to occur in clinical practice, despite our best preventive efforts. It is essential that radiologists, both as individuals and as a part of organizations, learn from such events and make appropriate changes to decrease the likelihood that such events will recur. Root cause analysis (RCA) is a process to (a) identify factors that underlie variation in performance or that predispose an event toward undesired outcomes and (b) allow for development of effective strategies to decrease the likelihood of similar adverse events occurring in the future. An RCA process should be performed within the environment of a culture of safety, focusing on underlying system contributors and, in a confidential manner, taking into account the emotional effects on the staff involved. The Joint Commission now requires that a credible RCA be performed within 45 days for all sentinel or major adverse events, emphasizing the need for all radiologists to understand the processes with which an effective RCA can be performed. Several RCA-related tools that have been found to be useful in the radiology setting include the "five whys" approach to determine causation; cause-and-effect, or Ishikawa, diagrams; causal tree mapping; affinity diagrams; and Pareto charts. © RSNA, 2015.

[Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception].

PubMed

Pérez-Vilar, S; Díez-Domingo, J; Gomar-Fayos, J; Pastor-Villalba, E; Sastre-Cantón, M; Puig-Barberà, J

2014-08-01

The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011. The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry. The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%. Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

2009 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

2010-01-01

This year, NASA Range Safety transitioned to a condensed annual report to allow for Secretariat support to the Range Safety Group, Risk Committee. Although much shorter than in previous years, this report contains full-length articles concerning various subject areas, as well as links to past reports. Additionally, summaries from various NASA Range Safety Program activities that took place throughout the year are presented, as well as information on several projects that may have a profound impact on the way business will be done in the future. The sections include a program overview and 2009 highlights; Range Safety Training; Range Safety Policy; Independent Assessments Support to Program Operations at all ranges conducting NASA launch operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities.

Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007.

PubMed

Niu, Manette T; Ball, Robert; Woo, Emily Jane; Burwen, Dale R; Knippen, Maureen; Braun, M Miles

2009-01-07

During the period March 1, 1998 to January 14, 2007, approximately 6 million doses of Anthrax vaccine adsorbed (AVA) vaccine were administered. As of January 16, 2007, 4753 reports of adverse events following receipt of AVA vaccination had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Taken together, reports to VAERS did not definitively link any serious unexpected risk to this vaccine, and review of death and serious reports did not show a distinctive pattern indicative of a causal relationship to AVA vaccination. Continued monitoring of VAERS and analysis of potential associations between AVA vaccination and rare, serious events is warranted.

Summary and bibliography of safety-related events at boiling-water nuclear power plants as reported in 1980

DOE Office of Scientific and Technical Information (OSTI.GOV)

McCormack, K.E.; Gallaher, R.B.

1982-03-01

This document presents a bibliography that contains 100-word abstracts of event reports submitted to the US Nuclear Regulatory Commission concerning operational events that occurred at boiling-water-reactor nuclear power plants in 1980. The 1547 abstracts included on microfiche in this bibliography describe incidents, failures, and design or construction deficiencies that were experienced at the facilities. These abstracts are arranged alphabetically by reactor name and then chronologically for each reactor. Full-size keyword and permuted-title indexes to facilitate location of individual abstracts are provided following the text. Tables that summarize the information contained in the bibliography are also provided. The information in themore » tables includes a listing of the equipment items involved in the reported events and the associated number of reports for each item. Similar information is given for the various kinds of instrumentation and systems, causes of failures, deficiencies noted, and the time of occurrence (i.e., during refueling, operation, testing, or construction).« less

Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

PubMed

Hoffman, Keith B; Demakas, Andrea R; Dimbil, Mo; Tatonetti, Nicholas P; Erdman, Colin B

2014-11-01

The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.

Error reporting in transfusion medicine at a tertiary care centre: a patient safety initiative.

PubMed

Elhence, Priti; Shenoy, Veena; Verma, Anupam; Sachan, Deepti

2012-11-01

Errors in the transfusion process can compromise patient safety. A study was undertaken at our center to identify the errors in the transfusion process and their causes in order to reduce their occurrence by corrective and preventive actions. All near miss, no harm events and adverse events reported in the 'transfusion process' during 1 year study period were recorded, classified and analyzed at a tertiary care teaching hospital in North India. In total, 285 transfusion related events were reported during the study period. Of these, there were four adverse (1.5%), 10 no harm (3.5%) and 271 (95%) near miss events. Incorrect blood component transfusion rate was 1 in 6031 component units. ABO incompatible transfusion rate was one in 15,077 component units issued or one in 26,200 PRBC units issued and acute hemolytic transfusion reaction due to ABO incompatible transfusion was 1 in 60,309 component units issued. Fifty-three percent of the antecedent near miss events were bedside events. Patient sample handling errors were the single largest category of errors (n=94, 33%) followed by errors in labeling and blood component handling and storage in user areas. The actual and near miss event data obtained through this initiative provided us with clear evidence about latent defects and critical points in the transfusion process so that corrective and preventive actions could be taken to reduce errors and improve transfusion safety.

2011 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2012-01-01

Welcome to the 2011 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. As is typical with odd year editions, this is an abbreviated Range Safety Annual Report providing updates and links to full articles from the previous year's report. It also provides more complete articles covering new subject areas, summaries of various NASA Range Safety Program activities conducted during the past year, and information on several projects that may have a profound impact on the way business will be done in the future. Specific topics discussed and updated in the 2011 NASA Range Safety Annual Report include a program overview and 2011 highlights; Range Safety Training; Range Safety Policy revision; Independent Assessments; Support to Program Operations at all ranges conducting NASA launch/flight operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. Once again the web-based format was used to present the annual report. We continually receive positive feedback on the web-based edition and hope you enjoy this year's product as well. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. In conclusion, it has been a busy and productive year. I'd like to extend a personal Thank You to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the upcoming year.

[Adverse events management. Methods and results of a development project].

PubMed

Rabøl, Louise Isager; Jensen, Elisabeth Brøgger; Hellebek, Annemarie H; Pedersen, Beth Lilja

2006-11-27

This article describes the methods and results of a project in the Copenhagen Hospital Corporation (H:S) on preventing adverse events. The aim of the project was to raise awareness about patients' safety, test a reporting system for adverse events, develop and test methods of analysis of events and propagate ideas about how to prevent adverse events. H:S developed an action plan and a reporting system for adverse events, founded an organization and developed an educational program on theories and methods of learning from adverse events for both leaders and employees. During the three-year period from 1 January 2002 to 31 December 2004, the H:S staff reported 6011 adverse events. In the same period, the organization completed 92 root cause analyses. More than half of these dealt with events that had been optional to report, the other half events that had been mandatory to report. The number of reports and the front-line staff's attitude towards reporting shows that the H:S succeeded in founding a safety culture. Future work should be centred on developing and testing methods that will prevent adverse events from happening. The objective is to suggest and complete preventive initiatives which will help increase patient safety.

Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chopra, Omesh K.; Diercks, Dwight R.; Ma, David Chia-Chiun

At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In themore » U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned

78 FR 13811 - Safety Zone; Underwater Escape Event, Seaport, East River, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-01

... York Zone on the specified date and time. This action is necessary to ensure the safety of participants... Coast Guard will enforce the safety zone listed in 33 CFR 165.160 on the specified date and time as... Zone; Underwater Escape Event, Seaport, East River, NY AGENCY: Coast Guard, DHS. ACTION: Notice of...

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

PubMed

Downing, Nicholas S; Shah, Nilay D; Aminawung, Jenerius A; Pease, Alison M; Zeitoun, Jean-David; Krumholz, Harlan M; Ross, Joseph S

2017-05-09

Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time. A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001

78 FR 9743 - Event Reporting Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0237] Event Reporting Guidelines AGENCY: Nuclear... Regulatory Commission (NRC) has issued NUREG- 1022, Revision 3, ``Event Reporting Guidelines: 10 CFR 50.72 and 50.73.'' [[Page 9744

Sharing adverse drug event data using business intelligence technology.

PubMed

Horvath, Monica M; Cozart, Heidi; Ahmad, Asif; Langman, Matthew K; Ferranti, Jeffrey

2009-03-01

Duke University Health System uses computerized adverse drug event surveillance as an integral part of medication safety at 2 community hospitals and an academic medical center. This information must be swiftly communicated to organizational patient safety stakeholders to find opportunities to improve patient care; however, this process is encumbered by highly manual methods of preparing the data. Following the examples of other industries, we deployed a business intelligence tool to provide dynamic safety reports on adverse drug events. Once data were migrated into the health system data warehouse, we developed census-adjusted reports with user-driven prompts. Drill down functionality enables navigation from aggregate trends to event details by clicking report graphics. Reports can be accessed by patient safety leadership either through an existing safety reporting portal or the health system performance improvement Web site. Elaborate prompt screens allow many varieties of reports to be created quickly by patient safety personnel without consultation with the research analyst. The reduction in research analyst workload because of business intelligence implementation made this individual available to additional patient safety projects thereby leveraging their talents more effectively. Dedicated liaisons are essential to ensure clear communication between clinical and technical staff throughout the development life cycle. Design and development of the business intelligence model for adverse drug event data must reflect the eccentricities of the operational system, especially as new areas of emphasis evolve. Future usability studies examining the data presentation and access model are needed.

A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation.

PubMed

Kaye, Stephen; Baddon, Andrew; Jones, Mark; Armitage, W John; Fehily, Deirdre; Warwick, Ruth M

2010-02-01

Reporting and investigation of serious adverse events and reactions associated with tissue and cell transplantation is a fundamental aspect of ensuring adequate levels of safety and quality and is a requirement of the European Union Directives on tissues and cells. In the UK, a system for the reporting and analysis of events and reactions associated with ocular tissue transplantation is well established. It is operated by a network of individuals and organisations, each with clearly defined roles and responsibilities, following written procedures for reporting and investigation. Analysis of reports indicates that the most important adverse reactions associated with this type of tissue transplantation are endophthalmitis (0.58%) and primary graft failure (0.3%). This system allows the analysis of all types of events and reactions by the professionals involved so that trends can be identified and services improved. Tools to evaluate the severity and imputability of individual events or reactions, such as those developed by the EUSTITE project, can be utilised to facilitate the selection of those cases meeting the criteria for reporting to the Competent Authority. This vigilance model has been shown to be effective and could be applied in other fields of tissue or cell transplantation.

Using FDA reports to inform a classification for health information technology safety problems

PubMed Central

Ong, Mei-Sing; Runciman, William; Coiera, Enrico

2011-01-01

Objective To expand an emerging classification for problems with health information technology (HIT) using reports submitted to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Design HIT events submitted to MAUDE were retrieved using a standardized search strategy. Using an emerging classification with 32 categories of HIT problems, a subset of relevant events were iteratively analyzed to identify new categories. Two coders then independently classified the remaining events into one or more categories. Free-text descriptions were analyzed to identify the consequences of events. Measurements Descriptive statistics by number of reported problems per category and by consequence; inter-rater reliability analysis using the κ statistic for the major categories and consequences. Results A search of 899 768 reports from January 2008 to July 2010 yielded 1100 reports about HIT. After removing duplicate and unrelated reports, 678 reports describing 436 events remained. The authors identified four new categories to describe problems with software functionality, system configuration, interface with devices, and network configuration; the authors' classification with 32 categories of HIT problems was expanded by the addition of these four categories. Examination of the 436 events revealed 712 problems, 96% were machine-related, and 4% were problems at the human–computer interface. Almost half (46%) of the events related to hazardous circumstances. Of the 46 events (11%) associated with patient harm, four deaths were linked to HIT problems (0.9% of 436 events). Conclusions Only 0.1% of the MAUDE reports searched were related to HIT. Nevertheless, Food and Drug Administration reports did prove to be a useful new source of information about the nature of software problems and their safety implications with potential to inform strategies for safe design and implementation. PMID:21903979

Examination of adult and child bicyclist safety-relevant events using naturalistic bicycling methodology.

PubMed

Hamann, Cara J; Peek-Asa, Corinne

2017-05-01

Among roadway users, bicyclists are considered vulnerable due to their high risk for injury when involved in a crash. Little is known about the circumstances leading to near crashes, crashes, and related injuries or how these vary by age and gender. The purpose of this study was to examine the rates and characteristics of safety-relevant events (crashes, near crashes, errors, and traffic violations) among adult and child bicyclists. Bicyclist trips were captured using Pedal Portal, a data acquisition and coding system which includes a GPS-enabled video camera and graphical user interface. A total of 179 safety-relevant events were manually coded from trip videos. Overall, child errors and traffic violations occurred at a rate of 1.9 per 100min of riding, compared to 6.3 for adults. However, children rode on the sidewalk 56.4% of the time, compared with 12.7% for adults. For both adults and children, the highest safety-relevant event rates occurred on paved roadways with no bicycle facilities present (Adults=8.6 and Children=7.2, per 100min of riding). Our study, the first naturalistic study to compare safety-relevant events among adults and children, indicates large variation in riding behavior and exposure between child and adult bicyclists. The majority of identified events were traffic violations and we were not able to code all risk-relevant data (e.g., subtle avoidance behaviors, failure to check for traffic, probability of collision). Future naturalistic cycling studies would benefit from enhanced instrumentation (e.g., additional camera views) and coding protocols able to fill these gaps. Copyright © 2017 Elsevier Ltd. All rights reserved.

MO-F-16A-04: Case Study: Estimation of Peak Skin Dose Following a Physician Reported “High Dose” Case and Sentinel Event Considerations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Supanich, M; Chu, J; Wehmeyer, A

2014-06-15

Purpose: This work offers as a teaching example a reported high dose fluoroscopy case and the workflow the institution followed to self-report a radiation overdose sentinel event to the Joint Commission. Methods: Following the completion of a clinical case in a hybrid OR room with a reported air kerma of >18 Gy at the Interventional Reference Point (IRP) the physicians involved in the case referred study to the institution's Radiation Safety Committee (RSC) for review. The RSC assigned a Diagnostic Medical Physicist (DMP) to estimate the patient's Peak Skin Dose (PSD) and analyze the case. Following the DMP's analysis andmore » estimate of a PSD of >15 Gy the institution's adverse event committee was convened to discuss the case and to self-report the case as a radiation overdose sentinel event to the Joint Commission. The committee assigned a subgroup to perform the root cause analysis and develop institutional responses to the event. Results: The self-reporting of the sentinel event and the associated root cause analysis resulted in several institutional action items that are designed to improve process and safety. A formal reporting and analysis mechanism was adopted to review fluoroscopy cases with air kerma greater than 6 Gy at the IRP. An improved and formalized radiation safety training program for physicians using fluoroscopy equipment was implemented. Additionally efforts already under way to monitor radiation exposure in the Radiology department were expanded to include all fluoroscopy equipment capable of automated dose reporting. Conclusion: The adverse event review process and the root cause analysis following the self-reporting of the sentinel event resulted in policies and procedures that are expected to improve the quality and safe usage of fluoroscopy throughout the institution.« less

What Does a Hospital Survey on Patient Safety Reveal About Patient Safety Culture of Surgical Units Compared With That of Other Units?

PubMed

Shu, Qin; Cai, Miao; Tao, Hong-Bing; Cheng, Zhao-Hui; Chen, Jing; Hu, Yin-Huan; Li, Gang

2015-07-01

The objective of this study was to examine the strengths and weaknesses of surgical units as compared with other units, and to provide an opportunity to improve patient safety culture in surgical settings by suggesting targeted actions using Hospital Survey on Patient Safety Culture (HSOPSC) investigation.A Hospital Survey on Patient Safety questionnaire was conducted to physicians and nurses in a tertiary hospital in Shandong China. 12 patient safety culture dimensions and 2 outcome variables were measured.A total of 23.5% of respondents came from surgical units, and 76.5% worked in other units. The "overall perceptions of safety" (48.1% vs 40.4%, P < 0.001) and "frequency of events reported" (63.7% vs 60.7%, P = 0.001) of surgical units were higher than those of other units. However, the communication openness (38.7% vs 42.5%, P < 0.001) of surgical units was lower than in other units. Medical workers in surgical units reported more events than those in other units, and more respondents in the surgical units assess "patient safety grade" to be good/excellent. Three dimensions were considered as strengths, whereas 5 other dimensions were considered to be weaknesses in surgical units. Six dimensions have potential to aid in improving events reporting and patient safety grade. Appropriate working times will also contribute to ensuring patient safety. Medical staff with longer years of experience reported more events.Surgical units outperform the nonsurgical ones in overall perception of safety and the number of events reported but underperform in the openness of communication. Four strategies, namely deepening the understanding about patient safety of supervisors, narrowing the communication gap within and across clinical units, recruiting more workers, and employing the event reporting system and building a nonpunitive culture, are recommended to improve patient safety in surgical units in the context of 1 hospital.

Exploring relationships between hospital patient safety culture and Consumer Reports safety scores.

PubMed

Smith, Scott Alan; Yount, Naomi; Sorra, Joann

2017-02-16

A number of private and public companies calculate and publish proprietary hospital patient safety scores based on publicly available quality measures initially reported by the U.S. federal government. This study examines whether patient safety culture perceptions of U.S. hospital staff in a large national survey are related to publicly reported patient safety ratings of hospitals. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (Hospital SOPS) assesses provider and staff perceptions of hospital patient safety culture. Consumer Reports (CR), a U.S. based non-profit organization, calculates and shares with its subscribers a Hospital Safety Score calculated annually from patient experience survey data and outcomes data gathered from federal databases. Linking data collected during similar time periods, we analyzed relationships between staff perceptions of patient safety culture composites and the CR Hospital Safety Score and its five components using multiple multivariate linear regressions. We analyzed data from 164 hospitals, with patient safety culture survey responses from 140,316 providers and staff, with an average of 856 completed surveys per hospital and an average response rate per hospital of 56%. Higher overall Hospital SOPS composite average scores were significantly associated with higher overall CR Hospital Safety Scores (β = 0.24, p < 0.05). For 10 of the 12 Hospital SOPS composites, higher patient safety culture scores were associated with higher CR patient experience scores on communication about medications and discharge. This study found a relationship between hospital staff perceptions of patient safety culture and the Consumer Reports Hospital Safety Score, which is a composite of patient experience and outcomes data from federal databases. As hospital managers allocate resources to improve patient safety culture within their organizations, their efforts may also indirectly improve consumer

TA-55 Final Safety Analysis Report Comparison Document and DOE Safety Evaluation Report Requirements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alan Bond

2001-04-01

This document provides an overview of changes to the currently approved TA-55 Final Safety Analysis Report (FSAR) that are included in the upgraded FSAR. The DOE Safety Evaluation Report (SER) requirements that are incorporated into the upgraded FSAR are briefly discussed to provide the starting point in the FSAR with respect to the SER requirements.

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

PubMed Central

Downing, Nicholas S.; Shah, Nilay D.; Aminawung, Jenerius A.; Pease, Alison M.; Zeitoun, Jean-David; Krumholz, Harlan M.

2017-01-01

Importance Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. Objectives To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Design and Setting Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Exposures Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near–regulatory deadline approval, and regulatory review time. Main Outcomes and Measures A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. Results From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for

Aviation Safety Reporting System: Process and Procedures

NASA Technical Reports Server (NTRS)

Connell, Linda J.

1997-01-01

The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

2006 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

TenHaken, Ron; Daniels, B.; Becker, M.; Barnes, Zack; Donovan, Shawn; Manley, Brenda

2007-01-01

Throughout 2006, Range Safety was involved in a number of exciting and challenging activities and events, from developing, implementing, and supporting Range Safety policies and procedures-such as the Space Shuttle Launch and Landing Plans, the Range Safety Variance Process, and the Expendable Launch Vehicle Safety Program procedures-to evaluating new technologies. Range Safety training development is almost complete with the last course scheduled to go on line in mid-2007. Range Safety representatives took part in a number of panels and councils, including the newly formed Launch Constellation Range Safety Panel, the Range Commanders Council and its subgroups, the Space Shuttle Range Safety Panel, and the unmanned aircraft systems working group. Space based range safety demonstration and certification (formerly STARS) and the autonomous flight safety system were successfully tested. The enhanced flight termination system will be tested in early 2007 and the joint advanced range safety system mission analysis software tool is nearing operational status. New technologies being evaluated included a processor for real-time compensation in long range imaging, automated range surveillance using radio interferometry, and a space based range command and telemetry processor. Next year holds great promise as we continue ensuring safety while pursuing our quest beyond the Moon to Mars.

2013 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2013-01-01

Welcome to the 2013 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides an Agency overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various activities performed during the past year, links to past reports, and information on several projects that may have a profound impact on the way business will be conducted in the future. Specific topics discussed in the 2013 NASA Range Safety Annual Report include a program overview and 2013 highlights, Range Safety Training, Independent Assessments, support to Program Operations at all ranges conducting NASA launch/flight operations, a continuing overview of emerging range safety-related technologies, and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. As is the case each year, we had a wide variety of contributors to this report from across our NASA Centers and the national range safety community at large, and I wish to thank them all. On a sad note, we lost one of our close colleagues, Dr. Jim Simpson, due to his sudden passing in December. His work advancing the envelope of autonomous flight safety systems software/hardware development leaves a lasting impression on our community. Such systems are being flight tested today and may one day be considered routine in the range safety business. The NASA family has lost a pioneer in our field, and he will surely be missed. In conclusion, it has been a very busy and productive year, and I look forward to working with all of you in NASA Centers/Programs/Projects and with the national Range Safety community in making Flight/Space activities as safe as they can be in the upcoming year.

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

PubMed

Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

2016-12-15

Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

Using a quantitative risk register to promote learning from a patient safety reporting system.

PubMed

Mansfield, James G; Caplan, Robert A; Campos, John S; Dreis, David F; Furman, Cathie

2015-02-01

Patient safety reporting systems are now used in most health care delivery organizations. These systems, such as the one in use at Virginia Mason (Seattle) since 2002, can provide valuable reports of risk and harm from the front lines of patient care. In response to the challenge of how to quantify and prioritize safety opportunities, a risk register system was developed and implemented. Basic risk register concepts were refined to provide a systematic way to understand risks reported by staff. The risk register uses a comprehensive taxonomy of patient risk and algorithmically assigns each patient safety report to 1 of 27 risk categories in three major domains (Evaluation, Treatment, and Critical Interactions). For each category, a composite score was calculated on the basis of event rate, harm, and cost. The composite scores were used to identify the "top five" risk categories, and patient safety reports in these categories were analyzed in greater depth to find recurrent patterns of risk and associated opportunities for improvement. The top five categories of risk were easy to identify and had distinctive "profiles" of rate, harm, and cost. The ability to categorize and rank risks across multiple dimensions yielded insights not previously available. These results were shared with leadership and served as input for planning quality and safety initiatives. This approach provided actionable input for the strategic planning process, while at the same time strengthening the Virginia Mason culture of safety. The quantitative patient safety risk register serves as one solution to the challenge of extracting valuable safety lessons from large numbers of incident reports and could profitably be adopted by other organizations.

47 CFR 1.2114 - Reporting of eligibility event.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 1 2013-10-01 2013-10-01 false Reporting of eligibility event. 1.2114 Section... event. (a) A designated entity must seek Commission approval for all reportable eligibility events. A reportable eligibility event is: (1) Any spectrum lease (as defined in § 1.9003) or resale arrangement...

47 CFR 1.2114 - Reporting of eligibility event.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 1 2012-10-01 2012-10-01 false Reporting of eligibility event. 1.2114 Section... event. (a) A designated entity must seek Commission approval for all reportable eligibility events. A reportable eligibility event is: (1) Any spectrum lease (as defined in § 1.9003) or resale arrangement...

Farm-related injury event, social consequences and injury reporting in the Land Lantbruk newspaper in Sweden: a retrospective study of farm-related injury reporting during 2000-2005.

PubMed

Lundälv, Jörgen

2006-12-01

The aim of the present study was to detect how a leading news paper, the Land Lantbruk in Stockholm, Sweden, informs the public and specifically the rural sector in Sweden and the Scandinavian countries concerning injury events (farm-related injury event) and the use of injury prevention and control. Injury reporting in the Land Lantbruk has been studied from the point of injury prevention and control. A study of injury prevention and rural health and safety in Australia shows that the newspaper The Land that serves Australia's rural community should 'be an under-utilised vehicle for news and commentary on rural health and safety issues'. The study period was from January 2000 to February 2005. A total of 178 articles were reviewed and analysed. The articles were available on a newspaper database in the Land Lantbruk newspaper. Articles that addressed farm-related injury event and rural health and safety were chosen and organised into subgroups. Tractor and motor vehicle safety (35%) was most common among the injury reporting. Although the newspaper Land Lantbruk provided excellent coverage of the causes of these events, the reports tended to focus on circumstances and did not provide information on injury prevention or the advantages of also coverage of the social and psychosocial long-term consequences of accidents. In the prevention work of reducing farm-related injuries in the rural sector in the Scandinavian countries and decreasing the human suffering represented by this health problem, rural politicians, insurance companies, rural authorities and also handicap organisations should listen more to the injured individuals and their own experiences relative to the difficulty of life after an accident. The reaction of family and relatives, and experiences of the long-term social consequences, have not been included in the media coverage. Journalists at the Land Lantbruk could also share experiences of the Swedish coverage of rural health and safety from

Can Patient Safety Incident Reports Be Used to Compare Hospital Safety? Results from a Quantitative Analysis of the English National Reporting and Learning System Data.

PubMed

Howell, Ann-Marie; Burns, Elaine M; Bouras, George; Donaldson, Liam J; Athanasiou, Thanos; Darzi, Ara

2015-01-01

The National Reporting and Learning System (NRLS) collects reports about patient safety incidents in England. Government regulators use NRLS data to assess the safety of hospitals. This study aims to examine whether annual hospital incident reporting rates can be used as a surrogate indicator of individual hospital safety. Secondly assesses which hospital characteristics are correlated with high incident reporting rates and whether a high reporting hospital is safer than those lower reporting hospitals. Finally, it assesses which health-care professionals report more incidents of patient harm, which report more near miss incidents and what hospital factors encourage reporting. These findings may suggest methods for increasing the utility of reporting systems. This study used a mix methods approach for assessing NRLS data. The data were investigated using Pareto analysis and regression models to establish which patients are most vulnerable to reported harm. Hospital factors were correlated with institutional reporting rates over one year to examine what factors influenced reporting. Staff survey findings regarding hospital safety culture were correlated with reported rates of incidents causing harm; no harm and death to understand what barriers influence error disclosure. 5,879,954 incident reports were collected from acute hospitals over the decade. 70.3% of incidents produced no harm to the patient and 0.9% were judged by the reporter to have caused severe harm or death. Obstetrics and Gynaecology reported the most no harm events [OR 1.61(95%CI: 1.12 to 2.27), p<0.01] and pharmacy was the hospital location where most near-misses were captured [OR 3.03(95%CI: 2.04 to 4.55), p<0.01]. Clinicians were significantly more likely to report death than other staff [OR 3.04(95%CI: 2.43 to 3.80) p<0.01]. A higher ratio of clinicians to beds correlated with reduced rate of harm reported [RR = -1.78(95%Cl: -3.33 to -0.23), p = 0.03]. Litigation claims per bed were

Dietary supplement adverse events: report of a one-year poison center surveillance project.

PubMed

Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

2008-06-01

The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

47 CFR 1.2114 - Reporting of eligibility event.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 1 2014-10-01 2014-10-01 false Reporting of eligibility event. 1.2114 Section... event. Link to an amendment published at 79 FR 48530, August 15, 2014. (a) A designated entity must seek Commission approval for all reportable eligibility events. A reportable eligibility event is: (1) Any...

21 CFR 314.540 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Postmarketing safety reporting. 314.540 Section... New Drugs for Serious or Life-Threatening Illnesses § 314.540 Postmarketing safety reporting. Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting...

47 CFR 1.2114 - Reporting of eligibility event.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Reporting of eligibility event. 1.2114 Section... Competitive Bidding Proceedings General Procedures § 1.2114 Reporting of eligibility event. (a) A designated entity must seek Commission approval for all reportable eligibility events. A reportable eligibility...

47 CFR 1.2114 - Reporting of eligibility event.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Reporting of eligibility event. 1.2114 Section... Competitive Bidding Proceedings General Procedures § 1.2114 Reporting of eligibility event. (a) A designated entity must seek Commission approval for all reportable eligibility events. A reportable eligibility...

Reporting vaccine-associated adverse events.

PubMed Central

Duclos, P.; Hockin, J.; Pless, R.; Lawlor, B.

1997-01-01

OBJECTIVE: To determine family physicians' awareness of the need to monitor and report vaccine-associated adverse events (VAAE) in Canada and to identify mechanisms that could facilitate reporting. DESIGN: Mailed survey. SETTING: Canadian family practices. PARTICIPANTS: Random sample of 747 family physicians. Overall response rate was 32% (226 of 717 eligible physicians). MAIN OUTCOME MEASURES: Access to education on VAAE; knowledge about VAAE monitoring systems, reporting criteria, and reporting forms; method of reporting VAAEs and reasons for not reporting them; and current experience with VAAEs. RESULTS: Of 226 respondents, 55% reported observing VAAEs, and 42% reported the event. Fewer than 50% were aware of a monitoring system for VAAE, and only 39% had had VAAE-related education during medical training. Only 28% knew the reporting criteria. Reporting was significantly associated with knowledge of VAAE monitoring systems and reporting criteria (P < 0.01). CONCLUSION: Physicians need more feedback and education on VAAE reporting and more information about the importance of reporting and about reporting criteria and methods. PMID:9303234

49 CFR 191.23 - Reporting safety-related conditions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Reporting safety-related conditions. 191.23... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE; ANNUAL REPORTS, INCIDENT REPORTS, AND SAFETY-RELATED...

The aviation safety reporting system

NASA Technical Reports Server (NTRS)

Reynard, W. D.

1984-01-01

The aviation safety reporting system, an accident reporting system, is presented. The system identifies deficiencies and discrepancies and the data it provides are used for long term identification of problems. Data for planning and policy making are provided. The system offers training in safety education to pilots. Data and information are drawn from the available data bases.

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis

PubMed Central

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-01-01

Introduction: Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. Materials and Methods: We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. Results: A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar®), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups “41-65” (39.07%) and “over 65” (27.9%) were the most affected. Conclusions: Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed. PMID:24347984

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

PubMed

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-12-01

Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

78 FR 20277 - Safety Zones & Special Local Regulations; Recurring Marine Events in Captain of the Port Long...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-04

...The Coast Guard proposes to add, delete, and modify safety zones and special local regulations and add language to clarify time frames and notification requirements for annual marine events in the Sector Long Island Sound Captain of the Port (COTP) Zone. When these regulated areas are activated and subject to enforcement, this rule would restrict vessels from portions of water areas during these recurring events. The safety zones and special local regulations will facilitate public notification of events and provide protective measures for the maritime public and event participants from the hazards associated with these recurring events.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

Billings, C. E.; Lauber, J. K.; Funkhouser, H.; Lyman, E. G.; Huff, E. M.

1976-01-01

The origins and development of the NASA Aviation Safety Reporting System (ASRS) are briefly reviewed. The results of the first quarter's activity are summarized and discussed. Examples are given of bulletins describing potential air safety hazards, and the disposition of these bulletins. During the first quarter of operation, the ASRS received 1464 reports; 1407 provided data relevant to air safety. All reports are being processed for entry into the ASRS data base. During the reporting period, 130 alert bulletins describing possible problems in the aviation system were generated and disseminated. Responses were received from FAA and others regarding 108 of the alert bulletins. Action was being taken with respect to 70 of the 108 responses received. Further studies are planned of a number of areas, including human factors problems related to automation of the ground and airborne portions of the national aviation system.

76 FR 31843 - Safety Zone; Temporary Change to Enforcement Location of Recurring Fireworks Display Event...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

...-AA00 Safety Zone; Temporary Change to Enforcement Location of Recurring Fireworks Display Event... Guard is temporarily changing the enforcement location of a safety zone for one specific recurring... originated from a barge but will this year originate from a location on land. The safety zone is necessary to...

Detecting, Monitoring, and Reporting Possible Adverse Drug Events Using an Arden-Syntax-based Rule Engine.

PubMed

Fehre, Karsten; Plössnig, Manuela; Schuler, Jochen; Hofer-Dückelmann, Christina; Rappelsberger, Andrea; Adlassnig, Klaus-Peter

2015-01-01

The detection of adverse drug events (ADEs) is an important aspect of improving patient safety. The iMedication system employs predefined triggers associated with significant events in a patient's clinical data to automatically detect possible ADEs. We defined four clinically relevant conditions: hyperkalemia, hyponatremia, renal failure, and over-anticoagulation. These are some of the most relevant ADEs in internal medical and geriatric wards. For each patient, ADE risk scores for all four situations are calculated, compared against a threshold, and judged to be monitored, or reported. A ward-based cockpit view summarizes the results.

Getting the right blood to the right patient: the contribution of near-miss event reporting and barrier analysis.

PubMed

Kaplan, H S

2005-11-01

Safety and reliability in blood transfusion are not static, but are dynamic non-events. Since performance deviations continually occur in complex systems, their detection and correction must be accomplished over and over again. Non-conformance must be detected early enough to allow for recovery or mitigation. Near-miss events afford early detection of possible system weaknesses and provide an early chance at correction. National event reporting systems, both voluntary and involuntary, have begun to include near-miss reporting in their classification schemes, raising awareness for their detection. MERS-TM is a voluntary safety reporting initiative in transfusion. Currently 22 hospitals submit reports anonymously to a central database which supports analysis of a hospital's own data and that of an aggregate database. The system encourages reporting of near-miss events, where the patient is protected from receiving an unsuitable or incorrect blood component due to a planned or unplanned recovery step. MERS-TM data suggest approximately 90% of events are near-misses, with 10% caught after issue but before transfusion. Near-miss reporting may increase total reports ten-fold. The ratio of near-misses to events with harm is 339:1, consistent with other industries' ratio of 300:1, which has been proposed as a measure of reporting in event reporting systems. Use of a risk matrix and an event's relation to protective barriers allow prioritization of these events. Near-misses recovered by planned barriers occur ten times more frequently then unplanned recoveries. A bedside check of the patient's identity with that on the blood component is an essential, final barrier. How the typical two person check is performed, is critical. Even properly done, this check is ineffective against sampling and testing errors. Blood testing at bedside just prior to transfusion minimizes the risk of such upstream events. However, even with simple and well designed devices, training may be a

Effects of an educational patient safety campaign on patients' safety behaviours and adverse events.

PubMed

Schwappach, David L B; Frank, Olga; Buschmann, Ute; Babst, Reto

2013-04-01

Rationale, aims and objectives  The study aims to investigate the effects of a patient safety advisory on patients' risk perceptions, perceived behavioural control, performance of safety behaviours and experience of adverse incidents. Method  Quasi-experimental intervention study with non-equivalent group comparison was used. Patients admitted to the surgical department of a Swiss large non-university hospital were included. Patients in the intervention group received a safety advisory at their first clinical encounter. Outcomes were assessed using a questionnaire at discharge. Odds ratios for control versus intervention group were calculated. Regression analysis was used to model the effects of the intervention and safety behaviours on the experience of safety incidents. Results  Two hundred eighteen patients in the control and 202 in the intervention group completed the survey (75 and 77% response rates, respectively). Patients in the intervention group were less likely to feel poorly informed about medical errors (OR = 0.55, P = 0.043). There were 73.1% in the intervention and 84.3% in the control group who underestimated the risk for infection (OR = 0.51, CI 0.31-0.84, P = 0.009). Perceived behavioural control was lower in the control group (meanCon  = 3.2, meanInt  = 3.5, P = 0.010). Performance of safety-related behaviours was unaffected by the intervention. Patients in the intervention group were less likely to experience any safety-related incident or unsafe situation (OR for intervention group = 0.57, CI 0.38-0.87, P = 0.009). There were no differences in concerns for errors during hospitalization. There were 96% of patients (intervention) who would recommend other patients to read the advisory. Conclusions  The results suggest that the safety advisory decreases experiences of adverse events and unsafe situations. It renders awareness and perceived behavioural control without increasing concerns for safety and

2008 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Lamoreaux, Richard W.

2008-01-01

Welcome to the 2008 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. This year, along with full length articles concerning various subject areas, we have provided updates to standard subjects with links back to the 2007 original article. Additionally, we present summaries from the various NASA Range Safety Program activities that took place throughout the year, as well as information on several special projects that may have a profound impact on the way we will do business in the future. The sections include a program overview and 2008 highlights of Range Safety Training; Range Safety Policy; Independent Assessments and Common Risk Analysis Tools Development; Support to Program Operations at all ranges conducting NASA launch operations; a continuing overview of emerging Range Safety-related technologies; Special Interests Items that include recent changes in the ELV Payload Safety Program and the VAS explosive siting study; and status reports from all of the NASA Centers that have Range Safety responsibilities. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. We have made a great effort to include the most current information available. We recommend that this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. This is the third year we have utilized this web-based format for the annual report. We continually receive positive feedback on the web-based edition, and we hope you enjoy this year's product as well. It has been a very busy and productive year on many fronts as you will note as you review this report. Thank you to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the

78 FR 35790 - Safety Zones; Recurring Events in Captain of the Port Boston Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

...: Notice of proposed rulemaking. SUMMARY: The Coast Guard proposes to add three new permanent safety zones... during annual recurring events. These three permanent safety zones would expedite public notification of..., Coast Guard Sector Boston Waterways Management Division, telephone 617-223-4000, email Mark.E.Cutter...

10 CFR 37.57 - Reporting of events.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Reporting of events. 37.57 Section 37.57 Energy NUCLEAR... Physical Protection Requirements During Use § 37.57 Reporting of events. (a) The licensee shall immediately... response to the event, the licensee shall notify the NRC's Operations Center (301-816-5100). In no case...

Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.

PubMed

Park-Wyllie, Laura; van Stralen, Judy; Castillon, Genaro; Sherman, Stephen E; Almagor, Doron

2017-10-01

Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands. Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispensed. An in-depth analysis of narratives of individual case safety reports (ICSRs) with the use of the generic product was conducted in duplicate by 2 physicians to assess causality and to characterize the potential safety risk and clinical pattern of therapeutic failure. Similar secondary analyses were conducted on the US-marketed products. Reporting rates of therapeutic failure with the use of methylphenidate ER-C (generic) and OROS methylphenidate (brand name) were 411.5 and 37.5 cases per 100,000 patient-years, respectively (reporting rate ratio, 10.99; 95% CI, 5.93-22.21). In-depth analysis of narratives of 230 ICSRs of therapeutic failure with the Canadian-marketed generic determined that all ICSRs were either probably (60 [26%]) or possibly (170 [74%]) causally related to methylphenidate ER-C. Clinical symptoms suggestive of overdose were present in 31 reports of loss of efficacy (13.5%) and occurred primarily in the morning, and

Adverse event reporting in cancer clinical trial publications.

PubMed

Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

2014-01-10

Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm.

PubMed

McDonald, Cameron J; Kalisch Ellett, Lisa M; Barratt, John D; Caughey, Gillian E

2014-12-01

Concerns with the safety profiles of the newer anticoagulants have been raised because of differences in treatment populations between pre-marketing studies (randomized controlled trials) and clinical practice. Little is known about the potential safety issues and the reporting in spontaneous adverse event databases associated with rivaroxaban. To analyse spontaneous adverse event reports associated with the oral anticoagulant rivaroxaban from Australia, Canada and the USA; and to examine concomitant medicine use that may increase the risk of adverse events. Spontaneous adverse event report databases from Australia, Canada and the USA were examined for all reports of adverse events associated with rivaroxaban and concomitant medicines from 1 August 2005 to 31 March 2013. Disproportionality analysis (the proportional reporting ratio [PRR] and reporting odds ratio [ROR]) was conducted for quantitative detection of signals, using the US database. There were 244 spontaneous adverse event reports associated with rivaroxaban from Australia, 536 from Canada and 1,638 from the USA. Reporting of haemorrhage (any type) was common, ranging from 30.7% for Australia to 37.5% for Canada. Gastrointestinal haemorrhage was the most commonly reported haemorrhage, accounting for 13.9% of Australian, 16.4% of Canadian and 11.1% of US adverse event reports. Positive signals were confirmed in the US data (haemorrhage [any type] PRR 11.93, χ (2) 4,414.78 and ROR 13.41, 95% confidence interval [CI] 12.13-14.81; gastrointestinal haemorrhage PRR 12.52, χ (2) 2,018.48 and ROR 13.15, 95% CI 11.36-15.21). Reporting of concomitant use of medicines with the potential to increase bleeding risk ranged from 63.7% in Australia to 89.2% in Canada. A large proportion of adverse event reports for rivaroxaban were associated with use of concomitant medicines, which may have increased the risk of adverse events-in particular, haemorrhage. Increased awareness of a patient's comorbidity and associated

Clinical Correlates of Surveillance Events Detected by National Healthcare Safety Network Pneumonia and Lower Respiratory Infection Definitions-Pennsylvania, 2011-2012.

PubMed

See, Isaac; Chang, Julia; Gualandi, Nicole; Buser, Genevieve L; Rohrbach, Pamela; Smeltz, Debra A; Bellush, Mary Jo; Coffin, Susan E; Gould, Jane M; Hess, Debra; Hennessey, Patricia; Hubbard, Sydney; Kiernan, Andrea; O'Donnell, Judith; Pegues, David A; Miller, Jeffrey R; Magill, Shelley S

2016-07-01

OBJECTIVE To determine the clinical diagnoses associated with the National Healthcare Safety Network (NHSN) pneumonia (PNEU) or lower respiratory infection (LRI) surveillance events DESIGN Retrospective chart review SETTING A convenience sample of 8 acute-care hospitals in Pennsylvania PATIENTS All patients hospitalized during 2011-2012 METHODS Medical records were reviewed from a random sample of patients reported to the NHSN to have PNEU or LRI, excluding adults with ventilator-associated PNEU. Documented clinical diagnoses corresponding temporally to the PNEU and LRI events were recorded. RESULTS We reviewed 250 (30%) of 838 eligible PNEU and LRI events reported to the NHSN; 29 reported events (12%) fulfilled neither PNEU nor LRI case criteria. Differences interpreting radiology reports accounted for most misclassifications. Of 81 PNEU events in adults not on mechanical ventilation, 84% had clinician-diagnosed pneumonia; of these, 25% were attributed to aspiration. Of 43 adult LRI, 88% were in mechanically ventilated patients and 35% had no corresponding clinical diagnosis (infectious or noninfectious) documented at the time of LRI. Of 36 pediatric PNEU events, 72% were ventilator associated, and 70% corresponded to a clinical pneumonia diagnosis. Of 61 pediatric LRI patients, 84% were mechanically ventilated and 21% had no corresponding clinical diagnosis documented. CONCLUSIONS In adults not on mechanical ventilation and in children, most NHSN-defined PNEU events corresponded with compatible clinical conditions documented in the medical record. In contrast, NHSN LRI events often did not. As a result, substantial modifications to the LRI definitions were implemented in 2015. Infect Control Hosp Epidemiol 2016;37:818-824.

Clinical Correlates of Surveillance Events Detected by National Healthcare Safety Network Pneumonia and Lower Respiratory Infection Definitions—Pennsylvania, 2011–2012

PubMed Central

See, Isaac; Chang, Julia; Gualandi, Nicole; Buser, Genevieve L.; Rohrbach, Pamela; Smeltz, Debra A.; Bellush, Mary Jo; Coffin, Susan E.; Gould, Jane M.; Hess, Debra; Hennessey, Patricia; Hubbard, Sydney; Kiernan, Andrea; O’Donnell, Judith; Pegues, David A.; Miller, Jeffrey R.; Magill, Shelley S.

2017-01-01

Objective To determine the clinical diagnoses associated with National Healthcare Safety Network (NHSN) pneumonia (PNEU) or lower respiratory infection (LRI) surveillance events. Design Retrospective chart review. Setting Eight acute care hospitals in Pennsylvania. Patients All patients hospitalized during 2011–2012. Methods Medical records were reviewed from a random sample of patients reported to NHSN to have PNEU or LRI, excluding adults with ventilator-associated PNEU. Documented clinical diagnoses corresponding temporally to the PNEU/LRI events were recorded. Results We reviewed 250 (30%) of 838 eligible PNEU and LRI events reported to NHSN; 29 (12%) of reported events fulfilled neither PNEU nor LRI case criteria. Differences interpreting radiology reports accounted for most misclassification. Of 81 PNEU events in adults not on mechanical ventilation, 84% had clinician-diagnosed pneumonia, of which 25% were attributed to aspiration. Of 43 adult LRI, 88% were in mechanically ventilated patients and 35% had no corresponding clinical diagnosis (infectious or non-infectious) documented at the time of LRI. Of 36 pediatric PNEU events, 72% were ventilator-associated, and 70% corresponded to a clinical pneumonia diagnosis. Of 61 pediatric LRI, 84% were in mechanically-ventilated patients, and 21% had no corresponding clinical diagnosis documented. Conclusions In adults not on mechanical ventilation and in children, most NHSN-defined PNEU events corresponded to compatible clinical conditions documented in the medical record. In contrast, NHSN LRI events often did not. As a result, substantial modifications to the LRI definitions were implemented in 2015. PMID:27072043

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1977-01-01

During the third quarter of operation of the Aviation Safety Reporting System (ASRS), 1429 reports concerning aviation safety were received from pilots, air traffic controllers, and others in the national aviation system. Details of the administration and results of the program are discussed. The design and construction of the ASRS data base are briefly presented. Altitude deviations and potential aircraft conflicts associated with misunderstood clearances were studied and the results are discussed. Summary data regarding alert bulletins, examples of alert bulletins and responses to them, and a sample of deidentified ASRS reports are provided.

Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

PubMed Central

Nomura, Kaori; Takahashi, Kunihiko; Hinomura, Yasushi; Kawaguchi, Genta; Matsushita, Yasuyuki; Marui, Hiroko; Anzai, Tatsuhiko; Hashiguchi, Masayuki; Mochizuki, Mayumi

2015-01-01

Background The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER) database and the US Food and Drug Administration Adverse Event Reporting System (FAERS), and how they affect signal detection. Methods Two AE data sources from 2010 were examined, ie, JADER cases (JP) and Japanese cases extracted from the FAERS (FAERS-JP). Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS), were used on drug-event combinations for three substances frequently recorded in both systems. Results The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37) in the JP and 3.3±3.5 (maximum 62) in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and paroxetine. Signals identified by GPS for the JP and FAERS-JP, as referenced by Japanese labeling, showed higher positive sensitivity than was expected. Conclusion The FAERS-JP was different from the JADER. Signals derived from both datasets identified different results, but shared certain signals. Discrepancies in type of AEs, drugs reported, and average number of AEs per case were potential contributing factors. This study will help those concerned with pharmacovigilance better understand the use and pitfalls of using spontaneous AE data. PMID:26109846

1995 Bicycle and Pedestrian Safety Report

DOT National Transportation Integrated Search

1995-03-01

This report provides a review of the current data on bicycle and pedestrian : safety across the United States, finding that safety and education : programs could significantly improve bicycle and pedestrian safety in the : Dallas-Fort Worth Metropoli...

10 CFR 73.71 - Reporting of safeguards events.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Reporting of safeguards events. 73.71 Section 73.71 Energy... § 73.71 Reporting of safeguards events. (a)(1) Each licensee subject to the provisions of §§ 73.25, 73... revised information. Each licensee shall maintain a copy of the written report of an event submitted under...

10 CFR 73.71 - Reporting of safeguards events.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Reporting of safeguards events. 73.71 Section 73.71 Energy... § 73.71 Reporting of safeguards events. (a)(1) Each licensee subject to the provisions of §§ 73.25, 73... revised information. Each licensee shall maintain a copy of the written report of an event submitted under...

10 CFR 73.71 - Reporting of safeguards events.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Reporting of safeguards events. 73.71 Section 73.71 Energy... § 73.71 Reporting of safeguards events. (a)(1) Each licensee subject to the provisions of §§ 73.25, 73... revised information. Each licensee shall maintain a copy of the written report of an event submitted under...

Canadian Adverse Events Following Immunization Surveillance System (CAEFISS): Annual report for vaccines administered in 2012

PubMed Central

Law, BJ; Laflèche, J; Ahmadipour, N; Anyoti, H

2014-01-01

Background To describe the adverse event following immunization (AEFI) reporting profile for vaccines administered in Canada during 2012 and surveillance trends relative to reports for vaccines administered from 2005 through 2011. Methods Analysis of data based on AEFI reports received by the Public Health Agency of Canada by April 30, 2013, for vaccines marketed in Canada and administered from January 1, 2005, through December 31, 2012. Results The AEFI reporting rate was 10.1 per 100,000 population in Canada for vaccines administered in 2012 and was inversely proportional to age. There was a trend of declining rates from 2005 (14.8) to 2012 overall and by age group. The vast majority of reports (94%−95%) were non-serious involving reactions at or near the vaccination site, rash and febrile events. Conclusion Canada has a strong pharmacovigilance system for vaccines with one of the highest AEFI reporting rates in developed countries. Vaccines marketed in Canada have a very good safety profile. This report enables comparisons across jurisdictions in Canada and globally. PMID:29769908

75 FR 19304 - Safety Zones; Annual Fireworks Events in the Captain of the Port Detroit Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-14

... zones for annual events in the Captain of the Port Detroit zone. This proposed rule adds events not... proposed rule will add additional events not previously published in the regulations found in 33 CFR 165...-AA00 Safety Zones; Annual Fireworks Events in the Captain of the Port Detroit Zone AGENCY: Coast Guard...

10 CFR Appendix A to Part 70 - Reportable Safety Events

Code of Federal Regulations, 2013 CFR

2013-01-01

... quantitative standards established to satisfy the requirements in § 70.61(b)(4). (4) An event or condition such... material or hazardous chemicals produced from licensed materials that exceeds the quantitative standards...

10 CFR Appendix A to Part 70 - Reportable Safety Events

Code of Federal Regulations, 2012 CFR

2012-01-01

... quantitative standards established to satisfy the requirements in § 70.61(b)(4). (4) An event or condition such... material or hazardous chemicals produced from licensed materials that exceeds the quantitative standards...

10 CFR Appendix A to Part 70 - Reportable Safety Events

Code of Federal Regulations, 2010 CFR

2010-01-01

... quantitative standards established to satisfy the requirements in § 70.61(b)(4). (4) An event or condition such... material or hazardous chemicals produced from licensed materials that exceeds the quantitative standards...

10 CFR Appendix A to Part 70 - Reportable Safety Events

Code of Federal Regulations, 2011 CFR

2011-01-01

... quantitative standards established to satisfy the requirements in § 70.61(b)(4). (4) An event or condition such... material or hazardous chemicals produced from licensed materials that exceeds the quantitative standards...

10 CFR Appendix A to Part 70 - Reportable Safety Events

Code of Federal Regulations, 2014 CFR

2014-01-01

... quantitative standards established to satisfy the requirements in § 70.61(b)(4). (4) An event or condition such... material or hazardous chemicals produced from licensed materials that exceeds the quantitative standards...

Adverse event assessment and reporting in trials of newer treatments for post-operative pain.

PubMed

Hoffer, D; Smith, S M; Parlow, J; Allard, R; Gilron, I

2016-08-01

Assessment and reporting of adverse events (AEs) in studies of perioperative interventions is critical given the potential for unintended and preventable iatrogenic morbidity and mortality. This focused review evaluated the quality of AE assessment and reporting in acute post-operative pain treatment trials. Since older analgesics (e.g., opioids, NSAIDs) already have a well-characterized safety profile, we concentrated on trials of pregabalin and gabapentin as a representative sample of studies where the perioperative safety profile was relatively unknown. We reviewed primary reports of trials of pregabalin and gabapentin for treatment of acute post-operative pain for: (1) adherence to the 10 recommendations from the 'CONSORT Extension for Harms,' (2) AE assessment method, (3) timing of AE assessment and reporting, and (4) assessment and reporting of AE severity. We identified 31 trials of pregabalin and 59 of gabapentin. The median number of CONSORT harms recommendations that were satisfied was 7 of 10. The most common (41%) method of AE assessment was direct questioning about specific AEs by investigators. However, AE assessment method was not described in 18% of trials. AE assessments were reported for specified perioperative time points in only 24% of trials. Of greatest concern, no AE data were reported whatsoever in 8 of the included publications. Considerable widespread improvements are needed in AE reporting for post-operative pain treatment trials. In addition to heightened awareness among clinical investigators, mandatory journal editorial policies may further facilitate improvements in safety assessment and reporting. © 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

What Does a Hospital Survey on Patient Safety Reveal About Patient Safety Culture of Surgical Units Compared With That of Other Units?

PubMed Central

Shu, Qin; Cai, Miao; Tao, Hong-bing; Cheng, Zhao-hui; Chen, Jing; Hu, Yin-huan; Li, Gang

2015-01-01

Abstract The objective of this study was to examine the strengths and weaknesses of surgical units as compared with other units, and to provide an opportunity to improve patient safety culture in surgical settings by suggesting targeted actions using Hospital Survey on Patient Safety Culture (HSOPSC) investigation. A Hospital Survey on Patient Safety questionnaire was conducted to physicians and nurses in a tertiary hospital in Shandong China. 12 patient safety culture dimensions and 2 outcome variables were measured. A total of 23.5% of respondents came from surgical units, and 76.5% worked in other units. The “overall perceptions of safety” (48.1% vs 40.4%, P < 0.001) and “frequency of events reported” (63.7% vs 60.7%, P = 0.001) of surgical units were higher than those of other units. However, the communication openness (38.7% vs 42.5%, P < 0.001) of surgical units was lower than in other units. Medical workers in surgical units reported more events than those in other units, and more respondents in the surgical units assess “patient safety grade” to be good/excellent. Three dimensions were considered as strengths, whereas 5 other dimensions were considered to be weaknesses in surgical units. Six dimensions have potential to aid in improving events reporting and patient safety grade. Appropriate working times will also contribute to ensuring patient safety. Medical staff with longer years of experience reported more events. Surgical units outperform the nonsurgical ones in overall perception of safety and the number of events reported but underperform in the openness of communication. Four strategies, namely deepening the understanding about patient safety of supervisors, narrowing the communication gap within and across clinical units, recruiting more workers, and employing the event reporting system and building a nonpunitive culture, are recommended to improve patient safety in surgical units in the context of 1 hospital. PMID:26166083

77 FR 39633 - Special Local Regulation and Safety Zones; Marine Events in Captain of the Port Sector Long...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-05

... displays and swim events. This action is necessary to provide for the safety of life on navigable waters... order to provide for the safety of life on navigable waterways during regattas, fireworks displays and... the following events: Davis Park Fireworks, Charles W. Morgan Anniversary Fireworks and Waves of Hope...

Safety Culture and Senior Leadership Behavior: Using Negative Safety Ratings to Align Clinical Staff and Senior Leadership.

PubMed

O'Connor, Shawn; Carlson, Elizabeth

2016-04-01

This report describes how staff-designed behavior changes among senior leaders can have a positive impact on clinical nursing staff and enhance the culture of safety in a community hospital. A positive culture of safety in a hospital improves outcomes for patients and staff. Senior leaders are accountable for developing an environment that supports a culture of safety. At 1 community hospital, surveys demonstrated that staff members did not view senior leaders as supportive of or competent in creating a culture of safety. After approval from the hospital's institutional review board was obtained, clinical nurses generated and selected ideas for senior leader behavior change. The new behaviors were assessed by a convenience sample survey of clinical nurses. In addition, culture of safety survey results were compared. Risk reports and harm events were also measured before and after behavior changes. The volume of risk and near-miss reports increased, showing that clinical staff were more inclined to report events after senior leader communication, access, and visibility increased. Harm events went down. The culture of safety survey demonstrated an improvement in the senior leadership domain in 4 of 6 units. The anonymous convenience survey demonstrated that staff members recognized changes that senior leaders had made and felt that these changes positively impacted the culture of safety. By developing skills in communication, advocacy, visibility, and access, senior leaders can enhance a hospital's culture of safety and create stronger ties with clinical staff.

Workplace Violence and Perceptions of Safety Among Emergency Department Staff Members: Experiences, Expectations, Tolerance, Reporting, and Recommendations.

PubMed

Copeland, Darcy; Henry, Melissa

Workplace violence (WPV) is a widely recognized problem in emergency departments (EDs). The majority of WPV studies do not include nonclinical staff and do not address expectations of violence, tolerance to violence, or perceptions of safety. Among a multidisciplinary sample of ED staff members, specific study aims were to (a) describe exposure to WPV; (b) describe perceptions of safety, tolerance to violence, and expectation of violence; (c) describe reporting behaviors and perceived barriers to reporting violence; (d) examine relationships between demographic variables, experiences of violence, tolerance to violence, perceptions of safety, and reporting behaviors; and (e) identify perceptions of viable interventions to improve workplace safety. A cross-sectional design was used to survey ED staff members in a Level 1 Shock Trauma center. Eleven disciplines were represented in 147 completed surveys; 88% of respondents reported exposure to WPV in the previous 6 months. Members of every discipline reported exposure to WPV; 98% of the sample felt safe at work and 64% felt violence was an expected part of the job. Most violence was not reported, primarily because "nobody was hurt." Emergency department staff members expected and experienced violence; nevertheless, there was a widespread perception of safety. Perceptions of safety and reasons for not reporting did not mirror previous findings. The WPV exposure is not isolated to clinical staff members and occurs even when prevention strategies are in place. The definition of WPV and the individual's interpretation of the event might preclude reporting.

Transportation Safety Information Report : 1982 Annual Summary

DOT National Transportation Integrated Search

1983-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data for transportation fatalities, accidents, and injuries f...

Transportation Safety Information Report : 1987 Annual Summary

DOT National Transportation Integrated Search

1988-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data for transportation fatalities, accidents, and injuries f...

[Current movements of four serious adverse events induced by medicinal drugs based on spontaneous reports in Japan].

PubMed

Sudo, Chie; Azuma, Yu-ichiro; Maekawa, Keiko; Kaniwa, Nahoko; Sai, Kimie; Saito, Yoshiro

2011-01-01

Spontaneous reports on suspected serious adverse events caused by medicines from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated by the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety features. Although causal relationship between the medicine and the adverse event is not evaluated, and one incidence may be redundantly reported, this information would be useful to roughly grasp the current movements of drug-related serious adverse events, We searched open-source data of the spontaneous reports publicized by Pharmaceutical and Medical Devices Agency for 4 serious adverse events (interstitial lung disease, rhabdomyolysis, anaphylaxis, and Stevens-Johnson syndrome/toxic epidermal necrolysis) from 2004 to 2010 fiscal year (for 2010, from April 1 st to January 31th). Major drug-classes suspected to the adverse events were antineoplastics for interstitial lung disease, hyperlipidemia agents and psychotropics for rhabdomyolysis, antibiotics/chemotherapeutics, antineoplastics and intracorporeal diagnostic agents for anaphylaxis (anaphylactic shock, anaphylactic reactions, anaphylactoid shock and anaphylactoid reactions), and antibiotics/chemotherapeutics, antipyretics and analgesics, anti-inflammatory agents/common cold drugs, and antiepileptics for Stevens-Johnson syndrome/toxic epidermal necrolysis. These results would help understanding of current situations of the 4 drug-related serious adverse events in Japan.

78 FR 13576 - Special Local Regulations and Safety Zones; Recurring Marine Events and Fireworks Displays Within...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-28

... area April--2nd Saturday St. Mary's College Seahawk Specified waters of St. Mary's Sprint River... regulations by adding 15 new annual recurring marine events, fireworks displays and revising event date(s) and... provide for the safety of life on navigable waters during these events, reduce the Coast Guard's...

Building a time-saving and adaptable tool to report adverse drug events.

PubMed

Parès, Yves; Declerck, Gunnar; Hussain, Sajjad; Ng, Romain; Jaulent, Marie-Christine

2013-01-01

The difficult task of detecting adverse drug events (ADEs) and the tedious process of building manual reports of ADE occurrences out of patient profiles result in a majority of adverse reactions not being reported to health regulatory authorities. The SALUS individual case safety report (ICSR) reporting tool, a component currently developed within the SALUS project, aims to support semi-automatic reporting of ADEs to regulatory authorities. In this paper, we present an initial design and current state of of our ICSR reporting tool that features: (i) automatic pre-population of reporting forms through extraction of the patient data contained in an Electronic Health Record (EHR); (ii) generation and electronic submission of the completed ICSRs by the physician to regulatory authorities; and (iii) integration of the reporting process into the physician's work-flow to limit the disturbance. The objective is to increase the rates of ADE reporting and the quality of the reported data. The SALUS interoperability platform supports patient data extraction independently of the EHR data model in use and allows generation of reports using the format expected by regulatory authorities.

Can Natural Language Processing Improve the Efficiency of Vaccine Adverse Event Report Review?

PubMed

Baer, B; Nguyen, M; Woo, E J; Winiecki, S; Scott, J; Martin, D; Botsis, T; Ball, R

2016-01-01

Individual case review of spontaneous adverse event (AE) reports remains a cornerstone of medical product safety surveillance for industry and regulators. Previously we developed the Vaccine Adverse Event Text Miner (VaeTM) to offer automated information extraction and potentially accelerate the evaluation of large volumes of unstructured data and facilitate signal detection. To assess how the information extraction performed by VaeTM impacts the accuracy of a medical expert's review of the vaccine adverse event report. The "outcome of interest" (diagnosis, cause of death, second level diagnosis), "onset time," and "alternative explanations" (drug, medical and family history) for the adverse event were extracted from 1000 reports from the Vaccine Adverse Event Reporting System (VAERS) using the VaeTM system. We compared the human interpretation, by medical experts, of the VaeTM extracted data with their interpretation of the traditional full text reports for these three variables. Two experienced clinicians alternately reviewed text miner output and full text. A third clinician scored the match rate using a predefined algorithm; the proportion of matches and 95% confidence intervals (CI) were calculated. Review time per report was analyzed. Proportion of matches between the interpretation of the VaeTM extracted data, compared to the interpretation of the full text: 93% for outcome of interest (95% CI: 91-94%) and 78% for alternative explanation (95% CI: 75-81%). Extracted data on the time to onset was used in 14% of cases and was a match in 54% (95% CI: 46-63%) of those cases. When supported by structured time data from reports, the match for time to onset was 79% (95% CI: 76-81%). The extracted text averaged 136 (74%) fewer words, resulting in a mean reduction in review time of 50 (58%) seconds per report. Despite a 74% reduction in words, the clinical conclusion from VaeTM extracted data agreed with the full text in 93% and 78% of reports for the outcome of

Transportation Safety Information Report : Second Quarter 1984

DOT National Transportation Integrated Search

1984-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

Transportation Safety Information Report : Second Quarter 1985

DOT National Transportation Integrated Search

1985-10-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

Consumer perceptions of safety in hospitals

PubMed Central

Evans, Sue M; Berry, Jesia G; Smith, Brian J; Esterman, Adrian J

2006-01-01

Background Studies investigating adverse events have traditionally been principally undertaken from a medical perspective. The impact that experience of an adverse event has on consumer confidence in health care is largely unknown. The objectives of the study were to seek public opinion on 1) the rate and severity of adverse events experienced in hospitals; and 2) the perception of safety in hospitals, so that predictors of lack of safety could be identified. Methods A multistage, clustered survey of persons residing in South Australia (2001), using household interviews (weighted n = 2,884). Results A total of 67% of respondents aged over forty years reported having at least one member of their household hospitalised in the past five years; with the average being two hospital admissions in five years. Respondents stated that 7.0% (95%CI: 6.2% to 7.9%) of those hospital admissions were associated with an adverse event; 59.7% of respondents (95% CI: 51.4% to 67.5%) rated the adverse event as really serious and 48.5% (95% CI: 40.4% to 56.8%) stated prolonged hospitalisation was required as a consequence of the adverse event. Perception of safety in hospitals was largely affected by the experience of an adverse event; really serious events were the most significant predictor of lack of safety in those aged 40 years and over (RR 2.38; p<0.001). Conclusion The experience of adverse events negatively impacted on public confidence in hospitals. The consumer-reported adverse event rate in hospitals (7.0%) is similar to that identified using medical record review. Based on estimates from other studies, self-reported claims of adverse events in hospital by consumers appear credible, and should be considered when developing appropriate treatment regimes. PMID:16504067

Consumer perceptions of safety in hospitals.

PubMed

Evans, Sue M; Berry, Jesia G; Smith, Brian J; Esterman, Adrian J

2006-02-22

Studies investigating adverse events have traditionally been principally undertaken from a medical perspective. The impact that experience of an adverse event has on consumer confidence in health care is largely unknown. The objectives of the study were to seek public opinion on 1) the rate and severity of adverse events experienced in hospitals; and 2) the perception of safety in hospitals, so that predictors of lack of safety could be identified. A multistage, clustered survey of persons residing in South Australia (2001), using household interviews (weighted n = 2,884). A total of 67% of respondents aged over forty years reported having at least one member of their household hospitalised in the past five years; with the average being two hospital admissions in five years. Respondents stated that 7.0% (95%CI: 6.2% to 7.9%) of those hospital admissions were associated with an adverse event; 59.7% of respondents (95% CI: 51.4% to 67.5%) rated the adverse event as really serious and 48.5% (95% CI: 40.4% to 56.8%) stated prolonged hospitalisation was required as a consequence of the adverse event. Perception of safety in hospitals was largely affected by the experience of an adverse event; really serious events were the most significant predictor of lack of safety in those aged 40 years and over (RR 2.38; p<0.001). The experience of adverse events negatively impacted on public confidence in hospitals. The consumer-reported adverse event rate in hospitals (7.0%) is similar to that identified using medical record review. Based on estimates from other studies, self-reported claims of adverse events in hospital by consumers appear credible, and should be considered when developing appropriate treatment regimes.

10 CFR 37.81 - Reporting of events.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Reporting of events. 37.81 Section 37.81 Energy NUCLEAR REGULATORY COMMISSION PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL Physical Protection in Transit § 37.81 Reporting of events. (a) The shipping licensee shall notify the...

Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system.

PubMed

Raschi, Emanuel; Poluzzi, Elisabetta; Koci, Ariola; Salvo, Francesco; Pariente, Antoine; Biselli, Maurizio; Moretti, Ugo; Moore, Nicholas; De Ponti, Fabrizio

2015-08-01

We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the publicly available US-FDA adverse event reporting system (FAERS). We extracted reports of drug-induced liver injury (DILI) associated with NOACs, including acute liver failure (ALF) events. Based on US marketing authorizations, we performed disproportionality analyses, calculating reporting odds ratios (RORs) with 95% confidence interval (CI), also to test for event- and drug-related competition bias, and case-by-case evaluation for concomitant medications. DILI reports represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. No statistically significant association was found for dabigatran, in primary and secondary analyses. Disproportionality signals emerged for rivaroxaban in primary analysis (ALF: n = 25, ROR = 2.08, 95% CI 1.34, 3.08). In a large proportion of DILI reports concomitant hepatotoxic and/or interacting drugs were recorded: 42% and 37% (rivaroxaban and dabigatran, respectively), especially statins, paracetamol and amiodarone. Among ALF reports, fatal outcome occurred in 49% of cases (44% and 51%, rivaroxaban and dabigatran, respectively), whereas rapid onset of the event (<1 week) was detected in 46% of patients (47% and 44%, respectively). The disproportionality signal for rivaroxaban calls for further comparative population-based studies to characterize and quantify the actual DILI risk of NOACs, taking into account drug- and patient-related risk factors. As DILI is unpredictable, our findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals of DILI through FAERS and other data sources, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of NOACs when they diagnose a liver injury. © 2015 The British Pharmacological Society.

Hospital staff should use more than one method to detect adverse events and potential adverse events: incident reporting, pharmacist surveillance and local real‐time record review may all have a place

PubMed Central

Olsen, Sisse; Neale, Graham; Schwab, Kat; Psaila, Beth; Patel, Tejal; Chapman, E Jane; Vincent, Charles

2007-01-01

Background Over the past five years, in most hospitals in England and Wales, incident reporting has become well established but it remains unclear how well reports match clinical adverse events. International epidemiological studies of adverse events are based on retrospective, multi‐hospital case record review. In this paper the authors describe the use of incident reporting, pharmacist surveillance and local real‐time record review for the recognition of clinical risks associated with hospital inpatient care. Methodology Data on adverse events were collected prospectively on 288 patients discharged from adult acute medical and surgical units in an NHS district general hospital using incident reports, active surveillance of prescription charts by pharmacists and record review at time of discharge. Results Record review detected 26 adverse events (AEs) and 40 potential adverse events (PAEs) occurring during the index admission. In contrast, in the same patient group, incident reporting detected 11 PAEs and no AEs. Pharmacy surveillance found 10 medication errors all of which were PAEs. There was little overlap in the nature of events detected by the three methods. Conclusion The findings suggest that incident reporting does not provide an adequate assessment of clinical adverse events and that this method needs to be supplemented with other more systematic forms of data collection. Structured record review, carried out by clinicians, provides an important component of an integrated approach to identifying risk in the context of developing a safety and quality improvement programme. PMID:17301203

78 FR 22778 - Safety Zone; Corp. Event Finale UHC, St. Thomas Harbor; St. Thomas, U.S.V.I.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

...-AA00 Safety Zone; Corp. Event Finale UHC, St. Thomas Harbor; St. Thomas, U.S.V.I. AGENCY: Coast Guard... waters of St. Thomas Harbor in St. Thomas, U.S. Virgin Islands during the Corp. Event Finale UHC, a... barge being positioned near the St. Thomas Harbor channel from which fireworks will be lit. The safety...

Assessment of patient safety culture in Palestinian public hospitals.

PubMed

Hamdan, Motasem; Saleem, Abed Alra'oof

2013-04-01

To assess the prevalent patient safety culture in Palestinian public hospitals. A cross-sectional design, Arabic translated version of the Hospital Survey on Patient Safety Culture was used. All the 11 general public hospitals in the West Bank. A total of 1460 clinical and non-clinical hospital staff. No. Twelve patient safety culture composites and 2 outcome variables (patient safety grade and events reported in the past year) were measured. Most of the participants were nurses and physicians (69.2%) with direct contact with patients (92%), mainly employed in medical/surgical units (55.1%). The patient safety composites with the highest positive scores were teamwork within units (71%), organizational learning and continuous improvement (62%) and supervisor/manager expectations and actions promoting patient safety (56%). The composites with the lowest scores were non-punitive response to error (17%), frequency of events reported (35%), communication openness (36%), hospital management support for patient safety (37%) and staffing (38%). Although 53.2% of the respondents did not report any event in the past year, 63.5% rated patient safety level as 'excellent/very good'. Significant differences in patient safety scores and outcome variables were found between hospitals of different size and in relation to staff positions and work hours. This study highlights the existence of a punitive and blame culture, under-reporting of events, lack of communication openness and inadequate management support that are key challenges for patient safe hospital care. The baseline survey results are valuable for designing and implementing the patient safety program and for measuring future progress.

Automatic signal extraction, prioritizing and filtering approaches in detecting post-marketing cardiovascular events associated with targeted cancer drugs from the FDA Adverse Event Reporting System (FAERS).

PubMed

Xu, Rong; Wang, Quanqiu

2014-02-01

Targeted drugs dramatically improve the treatment outcomes in cancer patients; however, these innovative drugs are often associated with unexpectedly high cardiovascular toxicity. Currently, cardiovascular safety represents both a challenging issue for drug developers, regulators, researchers, and clinicians and a concern for patients. While FDA drug labels have captured many of these events, spontaneous reporting systems are a main source for post-marketing drug safety surveillance in 'real-world' (outside of clinical trials) cancer patients. In this study, we present approaches to extracting, prioritizing, filtering, and confirming cardiovascular events associated with targeted cancer drugs from the FDA Adverse Event Reporting System (FAERS). The dataset includes records of 4,285,097 patients from FAERS. We first extracted drug-cardiovascular event (drug-CV) pairs from FAERS through named entity recognition and mapping processes. We then compared six ranking algorithms in prioritizing true positive signals among extracted pairs using known drug-CV pairs derived from FDA drug labels. We also developed three filtering algorithms to further improve precision. Finally, we manually validated extracted drug-CV pairs using 21 million published MEDLINE records. We extracted a total of 11,173 drug-CV pairs from FAERS. We showed that ranking by frequency is significantly more effective than by the five standard signal detection methods (246% improvement in precision for top-ranked pairs). The filtering algorithm we developed further improved overall precision by 91.3%. By manual curation using literature evidence, we show that about 51.9% of the 617 drug-CV pairs that appeared in both FAERS and MEDLINE sentences are true positives. In addition, 80.6% of these positive pairs have not been captured by FDA drug labeling. The unique drug-CV association dataset that we created based on FAERS could facilitate our understanding and prediction of cardiotoxic events associated with

Telemedicine to promote patient safety: Use of phone-based interactive voice response system (IVRS) to reduce adverse safety events in predialysis CKD

PubMed Central

Weiner, Shoshana; Fink, Jeffery C.

2017-01-01

Chronic kidney disease (CKD) patients have several features conferring upon them a high risk of adverse safety events, which are defined as incidents with unintended harm related to processes of care or medications. These characteristics include impaired renal function, polypharmacy, and frequent health system encounters. The consequences of such events in CKD can include new or prolonged hospitalization, accelerated renal function loss, acute kidney injury, end-stage renal disease and death. Health information technology administered via telemedicine presents opportunities for CKD patients to remotely communicate safety-related findings to providers for the purpose of improving their care. However, many CKD patients have limitations which hinder their use of telemedicine and access to the broad capabilities of health information technology. In this review we summarize previous assessments of the pre-dialysis CKD populations’ proficiency in using telemedicine modalities and describe the use of interactive voice-response system (IVRS) to gauge the safety phenotype of the CKD patient. We discuss the potential for expanded IVRS use in CKD to address the safety threats inherent to this population. PMID:28224940

Safety of saxagliptin: events of special interest in 9156 patients with type 2 diabetes mellitus.

PubMed

Hirshberg, Boaz; Parker, Artist; Edelberg, Helen; Donovan, Mark; Iqbal, Nayyar

2014-10-01

A post hoc pooled analysis was undertaken to evaluate the safety of saxagliptin in patients with type 2 diabetes mellitus, with attention to events of special interest for dipeptidyl peptidase-4 inhibitors. Pooled analyses were performed for 20 randomized controlled studies (N = 9156) of saxagliptin as monotherapy or add-on therapy, and a subset of 11 saxagliptin + metformin studies. Adverse events and events of special interest (gastrointestinal adverse events, infections, hypersensitivity, pancreatitis, skin lesions, lymphopenia, thrombocytopenia, hypoglycaemia, bone fracture, severe cutaneous adverse reactions, opportunistic infection, angioedema, malignancy, worsening renal function, and specific laboratory events) were assessed; incidence rates (events/100 person-years) and incidence rates ratios (saxagliptin/control) were calculated (Mantel-Haenszel method). In both pooled datasets, the incidence rates for deaths, serious adverse events, discontinuations due to adverse events, pancreatitis, malignancy, and most other events of special interest, excepting bone fractures and hypersensitivity, were similar between treatments, with 95% confidence intervals (CIs) for incidence rates ratios including 1. In the 20-study pool, the incidence rates per 100 person-years was higher with saxagliptin versus control for bone fractures [1.1 vs 0.6; incidence rates ratio (95% CI), 1.81 (1.04-3.28)] and hypersensitivity adverse events [1.3 vs 0.8; 1.67 (1.01-2.87)]. Pooled data from 20 studies confirm that saxagliptin has a favourable safety and benefit-risk profile. Copyright © 2013 John Wiley & Sons, Ltd.

Safety design approach for external events in Japan sodium-cooled fast reactor

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yamano, H.; Kubo, S.; Tani, A.

2012-07-01

This paper describes a safety design approach for external events in the design study of Japan sodium-cooled fast reactor. An emphasis is introduction of a design extension external condition (DEEC). In addition to seismic design, other external events such as tsunami, strong wind, abnormal temperature, etc. were addressed in this study. From a wide variety of external events consisting of natural hazards and human-induced ones, a screening method was developed in terms of siting, consequence, frequency to select representative events. Design approaches for these events were categorized on the probabilistic, statistical and deterministic basis. External hazard conditions were considered mainlymore » for DEECs. In the probabilistic approach, the DEECs of earthquake, tsunami and strong wind were defined as 1/10 of exceedance probability of the external design bases. The other representative DEECs were also defined based on statistical or deterministic approaches. (authors)« less

Undergraduate baccalaureate nursing students' self-reported confidence in learning about patient safety in the classroom and clinical settings: an annual cross-sectional study (2010-2013).

PubMed

Lukewich, Julia; Edge, Dana S; Tranmer, Joan; Raymond, June; Miron, Jennifer; Ginsburg, Liane; VanDenKerkhof, Elizabeth

2015-05-01

Given the increasing incidence of adverse events and medication errors in healthcare settings, a greater emphasis is being placed on the integration of patient safety competencies into health professional education. Nurses play an important role in preventing and minimizing harm in the healthcare setting. Although patient safety concepts are generally incorporated within many undergraduate nursing programs, the level of students' confidence in learning about patient safety remains unclear. Self-reported patient safety competence has been operationalized as confidence in learning about various dimensions of patient safety. The present study explores nursing students' self-reported confidence in learning about patient safety during their undergraduate baccalaureate nursing program. Cross-sectional study with a nested cohort component conducted annually from 2010 to 2013. Participants were recruited from one Canadian university with a four-year baccalaureate of nursing science program. All students enrolled in the program were eligible to participate. The Health Professional Education in Patient Safety Survey was administered annually. The Health Professional Education in Patient Safety Survey captures how the six dimensions of the Canadian Patient Safety Institute Safety Competencies Framework and broader patient safety issues are addressed in health professional education, as well as respondents' self-reported comfort in speaking up about patient safety issues. In general, nursing students were relatively confident in what they were learning about the clinical dimensions of patient safety, but they were less confident about the sociocultural aspects of patient safety. Confidence in what they were learning in the clinical setting about working in teams, managing adverse events and responding to adverse events declined in upper years. The majority of students did not feel comfortable speaking up about patient safety issues. The nested cohort analysis confirmed these

Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database.

PubMed

Chatterjee, Saurav; Herrmann, Howard C; Wilensky, Robert L; Hirshfeld, John; McCormick, Daniel; Frankel, David S; Yeh, Robert W; Armstrong, Ehrin J; Kumbhani, Dharam J; Giri, Jay

2015-07-01

The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. Data were abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE data set. Procedural adverse events and procedural success. In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures). In the FDA MAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA

Vaccine Safety

MedlinePlus

... Search Form Controls Cancel Submit Search The CDC Vaccine Safety Note: Javascript is disabled or is not ... CDC.gov . Recommend on Facebook Tweet Share Compartir Vaccine Adverse Events Reporting System (VAERS) New website and ...

To Report or Not to Report: Exploring Healthy Volunteers' Rationales for Disclosing Adverse Events in Phase I Drug Trials.

PubMed

McManus, Lisa; Fisher, Jill A

2018-04-25

Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants' self-reports of any symptoms they experience during the trial. In some cases, experiencing AEs can result in trial participation being terminated. Because of the economic incentives underlying their motivation to participate, there is concern that healthy volunteers routinely fail to report AEs and, thereby, jeopardize the validity of the trial results. We interviewed 131 U.S. healthy volunteers about their experiences with AEs, including their rationales for reporting or failing to report symptoms. We found that participants have three primary rationales for their AE reporting behavior: economic, health-oriented, and data integrity. Participants often make decisions about whether to report AEs on a case-by-case basis evaluating what effects reporting or not reporting might have on the compensation they receive from the trial, the risk to their health, and the results of the particular clinical trial. Participants' interpretations of clinic policies, staff behaviors, and personal or vicarious experiences with reporting AEs also shape reporting decisions. Our findings demonstrate that participants' reporting behavior is more complex than previous portraits of healthy volunteers have suggested. Rather than finding participants who were so focused on the financial compensation that they were willing to subvert trial results, our study indicates that participants are willing in most cases to forgo their full compensation if they believe not reporting their symptoms jeopardizes their own safety or the validity of the research.

77 FR 75559 - Safety Zone; Fireworks Event in Captain of the Port New York Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2012-1064] Safety Zone; Fireworks Event in Captain of the Port New York Zone AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce a safety zone in the Captain of the Port New...

77 FR 39413 - Safety Zone: Crescent City Fourth of July Fireworks Event, Crescent City, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

...-AA00 Safety Zone: Crescent City Fourth of July Fireworks Event, Crescent City, CA AGENCY: Coast Guard... the navigable waters near Crescent City Harbor in Crescent City, CA in support of the Crescent City... establish safety zones (33 U.S.C sections 1221 et seq.). Crescent City-Del Norte County Chamber of Commerce...

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan

Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

PubMed

Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

2018-04-01

Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

Do specialty registrars change their attitudes, intentions and behaviour towards reporting incidents following a patient safety course?

PubMed Central

2010-01-01

Background Reporting incidents can contribute to safer health care, as an awareness of the weaknesses of a system could be considered as a starting point for improvements. It is believed that patient safety education for specialty registrars could improve their attitudes, intentions and behaviour towards incident reporting. The objective of this study was to examine the effect of a two-day patient safety course on the attitudes, intentions and behaviour concerning the voluntary reporting of incidents by specialty registrars. Methods A patient safety course was designed to increase specialty registrars' knowledge, attitudes and skills in order to recognize and cope with unintended events and unsafe situations at an early stage. Data were collected through an 11-item questionnaire before, immediately after and six months after the course was given. Results The response rate at all three points in time assessed was 100% (n = 33). There were significant changes in incident reporting attitudes and intentions immediately after the course, as well as during follow-up. However, no significant changes were found in incident reporting behaviour. Conclusions It is shown that patient safety education can have long-term positive effects on attitudes towards reporting incidents and the intentions of registrars. However, further efforts need to be undertaken to induce a real change in behaviour. PMID:20416053

78 FR 41694 - Safety Zone; Fireworks Events in Captain of the Port New York Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-11

... Zone; Fireworks Events in Captain of the Port New York Zone AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce safety zones in the Captain of the Port New York Zone on the specified dates and times. This action is necessary to ensure the safety of vessels...

Visually impaired individuals, safety perceptions and traumatic events: a qualitative study of hazards, reactions and coping.

PubMed

Saur, Randi; Hansen, Marianne Bang; Jansen, Anne; Heir, Trond

2017-04-01

To explore the types of risks and hazards that visually impaired individuals face, how they manage potential threats and how reactions to traumatic events are manifested and coped with. Participants were 17 visually impaired individuals who had experienced some kind of potentially traumatic event. Two focus groups and 13 individual interviews were conducted. The participants experienced a variety of hazards and potential threats in their daily life. Fear of daily accidents was more pronounced than fear of disasters. Some participants reported avoiding help-seeking in unsafe situations due to shame at not being able to cope. The ability to be independent was highlighted. Traumatic events were re-experienced through a variety of sense modalities. Fear of labelling and avoidance of potential risks were recurring topics, and the risks of social withdrawal and isolation were addressed. Visual impairment causes a need for predictability and adequate information to increase and prepare for coping and self-efficacy. The results from this study call for greater emphasis on universal design in order to ensure safety and predictability. Fear of being labelled may inhibit people from using assistive devices and adequate coping strategies and seeking professional help in the aftermath of a trauma. Implications for Rehabilitation Visual impairment entails a greater susceptibility to a variety of hazards and potential threats in daily life. This calls for a greater emphasis on universal design in public spaces to ensure confidence and safety. Visual impairment implies a need for predictability and adequate information to prepare for coping and self-efficacy. Rehabilitation professionals should be aware of the need for independence and self-reliance, the possible fear of labelling, avoidance of help-seeking or reluctance to use assistive devices. In rehabilitation after accidents or potential traumatizing events, professionals' knowledge about the needs for information, training

77 FR 22706 - Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-17

...] Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA AGENCY: Coast... regulation and temporary safety zone proposed for those portions of the ``America's Cup World Series,'' the ``Louis Vuitton Cup'' challenger selection series, and the ``America's Cup Finals Match'' sailing regattas...

Consistency of Reporting for Stressful Life Events Among Nondeployed Soldiers.

PubMed

Pless Kaiser, Anica; Proctor, Susan P; Vasterling, Jennifer J

2016-10-01

Measurement of stress exposure is central to understanding military mental health outcomes. Although temporal stability of combat event reporting has been examined, less is known about the stability of reporting for noncombat events in military samples. Objectives are to examine consistency in reporting stressful life events in nondeployed U.S. Army soldiers and its association with posttraumatic stress disorder (PTSD) symptomatology. Examined reporting consistency over approximately 8 months among 466 soldiers. Regression models examined factors associated with decreased, increased, and stable reporting. Stability of the number of events endorsed over time was high. However, item-level agreement was slight to moderate (kappas: .13-.54), with inconsistencies due primarily to decreased reporting. After adjusting for covariates and initial PTSD, second assessment PTSD was associated with increased and stable reporting. Inconsistent reporting extends beyond combat events to other stressful life events in military personnel and is associated with PTSD. © 2016 Wiley Periodicals, Inc.

78 FR 57482 - Safety Zone; Fireworks Event in Captain of the Port New York Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-19

... York Zone on the specified date and time. This action is necessary to ensure the safety of vessels and... regulation for the safety zone described in 33 CFR 165.160 will be enforced on the date and time listed in... Zone; Fireworks Event in Captain of the Port New York Zone AGENCY: Coast Guard, DHS. ACTION: Notice of...

77 FR 59551 - Safety Zone; Fireworks Event in Captain of the Port New York Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

... Zone; Fireworks Event in Captain of the Port New York Zone AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce a safety zone in the Captain of the Port New York Zone on the specified date and time. This action is necessary to ensure the safety of vessels and...

78 FR 40961 - Safety Zones; Annual Events in the Captain of the Port Detroit Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... events: (1) Bay-Rama Fishfly Festival Fireworks, New Baltimore, MI. The safety zone listed in 33 CFR 165... Festival Fireworks, Lexington, MI. The safety zone listed in 33 CFR 165.941(a)(42) will be enforced from 10.... until 11:00 p.m. on July 20, 2013. (14) Detroit International Jazz Festival Fireworks, Detroit, MI. The...

10 CFR 35.3045 - Report and notification of a medical event.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Report and notification of a medical event. 35.3045... Report and notification of a medical event. (a) A licensee shall report any event, except for an event... migrated outside the treatment site). (b) A licensee shall report any event resulting from intervention of...

10 CFR 35.3045 - Report and notification of a medical event.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Report and notification of a medical event. 35.3045... Report and notification of a medical event. (a) A licensee shall report any event, except for an event... migrated outside the treatment site). (b) A licensee shall report any event resulting from intervention of...

Fusion Safety Program annual report, fiscal year 1994

NASA Astrophysics Data System (ADS)

Longhurst, Glen R.; Cadwallader, Lee C.; Dolan, Thomas J.; Herring, J. Stephen; McCarthy, Kathryn A.; Merrill, Brad J.; Motloch, Chester C.; Petti, David A.

1995-03-01

This report summarizes the major activities of the Fusion Safety Program in fiscal year 1994. The Idaho National Engineering Laboratory (INEL) is the designated lead laboratory and Lockheed Idaho Technologies Company is the prime contractor for this program. The Fusion Safety Program was initiated in 1979. Activities are conducted at the INEL, at other DOE laboratories, and at other institutions, including the University of Wisconsin. The technical areas covered in this report include tritium safety, beryllium safety, chemical reactions and activation product release, safety aspects of fusion magnet systems, plasma disruptions, risk assessment failure rate data base development, and thermalhydraulics code development and their application to fusion safety issues. Much of this work has been done in support of the International Thermonuclear Experimental Reactor (ITER). Also included in the report are summaries of the safety and environmental studies performed by the Fusion Safety Program for the Tokamak Physics Experiment and the Tokamak Fusion Test Reactor and of the technical support for commercial fusion facility conceptual design studies. A major activity this year has been work to develop a DOE Technical Standard for the safety of fusion test facilities.

76 FR 53337 - Special Local Regulation and Safety Zones; Marine Events in Captain of the Port Long Island Sound...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

... action is necessary to provide for the safety of life on navigable waters during the events. Entry into... Waves of Hope Swim, Stonewall Swim, Hartford Dragon Boat Races and Kayak for a Cause have hundreds of... safety of life during this year's event. For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard...

76 FR 37646 - Safety Zone; Northern California Annual Fireworks Events, Fourth of July Fireworks, City of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-28

... Zone; Northern California Annual Fireworks Events, Fourth of July Fireworks, City of Sausalito... Guard will enforce the Fourth of July Fireworks, City of Sausalito annual safety zone. This action is... through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM). DATES: The...

The business case for patient safety.

PubMed

Hwang, Raymond W; Herndon, James H

2007-04-01

Recent trends have focused attention on improving patient safety in the United States healthcare system. Lapses in patient safety create undue, often preventable, morbidity. These include adverse drug events, adverse surgical events and nosocomial infections. From an organizational perspective, these events are both inefficient and expensive. Many safe practices and quality enhancing improvements, such as computer provider order entry, proper infection surveillance, telemedicine intensive care, and registered nurse staffing are in fact cost-effective. However, in order to fully achieve higher quality, better adverse event reporting and a culture of safety must first be developed. Increased provider recognition, models of success, public awareness and consumer demand are propelling improvements. As we will outline in this review of the current literature, the business case for patient safety is a compelling one, offering substantial economic incentives for achieving the necessary goal of improved patient outcomes.

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

PubMed

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

The architecture of safety: hospital design.

PubMed

Joseph, Anjali; Rashid, Mahbub

2007-12-01

This paper reviews recent research literature reporting the effects of hospital design on patient safety. Features of hospital design that are linked to patient safety in the literature include noise, air quality, lighting conditions, patient room design, unit layout, and several other interior design features. Some of these features act as latent conditions for adverse events, and impact safety outcomes directly and indirectly by impacting staff working conditions. Others act as barriers to adverse events by providing hospital staff with opportunities for preventing accidents before they occur. Although the evidence linking hospital design to patient safety is growing, much is left to be done in this area of research. Nevertheless, the evidence reported in the literature may already be sufficient to have a positive impact on hospital design.

Perceived safety and controllability of events: Markers of risk for marijuana use in young adults?

PubMed

Sartor, Carolyn E; Ecker, Anthony H; Kraus, Shane W; Leeman, Robert F; Dukes, Kristin N; Foster, Dawn W

2017-03-01

Drawing on constructs from the trauma literature, the current study evaluated perceptions of safety and controllability of events as potential markers of risk for marijuana use. In addition, we characterized these perceptions in relation to individual level substance abuse risk factors (marijuana expectancies, impulsivity, depression, and anxiety), gender, and race. Data were collected via web survey from college students at two northeastern universities (n=228, 82.0% female). Controllability of events (CE) was rated significantly higher by Blacks than Whites. Safety/vulnerability (SV) and CE were associated with impulsivity, depression, and anxiety. CE was also associated with marijuana expectancies. Logistic regression analyses revealed a modest but significant association between SV and lifetime use even after adjusting for race, gender, age, and individual level substance abuse risk factors (odds ratio=1.10, 95% confidence intervals:1.02-1.18). No association between SV and past 3month frequency of use or between CE and either marijuana outcome was found. Findings support a link between perceptions of safety and ever using marijuana. They further demonstrate overlap of both perceived safety and controllability of events with substance use related risk factors, and suggest that they differ by race. Additional studies that assess substance use more broadly and query trauma history, using larger, more diverse samples, are needed to more fully grasp the relevance of these constructs to substance use, including their potential as targets for substance abuse prevention efforts. Copyright © 2016 Elsevier Ltd. All rights reserved.

Acute Kidney Injury and Bisphosphonate Use in Cancer: A Report From the Research on Adverse Drug Events and Reports (RADAR) Project

PubMed Central

Edwards, Beatrice J.; Usmani, Sarah; Raisch, Dennis W.; McKoy, June M.; Samaras, Athena T.; Belknap, Steven M.; Trifilio, Steven M.; Hahr, Allison; Bunta, Andrew D.; Abu-Alfa, Ali; Langman, Craig B.; Rosen, Steve T.; West, Dennis P.

2013-01-01

Purpose: To determine whether acute kidney injury (AKI) is identified within the US Food and Drug Administration's Adverse Events and Reporting System (FDA AERS) as an adverse event resulting from bisphosphonate (BP) use in cancer therapy. Methods: A search of the FDA AERS records from January 1998 through June 2009 was performed; search terms were “renal problems” and all drug names for BPs. The search resulted in 2,091 reports. We analyzed for signals of disproportional association by calculating the proportional reporting ratio for zoledronic acid (ZOL) and pamidronate. Literature review of BP-associated renal injury within the cancer setting was conducted. Results: Four hundred eighty cases of BP-associated acute kidney injury (AKI) were identified in patients with cancer. Two hundred ninety-eight patients (56%) were female; mean age was 66 ± 10 years. Multiple myeloma (n = 220, 46%), breast cancer (n = 98, 20%), and prostate cancer (n = 24, 5%) were identified. Agents included ZOL (n = 411, 87.5%), pamidronate (n = 8, 17%), and alendronate (n = 36, 2%). Outcomes included hospitalization (n = 304, 63.3%) and death (n = 68, 14%). The proportional reporting ratio for ZOL was 1.22 (95% CI, 1.13 to 1.32) and for pamidronate was 1.55 (95% CI, 1.25 to 1.65), reflecting a nonsignificant safety signal for both drugs. Conclusion: AKI was identified in BP cancer clinical trials, although a safety signal for BPs and AKI within the FDA AERS was not detected. Our findings may be attributed, in part, to clinicians who believe that AKI occurs infrequently; ascribe the AKI to underlying premorbid disease, therapy, or cancer progression; or consider that AKI is a known adverse drug reaction of BPs and thus under-report AKI to the AERS. PMID:23814519

75 FR 52465 - Safety Zones; Swim Events Within the Sector New York Captain of the Port Zone

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-26

...-AA00 Safety Zones; Swim Events Within the Sector New York Captain of the Port Zone AGENCY: Coast Guard... zones for swim events occurring on waters of the Hudson River, East River and Long Island Sound. These... with the swim events. Persons and vessels are prohibited from entering into, transiting through, or...

77 FR 73311 - Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-10

...-AA00; 1625-AA08 Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco... the 2013 America's Cup events. This document corrects those erroneous coordinates. DATES: Effective on... published a temporary final rule regulating the on-water activities associated with the ``Louis Vuitton Cup...

Occupational Safety Review of High Technology Facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee Cadwallader

2005-01-31

This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

Examining Wrong Eye Implant Adverse Events in the Veterans Health Administration With a Focus on Prevention: A Preliminary Report.

PubMed

Neily, Julia; Chomsky, Amy; Orcutt, James; Paull, Douglas E; Mills, Peter D; Gilbert, Christina; Hemphill, Robin R; Gunnar, William

2018-03-01

The study goals were to examine wrong intraocular lens (IOL) implant adverse events in the Veterans Health Administration (VHA), identify root causes and contributing factors, and describe system changes that have been implemented to address this challenge. This study represents collaboration between the VHA's National Center for Patient Safety (NCPS) and the National Surgery Office (NSO). This report includes 45 wrong IOL implant surgery adverse events reported to established VHA NCPS and NSO databases between July 1, 2006, and June 31, 2014. There are approximately 50,000 eye implant procedures performed each year in the VHA. Wrong IOL implant surgery adverse events are reported by VHA facilities to the NCPS and the NSO. Two authors (A.C. and J.N.) coded the reports for event type (wrong lens or expired lens) and identified the primary contributing factor (coefficient κ = 0.837). A descriptive analysis was conducted, which included the reported yearly event rate. The main outcome measure was the reported wrong IOL implant surgery adverse events. There were 45 reported wrong IOL implant surgery adverse events. Between 2011 and June 30, 2014, there was a significant downward trend (P = 0.02, R = 99.7%) at a pace of -0.08 (per 10,000 cases) every year. The most frequently coded primary contributing factor was incomplete preprocedure time-out (n = 12) followed by failure to perform double check of preprocedural calculations based upon original data and implant read-back at the time the surgical eye implant was performed (n = 10). Preventing wrong IOL implant adverse events requires diligence beyond performance of the preprocedural time-out. In 2013, the VHA has modified policy to ensure double check of preprocedural calculations and implant read-back with positive impact. Continued analysis of contributing human factors and improved surgical team communication are warranted.

Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database

PubMed Central

Park, Kyounghoon; Soukavong, Mick; Kim, Jungmee; Kwon, Kyoung-eun; Jin, Xue-mei; Lee, Joongyub; Yang, Bo Ram

2017-01-01

Purpose To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). Materials and Methods We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries. Results There were 807582 spontaneous AEs reports in the KIDS-KD. Among those, the number of antibiotics related AEs was 192510; 3382 reports were associated with imipenem. The most common imipenem-associated AE was the drug eruption; 353 times. We calculated the signal by comparing with all other antibiotics and drugs; 58 and 53 signals satisfied the three methods. We compared the drug labelling information of nine countries, including the USA, the UK, Japan, Italy, Switzerland, Germany, France, Canada, and South Korea, and discovered that the following signals were currently not included in drug labels: hypokalemia, cardiac arrest, cardiac failure, Parkinson's syndrome, myocardial infarction, and prostate enlargement. Hypokalemia was an additional signal compared with all other antibiotics, and the other signals were not different compared with all other antibiotics and all other drugs. Conclusion We detected new signals that were not listed on the drug labels of nine countries. However, further pharmacoepidemiologic research is needed to evaluate the causality of these signals. PMID:28332362

Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database.

PubMed

Park, Kyounghoon; Soukavong, Mick; Kim, Jungmee; Kwon, Kyoung Eun; Jin, Xue Mei; Lee, Joongyub; Yang, Bo Ram; Park, Byung Joo

2017-05-01

To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries. There were 807582 spontaneous AEs reports in the KIDS-KD. Among those, the number of antibiotics related AEs was 192510; 3382 reports were associated with imipenem. The most common imipenem-associated AE was the drug eruption; 353 times. We calculated the signal by comparing with all other antibiotics and drugs; 58 and 53 signals satisfied the three methods. We compared the drug labelling information of nine countries, including the USA, the UK, Japan, Italy, Switzerland, Germany, France, Canada, and South Korea, and discovered that the following signals were currently not included in drug labels: hypokalemia, cardiac arrest, cardiac failure, Parkinson's syndrome, myocardial infarction, and prostate enlargement. Hypokalemia was an additional signal compared with all other antibiotics, and the other signals were not different compared with all other antibiotics and all other drugs. We detected new signals that were not listed on the drug labels of nine countries. However, further pharmacoepidemiologic research is needed to evaluate the causality of these signals. © Copyright: Yonsei University College of Medicine 2017

Adverse drug events and the Freedom of Information Act: an apple in Eden.

PubMed

Stang, P E; Fox, J L

1992-02-01

To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports. The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions. The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.

Cardiovascular safety of linagliptin in type 2 diabetes: a comprehensive patient-level pooled analysis of prospectively adjudicated cardiovascular events.

PubMed

Rosenstock, Julio; Marx, Nikolaus; Neubacher, Dietmar; Seck, Thomas; Patel, Sanjay; Woerle, Hans-Juergen; Johansen, Odd Erik

2015-05-21

The cardiovascular (CV) safety of linagliptin was evaluated in subjects with type 2 diabetes (T2DM). Pre-specified patient-level pooled analysis of all available double-blind, randomized, controlled trials, ≥ 12 weeks' duration (19 trials, 9459 subjects) of linagliptin versus placebo/active treatment. Primary end point: composite of prospectively adjudicated CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina (4P-MACE). Hospitalization for congestive heart failure (CHF) was also evaluated; adjudication of CHF was introduced during the phase 3 program (8 trials; 3314 subjects). 4P-MACE was assessed in placebo-controlled trials (subgroup of 18 trials; 7746 subjects). Investigator-reported events suggestive of CHF from 24 placebo-controlled trials (including trials <12 weeks' duration, 8778 subjects) were also analyzed. 5847 patients received linagliptin (5 mg: 5687, 10 mg: 160) and 3612 comparator (glimepiride: 775, voglibose: 162, placebo: 2675); cumulative exposure, 4421.3 and 3254.7 patient-years, respectively. 4P-MACE incidence rates: 13.4 per 1000 patient-years, linagliptin (60 events), 18.9, total comparators (62 events); overall hazard ratio (HR), 0.78 (95% confidence interval [CI], 0.55-1.12). HR for adjudicated hospitalization for CHF (n = 21): 1.04 (0.43-2.47). For placebo-controlled trials, 4P-MACE incidence rates: 14.9 per 1000 patient-years, linagliptin (43 events), 16.4, total comparators (29 events); overall HR, 1.09 (95% CI, 0.68-1.75). Occurrence of investigator-reported events suggestive of CHF was low for linagliptin- (26 events, 0.5%; serious: 16 events, 0.3%) and placebo-treated (8 events, 0.2%; serious: 6 events, 0.2%) patients. Linagliptin is not associated with increased CV risk versus pooled active comparators or placebo in patients with T2DM.

77 FR 46285 - Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-03

...] Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA AGENCY: Coast... 2012 program calendar for the on-water activities associated with the ``2012 America's Cup World Series... waters of San Francisco Bay associated with the 34th America's Cup sailing events taking place adjacent...

The development of an incident event reporting system for nursing students.

PubMed

Chiou, Shwu-Fen; Huang, Ean-Wen; Chuang, Jen-Hsiang

2009-01-01

Incident events may occur when nursing students are present in the clinical setting. Their inexperience and unfamiliarity with clinical practice put them at risk for making mistakes that could potentially harm patients and themselves. However, there are deficiencies with incident event reporting systems, including incomplete data and delayed reports. The purpose of this study was to develop an incident event reporting system for nursing students in clinical settings and evaluate its effectiveness. This study was undertaken in three phases. In the first phase, a literature review and focus groups were used to develop the architecture of the reporting system. In the second phase, the reporting system was implemented. Data from incident events that involved nursing students were collected for a 12-month period. In the third phase, a pre-post trial was undertaken to evaluate the performance of the reporting system. The ASP.NET software and Microsoft Access 2003 were used to create an interactive web-based interface and design a database for the reporting system. Email notifications alerted the nursing student's teacher when an incident event was reported. One year after installing the reporting system, the number of reported incident events increased tenfold. However, the time to report the incident event and the time required to complete the reporting procedures were shorter than before implementation of the reporting system. The incident event reporting system appeared to be effective in more comprehensively reporting the number of incident events and shorten the time required for reporting them compared to traditional written reports.

Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008-2012.

PubMed

Hibbs, Beth F; Miller, Elaine; Shi, Jing; Smith, Kamesha; Lewis, Paige; Shimabukuro, Tom T

2018-01-25

Vaccines should be stored and handled according to manufacturer specifications. Inadequate cold chain management can affect potency; but, limited data exist on adverse events (AE) following administration of vaccines kept outside of recommended temperatures. To describe reports to the Vaccine Adverse Event Reporting System (VAERS) involving vaccines inappropriately stored outside of recommended temperatures and/or exposed to temperatures outside of manufacturer specifications for inappropriate amounts of time. We searched the VAERS database (analytic period 2008-2012) for reports describing vaccines kept outside of recommended temperatures. We analyzed reports by vaccine type, length outside of recommended temperature and type of temperature excursion, AE following receipt of potentially compromised vaccine, and reasons for cold chain breakdown. We identified 476 reports of vaccines kept outside of recommended temperatures; 77% described cluster incidents involving multiple patients. The most commonly reported vaccines were quadrivalent human papillomavirus (n = 146, 30%), 23-valent pneumococcal polysaccharide (n = 51, 11%), and measles, mumps, and rubella (n = 45, 9%). Length of time vaccines were kept outside of recommended temperatures ranged from 15 mins to 6 months (median 51 h). Most (n = 458, 96%) reports involved patients who were administered potentially compromised vaccines; AE were reported in 32 (7%), with local reactions (n = 21) most frequent. Two reports described multiple patients contracting diseases they were vaccinated against, indicating possible influenza vaccine failure. Lack of vigilance, inadequate training, and equipment failure were reasons cited for cold chain management breakdowns. Our review does not indicate any substantial direct health risk from administration of vaccines kept outside of recommended temperatures. However, there are potential costs and risks, including vaccine wastage, possible decreased

Safety of railroad passenger vehicle dynamics : final summary report

DOT National Transportation Integrated Search

2002-07-01

This report is a summary of all the work done by Foster-Miller on the passenger rail vehicle dynamic safety under the contract awarded by the FRA. The report presents key issues and findings in the safety assessments and a safety assessment methodolo...

78 FR 32990 - Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-03

...] Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA AGENCY: Coast... ``Louis Vuitton Cup, Red Bull Youth America's Cup and the 34th America's Cup'' regatta scheduled from July... associated with the 34th America's Cup sailing events taking place adjacent to the City of San Francisco...

Improving the safety of vaccine delivery.

PubMed

Evans, Huw P; Cooper, Alison; Williams, Huw; Carson-Stevens, Andrew

2016-05-03

Vaccines save millions of lives per annum as an integral part of community primary care provision worldwide. Adverse events due to the vaccine delivery process outnumber those arising from the pharmacological properties of the vaccines themselves. Whilst one in three patients receiving a vaccine will encounter some form of error, little is known about their underlying causes and how to mitigate them in practice. Patient safety incident reporting systems and adverse drug event surveillance offer a rich opportunity for understanding the underlying causes of those errors. Reducing harm relies on the identification and implementation of changes to improve vaccine safety at multiple levels: from patient interventions through to organizational actions at local, national and international levels. Here we highlight the potential for maximizing learning from patient safety incident reports to improve the quality and safety of vaccine delivery.

Safety awareness, pilot education, and incident reporting programs

NASA Technical Reports Server (NTRS)

Enders, J.

1984-01-01

Education in safety awareness, pilot training, and accident reporting is discussed. Safety awareness and risk management are examined. Both quantitative and qualitive risk management are explored. Information dissemination on safety is considered.

Reconciling Horse Welfare, Worker Safety, and Public Expectations: Horse Event Incident Management Systems in Australia

PubMed Central

Fiedler, Julie M.; McGreevy, Paul D.

2016-01-01

Simple Summary Although often highly rewarding, human-horse interactions can also be dangerous. Using examples from equine and other contexts, this article acknowledges the growing public awareness of animal welfare, work underway towards safer equestrian workplaces, and the potential for adapting large animal rescue skills for the purposes of horse event incident management. Additionally, we identity the need for further research into communication strategies that address animal welfare and safety issues that arise when humans and horses interact in the workplace. Abstract Human-horse interactions have a rich tradition and can be highly rewarding, particularly within sport and recreation pursuits, but they can also be dangerous or even life-threatening. In parallel, sport and recreation pursuits involving animals, including horses, are facing an increased level of public scrutiny in relation to the use of animals for these purposes. However, the challenge lies with event organisers to reconcile the expectations of the public, the need to meet legal requirements to reduce or eliminate risks to paid and volunteer workers, and address horse welfare. In this article we explore incident management at horse events as an example of a situation where volunteers and horses can be placed at risk during a rescue. We introduce large animal rescue skills as a solution to improving worker safety and improving horse welfare outcomes. Whilst there are government and horse industry initiatives to improve safety and address animal welfare, there remains a pressing need to invest in a strong communication plan which will improve the safety of workplaces in which humans and horses interact. PMID:26927189

Logistic Regression Likelihood Ratio Test Analysis for Detecting Signals of Adverse Events in Post-market Safety Surveillance.

PubMed

Nam, Kijoeng; Henderson, Nicholas C; Rohan, Patricia; Woo, Emily Jane; Russek-Cohen, Estelle

2017-01-01

The Vaccine Adverse Event Reporting System (VAERS) and other product surveillance systems compile reports of product-associated adverse events (AEs), and these reports may include a wide range of information including age, gender, and concomitant vaccines. Controlling for possible confounding variables such as these is an important task when utilizing surveillance systems to monitor post-market product safety. A common method for handling possible confounders is to compare observed product-AE combinations with adjusted baseline frequencies where the adjustments are made by stratifying on observable characteristics. Though approaches such as these have proven to be useful, in this article we propose a more flexible logistic regression approach which allows for covariates of all types rather than relying solely on stratification. Indeed, a main advantage of our approach is that the general regression framework provides flexibility to incorporate additional information such as demographic factors and concomitant vaccines. As part of our covariate-adjusted method, we outline a procedure for signal detection that accounts for multiple comparisons and controls the overall Type 1 error rate. To demonstrate the effectiveness of our approach, we illustrate our method with an example involving febrile convulsion, and we further evaluate its performance in a series of simulation studies.

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

2017-09-01

Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected P<0.01. A total of 27,150 events with lamotrigine, 13,950 events with carbamazepine, and 5077 events with oxcarbazepine were reported, with generics accounting for 27%, 41%, and 32% of reports, respectively. Although RORs for the majority of known AEs were different between brand and generics for all three drugs of interest (Breslow-Day P<0.001), RORs generally were similar for AG and generic comparisons. Generic lamotrigine and carbamazepine were more commonly involved in reports of suicide or suicidal ideation compared with the respective AGs based on a multiple comparison-adjusted P<0.01. Similar AED reporting rates were observed for the AG and generic comparisons for most outcomes and drugs, suggesting that brands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B

The role of adverse events and related safety data in the pre-market evaluation of drug abuse potential.

PubMed

Mansbach, Robert S; Schoedel, Kerri A; Kittrelle, Jeffrey P; Sellers, Edward M

2010-12-01

The scientific and regulatory assessment of abuse and dependence potential of drugs involves a multi-layered evaluation of its properties related to chemistry, formulation, pharmacology, animal behavior and clinical response. In addition to the primary laboratory-based assessment in experienced drug users, data are also reviewed from studies in healthy volunteers and in the patient population. Much of the emphasis in these latter studies is placed on adverse events that are reported by the subject or observed by the investigator. Unlike other aspects of abuse potential assessment, the evaluation of abuse- and dependence-related events has not been the subject of scholarly research. The present commentary presents recommendations for several areas that would benefit from a consensus review to result in greater standardization for the analysis and presentation of abuse- and dependence-related data from clinical trials. These include special investigator training, a system of weighted primary and secondary terms, adjudication of individual events, case report management, organization of integrated safety data, and protocols for drug accountability. Such an effort would aid in implementing the evolving efforts of health authorities to guide drug developers in the collection and presentation of data needed for the regulation of drugs with the potential for abuse and dependence. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Overview of Energy Systems' safety analysis report programs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility's safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This Overview of Energy Systems Safety Analysis Report Programs'' Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Serenoa repens (saw palmetto): a systematic review of adverse events.

PubMed

Agbabiaka, Taofikat B; Pittler, Max H; Wider, Barbara; Ernst, Edzard

2009-01-01

Serenoa repens (W. Bartram) Small, also known as saw palmetto, is one of the most widely used herbal preparations for the treatment of lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Although a number of randomized controlled trials (RCTs) and systematic reviews of the efficacy of S. repens for the treatment of LUTS and BPH have been published, no systematic review on its drug interactions or adverse events currently exists. This review assesses all available human safety data of S. repens monopreparations. Systematic literature searches were conducted from date of inception to February 2008 in five electronic databases; reference lists and our departmental files were checked for further relevant publications. Information was requested from spontaneous reporting schemes of the WHO and national safety bodies. Twenty-four manufacturers/distributors of S. repens preparations and four herbalist organizations were contacted for additional information. No language restrictions were imposed. Only reports of adverse events in humans from monopreparations of S. repens were included. Data from all articles, regardless of study design, reporting adverse events or interactions were independently extracted by the first author and validated by the second. Forty articles (26 randomized controlled trials, 4 non-randomized controlled trials, 6 uncontrolled trials and 4 case reports/series) were included. They suggest that adverse events associated with the use of S. repens are mild and similar to those with placebo. The most frequently reported adverse events are abdominal pain, diarrhoea, nausea, fatigue, headache, decreased libido and rhinitis. More serious adverse events such as death and cerebral haemorrhage are reported in isolated case reports and data from spontaneous reporting schemes, but causality is questionable. No drug interactions were reported. Currently available data suggest that S. repens is well tolerated by most users and is not

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1976-01-01

During the second quarter of the Aviation Safety Reporting System (ASRS) operation, 1,497 reports were received from pilots, controllers, and others in the national aviation system. Details of the administration and results of the program to date are presented. Examples of alert bulletins disseminated to the aviation community are presented together with responses to those bulletins. Several reports received by ASRS are also presented to illustrate the diversity of topics covered by reports to the system.

Roy's safety-first portfolio principle in financial risk management of disastrous events.

PubMed

Chiu, Mei Choi; Wong, Hoi Ying; Li, Duan

2012-11-01

Roy pioneers the concept and practice of risk management of disastrous events via his safety-first principle for portfolio selection. More specifically, his safety-first principle advocates an optimal portfolio strategy generated from minimizing the disaster probability, while subject to the budget constraint and the mean constraint that the expected final wealth is not less than a preselected disaster level. This article studies the dynamic safety-first principle in continuous time and its application in asset and liability management. We reveal that the distortion resulting from dropping the mean constraint, as a common practice to approximate the original Roy's setting, either leads to a trivial case or changes the problem nature completely to a target-reaching problem, which produces a highly leveraged trading strategy. Recognizing the ill-posed nature of the corresponding Lagrangian method when retaining the mean constraint, we invoke a wisdom observed from a limited funding-level regulation of pension funds and modify the original safety-first formulation accordingly by imposing an upper bound on the funding level. This model revision enables us to solve completely the safety-first asset-liability problem by a martingale approach and to derive an optimal policy that follows faithfully the spirit of the safety-first principle and demonstrates a prominent nature of fighting for the best and preventing disaster from happening. © 2012 Society for Risk Analysis.

Cultivating quality: implementing standardized reporting and safety checklists.

PubMed

Stevens, James D; Bader, Mary Kay; Luna, Michele A; Johnson, Linda M

2011-05-01

Developing processes to create a culture of safety. It's estimated that as many as 98,000 hospitalized patients lose their lives each year in the United States because of medical errors that could have been prevented. While standardized reporting and safety checklists have been shown to improve communication and patient safety, implementation of these tools in hospitals remains challenging. To implement standardized nurse-to-nurse reporting along with safety checklists at Mission Hospital, a 522-bed facility in Mission Viejo, California, using Lewin's change theory and Knowles's adult learning theory. Nurses were tested to assess their knowledge of the standardized nurse-to-physician reporting method called SBAR (Situation, Background, Assessment, Recommendation), their understanding of the concept of the nurse-to-nurse reporting method called SBAP (Situation, Background, Assessment, Plan), and the use of safety checklists. Then, after viewing a 22-minute educational video, they were retested. A total of 482 nurses completed the pretest and posttest. On the pretest, the nurses' mean score was 15.935 points (SD, 3.529) out of 20. On the posttest, the mean score was 18.94 (SD, 1.53) out of 20. A Wilcoxon matched-pairs signed-rank test was performed; the two-tailed P value was < 0.001. The application of Lewin's change theory and Knowles's adult learning theory was successful in the process of implementing standardized nurse-to-nurse reporting and safety checklists at Mission Hospital.

Effect of an anonymous reporting system on near-miss and harmful medical error reporting in a pediatric intensive care unit.

PubMed

Grant, Mary Jo C; Larsen, Gitte Y

2007-01-01

Adverse event reporting is a key element for improving patient safety. This study describes a new voluntary, anonymous reporting system that facilitates reporting of near-miss and patient harm events and an assessment of patient harm by the bedside care provider in a pediatric intensive care unit. The results demonstrated the effectiveness of the Patient Safety Report as a method to capture near-miss and patient harm events.

Sky Event Reporting Metadata (VOEvent) Version 2.0

NASA Technical Reports Server (NTRS)

Seaman, Rob; Williams, Roy; Allan, Alasdair; Barthelmy, Scott; Bloom, Joshua S.; Brewer, John M.; Denny, Robert B.; Fitzpatrick, Mike; Graham, Matthew; Gray, Norman;

A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes.

PubMed

Hoffman, Keith B; Dimbil, Mo; Kyle, Robert F; Tatonetti, Nicholas P; Erdman, Colin B; Demakas, Andrea; Chen, Dingguo; Overstreet, Brian M

2015-12-01

Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there is an acute need for the development of analytics that reflect drug safety in heterogeneous, real-world populations. To develop a drug safety statistic that estimates downstream medical costs associated with serious adverse events (AEs) and unfavorable patient outcomes associated with the use of 706 FDA-approved drugs. All primary suspect case reports for each drug were collected from the FDA's Adverse Event Reporting System database (FAERS) from 2010-2014. The Medical Dictionary for Regulatory Activities (MedDRA) was used to code serious AEs and outcomes, which were tallied for each case report. Medical costs associated with AEs and poor patient outcomes were derived from Agency for Healthcare Research and Quality (AHRQ) survey data, and their corresponding ICD-9-CM codes were mapped to MedDRA terms. Nonserious AEs and outcomes were not included. For each case report, either the highest AE cost or, if no eligible AE was listed, the highest outcome cost was used. All costed cases were aggregated for each drug and divided by the number of patients exposed to obtain a downstream estimated direct medical cost burden per exposure. Each drug was assigned a corresponding 1-100 point total. The 706 drugs showed an exponential distribution of downstream costs, and the data were transformed using the natural log to approximate a normal distribution. The minimum score was 8.29, and the maximum score was 99.25, with a mean of 44.32. Drugs with the highest individual scores tended to be kinase inhibitors, thalidomide analogs, and endothelin receptor antagonists. When scores were analyzed across Established Pharmacologic Class (EPC), the kinase inhibitor and endothelin receptor antagonist classes had the highest total. However

Selected control events and reporting odds ratio in signal detection methodology.

PubMed

Ooba, Nobuhiro; Kubota, Kiyoshi

2010-11-01

To know whether the reporting odds ratio (ROR) using "control events" can detect signals hidden behind striking reports on one or more particular events. We used data of 956 drug use investigations (DUIs) conducted between 1970 and 1998 in Japan and domestic spontaneous reports (SRs) between 1998 and 2008. The event terms in DUIs were converted to the preferred terms in Medical Dictionary for Regulatory Activities (MedDRA). We calculated the incidence proportion for various events and selected 20 "control events" with a relatively constant incidence proportion across DUIs and also reported regularly to the spontaneous reporting system. A "signal" was generated for the drug-event combination when the lower limit of 95% confidence interval of the ROR exceeded 1. We also compared the ROR in SRs with the RR in DUIs. The "control events" accounted for 18.2% of all reports. The ROR using "control events" may detect some hidden signals for a drug with the proportion of "control events" lower than the average. The median of the ratios of the ROR using "control events" to RR was around the unity indicating that "control events" roughly represented the exposure distribution though the range of the ratios was so diverse that the individual ROR might not be regarded as the estimate of RR. The use of the ROR with "control events" may give an adjunctive to the traditional signal detection methods to find a signal hidden behind some major events. Copyright © 2010 John Wiley & Sons, Ltd.

Avation Safety Reporting System (ASRS) 40th Anniversary

NASA Image and Video Library

2016-09-28

Avation Safety Reporting System (ASRS) 40th Anniversary lunch and open house at the Sunnyvale office. Thomas A Edwards, Deputy Center Director NASA Ames (Left), presents a plaque On the anniversary of the aviation safety reporting system, this award is in recognition of 18 years of outstanding leadership as Program Director, resulting in strong program growth, expanded partnership and a widely recognized impact on National and Global transportation safety. Presented to Linda J. Connell, ASRS Program Director (Right)

The NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

1983-01-01

This is the fourteenth in a series of reports based on safety-related incidents submitted to the NASA Aviation Safety Reporting System by pilots, controllers, and, occasionally, other participants in the National Aviation System (refs. 1-13). ASRS operates under a memorandum of agreement between the National Aviation and Space Administration and the Federal Aviation Administration. The report contains, first, a special study prepared by the ASRS Office Staff, of pilot- and controller-submitted reports related to the perceived operation of the ATC system since the 1981 walkout of the controllers' labor organization. Next is a research paper analyzing incidents occurring while single-pilot crews were conducting IFR flights. A third section presents a selection of Alert Bulletins issued by ASRS, with the responses they have elicited from FAA and others concerned. Finally, the report contains a list of publications produced by ASRS with instructions for obtaining them.

EMS helicopter incidents reported to the NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

Connell, Linda J.; Reynard, William D.

1993-01-01

The objectives of this evaluation were to: Identify the types of safety-related incidents reported to the Aviation Safety Reporting System (ASRS) in Emergency Medical Service (EMS) helicopter operations; Describe the operational conditions surrounding these incidents, such as weather, airspace, flight phase, time of day; and Assess the contribution to these incidents of selected human factors considerations, such as communication, distraction, time pressure, workload, and flight/duty impact.

Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection.

PubMed

Xu, Rong; Wang, QuanQiu

2014-01-15

Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance.

Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

PubMed Central

2014-01-01

Background Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. Results The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. Conclusions We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance. PMID:24428898

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting.

PubMed

Ward, Jane K; McEachan, Rosemary R C; Lawton, Rebecca; Armitage, Gerry; Watt, Ian; Wright, John

2011-05-27

Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS), and a patient incident reporting tool (PIRT) - to help the NHS prevent patient safety incidents by learning more about when and why they occur. To develop the PMOS 1) literature will be reviewed to identify similar measures and key contributory factors to error; 2) four patient focus groups will ascertain practicality and feasibility; 3) 25 patient interviews will elicit approximately 60 items across 10 domains; 4) 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis.To develop the PIRT 1) individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2) nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50) will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their priorities for patient safety. A patient

Cabin Safety Issues Related to Pre-Departure and Inflight Issues

NASA Technical Reports Server (NTRS)

Connell, Linda

2014-01-01

The Aviation Safety Reporting System (ASRS) in a partnership between the National Aeronautics and Space Administration (NASA), the Federal Aviation Administration (FAA), participating carriers, and labor organizations. It is designed to improve the National Airspace System by collecting and studying reports detailing unsafe conditions and events in the aviation industry. Employees are able to report safety issues or concerns with confidentiality and without fear of discipline. Safety reports highlighting the human element in cabin safety issues and concerns.

10 CFR 72.248 - Safety analysis report updating.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder...

Dynamic event tree analysis with the SAS4A/SASSYS-1 safety analysis code

DOE PAGES

Jankovsky, Zachary K.; Denman, Matthew R.; Aldemir, Tunc

2018-02-02

The consequences of a transient in an advanced sodium-cooled fast reactor are difficult to capture with the traditional approach to probabilistic risk assessment (PRA). Numerous safety-relevant systems are passive and may have operational states that cannot be represented by binary success or failure. In addition, the specific order and timing of events may be crucial which necessitates the use of dynamic PRA tools such as ADAPT. The modifications to the SAS4A/SASSYS-1 sodium-cooled fast reactor safety analysis code for linking it to ADAPT to perform a dynamic PRA are described. A test case is used to demonstrate the linking process andmore » to illustrate the type of insights that may be gained with this process. Finally, newly-developed dynamic importance measures are used to assess the significance of reactor parameters/constituents on calculated consequences of initiating events.« less

Dynamic event tree analysis with the SAS4A/SASSYS-1 safety analysis code

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jankovsky, Zachary K.; Denman, Matthew R.; Aldemir, Tunc

The consequences of a transient in an advanced sodium-cooled fast reactor are difficult to capture with the traditional approach to probabilistic risk assessment (PRA). Numerous safety-relevant systems are passive and may have operational states that cannot be represented by binary success or failure. In addition, the specific order and timing of events may be crucial which necessitates the use of dynamic PRA tools such as ADAPT. The modifications to the SAS4A/SASSYS-1 sodium-cooled fast reactor safety analysis code for linking it to ADAPT to perform a dynamic PRA are described. A test case is used to demonstrate the linking process andmore » to illustrate the type of insights that may be gained with this process. Finally, newly-developed dynamic importance measures are used to assess the significance of reactor parameters/constituents on calculated consequences of initiating events.« less

A multicenter, double-blind, safety study of QR-333 for the treatment of symptomatic diabetic peripheral neuropathy. A preliminary report.

PubMed

Valensi, Paul; Le Devehat, Claude; Richard, Jean-Louis; Farez, Cherifo; Khodabandehlou, Taraneh; Rosenbloom, Richard A; LeFante, Carolyn

2005-01-01

QR-333, a topical compound that contains quercetin, a flavonoid with aldose reductase inhibitor effects, ascorbyl palmitate, and vitamin D(3), was formulated to decrease the oxidative stress that contributes to peripheral diabetic neuropathy and thus alleviate its symptoms. This proof-of-principle study assessed the efficacy and safety of QR-333 against placebo in a small cohort of patients with diabetic neuropathy. This randomized, placebo-controlled, double-blind trial included 34 men and women (21-71 years of age) with Type 1 or 2 diabetes and diabetic neuropathy who applied QR-333 or placebo (2:1 ratio), three times daily for 4 weeks, to each foot where symptoms were experienced. Five-point scales were used to determine changes from baseline to endpoint in symptoms and quality of life (efficacy). Safety was assessed through concomitant medications, adverse events, laboratory evaluations, and physical examinations. QR-333 reduced the severity of numbness, jolting pain, and irritation from baseline values. Improvements were also seen in overall and specific quality-of-life measures. QR-333 was well tolerated. Eleven patients in the QR-333 group reported 23 adverse events (all mild or moderate); 4 in the placebo group reported 5 events (all moderate). One patient who applied QR-333 noted a pricking sensation twice, the only adverse event considered possibly related to study treatment. From this preliminary safety study, it appears that QR-333 may safely offer relief of symptoms of diabetic neuropathy and improve quality of life. These findings warrant further investigation of this topical compound.

76 FR 37646 - Safety Zone; Northern California Annual Fireworks Events, Fourth of July Fireworks, Lake Tahoe, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-28

... Zone; Northern California Annual Fireworks Events, Fourth of July Fireworks, Lake Tahoe, CA AGENCY... annual safety zone for the Fourth of July Fireworks, Lake Tahoe, California, located off Incline Village...,000 foot safety zone for the annual Fourth of July Fireworks Display in 33 CFR 165.1191 on July 4...

A novel briefing checklist at shift handoff in an emergency department improves situational awareness and safety event identification.

PubMed

Mullan, Paul C; Macias, Charles G; Hsu, Deborah; Alam, Sartaj; Patel, Binita

2015-04-01

Emergency department (ED) shift handoffs are sources of potential medical error, delays in care, and medicolegal liabilities. Few handoff studies exist in the ED literature. We aimed to describe the implementation of a standardized checklist for improving situational awareness during physician handoffs in a pediatric ED. This is a descriptive observational study in a large academic pediatric ED. Checklists were evaluated for rates of use, completion, and identification of potential safety events. We defined a complete checklist as 80% or more of items checked.  A user perception survey was used. After 1 year, all checklist users (residents, fellows, faculty, and charge nurses with ED experience before and after checklist implementation) were anonymously surveyed to assess the checklist's usability, perceived contributions to Institute of Medicine quality domains, and situational awareness. The electronically administered survey used Likert frequency scales. Of 732 handoffs, 98% used the checklist, and 89% were complete. A mean of 1.7 potential safety events were identified per handoff. The most frequent potential safety events were identification of intensive care unit-level patients in the ED (48%), equipment problems (46%), staffing issues (21%), and intensive care unit-level patients in transport (16%). Eighty-one subjects (88%) responded to the survey. The users agreed that the checklist promoted better communication, safety, efficiency, effective care, and situational awareness. The Physician Active Shift Signout in the Emergency Department briefing checklist was used often and at a high completion rate, frequently identifying potential safety events. The users found that it improved the quality of care and team communication. Future studies on outcomes and processes are needed.

Work Placements as Learning Environments for Patient Safety: Finnish and British Preregistration Nursing Students' Important Learning Events

ERIC Educational Resources Information Center

Tella, Susanna; Smith, Nancy-Jane; Partanen, Pirjo; Turunen, Hannele

2016-01-01

Learning to ensure patient safety in complex health care environments is an internationally recognised concern. This article explores and compares Finnish (n = 22) and British (n = 32) pre-registration nursing students' important learning events about patient safety from their work placements in health care organisations. Written descriptions were…

An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.

PubMed

Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne; Darsø, Perle; Christophersen, Anette Kvindebjerg; Borck, Bille; Christensen, Catrine; Hansen, Melissa Voigt; Halladin, Natalie Monica Løvland; Christensen, Mikkel Bring; Harboe, Kirstine Moll; Lund, Marie; Jimenez-Solem, Espen

2017-01-01

Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively. A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. none. not relevant. .

Safety analysis and review system (SARS) assessment report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Browne, E.T.

1981-03-01

Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

20 CFR 408.708 - What events must you report to us?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false What events must you report to us? 408.708... II VETERANS Reporting Requirements § 408.708 What events must you report to us? This section describes the events that you must report to us. They are— (a) A change of address or residence. You must...

20 CFR 408.708 - What events must you report to us?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false What events must you report to us? 408.708... II VETERANS Reporting Requirements § 408.708 What events must you report to us? This section describes the events that you must report to us. They are— (a) A change of address or residence. You must...

20 CFR 408.708 - What events must you report to us?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false What events must you report to us? 408.708... II VETERANS Reporting Requirements § 408.708 What events must you report to us? This section describes the events that you must report to us. They are— (a) A change of address or residence. You must...

20 CFR 408.708 - What events must you report to us?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false What events must you report to us? 408.708... II VETERANS Reporting Requirements § 408.708 What events must you report to us? This section describes the events that you must report to us. They are— (a) A change of address or residence. You must...

20 CFR 408.708 - What events must you report to us?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false What events must you report to us? 408.708... II VETERANS Reporting Requirements § 408.708 What events must you report to us? This section describes the events that you must report to us. They are— (a) A change of address or residence. You must...

14 CFR 91.25 - Aviation Safety Reporting Program: Prohibition against use of reports for enforcement purposes.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Aviation Safety Reporting Program... GENERAL OPERATING AND FLIGHT RULES General § 91.25 Aviation Safety Reporting Program: Prohibition against... to the National Aeronautics and Space Administration under the Aviation Safety Reporting Program (or...

Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013.

PubMed

Haber, Penina; Moro, Pedro L; McNeil, Michael M; Lewis, Paige; Woo, Emily Jane; Hughes, Hayley; Shimabukuro, Tom T

2014-11-12

Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults. We searched Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged ≥ 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season. During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n=207, 17%), headache (n=192, 16%), and fever (n=133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n=40, 39%), cardiovascular (n=14, 14%), and other non-infectious conditions (n=20, 19%). We noted a higher proportion of Guillain-Barré syndrome (GBS) and cardiovascular reports in the Department of Defense (DoD) population compared to the civilian population. Data mining detected disproportional reporting of ataxia (n=15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS. Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in the DoD population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications. Published by Elsevier Ltd.