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Sample records for adverse incident reporting

  1. Reasons for not reporting adverse incidents: an empirical study.

    PubMed

    Vincent, C; Stanhope, N; Crowley-Murphy, M

    1999-02-01

    A previous study (Stanhope et al. 1998) established that staff in two obstetric units reported less than a quarter of designated incidents to the units' risk managers. A questionnaire was administered to 42 obstetricians and 156 midwives at the same two obstetric units, exploring the reasons for low rates of reporting. Questions concerned their knowledge of their unit's incident reporting system; whether they would report a series of 10 designated adverse obstetric incidents to the risk manager; and their views on 12 potential reasons for not reporting incidents. Most staff knew about the incident-reporting system in their unit, but almost 30% did not know how to find a list of reportable incidents. Views on the necessity of reporting the 10 designated obstetric incidents varied considerably. For example, 96% of staff stated they would always report a maternal death, whereas less than 40% would report a baby's unexpected admission to the Special Care Baby Unit. Midwives said they were more likely to report incidents than doctors, and junior staff were more likely to report than senior staff. The main reasons for not reporting were fears that junior staff would be blamed, high workload and the belief (even though the incident was designated as reportable) that the circumstances or outcome of a particular case did not warrant a report. Junior doctors felt less supported by their colleagues than senior doctors. Current systems of incident reporting, while providing some valuable information, do not provide a reliable index of the rate of adverse incidents. Recommended measures to increase reliability include clearer definitions of incidents, simplified methods of reporting, designated staff to record incidents and education, feedback and reassurance to staff about the nature and purpose of such systems.

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

    PubMed Central

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

    2016-01-01

    BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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

  3. 40 CFR 159.184 - Toxic or adverse effect incident reports.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., respiratory, oral). (B) List signs/symptoms/adverse effects. (C) If laboratory tests were performed, list name... effect). (D) Route of exposure (e.g., skin, eye, respiratory, oral). (E) Time between exposure and onset... of systems supplied. (C) If finished water samples, water supply systems sampled. (D) If...

  4. Critical incident reporting systems.

    PubMed

    Ahluwalia, Jag; Marriott, Lin

    2005-02-01

    Approximately 10% of all hospital admissions are complicated by critical incidents in which harm is caused to the patient - this amounts to more than 850,000 incidents annually. Critical incident reporting (CIR) systems refer to the structured reporting, collation and analysis of such incidents. This article describes the attributes required for an effective CIR system. Example neonatal trigger events and a management pathway for handling a critical incident report are described. The benefits and limitations of CIR systems, reactive and prospective approaches to the analysis of actual or potential critical incidents and the assessment of risk are also reviewed. Individual human error is but one contributor in the majority of critical incidents. Recognition of this and the fostering of an organisational culture that views critical incident reports as an opportunity to learn and to improve future patient care is vital if CIR systems are to be effective.

  5. Contribution of patient and hospital characteristics to adverse patient incidents.

    PubMed Central

    Elnicki, R A; Schmitt, J P

    1980-01-01

    The 1974 medical malpractice "crisis" brought about extensive legislation and insurance regulation in the United States. Hospitals in many states are now required to support risk management programs that include investigation and systematic analyses of adverse patient incidents. However, no research supports the hypothesis that systematic analysis of adverse patient incidents can identify contributory factors. In this study, a simple prediction model was used to estimate relationships between adverse incidents and selected patient and environmental characteristics in a large hospital. While some of the incident-characteristic relationships were significant, none of the estimated equations yielded results that could be logically translated into policy recommendations for the hospital. These results point to the need for further research. The benefits that positive research results would have for patients, hospitals, an the bill-paying public are obvious. Additional negative results would suggest that many legislative bodies and regulatory agencies were presumptions in requiring hospitals to conduct analyses of incidents. PMID:7461973

  6. Incident analysis report

    SciTech Connect

    Gregg, D.W.; Buerer, A.; Leeds, S.

    1996-02-20

    This document presents information about a fire that occurred in January 1996 at Lawrence Livermore National Laboratory. This fire was caused by the spontaneous combustion of 100% fuming nitric acid. Topics discussed include: Summary of the incident; technical background; procedural background; supervision; previous incidents with 100% fuming nitric acid; and judgment of potential hazards.

  7. Increased incidence of adverse perinatal outcome with low maternal blood viscosity in preeclampsia.

    PubMed

    Pepple, D J; Mullings, A M; Reid, H L

    2004-01-01

    Hyperviscosity of the maternal blood has been reported to be associated with an increased incidence of adverse perinatal outcome in preeclampsia. We related the changes in maternal blood viscosity to perinatal outcome in 47 preeclamptic, nulliparous, black Jamaican women. A group of 49 non-preeclamptic, nulliparous, gestation-matched women acted as controls. Perinatal outcome was also compared between the women with high blood viscosity (> or = 5 mPa.s) and those with low blood viscosity (< 5 mPa.s) in both the preeclamptic and non-preeclamptic groups. Data was analysed by the comparison of two proportions, the chi-squared test, the Fisher's exact test and the Pearson's correlation method. The level of statistical significance was taken at p < 0.05. The incidence of adverse perinatal outcome was significantly (p < 0.001) higher in the preeclamptic women as compared with that of the non-preeclamptic controls. However, of interest, was the fact that within the preeclamptic group, the incidence of adverse perinatal outcome was significantly (p = 0.001, Fisher's exact test) higher in those with low blood viscosity as compared with those with high blood viscosity. These results suggest that low maternal blood viscosity may be related to increased incidence of adverse perinatal outcome in Jamaican women with preeclampsia.

  8. Safety incident reporting in emergency radiology: analysis of 1717 safety incident reports.

    PubMed

    Mansouri, Mohammad; Shaqdan, Khalid W; Aran, Shima; Raja, Ali S; Lev, Michael H; Abujudeh, Hani H

    2015-12-01

    The aim of this article is to describe the incidence and types of safety reports logged in the radiology safety incident reporting system in our emergency radiology section over an 8-year period. Electronic incident reporting system of our institute was searched for the variables in emergency radiology. All reports from April 2006 to June 2014 were included and deindentified. The following event classifications were investigated in radiography, CT, and MRI modalities: diagnostic test orders, ID/documentation/consent, safety/security/conduct, service coordination, surgery/procedure, line/tube, fall, medication/IV safety, employee general incident, environment/equipment, adverse drug reaction, skin/tissue, and diagnosis/treatment. A total of 881,194 emergency radiology examinations were performed during the study period, 1717 (1717/881,194 = 0.19 %) of which resulted in safety reports. Reports were classified into 14 different categories, the most frequent of which were "diagnostic test orders" (481/1717 = 28 % total incident reports), "medication/IV safety" (302/1717 = 18 % total incident reports), and "service coordination" (204/1717 = 12 % total incident reports). X-ray had the highest report rate (873/1717 = 50 % total incident reports), followed by CT (604/1717 = 35 % total incident reports) and MRI (240/1717 = 14 % total incident reports). Forty-six percent of safety incidents (789/1717) caused no harm and did not reach the patient, 36 % (617/1717) caused no harm but reached the patient, 18 % (308/1717) caused temporary or minor harm/ damage, and less than 1 % caused permanent or major harm/ damage or death. Our study shows an overall safety incident report rate of 0.19 % in emergency radiology including radiography, CT, and MRI modalities. The most common safety incidents were diagnostic test orders, medication/IV safety, and service coordination.

  9. Causal Factors and Adverse Conditions of Aviation Accidents and Incidents Related to Integrated Resilient Aircraft Control

    NASA Technical Reports Server (NTRS)

    Reveley, Mary S.; Briggs, Jeffrey L.; Evans, Joni K.; Sandifer, Carl E.; Jones, Sharon Monica

    2010-01-01

    The causal factors of accidents from the National Transportation Safety Board (NTSB) database and incidents from the Federal Aviation Administration (FAA) database associated with loss of control (LOC) were examined for four types of operations (i.e., Federal Aviation Regulation Part 121, Part 135 Scheduled, Part 135 Nonscheduled, and Part 91) for the years 1988 to 2004. In-flight LOC is a serious aviation problem. Well over half of the LOC accidents included at least one fatality (80 percent in Part 121), and roughly half of all aviation fatalities in the studied time period occurred in conjunction with LOC. An adverse events table was updated to provide focus to the technology validation strategy of the Integrated Resilient Aircraft Control (IRAC) Project. The table contains three types of adverse conditions: failure, damage, and upset. Thirteen different adverse condition subtypes were gleaned from the Aviation Safety Reporting System (ASRS), the FAA Accident and Incident database, and the NTSB database. The severity and frequency of the damage conditions, initial test conditions, and milestones references are also provided.

  10. Causal Factors and Adverse Events of Aviation Accidents and Incidents Related to Integrated Vehicle Health Management

    NASA Technical Reports Server (NTRS)

    Reveley, Mary S.; Briggs, Jeffrey L.; Evans, Joni K.; Jones, Sharon M.; Kurtoglu, Tolga; Leone, Karen M.; Sandifer, Carl E.

    2011-01-01

    Causal factors in aviation accidents and incidents related to system/component failure/malfunction (SCFM) were examined for Federal Aviation Regulation Parts 121 and 135 operations to establish future requirements for the NASA Aviation Safety Program s Integrated Vehicle Health Management (IVHM) Project. Data analyzed includes National Transportation Safety Board (NSTB) accident data (1988 to 2003), Federal Aviation Administration (FAA) incident data (1988 to 2003), and Aviation Safety Reporting System (ASRS) incident data (1993 to 2008). Failure modes and effects analyses were examined to identify possible modes of SCFM. A table of potential adverse conditions was developed to help evaluate IVHM research technologies. Tables present details of specific SCFM for the incidents and accidents. Of the 370 NTSB accidents affected by SCFM, 48 percent involved the engine or fuel system, and 31 percent involved landing gear or hydraulic failure and malfunctions. A total of 35 percent of all SCFM accidents were caused by improper maintenance. Of the 7732 FAA database incidents affected by SCFM, 33 percent involved landing gear or hydraulics, and 33 percent involved the engine and fuel system. The most frequent SCFM found in ASRS were turbine engine, pressurization system, hydraulic main system, flight management system/flight management computer, and engine. Because the IVHM Project does not address maintenance issues, and landing gear and hydraulic systems accidents are usually not fatal, the focus of research should be those SCFMs that occur in the engine/fuel and flight control/structures systems as well as power systems.

  11. Recognizing and reporting adverse drug reactions.

    PubMed Central

    Lucas, L. M.; Colley, C. A.

    1992-01-01

    Although physicians in practice are most likely to see patients with adverse drug reactions, they may fail to recognize an adverse effect or to attribute it to a drug effect and, when recognized, they may fail to report serious reactions to the US Food and Drug Administration (FDA). To recognize and attribute an adverse event to a drug effect, physicians should review the patient's clinical course, looking at patient risk factors, the known adverse reactions to the suspected drug, and the likelihood of a causal relationship between the drug and the adverse event-based on the temporal relationship, response to stopping or restarting the drug, and whether other factors could explain the reaction. Once an adverse drug reaction has been identified, the patient should be informed and appropriate documentation made in the patient's medical record. Serious known reactions and all reactions to newly released drugs or those not previously known to occur (even if the certainty is low) should be reported to the FDA. PMID:1536067

  12. INCIDENT REPORTING: LEARNING FROM EXPERIENCE

    SciTech Connect

    Weiner, Steven C.; Kinzey, Bruce R.; Dean, Jesse D.; Davis, Patrick B.; Ruiz, Antonio

    2007-09-12

    Experience makes a superior teacher. Sharing the details surrounding safety events is one of the best ways to help prevent their recurrence elsewhere. This approach requires an open, non-punitive environment to achieve broad benefits. The Hydrogen Incident Reporting Tool (www.h2incidents.org) is intended to facilitate the sharing of lessons learned and other relevant information gained from actual experiences using and working with hydrogen and hydrogen systems. Its intended audience includes those involved in virtually any aspect of hydrogen technology, systems and use, with an emphasis towards energy and transportation applications. The database contains records of safety events both publicly available and/or voluntarily submitted. Typical records contain a general description of the occurrence, contributing factors, equipment involved, and some detailing of consequences and changes that have been subsequently implemented to prevent recurrence of similar events in the future. The voluntary and confidential nature and other characteristics surrounding the database mean that any analysis of apparent trends in its contents cannot be considered statistically valid for a universal population. A large portion of reported incidents have occurred in a laboratory setting due to the typical background of the reporting projects, for example. Yet some interesting trends are becoming apparent even at this early stage of the database’s existence and general lessons can already be taken away from these experiences. This paper discusses the database and a few trends that have already become apparent for the reported incidents. Anticipated future uses of this information are also described. This paper is intended to encourage wider participation and usage of the incidents reporting database and to promote the safety benefits offered by its contents.

  13. [Analysis of Spontaneously Reported Adverse Events].

    PubMed

    Nakamura, Mitsuhiro

    2016-01-01

    Observational study is necessary for the evaluation of drug effectiveness in clinical practice. In recent years, the use of spontaneous reporting systems (SRS) for adverse drug reactions has increased and they have become an important resource for regulatory science. SRS, being the largest and most well-known databases worldwide, are one of the primary tools used for postmarketing surveillance and pharmacovigilance. To analyze SRS, the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report Database (JADER) are reviewed. Authorized pharmacovigilance algorithms were used for signal detection, including the reporting odds ratio. An SRS is a passive reporting database and is therefore subject to numerous sources of selection bias, including overreporting, underreporting, and a lack of a denominator. Despite the inherent limitations of spontaneous reporting, SRS databases are a rich resource and data mining index that provide powerful means of identifying potential associations between drugs and their adverse effects. Our results, which are based on the evaluation of SRS databases, provide essential knowledge that could improve our understanding of clinical issues.

  14. Consumer reporting of adverse events following immunization

    PubMed Central

    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. PMID:25483686

  15. Standardizing drug adverse event reporting data.

    PubMed

    Wang, Liwei; Jiang, Guoqian; Li, Dingcheng; Liu, Hongfang

    2013-01-01

    Normalizing data in the Adverse Event Reporting System (AERS), an FDA database, would improve the mining capacity of AERS for drug safety signal detection. In this study, we aim to normalize AERS and build a publicly available normalized Adverse drug events (ADE) data source.he drug information in AERS is normalized to RxNorm, a standard terminology source for medication. Drug class information is then obtained from the National Drug File - Reference Terminology (NDF-RT). Adverse drug events (ADE) are aggregated through mapping with the PT (Preferred Term) and SOC (System Organ Class) codes of MedDRA. Our study yields an aggregated knowledge-enhanced AERS data mining set (AERS-DM). The AERS-DM could provide more perspectives to mine AERS database for drug safety signal detection and could be used by research community in the data mining field.

  16. Incidence and types of preventable adverse events in elderly patients: population based review of medical records

    PubMed Central

    Thomas, Eric J; Brennan, Troyen A

    2000-01-01

    Objective To determine the incidence and types of preventable adverse events in elderly patients. Design Review of random sample of medical records in two stage process by nurses and physicians to detect adverse events. Two study investigators then judged preventability. Setting Hospitals in US states of Utah and Colorado, excluding psychiatric and Veterans Administration hospitals. Subjects 15 000 hospitalised patients discharged in 1992. Main outcome measures Incidence of preventable adverse events (number of preventable events per 100 discharges) in elderly patients (⩾65 years old) and non-elderly patients (16-64 years). Results When results were extrapolated to represent all discharges in 1992 in both states, non-elderly patients had 8901 adverse events (incidence 2.80% (SE 0.18%)) compared with 7419 (5.29% (0.37%)) among elderly patients (P=0.001). Non-elderly patients had 5038 preventable adverse events (incidence 1.58% (0.14%)) compared with 4134 (2.95% (0.28%)) in elderly patients (P=0.001). Elderly patients had a higher incidence of preventable events related to medical procedures (such as thoracentesis, cardiac catheterisation) (0.69% (0.14%) v 0.13% (0.04%)), preventable adverse drug events (0.63% (0.14%) v 0.17% (0.05%)), and preventable falls (0.10% (0.06%) v 0.01% (0.02%)). In multivariate analyses, adjusted for comorbid illnesses and case mix, age was not an independent predictor of preventable adverse events. Conclusions Preventable adverse events were more common among elderly patients, probably because of the clinical complexity of their care rather than age based discrimination. Preventable adverse drug events, events related to medical procedures, and falls were especially common in elderly patients and should be targets for efforts to prevent errors. PMID:10720355

  17. 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

  18. Age-related trends in injection site reaction incidence induced by the tumor necrosis factor-α (TNF-α) inhibitors etanercept and adalimumab: the Food and Drug Administration adverse event reporting system, 2004-2015

    PubMed Central

    Matsui, Toshinobu; Umetsu, Ryogo; Kato, Yamato; Hane, Yuuki; Sasaoka, Sayaka; Motooka, Yumi; Hatahira, Haruna; Abe, Junko; Fukuda, Akiho; Naganuma, Misa; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2017-01-01

    Tumor necrosis factor-α (TNF-α) inhibitors are increasingly being used as treatment for rheumatoid arthritis (RA). However, the administration of these drugs carries the risk of inducing injection site reaction (ISR). ISR gives rise to patient stress, nervousness, and a decrease in quality of life (QoL). In order to alleviate pain and other symptoms, early countermeasures must be taken against this adverse event. In order to improve understanding of the risk factors contributing to the induction of ISR, we evaluated the association between TNF-α inhibitors and ISR by applying a logistic regression model to age-stratified data obtained from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. The FAERS database contains 7,561,254 reports from January 2004 to December 2015. Adjusted reporting odds ratios (RORs) (95% Confidence Intervals) were obtained for interaction terms for age-stratified groups treated with etanercept (ETN) and adalimumab (ADA). The adjusted RORs for ETN* ≥ 70 and ADA* ≥ 70 groups were the lowest among the age-stratified groups undergoing the respective monotherapies. Furthermore, we found that crude RORs for ETN + methotrexate (MTX) combination therapy and ADA + MTX combination therapy were lower than those for the respective monotherapies. This study was the first to evaluate the relationship between aging and ISR using the FAERS database. PMID:28260984

  19. Multidisciplinary Treatments, Patient Characteristics, Context of Care, and Adverse Incidents in Older, Hospitalized Adults

    PubMed Central

    Shever, Leah L.; Titler, Marita G.

    2012-01-01

    The purpose of this study was to examine factors that contribute to adverse incidents by creating a model that included patient characteristics, clinical conditions, nursing unit context of care variables, medical treatments, pharmaceutical treatments, and nursing treatments. Data were abstracted from electronic, administrative, and clinical data repositories. The sample included older adults hospitalized during a four-year period at one, academic medical facility in the Midwestern United States who were at risk for falling. Relational databases were built and a multistep, statistical model building analytic process was used. Total registered nurse (RN) hours per patient day (HPPD) and HPPDs dropping below the nursing unit average were significant explanatory variables for experiencing an adverse incident. The number of medical and pharmaceutical treatments that a patient received during hospitalization as well as many specific nursing treatments (e.g., restraint use, neurological monitoring) were also contributors to experiencing an adverse incident. PMID:22530112

  20. [Nursing workload and occurrence of incidents and adverse events in ICU patients].

    PubMed

    Novaretti, Marcia Cristina Zago; Santos, Edzangela de Vasconcelos; Quitério, Ligia Maria; Daud-Gallotti, Renata Mahfuz

    2014-01-01

    This prospective cohort study aimed to identify the influence of nursing work overload on the occurrence of incidents without injury and adverse events in 399 patients hospitalized in Intensive Care Units (ICU). For data collection, a structured questionnaire was administered and an analysis of medical records was performed. In these admissions, approximately 78% of incidents without injury and adverse events in patients were related to the sphere of Nursing. These occurrences were attributed to overwork, increased the number of days of hospitalization and the risk of death of patients. It is essential that nursing managers work on the staff hospital management avoiding work overload to contribute for patient safety.

  1. Improving incident reporting among junior doctors

    PubMed Central

    Hotton, Emily; Jordan, Lesley; Peden, Carol

    2014-01-01

    To ensure systems in hospitals improve to make patient care safer, learning must occur when things go wrong. Incident reporting is one of the commonest mechanisms used to learn from harm events and near misses. Only a relatively small number of incidents that occur are actually reported and different groups of staff have different rates of reporting. Nationally, junior doctors are low reporters of incidents, a finding supported by our local data. We set out to explore the culture and awareness around incident reporting among our junior doctors, and to improve the incident reporting rate within this important staff group. In order to achieve this we undertook a number of work programmes focused on junior doctors, including: assessment of their knowledge, confidence and understanding of incident reporting, education on how and why to report incidents with a focus on reporting on clinical themes during a specific time period, and evaluation of the experience of those doctors who reported incidents. Junior doctors were asked to focus on incident reporting during a one week period. Before and after this focussed week, they were invited to complete a questionnaire exploring their confidence about what an incident was and how to report. Prior to “Incident Reporting Week”, on average only two reports were submitted a month by junior doctors compared with an average of 15 per month following the education and awareness week. This project highlights the fact that using a focussed reporting period and/or specific clinical themes as an education tool can benefit a hospital by promoting awareness of incidents and by increasing incident reporting rates. This can only assist in improving hospital systems, and ultimately increase patient safety. PMID:26734264

  2. Incident opioid drug use and adverse respiratory outcomes among older adults with COPD.

    PubMed

    Vozoris, Nicholas T; Wang, Xuesong; Fischer, Hadas D; Bell, Chaim M; O'Donnell, Denis E; Austin, Peter C; Stephenson, Anne L; Gill, Sudeep S; Rochon, Paula A

    2016-09-01

    We evaluated risk of adverse respiratory outcomes associated with incident opioid use among older adults with chronic obstructive pulmonary diseases (COPD).This was a retrospective population-based cohort study using a validated algorithm applied to health administrative data to identify adults aged 66 years and older with COPD. Inverse probability of treatment weighting using the propensity score was used to estimate hazard ratios comparing adverse respiratory outcomes within 30 days of incident opioid use compared to controls.Incident opioid use was associated with significantly increased emergency room visits for COPD or pneumonia (HR 1.14, 95% CI 1.00-1.29; p=0.04), COPD or pneumonia-related mortality (HR 2.16, 95% CI 1.61-2.88; p<0.0001) and all-cause mortality (HR 1.76, 95% CI 1.57-1.98; p<0.0001), but significantly decreased outpatient exacerbations (HR 0.88, 95% CI 0.83-0.94; p=0.0002). Use of more potent opioid-only agents was associated with significantly increased outpatient exacerbations, emergency room visits and hospitalisations for COPD or pneumonia, and COPD or pneumonia-related and all-cause mortality.Incident opioid use, and in particular use of the generally more potent opioid-only agents, was associated with increased risk for adverse respiratory outcomes, including respiratory-related mortality, among older adults with COPD. Potential adverse respiratory outcomes should be considered when prescribing new opioids in this population.

  3. Narrativizing errors of care: critical incident reporting in clinical practice.

    PubMed

    Iedema, Rick; Flabouris, Arthas; Grant, Susan; Jorm, Christine

    2006-01-01

    This paper considers the rise across acute care settings in the industrialized world of techniques that encourage clinicians to record their experiences about adverse events they are personally involved in; that is, to share narratives about errors, mishaps or 'critical incidents'. The paper proposes that critical incident reporting and the 'root cause' investigations it affords, are both central to the effort to involve clinicians in managing and organizing their work, and a departure from established methods and approaches to achieve clinicians' involvement in these non-clinical domains of health care. We argue that critical incident narratives render visible details of the clinical work that have thus far only been discussed in closed, paperless meetings, and that, as narratives, they incite individuals to share personal experiences with parties previously excluded from knowledge about failure. Drawing on a study of 124 medical retrieval incident reports, the paper provides illustrations and interpretations of both the narrative and the meta-discursive dimensions of critical incident reporting. We suggest that, as a new and complex genre, critical incident reporting achieves three important objectives. First, it provides clinicians with a channel for dealing with incidents in a way that brings problems to light in a non-blaming way and that might therefore be morally satisfying and perhaps even therapeutic. Second, these narrations make available new spaces for the apprehension, identification and performance of self. Here, the incident report becomes a space where clinicians publicly perform concern about what happened. Third, incident reporting becomes the basis for radically altering the clinician-organization relationship. As a complex expression of clinical failure and its re-articulation into organizational meta-discourse, incident reporting puts doctors' selves and feelings at risk not just within the relative safety of personal or intra

  4. Semantic Theme Analysis of Pilot Incident Reports

    NASA Technical Reports Server (NTRS)

    Thirumalainambi, Rajkumar

    2009-01-01

    Pilots report accidents or incidents during take-off, on flight and landing to airline authorities and Federal aviation authority as well. The description of pilot reports for an incident contains technical terms related to Flight instruments and operations. Normal text mining approaches collect keywords from text documents and relate them among documents that are stored in database. Present approach will extract specific theme analysis of incident reports and semantically relate hierarchy of terms assigning weights of themes. Once the theme extraction has been performed for a given document, a unique key can be assigned to that document to cross linking the documents. Semantic linking will be used to categorize the documents based on specific rules that can help an end-user to analyze certain types of accidents. This presentation outlines the architecture of text mining for pilot incident reports for autonomous categorization of pilot incident reports using semantic theme analysis.

  5. Incidence of adverse events in paediatric procedural sedation in the emergency department: a systematic review and meta-analysis

    PubMed Central

    Bellolio, M Fernanda; Puls, Henrique A; Anderson, Jana L; Gilani, Waqas I; Murad, M Hassan; Barrionuevo, Patricia; Erwin, Patricia J; Wang, Zhen; Hess, Erik P

    2016-01-01

    Objective and design We conducted a systematic review and meta-analysis to evaluate the incidence of adverse events in the emergency department (ED) during procedural sedation in the paediatric population. Randomised controlled trials and observational studies from the past 10 years were included. We adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Setting ED. Participants Children. Interventions Procedural sedation. Outcomes Adverse events like vomiting, agitation, hypoxia and apnoea. Meta-analysis was performed with random-effects model and reported as incidence rates with 95% CIs. Results A total of 1177 studies were retrieved for screening and 258 were selected for full-text review. 41 studies reporting on 13 883 procedural sedations in 13 876 children (≤18 years) were included. The most common adverse events (all reported per 1000 sedations) were: vomiting 55.5 (CI 45.2 to 65.8), agitation 17.9 (CI 12.2 to 23.7), hypoxia 14.8 (CI 10.2 to 19.3) and apnoea 7.1 (CI 3.2 to 11.0). The need to intervene with either bag valve mask, oral airway or positive pressure ventilation occurred in 5.0 per 1000 sedations (CI 2.3 to 7.6). The incidences of severe respiratory events were: 34 cases of laryngospasm among 8687 sedations (2.9 per 1000 sedations, CI 1.1 to 4.7; absolute rate 3.9 per 1000 sedations), 4 intubations among 9136 sedations and 0 cases of aspiration among 3326 sedations. 33 of the 34 cases of laryngospasm occurred in patients who received ketamine. Conclusions Serious adverse respiratory events are very rare in paediatric procedural sedation in the ED. Emesis and agitation are the most frequent adverse events. Hypoxia, a late indicator of respiratory depression, occurs in 1.5% of sedations. Laryngospasm, though rare, happens most frequently with ketamine. The results of this study provide quantitative risk estimates to facilitate shared decision-making, risk communication, informed consent and

  6. Incident reporting: the bureau investigation.

    PubMed

    Mains, Paul

    2015-01-01

    The Bureau Investigation (BI) is a type of report that lends itself to the internal complaints often generated within a bureaucracy, the author reports, and ranges from discourtesy complaints on a single shift or a single officer to the more complex, sensitive inquiries called for by the senior administration. In this article he explores the many facets of the BI which must be mastered.

  7. Incidence | Cancer Trends Progress Report

    Cancer.gov

    The Cancer Trends Progress Report, first issued in 2001, summarizes our nation's advances against cancer in relation to Healthy People targets set forth by the Department of Health and Human Services.

  8. Promoting adverse drug reaction reporting: comparison of different approaches

    PubMed Central

    Ribeiro-Vaz, Inês; Santos, Cristina Costa; Cruz-Correia, Ricardo

    2016-01-01

    ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report. PMID:27143614

  9. Incidence of adverse cutaneous drug reactions in 22,866 Chinese inpatients: a prospective study.

    PubMed

    Tian, Xiao-Yin; Liu, Bing; Shi, Hao; Zhao, Zi-Ran; Zhou, Xi-Ping; Zhang, Tao; Sun, Qiu-Ning; Zuo, Ya-Gang

    2015-11-01

    Cutaneous adverse drug reactions (ADRs) are common. However, no prospective study assessing cutaneous ADRs is available for Chinese populations. This study aimed to assess the incidence, manifestations, causative drugs, and other factors related to cutaneous ADRs. A total of 22,866 inpatients were surveyed prospectively from January to April 2012 at the Peking Union Medical College Hospital. Only cutaneous ADRs induced by systemic drugs were considered. Fifty cases were confirmed as cutaneous ADRs, for an estimated incidence of 2.2 per 1000 during this period (95 % confidence interval 1.6-2.8). Cases of cutaneous ADRs comprised 69 % females, while 63 % of all inpatients were female (χ (2) = 0.641, P = 0.427). The department of infectious diseases was the most frequently involved department. Morbilliform exanthema (40 %) was the most frequent cutaneous ADR, followed by urticaria (23.1 %). Anti-infection drugs (36.9 %) caused most cases of cutaneous ADRs, followed by iodinated contrast media (ICM, 18.5 %) and non-steroidal anti-inflammatory drugs (NSAIDs, 18.5 %). The most frequently associated disorders were cancer (24 %), infection (22 %), cardiovascular and cerebrovascular diseases (20 %), and autoimmune diseases (18 %). In this first prospective study assessing the incidence of cutaneous ADRs in China, anti-infection drugs were the most commonly involved drugs, followed by ICM and NSAIDs. No evidence of increased cutaneous ADR incidence in AIDS or SLE patients was observed. Our findings indicate that cancer and its treatments were often related to cutaneous ADRs in China.

  10. Incidence of spontaneous notifications of adverse reactions with aceclofenac, meloxicam, and rofecoxib during the first year after marketing in the United Kingdom

    PubMed Central

    Raber, Anna; Heras, Joan; Costa, Joan; Fortea, Josep; Cobos, Albert

    2007-01-01

    The objective was to compare the incidence of adverse reactions reported with three nonsteroidal anti-inflammatory drugs with different cyclo-oxygenase (COX)-2 selectivity. All spontaneous adverse reaction notifications in the pharmacovigilance database of the World Health Organisation Collaborating Centre for International Drug Monitoring with aceclofenac, meloxicam, and rofecoxib that were recorded during the first year of marketing were included. The incidence rate (adverse reactions/106 defined daily dose) and 95% confidence interval for total adverse reactions was 8.7 (6.1–12.0) for aceclofenac, 24.8 (23.1–26.6) for meloxicam, and 52.6 (49.9–55.4) for rofecoxib. Aceclofenac had a lower incidence of gastrointestinal bleeding, abdominal pain, and arterial hypertension than meloxicam and a lower incidence of gastrointestinal bleeding, abdominal pain, liver toxicity, thromboembolic cardiovascular events, arterial hypertension, and edema than rofecoxib. The incidence of total and gastrointestinal adverse reactions was significantly lower with aceclofenac than with meloxicam or rofecoxib, thus raising doubts about the hypothetical advantage of COX-2 selective inhibitors. PMID:18360631

  11. Reporting hospital adverse events using the Alfred Hospital's morbidity data.

    PubMed

    Carroll, Rhonda; McLean, Jenny; Walsh, Michael

    2003-01-01

    Hospital morbidity data were analysed to determine their usefulness for reporting adverse events. The entire ICD-10-AM classification system was reviewed in conjunction with the Australian Coding Standards to identify external cause codes and code prefixes associated with adverse events. For the 50,712 separations registered at The Alfred from July 2000-June 2001, 4,740 external cause codes were associated with adverse events. Place of occurrence code CY92.22 was considered the best indicator of the number of separations associated with adverse events. Approximately 4% of all separations were associated with adverse events occurring during an episode of care. Results suggest that hospital morbidity data are useful for monitoring adverse events at hospital level. Reliable reporting across the health care industry requires consistent reporting requirements at state and national levels and the adoption of standard code prefixes nationally.

  12. Data consistency in a voluntary medical incident reporting system.

    PubMed

    Gong, Yang

    2011-08-01

    Voluntary medical incident reporting systems are a valuable source for studying adverse events and near misses. Unfortunately, such systems usually contain a large amount of incomplete and inaccurate reports which negatively affect their utility for medical error research. To investigate the reporting quality and propose solutions towards quality voluntary reports, we employed a content analysis method to examine one-year voluntary medical incident reports of a University Hospital. Results indicate that there is a large amount of inconsistent records within the reports. About 25% of the reports were labeled as "miscellaneous" and "other". Through an in-depth analysis, those "miscellaneous" and "other" were substituted by their real incident types or error descriptions. Analysis shows that the pre-defined reporting categories serve well in general for the voluntary reporting need. In some cases, human factors play a key role in selecting accurate categories since reporters lack time or information to complete the report. We suggest that a human-centered, ontology based system design for voluntary reporting is feasible. Such a design could help improve the completeness and accuracy, and interoperability among national and international standards.

  13. A simple Bayesian approach to quantifying confidence level of adverse event incidence proportion in small samples.

    PubMed

    Liu, Fang

    2016-01-01

    In both clinical development and post-marketing of a new therapy or a new treatment, incidence of an adverse event (AE) is always a concern. When sample sizes are small, large sample-based inferential approaches on an AE incidence proportion in a certain time period no longer apply. In this brief discussion, we introduce a simple Bayesian framework to quantify, in small sample studies and the rare AE case, (1) the confidence level that the incidence proportion of a particular AE p is over or below a threshold, (2) the lower or upper bounds on p with a certain level of confidence, and (3) the minimum required number of patients with an AE before we can be certain that p surpasses a specific threshold, or the maximum allowable number of patients with an AE after which we can no longer be certain that p is below a certain threshold, given a certain confidence level. The method is easy to understand and implement; the interpretation of the results is intuitive. This article also demonstrates the usefulness of simple Bayesian concepts when it comes to answering practical questions.

  14. Toward a human-centered voluntary medical incident reporting system.

    PubMed

    Gong, Yang

    2010-01-01

    Voluntary medical incident reports are a valuable source for studying adverse events and near misses. Underreporting and low quality of reports in local organizations, however, have become the impediments in identifying trends and patterns relating at the local, regional and national level. Human factors on usefulness and ease of use have shown their important role in acceptance of voluntary reporting systems. To understand and identify the obstacles of quality reporting, we employed a set of human-centered analysis methods to examine one-year voluntary medical incident reports of a University Hospital. We found about 30% of the reports labeled as "miscellaneous" and "other", and their real incident types or error descriptions were identified through an in-depth recoding. Human-centered analyses show that the pre-defined reporting categories could serve well for the voluntary reporting need if reporters' tasks were better represented on user-friendly interfaces. We suggest that a human-centered, ontology based system design for voluntary reporting is feasible which could help improve completeness, accuracy, and interoperability among national and international standards.

  15. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and.... (b) Review of adverse experiences. Any person having a biologics license under § 601.20 of this... Evaluation and Research (see mailing addresses in § 600.2). Submit all vaccine adverse experience reports...

  16. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and.... (b) Review of adverse experiences. Any person having a biologics license under § 601.20 of this... Evaluation and Research (see mailing addresses in § 600.2). Submit all vaccine adverse experience reports...

  17. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and.... (b) Review of adverse experiences. Any person having a biologics license under § 601.20 of this... Evaluation and Research (see mailing addresses in § 600.2). Submit all vaccine adverse experience reports...

  18. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and.... (b) Review of adverse experiences. Any person having a biologics license under § 601.20 of this... Evaluation and Research (see mailing addresses in § 600.2). Submit all vaccine adverse experience reports...

  19. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and.... (b) Review of adverse experiences. Any person having a biologics license under § 601.20 of this... Evaluation and Research (see mailing addresses in § 600.2). Submit all vaccine adverse experience reports...

  20. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.

    PubMed

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

    2016-09-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability.

  1. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database

    PubMed Central

    2016-01-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability. PMID:27510377

  2. How to Report a Pesticide Incident Involving Exposures to People

    EPA Pesticide Factsheets

    Pesticides incidents must be reported by pesticide registrants. Others, such as members of the public and environmental professionals, would like to report pesticide incidents. This website will facilitate such incident reporting.

  3. Incidence of Thyroid-Related Adverse Events in Melanoma Patients Treated With Pembrolizumab

    PubMed Central

    Jansen, Yanina; Schreuer, Max; Everaert, Hendrik; Velkeniers, Brigitte; Neyns, Bart; Bravenboer, Bert

    2016-01-01

    Context: Immune checkpoint blockade is associated with endocrine-related adverse events. Thyroid dysfunction during pembrolizumab therapy, an anti-programmed cell death 1 (PD-1) receptor monoclonal antibody, remains to be fully characterized. Objective: To assess the incidence and characteristics of pembrolizumab-associated thyroid dysfunction. Design and Setting: Thyroid function was monitored prospectively in melanoma patients who initiated pembrolizumab within an expanded access program at a referral oncology center. 18Fluorodeoxyglucose uptake on positron emission tomography/computed tomography (18FDG-PET/CT) was reviewed in cases compatible with inflammatory thyroiditis. Patients: Ninety-nine patients with advanced melanoma (age, 26.3–93.6 years; 63.6% females) who received at least one administration of pembrolizumab. Main Outcome Measures: Patient characteristics, thyroid function (TSH, free T4), thyroid autoantibodies, and 18FDG-PET/CT. Results: Eighteen adverse events of thyroid dysfunction were observed in 17 patients. Thyrotoxicosis occurred in 12 patients, of which nine evolved to hypothyroidism. Isolated hypothyroidism was present in six patients. Levothyroxine therapy was required in 10 of 15 hypothyroid patients. Thyroid autoantibodies were elevated during thyroid dysfunction in four of 10 cases. Diffuse increased 18FDG uptake by the thyroid gland was observed in all seven thyrotoxic patients who progressed to hypothyroidism. Conclusions: Thyroid dysfunction is common in melanoma patients treated with pembrolizumab. Hypothyroidism and thyrotoxicosis related to inflammatory thyroiditis are the most frequent presentations. Serial measurements of thyroid function tests are indicated during anti-PD-1 monoclonal antibody therapy. Thyrotoxicosis compatible with inflammatory thyroiditis was associated with diffuse increased 18FDG uptake by the thyroid gland. The prospective role of thyroid autoantibodies should be further investigated, together with the

  4. Incidence and management of life-threatening adverse events during cardiac catheterization for congenital heart disease.

    PubMed

    Lin, C Huie; Hegde, Sanjeet; Marshall, Audrey C; Porras, Diego; Gauvreau, Kimberlee; Balzer, David T; Beekman, Robert H; Torres, Alejandro; Vincent, Julie A; Moore, John W; Holzer, Ralf; Armsby, Laurie; Bergersen, Lisa

    2014-01-01

    Continued advancements in congenital cardiac catheterization and interventions have resulted in increased patient and procedural complexity. Anticipation of life-threatening events and required rescue measures is a critical component to preprocedural preparation. We sought to determine the incidence and nature of life-threatening adverse events in congenital and pediatric cardiac catheterization, risk factors, and resources necessary to anticipate and manage events. Data from 8905 cases performed at the 8 participating institutions of the Congenital Cardiac Catheterization Project on Outcomes were captured between 2007 and 2010 [median 1,095/site (range 133-3,802)]. The incidence of all life-threatening events was 2.1 % [95 % confidence interval (CI) 1.8-2.4 %], whereas mortality was 0.28 % (95 % CI 0.18-0.41 %). Fifty-seven life-threatening events required cardiopulmonary resuscitation, whereas 9 % required extracorporeal membrane oxygenation. Use of a risk adjustment model showed that age <1 year [odd ratio (OR) 1.9, 95 % CI 1.4-2.7, p < 0.001], hemodynamic vulnerability (OR 1.6, 95 % CI 1.1-2.3, p < 0.01), and procedure risk (category 3: OR 2.3, 95 % CI 1.3-4.1; category 4: OR 4.2, 95 % CI 2.4-7.4) were predictors of life-threatening events. Using this model, standardized life-threatening event ratios were calculated, thus showing that one institution had a life-threatening event rate greater than expected. Congenital cardiac catheterization and intervention can be performed safely with a low rate of life-threatening events and mortality; preprocedural evaluation of risk may optimize preparation of emergency rescue and bailout procedures. Risk predictors (age < 1, hemodynamic vulnerability, and procedure risk category) can enhance preprocedural patient risk stratification and planning.

  5. Incidence of hospital admissions due to adverse drug reactions in France: the EMIR study.

    PubMed

    Bénard-Laribière, Anne; Miremont-Salamé, Ghada; Pérault-Pochat, Marie-Christine; Noize, Pernelle; Haramburu, Françoise

    2015-02-01

    To assess the incidence of hospital admissions related to adverse drug reactions (ADRs) in France and the frequency of preventable ADRs in France, a prospective study was conducted among a representative randomly selected sample of medical wards in public hospitals between December 2006 and June 2007; all patients admitted during a 2-week period were included. An ADR-related hospitalization case was defined as a hospital admission because of an ADR, and an independent committee reviewed and validated all potential cases. Preventability was assessed using the French ADR preventability scale. Data were extrapolated to the population of France. Among 2692 admissions, 97 were related to an ADR (incidence 3.6%, 95% confidence interval, CI [2.8-4.4]). Patients admitted for an ADR were significantly older than those admitted for other reasons (P < 0.001). A third (32.0%) of ADR-related hospitalizations were 'preventable', 16.5% 'potentially preventable'. Drug interactions accounted for 29.9% of ADR-related hospitalizations. The most frequent causes of ADR-related hospitalizations were vascular disorders (20.6%), mainly bleeding complications, central nervous system disorders (11.3%), gastrointestinal disorders, and general disorders (9.3%). Antithrombotic and antineoplastic agents were the most frequently involved (12.6% each), followed by diuretics and analgesics (9.0% each). Vitamin-K-antagonists (VKAs) were the most common drugs associated with admission. The estimated annual number of ADR-related hospitalizations in France was 143 915 (95% CI [112 063-175 766]). ADRs were a significant cause of hospital admission in 2006-2007, in particular those due to VKAs. As new oral anticoagulants (NOACs) have been marketed, more attention needs to be paid to ensure a safe use of antithrombotic agents.

  6. Guidelines for submitting adverse event reports for publication.

    PubMed

    Kelly, William; Arellano, Felix; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph; Fernandez, Alina; Freedman, Stephen; Goldsmith, David; Huang, Kui; Jones, Judith; McLeay, Rachel; Moore, Nicholas; Stather, Rosie; Trenque, Thierry; Troutman, William; van Puijenbroek, Eugène; Williams, Frank; Wise, Robert

    2009-01-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation and reporting of suspected drug or other medical product adverse events.

  7. Guidelines for submitting adverse event reports for publication.

    PubMed

    Kelly, William N; Arellano, Felix M; Barnes, Joanne; Bergman, Ulf; Edwards, I Ralph; Fernandez, Alina M; Freedman, Stephen B; Goldsmith, David I; Huang, Kui; Jones, Judith K; McLeay, Rachel; Moore, Nicholas; Stather, Rosie H; Trenque, Thierry; Troutman, William G; van Puijenbroek, Eugene; Williams, Frank; Wise, Robert P

    2007-05-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

  8. Guidelines for submitting adverse event reports for publication.

    PubMed

    Kelly, William N; Arellano, Felix M; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph I; Fernandez, Alina M; Freedman, Stephen B; Goldsmith, David I; Huang, Kui A; Jones, Judith K; McLeay, Rachel; Moore, Nicholas; Stather, Rosie H; Trenque, Thierry; Troutman, William G; van Puijenbroek, Eugene; Williams, Frank; Wise, Robert P

    2007-01-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

  9. Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events

    PubMed Central

    Cozac, Vitalii V.; Ehrensperger, Michael M.; Gschwandtner, Ute; Hatz, Florian; Meyer, Antonia; Monsch, Andreas U.; Schuepbach, Michael; Taub, Ethan; Fuhr, Peter

    2016-01-01

    Objective: To investigate the incidence of serious adverse events (SAE) of subthalamic deep brain stimulation (STN-DBS) in elderly patients with Parkinson's disease (PD). Methods: We investigated a group of 26 patients with PD who underwent STN-DBS at mean age 63.2 ± 3.3 years. The operated patients from the EARLYSTIM study (mean age 52.9 ± 6.6) were used as a comparison group. Incidences of SAE were compared between these groups. Results: A higher incidence of psychosis and hallucinations was found in these elderly patients compared to the younger patients in the EARLYSTIM study (p < 0.01). Conclusions: The higher incidence of STN-DBS-related psychiatric complications underscores the need for comprehensive psychiatric pre- and postoperative assessment in older DBS candidates. However, these psychiatric SAE were transient, and the benefits of DBS clearly outweighed its adverse effects. PMID:27375478

  10. [Adverse drug reactions reporting is helping "non substituable" prescription!].

    PubMed

    Jacquot, Julien; Bagheri, Haleh; Montastruc, Jean-Louis

    2014-01-01

    In August 2012, general practitioners of Haute- Garonne received a letter from Health insurance system, informing that prescriptions could be endorsed by "not substituable" after reporting an adverse drug reactions (ADR). Compared to an equivalent period before this letter, we observed an increase of ADRs reports for generics, mainly concerning gastrointestinal ADR and lack of efficacy.

  11. Systematic Analysis of Adverse Event Reports for Sex Differences in Adverse Drug Events

    PubMed Central

    Yu, Yue; Chen, Jun; Li, Dingcheng; Wang, Liwei; Wang, Wei; Liu, Hongfang

    2016-01-01

    Increasing evidence has shown that sex differences exist in Adverse Drug Events (ADEs). Identifying those sex differences in ADEs could reduce the experience of ADEs for patients and could be conducive to the development of personalized medicine. In this study, we analyzed a normalized US Food and Drug Administration Adverse Event Reporting System (FAERS). Chi-squared test was conducted to discover which treatment regimens or drugs had sex differences in adverse events. Moreover, reporting odds ratio (ROR) and P value were calculated to quantify the signals of sex differences for specific drug-event combinations. Logistic regression was applied to remove the confounding effect from the baseline sex difference of the events. We detected among 668 drugs of the most frequent 20 treatment regimens in the United States, 307 drugs have sex differences in ADEs. In addition, we identified 736 unique drug-event combinations with significant sex differences. After removing the confounding effect from the baseline sex difference of the events, there are 266 combinations remained. Drug labels or previous studies verified some of them while others warrant further investigation. PMID:27102014

  12. Patient knowledge on reporting adverse drug reactions in Poland

    PubMed Central

    Staniszewska, Anna; Dąbrowska-Bender, Marta; Olejniczak, Dominik; Duda-Zalewska, Aneta; Bujalska-Zadrożny, Magdalena

    2017-01-01

    Aim The aim of the study was to assess patient knowledge on reporting of adverse drug reactions. Materials and methods A prospective study was conducted among 200 patients. The study was based on an original survey composed of 15 single- and multiple-choice questions. The study involved individuals who have experienced adverse reactions as well as individuals who have never experienced any adverse reactions; people over the age of 18; literate; residing in Mazowieckie Voivodeship, who have not been diagnosed with any disease that could compromise their logical thinking skills. Results The respondents who lived in the city had a greater knowledge compared to the respondents who lived in the countryside (Pearson’s χ2=47.70, P=0.0013). The respondents who lived in the city were also more statistically likely to provide a correct answer to the question about the type of adverse reactions to be reported (Pearson’s χ2=50.66, P=0.012). Statistically significant associations were found between the place of residence of the respondents and the correct answer to the question about the data that must be included in the report on adverse reactions (Pearson’s χ2=11.7, P<0.0001). PMID:28096661

  13. Unplanned Intensive Care Unit Admission following Elective Surgical Adverse Events: Incidence, Patient Characteristics, Preventability, and Outcome

    PubMed Central

    Meziane, Mohammed; El Jaouhari, Sidi Driss; ElKoundi, Abdelghafour; Bensghir, Mustapha; Baba, Hicham; Ahtil, Redouane; Aboulaala, Khalil; Balkhi, Hicham; Haimeur, Charki

    2017-01-01

    Context: Adverse events (AEs) are a persistent and an important reason for Intensive Care Unit (ICU) admission. They lead to death, disability at the time of discharge, unplanned ICU admission (UIA), and prolonged hospital stay. They impose large financial costs on health-care systems. Aims: This study aimed to determine the incidence, patient characteristics, type, preventability, and outcome of UIA following elective surgical AE. Settings and Design: This is a single-center prospective study. Methods: Analysis of 15,372 elective surgical procedures was performed. We defined UIA as an ICU admission that was not anticipated preoperatively but was due to an AE occurring within 5 days after elective surgery. Statistical Analysis: Descriptive analysis using SPSS software version 18 was used for statistical analysis. Results: There were 75 UIA (0.48%) recorded during the 2-year study period. The average age of patients was 54.64 ± 18.02 years. There was no sex predominance, and the majority of our patients had an American Society of Anesthesiologist classes 1 and 2. Nearly 29% of the UIA occurred after abdominal surgery and 22% after a trauma surgery. Regarding the causes of UIA, we observed that 44 UIA (58.7%) were related to surgical AE, 24 (32%) to anesthetic AE, and 7 (9.3%) to postoperative AE caused by care defects. Twenty-three UIA were judged as potentially preventable (30.7%). UIA was associated with negative outcomes, including increased use of ICU-specific interventions and high mortality rate (20%). Conclusions: Our analysis of UIA is a quality control exercise that helps identify high-risk patient groups and patterns of anesthesia or surgical care requiring improvement.

  14. Mixed-effects Poisson regression analysis of adverse event reports

    PubMed Central

    Gibbons, Robert D.; Segawa, Eisuke; Karabatsos, George; Amatya, Anup K.; Bhaumik, Dulal K.; Brown, C. Hendricks; Kapur, Kush; Marcus, Sue M.; Hur, Kwan; Mann, J. John

    2008-01-01

    SUMMARY A new statistical methodology is developed for the analysis of spontaneous adverse event (AE) reports from post-marketing drug surveillance data. The method involves both empirical Bayes (EB) and fully Bayes estimation of rate multipliers for each drug within a class of drugs, for a particular AE, based on a mixed-effects Poisson regression model. Both parametric and semiparametric models for the random-effect distribution are examined. The method is applied to data from Food and Drug Administration (FDA)’s Adverse Event Reporting System (AERS) on the relationship between antidepressants and suicide. We obtain point estimates and 95 per cent confidence (posterior) intervals for the rate multiplier for each drug (e.g. antidepressants), which can be used to determine whether a particular drug has an increased risk of association with a particular AE (e.g. suicide). Confidence (posterior) intervals that do not include 1.0 provide evidence for either significant protective or harmful associations of the drug and the adverse effect. We also examine EB, parametric Bayes, and semiparametric Bayes estimators of the rate multipliers and associated confidence (posterior) intervals. Results of our analysis of the FDA AERS data revealed that newer antidepressants are associated with lower rates of suicide adverse event reports compared with older antidepressants. We recommend improvements to the existing AERS system, which are likely to improve its public health value as an early warning system. PMID:18404622

  15. Analysis of Neuropsychiatric Adverse Events in Patients Treated with Oseltamivir in Spontaneous Adverse Event Reports.

    PubMed

    Ueda, Natsumi; Umetsu, Ryogo; Abe, Junko; Kato, Yamato; Nakayama, Yoko; Kato, Zenichiro; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    There have been concerns that oseltamivir causes neuropsychiatric adverse events (NPAEs). We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model. NPAE data were obtained from the U.S. Food and Drug Administration Adverse Event Reporting System (2004 to 2013). The lower limit of the reporting odds ratio (ROR) 95% confidence interval (CI) of "abnormal behavior" in Japan, Singapore, and Taiwan was ≥1. The effects of the interaction terms for oseltamivir in male patients aged 10-19 years were statistically significant. The adjusted ROR of "abnormal behavior" was 96.4 (95% CI, 77.5-119.9) in male patients aged 10-19 years treated with osletamivir. In female patients, the results of the likelihood ratio test for "abnormal behavior" were not statistically significant. The adjusted NPAE RORs were increased in male and female patients under the age of 20 years. Oseltamivir use could be associated with "abnormal behavior" in males aged 10-19 years. After considering the causality restraints of the current analysis, further epidemiological studies are recommended.

  16. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy

    PubMed Central

    Srikanth, B. Akshaya; Babu, S. Chandra; Yadav, Harlokesh Narayan; Jain, Sunil Kumar

    2012-01-01

    To estimate the incidence of adverse drug reactions (ADRs) in Human immune deficiency virus (HIV) patients on highly active antiretroviral therapy (HAART). To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%). The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52%) was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm3 with comorbid conditions. PMID:22470896

  17. 49 CFR 225.11 - Reporting of accidents/incidents.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Reporting of accidents/incidents. 225.11 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD ACCIDENTS/INCIDENTS: REPORTS CLASSIFICATION, AND INVESTIGATIONS § 225.11 Reporting of accidents/incidents. Each railroad subject to this part shall submit to...

  18. 49 CFR 225.11 - Reporting of accidents/incidents.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Reporting of accidents/incidents. 225.11 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD ACCIDENTS/INCIDENTS: REPORTS CLASSIFICATION, AND INVESTIGATIONS § 225.11 Reporting of accidents/incidents. (a) Each railroad subject to this part shall submit...

  19. 49 CFR 225.11 - Reporting of accidents/incidents.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Reporting of accidents/incidents. 225.11 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD ACCIDENTS/INCIDENTS: REPORTS CLASSIFICATION, AND INVESTIGATIONS § 225.11 Reporting of accidents/incidents. (a) Each railroad subject to this part shall submit...

  20. 49 CFR 225.11 - Reporting of accidents/incidents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Reporting of accidents/incidents. 225.11 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD ACCIDENTS/INCIDENTS: REPORTS CLASSIFICATION, AND INVESTIGATIONS § 225.11 Reporting of accidents/incidents. (a) Each railroad subject to this part shall submit...

  1. 49 CFR 225.11 - Reporting of accidents/incidents.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Reporting of accidents/incidents. 225.11 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD ACCIDENTS/INCIDENTS: REPORTS CLASSIFICATION, AND INVESTIGATIONS § 225.11 Reporting of accidents/incidents. (a) Each railroad subject to this part shall submit...

  2. Adverse drug reactions: a hospital pharmacy-based reporting scheme.

    PubMed Central

    Winstanley, P A; Irvin, L E; Smith, J C; Orme, M L; Breckenridge, A M

    1989-01-01

    A pharmacy-based adverse drug reaction (ADR) reporting scheme, using pharmacists, nurses and medical practitioners as initiators of reports, was set up at the end of 1984 in the Royal Liverpool Hospital in order to encourage reporting. New reports were inspected at weekly intervals by a staff pharmacist, and a clinical pharmacologist. Reports were forwarded to the Committee on Safety of Medicines if the reaction was considered to be serious by the clinicians, or the ADR team or involved 'black triangle' drugs. The total number of ADR reports was increased eightfold by the introduction of the scheme (from 14 in 1984 to 76, 102 and 94 in 1985, 1986 and 1987 respectively), and this rate of reporting has been sustained. PMID:2775609

  3. Statin safety: an appraisal from the adverse event reporting system.

    PubMed

    Davidson, Michael H; Clark, John A; Glass, Lucas M; Kanumalla, Anju

    2006-04-17

    The adverse event (AE) profiles of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) agents are of great interest, in particular the most recently approved statin, rosuvastatin. The forwarding of reports of AEs has been shown to be influenced by several reporting biases, including secular trend, the new drug reporting effect, product withdrawals, and publicity. Comparative assessments that use AE reporting rates are difficult to interpret under these circumstances, because such effects can themselves lead to marked increases in AE reporting. Consequently, many comparative reporting rate analyses are best carried out in conjunction with other metrics that put reporting burden into context, such as report proportion. All-AE reporting rates showed a temporal profile that resembled those of other statins when marketing cycle and secular trend were taken into account. A before-and-after cerivastatin withdrawal comparison showed a substantial increase in the reporting of AEs of interest for the statin class overall. Report proportion analyses indicated that the burden of rosuvastatin-associated AEs was similar to that for other statin agents. Analyses of monthly reporting rates showed that the reporting of rosuvastatin-associated rhabdomyolysis and renal failure have increased following AE-specific mass media publicity. Postrosuvastatin AE reporting patterns were comparable to those seen with other statins and did not resemble cerivastatin.

  4. Use of Critical Incident Reports in Medical Education

    PubMed Central

    Branch, William T

    2005-01-01

    Critical incident reports are now being widely used in medical education. They are short narrative accounts focusing on the most important professional experiences of medical students, residents, and other learners. As such, critical incident reports are ideally suited for addressing values and attitudes, and teaching professional development. This manuscript describes critical incident reports and gives examples of their use, provides a theoretical underpinning that explains their effectiveness, and describes the educational impacts of critical incident reports and similar methods that use reflective learning. The author recommends critical incident reports as an especially effective means to address learners' most deeply held values and attitudes in the context of their professional experiences. PMID:16307635

  5. Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions

    PubMed Central

    Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

    2015-01-01

    Objective We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Methods Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary’s teaching hospital, Daejeon, Korea) from 2010–2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton’s preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Results Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization–Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001). Conclusions We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse

  6. Fourth-year nursing student perceptions of incidents and incident reporting.

    PubMed

    Espin, Sherry; Meikle, Diane

    2014-04-01

    This study explored how fourth-year nursing students (n = 10) from one urban baccalaureate nursing program perceived incidents potentially harmful to patients, as well as incident reporting. Individual interviews were conducted. Five scenarios were presented in the interviews, with each scenario portraying a situation that varied in terms of the severity of potential for patient harm and the clinical team members involved. Participants' responses were analyzed using a descriptive thematic approach. Of the 50 events (10 participants × 5 scenarios), participants identified 37 events as incidents. Three themes emerged regarding how participants identified an incident: scope of practice, professional roles, and harm to the patient. Regarding 48 of the 50 events, participants said they would report these incidents either informally or formally. Findings from this study suggest a need for nursing education regarding what constitutes an incident, as well as how and when to report incidents.

  7. 33 CFR 150.830 - Reporting a pollution incident.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Reporting a pollution incident. 150.830 Section 150.830 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY... pollution incident. Oil pollution incidents involving a deepwater port are reported according to §§...

  8. 33 CFR 150.830 - Reporting a pollution incident.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Reporting a pollution incident. 150.830 Section 150.830 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY... pollution incident. Oil pollution incidents involving a deepwater port are reported according to §§...

  9. 33 CFR 150.830 - Reporting a pollution incident.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Reporting a pollution incident. 150.830 Section 150.830 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY... pollution incident. Oil pollution incidents involving a deepwater port are reported according to §§...

  10. 33 CFR 150.830 - Reporting a pollution incident.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Reporting a pollution incident. 150.830 Section 150.830 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY... pollution incident. Oil pollution incidents involving a deepwater port are reported according to §§...

  11. 33 CFR 150.830 - Reporting a pollution incident.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Reporting a pollution incident. 150.830 Section 150.830 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY... pollution incident. Oil pollution incidents involving a deepwater port are reported according to §§...

  12. [Reported adverse reactions of veterinary drugs and vaccines in 2005].

    PubMed

    Müntener, C R; Bruckner, L; Gassner, B; Demuth, D C; Althaus, F R; Zwahlen, R

    2007-02-01

    We received 105 reports of suspected adverse events (SARs) following the use of veterinary drugs for the year 2005. This corresponds to a 35% increase compared to 2004. Practicing veterinarians sent most of these declarations. 73% of these concerned drugs used on companion animals. Antiparasitic drugs approved for topical use were the most frequently represented group with 48%, followed by drugs used to treat gastrointestinal disorders (11%) and drugs used off-label (14%; other target species or other indication). For the first time 2 declarations concerning the application of permethrin containing spot-on preparations used by mistake on cats were received. An overview of 20 declarations about adverse reactions following application of different vaccines is also presented with emphasis on the problem of fibrosarcoma in cats. We are pleased by the growing interest shown by practicing veterinarians for the vigilance system and hope to further develop this collaboration in the future.

  13. Rare adverse events due to house dust mite sublingual immunotherapy in pediatric practice: two case reports.

    PubMed

    Galip, Nilufer; Bahceciler, Nerin

    2015-01-01

    Sublingual route, a noninjective way of allergen administration appears to be associated with a lower incidence of severe systemic reactions compared with the subcutaneous route. Local adverse reactions are reported which resolve spontaneously within a few days without need for discontinuation of treatment. Hereby, we report two pediatric cases, one with persistent asthma and the other one with persistent allergic rhinitis. Both were treated by house dust mite sublingual immunotherapy, one of whom developed severe wheezing (grade 2 systemic reaction based on World Allergy Organization subcutaneous systemic reaction grading system) and the other intractable vomiting (grade 3 local reaction based on World Allergy Organization sublingual immunotherapy local adverse events grading system) at the end of the build-up phase which repeated on re-administration of the same dose. Both of those two cases completed their 3-year immunotherapy successfully by patient-based adjustment of the highest tolerated dose of the maintenance.

  14. Confidential incident reporting systems create vital awareness of safety problems.

    PubMed

    O'Leary, M; Chappell, S L

    1996-10-01

    The aviation safety reporting system (ASRS) developed by NASA is discussed as an example of aviation incident reporting. Approaches which encourage reporting include trust and confidentiality. Reporting and analysis systems and their administration at organizational and national levels are reviewed.

  15. 78 FR 14877 - Pipeline Safety: Incident and Accident Reports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-07

    ... Pipeline and Hazardous Materials Safety Administration Pipeline Safety: Incident and Accident Reports... availability of revised incident and accident report forms and request for supplemental reports. SUMMARY: In... Gathering Pipeline Systems and PHMSA F 7000-1--Accident Report--Hazardous Liquid Pipeline Systems....

  16. Incidence, risk factors and risk prediction of hospital-acquired suspected adverse drug reactions: a prospective cohort of Ugandan inpatients

    PubMed Central

    Kiguba, Ronald; Karamagi, Charles; Bird, Sheila M

    2017-01-01

    Objectives To determine the incidence and risk factors of hospital-acquired suspected adverse drug reactions (ADRs) among Ugandan inpatients. We also constructed risk scores to predict and qualitatively assess for peculiarities between low-risk and high-risk ADR patients. Methods Prospective cohort of consented adults admitted on medical and gynaecological wards of the 1790-bed Mulago National Referral Hospital. Hospital-acquired suspected ADRs were dichotomised as possible (possible/probable/definite) or not and probable (probable/definite) or not, using the Naranjo scale. Risk scores were generated from coefficients of ADR risk-factor logistic regression models. Results The incidence of possible hospital-acquired suspected ADRs was 25% (194/762, 95% CI: 22% to 29%): 44% (85/194) experienced serious possible ADRs. The risk of probable ADRs was 11% (87/762, 95% CI 9% to 14%): 46% (40/87) had serious probable ADRs. Antibacterials-only (51/194), uterotonics-only (21/194), cardiovascular drugs-only (16/194), antimalarials-only (12/194) and analgesics-only (10/194) were the most frequently implicated. Treatment with six or more conventional medicines during hospitalisation (OR=2.31, 95% CI 1.29 to 4.15) and self-reported herbal medicine use during the 4 weeks preadmission (OR=1.96, 95% CI 1.22 to 3.13) were the risk factors for probable hospital-acquired ADRs. Risk factors for possible hospital-acquired ADRs were: treatment with six or more conventional medicines (OR=2.72, 95% CI 1.79 to 4.13), herbal medicine use during the 4 weeks preadmission (OR=1.68, 95% CI 1.16 to 2.43), prior 3 months hospitalisation (OR=1.57, 95% CI 1.09 to 2.26) and being on gynaecological ward (OR=2.16, 95% CI 1.36 to 3.44). More drug classes were implicated among high-risk ADR-patients, with cardiovascular drugs being the most frequently linked to possible ADRs. Conclusions The risk of hospital-acquired suspected ADRs was higher with preadmission herbal medicine use and treatment with

  17. Voluntary Electronic Reporting of Medical Errors and Adverse Events

    PubMed Central

    Milch, Catherine E; Salem, Deeb N; Pauker, Stephen G; Lundquist, Thomas G; Kumar, Sanjaya; Chen, Jack

    2006-01-01

    OBJECTIVE To describe the rate and types of events reported in acute care hospitals using an electronic error reporting system (e-ERS). DESIGN Descriptive study of reported events using the same e-ERS between January 1, 2001 and September 30, 2003. SETTING Twenty-six acute care nonfederal hospitals throughout the U.S. that voluntarily implemented a web-based e-ERS for at least 3 months. PARTICIPANTS Hospital employees and staff. INTERVENTION A secure, standardized, commercially available web-based reporting system. RESULTS Median duration of e-ERS use was 21 months (range 3 to 33 months). A total of 92,547 reports were obtained during 2,547,154 patient-days. Reporting rates varied widely across hospitals (9 to 95 reports per 1,000 inpatient-days; median=35). Registered nurses provided nearly half of the reports; physicians contributed less than 2%. Thirty-four percent of reports were classified as nonmedication-related clinical events, 33% as medication/infusion related, 13% were falls, 13% as administrative, and 6% other. Among 80% of reports that identified level of impact, 53% were events that reached a patient (“patient events”), 13% were near misses that did not reach the patient, and 14% were hospital environment problems. Among 49,341 patient events, 67% caused no harm, 32% temporary harm, 0.8% life threatening or permanent harm, and 0.4% contributed to patient deaths. CONCLUSIONS An e-ERS provides an accessible venue for reporting medical errors, adverse events, and near misses. The wide variation in reporting rates among hospitals, and very low reporting rates by physicians, requires investigation. PMID:16390502

  18. Knowledge and attitudes to reporting adverse drug reactions.

    PubMed

    Pulford, Andrew; Malcolm, William

    The reporting of adverse drug reactions (ADRs) by health professionals forms an important component of ongoing surveillance of post-marketing drug safety. The extension of responsibility for all health professionals to report ADRs has coincided with national immunization programmes, such as the national childhood immunization, human papillomavirus (HPV), and seasonal and H1N1 influenza programmes. The study objective was to evaluate knowledge of, and attitudes to, reporting ADRs among the professional groups most likely to see suspected reactions to vaccines. This included nursing professionals, whose views have not been included in previous studies. A survey of 91 practice nurses, health visitors, school nurses and GPs working in Ayrshire and Arran during June, July and August 2007 was undertaken. The respondents' knowledge of ADR reporting varied considerably. Although the majority of respondents recognized that it is the responsibility of health professionals to report suspected ADRs, there were lower levels of knowledge about the purpose of the Yellow Card system specifically; less than 50% of the respondents reported good knowledge about the system. The study suggests implications for practice with regard to the implementation of large-scale immunization programmes and potential solutions to under-reporting among these professional groups.

  19. 28 CFR 541.14 - Incident report and investigation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the investigation, and staff may not question the inmate until the Federal Bureau of Investigation or... report and investigation. (a) Incident report. The Bureau of Prisons encourages informal resolution... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Incident report and investigation....

  20. 49 CFR 191.9 - Distribution system: Incident report.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 false Distribution system: Incident report. 191.9... CONDITION REPORTS § 191.9 Distribution system: Incident report. (a) Except as provided in paragraph (c) of this section, each operator of a distribution pipeline system shall submit Department of...

  1. Incidence and Patterns of Adverse Event Onset During the First 60 Days After Ventricular Assist Device Implantation

    PubMed Central

    Genovese, Elizabeth A.; Dew, Mary Amanda; Teuteberg, Jeffrey J.; Simon, Marc A.; Kay, Joy; Siegenthaler, Michael P.; Bhama, Jay K.; Bermudez, Christian A.; Lockard, Kathleen L; Winowich, Steve; Kormos, Robert L.

    2009-01-01

    Background Although ventricular assist devices (VADs) provide effective treatment for end-stage heart failure, VAD support remains associated with significant risk for adverse events (AEs). To date there has been no detailed assessment of the incidence of a full range of AEs using standardized event definitions. We sought to characterize the frequency and timing of AE onset during the first 60 days of VAD support, a period during which clinical observation suggests the risk of incident AEs is high. Methods A retrospective analysis was performed utilizing prospectively collected data from a single-site clinical database including 195 patients aged ≥18 receiving VADs between 1996 and 2006. AEs were coded using standardized criteria. Cumulative incidence rates were determined, controlling for competing risks (death, transplantation, recovery/wean). Results During the first 60 days after implantation, the most common AEs were bleeding, infection, and arrhythmias (cumulative incidence rates, 36%–48%), followed by tamponade, respiratory events, reoperations, and neurologic events (24%–31%). Other events (e.g., hemolysis, renal, hepatic events) were less common (rates <15%). Some events (e.g., bleeding, arrhythmias) showed steep onset rates early after implantation. Others (e.g., infections, neurologic events) had gradual onsets during the 60-day period. Incidence of most events did not vary by implant era (1996–2000 vs. 2001–2006) or by left ventricular vs. biventricular support. Conclusions Understanding differential temporal patterns of AE onset will allow preventive strategies to be targeted to the time periods when specific AE risks are greatest. The AE incidence rates provide benchmarks against which future studies of VAD-related risks may be compared. PMID:19766801

  2. Patient safety incidents are common in primary care: A national prospective active incident reporting survey

    PubMed Central

    Brami, Jean; Chanelière, Marc; Kret, Marion; Mosnier, Anne; Dupie, Isabelle; Haeringer-Cholet, Anouk; Keriel-Gascou, Maud; Maradan, Claire; Villebrun, Frédéric; Makeham, Meredith; Quenon, Jean-Luc

    2017-01-01

    Background The study objectives were to describe the incidence and the nature of patient safety incidents (PSIs) in primary care general practice settings, and to explore the association between these incidents and practice or organizational characteristics. Methods GPs, randomly selected from a national influenza surveillance network (n = 800) across France, prospectively reported any incidents observed each day over a one-week period between May and July 2013. An incident was an event or circumstance that could have resulted, or did result, in harm to a patient, which the GP would not wish to recur. Primary outcome was the incidence of PSIs which was determined by counting reports per total number of patient encounters. Reports were categorized using existing taxonomies. The association with practice and organizational characteristics was calculated using a negative binomial regression model. Results 127 GPs (participation rate 79%) reported 317 incidents of which 270 were deemed to be a posteriori judged preventable, among 12,348 encounters. 77% had no consequences for the patient. The incidence of reported PSIs was 26 per 1000 patient encounters per week (95% CI [23‰ -28‰]). Incidents were three times more frequently related to the organization of healthcare than to knowledge and skills of health professionals, and especially to the workflow in the GPs’ offices and to the communication between providers and with patients. Among GP characteristics, three were related with an increased incidence in the final multivariable model: length of consultation higher than 15 minutes, method of receiving radiological results (by fax compared to paper or email), and being in a multidisciplinary clinic compared with sole practitioners. Conclusions Patient safety incidents (PSIs) occurred in mean once every two days in the sampled GPs and 2% of them were associated with a definite possibility for harm. Studying the association between organizational features of general

  3. Improving the reporting of adverse drug reactions in the hospital setting.

    PubMed

    Pushkin, Richard; Frassetto, Lynda; Tsourounis, Candy; Segal, Eleanor S; Kim, Stephanie

    2010-11-01

    The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.

  4. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital

    PubMed Central

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2015-01-01

    OBJECTIVE: With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. METHODS: This descriptive-cross sectional study was performed in 112 nurses working in a public hospital. The questionnaire was applied about pharmacovigilance and adverse drug reactions. The knowledge, attitudes and practices about adverse drug reactions were asked. RESULTS: The 74.1% of the nurses definition of “severe adverse effect” of drug therapy. The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%. Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM). Only 8% of nurses reported ADRs in their professionality. CONCLUSION: Although most of the participants knew the importance of ADR event reporting, event reporting was low. Thiese results showed that there is a lack of knowledge about pharmacovigilance. Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance. PMID:28058321

  5. IMPACT OF ABDOMINAL OBESITY ON INCIDENCE OF ADVERSE METABOLIC EFFECTS ASSOCIATED WITH ANTIHYPERTENSIVE MEDICATIONS

    PubMed Central

    Cooper-DeHoff, Rhonda M.; Wen, Sheron; Beitelshees, Amber L.; Zineh, Issam; Gums, John G.; Turner, Stephen T.; Gong, Yan; Hall, Karen; Parekh, Vishal; Chapman, Arlene B.; Boerwinkle, Eric; Johnson, Julie A.

    2009-01-01

    We assessed adverse metabolic effects (AMEs) of atenolol and hydrochlorothiazide (HCTZ) among hypertensive patients with and without abdominal obesity using data from a randomized, open-label study of hypertensive patients without evidence of cardiovascular disease or diabetes. Intervention included randomization to HCTZ 25mg or atenolol 100mg monotherapy followed by their combination. Fasting glucose, insulin, triglycerides, HDL cholesterol and uric acid were measured at baseline and after mono-and combination therapy. Outcomes included new occurrence of and predictors for new cases of glucose ≥ 100mg/dl (impaired fasting glucose [IFG]), triglyceride ≥ 150 mg/dl, HDL ≤ 40mg/dl for men or ≤ 50mg/dl for women, or new onset diabetes according to presence or absence of abdominal obesity. Abdominal obesity was present in 167/395 (58%). Regardless of strategy, in those with abdominal obesity, 20% had IFG at baseline compared with 40% at end of study (p<0.0001). Proportion with triglycerides ≥ 150 mg/dl increased from 33% at baseline to 46% at end of study (p<0.01). New onset diabetes occurred in 13 (6%) with and in 4 (2%) without abdominal obesity. Baseline levels of glucose, triglyceride and HDL predicted adverse outcomes and predictors for new onset diabetes after monotherapy in those with abdominal obesity included HCTZ strategy (OR 47, 95% CI 2.55-862), female sex (OR 31.3, 95% CI 2.10-500) and uric acid (OR 3.2, 95% CI 2.35-7.50). Development of AME, including new onset diabetes associated with short term exposure to HCTZ and atenolol was more common in those with abdominal obesity. PMID:19917874

  6. Developing a user-centered voluntary medical incident reporting system.

    PubMed

    Hua, Lei; Gong, Yang

    2010-01-01

    Medical errors are one of leading causes of death among adults in the United States. According to the Institute of Medicine, reporting of medical incidents could be a cornerstone to learn from errors and to improve patient safety, if incident data are collected in a properly structured format which is useful for the detection of patterns, discovery of underlying factors, and generation of solutions. Globally, a number of medical incident reporting systems were deployed for collecting observable incident data in care delivery organizations (CDO) over the past several years. However, few researches delved into design of user-centered reporting system for improving completeness and accuracy of medical incident collection, let alone design models created for other institutes to follow. In this paper, we introduce the problems identified in a current using voluntary reporting system and our effort is being made towards complete, accurate and useful user-centered new reporting system through a usability engineering process.

  7. Adverse Drug Reactions and quality deviations monitored by spontaneous reports

    PubMed Central

    Visacri, Marília Berlofa; de Souza, Cinthia Madeira; Sato, Catarina Miyako Shibata; Granja, Silvia; de Marialva, Mécia; Mazzola, Priscila Gava; Moriel, Patricia

    2014-01-01

    Objectives The aim of this study was to determine the frequency and profile of spontaneous reports of Adverse Drug Reactions (ADRs) and quality deviations in a Brazilian teaching hospital and propose a consistent classification to study quality deviations. Methods This is a descriptive and retrospective study involving the analysis of spontaneous reports of ADRs and quality deviations in 2010. ADRs were classified according to the reaction mechanism, severity, and causality. The drugs were classified according to their therapeutic classes and symptoms according to the affected organ. The quality deviations were classified according to the type of deviation and type of medicine available in the Brazilian market. Results A total of 68 forms were examined; ADRs accounted for 39.7% of the notifications, while quality deviations accounted for 60.3%. ADRs occurred more frequently in men (51.9%) and adults (63.0%). The skin (28.0%) was the most affected organ, while anti-infectives (40.7%) were the therapeutic class that caused the most ADRs. The most common ADRs were type B (74.0%), moderates (37.0%), and probables (55.6%). In relation to quality deviations, the most frequent notifications were breaks, splits and leaks (20.9%) and related to generic drugs (43.9%). Conclusion The classification system to study quality deviations was clear and consistent. This study demonstrated that practices and public policies related to more effective pharmacovigilance need to be implemented so that the number of spontaneous reports increases. PMID:25972731

  8. Vaccine adverse events reported in post-marketing study of the Kitasato Institute from 1994 to 2004.

    PubMed

    Nakayama, Tetsuo; Onoda, Kazumasa

    2007-01-05

    General physicians, pediatricians and parents realize that serious adverse events occur with an extremely rare incidence, but have no information on the incidences of vaccine-associated adverse events. A proper understanding of vaccine adverse events would be helpful in promoting an immunization strategy. Causal association can rarely be determined in adverse events through laboratory examinations. We examined the cases reported in the post-marketing surveillance of the Kitasato Institute, categorizing them into two groups: allergic reactions and severe systemic illnesses. Anaphylactic patients with gelatin allergy after immunization with live measles, rubella and mumps monovalent vaccines have been reported since 1993, but the number of reported cases with anaphylaxis dramatically decreased after 1999 when gelatin was removed from all brands of DPT. The incidence of anaphylactic reaction was estimated to be 0.63 per million for Japanese encephalitis virus (JEV) vaccine, 0.95 for DPT and 0.68 for Influenza vaccine, but the causative component has not yet been specified. Among 67.2 million immunization practices, 6 cases with encephalitis or encephalopathy, 7 with acute disseminated encephalomyelitis (ADEM), 10 with Guillain-Barré syndrome and 12 with idiopathic thrombocytopenic purpura (ITP) were reported. The wild-type measles virus genome was detected in a patient with encephalitis and in two of four bone marrow aspirates obtained from ITP after measles vaccination. Enterovirus infection was identified in two patients after mumps vaccination (one each with encephalitis and ADEM), one patient with encephalitis after immunization with JEV vaccine, and one with aseptic meningitis after immunization with influenza vaccine. The total estimated incidence of serious neurological illness after vaccination was 0.1-0.2 per million immunization practices. We found that enterovirus or wild-type measles virus infection was coincidentally associated with vaccination in

  9. Developmental Regression and Autism Reported to the Vaccine Adverse Event Reporting System

    ERIC Educational Resources Information Center

    Woo, Emily Jane; Ball, Robert; Landa, Rebecca; Zimmerman, Andrew W.; Braun, M. Miles

    2007-01-01

    We report demographic and clinical characteristics of children reported to the US Vaccine Adverse Event Reporting System (VAERS) as having autism or another developmental disorder after vaccination. We completed 124 interviews with parents and reviewed medical records for 31 children whose records contained sufficient information to evaluate the…

  10. Adverse events following pertussis and rubella vaccines. Summary of a report of the Institute of Medicine.

    PubMed

    Howson, C P; Fineberg, H V

    1992-01-15

    In August 1991, the Institute of Medicine released a report entitled Adverse Effects of Pertussis and Rubella Vaccines, which examined 18 adverse events in relation to diphtheria-tetanus-pertussis (DTP) vaccine and four adverse events in relation to the currently used rubella vaccine strain, RA 27/3. The committee spent 20 months reviewing a wide range of information sources, including case series and individual case reports, both published and unpublished, epidemiologic studies, studies in animals, and other laboratory studies. The committee found that the evidence indicates a causal relation between DTP vaccine and anaphylaxis and between the pertussis component of DTP vaccine and extended periods of inconsolable crying or screaming. The committee also reported that the evidence indicates a causal relation between the rubella vaccine and acute arthritis in adult women. The committee found the available evidence weaker but still consistent with a causal relation between DTP vaccine and two conditions--acute encephalopathy and hypotonic, hyporesponsive episodes--and between rubella vaccine and chronic arthritis in adult women. Estimated incidence rates of these adverse events following vaccination are provided, where possible. The committee found that the evidence does not indicate a causal relation between the DTP vaccine and infantile spasms, hypsarrhythmia, Reye's syndrome, and sudden infant death syndrome. The committee found insufficient evidence to indicate either the presence or absence of a causal relation between DTP vaccine and chronic neurologic damage, aseptic meningitis, erythema multiforme or other rash, Guillain-Barré syndrome, hemolytic anemia, juvenile diabetes, learning disabilities and attention-deficit disorder, peripheral mononeuropathy, or thrombocytopenia, and between rubella vaccine and radiculoneuritis and other neuropathies or thrombocytopenic purpura. The committee's evaluative methods are briefly described and a summary of research

  11. C2-Related Incidents Reported by UAS Pilots

    NASA Technical Reports Server (NTRS)

    Hobbs, Alan; Cardoza, Colleen; Null, Cynthia

    2016-01-01

    It has been estimated that aviation accidents are typically preceded by numerous minor incidents arising from the same causal factors that ultimately produced the accident. Accident databases provide in-depth information on a relatively small number of occurrences, however incident databases have the potential to provide insights into the human factors of Remotely Piloted Aircraft System (RPAS) operations based on a larger volume of less-detailed reports. Currently, there is a lack of incident data dealing with the human factors of unmanned aircraft systems. An exploratory study is being conducted to examine the feasibility of collecting voluntary critical incident reports from RPAS pilots. Twenty-three experienced RPAS pilots volunteered to participate in focus groups in which they described critical incidents from their own experience. Participants were asked to recall (1) incidents that revealed a system flaw, or (2) highlighted a case where the human operator contributed to system resilience or mission success. Participants were asked to only report incidents that could be included in a public document. During each focus group session, a note taker produced a de-identified written record of the incident narratives. At the end of the session, participants reviewed each written incident report, and made edits and corrections as necessary. The incidents were later analyzed to identify contributing factors, with a focus on design issues that either hindered or assisted the pilot during the events. A total of 90 incidents were reported. This presentation focuses on incidents that involved the management of the command and control (C2) link. The identified issues include loss of link, interference from undesired transmissions, voice latency, accidental control transfer, and the use of the lost link timer, or lost link OK features.

  12. WHO Efforts to Promote Reporting of Adverse Events and Global Learning.

    PubMed

    Larizgoitia, Itziar; Bouesseau, Marie-Charlotte; Kelley, Edward

    2013-12-01

    Despite the importance of reporting systems to learn about the casual chain and consequences of patient safety incidents, this is an area that requires of further conceptual and technical developments to conduce reporting to effective learning. The World Health Organization, through its Patient Safety Programme, adopted as a priority the objective to facilitate and stimulate global learning through enhanced reporting of patient safety incidents. Landmark developments were the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, and the Conceptual Framework for the International Classification for Patient Safety, as well as the Global Community of Practice for Reporting and Learning Systems. WHO is currently working with a range of scientists, medical informatics specialists and healthcare officials from various countries around the world, to arrive at a Minimal Information Model that could serve as a basis to structure the core of reporting systems in a comparable manner across the world. Undoubtedly, there is much need for additional scientific developments in this challenging and innovative area. For effective reporting systems and enhanced global learning, other key contextual factors are essential for reporting to serve to the needs of clinicians, patients and the healthcare system at large. Moreover, the new data challenges and needs of organizations must be assessed as the era of big data comes to heath care. These considerations delineate a broad agenda for action, which offer an ambitious challenge for WHO and their partners interested in strengthening learning for improving through reporting and communicating about patient safety incidents. Significance for public healthUnderstanding the causes and consequences of incidents is cornerstone for patient safety improvement. Likewise, setting up systems to facilitate such understanding and communicate the learning across all healthcare actors is crucial. Over the past decade, the World Health

  13. WHO Efforts to Promote Reporting of Adverse Events and Global Learning

    PubMed Central

    Larizgoitia, Itziar; Bouesseau, Marie-Charlotte; Kelley, Edward

    2013-01-01

    Despite the importance of reporting systems to learn about the casual chain and consequences of patient safety incidents, this is an area that requires of further conceptual and technical developments to conduce reporting to effective learning. The World Health Organization, through its Patient Safety Programme, adopted as a priority the objective to facilitate and stimulate global learning through enhanced reporting of patient safety incidents. Landmark developments were the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, and the Conceptual Framework for the International Classification for Patient Safety, as well as the Global Community of Practice for Reporting and Learning Systems. WHO is currently working with a range of scientists, medical informatics specialists and healthcare officials from various countries around the world, to arrive at a Minimal Information Model that could serve as a basis to structure the core of reporting systems in a comparable manner across the world. Undoubtedly, there is much need for additional scientific developments in this challenging and innovative area. For effective reporting systems and enhanced global learning, other key contextual factors are essential for reporting to serve to the needs of clinicians, patients and the healthcare system at large. Moreover, the new data challenges and needs of organizations must be assessed as the era of big data comes to heath care. These considerations delineate a broad agenda for action, which offer an ambitious challenge for WHO and their partners interested in strengthening learning for improving through reporting and communicating about patient safety incidents. Significance for public health Understanding the causes and consequences of incidents is cornerstone for patient safety improvement. Likewise, setting up systems to facilitate such understanding and communicate the learning across all healthcare actors is crucial. Over the past decade, the World Health

  14. The incidence and nature of adverse reactions to injection immunotherapy in bee and wasp venom allergy.

    PubMed

    Youlten, L J; Atkinson, B A; Lee, T H

    1995-02-01

    The incidence, time course and nature of systemic reactions to injections of bee and wasp venom during immunotherapy have been estimated in an open, prospective, single centre study. One hundred and nine survivors of moderate to severe systemic reactions to stings from hymenoptera, received courses of bee or wasp venom by monthly subcutaneous injection for up to 3 years. Systemic reactions were recorded after 7.5% of 946 weekly venom injections during the initial phase of treatment, and after 2.1% of 1789 monthly maintenance injections. In both phases of treatment, reactions were more frequent after bee (17% of initial phase, 7.8% of maintenance treatment) than after wasp (3% of initial phase, 0.3% of maintenance treatment) venom injections. The percentage of patients experiencing at least one reaction was also higher for bee (46%) than for wasp (14%) sensitive patients. Over 80% of reactions began within 30 min of injection, over 90% within 1 h and only two (2%), between 1 and 2 h, the remaining six (5.5%) starting more than 2 h after injection. Only 0.47% of venom injections produced a systemic reaction which was severe enough to require adrenaline treatment. The female patients experienced more reactions (21% of the wasp, 60% of the bee, sensitive) than the males (5.5% wasp, 20% bee). Age and atopy did not appear to be significant risk factors for systemic reactions. We conclude that wasp and bee venom immunotherapy in a conventional dosage regimen was generally well tolerated.(ABSTRACT TRUNCATED AT 250 WORDS)

  15. SU-E-P-07: Retrospective Analysis of Incident Reports at a Radiology Department: Feedback From Incident Reporting System

    SciTech Connect

    Kakinohana, Y; Toita, T; Heianna, J; Murayama, S

    2015-06-15

    Purpose: To provide an overview of reported incidents that occurred in a radiology department and to describe the most common causal source of incidents. Methods: Incident reports from the radiology department at the University of the Ryukyus Hospital between 2008 and 2013 were collected and analyzed retrospectively. The incident report form contains the following items, causal factors of the incident and desirable corrective actions to prevent recurrence of similar incidents. These items allow the institution to investigate/analyze root causes of the incidents and suggest measures to be taken to prevent further, similar incidents. The ‘causal factors of the incident’ item comprises multiple selections from among 24 selections and includes some synonymous selections. In this study, this item was re-categorized into four causal source types: (i) carelessness, (ii) lack of skill or knowledge, (iii) deficiencies in communication, and (iv) external factors. Results: There were a total of 7490 incident reports over the study period and 276 (3.7%) were identified as originating from the radiology department. The most frequent causal source type was carelessness (62%). The other three types showed similar frequencies (10–14%). The staff members involved in incidents indicate three predominant desirable corrective actions to prevent or decrease the recurrence of similar incidents. These are ‘improvement in communication’ (24%), ‘staff training/education’ (19%), and ‘daily medical procedures’ (22%), and the most frequent was ‘improvement in communication’. Even though the most frequent causal factor was related to carelessness, the most desirable corrective action indicated by the staff members was related to communication. Conclusion: Our finding suggests that the most immediate causes are strongly related to carelessness. However, the most likely underlying causes of incidents would be related to deficiencies in effective communication. At our

  16. Adverse Outcome Pathways: From Research to Regulation - Scientific Workshop Report

    EPA Science Inventory

    An adverse outcome pathway (AOP) organizes existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify...

  17. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    MedlinePlus

    ... Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it More ... information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety Information ...

  18. 45 CFR 60.11 - Reporting adverse actions on clinical privileges.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) of this section, the Secretary will designate another qualified entity for the reporting of this... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting adverse actions on clinical privileges... Reporting of Information § 60.11 Reporting adverse actions on clinical privileges. (a) Reporting to...

  19. [International reporting of adverse drug reactions. Final report of CIOMS ADR Working Group].

    PubMed

    Royer, R J; Benichou, C

    1991-01-01

    Under the auspices of the Council for International Organizations of Medical Sciences, a working group composed of representatives of seven multinational pharmaceutical manufacturers and six regulatory authorities developed and implemented a standardized method for reporting post-approval adverse drug reactions (ADR). The method is based on a set of uniform definitions and procedures and a single reporting form, and has been demonstrated to be feasible and effective. Regulators and manufacturers, in establishing requirements and systems for reporting of adverse drug reactions, should consider adopting this method.

  20. [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.

  1. Incidence of adverse drug events in public and private hospitals in Riyadh, Saudi Arabia: the (ADESA) prospective cohort study

    PubMed Central

    Aljadhey, Hisham; Mahmoud, Mansour A; Ahmed, Yusuf; Sultana, Razia; Zouein, Salah; Alshanawani, Sulafah; Mayet, Ahmed; Alshaikh, Mashael K; Kalagi, Nora; Al Tawil, Esraa; El Kinge, Abdul Rahman; Arwadi, Abdulmajid; Alyahya, Maha; Murray, Michael D; Bates, David

    2016-01-01

    Objectives To determine the incidence of adverse drug events (ADEs) and assess their severity and preventability in four Saudi hospitals. Design Prospective cohort study. Setting The study included patients admitted to medical, surgical and intensive care units (ICUs) of four hospitals in Saudi Arabia. These hospitals include a 900-bed tertiary teaching hospital, a 400-bed private hospital, a 1400-bed large government hospital and a 350-bed small government hospital. Participants All patients (≥12 years) admitted to the study units over 4 months. Primary and secondary outcome measures Incidents were collected by pharmacists and reviewed by independent clinicians. Reviewers classified the identified incidents as ADEs, potential ADEs (PADEs) or medication errors and then determined their severity and preventability. Results We followed 4041 patients from admission to discharge. Of these, 3985 patients had complete data for analysis. The mean±SD age of patients in the analysed cohort was 43.4±19.0 years. A total of 1676 ADEs were identified by pharmacists during the medical chart review. Clinician reviewers accepted 1531 (91.4%) of the incidents identified by the pharmacists (245 ADEs, 677 PADEs and 609 medication errors with low risk of causing harm). The incidence of ADEs was 6.1 (95% CI 5.4 to 6.9) per 100 admissions and 7.9 (95% CI 6.9 to 8.9) per 1000 patient-days. The occurrence of ADEs was most common in ICUs (149 (60.8%)) followed by medical (67 (27.3%)) and surgical (29 (11.8%)) units. In terms of severity, 129 (52.7%) of the ADEs were significant, 91 (37.1%) were serious, 22 (9%) were life-threatening and three (1.2%) were fatal. Conclusions We found that ADEs were common in Saudi hospitals, especially in ICUs, causing significant morbidity and mortality. Future studies should focus on investigating the root causes of ADEs at the prescribing stage, and development and testing of interventions to minimise harm from medications. PMID:27406640

  2. SU-E-T-524: Web-Based Radiation Oncology Incident Reporting and Learning System (ROIRLS)

    SciTech Connect

    Kapoor, R; Palta, J; Hagan, M; Grover, S; Malik, G

    2014-06-01

    Purpose: Describe a Web-based Radiation Oncology Incident Reporting and Learning system that has the potential to improve quality of care for radiation therapy patients. This system is an important facet of continuing effort by our community to maintain and improve safety of radiotherapy.Material and Methods: The VA National Radiation Oncology Program office has embarked on a program to electronically collect adverse events and near miss data of radiation treatment of over 25,000 veterans treated with radiotherapy annually. Software used for this program is deployed on the VAs intranet as a Website. All data entry forms (adverse event or near miss reports, work product reports) utilize standard causal, RT process step taxonomies and data dictionaries defined in AAPM and ASTRO reports on error reporting (AAPM Work Group Report on Prevention of Errors and ASTROs safety is no accident report). All reported incidents are investigated by the radiation oncology domain experts. This system encompasses the entire feedback loop of reporting an incident, analyzing it for salient details, and developing interventions to prevent it from happening again. The operational workflow is similar to that of the Aviation Safety Reporting System. This system is also synergistic with ROSIS and SAFRON. Results: The ROIRLS facilitates the collection of data that help in tracking adverse events and near misses and develop new interventions to prevent such incidents. The ROIRLS electronic infrastructure is fully integrated with each registered facility profile data thus minimizing key strokes and multiple entries by the event reporters. Conclusions: OIRLS is expected to improve the quality and safety of a broad spectrum of radiation therapy patients treated in the VA and fulfills our goal of Effecting Quality While Treating Safely The Radiation Oncology Incident Reporting and Learning System software used for this program has been developed, conceptualized and maintained by TSG Innovations

  3. Methodology of AA CRASH: a prospective observational study evaluating the incidence and pathogenesis of adverse post-traumatic sequelae in African-Americans experiencing motor vehicle collision

    PubMed Central

    Linnstaedt, Sarah D; Hu, JunMei; Liu, Andrea Y; Soward, April C; Bollen, Kenneth A; Wang, Henry E; Hendry, Phyllis L; Zimny, Erin; Lewandowski, Christopher; Velilla, Marc-Anthony; Damiron, Kathia; Pearson, Claire; Domeier, Robert; Kaushik, Sangeeta; Feldman, James; Rosenberg, Mark; Jones, Jeffrey; Swor, Robert; Rathlev, Niels; McLean, Samuel A

    2016-01-01

    Introduction A motor vehicle collision (MVC) is one of the most common life-threatening events experienced by individuals living in the USA. While most individuals recover following MVC, a significant proportion of individuals develop adverse post-traumatic sequelae such as post-traumatic stress disorder or persistent musculoskeletal pain. Adverse post-traumatic sequelae are common, morbid and costly public health problems in the USA and other industrialised countries. The pathogenesis of these disorders following MVC remains poorly understood. In the USA, available data suggest that African-Americans experience an increased burden of adverse post-traumatic sequelae after MVC compared to European Americans, but to date no studies examining the pathogenesis of these disorders among African-Americans experiencing MVC have been performed. Methods and analysis The African-American CRASH (AA CRASH) study is an NIH-funded, multicentre, prospective study that enrols African-Americans (n=900) who present to the emergency department (ED) within 24 hours of MVC. Participants are enrolled at 13 ED sites in the USA. Individuals who are admitted to the hospital or who report a fracture or tissue injury are excluded. Participants complete a detailed ED interview that includes an assessment of crash history, current post-traumatic symptoms and health status prior to the MVC. Blood samples are also collected in the ED using PAXgene DNA and PAXgene RNA tubes. Serial mixed-mode assessments 6 weeks, 6 months and 1 year after MVC include an assessment of adverse sequelae, general health status and health service utilisation. The results from this study will provide insights into the incidence and pathogenesis of persistent pain and other post-traumatic sequelae in African-Americans experiencing MVC. Ethics and dissemination AA CRASH has ethics approval in the USA, and the results will be published in a peer-reviewed journal. PMID:27601501

  4. FDI report on adverse reactions to resin-based materials.

    PubMed

    Fan, P L; Meyer, D M

    2007-02-01

    Resin-based restorative materials are considered safe for the vast majority of dental patients. Although constituent chemicals such as monomers, accelerators and initiators can potentially leach out of cured resin-based materials after placement, adverse reactions to these chemicals are rare and reaction symptoms commonly subside after removal of the materials. Dentists should be aware of the rare possibility that patients could have adverse reactions to constituents of resin-based materials and be vigilant in observing any adverse reactions after restoration placement. Dentists should also be cognisant of patient complaints about adverse reactions that may result from components of resin-based materials. To minimise monomer leaching and any potential risk of dermatological reactions, resin-based materials should be adequately cured. Dental health care workers should avoid direct skin contact with uncured resin-based materials. Latex and vinyl gloves do not provide adequate barrier protection to the monomers in resin-based materials.

  5. The evaluation of a web-based incident reporting system.

    PubMed

    Kuo, Ya-Hui; Lee, Ting-Ting; Mills, Mary Etta; Lin, Kuan-Chia

    2012-07-01

    A Web-based reporting system is essential to report incident events anonymously and confidentially. The purpose of this study was to evaluate a Web-based reporting system in Taiwan. User satisfaction and impact of system use were evaluated through a survey answered by 249 nurses. Incident events reported in paper and electronic systems were collected for comparison purposes. Study variables included system user satisfaction, willingness to report, number of reports, severity of the events, and efficiency of the reporting process. Results revealed that senior nurses were less willing to report events, nurses on internal medicine units had higher satisfaction than others, and lowest satisfaction was related to the time it took to file a report. In addition, the Web-based reporting system was used more often than the paper system. The percentages of events reported were significantly higher in the Web-based system in laboratory, environment/device, and incidents occurring in other units, whereas the proportions of reports involving bedsores and dislocation of endotracheal tubes were decreased. Finally, moderate injury event reporting decreased, whereas minor or minimal injury event reporting increased. The study recommends that the data entry process be simplified and the network system be improved to increase user satisfaction and reporting rates.

  6. Development of Incident Report Database for Organizational Learning

    NASA Astrophysics Data System (ADS)

    Otsuka, Yuichi; Abe, Tomotaka; Noguchi, Hiroshi; Makinouchi, Akifumi

    The necessity of an incident reporting system has recently been increasing for hospitals. Japan Council for Quality Health Care (JCQHC) started operating a national incident reporting system to which domestic hospitals would report their incidents. However, the reporting system obtained an additional problem for the hospitals. They managed their own systems which collected reports by papers. The purposes of the reporting systems was to analyze considerable causes involved in incidents to improve the quality of patient safety management. On the contrary, the national reporting system aimed at collecting a statistical tendency of normal incidents. Simultaneously operating the two systems would be too much workload for safety managers. The load may have the managers rest only a short time for summarizing occurrences, not enough for analyzing their causes. However, to the authors' knowledge, there has not been an integrating policy of the two forms to adapt them to practical situations in patient safety management. The scope of this paper is to establish the integrated form in order to use in analyzing the causes of incidents as well as reporting for the national system. We have developed new data base system using XML + XSLT and Java Servlet. The developed system is composed of three computers; DB server , DB client and Data sending server. To investigate usability of the developed system, we conducted a monitoring test by real workers in reporting workplaces. The result of subjective evaluations by examinees was so preferable for the developed system. The results of usability test and the achievement of increasing the number of reports after the introduction can demonstrate the enough effectiveness of the developed system for supporting the activity of patient safety management.

  7. Spatial Distribution of Black Bear Incident Reports in Michigan.

    PubMed

    McFadden-Hiller, Jamie E; Beyer, Dean E; Belant, Jerrold L

    2016-01-01

    Interactions between humans and carnivores have existed for centuries due to competition for food and space. American black bears are increasing in abundance and populations are expanding geographically in many portions of its range, including areas that are also increasing in human density, often resulting in associated increases in human-bear conflict (hereafter, bear incidents). We used public reports of bear incidents in Michigan, USA, from 2003-2011 to assess the relative contributions of ecological and anthropogenic variables in explaining the spatial distribution of bear incidents and estimated the potential risk of bear incidents. We used weighted Normalized Difference Vegetation Index mean as an index of primary productivity, region (i.e., Upper Peninsula or Lower Peninsula), primary and secondary road densities, and percentage land cover type within 6.5-km2 circular buffers around bear incidents and random points. We developed 22 a priori models and used generalized linear models and Akaike's Information Criterion (AIC) to rank models. The global model was the best compromise between model complexity and model fit (w = 0.99), with a ΔAIC 8.99 units from the second best performing model. We found that as deciduous forest cover increased, the probability of bear incident occurrence increased. Among the measured anthropogenic variables, cultivated crops and primary roads were the most important in our AIC-best model and were both positively related to the probability of bear incident occurrence. The spatial distribution of relative bear incident risk varied markedly throughout Michigan. Forest cover fragmented with agriculture and other anthropogenic activities presents an environment that likely facilitates bear incidents. Our map can help wildlife managers identify areas of bear incident occurrence, which in turn can be used to help develop strategies aimed at reducing incidents. Researchers and wildlife managers can use similar mapping techniques to

  8. Spatial Distribution of Black Bear Incident Reports in Michigan

    PubMed Central

    McFadden-Hiller, Jamie E.; Beyer, Dean E.; Belant, Jerrold L.

    2016-01-01

    Interactions between humans and carnivores have existed for centuries due to competition for food and space. American black bears are increasing in abundance and populations are expanding geographically in many portions of its range, including areas that are also increasing in human density, often resulting in associated increases in human-bear conflict (hereafter, bear incidents). We used public reports of bear incidents in Michigan, USA, from 2003–2011 to assess the relative contributions of ecological and anthropogenic variables in explaining the spatial distribution of bear incidents and estimated the potential risk of bear incidents. We used weighted Normalized Difference Vegetation Index mean as an index of primary productivity, region (i.e., Upper Peninsula or Lower Peninsula), primary and secondary road densities, and percentage land cover type within 6.5-km2 circular buffers around bear incidents and random points. We developed 22 a priori models and used generalized linear models and Akaike’s Information Criterion (AIC) to rank models. The global model was the best compromise between model complexity and model fit (w = 0.99), with a ΔAIC 8.99 units from the second best performing model. We found that as deciduous forest cover increased, the probability of bear incident occurrence increased. Among the measured anthropogenic variables, cultivated crops and primary roads were the most important in our AIC-best model and were both positively related to the probability of bear incident occurrence. The spatial distribution of relative bear incident risk varied markedly throughout Michigan. Forest cover fragmented with agriculture and other anthropogenic activities presents an environment that likely facilitates bear incidents. Our map can help wildlife managers identify areas of bear incident occurrence, which in turn can be used to help develop strategies aimed at reducing incidents. Researchers and wildlife managers can use similar mapping techniques to

  9. Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two “challenging” case reports

    PubMed Central

    Palleria, Caterina; Leporini, Christian; Chimirri, Serafina; Marrazzo, Giuseppina; Sacchetta, Sabrina; Bruno, Lucrezia; Lista, Rosaria M.; Staltari, Orietta; Scuteri, Antonio; Scicchitano, Francesca; Russo, Emilio

    2013-01-01

    Introduction: Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. Materials and Methods: We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. Results: First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. Discussion and Conclusion: Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health. PMID:24347986

  10. Patterns of Error in Confidential Maintenance Incident Reports

    NASA Technical Reports Server (NTRS)

    Hobbs, Alan; Kanki, Barbara G.

    2008-01-01

    Confidential reports of maintenance incidents are a valuable source of information on maintenance errors and the contexts within which they occur. NASA's Aviation Safety Reporting System (ASRS) has been receiving an increasing number of maintenance incident reports since a specialized maintenance reporting form was introduced in 1996. In a series of studies, the database of ASRS maintenance incidents was examined using correspondence analysis, a statistical technique that converts complex data tables into a visual form. The analyses revealed patterns within the ASRS data set that would have otherwise been difficult to detect. The results have implications for a range of purposes including human factors training, the design of procedures, and the identification of improvements in aircraft design.

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

    PubMed

    Umetsu, Ryogo; Abe, Junko; Ueda, Natsumi; Kato, Yamato; Nakayama, Yoko; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Over-the-counter (OTC) drugs play an important role in self-medication. To ensure patient safety, pharmacists should ask patients to pay attention to possible adverse events (AE) associated with OTC drugs and educate patients about the symptoms related to those AEs. The aims of the present study were as follows: (1) to assess the tendency of AEs to occur with OTC drug use in Japan; (2) to detect a safety signal for OTC drugs using the reporting odds ratio (ROR); and (3) to evaluate clustery features, which include suspected drugs and therapeutic classifications, and safety signal indices (number of reports and the ROR), using cluster analysis. The number of reports of AEs following use of combination cold remedy, antipyretic and analgesic remedy, and herbal medicine was 1007, 566, and 221, respectively. We set the cluster number at five; clustery features obtained were as follows: (1) high reporting rate for skin and subcutaneous tissue disorder AEs was the largest group related to combination cold remedy; (2) high reporting rate for nervous system disorder AEs including dizziness was the second largest group. The same medicinal ingredient may demonstrate similar tendencies of the occurrence of AEs and similar clustery features in the Japanese Adverse Drug Event Report database. Our analysis of AEs associated with OTC drugs may be useful for pharmacists and patients alike. Further studies are required to draw better-informed conclusions.

  12. Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

    PubMed Central

    Brown, S L; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

    1998-01-01

    OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to SGBIs accounted for 2.4% of the 14,473 mandatory reports entered into the FDA database on medical devices. In 1992, SGBI-related reports accounted for 30.3% of the total 66,476 mandatory reports of adverse events. The most frequently reported adverse event in 1988, before the widespread publicity on breast implants, was implant burst or rupture. In contrast, in 1992 the most frequently reported event was reaction, a term used to describe a range of adverse effects. CONCLUSIONS: The numbers of mandatory and voluntary reports of SGBI-related adverse events increased exponentially, as did the complexity of the reports, following publicity over the lack of safety data on breast implants and a short voluntary moratorium on their sale. A significant proportion of reports lacked information on specific medical symptoms or diagnoses. PMID:9847926

  13. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    PubMed Central

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  14. Adverse outcome pathways: From research to regulation scientific workshop report.

    PubMed

    Kleinstreuer, Nicole C; Sullivan, Kristie; Allen, David; Edwards, Stephen; Mendrick, Donna L; Embry, Michelle; Matheson, Joanna; Rowlands, J Craig; Munn, Sharon; Maull, Elizabeth; Casey, Warren

    2016-04-01

    An adverse outcome pathway (AOP) helps to organize existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify knowledge gaps where more research is needed to understand the underlying mechanisms, aid in chemical hazard characterization, and guide the development of new testing approaches that use fewer or no animals. A September 2014 workshop in Bethesda, Maryland considered how the AOP concept could improve regulatory assessments of chemical toxicity. Scientists from 21 countries, representing industry, academia, regulatory agencies, and special interest groups, attended the workshop, titled Adverse Outcome Pathways: From Research to Regulation. Workshop plenary presentations were followed by breakout sessions that considered regulatory acceptance of AOPs and AOP-based tools, criteria for building confidence in an AOP for regulatory use, and requirements to build quantitative AOPs and AOP networks. Discussions during the closing session emphasized a need to increase transparent and inclusive collaboration, especially with disciplines outside of toxicology. Additionally, to increase impact, working groups should be established to systematically prioritize and develop AOPs. Multiple collaborative projects and follow-up activities resulted from the workshop.

  15. Major incidents in Britain over the past 28 years: the case for the centralised reporting of major incidents

    PubMed Central

    Carley, S.; Mackway-Jones, K.; Donnan, S.

    1998-01-01

    STUDY OBJECTIVES: To describe the incidence and epidemiology of major incidents occurring in Britain over the past 28 years. METHODS: Major incidents were identified through a MEDLINE search, a hand search of journals and government reports at the Home Office Emergency Planning College, newspaper reports, a postal survey of ambulance emergency planning officers, and through requests for information posted on the internet. MAIN RESULTS: Brief incidents profiles from 108 British major incidents are presented. Most major incidents pass unreported in the medical literature. On average three to four major incidents occur in Britain each year (range 0-11). Sixty three of 108 (59.2%) of incidents involve public transportation. The next two largest groups are civil disturbance 22 of 108 (20.3%) and industrial accidents 16 of 108 (14.8%). Although incidents at sports stadiums are rare they produce large numbers of casualties. The data currently available on major incidents are difficult to find and of questionable accuracy. CONCLUSIONS: The lack of data makes planning for major incidents and exercising major incident plans difficult. Casualty incident profiles (CIPs) may assist major incidents exercises and planning. CIPs from future major incidents should be collated and made available to all major incident planners.   PMID:9764261

  16. Risk of Adverse Cognitive or Behavioral Conditions and Psychiatric Disorders: Evidence Report

    NASA Technical Reports Server (NTRS)

    Slack, Kelley J.; Williams, Thomas J.; Schneiderman, Jason S.; Whitmire, Alexandra M.; Picano, James J.; Leveton, Lauren B.; Schmidt, Lacey L.; Shea, Camille

    2016-01-01

    In April 2010, President Obama declared a space pioneering goal for the United States in general and NASA in particular. "Fifty years after the creation of NASA, our goal is no longer just a destination to reach. Our goal is the capacity for people to work and learn and operate and live safely beyond the Earth for extended periods of time, ultimately in ways that are more sustainable and even indefinite." Thus NASA's Strategic Objective 1.1 emerged as "expand human presence into the solar system and to the surface of Mars to advance exploration, science, innovation, benefits to humanity, and international collaboration" (NASA 2015b). Any space flight, be it of long or short duration, occurs in an extreme environment that has unique stressors. Even with excellent selection methods, the potential for behavioral problems among space flight crews remain a threat to mission success. Assessment of factors that are related to behavioral health can help minimize the chances of distress and, thus, reduce the likelihood of adverse cognitive or behavioral conditions and psychiatric disorders arising within a crew. Similarly, countermeasures that focus on prevention and treatment can mitigate the cognitive or behavioral conditions that, should they arise, would impact mission success. Given the general consensus that longer duration, isolation, and confined missions have a greater risk for behavioral health ensuring crew behavioral health over the long term is essential. Risk, which within the context of this report is assessed with respect to behavioral health and performance, is addressed to deter development of cognitive and behavioral degradations or psychiatric conditions in space flight and analog populations, and to monitor, detect, and treat early risk factors, predictors and other contributing factors. Based on space flight and analog evidence, the average incidence rate of an adverse behavioral health event occurring during a space mission is relatively low for the

  17. 76 FR 30855 - Accident/Incident Reporting Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-27

    ... Federal Railroad Administration 49 CFR Part 225 RIN 2130-AB82 Accident/Incident Reporting Requirements AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Final rule... available for railroad casualty analysis. This document amends and clarifies the final rule based on...

  18. 18 CFR 12.10 - Reporting safety-related incidents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Reporting safety-related incidents. 12.10 Section 12.10 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS...

  19. 18 CFR 12.10 - Reporting safety-related incidents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Reporting safety-related incidents. 12.10 Section 12.10 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS...

  20. 18 CFR 12.10 - Reporting safety-related incidents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Reporting safety-related incidents. 12.10 Section 12.10 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS...

  1. 18 CFR 12.10 - Reporting safety-related incidents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Reporting safety-related incidents. 12.10 Section 12.10 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS...

  2. 18 CFR 12.10 - Reporting safety-related incidents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Reporting safety-related incidents. 12.10 Section 12.10 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS...

  3. Blind Persons Report Critical Incidents of Science and Mathematics Instruction.

    ERIC Educational Resources Information Center

    Sica, Morris G.

    This project identified over 500 critical incidents of successful and unsuccessful instruction in science and mathematics courses reported through interviews of 105 blind college students. The principal categories of effective teacher behavior included planned concrete learning experiences, creative use of learning materials, and detailed…

  4. Incident Reporting Behaviours and Associated Factors among Nurses Working in Gondar University Comprehensive Specialized Hospital, Northwest Ethiopia

    PubMed Central

    2016-01-01

    Background. A comprehensive and systematic approach to incident reporting would help learn from errors and adverse events within a healthcare facility. Objective. The aim of the study was to assess incident reporting behaviours and associated factors among nurses. Methods. An institution-based cross-sectional study was conducted from April 14 to 29, 2015. Simple random sampling technique was used to select the study participants. Data were coded, entered into Epi Info 7, and exported to SPSS version 20 software for analysis. A multivariate logistic regression model was fitted and adjusted odds ratio with 95% confidence interval was used to determine the strength of association. Results. The proportion of nurses who reported incidents was 25.4%. Training on incident reporting (Adjusted Odds Ratio (AOR) [95% CI] 2.96 [1.34–6.26]), reason to report (to help patient) (AOR [95% CI] 3.08 [1.70–5.59]), fear of administrative sanctions (AOR [95% CI] 0.27 [0.12–0.58]), fear of legal penalty (AOR [95% CI] 0.09 [0.03–0.21]), and fear of loss of prestige among colleagues (AOR [95% CI] 0.25 [0.12–0.53]) were significantly associated factors with the incident reporting behaviour of nurses. Conclusion and Recommendation. The proportion of nurses who reported incidents was very low. Establishing a system which promotes incident reporting is vital. PMID:28116219

  5. Early Warning: Development of Confidential Incident Reporting Systems

    NASA Technical Reports Server (NTRS)

    OLeary, Mike J.; Chappell, Sheryl L.; Connell, Linda (Technical Monitor)

    1996-01-01

    Accidents hardly ever happen without warning. The combination, or sequence, of failures and mistakes that cause an accident may indeed be unique but the individual failures and mistakes rarely are. In the USA in 1974 the crews on two different aircraft misunderstood the same aeronautical chart and descended towards their destination dangerously early towards a mountain. The first crew were in good weather conditions and could see the mountain and resolved their misinterpretation of the chart. The second crew six weeks later were not so lucky. In cloud they had no clues to point out their mistake nor the presence of the mountain. The resulting crash and the ensuing inquiry, which brought to light the previous incident, shocked the country but gave it the impetus to instigate a safety reporting system. This system eventually became the NASA's Aviation Safety Reporting System (ASRS). The programme collects incident reports from pilots, controllers, mechanics, cabin attendants and many others involved in aviation operations. By disseminating this safety information the ASRS has helped enormously to give US airlines and airspace the highest safety standards. Accident prevention is a goal sought by everyone in the aviation industry and establishing effective incident reporting programmes can go a long way toward achieving that goal. This article will describe the steps and issues required to establish an incident reporting system. The authors summarize the lessons learned from the ASRS, now in its twentieth year of operation and from the Confidential Human Factors Reporting (HER) Programme run by British Airways, an airline that is a recognized world leader in safety reporting and analysis. The differences between government and airline operation of confidential safety reporting systems will be addressed.

  6. Developmental regression and autism reported to the Vaccine Adverse Event Reporting System.

    PubMed

    Woo, Emily Jane; Ball, Robert; Landa, Rebecca; Zimmerman, Andrew W; Braun, M Miles

    2007-07-01

    We report demographic and clinical characteristics of children reported to the US Vaccine Adverse Event Reporting System (VAERS) as having autism or another developmental disorder after vaccination. We completed 124 interviews with parents and reviewed medical records for 31 children whose records contained sufficient information to evaluate the child's developmental history. Medical record review indicated that 27 of 31 (87%) children had autism/ASD and 19 (61.3%) had evidence of developmental regression (loss of social, language, or motor skills). The proportion of VAERS cases of autism with regression was greater than that reported in population-based studies, based on the subset of VAERS cases with medical record confirmation. This difference may reflect preferential reporting to VAERS of autism with regression. In other respects, the children in this study appear to be similar to other children with autism. Further research might determine whether the pathogenesis of autism with developmental regression differs from that of autism without regression.

  7. Adverse Reaction to Nicotine Gum in Malay Female Smoker: A Case Report

    ERIC Educational Resources Information Center

    Noorzurani, Md Haris Robson; Bond, Alyson; Wolff, Kim

    2008-01-01

    Nicotine replacement therapies (NRT) are prescribed in smoking cessation programmes to help smokers stop smoking. The ideal dosage of NRT should control cravings and withdrawal symptoms but avoid adverse reactions. This report describes a case of adverse reaction to nicotine gum in a female Malay smoker. Assays taken 2 h after the gum, showed that…

  8. Child maltreatment increases sensitivity to adverse social contexts: Neighborhood physical disorder and incident binge drinking in Detroit

    PubMed Central

    Keyes, Katherine M.; McLaughlin, Katie A.; Koenen, Karestan C.; Goldmann, Emily; Uddin, Monica; Galea, Sandro

    2011-01-01

    INTRODUCTION Exposure to child maltreatment is associated with elevated risk for behavioral disorders in adulthood. One explanation for this life-course association is that child maltreatment increases vulnerability to the effects of subsequent stressors; however, the extent to which maltreatment increases sensitivity to social context has never been examined. We evaluated whether the association between neighborhood physical disorder and binge drinking was modified by child maltreatment exposure. METHODS Data were drawn from the Detroit Neighborhood Health Study, a prospective representative sample of predominately African Americans in the Detroit population. Neighborhood physical disorder was measured via systematic neighborhood assessment. Child maltreatment indicators included self-reported physical, sexual, and emotional abuse. Incident binge drinking was defined as at least one episode of ≥5 drinks (men) or ≥4 drinks (women) in the past 30-day period among those with no binge drinking at baseline (N=1,013). RESULTS Child maltreatment and neighborhood physical disorder interacted to predict incident binge drinking (B=0.16, p=0.02) and maximum number of past 30-day drinks (B=0.15, p=0.04), such that neighborhood physical disorder predicted problematic alcohol use only among individuals with high exposure to child maltreatment. CONCLUSION The results add to the growing literature that African Americans in the U.S. are exposed to an array of stressors that have pernicious consequences for problematic alcohol use. Our results document the need for increased attention to the potential for at-risk alcohol use among populations with a high degree of stress exposure. PMID:21981990

  9. Severe adverse reactions caused by omeprazole: A case report

    PubMed Central

    Yu, Meiling; Qian, Jianghua; Guo, Daohua; Li, Li; Liu, Xiaolin

    2016-01-01

    A 61-year-old female patient was admitted to hospital following development of a whole-body rash for 10 days, diarrhea for 7 days, and unconsciousness and oliguria for 1 day. The patient had developed stomach discomfort following the oral administration of non-steroidal anti-inflammatory drugs, the exact nature of which was unknown, for the treatment of arthritic pain for >1 month. The patient was then prescribed omeprazole enteric-coated tablets (20 mg twice daily) for treatment of this symptom. However, the patient developed a whole-body rash 7 days after administering omeprazole, 10 days prior to admission. This symptom was followed by severe diarrhea with nausea and vomiting after 10 days, then shock. The shock occurred after administering omeprazole for 16 days. The patient developed a whole body rash 7 days after administering omeprazole, then 3 days later (after administering omeprazole for 10 days) severe diarrhea with nausea and vomiting occurred. The shock remained until administering omeprazole on the 16th day, with severe diarrhea with nausea and vomiting occurring 6 days later. The patient's condition did not improve following treatment for allergies, low blood pressure and oliguria in the Intensive Care Unit (ICU) department at Suzhou Municipal Hospital. For further diagnosis and treatment, the patient was admitted to the ICU department of The First Affiliated Hospital of Bengbu Medical College and was given a fluid infusion, antibiotics and phlegm-reducing treatment, a plasma infusion, blood filtration, and anti-diarrheal and anti-allergy treatment. The patient's vital signs were stable, with a normal temperature and hemogram results, and improved kidney function and deflorescence. Genetic screening revealed that the patient poorly metabolized omeprazole. Therefore, severe adverse reactions (allergic shock, rash and diarrhea) experienced by the patient were caused by the accumulation of omeprazole metabolites resulting from its slow metabolism in

  10. [Incident-reporting electronic-based system in internal medicine].

    PubMed

    Servet, J; Bart, P-A; Wasserfallen, J-B; Castioni, J

    2015-11-04

    How to recognize, announce and analyze incidents in internal medicine units is a daily challenge that is taught to all hospital staff. It allows suggesting useful improvements for patients, as well as for the medical department and the institution. Here is presented the assessment made in the CHUV internal medicine department one year after the beginning of the institutional procedure which promotes an open process regarding communication and risk management. The department of internal medicine underlines the importance of feedback to the reporters, ensures the staff of regular follow-up concerning the measures being taken and offers to external reporters such as general practioners the possibility of using this reporting system too.

  11. Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review

    PubMed Central

    Golder, Su; Wright, Kath

    2016-01-01

    Background We performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events. Methods and Findings Studies were identified from 15 databases (including MEDLINE and Embase) and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs) and/or risk ratios (RRs) for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95

  12. Development of the Space Operations Incident Reporting Tool (SOIRT)

    NASA Technical Reports Server (NTRS)

    Minton, Jacquie

    1997-01-01

    The space operations incident reporting tool (SOIRT) is an instrument used to record information about an anomaly occurring during flight which may have been due to insufficient and/or inappropriate application of human factors knowledge. We originally developed the SOIRT form after researching other incident reporting systems of this type. We modified the form after performing several in-house reviews and a pilot test to access usability. Finally, crew members from Space Shuttle flights participated in a usability test of the tool after their missions. Since the National Aeronautics and Space Administration (NASA) currently has no system for continuous collection of this type of information, the SOIRT was developed to report issues such as reach envelope constraints, control operation difficulties, and vision impairments. However, if the SOIRT were to become a formal NASA process, information from crew members could be collected in a database and made available to individuals responsible for improving in-flight safety and productivity. Potential benefits include documentation to justify the redesign or development of new equipment/systems, provide the mission planners with a method for identifying past incidents, justify the development of timelines and mission scenarios, and require the creation of more appropriate work/rest cycles.

  13. Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS).

    PubMed

    Wong, Charlene; Krashin, Jamie; Rue-Cover, Alison; Saraiya, Mona; Unger, Elizabeth; Calugar, Angela; Markowitz, Lauri

    2010-03-01

    The quadrivalent human papillomavirus (HPV) vaccine was recommended in 2006 for routine vaccination of 11 or 12-year-old girls, with catchup through age 26 years, for the prevention of genital HPV-related diseases. The Vaccine Adverse Event Reporting System (VAERS) is a national spontaneous surveillance system of adverse events following vaccination in the United States. The objective of this study was to identify and review VAERS reports of invasive and in situ cervical cancer in women immunized with the quadrivalent HPV vaccine. A VAERS database search was performed to identify such cases reported in the United States from January 1, 2006, through April 9, 2009. Medical Dictionary for Regulatory Activities (MedDRA) search terms used were "cervix carcinoma," "cervix carcinoma stage 0," "cervix carcinoma stage III," "carcinoma in situ," and "cervical dysplasia." Case inclusion required a report to contain a clear statement of a cervical carcinoma or carcinoma in situ diagnosis on any screening or diagnostic test after at least one dose of the HPV vaccine. All reports were reviewed by two investigators. Four VAERS reports for MedDRA term "cervix carcinoma," one for "cervix carcinoma stage 0," none for "cervix carcinoma stage III," three for "carcinoma in situ," and 53 for "cervical dysplasia" were identified. Of these, three cases of carcinoma in situ and one case of microinvasive cervical cancer met study inclusion criteria. Cases of cervical cancer and precancers are not unexpected in vaccinated women. Cervical cancer screening continues to be important, even for women who have received the HPV vaccine.

  14. Brief report: The bystander effect in cyberbullying incidents.

    PubMed

    Machackova, Hana; Dedkova, Lenka; Mezulanikova, Katerina

    2015-08-01

    This study examined the bystander effect in cyberbullying. Using self-reported data from 257 Czech respondents who had witnessed a cyberbullying attack, we tested whether provided help decreased with increased number of other bystanders. We controlled for several individual and contextual factors, including empathy, social self-efficacy, empathic response to victimization, and relationship to the victim. Results showed that participants tend to help the victims more in incidents with only one or two other bystanders. We also found that, as in the "offline" realm, bystander effect is not linear: no significant differences were found between incidents with a moderate number (3-10) and a larger number of total bystanders. Our findings, thus, provide support for the presence of the bystander effect in cyberbullying.

  15. What to do With Healthcare Incident Reporting Systems

    PubMed Central

    Pham, Julius Cuong; Girard, Thierry; Pronovost, Peter J.

    2013-01-01

    Incident Reporting Systems (IRS) are and will continue to be an important influence on improving patient safety. They can provide valuable insights into how and why patients can be harmed at the organizational level. However, they are not the panacea that many believe them to be. They have several limitations that should be considered. Most of these limitations stem from inherent biases of voluntary reporting systems. These limitations include: i) IRS can’t be used to measure safety (error rates); ii) IRS can’t be used to compare organizations; iii) IRS can’t be used to measure changes over time; iv) IRS generate too many reports; v) IRS often don’t generate in-depth analyses or result in strong interventions to reduce risk; vi) IRS are associated with costs. IRS do offer significant value; their value is found in the following: i) IRS can be used to identify local system hazards; ii) IRS can be used to aggregate experiences for uncommon conditions; iii) IRS can be used to share lessons within and across organizations; iv) IRS can be used to increase patient safety culture. Moving forward, several strategies are suggested to maximize their value: i) make reporting easier; ii) make reporting meaningful to the reporter; iii) make the measure of success system changes, rather than events reported; iv) prioritize which events to report and investigate, report and investigate them well; v) convene with diverse stakeholders to enhance the value of IRS. Significance for public health Incident Reporting Systems (IRS) are and will continue to be an important influence on improving patient safety. However, they are not the panacea that many believe them to be. They have several limitations that should be considered when utilizing them or interpreting their output: i) IRS can’t be used to measure safety (error rates); ii) IRS can’t be used to compare organizations; iii) IRS can’t be used to measure changes over time; iv) IRS generate too many reports; v) IRS

  16. Validity of Adult Retrospective Reports of Adverse Childhood Experiences: Review of the Evidence

    ERIC Educational Resources Information Center

    Hardt, Jochen; Rutter, Michael

    2004-01-01

    Background: Influential studies have cast doubt on the validity of retrospective reports by adults of their own adverse experiences in childhood. Accordingly, many researchers view retrospective reports with scepticism. Method: A computer-based search, supplemented by hand searches, was used to identify studies reported between 1980 and 2001 in…

  17. Voluntary Medical Incident Reporting Tool to Improve Physician Reporting of Medical Errors in an Emergency Department

    PubMed Central

    Okafor, Nnaemeka G.; Doshi, Pratik B.; Miller, Sara K.; McCarthy, James J.; Hoot, Nathan R.; Darger, Bryan F.; Benitez, Roberto C.; Chathampally, Yashwant G.

    2015-01-01

    Introduction Medical errors are frequently under-reported, yet their appropriate analysis, coupled with remediation, is essential for continuous quality improvement. The emergency department (ED) is recognized as a complex and chaotic environment prone to errors. In this paper, we describe the design and implementation of a web-based ED-specific incident reporting system using an iterative process. Methods A web-based, password-protected tool was developed by members of a quality assurance committee for ED providers to report incidents that they believe could impact patient safety. Results The utilization of this system in one residency program with two academic sites resulted in an increase from 81 reported incidents in 2009, the first year of use, to 561 reported incidents in 2012. This is an increase in rate of reported events from 0.07% of all ED visits to 0.44% of all ED visits. In 2012, faculty reported 60% of all incidents, while residents and midlevel providers reported 24% and 16% respectively. The most commonly reported incidents were delays in care and management concerns. Conclusion Error reporting frequency can be dramatically improved by using a web-based, user-friendly, voluntary, and non-punitive reporting system. PMID:26759657

  18. Data mining of the public version of the FDA Adverse Event Reporting System.

    PubMed

    Sakaeda, Toshiyuki; Tamon, Akiko; Kadoyama, Kaori; Okuno, Yasushi

    2013-01-01

    The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.

  19. Associations between Childhood Adversity and Depression, Substance Abuse and HIV and HSV2 Incident Infections in Rural South African Youth

    ERIC Educational Resources Information Center

    Jewkes, Rachel K.; Dunkle, Kristin; Nduna, Mzikazi; Jama, P. Nwabisa; Puren, Adrian

    2010-01-01

    Objectives: To describe prevalence of childhood experiences of adversity in rural South African youth and their associations with health outcomes. Methods: We analyzed questionnaires and blood specimens collected during a baseline survey for a cluster randomized controlled trial of a behavioral intervention, and also tested blood HIV and herpes…

  20. Reporter Concerns in 300 Mode-Related Incident Reports from NASA's Aviation Safety Reporting System

    NASA Technical Reports Server (NTRS)

    McGreevy, Michael W.

    1996-01-01

    A model has been developed which represents prominent reporter concerns expressed in the narratives of 300 mode-related incident reports from NASA's Aviation Safety Reporting System (ASRS). The model objectively quantifies the structure of concerns which persist across situations and reporters. These concerns are described and illustrated using verbatim sentences from the original narratives. Report accession numbers are included with each sentence so that concerns can be traced back to the original reports. The results also include an inventory of mode names mentioned in the narratives, and a comparison of individual and joint concerns. The method is based on a proximity-weighted co-occurrence metric and object-oriented complexity reduction.

  1. Report of cancer incidence and mortality in China, 2010

    PubMed Central

    Zheng, Rongshou; Zhang, Siwei; Zhao, Ping; Zeng, Hongmei; Zou, Xiaonong

    2014-01-01

    Purpose To estimate the cancer incidences and mortalities in China in 2010. Methods On basis of the evaluation procedures and data quality criteria described in the National Central Cancer Registry (NCCR), data from 219 cancer registries were evaluated. Data from 145 registries were identified as qualified and then accepted for the 2010 cancer registry report. The incidences and mortalities of major cancers and the overall incidence and mortality were stratified by residency (urban or rural), areas (eastern, middle, and western), gender, and age. The cancer cases and deaths were estimated based on age-specific rate and national population in 2010. The China 2010 Population Census data and Segi’s world population data were used for calculating the age-standardized cancer incidence/mortality rates. Results Data were obtained from a total of 145 cancer registries (63 in urban areas and 82 in rural areas) covering 158,403,248 people (92,433,739 in urban areas and 65,969,509 in rural areas). The percentage of morphologically verified cases (MV%) were 67.11%; 2.99% of incident cases were identified through proportion of death certification only (DCO%), with the mortality to incidence ratio of (M/I) 0.61. The estimates of new cancer cases and cancer deaths were 3,093,039 and 1,956,622 in 2010, respectively. The crude incidence was 235.23/105 (268.65/105 in males and 200.21/105 in females), the age-standardized rates by Chinese standard population (ASR China) and by world standard population (ASR world) were 184.58/105 and 181.49/105, and the cumulative incidence rate (0-74 age years old) was 21.11%. The cancer incidence and ASR China were 256.41/105 and 187.53/105 in urban areas and 213.71/105 and 181.10/105 in rural areas. The crude cancer mortality in China was 148.81/105 (186.37/105 in males and 109.42/105 in females), the age-standardized mortalities by Chinese standard population and by world standard population were 113.92/105 and 112.86/105, and the cumulative

  2. Relationship between tort claims and patient incident reports in the Veterans Health Administration

    PubMed Central

    Schmidek, J; Weeks, W

    2005-01-01

    Objective: The Veterans Health Administration's patient incident reporting system was established to obtain comprehensive data on adverse events that affect patients and to act as a harbinger for risk management. It maintains a dataset of tort claims that are made against Veterans Administration's employees acting within the scope of employment. In an effort to understand the thoroughness of reporting, we examined the relationship between tort claims and patient incident reports (PIRs). Methods: Using social security and record numbers, we matched 8260 tort claims and 32 207 PIRs from fiscal years 1993–2000. Tort claims and PIRs were considered to be related if the recorded dates of incident were within 1 month of each other. Descriptive statistics, odds ratios, and two sample t tests with unequal variances were used to determine the relationship between PIRs and tort claims. Results: 4.15% of claims had a related PIR. Claim payment (either settlement or judgment for plaintiff) was more likely when associated with a PIR (OR 3.62; 95% CI 2.87 to 4.60). Payment was most likely for medication errors (OR 8.37; 95% CI 2.05 to 73.25) and least likely for suicides (OR 0.25; 95% CI 0.11 to 0.55). Conclusions: Although few tort claims had a related PIR, if a PIR was present the tort claim was more likely to result in a payment; moreover, the payment was likely to be higher. Underreporting of patient incidents that developed into tort claims was evident. Our findings suggest that, in the Veterans Health Administration, there is a higher propensity to both report and settle PIRs with bad outcomes. PMID:15805457

  3. 30 CFR 285.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... report them? 285.831 Section 285.831 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, REGULATION, AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY ALTERNATE USES OF EXISTING FACILITIES ON THE... must I report, and when must I report them? (a) You must report the following incidents to...

  4. The stability of self-reported adverse experiences in childhood: a longitudinal study on obesity.

    PubMed

    da Silva, Susana Sofia Pereira; da Costa Maia, Angela

    2013-07-01

    The literature on the effect of maltreatment has revealed several methodological problems of retrospective studies, such as the validity and stability of retrospective reports, which may be influenced by factors such as one's mental health at the time of the report. This study aims to assess the temporal stability of self-reported adverse childhood experiences at three different time points, separated by 6 months each, and to analyze the relationship between general psychopathology and the number of reported experiences. Thirty obese participants responded to the Portuguese version of the Childhood History Questionnaire, a self-report measure that assesses adverse childhood experiences, and the Brief Symptom Inventory. The results suggest that adverse childhood experiences are common in these participants (time 1: X = 1.87, SD = 1.3; time 2: X = 1.98, SD = 1.6; time 3: X = 1.98, SD = 1.6). The agreement levels, as measured by kappa values, were satisfactory for the dimensions of maltreatment focused on the individual, with kappas ranging between .34 and .44. Our participants did not exhibit psychopathology at any of the time points, and the psychopathological symptoms were not related to total adversity reported. The major contribution of this study is the comparison of self-reports at three time points, separated by significant time intervals, and the inclusion of 10 different dimensions of childhood adversity. The data show an adequate stability in the report of maltreatment toward the individual (abuse and physical neglect) and in specific aspects of adversity in the family.

  5. Pattern of Adverse Drug Reactions Reported with Cardiovascular Drugs in a Tertiary Care Teaching Hospital

    PubMed Central

    Palaniappan, Muthiah; George, Melvin; Subramaniyan, Ganesan; Dkhar, Steven Aibor; Pillai, Ajith Ananthakrishna; Jayaraman, Balachander; Chandrasekaran, Adithan

    2015-01-01

    Background Cardiovascular diseases (CVD) are one of the leading causes of non-communicable disease related deaths globally. Patients with cardiovascular diseases are often prescribed multiple drugs and have higher risk for developing more adverse drug reactions due to polypharmacy. Aim To evaluate the pattern of adverse drug reactions reported with cardiovascular drugs in an adverse drug reaction monitoring centre (AMC) of a tertiary care hospital. Settings and Design Adverse drug reactions related to cardiovascular drugs reported to an AMC of a tertiary care hospital were included in this prospective observational study. Materials and Methods All cardiovascular drugs related adverse drug reactions (ADRs) received in AMC through spontaneous reporting system and active surveillance method from January 2011 to March 2013 were analysed for demographic profile, ADR pattern, severity and causality assessment. Statistical Analysis used The study used descriptive statistics and the values were expressed in numbers and percentages. Results During the study period, a total of 463 ADRs were reported from 397 patients which included 319 males (80.4%) and 78 females (19.6%). The cardiovascular drug related reports constituted 18.1% of the total 2188 ADR reports. In this study, the most common ADRs observed were cough (17.3%), gastritis (7.5%) and fatigue (6.5%). Assessment of ADRs using WHO-causality scale revealed that 62% of ADRs were possible, 28.2% certain and 6.8% probable. As per Naranjo’s scale most of the reports were possible (68.8%) followed by probable (29.7%). According to Hartwig severity scale majority of the reports were mild (95%) followed by moderate (4.5%). A system wise classification of ADRs showed that gastrointestinal system (20.7%) related reactions were the most frequently observed adverse reactions followed by respiratory system (18.4%) related adverse effects. From the reported ADRs, the drugs most commonly associated with ADRs were found to be

  6. ADVERSE PRE- AND POSTNATAL EVENTS REPORTED TO FDA IN ASSOCIATION WITH MATERNAL ATENOLOL TREATMENT IN PREGNANCY

    EPA Science Inventory

    Atenolol is a beta-adrenoreceptor blocker used for treatment of hypertension in pregnancy. This study evaluates the reporting frequency of adverse pre- and postnatal outcomes in a series of 70 cases of maternal exposure during gestation, derived from 140 reports to FDA with Ateno...

  7. Pediatric medication error reports in Korea adverse event reporting system database, 1989-2012: comparing with adult reports.

    PubMed

    Woo, Yeonju; Kim, Hyung Eun; Chung, Sooyoun; Park, Byung Joo

    2015-04-01

    Children have dynamic process of maturation and substantial changes in growth and development which eventually make the drug safety profiles different from adults. Medication errors (MEs) in pediatrics are reported to occur three times more likely than adults. The aims of this study were to identify the characteristics of pediatric MEs in Korea at national level and help raise awareness of risks from the MEs in pediatrics. We conducted a descriptive analysis with the pediatric ME reports in Korea Adverse Event Reporting System (KAERS) database from 1989 to 2012 and 208 ME reports in pediatrics were found. Based on KAERS database, the proportion of reported pediatric ME in adverse drug event (ADE) reports was 2.73 times (95% CI, 2.35-3.17) higher than that of adult ME. In 208 ME reports, we found a total of 236 ME-related terms within 19 types of MEs. The most common type of MEs was "accidental overdose" (n=58, 24.6%), followed by "drug maladministration" (n=50, 21.2%) and "medication error" (n=41, 17.4%). After the narratives of ME reports were reviewed, we noticed that most of them did no harm to patients, but some cases were needed for medical treatment. Our data suggest that MEs in pediatrics are not negligible in Korea. We expect that this study would increase the awareness of the problem in pediatric MEs and induce the need for further development of an effective national ME preventing system in Korea.

  8. Adverse event profile of tigecycline: data mining of the public version of the U.S. Food and Drug Administration adverse event reporting system.

    PubMed

    Kadoyama, Kaori; Sakaeda, Toshiyuki; Tamon, Akiko; Okuno, Yasushi

    2012-01-01

    The recent emergence of multidrug-resistant pathogens and/or pharmacokinetics-pharmacodynamics considerations may result in off-label use of a certain class of antibacterials, including tigecycline. This study was performed to clarify the safety profile of tigecycline in the user-derived manner and to compare it with the prescribing information provided by the manufacturer. Numerous spontaneous adverse event reports (AERs) submitted to the U.S. Food and Drug Administration (FDA) were analyzed after a revision of arbitrary drug names and the deletion of duplicated submissions. Standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Based on 22017956 co-occurrences, i.e., drug-adverse event pairs, found in 1644220 AERs from 2004 to 2009, 248 adverse events were suggested as tigecycline-associated ones. Adverse events with a relatively high frequency included nausea, vomiting, pancreatitis, hepatic failure, hypoglycemia, and increase in levels of alanine aminotransferase, bilirubin, alkaline phosphatase, aspartate aminotransferase, and gamma-glutamyltransferase. It is noted that cholestasis, jaundice, an increase in International Normalized Ratio, and Stevens-Johnson syndrome were also, although they were infrequent. The adverse events suggested were in agreement with information provided by the manufacturer, suggesting that off-label use hardly results in unexpected adverse events, presumably due to usage with extreme caution.

  9. 49 CFR 225.15 - Accidents/incidents not to be reported.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Accidents/incidents not to be reported. 225.15... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD ACCIDENTS/INCIDENTS: REPORTS CLASSIFICATION, AND INVESTIGATIONS § 225.15 Accidents/incidents not to be reported. A railroad need not report: (a) Casualties...

  10. Statin-Associated Muscular and Renal Adverse Events: Data Mining of the Public Version of the FDA Adverse Event Reporting System

    PubMed Central

    Sakaeda, Toshiyuki; Kadoyama, Kaori; Okuno, Yasushi

    2011-01-01

    Objective Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association. Methods After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. Results Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. Conclusions Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events. PMID:22205938

  11. International reporting on adverse drug reactions: the CIOMS project. CIOMS ADR Working Group.

    PubMed

    Faich, G A; Castle, W; Bankowski, Z

    1990-04-01

    A method for standardized postapproval adverse drug reaction (ADR) reporting has been developed and implemented by seven multinational pharmaceutical manufacturers and six regulatory authorities. This is based on a set of uniform definitions, procedures and a single reporting form, and has been demonstrated to be useful and effective. When regulators and manufacturers develop requirements and systems for ADR reporting they should consider adapting this method.

  12. Adjustable silicone gastric banding adverse events reported to the Food and Drug Administration.

    PubMed

    Brown, S Lori; Reid, Marie H; Duggirala, Hesha Jani

    2003-01-01

    A silicone adjustable gastric banding system was approved by the Food and Drug Administration (FDA) in June, 2001. The purpose of this report is to review and characterize the reports on silicone adjustable gastric banding systems received by the FDA through August 8, 2002. We also review medical literature on adverse events with silicone adjustable gastric banding systems. Manufacturers of regulated medical devices, such as adjustable silicone gastric bands, are required to report adverse events, including deaths and serious injuries, to the FDA. We reviewed all such reports received by the FDA through August 8, 2002, for adjustable silicone gastric bands and summarize the data by type of adverse event, reported device problems, and reported patient problems. The FDA received 556 reports of adverse events related to the use of adjustable silicone gastric bands. Two of these reports were for deaths, one during surgery and the other as a result of an erosion of the gastric band into the stomach 9 weeks after implantation. Forty-four reports were for injuries including band erosions, slippage, and infection. The most common type of report (499) was for device malfunction, and of these, 485 (97.2%) described a leak at or near the port. Of the 485 leaks reported as malfunctions, 99.4% were treated surgically. The majority of reports were related to disconnection, breakage, and leakage at or near the access port. Physicians and potential patients should be aware of these problems and recognize the possibility that additional surgery(ies) may be required for leaking access port/connections. The loose connection may cause pain and the device no longer performs as intended when there is a leak.

  13. Adverse reaction of Parasika Yavani (Hyoscyamus niger Linn): Two case study reports

    PubMed Central

    Aparna, K.; Joshi, Abhishek J.; Vyas, Mahesh

    2015-01-01

    Adverse drug reaction (ADR) is an unpleasant reaction related to the use of medicine at its therapeutic dose. Ayurveda is well aware of such adverse reactions. Parasika Yavani (Hyoscyamus niger Linn.) is an Ayurvedic drug effectively used in many psychological disorders, if not used judiciously it causes adverse reactions. In present study two cases of ADR on the usage of Parasika Yavani are reported. Churna in capsule form given in different dosage forms (500 mg once a day, 250 mg twice a day, 250 mg once a day) in Chittodwega (generalised anxiety disorder). 500mg capsule was given to many patients in the study, but no adverse reactions were noticed except in above given two cases. So, in these two cases, the dose was tapered down to 250 mg twice a day, and then to 250 mg once a day to avert the adverse reactions and to fix the therapeutic dose in such individuals (250 mg once a day). On analysis, these two individuals were found to be of Pitta Prakriti. Parasika Yavani is found to increase Pitta and triggers the establishment of ADRs. So, while administering therapeutic dosage, a physician should be vigilant. In the current study, it is observed that 500 mg of Parasika Yavani powder in Pitta Prakriti individuals triggered ADRs while 250 mg once a day was safe. It was also observed that Kapha and Vata Prakriti, patients did not develop any adverse reactions. PMID:27011719

  14. Technology-Induced Errors and Adverse Event Reporting in an Organizational Learning Perspective.

    PubMed

    Vinther, Line Dausel; Jensen, Christian Møller; Hjel-Mager, Ditte Meulengracht; Lyhne, Nicoline; Nøhr, Christian

    2017-01-01

    This paper addresses the possibilities of evaluating technology-induced errors, through the utilization of experiences of the Danish adverse event reporting system. The learning loop in the adverse event reporting system is identified and analyzed, to examine which elements can be utilized to evaluate technologies. The empirical data was collected through interviews and a workshop with members of the nursing staff at a nursing home in Aalborg, Denmark. It was found that, the establishment of sustainable feedback learning loops depends on shared visions in the organization and how creating shared visions requires involvement and participation. Secondly, care workers must possess fundamental knowledge about the technologies available to them. Thirdly comprehensive classification of adverse events should be established to allow for a systematic and goal directed feed-back process.

  15. 75 FR 68861 - Miscellaneous Amendments to the Federal Railroad Administration's Accident/Incident Reporting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-09

    ...This final rule revises FRA's existing regulations addressing accident/incident reporting in order to clarify ambiguous regulations and to enhance the quality of information available for railroad casualty analysis. In addition, FRA has revised the FRA Guide for Preparing Accident/Incident Reports (FRA Guide), its accident/incident recording and reporting forms and its Companion Guide:......

  16. 75 FR 922 - Notification and Reporting of Aircraft Accidents or Incidents and Overdue Aircraft, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-07

    ...The NTSB is amending its regulations concerning notification and reporting requirements regarding aircraft accidents or incidents. In particular, the NTSB is adding regulations to require operators to report certain incidents to the NTSB. The NTSB is also amending existing regulations to provide clarity and ensure that the appropriate means for notifying the NTSB of a reportable incident is......

  17. Harms from discharge to primary care: mixed methods analysis of incident reports

    PubMed Central

    Williams, Huw; Edwards, Adrian; Hibbert, Peter; Rees, Philippa; Prosser Evans, Huw; Panesar, Sukhmeet; Carter, Ben; Parry, Gareth; Makeham, Meredith; Jones, Aled; Avery, Anthony; Sheikh, Aziz; Donaldson, Liam; Carson-Stevens, Andrew

    2015-01-01

    Background Discharge from hospital presents significant risks to patient safety, with up to one in five patients experiencing adverse events within 3 weeks of leaving hospital. Aim To describe the frequency and types of patient safety incidents associated with discharge from secondary to primary care, and commonly described contributory factors to identify recommendations for practice. Design and setting A mixed methods analysis of 598 patient safety incident reports in England and Wales related to ‘Discharge’ from the National Reporting and Learning System. Method Detailed data coding (with 20% double-coding), data summaries generated using descriptive statistical analysis, and thematic analysis of special-case sample of reports. Incident type, contributory factors, type, and level of harm were described, informing recommendations for future practice. Results A total of 598 eligible reports were analysed. The four main themes were: errors in discharge communication (n = 151; 54% causing harm); errors in referrals to community care (n = 136; 73% causing harm); errors in medication (n = 97; 87% causing harm); and lack of provision of care adjuncts such as dressings (n = 62; 94% causing harm). Common contributory factors were staff factors (not following referral protocols); and organisational factors (lack of clear guidelines or inefficient processes). Improvement opportunities include developing and testing electronic discharge methods with agreed minimum information requirements and unified referrals systems to community care providers; and promoting a safety culture with ‘safe discharge’ checklists, discharge coordinators, and family involvement. Conclusion Significant harm was evident due to deficits in the discharge process. Interventions in this area need to be evaluated and learning shared widely. PMID:26622036

  18. Reporting adverse transfusion reactions: A retrospective study from tertiary care hospital from New Delhi, India

    PubMed Central

    Pahuja, Sangeeta; Puri, Vandana; Mahajan, Gunjan; Gupta, Prajwala; Jain, Manjula

    2017-01-01

    CONTEXT: Blood transfusion services have achieved newer heights in the last decade, with developments in cellular techniques, component separation, and integration of molecular methods. However, the system of recording and reporting of the adverse events related to blood transfusion is developing countries like India is grossly inadequate and voluntary in nature. AIMS: This study was undertaken to analyze the retrospective data on adverse events related to blood transfusions in our hospital. SUBJECTS AND METHODS: This retrospective study was done to examine all the transfusion related adverse events reported in a Regional Blood Bank Transfusion Centre of North India over a period of 9 years. Adverse transfusion events related to whole blood, red cell concentrates (RCCs), and all other components were analyzed and classified on the basis of their clinical features and laboratory tests. Average rate of transfusion reactions with the components was also assessed. STATISTICAL ANALYSIS USED: Categorical variables were analyzed using the Chi-square test. P < 0.05 was taken to indicate a significant difference. RESULTS: During this period, a total of 1,60,973 blood/blood component units were issued by our blood bank to various departments of the hospital and 314 immediate transfusion events were reported. The rate of immediate transfusion reactions during the study was 0.19%. Average transfusion reaction rate with RCC was 0.25% with febrile nonhemolytic reactions being the most common type of adverse event (37.2%). CONCLUSIONS: Awareness should be increased among clinicians to correctly prevent, identify, and report transfusion-related adverse events. These measures should be implemented to increase blood transfusion quality and safety. PMID:28316433

  19. The Role of a Research Administration Program in Adverse Event Reporting

    ERIC Educational Resources Information Center

    Fedor, Carol; Cola, Philip; Polites, Stephanie

    2007-01-01

    The reporting, analysis, and management of adverse events (AEs) provide an ongoing assessment of risk in the context of a clinical trial and enhance the protection of human research participants and the informed consent process. Effective and efficient review of AEs has been a long-standing challenge for Institutional Review Boards (IRBs) and…

  20. Incidence and management of renal adverse events in patients with relapsed and/or refractory multiple myeloma treated with single-agent carfilzomib.

    PubMed

    Shah, Jatin J

    2013-12-01

    Patients with multiple myeloma (MM) frequently experience renal dysfunction owing to patient-specific risk factors, the pathophysiology of MM, and treatment-related adverse events. The presence of renal complications in patients with MM may be associated with advanced disease and is a negative prognostic factor for survival. Frequently these patients receive reduced or modified dosing regimens, which can result in under-dosing and may adversely affect treatment efficacy. Consequently, there is a need for effective therapies with favorable renal safety profiles. Carfilzomib is a selective proteasome inhibitor approved in the United States as a single agent for the treatment of relapsed and refractory MM. Safety studies have demonstrated that single-agent carfilzomib is well tolerated in patients with relapsed and/or refractory MM and concomitant renal dysfunction. This article reviews the etiology and incidence of renal adverse events in patients with MM, the renal safety profile of single-agent carfilzomib from four phase II studies in patients with relapsed and/or refractory MM, and the management of patients with MM who receive carfilzomib and are at risk for renal complications.

  1. Relative Incidence of Acute Adverse Events with Ferumoxytol Compared to Other Intravenous Iron Compounds: A Matched Cohort Study

    PubMed Central

    Wetmore, James B.; Weinhandl, Eric D.; Zhou, Jincheng; Gilbertson, David T.

    2017-01-01

    Concerns persist about adverse reactions to intravenous (IV) iron. We aimed to determine the relative safety of ferumoxytol compared to other IV iron compounds. This retrospective cohort study with propensity-score matching for patients and drug doses used the Medicare 20% random sample to identify patients (1) without chronic kidney disease (non-CKD) and (2) with non-dialysis-dependent chronic kidney disease (NDD-CKD) who received a first dose of IV iron in 2010–2012. Exposures were ferumoxytol, iron sucrose, sodium ferric gluconate, or iron dextran. Outcomes were hypersensitivity symptoms, anaphylaxis, emergency department (ED) encounters, hospitalizations, and death after acute IV iron exposure. In the primary analysis for reactions on the day of or following exposure, there was no difference in hypersensitivity symptoms (hazard ratio 1.04, 95% confidence interval 0.94–1.16) or hypotension (0.83, 0.52–1.34) between 4289 non-CKD ferumoxytol users and an equal number of users of other compounds; results were similar for 7358 NDD-CKD patients and an equal number of controls. All-cause ED encounters or hospitalizations were less common in both the non-CKD (0.56, 0.45–0.70) and NDD-CKD ferumoxytol-treated patients (0.83, 0.71–0.95). Fewer than 10 deaths occurred in both the non-CKD and NDD-CKD ferumoxytol users and in matched controls; the hazard for death did not differ significantly between ferumoxytol users and controls in the non-CKD patients (2.00, 0.33–11.97) or in the NDD-CKD patients (0.25, 0.04–1.52). Multiple sensitivity analyses showed similar results. Ferumoxytol did not appear to be associated with more adverse reactions than other compounds for the treatment of iron-deficiency anemia in both non-CKD and NDD-CKD patients. PMID:28135334

  2. Reporting of Violent and Disruptive Incidents by Public Schools. Report 2005-S-38

    ERIC Educational Resources Information Center

    New York State Education Department, 2006

    2006-01-01

    The objective of this report was to determine whether the State Education Department (SED) has developed effective processes for (1) ensuring that school districts report violent and disruptive incidents to SED in accordance with State law and regulations, (2) identifying schools that should be designated as persistently dangerous because of their…

  3. Quality of Reporting of Serious Adverse Drug Events to an Institutional Review Board

    PubMed Central

    Dorr, David A.; Burdon, Rachel; West, Dennis P.; Lagman, Jennifer; Georgopoulos, Christina; Belknap, Steven M.; McKoy, June M.; Djulbegovic, Benjamin; Edwards, Beatrice J.; Weitzman, Sigmund A.; Boyle, Simone; Tallman, Martin S.; Talpaz, Moshe; Sartor, Oliver; Bennett, Charles L.

    2009-01-01

    Purpose Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P < 0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P < 0.05). Some key clinical information was discrepant between the two sources. Conclusions The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients. PMID:19458059

  4. Surveillance of adverse events following immunisation in Australia annual report, 2014.

    PubMed

    Dey, Aditi; Wang, Han; Quinn, Helen E; Hill, Richard; Macartney, Kristine K

    2016-09-30

    This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2014 reported to the Therapeutic Goods Administration for 2014 and describes reporting trends over the 15-year period 1 January 2000 to 31 December 2014. There were 3,087 AEFI records for vaccines administered in 2014; an annual AEFI reporting rate of 13.2 per 100,000 population. There was a decline of 5% in the overall AEFI reporting rate in 2014 compared with 2013. This decline in reported adverse events in 2014 compared with the previous year was mainly attributable to fewer reports following the human papillomavirus (HPV) vaccine as it was the 2nd year of the extension of the National HPV Vaccination Program to males. AEFI reporting rates for most vaccines were lower in 2014 compared with 2013. The most commonly reported reactions were injection site reaction (27%), pyrexia (18%), rash (16%), vomiting (9%), headache (7%), and syncope (5%). The majority of AEFI reports described non-serious events while 7% (n=211) were classified as serious. There were 5 deaths reported with no clear causal relationship with vaccination found.

  5. Mining multi-item drug adverse effect associations in spontaneous reporting systems

    PubMed Central

    2010-01-01

    Background Multi-item adverse drug event (ADE) associations are associations relating multiple drugs to possibly multiple adverse events. The current standard in pharmacovigilance is bivariate association analysis, where each single drug-adverse effect combination is studied separately. The importance and difficulty in the detection of multi-item ADE associations was noted in several prominent pharmacovigilance studies. In this paper we examine the application of a well established data mining method known as association rule mining, which we tailored to the above problem, and demonstrate its value. The method was applied to the FDAs spontaneous adverse event reporting system (AERS) with minimal restrictions and expectations on its output, an experiment that has not been previously done on the scale and generality proposed in this work. Results Based on a set of 162,744 reports of suspected ADEs reported to AERS and published in the year 2008, our method identified 1167 multi-item ADE associations. A taxonomy that characterizes the associations was developed based on a representative sample. A significant number (67% of the total) of potential multi-item ADE associations identified were characterized and clinically validated by a domain expert as previously recognized ADE associations. Several potentially novel ADEs were also identified. A smaller proportion (4%) of associations were characterized and validated as known drug-drug interactions. Conclusions Our findings demonstrate that multi-item ADEs are present and can be extracted from the FDA’s adverse effect reporting system using our methodology, suggesting that our method is a valid approach for the initial identification of multi-item ADEs. The study also revealed several limitations and challenges that can be attributed to both the method and quality of data. PMID:21044365

  6. An Adverse Drug Reaction to Trimethoprim-Sulfamethoxazole Revealing Primary HIV: A Case Report and Literature Review.

    PubMed

    Meyer, Charles; Behm, Nicole; Brown, Emily; Copeland, Nathanial K; Sklar, Marvin J

    2015-01-01

    Adverse drug reactions (ADRs) to antibiotics complicate the management of any infection, particularly opportunistic infections in advanced HIV as some ADRs are potentiated by HIV. Trimethoprim-sulfamethoxazole (TMP-SMX) causes ADRs in 40-80% of HIV infected individuals, compared to 3-5% in the general population. The incidence and severity of ADRs among HIV infected individuals appear to increase as they progress from latent infection to AIDS. We present a single case report of a 55-year-old African American male found to have an otherwise asymptomatic acute HIV infection who developed an ADR to TMP-SMX, despite having previously tolerating the medication. The proposed mechanisms for the increased incidence of sulfa hypersensitivity reactions among HIV infected individuals focus on either (1) HIV-induced changes in the immune function driven by falling levels of CD4 cells or (2) other HIV-specific factors correlated with rising viral load. To our knowledge this is the first reported case of new sulfa hypersensitivity in primary HIV and may provide clinical evidence to support the correlation between viral load and ADRs to TMP-SMX without a severely diminished CD4 count, though further research is necessary. This case also demonstrates a rare and easily overlooked presentation of HIV that may aid in early diagnosis.

  7. Adverse Health Effects of Benzene Exposure Among Children Following a Flaring Incident at the British Petroleum Refinery in Texas City.

    PubMed

    D'Andrea, Mark A; Reddy, G Kesava

    2016-03-01

    This study examined the health effects of benzene exposure among children from a flaring incident at the British Petroleum (BP) refinery in Texas City, Texas. A total of 899 children (benzene exposed, n = 641 and unexposed, n = 258), aged <17 years, were included. Hematological analysis showed that white blood cell (×10(3)/µL) counts were significantly decreased in the exposed children compared with the unexposed children (7.1 ± 2.2 versus 7.6 ± 2.1, P = .001). Similarly, the hemoglobin (g/dL) levels were decreased significantly in the exposed group compared with the unexposed group (12.7 ± 1.3 vs 13.1 ± 1.5, P = .001). Conversely, platelet (×10(3)/µL) counts were increased significantly in the exposed group compared with the unexposed group (318.6 ± 79.8 versus 266.9 ± 58.8, P = .001). Hepatic enzymes were also significantly elevated among exposed children compared with the unexposed children. These findings suggest that children exposed to benzene are at a higher risk of developing both hepatic and bone marrow-related disorders.

  8. 40 CFR 159.184 - Toxic or adverse effect incident reports.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... female, pregnant? (J) Exposure data: amount of pesticide; duration of exposure; weight of victim. (K) Was... of systems supplied. (C) If finished water samples, water supply systems sampled. (D) If finished water samples, percent surface water source by specific surface water sources to water supply...

  9. 40 CFR 159.184 - Toxic or adverse effect incident reports.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... female, pregnant? (J) Exposure data: amount of pesticide; duration of exposure; weight of victim. (K) Was... of systems supplied. (C) If finished water samples, water supply systems sampled. (D) If finished water samples, percent surface water source by specific surface water sources to water supply...

  10. 40 CFR 159.184 - Toxic or adverse effect incident reports.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... female, pregnant? (J) Exposure data: amount of pesticide; duration of exposure; weight of victim. (K) Was... of systems supplied. (C) If finished water samples, water supply systems sampled. (D) If finished water samples, percent surface water source by specific surface water sources to water supply...

  11. 40 CFR 159.184 - Toxic or adverse effect incident reports.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... female, pregnant? (J) Exposure data: amount of pesticide; duration of exposure; weight of victim. (K) Was... of systems supplied. (C) If finished water samples, water supply systems sampled. (D) If finished water samples, percent surface water source by specific surface water sources to water supply...

  12. A Retrospective Analysis of Reporting of Adverse Drug Reactions in a Tertiary Care Teaching Hospital: One Year Survey

    PubMed Central

    Pathak, Anuj Kumar; Dokania, Shambhu; Mohan, Lalit; Dikshit, Harihar

    2016-01-01

    Introduction Pharmacovigilance (PV) is related to detection, assessment, understanding and prevention of Adverse Drug Reactions (ADRs) which are incurred when drug is made available in the market and used in different physiological conditions. In many countries, ADRs ranks among the top ten leading cause of morbidity and mortality. There is a lack of formal culture for monitoring and reporting of ADRs in India, with ADR reporting rate being only 1% as compared to 5% in world. This type of academic detailing activity helps to create awareness of ADR reporting in the institutions. Aim This study was planned to evaluate and analyse the incidence and patterns of ADRs in various inpatient and outpatient departments of hospital. Materials and Methods This was an observational, retrospective and record based study conducted by analysing the spontaneous ADR forms, collected over a period of 12 months (September 2014 to August 2015) at Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India. Results During the period of one year, 292 ADR forms were collected from 4,34,965 patients attending OPD and inpatients of the hospital. Incidence of ADR was 0.67 per thousand patients and average of around 24 ADR collected per month. Male:Female ratio was 1.30. Adolescent (16-30 yr) was the most common age group affected. Department of Skin and VD reported the maximum number of ADRs (33.22%), followed by the Departments of Oncology (18.84%). Antibiotics were the most common drug implicated followed by anticancer drugs. Conclusion ADR reporting is an ongoing and continuous process. Studies from the institute helps to identify and rectify the problems related to ADR reporting. Pitfalls can be addressed by creating awareness among physicians and the patients to achieve finally the goal of Pharmacovigilant India. PMID:27656459

  13. Glacial Acetic Acid Adverse Events: Case Reports and Review of the Literature

    PubMed Central

    Doles, William; Wilkerson, Garrett; Morrison, Samantha

    2015-01-01

    Glacial acetic acid is a dangerous chemical that has been associated with several adverse drug events involving patients over recent years. When diluted to the proper concentration, acetic acid solutions have a variety of medicinal uses. Unfortunately, despite warnings, the improper dilution of concentrated glacial acetic acid has resulted in severe burns and other related morbidities. We report on 2 additional case reports of adverse drug events involving glacial acetic acid as well as a review of the literature. A summary of published case reports is provided, including the intended and actual concentration of glacial acetic acid involved, the indication for use, degree of exposure, and resultant outcome. Strategies that have been recommended to improve patient safety are summarized within the context of the key elements of the medication use process. PMID:26448660

  14. An Evaluation of Departmental Radiation Oncology Incident Reports: Anticipating a National Reporting System

    SciTech Connect

    Terezakis, Stephanie A.; Harris, Kendra M.; Ford, Eric; Michalski, Jeff; DeWeese, Theodore; Santanam, Lakshmi; Mutic, Sasa; Gay, Hiram

    2013-03-15

    Purpose: Systems to ensure patient safety are of critical importance. The electronic incident reporting systems (IRS) of 2 large academic radiation oncology departments were evaluated for events that may be suitable for submission to a national reporting system (NRS). Methods and Materials: All events recorded in the combined IRS were evaluated from 2007 through 2010. Incidents were graded for potential severity using the validated French Nuclear Safety Authority (ASN) 5-point scale. These incidents were categorized into 7 groups: (1) human error, (2) software error, (3) hardware error, (4) error in communication between 2 humans, (5) error at the human-software interface, (6) error at the software-hardware interface, and (7) error at the human-hardware interface. Results: Between the 2 systems, 4407 incidents were reported. Of these events, 1507 (34%) were considered to have the potential for clinical consequences. Of these 1507 events, 149 (10%) were rated as having a potential severity of ≥2. Of these 149 events, the committee determined that 79 (53%) of these events would be submittable to a NRS of which the majority was related to human error or to the human-software interface. Conclusions: A significant number of incidents were identified in this analysis. The majority of events in this study were related to human error and to the human-software interface, further supporting the need for a NRS to facilitate field-wide learning and system improvement.

  15. Evaluation of the Expression Profile of Extrapyramidal Symptoms Due to Antipsychotics by Data Mining of Japanese Adverse Drug Event Report (JADER) Database.

    PubMed

    Kose, Eiji; Uno, Kana; Hayashi, Hiroyuki

    2017-01-01

     Typical antipsychotics are easily expressed as adverse events such as extrapyramidal symptom (EPS). On the other hand, incidence of adverse events due to atypical antipsychotics is low. Therefore, currently, atypical antipsychotics are widely used to treat schizophrenia. However, it has been reported that there is no difference in the frequency of EPS in atypical and typical antipsychotics. This study aimed to evaluate the expression profile of EPS in atypical and typical antipsychotics treatment using the Japanese Adverse Drug Event Report (JADER) database. We analyzed reports of EPS in the JADER database and calculated the reporting odds ratio (ROR) of antipsychotics potentially associated with EPS. We applied the Weibull shape parameter to time-to-event data in the JADER database. Consequently, there was little information to distinguish between the ROR of atypical and typical antipsychotics. A significant difference related to the time of onset of EPS in both antipsychotics was not recognized. However, when comparing each drug, Paliperidone, Perospirone, Blonanserin, and Aripiprazole were relatively developed as EPS in the early stage. On the other hand, Risperidone, Clozapine, Olanzapine, and Quetiapine were developed as EPS not only at an early stage but also after long-term use. In addition, this finding was suggested from the result of the cumulative incidence of EPS in each drug and of the time-to-onset analysis using Weibull distribution. These findings may contribute to future clinical practice because we revealed the expression profile of EPS in treatment with atypical and typical antipsychotics.

  16. The Incidence, Classification, and Management of Acute Adverse Reactions to the Low-Osmolar Iodinated Contrast Media Isovue and Ultravist in Contrast-Enhanced Computed Tomography Scanning

    PubMed Central

    Zhang, Bin; Dong, Yuhao; Liang, Long; Lian, Zhouyang; Liu, Jing; Luo, Xiaoning; Chen, Wenbo; Li, Xinyu; Liang, Changhong; Zhang, Shuixing

    2016-01-01

    Abstract Some epidemiologic surveillance studies have recorded adverse drug reactions to radiocontrast agents. We aimed to investigate the incidence and management of acute adverse reactions (AARs) to Ultravist-370 and Isovue-370 in patients who underwent contrast-enhanced computed tomography (CT) scanning. Data from 137,473 patients were analyzed. They had undergone enhanced CT scanning with intravenous injection of Ultravist-370 or Isovue-370 during the period of January 1, 2006 to December 31, 2012 in our hospital. We investigated and classified AARs according to the American College of Radiology and the Chinese Society of Radiology (CSR) guidelines for iodinated contrast media. We analyzed risk factors for AARs and compared the AARs induced by Ultravist-370 and Isovue-370. Four hundred and twenty-eight (0.31%) patients experienced AARs, which included 330 (0.24%) patients with mild AARs, 82 (0.06%) patients with moderate AARs, and 16 (0.01%) patients with severe AARs (including 3 cases of cardiac arrest and one case of death). The incidence of AARs was higher with Ultravist-370 than with Isovue-370 (0.38% vs 0.24%, P < 0.001), but only for mild AARs (0.32% vs 0.16%, P < 0.001). Analyses on risk factors indicated that female patients (n = 221, 0.43%, P < 0.001), emergency patients (n = 11, 0.51%, P < 0.001), elderly patients aged 50 to 60 years (n = 135, 0.43%, P < 0.001), and patients who underwent coronary computed tomography angiography (CTA) (n = 55, 0.51%, P < 0.001) had a higher risk of AARs. Cutaneous manifestations (50.52%)—especially rash (59.74%)—were the most frequent mild AARs. Cardiovascular manifestations accounted for most moderate and severe AARs (62.91% and 48.28%, respectively). After proper management, the symptoms and signs of 96.5% of the AARs resolved within 24 hours without sequelae. Ultravist-370 and Isovue-370 are safe for patients undergoing enhanced CT scanning. The incidence of AARs is

  17. Measles incidence and reporting trends in Germany, 2007–2011

    PubMed Central

    Wichmann, Ole; Rieck, Thorsten; Matysiak-Klose, Dorothea

    2014-01-01

    Abstract Objective We aimed to quantify progress towards measles elimination in Germany from 2007 to 2011 and to estimate any potential underreporting over this period. Methods We determined the annual incidence of notified cases of measles – for each year – in northern, western, eastern and southern Germany and across the whole country. We then used measles-related health insurance claims to estimate the corresponding incidence. Findings In each year between 2007 and 2011, there were 6.9–19.6 (mean: 10.8) notified cases of measles per million population. Incidence decreased with age and showed geographical variation, with highest mean incidence – 20.3 cases per million – in southern Germany. Over the study period, incidence decreased by 10% (incidence rate ratio, IRR: 0.90; 95% confidence interval, CI: 0.85–0.95) per year in western Germany but increased by 77% (IRR: 1.77; 95% CI: 1.62–1.93) per year in eastern Germany. Although the estimated incidence of measles based on insurance claims showed similar trends, these estimates were 2.0- to 4.8-fold higher than the incidence of notified cases. Comparisons between the data sets indicated that the underreporting increased with age and was generally less in years when measles incidence was high than in low-incidence years. Conclusion Germany is still far from achieving measles elimination. There is substantial regional variation in measles epidemiology and, therefore, a need for region-specific interventions. Our analysis indicates underreporting in the routine surveillance system between 2007 and 2011, especially among adults. PMID:25378728

  18. [Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database].

    PubMed

    Sakai, Takamasa; Ohtsu, Fumiko; Sekiya, Yasuaki; Mori, Chiyo; Sakata, Hiroshi; Goto, Nobuyuki

    2016-01-01

    Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values differed between all reports in the JADER database and those on pregnant women, affecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals [PRR, 159.7; ROR, 669.9; 95% confidence interval (CI), 282.4-1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95%CI, 0.3-15.4). These findings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95%CI, 1.4-3.3). These findings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women.

  19. Sulfites--a food and drug administration review of recalls and reported adverse events.

    PubMed

    Timbo, Babgaleh; Koehler, Kathleen M; Wolyniak, Cecilia; Klontz, Karl C

    2004-08-01

    Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested > or = 10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

  20. Post-Finasteride Adverse Effects in Male Androgenic Alopecia: A Case Report of Vitiligo.

    PubMed

    Motofei, Ion G; Rowland, David L; Georgescu, Simona R; Tampa, Mircea; Paunica, Stana; Constantin, Vlad D; Balalau, Cristian; Manea, Mirela; Baleanu, Bogdan C; Sinescu, Ioanel

    2017-01-01

    Finasteride has proved to be relatively safe and effective in the therapeutic management of male androgenic alopecia. However, literature data report several endocrine imbalances inducing various adverse effects, which often persist after treatment cessation in the form of post-finasteride syndrome. Here we present the case of a 52-year-old man receiving finasteride (1 mg/day) who developed an uncommon adverse effect represented by generalized vitiligo 2 months after finasteride discontinuation. Associated adverse effects encountered were represented by mild sexual dysfunction (as determined by the International Index of Erectile Function, IIEF) and moderate depressive symptoms (according to DSM-V criteria), all of these manifestations aggregating within/as a possible post-finasteride syndrome. Further studies should develop and compare several therapeutic approaches, taking into account not only compounds that decrease the circulating dihydrotestosterone level but also those that could block the dihydrotestosterone receptors (if possible, compounds with selective tropism towards the skin). In addition, the possibility of predicting adverse effects of finasteride (according to hand preference and sexual orientation) should be taken into account.

  1. Reported respiratory symptoms and adverse home conditions after 9/11 among residents living near the World Trade Center.

    PubMed

    Lin, Shao; Jones, Rena; Reibman, Joan; Bowers, James; Fitzgerald, Edward F; Hwang, Syni-An

    2007-05-01

    This study investigated whether self-reported damage, dust, and odors in homes near the World Trade Center (WTC) after September 11, 2001, were related to increased rates of respiratory symptoms among residents and if multiple sources of exposure were associated with greater health risk. We mailed questionnaires to homes within 1.5 km of the WTC site (affected area) and in upper Manhattan (control area). Surveys asked about respiratory symptoms, unplanned medical visits, physician diagnoses, medication use, and conditions in the home after 9/11. Adverse home conditions were associated with new-onset (i.e., began after 9/11) and persistent (i.e., remained 1 year after 9/11) upper and lower respiratory symptoms in the affected area (Cumulative Incidence Ratios [CIRs] 1.20-1.71). Residents reporting longer duration of dust/odors or multiple sources of exposure had greater risk for symptoms compared to those reporting shorter duration and fewer sources. These data suggest that WTC-related contamination in the home after 9/11 was associated with new and persistent respiratory symptoms among residents living near the site. While we cannot eliminate potential biases related to self-reported data, we took strategies to minimize their impact, and the observed effects are biologically plausible.

  2. Reporting of the incidence of hospitalised injuries: numerator issues

    PubMed Central

    Boufous, S; Williamson, A

    2003-01-01

    Objectives: To examine and discuss the implications on the incidence of hospitalised injuries of selecting cases from principal diagnosis field only compared with considering all diagnosis fields, the inclusion compared with the exclusion of medical injuries, and the impact of identifying multiple admissions. Methods: Analysis of data from the 1999–2000 New South Wales Inpatient Statistics Collection, Australia, including an internal linkage of the same dataset. Results: Approximately 27.5% of records with a non-injury primary diagnosis include a nature of injury diagnosis in a subsequent diagnostic field. This figure increased to more than half (53%) of discharges for medical injuries. The internal linkage showed that 6.5% of discharges were repeat admissions for the same International Classification of Diseases, 10th revision (ICD-10) injury code and that 13.8% were repeat admissions for any ICD-10 injury code. The proportions of repeat admissions varied according to the type and the mechanism of injury. Conclusions: Selecting hospitalised injury cases from the principal diagnosis alone would underestimate medical injury cases as well as other injuries occurring in hospital. Repeat admissions should always be considered particularly in the case of thermal injuries, self harm, and medical injuries. Due to the limitations of data linkage, alternative methods need to be developed to identify repeat admissions. Other areas in which further research would be beneficial to a more uniform reporting of injury hospitalisations include better identification of injuries occurring in hospital, a review of ICD-10 injury codes, and the development an ICD-10 based severity measure which can be readily used with hospital discharge data. PMID:14693903

  3. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug... availability of a guidance for industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this guidance is to assist sponsors or...

  4. Analysis of factors associated with hiccups based on the Japanese Adverse Drug Event Report database

    PubMed Central

    Hosoya, Ryuichiro; Ishii-Nozawa, Reiko; Kagaya, Hajime

    2017-01-01

    Hiccups are occasionally experienced by most individuals. Although hiccups are not life-threatening, they may lead to a decline in quality of life. Previous studies showed that hiccups may occur as an adverse effect of certain medicines during chemotherapy. Furthermore, a male dominance in hiccups has been reported. However, due to the limited number of studies conducted on this phenomenon, debate still surrounds the few factors influencing hiccups. The present study aimed to investigate the influence of medicines and patient characteristics on hiccups using a large-sized adverse drug event report database and, specifically, the Japanese Adverse Drug Event Report (JADER) database. Cases of adverse effects associated with medications were extracted from JADER, and Fisher’s exact test was performed to assess the presence or absence of hiccups for each medication. In a multivariate analysis, we conducted a multiple logistic regression analysis using medication and patient characteristic variables exhibiting significance. We also examined the role of dexamethasone in inducing hiccups during chemotherapy. Medicines associated with hiccups included dexamethasone, levofolinate, fluorouracil, oxaliplatin, carboplatin, and irinotecan. Patient characteristics associated with hiccups included a male gender and greater height. The combination of anti-cancer agent and dexamethasone use was noted in more than 95% of patients in the dexamethasone-use group. Hiccups also occurred in patients in the anti-cancer agent-use group who did not use dexamethasone. Most of the medications that induce hiccups are used in chemotherapy. The results of the present study suggest that it is possible to predict a high risk of hiccups using patient characteristics. We confirmed that dexamethasone was the drug that has the strongest influence on the induction of hiccups. However, the influence of anti-cancer agents on the induction of hiccups cannot be denied. We consider the results of the

  5. 78 FR 38803 - Pipeline Safety: Information Collection Activities, Revisions to Incident and Annual Reports for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ... 7100.3 Incident Report--Liquefied Natural Gas Facilities; and PHMSA F 7100.3-1 Annual Report for Calendar Year 20---- Liquefied Natural Gas Facilities. In accordance with the Paperwork Reduction Act of.... Incident Report--Liquefied Natural Gas Facilities (PHMSA F 7100.3) PHMSA proposes to revise the PHMSA...

  6. 78 FR 71033 - Pipeline Safety: Information Collection Activities, Revisions to Incident and Annual Reports for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... Other Gas Transmission and Gathering Pipeline Systems; PHMSA F 7100.3 Incident Report--Liquefied Natural Gas Facilities; and PHMSA F 7100.3-1 Annual Report for Calendar Year 20xx Liquefied Natural Gas... Calendar Year 20xx for Distribution Operators; PHMSA F 7100.2 Incident Report-- Natural and Other...

  7. Statistical Mining of Potential Drug Interaction Adverse Effects in FDA's Spontaneous Reporting System.

    PubMed

    Harpaz, Rave; Haerian, Krystl; Chase, Herbert S; Friedman, Carol

    2010-11-13

    Many adverse drug effects (ADEs) can be attributed to drug interactions. Spontaneous reporting systems (SRS) provide a rich opportunity to detect novel post-marketed drug interaction adverse effects (DIAEs), as they include populations not well represented in clinical trials. However, their identification in SRS is nontrivial. Most existing research have addressed the statistical issues used to test or verify DIAEs, but not their identification as part of a systematic large scale database-wide mining process as discussed in this work. This paper examines the application of a highly optimized and tailored implementation of the Apriori algorithm, as well as methods addressing data quality issues, to the identification of DIAEs in FDAs SRS.

  8. A Descriptive Analysis of Incidents Reported by Community Aged Care Workers.

    PubMed

    Tariq, Amina; Douglas, Heather E; Smith, Cheryl; Georgiou, Andrew; Osmond, Tracey; Armour, Pauline; Westbrook, Johanna I

    2015-07-01

    Little is known about the types of incidents that occur to aged care clients in the community. This limits the development of effective strategies to improve client safety. The objective of the study was to present a profile of incidents reported in Australian community aged care settings. All incident reports made by community care workers employed by one of the largest community aged care provider organizations in Australia during the period November 1, 2012, to August 8, 2013, were analyzed. A total of 356 reports were analyzed, corresponding to a 7.5% incidence rate per client year. Falls and medication incidents were the most prevalent incident types. Clients receiving high-level care and those who attended day therapy centers had the highest rate of incidents with 14% to 20% of these clients having a reported incident. The incident profile indicates that clients on higher levels of care had higher incident rates. Incident data represent an opportunity to improve client safety in community aged care.

  9. Brief Report: Incidence of Ophthalmologic Disorders in Children with Autism

    ERIC Educational Resources Information Center

    Ikeda, Jamie; Davitt, Bradley V.; Ultmann, Monica; Maxim, Rolanda; Cruz, Oscar A.

    2013-01-01

    Purpose: To determine the incidence of ophthalmologic disorders in children with autism and related disorders. Design: Retrospective chart review. Four hundred and seven children diagnosed with autism or a related disorder between 1998 and 2006. One hundred and fifty-four of these children completed a comprehensive ophthalmology exam by a…

  10. Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.

    PubMed

    Hunsinger, Matthew; Smith, Shannon M; Rothstein, Daniel; McKeown, Andrew; Parkhurst, Melissa; Hertz, Sharon; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Rappaport, Bob A; Turk, Dennis C; Dworkin, Robert H

    2014-11-01

    Assessment of treatment safety is 1 of the primary goals of clinical trials. Organizations and working groups have created reporting guidelines for adverse events (AEs). Previous research examining AE reporting for pharmacologic clinical trials of analgesics in major pain journals found many reporting inadequacies, suggesting that analgesic trials are not adhering to existing AE reporting guidelines. The present systematic review documented AE reporting in 3 main pain journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain treatments. To broaden our pool of nonpharmacologic trials, we also included trials examining acupuncture, leech therapy, and noninvasive stimulation techniques (eg, transcutaneous electrical nerve stimulation). We documented AE reporting at 2 levels of specificity using coding manuals based on the Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We identified a number of inadequacies in AE reporting across the 3 journals. For example, using the ACTTION coding manual, we found that less than one-half of the trials reported specific AE assessment methods; approximately one-third of the trials reported withdrawals due to AEs for each study arm; and about one-fourth of the trials reported all specific AEs. We also examined differences in AE reporting across several trial characteristics, finding that AE reporting was generally more detailed in trials with patients versus those using healthy volunteers undergoing experimentally evoked pain. These results suggest that investigators conducting and reporting NP/NI clinical trials are not adequately describing the assessment and occurrence of AEs.

  11. Adverse events following yellow fever immunization: Report and analysis of 67 neurological cases in Brazil.

    PubMed

    Martins, Reinaldo de Menezes; Pavão, Ana Luiza Braz; de Oliveira, Patrícia Mouta Nunes; dos Santos, Paulo Roberto Gomes; Carvalho, Sandra Maria D; Mohrdieck, Renate; Fernandes, Alexandre Ribeiro; Sato, Helena Keico; de Figueiredo, Patricia Mandali; von Doellinger, Vanessa Dos Reis; Leal, Maria da Luz Fernandes; Homma, Akira; Maia, Maria de Lourdes S

    2014-11-20

    Neurological adverse events following administration of the 17DD substrain of yellow fever vaccine (YEL-AND) in the Brazilian population are described and analyzed. Based on information obtained from the National Immunization Program through passive surveillance or intensified passive surveillance, from 2007 to 2012, descriptive analysis, national and regional rates of YFV associated neurotropic, neurological autoimmune disease, and reporting rate ratios with their respective 95% confidence intervals were calculated for first time vaccinees stratified on age and year. Sixty-seven neurological cases were found, with the highest rate of neurological adverse events in the age group from 5 to 9 years (2.66 per 100,000 vaccine doses in Rio Grande do Sul state, and 0.83 per 100,000 doses in national analysis). Two cases had a combination of neurotropic and autoimmune features. This is the largest sample of YEL-AND already analyzed. Rates are similar to other recent studies, but on this study the age group from 5 to 9 years of age had the highest risk. As neurological adverse events have in general a good prognosis, they should not contraindicate the use of yellow fever vaccine in face of risk of infection by yellow fever virus.

  12. Text mining for the Vaccine Adverse Event Reporting System: medical text classification using informative feature selection

    PubMed Central

    Nguyen, Michael D; Woo, Emily Jane; Markatou, Marianthi; Ball, Robert

    2011-01-01

    Objective The US Vaccine Adverse Event Reporting System (VAERS) collects spontaneous reports of adverse events following vaccination. Medical officers review the reports and often apply standardized case definitions, such as those developed by the Brighton Collaboration. Our objective was to demonstrate a multi-level text mining approach for automated text classification of VAERS reports that could potentially reduce human workload. Design We selected 6034 VAERS reports for H1N1 vaccine that were classified by medical officers as potentially positive (Npos=237) or negative for anaphylaxis. We created a categorized corpus of text files that included the class label and the symptom text field of each report. A validation set of 1100 labeled text files was also used. Text mining techniques were applied to extract three feature sets for important keywords, low- and high-level patterns. A rule-based classifier processed the high-level feature representation, while several machine learning classifiers were trained for the remaining two feature representations. Measurements Classifiers' performance was evaluated by macro-averaging recall, precision, and F-measure, and Friedman's test; misclassification error rate analysis was also performed. Results Rule-based classifier, boosted trees, and weighted support vector machines performed well in terms of macro-recall, however at the expense of a higher mean misclassification error rate. The rule-based classifier performed very well in terms of average sensitivity and specificity (79.05% and 94.80%, respectively). Conclusion Our validated results showed the possibility of developing effective medical text classifiers for VAERS reports by combining text mining with informative feature selection; this strategy has the potential to reduce reviewer workload considerably. PMID:21709163

  13. The Relationship between Psychotropic Drug Use and Suicidal Behavior in Japan: Japanese Adverse Drug Event Report.

    PubMed

    Takeuchi, T; Takenoshita, S; Taka, F; Nakao, M; Nomura, K

    2017-03-01

    Introduction: Very few studies have explored the adverse effect of psychotropic drugs worldwide. Methods: This study analyzed 1 813 suicide-related drug reports involving 553 patients collected from the Japanese National Adverse Drug Report Database between October 2001 and January 2012 to investigate psychotropic drugs associated with completed suicide vs. other suicide-related behaviors, including ideation and self-injury. The drugs investigated included antidepressants, antipsychotics, benzodiazepines, non-benzodiazepine hypnotic agents, noradrenergic and specific serotonergic antidepressants, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, and other drugs. Results: These reports referenced 300 (54.2%) individuals who completed suicide. Adjusting for age, sex, and drugs used, the multivariate model revealed that participants who took antipsychotics were 1.70 times (95% CI, 1.11-2.61) more likely to complete suicide compared with those who did not. All other drugs became non-significant. Compared with those who took only one medication, those prescribed more than 4 drugs were more likely to complete suicide (OR 4.44, 95% CI, 2.40-8.20). Discussion: Antipsychotic drugs and polypharmacy may be regarded as predictors of completed suicide.

  14. Adverse Events Associated with Yoga: A Systematic Review of Published Case Reports and Case Series

    PubMed Central

    Cramer, Holger; Krucoff, Carol; Dobos, Gustav

    2013-01-01

    While yoga is gaining increased popularity in North America and Europe, its safety has been questioned in the lay press. The aim of this systematic review was to assess published case reports and case series on adverse events associated with yoga. Medline/Pubmed, Scopus, CAMBase, IndMed and the Cases Database were screened through February 2013; and 35 case reports and 2 case series reporting a total of 76 cases were included. Ten cases had medical preconditions, mainly glaucoma and osteopenia. Pranayama, hatha yoga, and Bikram yoga were the most common yoga practices; headstand, shoulder stand, lotus position, and forceful breathing were the most common yoga postures and breathing techniques cited. Twenty-seven adverse events (35.5%) affected the musculoskeletal system; 14 (18.4%) the nervous system; and 9 (11.8%) the eyes. Fifteen cases (19.7%) reached full recovery; 9 cases (11.3%) partial recovery; 1 case (1.3%) no recovery; and 1 case (1.3%) died. As any other physical or mental practice, yoga should be practiced carefully under the guidance of a qualified instructor. Beginners should avoid extreme practices such as headstand, lotus position and forceful breathing. Individuals with medical preconditions should work with their physician and yoga teacher to appropriately adapt postures; patients with glaucoma should avoid inversions and patients with compromised bone should avoid forceful yoga practices. PMID:24146758

  15. Case report of critical incident stress debriefing through translators.

    PubMed

    True, P K

    2000-01-01

    The United States Navy has SPRINT (Special Psychiatric Rapid Intervention Team) teams stationed in National Naval Medical Center in Bethesda, Maryland, Naval Regional Medical Center in Portsmouth, Virginia, Naval Regional Medical Center in San Diego, California, and US Naval Hospital, Bremerton, Washington. These teams are large units of psychiatrists, psychologists, nurses, chaplains, and hospital corpsmen who are trained in the techniques of Critical Incident Stress using the model developed by Jeffrey T. Mitchell and George S. Everly, Jr. (Mitchell & Everly, 1996; Everly & Mitchell, 1999). In addition to these large SPRINT teams, smaller Critical Incident Stress Management (CISM) teams exist at several Navy commands, including US Naval Hospital, Jacksonville, Florida. Since the formation of SPRINT teams, there have been several hundred interventions done at various military sites. This article discusses an intervention that was particularly unusual in that it was done by US military personnel for the members of the Argentine military, none of whom could speak English.

  16. Texting-Based Reporting of Adverse Drug Reactions to Ensure Patient Safety: A Feasibility Study

    PubMed Central

    Castillo-Carandang, Nina T; Juban, Noel R; Amarillo, Maria Lourdes; Tagle, Maria Pamela; Baja, Emmanuel S

    2015-01-01

    Background Paper-based adverse drug reaction (ADR) reporting has been in practice for more than 6 decades. Health professionals remain the primary source of reports, while the value of patients’ reporting is yet unclear. With the increasing popularity of using electronic gadgets in health, it is expected that the electronic transmission of reports will become the norm within a few years. Objective The aims of this study are to investigate whether short messaging service or texting can provide an alternative or supplemental method for ADR reporting given the increasing role of mobile phones in health care monitoring; to determine the usefulness of texting in addition to paper-based reporting of ADRs by resident physicians; and to describe the barriers to ADR reporting and estimate the cost for setting up and maintaining a texting-computer reporting system. Methods This was a pre-post cross-sectional study that measured the number of ADRs texted by 51 resident physicians for 12 months from the Department of Obstetrics and Gynecology and the Department of Adult Medicine of a tertiary government hospital in Manila, Philippines, with 1350-bed capacity. Reports were captured by a texting-computer reporting system. Prior to its implementation, key informant interview and focus group discussion were conducted. Baseline information and practice on the existing paper-based reporting system were culled from the records of the hospital’s Pharmacy and Therapeutics Committee. A postintervention survey questionnaire was administered at the end of 12 months. Results Only 3 ADRs were texted by 51 resident physicians in 12 months (reporting rate 3/51 or 6%). By contrast, 240 ADRs from the paper-based reporting system from 848 resident physicians of the study hospital were collected and tabulated (reporting rate 240/848 or 28.3%). Texting ADRs was not efficient because of power interruption, competition with the existing paper-based reporting system, and unforeseen expiration of

  17. Using Pareto Analysis with Trend Analysis: Statistical Techniques to Investigate Incident Reports within a Housing System

    ERIC Educational Resources Information Center

    Luna, Andrew L.

    1998-01-01

    The purpose of this study was to determine trends and difficulties concerning student incident reports within the residence halls as they relate to the incident reporting system from the Department of Housing and Residential Life at a Southeastern Doctoral I Granting Institution. This study used the frequency distributions of each classified…

  18. 77 FR 69925 - Assessment of Hazardous Materials Incident Data Collection, Analysis, Reporting, and Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-21

    ... for an assessment to improve the collection, analysis, reporting, and use of data related to accidents... to accidents and incidents involving the transportation of hazardous materials. Section 33006(b... improving the collection, analysis, reporting, and use of data related to accidents and incidents...

  19. 76 FR 76686 - Notification and Reporting of Aircraft Accidents or Incidents and Overdue Aircraft, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-08

    ... and Reporting of Aircraft Accidents or Incidents and Overdue Aircraft, and Preservation of Aircraft... reporting requirements with regard to aircraft accidents or incidents, found at paragraph (a)(10) of section...: 1. Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the...

  20. 49 CFR 191.15 - Transmission systems; gathering systems; and liquefied natural gas facilities: Incident report.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... liquefied natural gas facilities: Incident report. 191.15 Section 191.15 Transportation Other Regulations... OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE...; gathering systems; and liquefied natural gas facilities: Incident report. (a) Transmission or...

  1. 49 CFR 191.15 - Transmission systems; gathering systems; and liquefied natural gas facilities: Incident report.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... liquefied natural gas facilities: Incident report. 191.15 Section 191.15 Transportation Other Regulations... OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE...; gathering systems; and liquefied natural gas facilities: Incident report. (a) Transmission or...

  2. 49 CFR 191.15 - Transmission systems; gathering systems; and liquefied natural gas facilities: Incident report.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... liquefied natural gas facilities: Incident report. 191.15 Section 191.15 Transportation Other Regulations... OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE...; gathering systems; and liquefied natural gas facilities: Incident report. (a) Transmission or...

  3. 49 CFR 191.15 - Transmission systems; gathering systems; and liquefied natural gas facilities: Incident report.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... liquefied natural gas facilities: Incident report. 191.15 Section 191.15 Transportation Other Regulations... OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE...; gathering systems; and liquefied natural gas facilities: Incident report. (a) Transmission or...

  4. 49 CFR 191.15 - Transmission and gathering systems: Incident report.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 false Transmission and gathering systems: Incident...-RELATED CONDITION REPORTS § 191.15 Transmission and gathering systems: Incident report. (a) Except as provided in paragraph (c) of this section, each operator of a transmission or a gathering pipeline...

  5. 41 CFR 102-33.450 - How must we report accident and incident data?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false How must we report accident and incident data? 102-33.450 Section 102-33.450 Public Contracts and Property Management Federal...-MANAGEMENT OF GOVERNMENT AIRCRAFT Reporting Information on Government Aircraft Accident and Incident...

  6. 41 CFR 102-33.450 - How must we report accident and incident data?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false How must we report accident and incident data? 102-33.450 Section 102-33.450 Public Contracts and Property Management Federal...-MANAGEMENT OF GOVERNMENT AIRCRAFT Reporting Information on Government Aircraft Accident and Incident...

  7. 41 CFR 102-33.450 - How must we report accident and incident data?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false How must we report accident and incident data? 102-33.450 Section 102-33.450 Public Contracts and Property Management Federal...-MANAGEMENT OF GOVERNMENT AIRCRAFT Reporting Information on Government Aircraft Accident and Incident...

  8. 41 CFR 102-33.450 - How must we report accident and incident data?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false How must we report accident and incident data? 102-33.450 Section 102-33.450 Public Contracts and Property Management Federal...-MANAGEMENT OF GOVERNMENT AIRCRAFT Reporting Information on Government Aircraft Accident and Incident...

  9. 41 CFR 102-33.450 - How must we report accident and incident data?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false How must we report accident and incident data? 102-33.450 Section 102-33.450 Public Contracts and Property Management Federal...-MANAGEMENT OF GOVERNMENT AIRCRAFT Reporting Information on Government Aircraft Accident and Incident...

  10. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    PubMed Central

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  11. Two case reports of cutaneous adverse reactions following hepatitis B vaccine: lichen planus and granuloma annulare.

    PubMed

    Criado, P R; de Oliveira Ramos, R; Vasconcellos, C; Jardim Criado, R F; Valente, N Y S

    2004-09-01

    We report two cases of adverse cutaneous reactions following hepatitis B vaccination. The first case occurred 3 weeks after the first dose of hepatitis B vaccine in a 16-year-old white girl with the onset of lichen planus lesions on her thighs and abdomen. After the second dose a disseminated lichen planus developed within 2 weeks. The second case concerns to the development of papular and patch granuloma annulare in a 58-year-old white woman 2 months after the second dose of hepatitis B vaccine. To the best of our knowledge, only a few paediatric and adult cases of lichen planus as a complication of hepatitis B vaccination have been reported in medical literature so far. This is the second case of granuloma annulare following hepatitis B vaccine. Our report, similar to earlier papers, appears to support the onset of lichen planus and granuloma annulare as a possible rare complication of hepatitis B immunization.

  12. A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients

    PubMed Central

    Rosli, Rosliana; Abd Aziz, Noorizan; Manan, Mohamed Mansor

    2016-01-01

    Background Spontaneous reporting on adverse drug reactions (ADR) has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the Malaysian paediatric population and to relate the data to specific paediatric age groups. Methods Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification), category of ADR (according to system organ class) as well as the severity of the ADR. Results In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7%). The most common ADRs reported were from the following system organ classes: application site disorders (32.2%), skin and appendages disorders (20.6%), body as a whole general disorders (12.8%) and central and peripheral nervous system disorders (11.2%). Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0%) were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%). Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities. Discussion ADR reports concerning vaccines and anti-infectives were the most commonly reported in children, and are mainly

  13. Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy

    PubMed Central

    Petrova, Guenka; Stoimenova, Assena; Dimitrova, Maria; Kamusheva, Maria; Petrova, Daniela; Georgiev, Ognian

    2017-01-01

    Introduction: Adverse drug reactions can cause increased morbidity and mortality, and therefore information needs to be studied systematically. Little is known about the adverse drug reactions for chronic obstructive pulmonary disease therapy. The goal of this study is to assess the expectedness, seriousness and severity of adverse drug reactions during chronic obstructive pulmonary disease therapy based on their reporting in the national pharmacovigilance system. Methods: This was a prospective, observational, 1-year, real-life study about the pharmacotherapy of a sample of 390 chronic obstructive pulmonary disease patients. Prescribed medicines were systematized and national pharmacovigilance databases were searched for reported adverse drug reactions. The expectedness was evaluated through the review of the summary of product characteristics, the seriousness was evaluated by the clinicians based on the life threatening nature of the adverse drug reactions, and the severity was evaluated through Hartwig’s Severity Assessment Scale. Descriptive statistics of the reported adverse drug reactions was performed and the relative risk of developing an adverse drug reaction with all international non-proprietary names included in the analysis was calculated. Results: Results confirm that the chronic obstructive pulmonary disease is a disease with high appearance of adverse drug reactions, and causes many additional costs to the healthcare system. Unexpected and severe adverse drug reactions are frequent. A total of 4.8% of adverse drug reactions were evaluated as life threatening. Majority of adverse drug reactions are classified in Levels 1 (32.6%), 2 (26.4%) and 3 (19%) according to Hartwig’s Severity Assessment Scale. Approximately 22% of reported adverse drug reactions affect people’s everyday life to a greater extent and require additional therapy which might further increase the risk. The relative risk of developing an adverse drug reaction was highest for

  14. Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

    PubMed Central

    2013-01-01

    Background Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications. Methods ADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR. Results We located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline. Conclusions The majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified. PMID:23763896

  15. Incidence rates of treatment-emergent adverse events and related hospitalization are reduced with azacitidine compared with conventional care regimens in older patients with acute myeloid leukemia.

    PubMed

    Seymour, John F; Döhner, Hartmut; Minden, Mark D; Stone, Richard; Gambini, Dominique; Dougherty, Donna; Beach, C L; Weaver, Jerry; Dombret, Hervé

    2017-06-01

    Relative risks of treatment-emergent adverse events (TEAEs) and related hospitalization is most accurate when accounting for treatment exposure. AZA-AML-001 showed azacitidine (AZA) prolonged overall survival versus conventional care regimens (CCR) in older patients (≥65 years) with acute myeloid leukemia (AML) by 3.9 months. Preselection of CCR before study randomization allows evaluation of AZA safety in patient subgroups with similar clinical features. Within preselection groups, AZA exposure was greater than each CCR. Incidence rates (IRs; numbers of events normalized for drug exposure time) of hospitalizations and days in hospital for TEAEs per patient-year of exposure were to varying degrees lower with AZA versus each CCR. Overall survival was significantly prolonged with AZA versus best supportive care (BSC) in AZA-AML-001; this analysis showed 55% and 41% reductions in IRs of TEAE-related hospitalization and days in hospital, respectively, with AZA versus BSC. Older patients with AML unable to tolerate intensive therapy should be offered active low-intensity treatment.

  16. The Australian Incident Monitoring Study. Crisis management--validation of an algorithm by analysis of 2000 incident reports.

    PubMed

    Runciman, W B; Webb, R K; Klepper, I D; Lee, R; Williamson, J A; Barker, L

    1993-10-01

    Anaesthetists are called upon to manage complex life-threatening crises at a moment's notice. As there is evidence that this may require cognitive tasking beyond the information-processing capacity of the human brain, it was decided to try and develop a generic crisis management algorithm analogous to the "Phase I" immediate response routine used by airline pilots. Such an algorithm, based on the mnemonic "COVER ABCD, A SWIFT CHECK", was developed and refined over 3 meetings, each attended by 60-100 anaesthetists and aviation psychologists. It was validated against 1301 relevant incidents among the first 2000 incidents reported to the Australian Incident Monitoring Study. It proved sufficiently robust and safe to recommend its general use as an initial response to any incident or crisis which occurs when a patient is breathing gas from an anesthetic machine. It requires a limited knowledge base and is easily learnt and rehearsed during the anaesthetist's working day. It will provide a functional diagnosis in over 99% of cases and will correct 62% of the problems in 40-60 seconds. In the remaining 37% it will allow the anaesthetist to proceed with a "sub-algorithm", confident in the knowledge that some important step has not been missed. In just over 30% of incidents this will be for a problem familiar to all anaesthetists (e.g. laryngospasm, bradycardia); in just over 6% it will be for a less common, more complex, but finite, set of problems (3% cardiac arrest, 1% air embolism, 1% anaphylaxis, 1% for the remaining desaturations); in less than 1% diagnosis and correction will require a more complex checklist (e.g. for malignant hyperthermia, pneumothorax). The next stage, the development of specific sub-algorithms and a structured team approach for ongoing problems, is in progress.

  17. Label-inconsistent use of sibutramine in spontaneous adverse drug reaction reports in Germany.

    PubMed

    Seebeck, J; Wulf, F; Sachs, B

    2008-07-01

    In Germany, reports on adverse drug reactions (ADRs) are centrally collected and analyzed by the Federal Institute for Drugs and Medical Devices (BfArM). During routine analysis of ADR reports related to the antiobesity drug sibutramine, we repeatedly observed descriptions of its label*-inconsistent use (*European Summary of Product Characteristics (SmPC)). In order to quantify this observation, we analyzed all sibutramine-related ADR reports received by the BfArM so far. Using the same data source, we further analyzed the effect of a Dear Doctor Letter (DDL) which was distributed in 2002 in order to reinforce the label-consistent use of sibutramine. Out of a total of 170 identified reports, 104 were considered as suitable for further analysis. Of these, applying a catalogue of 24 SmPC-derived criteria, 34% (35 reports) contained information indicative of label-inconsistent use. The individual SmPC-criteria most often violated were (% of total analyzed reports): the recommended starting dose of 10 mg/day (9%), the body mass index (BMI)-related threshold permitting drug therapy (6%), and the contraindicated "history of drug abuse" (6%). The DDL was ineffective. The observed percentage of ADR reports, indicating a label-inconsistent use of sibutramine, is considered a signal for a therapeutic risk. This signal should be addressed in a drug utilization study investigating the use of sibutramine by means of a representative patient sample.

  18. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital

    PubMed Central

    Vallano, A; Cereza, G; Pedròs, C; Agustí, A; Danés, I; Aguilera, C; Arnau, J M

    2005-01-01

    Aim To describe the opinions of hospital physicians concerning problems regarding the spontaneous reporting of adverse drug reactions (ADRs) and ways to solve them. Methods A qualitative study was carried out. Fifteen focus groups were conducted among physicians working in a tertiary teaching hospital. A total of 208 physicians from different medical specialities participated. The focus group discussions were recorded by three different observers and the transcripts of each session were analysed for issues and themes emerging from the text. Results Four types of obstacles to spontaneous reporting were considered particularly important: (i) problems with the ADRs diagnosis; (ii) problems with the usual workload and lack of time; (iii) problems related to the organization and activities of the pharmacovigilance system; (iv) and problems related to potential conflicts. The potential solutions suggested for improving spontaneous reporting were to define the kind of ADRs which should be reported, to facilitate an easy contact and quick access to the hospital pharmacovigilance system, to facilitate information and support for reporting and feedback of pharmacovigilance activities. Conclusions The perception of the different obstacles by the hospital physicians is an important factor in determining the causes of the underreporting of ADRs and addressing these obstacles could lead to an improvement in spontaneous reporting. A closer relationship between the doctors and the pharmacovigilance centre is suggested as a means of solving these problems. More information is needed to improve the spontaneous reporting of ADRs in specialized healthcare. PMID:16305591

  19. A Profile of Criminal Incidents at School: Results from the 2003-05 National Crime Victimization Survey Crime Incident Report NCES 2010-318

    ERIC Educational Resources Information Center

    Ruddy, Sally A.; Bauer, Lynn; Neiman, Samantha

    2010-01-01

    This report provides estimates of criminal incidents that occur at school. Incident-level data were obtained from the National Crime Victimization Survey (NCVS), the nation's primary source of information on criminal victimization and criminal incidents in the United States. The NCVS collects demographic information on respondents in the NCVS…

  20. Annual report on adverse events related with vaccines use in Calabria (Italy): 2012

    PubMed Central

    Staltari, Orietta; Cilurzo, Felisa; Caroleo, Benedetto; Greco, Alexia; Corasaniti, Francesco; Genovesi, Maria Antonietta; Gallelli, Luca

    2013-01-01

    Vaccines are administered to large population of healthy individuals, particularly to millions of infants every year, through national immunization programs. Although vaccines represent a good defense against some infectious diseases, their administration may be related with the development of adverse vaccine events (AVEs); therefore their use is continually monitored to detect these side effects. In the presents work, we reported the suspected AVEs recorded in 2012 in Calabria, Italy. We performed a retrospective study on report forms of patients that developed AVEs in Calabria from January 1, 2012 to December 31, 2012. Naranjo score was used to evaluate the association between AVEs and vaccines and only suspected AVEs definable as certain, probable, or possible were included in this analysis. During the study period, we evaluated 461 records of adverse drug reactions (ADRs) and 18 (3.9%) were probably induced by vaccination. AVEs were common in females (almost 77.7%) and in children aged 0-3 years. The largest number of non-serious AVEs involved “skin and subcutaneous tissue disorders” and “general disorders and administration site conditions.” In conclusion, we documented that in Calabria the total number of AVEs is very low and it may be useful to increase the pharmacovigilance culture in order to evaluate the safety of these products in large populations. PMID:24347985

  1. When the safe place does not protect: reports of victimisation and adverse experiences in psychiatric institutions.

    PubMed

    Dos Santos Mesquita, Cristina; da Costa Maia, Ângela

    2016-12-01

    Psychiatric patients report higher levels of victimisation and are at risk for further victimisation in different contexts, such as psychiatric institutions. Studies in this field tend to focus on hospital staff as victims, experiencing classic forms of victimisation (e.g. physical assault, threats, verbal abuse), through qualitative studies. This is a quantitative retrospective study that aims to know the occurrence of psychiatric victimisation and other adverse experiences in Portuguese psychiatric patients. Ninety-five psychiatric patients, between 20 and 79 years old (M - 45.18, SD - 13.06), with a history of psychiatric hospitalisation answered the Experiences in Psychiatric Institution Inventory. Participants were recruited in four psychiatric hospitals. Inpatients were approached during their hospitalisation; outpatients were approached in scheduled appointment days. Only 23 (24.2%) participants reported no victimisation. Total Experiences of Self varied from 0 to 7 (M - 1.75, SD - 1.72), Total Witnessed Experiences varied from 0 to 7 (M - 1.17, SD - 1.64), and Total Global Experiences varied from 0 to 14 (M - 2.92, SD - 3.01). These results show that victimisation and adverse experiences in psychiatric contexts are frequent and go beyond classic forms of victimisation. A deeper knowledge of these experiences and their impact in the mental health of psychiatric patients may promote quality of care provided and lead to more effective treatments, thus reducing the number and length of hospitalisations, and the financial burden for public health services.

  2. Annual report on adverse events related with vaccines use in Calabria (Italy): 2012.

    PubMed

    Staltari, Orietta; Cilurzo, Felisa; Caroleo, Benedetto; Greco, Alexia; Corasaniti, Francesco; Genovesi, Maria Antonietta; Gallelli, Luca

    2013-12-01

    Vaccines are administered to large population of healthy individuals, particularly to millions of infants every year, through national immunization programs. Although vaccines represent a good defense against some infectious diseases, their administration may be related with the development of adverse vaccine events (AVEs); therefore their use is continually monitored to detect these side effects. In the presents work, we reported the suspected AVEs recorded in 2012 in Calabria, Italy. We performed a retrospective study on report forms of patients that developed AVEs in Calabria from January 1, 2012 to December 31, 2012. Naranjo score was used to evaluate the association between AVEs and vaccines and only suspected AVEs definable as certain, probable, or possible were included in this analysis. During the study period, we evaluated 461 records of adverse drug reactions (ADRs) and 18 (3.9%) were probably induced by vaccination. AVEs were common in females (almost 77.7%) and in children aged 0-3 years. The largest number of non-serious AVEs involved "skin and subcutaneous tissue disorders" and "general disorders and administration site conditions." In conclusion, we documented that in Calabria the total number of AVEs is very low and it may be useful to increase the pharmacovigilance culture in order to evaluate the safety of these products in large populations.

  3. Evaluation of the Defense Criminal Investigative Organizations’ Defense Incident-Based Reporting System Reporting and Reporting Accuracy

    DTIC Science & Technology

    2014-10-29

    crime statistics . The Act directs Federal agencies that routinely investigate complaints of criminal activity to report details about such crimes to the...not reporting criminal incident data to the Federal Bureau of Investigation (FBI) for inclusion in the annual Uniform Crime Reports to the President...Federal law. The FBI uses the data to develop a reliable set of criminal statistics for U.S. law enforcement agencies. Recommendations • The

  4. Chewing gum in the preoperative fasting period: an analysis of de-identified incidents reported to webAIRS.

    PubMed

    Shanmugam, S; Goulding, G; Gibbs, N M; Taraporewalla, K; Culwick, M

    2016-03-01

    The role of preoperative fasting is well established in current anaesthetic practice with different guidelines for clear fluids and food. However, chewing gum may not be categorised as either food or drink by some patients, and may not always be specified in instructions given to patients about preoperative fasting. The aim of this paper was to review anaesthesia incidents involving gum chewing reported to webAIRS to obtain information on the risks, if any, of gum chewing during the preoperative fasting period. There were nine incidents involving chewing gum reported between late 2009 and early 2015. There were no adverse outcomes from the nine incidents other than postponement of surgery in three cases and cancellation in one. In particular, there were no reports of aspiration or airway obstruction. Nevertheless, there were five cases in which the gum was not detected preoperatively and was found in the patient's mouth either intraoperatively or postoperatively. These cases of undetected gum occurred despite patient and staff compliance with their current preoperative checklists. While the risk of increased gastric secretions related to chewing gum preoperatively are not known, the potential for airway obstruction if the gum is not detected and removed preoperatively is very real. We recommend that patients should be specifically advised to avoid gum chewing once fasting from clear fluids is commenced, and that a specific question regarding the presence of chewing gum should be added to all preoperative checklists.

  5. Motor palsies of cranial nerves (excluding VII) after vaccination: reports to the US Vaccine Adverse Event Reporting System.

    PubMed

    Woo, Emily Jane; Winiecki, Scott K; Ou, Alan C

    2014-01-01

    We reviewed cranial nerve palsies, other than VII, that have been reported to the US Vaccine Adverse Event Reporting System (VAERS). We examined patterns for differences in vaccine types, seriousness, age, and clinical characteristics. We identified 68 reports of cranial nerve palsies, most commonly involving the oculomotor (III), trochlear (IV), and abducens (VI) nerves. Isolated cranial nerve palsies, as well as palsies occurring as part of a broader clinical entity, were reported. Forty reports (59%) were classified as serious, suggesting that a cranial nerve palsy may sometimes be the harbinger of a broader and more ominous clinical entity, such as a stroke or encephalomyelitis. There was no conspicuous clustering of live vs. inactivated vaccines. The patient age range spanned the spectrum from infants to the elderly. Independent data may help to clarify whether, when, and to what extent the rates of cranial nerve palsies following particular vaccines may exceed background levels.

  6. Reported Adverse Drug Reactions in Infants: A Nationwide Analysis in Malaysia.

    PubMed

    Rosli, Rosliana; Dali, Ahmad Fauzi; Aziz, Noorizan Abd; Ming, Long Chiau; Manan, Mohamed Mansor

    2017-01-01

    Spontaneous adverse drug reactions (ADRs) reporting is a useful source of drug safety information in infants as only adult patients are routinely tested in clinical trials. This study was aimed to evaluate the spontaneously reported ADRs using WHO Adverse Reaction Terminology and to identify the common drugs associated with ADRs in children under 2 years of age. A retrospective analysis of ADR data for children below 2 years old from 2000 to 2013 was conducted using the data extracted from Malaysia's national pharmacovigilance database, QUEST2 System. From 2000 to 2013, Malaysia's National Pharmaceutical Control Bureau received a total of 11,932 reports for children from various healthcare facilities in Malaysia. 14.0% (n = 1667) of the ADRs reported for those children were related to children under 2 years old. The data retrieved was analyzed in terms of age, gender, source of reporting, type of reporters, suspected medicines and characteristics of ADRs (category, onset, severity, and outcomes). A total of 1312 ADRs reported in 907 ADR reports were analyzed. The most common ADRs reported were skin appendage disorders (60.1%), and the most frequently reported symptoms were rash (n = 215), maculopapular rash (n = 206), urticaria (n = 169), erythematous rash (n = 76), and pruritus (n = 58). In general, drugs from antibacterials for systemic use (58.8%) appeared to be the most common contributors to ADRs in children below 2 years old. Penicillins and other β-Lactam Antibacterials accounted for more than 40% of all drugs implicated in ADRs. The majority of ADRs were subacute reactions that occurred within 24 h of exposure to the drug. A high proportion of ADRs was classified as mild, and most victims had no sequela. Only one fatality was seen. There were 10 cases for each symptom, namely erythema multiforme and Stevens-Johnson Syndrome, observed in this study. A large proportion of ADRs in children under 2 years old were mainly caused by drugs from antibacterial for

  7. Reported Adverse Drug Reactions in Infants: A Nationwide Analysis in Malaysia

    PubMed Central

    Rosli, Rosliana; Dali, Ahmad Fauzi; Aziz, Noorizan Abd.; Ming, Long Chiau; Manan, Mohamed Mansor

    2017-01-01

    Spontaneous adverse drug reactions (ADRs) reporting is a useful source of drug safety information in infants as only adult patients are routinely tested in clinical trials. This study was aimed to evaluate the spontaneously reported ADRs using WHO Adverse Reaction Terminology and to identify the common drugs associated with ADRs in children under 2 years of age. A retrospective analysis of ADR data for children below 2 years old from 2000 to 2013 was conducted using the data extracted from Malaysia’s national pharmacovigilance database, QUEST2 System. From 2000 to 2013, Malaysia’s National Pharmaceutical Control Bureau received a total of 11,932 reports for children from various healthcare facilities in Malaysia. 14.0% (n = 1667) of the ADRs reported for those children were related to children under 2 years old. The data retrieved was analyzed in terms of age, gender, source of reporting, type of reporters, suspected medicines and characteristics of ADRs (category, onset, severity, and outcomes). A total of 1312 ADRs reported in 907 ADR reports were analyzed. The most common ADRs reported were skin appendage disorders (60.1%), and the most frequently reported symptoms were rash (n = 215), maculopapular rash (n = 206), urticaria (n = 169), erythematous rash (n = 76), and pruritus (n = 58). In general, drugs from antibacterials for systemic use (58.8%) appeared to be the most common contributors to ADRs in children below 2 years old. Penicillins and other β-Lactam Antibacterials accounted for more than 40% of all drugs implicated in ADRs. The majority of ADRs were subacute reactions that occurred within 24 h of exposure to the drug. A high proportion of ADRs was classified as mild, and most victims had no sequela. Only one fatality was seen. There were 10 cases for each symptom, namely erythema multiforme and Stevens–Johnson Syndrome, observed in this study. A large proportion of ADRs in children under 2 years old were mainly caused by drugs from antibacterial

  8. Surveillance of adverse events following immunisation in Australia annual report, 2013.

    PubMed

    Mahajan, Deepika; Dey, Aditi; Cook, Jane; Harvey, Bronwen; Menzies, Rob; Macartney, Kristine

    2015-09-30

    This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2013 reported to the Therapeutic Goods Administration (TGA) for 2013 and describes reporting trends over the 14-year period 1 January 2000 to 31 December 2013. There were 3,161 AEFI records for vaccines administered in 2013. This is an annual AEFI reporting rate of 13.9 per 100,000 population, the 2nd highest since 2000 and an increase of 59% compared with 2012 (1,994 AEFI records; 8.8 per 100,000 population). The increase was partly due to implementation of enhancements to vaccine safety reporting. This included stimulated reporting of AEFI as part of the extension of national human papillomavirus (HPV) vaccination under the National Immunisation Program to males aged 12-13 years, along with a catch-up program for males aged 14 and 15 years in February 2013 (n=785; includes males and females), in which certain events, such as syncope, were closely monitored. Eighty-two per cent (n=341/414) of the syncope reports were following HPV vaccination and of these 57% (n=195) were males and 43% (n=146) were females. In addition, reporting rates for most other the vaccines were higher in 2013 compared with 2012. The majority of AEFI reports described non-serious events while 5% (n=158) were classified as serious. There were 4 reports of death; however, all deaths were investigated by the TGA and no clear causal relationship with vaccination was found. The most commonly reported reactions were injection site reaction (13%), rash (10%), pyrexia (8%), and syncope (7%).

  9. Pilot Critical Incident Reports as a Means to Identify Human Factors of Remotely Piloted Aircraft

    NASA Technical Reports Server (NTRS)

    Hobbs, Alan; Cardoza, Colleen; Null, Cynthia

    2016-01-01

    It has been estimated that aviation accidents are typically preceded by numerous minor incidents arising from the same causal factors that ultimately produced the accident. Accident databases provide in-depth information on a relatively small number of occurrences, however incident databases have the potential to provide insights into the human factors of Remotely Piloted Aircraft System (RPAS) operations based on a larger volume of less-detailed reports. Currently, there is a lack of incident data dealing with the human factors of unmanned aircraft systems. An exploratory study is being conducted to examine the feasibility of collecting voluntary critical incident reports from RPAS pilots. Twenty-three experienced RPAS pilots volunteered to participate in focus groups in which they described critical incidents from their own experience. Participants were asked to recall (1) incidents that revealed a system flaw, or (2) highlighted a case where the human operator contributed to system resilience or mission success. Participants were asked to only report incidents that could be included in a public document. During each focus group session, a note taker produced a de-identified written record of the incident narratives. At the end of the session, participants reviewed each written incident report, and made edits and corrections as necessary. The incidents were later analyzed to identify contributing factors, with a focus on design issues that either hindered or assisted the pilot during the events. A total of 90 incidents were reported. Human factor issues included the impact of reduced sensory cues, traffic separation in the absence of an out-the-window view, control latencies, vigilance during monotonous and ultra-long endurance flights, control station design considerations, transfer of control between control stations, the management of lost link procedures, and decision-making during emergencies. Pilots participated willingly and enthusiastically in the study

  10. Evidence Report: Risk of Crew Adverse Health Event Due to Altered Immune Response

    NASA Technical Reports Server (NTRS)

    Crucian, Brian; Sams, Clarence F.

    2013-01-01

    The Risk of Crew Adverse Health Event Due to Altered Immune Response is identified by the National Aeronautics and Space Administration (NASA) Human Research Program (HRP) as a recognized risk to human health and performance in space. The HRP Program Requirements Document (PRD) defines these risks. This Evidence Report provides a summary of the evidence that has been used to identify and characterize this risk. It is known that human immune function is altered in- and post-flight, but it is unclear at present if such alterations lead to increased susceptibility to disease. Reactivation of latent viruses has been documented in crewmembers, although this reactivation has not been directly correlated with immune changes or with observed diseases. As described in this report, further research is required to better characterize the relationships between altered immune response and susceptibility to disease during and after spaceflight. This is particularly important for future deep-space exploration missions.

  11. Adverse drug reactions in a psychiatric department of tertiary care teaching hospital in India: Analysis of spontaneously reported cases.

    PubMed

    Patel, Tejas K; Bhabhor, Prakash H; Desai, Nimisha; Shah, Saurabh; Patel, Parvati B; Vatsala, Ela; Panigrahi, Sanjibani

    2015-10-01

    The epidemiological data are limited for the spontaneous adverse drug reaction (ADR) reporting system in psychiatry and its comparison with intensive monitoring studies in terms of causative drugs, seriousness, preventability and drug interactions. This spontaneous ADR reporting study was carried out over a period of three years in the psychiatry department. We adopted WHO definition for an ADR, Naranjo's algorithm for causality, WHO-ADR terminology for the labeling of involved organ-system, International conference on harmonisation (ICH) E2A guidelines for seriousness, modified Schumock and Thornton's criteria for preventability and Medscape drug interaction checker for drug interactions. Two subgroup analyses were performed to find out the risk factors for the serious and preventable reactions. A total of 97 ADRs from 67 patients were included for analysis. The incidence of 'overall' and 'serious ADRs were 0.69% (95% CI: 0.54%, 0.88%) and 0.18% (95% CI: 0.12-0.29%), respectively. The females experienced more ADRs than males. The most commonly reported ADR, incriminated pharmacology group and drug, were extrapyramidal movement disorders (22.68%), atypical antipsychotics (35.62%) and escitalopram (13.91%), respectively. One out of five and one out three reactions were considered as 'serious' and 'preventable', respectively. The drug interactions contributed in 34.02% reactions. The factors significantly associated with 'serious' reactions were typical antipsychotics [OR: 5.47 (1.68, 17.87)], central and peripheral nervous system disorders [OR: 24.00 (5.12, 112.5)] and extrapyramidal reactions [OR: 14.03 (4.43, 44.43)]. The polypharmacy [OR: 5.85 (1.90, 18.03)] was significantly associated with 'preventable' reactions. The spontaneous reporting system is efficient to detect serious reactions and preventable reactions.

  12. Annual report: surveillance of adverse events following immunisation in Australia, 2009.

    PubMed

    Mahajan, Deepika; Roomiani, Ilnaz; Gold, Michael S; Lawrence, Glenda L; McIntyre, Peter B; Menzies, Rob I

    2010-09-01

    This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2009, and describes reporting trends over the 10-year period 2000 to 2009. There were 2,396 AEFI records for vaccines administered in 2009, the highest number reported, a 46% increase over the 1,638 in 2008. The increase was almost entirely due to reports related to the introduction of pandemic H1N1 (pH1N1) 2009 influenza vaccine from September 2009 (n = 1,312) largely from the members of the public. The pH1N1 AEFI reporting rate for people aged > or = 18 years was 34.2 per 100,000 administered doses compared with 2.8 for seasonal influenza vaccine. The rates in > or = 65 year-olds were 28.0, 1.6 and 13.3 for pH1N1, seasonal influenza and polysaccharide pneumococcal, respectively. The high reporting rate for pH1N1 vaccine is likely to be at least partly due to enhanced reporting seen for all new vaccines and greater levels of reporting from members of the public in response to the implementation of strategies to encourage reporting, as part of the pH1N1 program. For children < 7 years, AEFI reporting rates in 2009 (14.1 per 100,000 administered doses) were similar to previous years. There were 193 (8%) AEFI reports classified as serious; 6 deaths temporally associated with immunisation were reported but none were judged to have a causal association. As in previous years, the most commonly reported reactions were allergic reaction, injection site reaction, fever, headache, malaise, nausea and myalgia. The most commonly reported reactions following pH1N1 influenza vaccine were allergic reaction (n = 381), headache (n = 289), fever (n = 235), pain (n = 186), nausea (n = 180) and injection site reaction (n = 178). The data within the limitation of passive surveillance provide a reference point for ongoing reporting of trends in AEFI by age group, severity and vaccine type and illustrate the value of the

  13. Incidence of road injuries in Mexico: country report.

    PubMed

    Bartels, D; Bhalla, K; Shahraz, S; Abraham, J; Lozano, R; Murray, C J L

    2010-09-01

    We used data from various sources to triangulate to a national snapshot of the incidence of fatal and non-fatal road traffic injuries in Mexico in 2005. Data sources used include national death registration data, national hospital discharge data and a nationally representative health survey. We estimate that in 2005, 19,389 people died due to injuries and nearly one million were injured in road traffic crashes. While deaths in high-income countries are declining, this is not the case in Mexico. Young adult males are the demographic at the highest risk in non-fatal crashes, but the elderly have the highest road death rates primarily due to pedestrian crashes. Pedestrians alone comprise nearly half (48%) of all deaths. Cars pose a substantial threat to occupants (38% of deaths and 39% of hospital admissions) and to other road users.

  14. Longitudinal trends in organophosphate incidents reported to the National Pesticide Information Center, 1995–2007

    PubMed Central

    2009-01-01

    Background Regulatory decisions to phase-out the availability and use of common organophosphate pesticides among the general public were announced in 2000 and continued through 2004. Based on revised risk assessments, chlorpyrifos and diazinon were determined to pose unacceptable risks. To determine the impact of these decisions, organophosphate (OP) exposure incidents reported to the National Pesticide Information Center (NPIC) were analyzed for longitudinal trends. Methods Non-occupational human exposure incidents reported to NPIC were grouped into pre- (1995–2000) and post-announcement periods (2001–2007). The number of total OP exposure incidents, as well as reports for chlorpyrifos, diazinon and malathion, were analyzed for significant differences between these two periods. The number of informational inquiries from the general public was analyzed over time as well. Results The number of average annual OP-related exposure incidents reported to NPIC decreased significantly between the pre- and post-announcement periods (p < 0.001). A significant decrease in the number of chlorpyrifos and diazinon reports was observed over time (p < 0.001). No significant difference in the number of incident reports for malathion was observed (p = 0.4), which was not phased-out of residential use. Similar to exposure incidents, the number of informational inquiries received by NPIC declined over time following the phase-out announcement. Conclusion Consistent with other findings, the number of chlorpyrifos and diazinon exposure incidents reported to NPIC significantly decreased following public announcement and targeted regulatory action. PMID:19379510

  15. SU-E-T-469: Implementation of VAs Web-Based Radiotherapy Incident Reporting and Analysis System (RIRAS)

    SciTech Connect

    Kapoor, R; Palta, J; Hagan, M; Malik, G

    2015-06-15

    Purpose: This Web-based Radiotherapy Incident Reporting and Analysis System (RIRAS) is a tool to improve quality of care for radiation therapy patients. This system is an important facet of continuing effort by our community to maintain and improve safety of radiotherapy.Material and Methods: VA’s National Radiation Oncology Program office has embarked on a program to electronically collect adverse events and good-catch data of radiation treatment of over 25,000 veterans treated with radiotherapy annually. This VA-Intranet based software design has made use of dataset taxonomies and data dictionaries defined in AAPM/ASTRO reports on error reporting. We used proven industrial and medical event reporting techniques to avoid several common problems faced in effective data collection such as incomplete data due to data entry fatigue by the reporters, missing data due to data difficult to obtain or not familiar to most reporters, missing reports due to fear of reprisal etc. This system encompasses the entire feedback loop of reporting an incident, analyzing it for salient details, and developing interventions to prevent it from happening again. The analysis reports with corrective, learning actions are shared with the reporter/facility and made public to the community (after deidentification) as part of the learning process. Results: Till date 50 incident/good catches have been reported in RIRAS and we have completed analysis on 100% of these reports. This is done due to the fact that each reported incidents is investigated and a complete analysis/patient-safety-work-product report is generated by radiation oncology domain-experts. Conclusions Because of the completeness of the data, the system has enabled us to analyze process steps and track trends of major errors which in the future will lead to implementing system wide process improvement steps and safe standard operating procedures for each radiotherapy treatment modality/technique and fulfills our goal of

  16. Data mining in the US using the Vaccine Adverse Event Reporting System.

    PubMed

    Iskander, John; Pool, Vitali; Zhou, Weigong; English-Bullard, Roseanne

    2006-01-01

    The US Vaccine Adverse Event Reporting System (VAERS), which is charged with vigilance for detecting vaccine-related safety issues, faces an increasingly complex immunisation environment. Since 1990, steady increases in vaccine licensing and distribution have resulted in increasing numbers of reports to VAERS. Prominent features of current reports include more routine vaccine co-administration and frequent reports of new postvaccination clinical syndromes. Data-mining methods, based on disproportionality analyses, are one strategy being pursued by VAERS researchers to increase the utility of its complex database. The types of analyses used include proportional reporting ratios, association rule discovery, and various 'historic limits' methods that compare observed versus expected event counts. The use of such strategies in VAERS has been primarily supplemental and retrospective. Signals for inactivated influenza, typhoid and tetanus toxoid-containing vaccines have been successfully identified. Concerns flagged through data mining should always be subject to clinical case review as a first evaluation step. Persistent issues should be subject to formal hypothesis testing in large linked databases or other controlled-study settings. Automated data-mining techniques for prospective use are currently undergoing development and evaluation within VAERS. Their use (as one signal-detection tool among many) by trained medical evaluators who are aware of system limitations is one legitimate approach to improving the ability of VAERS to generate vaccine-safety hypotheses. Such approaches are needed as more new vaccines continue to be licensed.

  17. Designing a national combined reporting form for adverse drug reactions and medication errors.

    PubMed

    Tanti, A; Serracino-Inglott, A; Borg, J J

    2015-06-09

    The Maltese Medicines Authority was tasked with developing a reporting form that captures high-quality case information on adverse drug reactions (ADRs) and medication errors in order to fulfil its public-health obligations set by the European Union (EU) legislation on pharmacovigilance. This paper describes the process of introducing the first combined ADR/medication error reporting form in the EU for health-care professionals, the analysis of reports generated by it and the promotion of the system. A review of existing ADR forms was carried out and recommendations from the European Medicines Agency and World Health Organization audits integrated. A new, combined ADR/medication error reporting form was developed and pilot tested based on case studies. The Authority's quality system (ISO 9001 certified) was redesigned and a promotion strategy was deployed. The process used in Malta can be useful for countries that need to develop systems relative to ADR/medication error reporting and to improve the quality of data capture within their systems.

  18. Neurologic Adverse Events Associated with Voriconazole Therapy: Report of Two Pediatric Cases

    PubMed Central

    Demir, Sevliya Öcal; Atici, Serkan; Akkoç, Gülşen; Yakut, Nurhayat; İkizoğlu, Nilay Baş; Eralp, Ela Erdem; Soysal, Ahmet; Bakir, Mustafa

    2016-01-01

    Although voriconazole, a triazole antifungal, is a safe drug, treatment with this agent is associated with certain adverse events such as hepatic, neurologic, and visual disturbances. The current report presents two cases, one a 9-year-old boy and the other a 17-year-old girl, who experienced neurologic side effects associated with voriconazole therapy. Our aim is to remind readers of the side effects of voriconazole therapy in order to prevent unnecessary investigations especially for psychological and ophthalmologic problems. The first case was a 9-year-old boy with cystic fibrosis and invasive aspergillosis that developed photophobia, altered color sensation, and fearful visual hallucination. The second case was a 17-year-old girl with cystic fibrosis and allergic bronchopulmonary aspergillosis, and she experienced photophobia, fatigue, impaired concentration, and insomnia, when the dose of voriconazole therapy was increased from 12 mg/kg/day to 16 mg/kg/day. The complaints of the two patients disappeared after discontinuation of voriconazole therapy. Our experience in these patients reminded us of the importance of being aware of the neurologic adverse events associated with voriconazole therapy in establishing early diagnosis and initiating prompt treatment. In addition, although serum voriconazole concentration was not measured in the present cases, therapeutic drug monitoring for voriconazole seems to be critically important in preventing neurologic side effects in pediatric patients. PMID:27313918

  19. Human Factors of Remotely Piloted Aircraft Systems: Lessons from Incident Reports

    NASA Technical Reports Server (NTRS)

    Hobbs, Alan; Null, Cynthia

    2016-01-01

    An exploratory study is being conducted to examine the feasibility of collecting voluntary critical incident reports from RPAS pilots. Twenty-three experienced RPAS pilots volunteered to participate in focus groups in which they described critical incidents from their own experience. Participants were asked to recall (1) incidents that revealed a system flaw, or (2) highlighted a case where the human operator contributed to system resilience or mission success. Participants were asked to only report incidents that could be included in a public document. A total of 90 incidents were reported. Human factor issues included the impact of reduced sensory cues, traffic separation in the absence of an out-the-window view, control latencies, vigilance during monotonous and ultra-long endurance flights, control station design considerations, transfer of control between control stations, the management of lost link procedures, and decision-making during emergencies.

  20. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration

    PubMed Central

    Bielefeldt, Klaus

    2016-01-01

    AIM: To investigate the nature and severity of AE related to sacral neurostimulation (SNS). METHODS: Based on Pubmed and Embase searches, we identified published trials and case series of SNS for fecal incontinence (FI) and extracted data on adverse events, requiring an active intervention. Those problems were operationally defined as infection, device removal explant or need for lead and/or generator replacement. In addition, we analyzed the Manufacturer and User Device Experience registry of the Federal Drug Administration for the months of August - October of 2015. Events were included if the report specifically mentioned gastrointestinal (GI), bowel and FI as indication and if the narrative did not focus on bladder symptoms. The classification, reporter, the date of the recorded complaint, time between initial implant and report, the type of AE, steps taken and outcome were extracted from the report. In cases of device removal or replacement, we looked for confirmatory comments by healthcare providers or the manufacturer. RESULTS: Published studies reported adverse events and reoperation rates for 1954 patients, followed for 27 (1-117) mo. Reoperation rates were 18.6% (14.2-23.9) with device explants accounting for 10.0% (7.8-12.7) of secondary surgeries; rates of device replacement or explant or pocket site and electrode revisions increased with longer follow up. During the period examined, the FDA received 1684 reports of AE related to SNS with FI or GI listed as indication. A total of 652 reports met the inclusion criteria, with 52.7% specifically listing FI. Lack or loss of benefit (48.9%), pain or dysesthesia (27.8%) and complication at the generator implantation site (8.7%) were most commonly listed. Complaints led to secondary surgeries in 29.7% of the AE. Reoperations were performed to explant (38.2%) or replace (46.5%) the device or a lead, or revise the generator pocket (14.6%). Conservative management changes mostly involved changes in stimulation

  1. 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

  2. Brief Report: Incidence of and Risk Factors for Autistic Disorder in Neonatal Intensive Care Unit Survivors.

    ERIC Educational Resources Information Center

    Matsuishi, Toyojiro; Yamashita, Yushiro; Ohtani, Yasuyo; Ornitz, Edward; Kuriya, Norikazu; Murakami, Yoshihiko; Fukuda, Seiichi; Hashimoto, Takeo; Yamashita, Fumio

    1999-01-01

    Analysis of the incidence of autistic disorder (AD) among 5,271 children in a neonatal intensive care unit in Japan found that 18 children were later diagnosed with AD, an incidence more than twice as high as previously reported. Children with AD had a significantly higher history of the meconium aspiration syndrome than the controls. (Author/DB)

  3. 14 CFR 91.1021 - Internal safety reporting and incident/accident response.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .../accident response. 91.1021 Section 91.1021 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... incident/accident response. (a) Each program manager must establish an internal anonymous safety reporting.... (b) Each program manager must establish procedures to respond to an aviation incident/accident....

  4. 14 CFR 91.1021 - Internal safety reporting and incident/accident response.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .../accident response. 91.1021 Section 91.1021 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... incident/accident response. (a) Each program manager must establish an internal anonymous safety reporting.... (b) Each program manager must establish procedures to respond to an aviation incident/accident....

  5. 14 CFR 91.1021 - Internal safety reporting and incident/accident response.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .../accident response. 91.1021 Section 91.1021 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... incident/accident response. (a) Each program manager must establish an internal anonymous safety reporting.... (b) Each program manager must establish procedures to respond to an aviation incident/accident....

  6. 14 CFR 91.1021 - Internal safety reporting and incident/accident response.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .../accident response. 91.1021 Section 91.1021 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... incident/accident response. (a) Each program manager must establish an internal anonymous safety reporting.... (b) Each program manager must establish procedures to respond to an aviation incident/accident....

  7. 14 CFR 91.1021 - Internal safety reporting and incident/accident response.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .../accident response. 91.1021 Section 91.1021 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... incident/accident response. (a) Each program manager must establish an internal anonymous safety reporting.... (b) Each program manager must establish procedures to respond to an aviation incident/accident....

  8. [Learning from mistakes in hospitals. A system perspective on errors and incident reporting systems].

    PubMed

    Hofinger, G

    2009-06-01

    Analysis of incidents and near-incidents is an important factor for continuous improvement in patient safety in hospitals and for the promotion of organizational learning. From a system perspective, accidents occur when decision-making at several levels of a working system is faulty and the safety barriers fail. Human error is inevitable but accidents are not. Errors can be used as an opportunity for organizational learning and this is especially true for incidents when patients come to no harm. Starting with explanations of a system perspective on errors, this paper deals with the prerequisites for organizational learning and general rules for establishing incident reporting systems in hospitals.

  9. Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form

    PubMed Central

    Singh, Anshi; Bhatt, Parloop

    2012-01-01

    Despite comprehensive and stringent phases of clinical trials and surveillance efforts, unexpected and serious adverse drug reactions (ADRs) repeatedly occur after the drug is marketed. ADR reporting is an important aspect of an efficient and effective pharmacovigilance program. Although Medwatch, Yellow Card, CDSCO form, etc. are the protocol forms of ADR collection and reports, a number of countries design and use their respective ADR forms. This review compares similarities and dissimilarities of 13 ADR forms of countries representing their geographical location. This study extracted 73 data elements mentioned in 13 different ADR forms. Only 13 elements were common. An ADR form of Malaysia and Canada covers the highest number of data 43, while Brazil falls to the opposite end with a number of 17 data elements in lieu with the Generic ADR Form. The result of this review highlights 58 data elements of the proposed generic ADR form which ensures that requisite reporting information essential for correct causality assessment of ADRs are included. The proposed “Generic ADR form” could be adopted worldwide mandatorily for reporting any/all ADRs associated with marketed drugs. PMID:23129957

  10. Adverse Outcomes Among Homeless Adolescents and Young Adults Who Report a History of Traumatic Brain Injury

    PubMed Central

    Harpin, Scott B.; Grubenhoff, Joseph A.; Rivara, Frederick P.

    2014-01-01

    Objectives. We examined the prevalence of self-reported traumatic brain injury (TBI) among homeless young people and explored whether sociodemographic characteristics, mental health diagnoses, substance use, exposure to violence, or difficulties with activities of daily living (ADLs) were associated with TBI. Methods. We analyzed data from the Wilder Homelessness Study, in which participants were recruited in 2006 and 2009 from streets, shelters, and locations in Minnesota that provide services to homeless individuals. Participants completed 30-minute interviews to collect information about history of TBI, homelessness, health status, exposure to violence (e.g., childhood abuse, assault), and other aspects of functioning. Results. Of the 2732 participating adolescents and young adults, 43% reported a history of TBI. Participants with TBI became homeless at a younger age and were more likely to report mental health diagnoses, substance use, suicidality, victimization, and difficulties with ADLs. The majority of participants (51%) reported sustaining their first injury prior to becoming homeless or at the same age of their first homeless episode (10%). Conclusions. TBI occurs frequently among homeless young people and is a marker of adverse outcomes such as mental health difficulties, suicidal behavior, substance use, and victimization. PMID:25122029

  11. Incidence and Mortality Tables | Cancer Trends Progress Report

    Cancer.gov

    The Cancer Trends Progress Report, first issued in 2001, summarizes our nation's advances against cancer in relation to Healthy People targets set forth by the Department of Health and Human Services.

  12. Plutonium Reclamation Facility incident response project progress report

    SciTech Connect

    Austin, B.A.

    1997-11-25

    This report provides status of Hanford activities in response to process deficiencies highlighted during and in response to the May 14, 1997, explosion at the Plutonium Reclamation Facility. This report provides specific response to the August 4, 1997, memorandum from the Secretary which requested a progress report, in 120 days, on activities associated with reassessing the known and evaluating new vulnerabilities (chemical and radiological) at facilities that have been shut down, are in standby, are being deactivated or have otherwise changed their conventional mode of operation in the last several years. In addition, this report is intended to provide status on emergency response corrective activities as requested in the memorandum from the Secretary on August 28, 1997. Status is also included for actions requested in the second August 28, 1997, memorandum from the Secretary, regarding timely notification of emergencies.

  13. 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.

  14. Evaluating the risk of patient re-identification from adverse drug event reports

    PubMed Central

    2013-01-01

    Background Our objective was to develop a model for measuring re-identification risk that more closely mimics the behaviour of an adversary by accounting for repeated attempts at matching and verification of matches, and apply it to evaluate the risk of re-identification for Canada’s post-marketing adverse drug event database (ADE).Re-identification is only demonstrably plausible for deaths in ADE. A matching experiment between ADE records and virtual obituaries constructed from Statistics Canada vital statistics was simulated. A new re-identification risk is considered, it assumes that after gathering all the potential matches for a patient record (all records in the obituaries that are potential matches for an ADE record), an adversary tries to verify these potential matches. Two adversary scenarios were considered: (a) a mildly motivated adversary who will stop after one verification attempt, and (b) a highly motivated adversary who will attempt to verify all the potential matches and is only limited by practical or financial considerations. Methods The mean percentage of records in ADE that had a high probability of being re-identified was computed. Results Under scenario (a), the risk of re-identification from disclosing the province, age at death, gender, and exact date of the report is quite high, but the removal of province brings down the risk significantly. By only generalizing the date of reporting to month and year and including all other variables, the risk is always low. All ADE records have a high risk of re-identification under scenario (b), but the plausibility of that scenario is limited because of the financial and practical deterrent even for highly motivated adversaries. Conclusions It is possible to disclose Canada’s adverse drug event database while ensuring that plausible re-identification risks are acceptably low. Our new re-identification risk model is suitable for such risk assessments. PMID:24094134

  15. Infections and exposures: reported incidents associated with unsuccessful decontamination of reusable surgical instruments.

    PubMed

    Southworth, P M

    2014-11-01

    Reusable surgical instruments provide a potential route for the transmission of pathogenic agents between patients in healthcare facilities. As such, the decontamination process between uses is a vital component in the prevention of healthcare-associated infections. This article reviews reported outbreaks and incidents associated with inappropriate, inadequate, or unsuccessful decontamination of surgical instruments, indicating potential pitfalls of decontamination practices worldwide. To the author's knowledge, this is the first review of surgical instrument decontamination failures. Databases of medical literature, Medline and Embase, were searched systematically. Articles detailing incidents associated with unsuccessful decontamination of surgical instruments were identified. Twenty-one articles were identified reporting incidents associated with failures in decontamination. A large proportion of incidents involved the attempted disinfection, rather than sterilization, of surgical instruments (43% of articles), counter to a number of national guidelines. Instruments used in eye surgery were most frequently reported to be associated with decontamination failures (29% of articles). Of the few articles detailing potential or confirmed pathogenic transmission, Pseudomonas aeruginosa and Mycobacterium spp. were most represented. One incident of possible variant Creutzfeldt-Jakob disease transmission was also identified. Limitations of analysing only published incidents mean that the likelihood of under-reporting (including reluctance to publish failure) must be considered. Despite these limitations, the small number of articles identified suggests a relatively low risk of cross-infection through reusable surgical instruments when cleaning/sterilization procedures are adhered to. The diverse nature of reported incidents also suggests that failures are not systemic.

  16. National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: reporting on adverse and negative actions. Final rule.

    PubMed

    2010-01-28

    This final rule revises existing regulations under sections 401 through 432 of the Health Care Quality Improvement Act of 1986, governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, to incorporate statutory requirements under section 1921 of the Social Security Act, as amended by section 5(b) of the Medicare and Medicaid Patient and Program Protection Act of 1987 (MMPPPA), and as amended by the Omnibus Budget Reconciliation Act of 1990 (OBRA). The MMPPPA, along with certain additional provisions in the OBRA, was designed to protect program beneficiaries from unfit health care practitioners, and otherwise improve the anti-fraud provisions of Medicare and State health care programs. Section 1921, the statutory authority upon which this regulatory action is based, requires each State to adopt a system of reporting to the Secretary of Health and Human Services (the Secretary) certain adverse licensure actions taken against health care practitioners and health care entities licensed or otherwise authorized by a State (or a political subdivision thereof) to provide health care services. It also requires each State to report any negative actions or findings that a State licensing authority, peer review organization, or private accreditation entity has concluded against a health care practitioner or health care entity.

  17. Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students

    PubMed Central

    Tripathi, Raakhi Kaliprasad; Jalgaonkar, Sharmila Vinayak; Sarkate, Pankaj V.; Rege, Nirmala Narayan

    2016-01-01

    Objectives: Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated. Materials and Methods: The module consisted of (a) e-mailing an ADR narrative and online filling of the “suspected ADR reporting form” (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012–2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013–2014. The evaluation consisted of recording the number of students responding and the scores achieved. Results: A total of 171 students in 2012–2013 batch and 179 in 2013–2014 batch participated. In the 2012–2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013–2014 batch, the number (n = 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months. Conclusion: This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians. PMID:28031613

  18. 30 CFR 250.187 - What are MMS' incident reporting requirements?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL... incidents that may be required by other regulatory agencies. (d) You must report all spills of oil or...

  19. 29 CFR 1904.39 - Reporting fatalities and multiple hospitalization incidents to OSHA.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... to report a fatality caused by a heart attack at work? Yes, your local OSHA Area Office director will decide whether to investigate the incident, depending on the circumstances of the heart attack. (6) Do...

  20. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... carrier that provides scheduled passenger air transportation shall, within 15 days of the end of the month... Consumer Protection Division a report on any incidents involving the loss, injury, or death of an...

  1. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... carrier that provides scheduled passenger air transportation shall, within 15 days of the end of the month... Consumer Protection Division a report on any incidents involving the loss, injury, or death of an...

  2. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... carrier that provides scheduled passenger air transportation shall, within 15 days of the end of the month... Consumer Protection Division a report on any incidents involving the loss, injury, or death of an...

  3. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... carrier that provides scheduled passenger air transportation shall, within 15 days of the end of the month... Consumer Protection Division a report on any incidents involving the loss, injury, or death of an...

  4. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... carrier that provides scheduled passenger air transportation shall, within 15 days of the end of the month... Consumer Protection Division a report on any incidents involving the loss, injury, or death of an...

  5. Second Workshop on the Investigation and Reporting of Incidents and Accidents, IRIA 2003

    NASA Technical Reports Server (NTRS)

    Hayhurst, Kelly J. (Compiler); Holloway, C. Michael (Compiler)

    2003-01-01

    This publication consists of papers presented at the Second Workshop on the Investigation and Reporting of Incidents and Accidents, IRIA 2003, sponsored by NASA Langley Research Center and the University of Virginia.

  6. 75 FR 35329 - Notification and Reporting of Aircraft Accidents or Incidents and Overdue Aircraft, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... From the Federal Register Online via the Government Publishing Office NATIONAL TRANSPORTATION SAFETY BOARD 49 CFR Part 830 Notification and Reporting of Aircraft Accidents or Incidents and Overdue Aircraft, and Preservation of Aircraft Wreckage, Mail, Cargo, and Records AGENCY: National...

  7. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.

    PubMed

    Cheng, Chung-Wah; Bian, Zhao-Xiang; Li, You-Ping; Moher, David; Wu, Tai-Xiang; Dagenais, Simon; Li, Jing; Li, Ting-Qian

    2008-09-01

    Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

  8. Analysis of immediate transfusion incidents reported in a regional blood bank

    PubMed Central

    de Sousa Neto, Adriana Lemos; Barbosa, Maria Helena

    2011-01-01

    Background Blood transfusion is imperative when treating certain patients; however, it is not risk free. In addition to the possible transmission of contagious infectious diseases, incidents can occur immediately after transfusion and at a later time. Aims This study aimed to examine the immediate transfusion incidents reported in a regional blood bank in the state of Minas Gerais between December 2006 and December 2009. A retrospective quantitative epidemiological study was conducted. Data were obtained from 202 transfusion incident reports of 42 health institutions served by the blood bank. Data processing and analysis were carried out using the Statistical Package for the Social Sciences (SPSS) software. Results The rate of immediate transfusion incidents reported in the period was 0.24%; febrile non-hemolytic reactions were the most common type of incident (56.4%). The most frequent clinical manifestations listed in transfusion incident reports were chills (26.9%) and fever (21.6%). There was a statistically significant association (p-value < 0.05) between the infusion of platelet concentrates and febrile non-hemolytic reactions and between fresh frozen plasma and febrile non-hemolytic reaction. The majority (73.3%) of transfused patients who suffered immediate transfusion incidents had already been transfused and 36.5% of the cases had previous transfusion incident reports. Conclusions Data from the present study corroborate the implementation of new professional training programs aimed at blood transfusion surveillance. These measures should emphasize prevention, identification and reporting of immediate transfusion incidents aiming to increase blood transfusion quality and safety. PMID:23049336

  9. [Incident reporting systems in anesthesiology--methods and benefits using the example of PaSOS].

    PubMed

    Rall, Marcus; Reddersen, Silke; Zieger, Jörg; Schädle, Bertram; Hirsch, Patricia; Stricker, Eric; Martin, Jörg; Geldner, Götz; Schleppers, Alexander

    2008-09-01

    Preventing patient harm is one of the main tasks for the field of anesthesiology from early on. With the introduction of the national German incident reporting system PaSOS, which is hosted by the German anesthesia society, anesthesiology is again leading the field of patient safety. Important elements, success factors and background information for the introduction of successful incident reporting systems in an organization are given. Examples by and from PaSOS are given.

  10. Adverse drug effects attributed to phenylpropanolamine: a review of 142 case reports.

    PubMed

    Lake, C R; Gallant, S; Masson, E; Miller, P

    1990-08-01

    Phenylpropanolamine (PPA) is contained in about 106 products, over half of which are available over-the-counter (OTC). Most are cough/cold remedies; nine are OTC diet aids. More than nine million Americans were using OTC diet aids in 1981, making PPA the fifth most used drug in the United States, responsible for over $200 million in revenues. The safety of PPA remains controversial. Although most controlled studies indicate minimal pressor effects with recommended doses, adverse drug reactions (ADRs) continue to be documented. Since 1965, 142 ADRs have been reported in 85 studies, 69% of these in North America. Many such cases may go unrecognized. About two thirds of all ADRs occurred in females and in patients under 30. Of ADRs attributed to legitimately sold PPA products, 85% occurred after consumption of OTC products versus only 15% after prescription drugs. The PPA product often contained combination ingredients, or PPA was consumed along with additional drugs. An overdose of PPA was taken in about a third of the cases. After ingestion of non-overdose amounts, 82% of the ADRs were severe. The most frequent side effects involved symptoms compatible with acute hypertension, with severe headache the most common complaint. Twenty-four intracranial hemorrhages, eight seizures, and eight deaths (most due to stroke) were associated with PPA ingestion. We have summarized these data in an effort to alert clinicians to the prevalence of usage of PPA products and the potential for adverse effects. In patients who present with elevated blood pressure or signs of acute hypertension, especially hypertensive encephalopathy of undetermined origin, we recommend inquiry about recent ingestion of PPA-containing diet aids and cough/cold products and suggest having such patients remain upright rather than supine.

  11. Adverse reactions triggered by dental local anesthetics: a clinical survey.

    PubMed Central

    Kaufman, E.; Goharian, S.; Katz, Y.

    2000-01-01

    One hundred and seventy-nine patients completed a questionnaire focusing on adverse reactions to dental local anesthetics as manifested by 16 signs and symptoms. Twenty-six percent of the participants reported having at least 1 adverse reaction. It was found that most of the adverse reactions occurred within the first 2 hours following the injection of local anesthetics. Pallor, palpitations, diaphoresis, and dizziness were the most common adverse reactions reported in the study. The results pointed to a significant relationship between anxiety, gender, injection technique, and procedure with a higher incidence of adverse reactions. PMID:11432179

  12. Conceptualisation of socio-technical integrated information technology solutions to improve incident reporting through Maslow's hierarchy of needs: a qualitative study of junior doctors.

    PubMed

    Yee, Kwang Chien

    2007-01-01

    Medical errors are common, especially within the acute healthcare delivery. The identification of systemic factors associated with adverse events and the construction of models to improve the safety of the healthcare system seems straightforward, this process has been proven to be much more difficult in the realism of medical practice due to the failure of the incident reporting system to capture the essential information, especially from the perspective of junior doctors. The failure of incidence reporting system has been related to the lack of socio-technical consideration for both system designs and system implementations. The main reason of non-reporting can be conceptualised through the motivation psychology model: Maslow's hierarchy of needs; in order to achieve a change in the socio-cultural domain for incident reporting. This paper presents a qualitative research methodology approach to generate contextual-rich insights into the socio-cultural and technological factors of incident reporting among junior doctors. The research illuminates the guiding principles for future socio-technical integrated information communication technology designs and implementations. Using Maslow's hierarchy of needs as the conceptual framework, the guiding principles aim to design electronic incident reporting systems which will motivate junior doctors to participate in the process. This research paper aims to make a significant contribution to the fields of socio-technical systems and medical errors management. The design and implementation of the new incident reporting system has great potential to motivate junior doctors to change the culture of incident reporting and to work towards a safer future healthcare system.

  13. An exploratory factor analysis of the spontaneous reporting of severe cutaneous adverse reactions

    PubMed Central

    Hauben, Manfred; Hung, Eric; Hsieh, Wen-Yaw

    2016-01-01

    Background: Severe cutaneous adverse reactions (SCARs) are prominent in pharmacovigilance (PhV). They have some commonalities such as nonimmediate nature and T-cell mediation and rare overlap syndromes have been documented, most commonly involving acute generalized exanthematous pustulosis (AGEP) and drug rash with eosinophilia and systemic symptoms (DRESS), and DRESS and toxic epidermal necrolysis (TEN). However, they display diverse clinical phenotypes and variations in specific T-cell immune response profiles, plus some specific genotype–phenotype associations. A question is whether causation of a given SCAR by a given drug supports causality of the same drug for other SCARs. If so, we might expect significant intercorrelations between SCARs with respect to overall drug-reporting patterns. SCARs with significant intercorrelations may reflect a unified underlying concept. Methods: We used exploratory factor analysis (EFA) on data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) to assess reporting intercorrelations between six SCARs [AGEP, DRESS, erythema multiforme (EM), Stevens–Johnson syndrome (SJS), TEN, exfoliative dermatitis (ExfolDerm)]. We screened the data using visual inspection of scatterplot matrices for problematic data patterns. We assessed factorability via Bartlett’s test of sphericity, Kaiser-Myer-Olkin (KMO) statistic, initial estimates of communality and the anti-image correlation matrix. We extracted factors via principle axis factoring (PAF). The number of factors was determined by scree plot/Kaiser’s rule. We also examined solutions with an additional factor. We applied various oblique rotations. We assessed the strength of the solution by percentage of variance explained, minimum number of factors loading per major factor, the magnitude of the communalities, loadings and crossloadings, and reproduced- and residual correlations. Results: The data were generally adequate for factor analysis

  14. A progress report on grazing incidence optics fabrication and evaluation

    NASA Technical Reports Server (NTRS)

    Teague, Peter F.; Ulmer, Melville P.; Matsui, Yutaka; Briel, Ulrich; Burkert, Wolfgang

    1989-01-01

    The progress being made on a mirror array telescope for high energies (MARTHE) project is reported. As a first step, small mirror flats and full-size Wolter I mirrors are produced that are lacquer coated (mandrels) and then coated with gold or palladium. The up-to-date results of fabricating and testing these mirrors are presented. Currently, results can be provided on the micro-roughness, marco-figure, X-ray scattering, and reflectivity up to 8 keV from flats and Wolter I mirrors as well as optical measurements of the flats.

  15. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions.

    PubMed

    van Puijenbroek, Eugène; Diemont, Willem; van Grootheest, Kees

    2003-01-01

    The primary aim of spontaneous reporting systems (SRSs) is the timely detection of unknown adverse drug reactions (ADRs), or signal detection. Generally this is carried out by a systematic manual review of every report sent to an SRS. Statistical analysis of the data sets of an SRS, or quantitative signal detection, can provide additional information concerning a possible relationship between a drug and an ADR. We describe the role of quantitative signal detection and the way it is applied at the Netherlands Pharmacovigilance Centre Lareb. Results of the statistical analysis are implemented in the traditional case-by-case analysis. In addition, for data-mining purposes, a list of associations of ADRs and suspected drugs that are disproportionally present in the database is periodically generated. Finally, quantitative signal generation can be used to study more complex relationships, such as drug-drug interactions and syndromes. The results of quantitative signal detection should be considered as an additional source of information, complementary to the traditional analysis. Techniques for the detection of drug interactions and syndromes offer a new challenge for pharmacovigilance in the near future.

  16. Trajectories of Adverse Childhood Experiences and Self-Reported Health at Age 18

    PubMed Central

    Thompson, Richard; Flaherty, Emalee G.; English, Diana J.; Litrownik, Alan J.; Dubowitz, Howard; Kotch, Jonathan B.; Runyan, Desmond K.

    2014-01-01

    Objective Despite growing evidence of links between adverse childhood experiences (ACEs) and long-term health outcomes, there has been limited longitudinal investigation of such links in youth. The purpose of these analyses was to describe the patterns of exposure to ACEs over time and their links to youth health. Methods The current analyses used data from LONGSCAN, a prospective study of children at risk for or exposed to child maltreatment, who were followed from age 4 to age 18. The analyses focused on 802 youth with complete data. Cumulative exposure to ACEs between 4 and 16 was used to place participants in 3 trajectory-defined groups: chronic ACEs, early ACEs only, and limited ACEs. Links to self-reported age 18 health were examined using linear mixed models after controlling for earlier health status and demographics. Results The chronic ACEs group had increased self-reported health concerns and use of medical care at 18, but not poorer self-rated health status. The early ACEs only group did not significantly differ from limited ACEs on outcomes. Conclusions In addition to other negative outcomes, chronic ACEs appear to affect physical health in emerging adulthood. Interventions aimed at reducing exposure to ACEs and early mitigation of their effects may have lasting and widespread health benefits. PMID:25441654

  17. Adverse Drug Reactions in a Tertiary Care Emergency Medicine Ward - Prevalence, Preventability and Reporting

    PubMed Central

    Rydberg, Diana M.; Holm, Lennart; Engqvist, Ida; Fryckstedt, Jessica; Lindh, Jonatan D.; Stiller, Carl-Olav; Asker-Hagelberg, Charlotte

    2016-01-01

    Purpose To identify the prevalence and preventability of adverse drug reactions (ADRs) in an emergency ward setting in a tertiary hospital in Sweden and to what extent the detected ADRs were reported to the Medical Product Agency (MPA). Methods In this prospective cross sectional observational study, 706 patients admitted to one of the Emergency Wards, at the Karolinska University Hospital in Solna, Stockholm during September 2008 –September 2009, were included. The electronic patient records were reviewed for patients’ demographic parameters, prevalence of possible ADRs and assessment of their preventability. In addition, the extent of formal and required ADR reporting to national registers was studied. Results Approximately 40 percent of the patient population had at least one possible ADR (n = 284). In the multivariable regression model, age and number of drugs were significantly associated with risk of presenting with an ADR (p<0.01 and p<0.001, respectively). Sex was not identified as a significant predictor of ADRs (p = 0.27). The most common ADRs were cardiovascular, followed by electrolyte disturbances, and hemorrhage. In 18 percent of the patient population ADRs were the reason for admission or had contributed to admission and 24% of these ADRs were assessed as preventable. The under-reporting of ADRs to the MPA was 99%. Conclusions ADRs are common in Emergency Medicine in tertiary care in Sweden, but under-reporting of ADRs is substantial. The most frequent ADRs are caused by cardiovascular drugs, and significantly associated with age and number of drugs. However, only a minority of the detected serious ADRs contributing to admission could have been avoided by increased risk awareness. PMID:27622270

  18. Pre-Adoption Adversity and Self-Reported Behavior Problems in 7 Year-Old International Adoptees

    ERIC Educational Resources Information Center

    Gagnon-Oosterwaal, Noemi; Cossette, Louise; Smolla, Nicole; Pomerleau, Andree; Malcuit, Gerard; Chicoine, Jean-Francois; Jeliu, Gloria; Belhumeur, Celine; Berthiaume, Claude

    2012-01-01

    To further investigate the long-term impact of pre-adoption adversity on international adoptees, externalizing and internalizing symptoms were assessed using a self-report measure at school-age in addition to mothers' reports. The sample consisted of 95 adopted children and their mothers. Children's health and developmental status were assessed…

  19. 30 CFR 250.188 - What incidents must I report to MMS and when must I report them?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... calendar days after the incident: (1) All fatalities. (2) All injuries that require the evacuation of the.... (4) All fires and explosions. (5) All reportable releases of hydrogen sulfide (H2S) gas, as...

  20. Incident reporting: Its role in aviation safety and the acquisition of human error data

    NASA Technical Reports Server (NTRS)

    Reynard, W. D.

    1983-01-01

    The rationale for aviation incident reporting systems is presented and contrasted to some of the shortcomings of accident investigation procedures. The history of the United State's Aviation Safety Reporting System (ASRS) is outlined and the program's character explained. The planning elements that resulted in the ASRS program's voluntary, confidential, and non-punitive design are discussed. Immunity, from enforcement action and misuse of the volunteered data, is explained and evaluated. Report generation techniques and the ASRS data analysis process are described; in addition, examples of the ASRS program's output and accomplishments are detailed. Finally, the value of incident reporting for the acquisition of safety information, particularly human error data, is explored.

  1. [Allergies and adverse events associated with fluoroquinolones].

    PubMed

    Muller, Y; Andrey, D; Emonet, S; Harr, T; Spoerl, D

    2015-04-08

    The prescription ot fluoroquinolones has been constantly increasing over the past decade. consequently, an increasing number of hyper-sensitivity reactions and adverse events have been reported. The aim of the review is to discuss the incidence of hypersensitivity reactions either IgE (immediate) or T cells mediated (delayed). We will make an overview ofthe diagnostic tools available to detect such hypersensitivity reactions. Finally, the specific adverse events associated with fluoroquinolones, including tendinopathy, chondrotoxicity, peripheral neuropathy or retinal detachment will be discussed.

  2. Reasons for not reporting patient safety incidents in general practice: A qualitative study

    PubMed Central

    Kousgaard, Marius Brostrøm; Joensen, Anne Sofie; Thorsen, Thorkil

    2012-01-01

    Objective To explore the reasons for not reporting patient safety incidents in general practice. Design Qualitative interviews with general practitioners and members of the project group. Setting General practice clinics in the Region of Northern Jutland in Denmark. Subjects Twelve general practitioners. Main outcome measures The experiences and reflections of the involved professionals with regard to system use and non-use. Results While most respondents were initially positive towards the idea of reporting and learning from patient safety incidents, they actually reported very few incidents. The major reasons for the low reporting rates are found to be a perceived lack of practical usefulness, issues of time and effort in a busy clinic with competing priorities, and considerations of appropriateness in relation to other professionals. Conclusion The results suggest that the visions of formal, comprehensive, and systematic reporting of (and learning from) patient safety incidents will be quite difficult to realize in general practice. Future studies should investigate how various ways of organizing incident reporting at the regional level influence local activities of reporting and learning in general practice. PMID:23113662

  3. Patterns of Adverse Drug Reactions in Different Age Groups: Analysis of Spontaneous Reports by Community Pharmacists

    PubMed Central

    Yu, Yun Mi; Shin, Wan Gyoon; Lee, Ju-Yeun; Choi, Soo An; Jo, Yun Hee; Youn, So Jung; Lee, Mo Se; Choi, Kwang Hoon

    2015-01-01

    Purpose To evaluate the clinical manifestations and causative drugs associated with adverse drug reactions (ADRs) spontaneously reported by community pharmacists and to compare the ADRs by age. Methods ADRs reported to the Regional Pharmacovigilance Center of the Korean Pharmaceutical Association by community pharmacists from January 2013 to June 2014 were included. Causality was assessed using the WHO-Uppsala Monitoring Centre system. The patient population was classified into three age groups. We analyzed 31,398 (74.9%) ADRs from 9,705 patients, identified as having a causal relationship, from a total pool of 41,930 ADRs from 9,873 patients. Median patient age was 58.0 years; 66.9% were female. Results Gastrointestinal system (34.4%), nervous system (14.4%), and psychiatric (12.1%) disorders were the most frequent symptoms. Prevalent causative drugs were those for acid-related disorders (11.4%), anti-inflammatory products (10.5%), analgesics (7.2%), and antibacterials (7.1%). Comparisons by age revealed diarrhea and antibacterials to be most commonly associated with ADRs in children (p < 0.001), whereas dizziness was prevalent in the elderly (p < 0.001). Anaphylactic reaction was the most frequent serious event (19.7%), mainly associated with cephalosporins and non-steroidal anti-inflammatory drugs. Among 612 ADRs caused by nonprescription drugs, the leading symptoms and causative drugs were skin disorders (29.6%) and non-steroidal anti-inflammatory drugs (16.2%), respectively. Conclusions According to the community pharmacist reports, the leading clinical manifestations and causative drugs associated with ADRs in outpatients differed among age groups. PMID:26172050

  4. The Incidence of Human Papillomavirus in Tanzanian Adolescent Girls Before Reported Sexual Debut

    PubMed Central

    Houlihan, Catherine F.; Baisley, Kathy; Bravo, Ignacio G.; Kapiga, Saidi; de Sanjosé, Silvia; Changalucha, John; Ross, David A.; Hayes, Richard J.; Watson-Jones, Deborah

    2016-01-01

    Purpose Acquisition of human papillomavirus (HPV) in women occurs predominantly through vaginal sex. However, HPV has been detected in girls reporting no previous sex. We aimed to determine incidence and risk factors for HPV acquisition in girls who report no previous sex in Tanzania, a country with high HPV prevalence and cervical cancer incidence. Methods We followed 503 adolescent girls aged 15–16 years in Mwanza, Tanzania, with face-to-face interviews and self-administered vaginal swabs every 3 months for 18 months; 397 girls reported no sex before enrollment or during follow-up; of whom, 120 were randomly selected. Samples from enrollment, 6-, 12-, and 18-month visits were tested for 37 HPV genotypes. Incidence, clearance, point prevalence, and duration of any HPV and genotype-specific infections were calculated and associated factors were evaluated. Results Of 120 girls who reported no previous sex, 119 were included, contributing 438 samples. HPV was detected in 51 (11.6%) samples. The overall incidence of new HPV infections was 29.4/100 person-years (95% confidence interval: 15.9–54.2). The point prevalence of vaccine types HPV-6,-11,-16, and -18 was .9%, .9%, 2.0%, and 0%, respectively. Spending a night away from home and using the Internet were associated with incident HPV, and reporting having seen a pornographic movie was inversely associated with HPV incidence. Conclusions Incident HPV infections were detected frequently in adolescent girls who reported no previous sex over 18 months. This is likely to reflect under-reporting of sex. A low-point prevalence of HPV genotypes in licensed vaccines was seen, indicating that vaccination of these girls might still be effective. PMID:26725717

  5. Identification of Human Factors in Unmanned Aviation Via Pilot Incident Reports

    NASA Technical Reports Server (NTRS)

    Hobbs, Alan; Cardoza, Colleen; Null, Cynthia

    2015-01-01

    There is a need for incident data relevant to the operation of civilian unmanned aircraft systems (UAS) in the National Air Space (NAS). Currently, very limited incident and accident data are available from military sources, and the tightly-restricted civilian UAS industry has produced very few incident reports that could shed light on design issues relevant to human factors. An exploratory study is being conducted to examine the feasibility of collecting voluntary critical incident reports from UAS pilots, and using the information to identify areas where human factors guidelines will be of assistance. Experienced UAS pilots are participating in small focus groups in which they are prompted to describe critical incidents that either reveal a system flaw, or highlight a case where the human operator contributed to system resilience or mission success. The de-identified incidents are being analyzed to identify contributing factors, with a focus on design issues that either hindered or assisted the pilot in dealing with the incident. Preliminary findings will be described.

  6. Drug target prediction using adverse event report systems: a pharmacogenomic approach

    PubMed Central

    Takarabe, Masataka; Kotera, Masaaki; Nishimura, Yosuke; Goto, Susumu; Yamanishi, Yoshihiro

    2012-01-01

    Motivation: Unexpected drug activities derived from off-targets are usually undesired and harmful; however, they can occasionally be beneficial for different therapeutic indications. There are many uncharacterized drugs whose target proteins (including the primary target and off-targets) remain unknown. The identification of all potential drug targets has become an important issue in drug repositioning to reuse known drugs for new therapeutic indications. Results: We defined pharmacological similarity for all possible drugs using the US Food and Drug Administration's (FDA's) adverse event reporting system (AERS) and developed a new method to predict unknown drug–target interactions on a large scale from the integration of pharmacological similarity of drugs and genomic sequence similarity of target proteins in the framework of a pharmacogenomic approach. The proposed method was applicable to a large number of drugs and it was useful especially for predicting unknown drug–target interactions that could not be expected from drug chemical structures. We made a comprehensive prediction for potential off-targets of 1874 drugs with known targets and potential target profiles of 2519 drugs without known targets, which suggests many potential drug–target interactions that were not predicted by previous chemogenomic or pharmacogenomic approaches. Availability: Softwares are available upon request. Contact: yamanishi@bioreg.kyushu-u.ac.jp Supplementary Information: Datasets and all results are available at http://cbio.ensmp.fr/~yyamanishi/aers/. PMID:22962489

  7. Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

    PubMed

    Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

    2016-01-01

    Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

  8. Adverse events in healthcare: learning from mistakes.

    PubMed

    Rafter, N; Hickey, A; Condell, S; Conroy, R; O'Connor, P; Vaughan, D; Williams, D

    2015-04-01

    Large national reviews of patient charts estimate that approximately 10% of hospital admissions are associated with an adverse event (defined as an injury resulting in prolonged hospitalization, disability or death, caused by healthcare management). Apart from having a significant impact on patient morbidity and mortality, adverse events also result in increased healthcare costs due to longer hospital stays. Furthermore, a substantial proportion of adverse events are preventable. Through identifying the nature and rate of adverse events, initiatives to improve care can be developed. A variety of methods exist to gather adverse event data both retrospectively and prospectively but these do not necessarily capture the same events and there is variability in the definition of an adverse event. For example, hospital incident reporting collects only a very small fraction of the adverse events found in retrospective chart reviews. Until there are systematic methods to identify adverse events, progress in patient safety cannot be reliably measured. This review aims to discuss the need for a safety culture that can learn from adverse events, describe ways to measure adverse events, and comment on why current adverse event monitoring is unable to demonstrate trends in patient safety.

  9. Pattern of adverse drug reactions reported by the community pharmacists in Nepal

    PubMed Central

    Palaian, Subish; Ibrahim, Mohamed I.M.; Mishra, Pranaya

    2010-01-01

    The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. Objectives: To collect the demographic details of the patients experiencing adverse drug reactions (ADR) reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. Methods: The baseline Knowledge-Attitude-Practices (KAP) of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61) KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4) maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. Results: Altogether 71 ADRs, from 71 patients (37 males) were reported. Antibiotics/ antibacterials caused 42% (n=37) of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22)]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20), followed by generalized edema [8.6 % (n=10)]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49) of the cases. Over two third (69%) of the ADRs had a ‘possible’ association with the suspected drugs and a high percentage (70.4%) were of ‘mild (level 2)’ type. Nearly two third [64.7 % (n=46)] of the ADRs were ‘definitely preventable’. Conclusion: The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen/ Paracetamol

  10. Community pharmacy incident reporting: a new tool for community pharmacies in Canada.

    PubMed

    Ho, Certina; Hung, Patricia; Lee, Gary; Kadija, Medina

    2010-01-01

    Incident reporting offers insight into a variety of intricate processes in healthcare. However, it has been found that medication incidents are under reported in the community pharmacy setting. The Community Pharmacy Incident Reporting (CPhIR) program was created by the Institute for Safe Medication Practices Canada specifically for incident reporting in the community pharmacy setting in Canada. The initial development of key elements for CPhIR included several focus-group teleconferences with pharmacists from Ontario and Nova Scotia. Throughout the development and release of the CPhIR pilot, feedback from pharmacists and pharmacy technicians was constantly incorporated into the reporting program. After several rounds of iterative feedback, testing and consultation with community pharmacy practitioners, a final version of the CPhIR program, together with self-directed training materials, is now ready to launch. The CPhIR program provides users with a one-stop platform to report and record medication incidents, export data for customized analysis and view comparisons of individual and aggregate data. These unique functions allow for a detailed analysis of underlying contributing factors in medication incidents. A communication piece for pharmacies to share their experiences is in the process of development. To ensure the success of the CPhIR program, a patient safety culture must be established. By gaining a deeper understanding of possible causes of medication incidents, community pharmacies can implement system-based strategies for quality improvement and to prevent potential errors from occurring again in the future. This article highlights key features of the CPhIR program that will assist community pharmacies to improve their drug distribution system and, ultimately, enhance patient safety.

  11. [The critical incident reporting system as an instrument of risk management for better patient safety].

    PubMed

    Panzica, M; Krettek, C; Cartes, M

    2011-09-01

    The probability that an inpatient will be harmed by a medical procedure is at least 3% of all patients. As a consequence, hospital risk management has become a central management task in the health care sector. The critical incident reporting system (CIRS) as a voluntary instrument for reporting (near) incidents plays a key role in the implementation of a risk management system. The goal of the CIRS is to register system errors without assigning guilt or meting out punishment and at the same time increasing the number of voluntary reports.

  12. Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events

    PubMed Central

    Kottorp, Anders; Boettcher, Johanna; Andersson, Gerhard; Carlbring, Per

    2016-01-01

    Research conducted during the last decades has provided increasing evidence for the use of psychological treatments for a number of psychiatric disorders and somatic complaints. However, by focusing only on the positive outcomes, less attention has been given to the potential of negative effects. Despite indications of deterioration and other adverse and unwanted events during treatment, little is known about their occurrence and characteristics. Hence, in order to facilitate research of negative effects, a new instrument for monitoring and reporting their incidence and impact was developed using a consensus among researchers, self-reports by patients, and a literature review: the Negative Effects Questionnaire. Participants were recruited via a smartphone-delivered self-help treatment for social anxiety disorder and through the media (N = 653). An exploratory factor analysis was performed, resulting in a six-factor solution with 32 items, accounting for 57.64% of the variance. The derived factors were: symptoms, quality, dependency, stigma, hopelessness, and failure. Items related to unpleasant memories, stress, and anxiety were experienced by more than one-third of the participants. Further, increased or novel symptoms, as well as lack of quality in the treatment and therapeutic relationship rendered the highest self-reported negative impact. In addition, the findings were discussed in relation to prior research and other similar instruments of adverse and unwanted events, giving credence to the items that are included. The instrument is presently available in eleven different languages and can be freely downloaded and used from www.neqscale.com. PMID:27331907

  13. Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events.

    PubMed

    Rozental, Alexander; Kottorp, Anders; Boettcher, Johanna; Andersson, Gerhard; Carlbring, Per

    2016-01-01

    Research conducted during the last decades has provided increasing evidence for the use of psychological treatments for a number of psychiatric disorders and somatic complaints. However, by focusing only on the positive outcomes, less attention has been given to the potential of negative effects. Despite indications of deterioration and other adverse and unwanted events during treatment, little is known about their occurrence and characteristics. Hence, in order to facilitate research of negative effects, a new instrument for monitoring and reporting their incidence and impact was developed using a consensus among researchers, self-reports by patients, and a literature review: the Negative Effects Questionnaire. Participants were recruited via a smartphone-delivered self-help treatment for social anxiety disorder and through the media (N = 653). An exploratory factor analysis was performed, resulting in a six-factor solution with 32 items, accounting for 57.64% of the variance. The derived factors were: symptoms, quality, dependency, stigma, hopelessness, and failure. Items related to unpleasant memories, stress, and anxiety were experienced by more than one-third of the participants. Further, increased or novel symptoms, as well as lack of quality in the treatment and therapeutic relationship rendered the highest self-reported negative impact. In addition, the findings were discussed in relation to prior research and other similar instruments of adverse and unwanted events, giving credence to the items that are included. The instrument is presently available in eleven different languages and can be freely downloaded and used from www.neqscale.com.

  14. Transient paralysis during acupuncture therapy: a case report of an adverse event.

    PubMed

    Beable, Anne

    2013-09-01

    A patient with apparently well-controlled epilepsy with a painful musculoskeletal condition was treated successfully with two sessions of acupuncture. However, 4 h after the first treatment and during the second, an adverse event involving impairment of consciousness occurred. The patient subsequently experienced an increased frequency of complex partial seizures resulting in the loss of his driving licence. A detailed retrospective review of the past medical history indicated that the patient probably had comorbidities in the form of rapid eye movement sleep behaviour disorder and dysfunctional somatosensory/vestibular processing. Acupuncture may have triggered the adverse event via shared neurosubstrates. This adverse event raises possible implications regarding safe clinical acupuncture practice.

  15. [Evaluation of the Association of Hand-Foot Syndrome with Anticancer Drugs Using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) Databases].

    PubMed

    Sasaoka, Sayaka; Matsui, Toshinobu; Abe, Junko; Umetsu, Ryogo; Kato, Yamato; Ueda, Natsumi; Hane, Yuuki; Motooka, Yumi; Hatahira, Haruna; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2016-01-01

    The Japanese Ministry of Health, Labor, and Welfare lists hand-foot syndrome as a serious adverse drug event. Therefore, we evaluated its association with anticancer drug therapy using case reports in the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In addition, we calculated the reporting odds ratio (ROR) of anticancer drugs potentially associated with hand-foot syndrome, and applied the Weibull shape parameter to time-to-event data from JADER. We found that JADER contained 338224 reports from April 2004 to November 2014, while FAERS contained 5821354 reports from January 2004 to June 2014. In JADER, the RORs [95% confidence interval (CI)] of hand-foot syndrome for capecitabine, tegafur-gimeracil-oteracil, fluorouracil, sorafenib, and regorafenib were 63.60 (95%CI, 56.19-71.99), 1.30 (95%CI, 0.89-1.89), 0.48 (95%CI, 0.30-0.77), 26.10 (95%CI, 22.86-29.80), and 133.27 (95%CI, 112.85-157.39), respectively. Adverse event symptoms of hand-foot syndrome were observed with most anticancer drugs, which carry warnings of the propensity to cause these effects in their drug information literature. The time-to-event analysis using the Weibull shape parameter revealed differences in the time-dependency of the adverse events of each drug. Therefore, anticancer drugs should be used carefully in clinical practice, and patients may require careful monitoring for symptoms of hand-foot syndrome.

  16. An Analysis of Incident/Accident Reports from the Texas Secondary School Science Safety Survey, 2001

    ERIC Educational Resources Information Center

    Stephenson, Amanda L.; West, Sandra S.; Westerlund, Julie F.; Nelson, Nancy C.

    2003-01-01

    This study investigated safety in Texas secondary school science laboratory, classroom, and field settings. The Texas Education Agency (TEA) drew a random representative sample consisting of 199 secondary public schools in Texas. Eighty-one teachers completed Incident/Accident Reports. The reports were optional, anonymous, and open-ended; thus,…

  17. 75 FR 5640 - Pipeline Safety: Implementation of Revised Incident/Accident Report Forms for Distribution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-03

    ... Liquid Systems AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION... facilities and hazardous liquid pipeline facilities that the incident/ accident report forms for their... Transmission and Gathering Systems, and (3) PHMSA Form F 7000-1--Accident Report for Hazardous Liquid...

  18. Educators' Reports on Incidence of Harassment and Advocacy toward LGBTQ Students

    ERIC Educational Resources Information Center

    Dragowski, Eliza A.; McCabe, Paul C.; Rubinson, Florence

    2016-01-01

    This study is based on a national survey investigation of 968 educators, who reported the incidence of LGBTQ harassment in schools, and their advocacy efforts on behalf of this population. LGBTQ-related knowledge, attitudes, norms, and perceived ability to advocate were also assessed. Ninety percent of educators reported observing LGBTQ harassment…

  19. Increased incidence of second primary malignancy in patients with carcinoid tumors: case report and literature review.

    PubMed Central

    Rivadeneira, D. E.; Tuckson, W. B.; Naab, T.

    1996-01-01

    There is an increased incidence of second noncarcinoid neoplasms in patients with carcinoid tumors. This article reports a case of a synchronous malignant ileal carcinoid tumor in a patient with an adenocarcinoma of the sigmoid colon. This report illustrates the increased association of carcinoid tumors with other gastrointestinal malignancies. Images Figure 1 Figure 2 Figure 3 PMID:8667441

  20. Reported fatal and non-fatal incidents involving tourists in Thailand, July 1997-June 1999.

    PubMed

    Leggat, Peter A; Leggat, Frances W

    2003-05-01

    Objectives. To examine fatal and non-fatal incidents involving tourists in Thailand. Methods. Press records from a major English language newspaper for the period from July 1997 to June 1999 were examined for reports of fatal and non-fatal incidents involving tourists. Results. From July 1997 to June 1999, up to 233 deaths were reported and up to a further 216 were reported injured in incidents involving tourists. One hundred and one deaths and 45 injured were reported following one major domestic jet aircraft crash in southern Thailand, however, it was not stated what proportion of casualties were tourists. Approximately 90 people perished in a single hotel fire in southeast Thailand. Most of the victims were local travellers attending meetings of two Thai companies. Sixteen deaths and 86 injured resulted from five road accidents. The majority of deaths and injuries involved foreigners. Twelve deaths and at least 33 injured resulted from three ferry and tour boat accidents. Most victims were reported to be foreigners. Three deaths and 35 injured resulted from a single cable car accident in northern Thailand. Most of these were Thai tourists, however, four of the injured were foreigners. Eight deaths and six injured resulted from 11 muggings and other violent incidents. All were foreigners. Six deaths were reportedly connected to a scam at the airport in Bangkok involving unlicensed airport taxis. Three deaths and four injured were due to other reported incidents. Conclusions. Newspaper reports of fatal and non-fatal incidents involving tourists in Thailand were probably uncommon, particularly given the volume of tourists entering the Kingdom, although better reporting mechanisms are needed. With the exception of the unusual major incidents, most reported fatal and non-fatal incidents involving tourists were due to road trauma and other transportation accidents, muggings, and occasional water sports and other accidents, which could occur at any major tourist

  1. Veterans Health Care: Veterans Health Administration Processes for Responding to Reported Adverse Events

    DTIC Science & Technology

    2012-08-24

    outpatient, residential, and inpatient services.1 These health care services are delivered by physicians, dentists , and other providers and range...that may pose the risk of injury to a patient as the result of a medical intervention or lack of an appropriate intervention, such as a missed or...intervention. Close calls receive the same level of scrutiny as adverse events that result in actual patient injury. Adverse events may or may not

  2. Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia

    PubMed Central

    Gurmesa, Lense Temesgen

    2016-01-01

    Background. Adverse drug reactions are global problems of major concern. Adverse drug reaction reporting helps the drug monitoring system to detect the unwanted effects of those drugs which are already in the market. Aims. To assess the knowledge, attitude, and practice of health care professionals working in Nekemte town towards adverse drug reaction reporting. Methods and Materials. A cross-sectional study design was conducted on a total of 133 health care professionals by interview to assess their knowledge, attitude, and practice using structured questionnaire. Results. Of the total respondents, only 64 (48.2%), 56 (42.1%), and 13 (9.8%) health care professionals have correctly answered the knowledge, attitude, and practice assessment questions, respectively. Lack of awareness and knowledge on what, when, and to whom to report adverse drug reactions and lack of commitments of health care professionals were identified as the major discouraging factors against adverse drug reaction reporting. Conclusion. This study has revealed that the knowledge, attitude, and practice of the health care professionals working in Nekemte town towards spontaneous adverse drug reaction reporting were low that we would like to recommend the concerned bodies to strive on the improvement of the knowledge, attitude, and practice status of health care professionals. PMID:28042569

  3. Linguistic analysis of large-scale medical incident reports for patient safety.

    PubMed

    Fujita, Katsuhide; Akiyama, Masanori; Park, Keunsik; Yamaguchi, Etsuko Nakagami; Furukawa, Hiroyuki

    2012-01-01

    The analysis of medical incident reports is indispensable for patient safety. The cycles between analysis of incident reports and proposals to medical staffs are a key point for improving the patient safety in the hospital. Most incident reports are composed from freely written descriptions, but an analysis of such free descriptions is not sufficient in the medical field. In this study, we aim to accumulate and reinterpret findings using structured incident information, to clarify improvements that should be made to solve the root cause of the accident, and to ensure safe medical treatment through such improvements. We employ natural language processing (NLP) and network analysis to identify effective categories of medical incident reports. Network analysis can find various relationships that are not only direct but also indirect. In addition, we compare bottom-up results obtained by NLP with existing categories based on experts' judgment. By the bottom-up analysis, the class of patient managements regarding patients' fallings and medicines in top-down analysis is created clearly. Finally, we present new perspectives on ways of improving patient safety.

  4. Torsadogenic Risk of Antipsychotics: Combining Adverse Event Reports with Drug Utilization Data across Europe

    PubMed Central

    Raschi, Emanuel; Poluzzi, Elisabetta; Godman, Brian; Koci, Ariola; Moretti, Ugo; Kalaba, Marija; Bennie, Marion; Barbui, Corrado; Wettermark, Bjorn; Sturkenboom, Miriam; De Ponti, Fabrizio

    2013-01-01

    Background Antipsychotics (APs) have been associated with risk of torsade de Pointes (TdP). This has important public health implications. Therefore, (a) we exploited the public FDA Adverse Event Reporting System (FAERS) to characterize their torsadogenic profile; (b) we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. Methods FAERS data (2004-2010) were analyzed based on the following criteria: (1) ≥4 cases of TdP/QT abnormalities; (2) Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers); (3) ≥4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD); (4) Significant ROR for VA/SCD; (5) Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled) to group E (unclear/uncertain signal: only 2/5 criteria). Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID). Results Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone). In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia) to 13.99 (France, 2009). Considerable increment of Group A agents was found in several Countries (+3.47 in France): the exposure to olanzapine increased across all Countries (+1.84 in France) and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009). Among Group B drugs, levomepromazine peaked 3.78 (Serbia); fluphenazine 1.61 (Slovenia). Conclusions This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and

  5. The non-technical skills used by anaesthetic technicians in critical incidents reported to the Australian Incident Monitoring System between 2002 and 2008.

    PubMed

    Rutherford, J S; Flin, R; Irwin, A

    2015-07-01

    The outcome of critical incidents in the operating theatre has been shown to be influenced by the behaviour of anaesthetic technicians (ATs) assisting anaesthetists, but the specific non-technical skills involved have not been described. We performed a review of critical incidents (n=1433) reported to the Australian Incident Monitoring System between 2002 and 2008 to identify which non-technical skills were used by ATs. The reports were assessed if they mentioned anaesthetic assistance or had the boxes ticked to identify "inadequate assistance" or "absent supervision or assistance". A total of 90 critical incidents involving ATs were retrieved, 69 of which described their use of non-technical skills. In 20 reports, the ATs ameliorated the critical incident, whilst in 46 they exacerbated the critical incident, and three cases had both positive and negative non-technical skills described. Situation awareness was identified in 39 reports, task management in 23, teamwork in 21 and decision-making in two, but there were no descriptions of issues related to leadership, stress or fatigue management. Situation awareness, task management and teamwork appear to be important non-technical skills for ATs in the development or management of critical incidents in the operating theatre. This analysis has been used to support the development of a non-technical skills taxonomy for anaesthetic assistants.

  6. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., and reporting of postmarketing adverse drug experiences to FDA. (b) Definitions. The following... severity) if the labeling only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral... and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. (1) Postmarketing...

  7. A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

    PubMed

    Liu, Xiao; Chen, Hsinchun

    2015-12-01

    Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work.

  8. Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation

    SciTech Connect

    Chen Yuhchyau . E-mail: Yuhchyau_chen@urmc.rochester.edu; Trotti, Andy; Coleman, C. Norman; Machtay, Mitchell; Mirimanoff, Rene O.; Hay, John; O'Brien, Peter C.; El-Gueddari, Brahim; Salvajoli, Joao V.; Jeremic, Branislav

    2006-04-01

    Purpose: Recent research has enhanced our understanding of radiation injury at the molecular-cellular and tissue levels; significant strides have occurred in standardization of adverse event reporting in clinical trials. In response, the International Atomic Energy Agency, through its Division of Human Health and its section for Applied Radiation Biology and Radiotherapy, organized a consultation meeting in Atlanta (October 2, 2004) to discuss developments in radiobiology, normal tissue reactions, and adverse event reporting. Methods and Materials: Representatives from cooperative groups of African Radiation Oncology Group, Curriculo Radioterapeutica Ibero Latino Americana, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada Clinical Trials Group, Radiation Therapy Oncology Group, and Trans-Tasman Radiation Oncology Group held the meeting discussion. Results: Representatives of major radiotherapy groups/organizations and prominent leaders in radiotherapy discussed current understanding of normal tissue radiobiologic effects, the design and implementation of future clinical and translational projects for normal tissue injury, and the standardization of adverse-event reporting worldwide. Conclusions: The consensus was to adopt NCI comprehensive adverse event reporting terminology and grading system (CTCAE v3.0) as the new standard for all cooperative group trials. Future plans included the implementation of coordinated research projects focusing on normal tissue biomarkers and data collection methods.

  9. The role of media and the Internet on vaccine adverse event reporting: a case study of HPV vaccination

    PubMed Central

    Eberth, Jan M.; Kline, Kimberly N.; Moskowitz, David; Montealegre, Jane; Scheurer, Michael E.

    2013-01-01

    Purpose This study aimed to determine the temporal association of print media coverage and Internet search activity with adverse events reports associated with the human papillomavirus vaccine Gardasil® (HPV4) and the meningitis vaccine Menactra® (MNQ) among U.S. adolescents. Methods We used moderated linear regression to test the relationships between print media reports in top circulating newspapers, Internet search activity, and reports to the Vaccine Adverse Event Reporting System (VAERS) for HPV4 and MNQ during the first 2.5 years post-FDA approval. Results Compared to MNQ, HPV4 had more coverage in the print media and Internet search activity, which corresponded with the frequency of VAERS reports. In February 2007, we observed a spike in print media for HPV4. Although media coverage waned, Internet search activity remained stable and predicted the rise in HPV4-associated VAERS reports. Conclusions We demonstrate that media coverage and Internet search activity, in particular, may promote increased adverse event reporting. Public health officials who have long recognized the importance of proactive engagement with news media must now consider strategies for meaningful participation in Internet discussions. PMID:24257032

  10. Recommendations for Nuclear Medicine Technologists Drawn from an Analysis of Errors Reported in Australian Radiation Incident Registers.

    PubMed

    Kearney, Nicole; Denham, Gary

    2016-12-01

    When a radiation incident occurs in nuclear medicine in Australia, the incident is reported to the relevant state or territory authority, which performs an investigation and sends its findings to the Australian Radiation Protection and Nuclear Safety Agency. The agency then includes these data in its Australian Radiation Incident Register and makes them available to the public as an annual summary report on its website. The aim of this study was to analyze the radiation incidents included in these annual reports and in the publically available state and territory registers, identify any recurring themes, and make recommendations to minimize future incidents.

  11. Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005.

    PubMed

    Chaves, Sandra S; Haber, Penina; Walton, Kimp; Wise, Robert P; Izurieta, Hector S; Schmid, D Scott; Seward, Jane F

    2008-03-01

    Widespread use of varicella vaccine in the United States could enable detection of rare adverse events not identified previously. We reviewed data from 1995 to 2005 from the Vaccine Adverse Event Reporting System, including data from laboratory analyses, to distinguish adverse events associated with wild-type varicella-zoster virus (VZV) versus those associated with vaccine strain. Almost 48 million doses of varicella vaccine were distributed between 1995 and 2005. There were 25,306 adverse events reported (52.7/100,000 doses distributed); 5.0% were classified as serious (2.6/100,000 doses distributed). Adverse events associated with evidence of vaccine-strain VZV included meningitis in patients with concurrent herpes zoster. Patients with genetic predispositions may rarely have disease triggered by receipt of varicella vaccine. Overall, serious adverse events reported after varicella vaccination continue to be rare and must be considered relative to the substantial benefits of varicella vaccination. Ongoing safety surveillance and further studies may shed light on some of the hypothesized associations.

  12. Evaluation of an intervention aimed at improving voluntary incident reporting in hospitals

    PubMed Central

    Evans, Sue M; Smith, Brian J; Esterman, Adrian; Runciman, William B; Maddern, Guy; Stead, Karen; Selim, Pam; O'Shaughnessy, Jane; Muecke, Sandy; Jones, Sue

    2007-01-01

    Objectives To assess the effectiveness of an intervention package comprising intense education, a range of reporting options, changes in report management and enhanced feedback, in order to improve incident‐reporting rates and change the types of incidents reported. Design, setting and participants Non‐equivalent group controlled clinical trial involving medical and nursing staff working in 10 intervention and 10 control units in four major cities and two regional hospitals in South Australia. Main outcome measures Comparison of reporting rates by type of unit, profession, location of hospital, type of incident reported and reporting mechanism between baseline and study periods in control and intervention units. Results The intervention resulted in significant improvement in reporting in inpatient areas (additional 60.3 reports/10 000 occupied bed days (OBDs); 95% CI 23.8 to 96.8, p<0.001) and in emergency departments (EDs) (additional 39.5 reports/10 000 ED attendances; 95% CI 17.0 to 62.0, p<0.001). More reports were generated (a) by doctors in EDs (additional 9.5 reports/10 000 ED attendances; 95% CI 2.2 to 16.8, p = 0.001); (b) by nurses in inpatient areas (additional 59.0 reports/10 000 OBDs; 95% CI 23.9 to 94.1, p<0.001) and (c) anonymously (additional 20.2 reports/10 000 OBDs and ED attendances combined; 95% CI 12.6 to 27.8, p<0.001). Compared with control units, the study resulted in more documentation, clinical management and aggression‐related incidents in intervention units. In intervention units, more reports were submitted on one‐page forms than via the call centre (1005 vs 264 reports, respectively). Conclusions A greater variety and number of incidents were reported by the intervention units during the study, with improved reporting by doctors from a low baseline. However, there was considerable heterogeneity between reporting rates in different types of units. PMID:17545341

  13. 30 CFR 285.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... cannot continue until repairs are made; (6) Incidents involving crane or personnel/material handling.... Property or equipment damage means the cost of labor and material to restore all affected items to...

  14. A comparative assessment of immunization records in the Defense Medical Surveillance System and the Vaccine Adverse Event Reporting System.

    PubMed

    McNeil, Michael M; Ma, Guihua; Aranas, Aaron; Payne, Daniel C; Rose, Charles E

    2007-04-30

    We compared immunization data in the Defense Medical Surveillance System (DMSS) and immunization data for service members with an anthrax vaccine-associated adverse event reported to the Vaccine Adverse Event Reporting System (VAERS) during January 1998 through December 2004. Our main measure of agreement was sensitivity of the DMSS conditional on an immunization record(s) occurring in VAERS. The sensitivity of DMSS was 73% for all vaccines and 74% for the anthrax vaccine on the VAERS index immunization date. Our study is the first to quantify the agreement between immunization records in VAERS and DMSS. Our data suggest the immunization information in military VAERS reports and the DMSS is similar for anthrax and non-anthrax immunizations.

  15. Incidence and severity of reported acute sports injuries in 35 sports using insurance registry data.

    PubMed

    Åman, M; Forssblad, M; Henriksson-Larsén, K

    2016-04-01

    Acute injuries in sport are still a problem where limited knowledge of incidence and severity in different sports at national level exists. In Sweden, 80% of the sports federations have their mandatory injury insurance for all athletes in the same insurance company and injury data are systematically kept in a national database. The aim of the study was to identify high-risk sports with respect to incidence of acute and severe injuries in 35 sports reported to the database. The number and incidences of injuries as well as injuries leading to permanent medical impairment (PMI) were calculated during 2008-2011. Each year approximately 12,000 injuries and 1,162,660 licensed athletes were eligible for analysis. Eighty-five percent of the injuries were reported in football, ice hockey, floorball, and handball. The highest injury incidence as well as PMI was in motorcycle, handball, skating, and ice hockey. Females had higher risk of a PMI compared with males in automobile sport, handball, floorball, and football. High-risk sports with numerous injuries and high incidence of PMI injuries were motorcycle, handball, ice hockey, football, floorball, and automobile sports. Thus, these sports ought to be the target of preventive actions at national level.

  16. 76 FR 34812 - Proposed Information Collection (Report of Medical, Legal, and Other Expenses Incident to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ... for Injury or Death) Activity; Comment Request AGENCY: Department of Veterans Affairs, Veterans... Expenses Incident to Recovery for Injury or Death, VA Form 21-8416b. OMB Control Number: 2900-0545. Type of... report compensation awarded by another entity or government agency for personal injury or death....

  17. 77 FR 53779 - Reports by Air Carriers on Incidents Involving Animals During Air Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-04

    .... DATES: Comments must be received by September 27, 2012. Comments received after this date will be... requirement for air carriers to report to the Department incidents involving the loss, injury, or death of an... be received 60 days after publication of the NPRM, or by August 28, 2012. Request for Comment...

  18. 75 FR 51953 - Notification and Reporting of Aircraft Accidents or Incidents and Overdue Aircraft, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-24

    ... exclude military UASs, model aircraft, and commercial spacecraft operating under FAA waivers. ] List of... From the Federal Register Online via the Government Publishing Office NATIONAL TRANSPORTATION SAFETY BOARD 49 CFR Part 830 Notification and Reporting of Aircraft Accidents or Incidents and...

  19. 41 CFR 102-33.445 - What accident and incident data must we report?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false What accident and incident data must we report? 102-33.445 Section 102-33.445 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL...

  20. 41 CFR 102-33.445 - What accident and incident data must we report?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What accident and incident data must we report? 102-33.445 Section 102-33.445 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL...

  1. 41 CFR 102-33.445 - What accident and incident data must we report?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false What accident and incident data must we report? 102-33.445 Section 102-33.445 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL...

  2. 41 CFR 102-33.445 - What accident and incident data must we report?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false What accident and incident data must we report? 102-33.445 Section 102-33.445 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL...

  3. 41 CFR 102-33.445 - What accident and incident data must we report?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false What accident and incident data must we report? 102-33.445 Section 102-33.445 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL...

  4. 77 FR 38747 - Reports by Air Carriers on Incidents Involving Animals During Air Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-29

    ... all cats and dogs transported by the carrier, regardless of whether the cat or dog is transported as a... required to report all incidents involving the loss, injury, or death of cats and dogs that occur while they are traveling in an airline's care, custody, or control, regardless of whether the cat or dog...

  5. Adverse effects of cannabis.

    PubMed

    2011-01-01

    establish a causal relationship in either direction, because of these methodological limitations. In Australia, the marked increase in cannabis use has not been accompanied by an increased incidence of schizophrenia. On the basis of the available data, we cannot reach firm conclusions on whether or not cannabis use causes psychosis. It seems prudent to inform apparently vulnerable individuals that cannabis may cause acute psychotic decompensation, especially at high doses. Users can feel dependent on cannabis, but this dependence is usually psychological. Withdrawal symptoms tend to occur within 48 hours following cessation of regular cannabis use, and include increased irritability, anxiety, nervousness, restlessness, sleep difficulties and aggression. Symptoms subside within 2 to 12 weeks. Driving under the influence of cannabis doubles the risk of causing a fatal road accident. Alcohol consumption plays an even greater role. A few studies and a number of isolated reports suggest that cannabis has a role in the occurrence of cardiovascular adverse effects, especially in patients with coronary heart disease. Numerous case-control studies have investigated the role of cannabis in the incidence of some types of cancer. Its role has not been ruled out, but it is not possible to determine whether the risk is distinct from that of the tobacco with which it is often smoked. Studies that have examined the influence of cannabis use on the clinical course of hepatitis C are inconclusive. Alcohol remains the main toxic agent that hepatitis C patients should avoid. In practice, the adverse effects of low-level, recreational cannabis use are generally minor, although they can apparently be serious in vulnerable individuals. The adverse effects of cannabis appear overall to be less serious than those of alcohol, in terms of neuropsychological and somatic effects, accidents and violence.

  6. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Where can I find the reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG... the coding manual from CDRH's Web site at http://www.fda.gov/cdrh/mdr/mdr-forms.html; and from...

  7. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Where can I find the reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG... Form 3500A. You may obtain the coding manual from CDRH's Web site at...

  8. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Where can I find the reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG... the coding manual from CDRH's Web site at...

  9. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Where can I find the reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG... the coding manual from CDRH's Web site at...

  10. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Where can I find the reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG... the coding manual from CDRH's Web site at...

  11. Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib.

    PubMed

    Harvey, R Donald

    2014-01-01

    Carfilzomib, a selective proteasome inhibitor approved in the USA in 2012, is a single agent for relapsed and refractory multiple myeloma. Carfilzomib is administered as a 2-10-minute infusion on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle at a starting dose of 20 mg/m(2) for cycle 1 and a target dose of 27 mg/m(2) thereafter. In the pivotal Phase II study (PX-171-003-A1), carfilzomib 20/27 mg/m(2) provided durable responses in a heavily pretreated population with relapsed and refractory multiple myeloma (n=266), with an overall response rate of 22.9% and a median duration of response of 7.8 months. In an integrated safety analysis of four Phase II studies, common adverse events (32.7%-55.5%) included fatigue, anemia, nausea, thrombocytopenia, dyspnea, and diarrhea. Grade 3/4 adverse events were generally hematologic and included thrombocytopenia (23.4%), anemia (22.4%), and lymphopenia (18.1%). Serious adverse events included pneumonia (9.9%), acute renal failure (4.2%), pyrexia (3.4%), and congestive heart failure (3.4%). New or worsening peripheral neuropathy was infrequent (13.9% overall, 1.3% grade 3, no grade 4). This review discusses findings of the integrated safety analysis and provides practical experience from a single institution in managing treatment-related and disease-related adverse events. Individualized treatment with proactive management of side effects and complications allows patients with advanced multiple myeloma to remain on carfilzomib for extended periods.

  12. Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations.

    PubMed

    Smith, Shannon M; Wang, Anthony T; Katz, Nathaniel P; McDermott, Michael P; Burke, Laurie B; Coplan, Paul; Gilron, Ian; Hertz, Sharon H; Lin, Allison H; Rappaport, Bob A; Rowbotham, Michael C; Sampaio, Cristina; Sweeney, Michael; Turk, Dennis C; Dworkin, Robert H

    2013-07-01

    The development of valid and informative treatment risk-benefit profiles requires consistent and thorough information about adverse event (AE) assessment and participants' AEs during randomized controlled trials (RCTs). Despite a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement recommending the specific AE information that investigators should report, there is little evidence that analgesic RCTs adequately adhere to these recommendations. This systematic review builds on prior recommendations by describing a comprehensive checklist for AE reporting developed to capture clinically important AE information. Using this checklist, we coded AE assessment methods and reporting in all 80 double-blind RCTs of noninvasive pharmacologic treatments published in the European Journal of Pain, Journal of Pain, and PAIN® from 2006 to 2011. Across all trials, reports of AEs were frequently incomplete, inconsistent across trials, and, in some cases, missing. For example, >40% of trials failed to report any information on serious adverse events. Trials of participants with acute or chronic pain conditions and industry-sponsored trials typically provided more and better-quality AE data than trials involving pain-free volunteers or trials that were not industry sponsored. The results of this review suggest that improved AE reporting is needed in analgesic RCTs. We developed an ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks) AE reporting checklist that is intended to assist investigators in thoroughly and consistently capturing and reporting these critically important data in publications.

  13. The First 18 Months Following Food and Drug Administration Approval of Lumbar Total Disc Replacement in the United States: Reported Adverse Events Outside an Investigational Device Exemption Study Environment

    PubMed Central

    Guyer, Richard D.; Geisler, Fred H.; McAfee, Paul C.; Regan, John J.

    2007-01-01

    Background Introduction of a new surgical technology may result in higher rates of adverse events compared with rates reported in the study performed to gain regulatory approval. The purpose of our study was to describe the incidence of reported adverse events during the first 18 months following US Food and Drug Administration (FDA) approval of the first lumbar arthroplasty device available in the United States and to discern data trends. Methods Reports of adverse events submitted to the FDA in patients receiving the Charité artificial disc were reviewed and pooled by similarity. We analyzed 135 medical device reports filed with the FDA regarding the Charité artificial disc between October 26, 2004, and April 26, 2006. Sixteen reports were excluded for lack of information regarding cause or because described events were vague or unrelated to the procedure. Results Rate of adverse events reported to the FDA as a percentage of devices of which the device manufacturer was aware had been dispensed at 6, 12, and 18 months following approval was 0.58%, 2.34%, and 2.13%, respectively. The adverse event reported most frequently through 18 months was anterior migration with reoperation (0.65%); other reported adverse events were, in decreasing order, sizing and malposition errors resulting in reoperation (0.36%), posterior element fracture resulting in reoperation (0.30%), major vascular injury requiring a blood transfusion (0.23%), and subsidence requiring reoperation (0.20%). Three non–device-related patient deaths were reported following FDA approval. The reported rate of sizing/malposition errors leading to reoperation of 0.36% was the same rate as that seen in the investigational device exemption (IDE) study of the Charité artificial disc. All other reported rates were lower than rates of the same events reported in the study. Conclusions Medical device reporting is an important yet highly anecdotal and incomplete event-tracking process. However, it is the

  14. Adverse events temporally associated with meningococcal vaccines.

    PubMed Central

    Yergeau, A; Alain, L; Pless, R; Robert, Y

    1996-01-01

    OBJECTIVE: To determine the incidence of severe adverse events temporally associated with meningococcal vaccines administered as part of a mass vaccination program. DESIGN: Retrospective descriptive study of events reported to a passive provincial surveillance system. SETTING: The province of Quebec. PARTICIPANTS: The 1,198,751 individuals aged 6 months to 20 years who were vaccinated against meningococcal disease between Dec. 27, 1992, and Mar. 31, 1993. OUTCOME MEASURES: Total numbers and rates of severe adverse events, including allergic reactions, anaphylactic reactions, neurological events (other than abnormal crying and screaming) and other serious or unusual events. RESULTS: A total of 118 reports of severe adverse events were selected from the surveillance system. The most frequent were allergic reactions (9.2 per 100,000 doses). Few anaphylactic or neurologic reactions were reported (0.1 and 0.5 per 100,000 doses respectively). There were no reports of sequelae or of encephalopathy, meningitis or encephalitis. CONCLUSION: Meningococcal vaccines seem to be associated with fewer adverse events than have previously been reported. Existing surveillance programs are useful for determining the incidence of adverse events temporally associated with vaccines. PMID:8630839

  15. An updated report on the trends in cancer incidence and mortality in Japan, 1958-2013.

    PubMed

    Katanoda, Kota; Hori, Megumi; Matsuda, Tomohiro; Shibata, Akiko; Nishino, Yoshikazu; Hattori, Masakazu; Soda, Midori; Ioka, Akiko; Sobue, Tomotaka; Nishimoto, Hiroshi

    2015-04-01

    The analysis of cancer trends in Japan requires periodic updating. Herein, we present a comprehensive report on the trends in cancer incidence and mortality in Japan using recent population-based data. National cancer mortality data between 1958 and 2013 were obtained from published vital statistics. Cancer incidence data between 1985 and 2010 were obtained from high-quality population-based cancer registries of three prefectures (Yamagata, Fukui and Nagasaki). Joinpoint regression analysis was performed to examine the trends in age-standardized rates of cancer incidence and mortality. All-cancer mortality decreased from the mid-1990s, with an annual percent change of -1.3% (95% confidence interval [CI]: -1.4, -1.3). During the most recent 10 years, over 60% of the decrease in cancer mortality was accounted for by a decrease in stomach and liver cancers (63% for males and 66% for females). The long-term increase in female breast cancer mortality, beginning in the 1960s, plateaued in 2008. All-cancer incidence continuously increased, with annual percent changes of 0.6% (95% CI: 0.5, 0.8) between 1985 and 2005, and 1.8% (95% CI: 0.6, 2.9) between 2005 and 2010. During the most recent 10 years, almost half of the increase in cancer incidence was accounted for by an increase in prostate cancer (60%) in males and breast cancer (46%) in females. The cancer registry quality indices also began to increase from ∼2005. Decreases in stomach and liver cancers observed for incidence and mortality reflect the reduced attribution of infection-related factors (i.e. Helicobacter pylori and hepatitis virus). However, it should be noted that cervical cancer incidence and mortality rates began to increase from ∼1990.

  16. Bell's palsy associated with linezolid therapy: case report and review of neuropathic adverse events.

    PubMed

    Thai, Xia C; Bruno-Murtha, Lou Ann

    2006-08-01

    Bell's palsy is one of the most common neurologic disorders affecting the seventh cranial nerve. Several disease states have been associated with facial paralysis. Drugs, however, have been rarely implicated as an etiology. We describe a 49-year-old man who developed peripheral facial paralysis after 3 weeks of linezolid therapy, along with recurrence of symptoms on rechallenge. He had insulin-dependent diabetes mellitus and a longstanding history of bilateral diabetes-related foot problems. After hospitalization, debridement, and vancomycin therapy for methicillin-resistant Staphylococcus aureus osteomyelitis, the patient was discharged to home with oral linezolid therapy. On day 23 of linezolid therapy, he developed signs and symptoms that were consistent with Bell's palsy. Linezolid was discontinued; the Bell's palsy gradually improved, with complete resolution occurring at month 3. On rechallenge with linezolid for recurrent osteomyelitis, the patient developed a second episode of Bell's palsy within a similar time frame as in the first episode. Assessment of causality using the Naranjo adverse drug reaction probability scale revealed a probable relationship between this adverse drug event and linezolid therapy. Clinicians should be aware that Bell's palsy may be another neuropathic adverse effect associated with linezolid.

  17. Analysis of the sex ratio of reported gonorrhoea incidence in Shenzhen, China

    PubMed Central

    Xiong, Mingzhou; Lan, Lina; Feng, Tiejian; Zhao, Guanglu; Wang, Feng; Hong, Fuchang; Wu, Xiaobing; Zhang, Chunlai; Wen, Lizhang; Liu, Aizhong; Best, John McCulloch; Tang, Weiming

    2016-01-01

    Objective To assess the clinical process of gonorrhoea diagnosis and report in China, and to determine the difference of sex ratio between reported incidence based on reporting data and true diagnosis rate based on reference tests of gonorrhoea. Setting A total of 26 dermatology and sexually transmitted disease (STD) departments, 34 obstetrics-gynaecology clinics and 28 urology outpatient clinics selected from 34 hospitals of Shenzhen regarded as our study sites. Participants A total of 2754 participants were recruited in this study, and 2534 participants completed the questionnaire survey and provided genital tract secretion specimens. There were 1106 male and 1428 female participants. Eligible participants were patients who presented for outpatient STD care at the selected clinics for the first time in October 2012 were at least 18 years old, and were able to give informed consent. Outcome measures Untested rate, true-positive rate, false-negative rate and unreported rate of gonorrhoea, as well as reported gonorrhoea incidence sex ratio and true diagnosis sex ratio were calculated and used to describe the results. Results 2534 participants were enrolled in the study. The untested rate of gonorrhoea among females was significantly higher than that among males (female 88.1%, male 68.3%, p=0.001). The male-to-female sex ratios of untested rate, true-positive rate, false-negative rate and unreported rate were 1:1.3, 1.2:1, 1:1.6 and 1:1.4, respectively. The reported gonorrhoea incidence sex ratio of new diagnosed gonorrhoea was 19.8:1 (male vs female: 87/1106 vs 5/1420), while the true diagnosis sex ratio was 2.5:1 (male vs female: 161/1106 vs 84/1420). These data indicate that the sex ratio of reported gonorrhoea incidence has been overestimated by a factor of 7.9 (19.8/2.5). Conclusions We found the current reported gonorrhoea incidence and sex ratios to be inaccurate due to underestimations of gonorrhoea incidence, especially among women. PMID:26975933

  18. Building a knowledge base of severe adverse drug events based on AERS reporting data using semantic web technologies.

    PubMed

    Jiang, Guoqian; Wang, Liwei; Liu, Hongfang; Solbrig, Harold R; Chute, Christopher G

    2013-01-01

    A semantically coded knowledge base of adverse drug events (ADEs) with severity information is critical for clinical decision support systems and translational research applications. However it remains challenging to measure and identify the severity information of ADEs. The objective of the study is to develop and evaluate a semantic web based approach for building a knowledge base of severe ADEs based on the FDA Adverse Event Reporting System (AERS) reporting data. We utilized a normalized AERS reporting dataset and extracted putative drug-ADE pairs and their associated outcome codes in the domain of cardiac disorders. We validated the drug-ADE associations using ADE datasets from SIDe Effect Resource (SIDER) and the UMLS. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the ADEs into the CTCAE in the Web Ontology Language (OWL). We identified and validated 2,444 unique Drug-ADE pairs in the domain of cardiac disorders, of which 760 pairs are in Grade 5, 775 pairs in Grade 4 and 2,196 pairs in Grade 3.

  19. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study

    PubMed Central

    Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient’s trial identification number. Using the patient’s trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. Setting 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Data sources Clinical study reports obtained from the EMA in 2011. Results Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Conclusion Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the

  20. WindVOiCe, a Self-Reporting Survey: Adverse Health Effects, Industrial Wind Turbines, and the Need for Vigilance Monitoring

    ERIC Educational Resources Information Center

    Krogh, Carmen M. E.; Gillis, Lorrie; Kouwen, Nicholas; Aramini, Jeff

    2011-01-01

    Industrial wind turbines have been operating in many parts of the globe. Anecdotal reports of perceived adverse health effects relating to industrial wind turbines have been published in the media and on the Internet. Based on these reports, indications were that some residents perceived they were experiencing adverse health effects. The purpose…

  1. Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

    PubMed

    Du, Dongyi; Goldsmith, John; Aikin, Kathryn J; Encinosa, William E; Nardinelli, Clark

    2012-05-01

    In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

  2. Reported fatal and non-fatal incidents involving tourists in Hawaii Volcanoes National Park, 1992-2002.

    PubMed

    Heggie, Travis W

    2005-08-01

    Objectives. To examine fatal and non-fatal incidents involving tourists in Hawaii Volcanoes National Park. Methods. Official press releases from the public relations office at Hawaii Volcanoes National Park were examined for reports of fatal and non-fatal incidents involving tourists. Results. Between 1992 and 2002 there were 65 press releases reporting 40 fatalities, 45 serious injuries, 53 minor injuries, and 25 no injury events. Severity information was unavailable for four additional tourists. Aircraft and backcountry incidents each accounted for 30% of all incidents followed by road incidents (22%) and frontcountry incidents (17%). Aircraft incidents reported 17 fatalities, backcountry incidents accounted for 10 fatalities, frontcountry incidents reported seven fatalities, and road incidents totaled six fatalities. One fatality was classified as a suicide. Backcountry (23) and road (10) incidents had the highest number of serious incidents. Male tourists (62) were more frequently involved in incidents than female tourists (41) and tourists aged 20-29 years and 40-49 years accounted for the highest number of fatalities and total incidents. Conclusions. Helicopter tours, hiking in areas with active lava flows, falls into steam vents and earthcracks, and driving unfamiliar rental cars in unfamiliar locations are the major activities resulting in death and serious injury. Additional factors such as tourists ignoring warning signs, wandering off-trail or hiking at night, tourists misinformed by guidebooks and other tourists, and tourists with pre-existing heart and asthma conditions are contributing causes in many incidents. The findings of this study provide information that allows prospective tourists, tourism managers, and travel health providers make informed decisions that promote safe tourism and can aid future efforts in developing preventative strategies at tourist destinations with similar environments and activities. However, in order for preventative

  3. New York City Board of Education Division of School Safety: Incident Reporting System Needs To Be Strengthened To Ensure Accurate Reporting of School Safety Incidents, No. A-7-95.

    ERIC Educational Resources Information Center

    New York State Office of the Comptroller, Albany.

    The New York State Board of Education's Division of School Safety is responsible for maintaining a safe and secure environment to ensure that schools are free from disruption. This report presents findings of an audit that investigated whether the division's incident reporting system database accurately captured all school safety incidents that…

  4. VA Health Care: Actions Needed to Assess Decrease in Root Cause Analyses of Adverse Events

    DTIC Science & Technology

    2015-07-01

    VA HEALTH CARE Actions Needed to Assess Decrease in Root Cause Analyses of Adverse Events Report to Congressional...2015 4. TITLE AND SUBTITLE VA Health Care: Actions Needed to Assess Decrease in Root Cause Analyses of Adverse Events 5a. CONTRACT NUMBER 5b...Analyses of Adverse Events Why GAO Did This Study Adverse events are incidents that pose a risk of injury to a patient as the result of a medical

  5. [Suspected adverse reactions after vaccination. Results from the German Health Interview and Examination Survey for Children and Adolescents. Part 2: predictors of parental reporting of suspected adverse reactions after vaccinations].

    PubMed

    Poethko-Müller, C; Atzpodien, K; Schmitz, R; Schlaud, M

    2011-03-01

    Each method to monitor vaccine safety has strengths and limitations. Therefore, vaccine safety monitoring should rely on different types of data sources. Methods commonly rely on patient-reported adverse reactions. Little is, however, known about factors that may affect the probability with which patients report adverse reactions to vaccines. From 2003-2006, the representative National Health Interview and Examination Survey for Children and Adolescents ("Kinder- und Jugendgesundheitssurvey", KiGGS) retrospectively collected information about vaccines, vaccination dates, and suspected vaccine related adverse reactions from a total of 17,641 participants (<17 years). Poorly tolerated vaccinations were more likely reported from parents living in former West Germany compared to former East Germany (OR 1.61; 95% CI 1.08-2.39), parents of children with special health care needs (OR 1.49; 95% CI 1.08-2.04), and from parents reporting reservations against vaccinations (OR 3.29; 95% CI 2.28-4.75). Parental reporting of adverse vaccine reactions appears to be associated with parental perception and assessment of possible adverse vaccine reactions, as well as with the parents' attitude towards immunization in general.

  6. Adverse effects reported in the use of gastroesophageal reflux disease treatments in children: a 10 years literature review.

    PubMed

    Cohen, Shlomi; Bueno de Mesquita, Mirjam; Mimouni, Francis B

    2015-08-01

    Gastroesophageal reflux (GER) is commonly observed in children, particularly during the first year of life. Pharmacological therapy is mostly reserved for symptomatic infants diagnosed with GER disease (GERD), usually as defined in a recent consensus statement. The purpose of the present article was to review the reported adverse effects of pharmacological agents used in the treatment of paediatric GERD. We conducted this review using the electronic journal database Pubmed and Cochrane database systematic reviews using the latest 10-year period (1 January 2003 to 31 December 2012). Our search strategy included the following keywords: omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, rantidine, cimetidine, famotidine, nizatidine, domperidone, metoclopramide, betanechol, erythromycin, baclofen, alginate. We used Pubmed's own filter of: 'child: birth-18 years'. All full articles were reviewed and we only included randomized controlled trials retrieved from our search. We addressed a summary of our search on a drug-by-drug basis with regard to its mechanism of action and clinical applications, and reviewed all of the adverse effects reported and the safety profile of each drug. Adverse effects have been reported in at least 23% of patients treated with histamine H2 receptor antagonists (H2 RAs) and 34% of those treated with proton pump inhibitors (PPIs), and mostly include headaches, diarrhoea, nausea (H2 RAs and PPIs) and constipation (PPIs). Acid suppression may place immune-deficient infants and children, or those with indwelling catheters, at risk for the development of lower respiratory tract infections and nosocomial sepsis. Prokinetic agents have many adverse effects, without major benefits to support their routine use.

  7. Adverse effects reported in the use of gastroesophageal reflux disease treatments in children: a 10 years literature review

    PubMed Central

    Cohen, Shlomi; Bueno de Mesquita, Mirjam; Mimouni, Francis B

    2015-01-01

    Gastroesophageal reflux (GER) is commonly observed in children, particularly during the first year of life. Pharmacological therapy is mostly reserved for symptomatic infants diagnosed with GER disease (GERD), usually as defined in a recent consensus statement. The purpose of the present article was to review the reported adverse effects of pharmacological agents used in the treatment of paediatric GERD. We conducted this review using the electronic journal database Pubmed and Cochrane database systematic reviews using the latest 10-year period (1 January 2003 to 31 December 2012). Our search strategy included the following keywords: omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, rantidine, cimetidine, famotidine, nizatidine, domperidone, metoclopramide, betanechol, erythromycin, baclofen, alginate. We used Pubmed’s own filter of: ’child: birth–18 years’. All full articles were reviewed and we only included randomized controlled trials retrieved from our search. We addressed a summary of our search on a drug-by-drug basis with regard to its mechanism of action and clinical applications, and reviewed all of the adverse effects reported and the safety profile of each drug. Adverse effects have been reported in at least 23% of patients treated with histamine H2 receptor antagonists (H2RAs) and 34% of those treated with proton pump inhibitors (PPIs), and mostly include headaches, diarrhoea, nausea (H2RAs and PPIs) and constipation (PPIs). Acid suppression may place immune-deficient infants and children, or those with indwelling catheters, at risk for the development of lower respiratory tract infections and nosocomial sepsis. Prokinetic agents have many adverse effects, without major benefits to support their routine use. PMID:25752807

  8. Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS).

    PubMed

    Zhang, Xiaoyan; Hamadeh, Issam S; Song, Shuang; Katz, Joseph; Moreb, Jan S; Langaee, Taimour Y; Lesko, Lawrence J; Gong, Yan

    2016-02-01

    Osteonecrosis of the jaw (ONJ) is a serious adverse drug event that was initially reported with intravenous bisphosphonates (BPs) and more recently with other classes of drugs such as receptor activator of NF-κB ligand (RANKL) inhibitor, antiangiogenic agents, and mammalian target of rapamycin (m-TOR) inhibitors. The purpose of this study is to analyze the ONJ cases and the associated drugs in the US Food and Drug Administration's adverse event reporting system (FAERS). The FAERS database was queried for the adverse drug events reported from the first quarter of 2010 to the first quarter of 2014. The reporting odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each queried drug. A total of 17,119 unique ONJ cases were identified. In the overall analysis, the drugs with the highest reporting ORs were BPs: pamidronate (OR = 498.9), zoledronate (OR = 171.7), and alendronate (OR = 63.6), whereas denosumab had lower ORs than all the BPs except for etidronate. The antiangiogenic and m-TOR inhibitors had the lowest ORs. In cancer patients who were treated for prevention of skeletal-related events (SREs), the reporting ORs for zoledronate and denosumab were 125.2 and 4.9, respectively. In patients with osteoporosis, the ORs were 1.1 (1.0-1.18) for zoledronate and 0.63 (0.56-0.70) for denosumab, respectively. Our analysis of the FAERS database showed that the intravenous BPs were associated with the highest risk for ONJ, RANKL inhibitor was associated with risk comparable to BPs used for osteoporosis such as etidronate, and the antiangiogenic agents and m-TOR inhibitors were associated with the lowest risk for ONJ. The high risk for ONJ with zoledronate and denosumab was mainly observed in those who were treated for prevention of SREs, whereas there was limited evidence for such risk in those who were treated for osteoporosis.

  9. Technical evaluation report, AGARD Fluid Dynamics Panel Symposium on Effects of Adverse Weather on Aerodynamics

    NASA Technical Reports Server (NTRS)

    Reinmann, J. J.

    1991-01-01

    The purpose of the meeting on Effects of Adverse Weather on Aerodynamics was to provide an update of the stae-of-the-art with respect to the prediction, simulation, and measurement of the effects of icing, anti-icing fluids, and various precipitation on the aerodynamic characteristics of flight vehicles. Sessions were devoted to introductory and survey papers and icing certification issues, to analytical and experimental simulation of ice frost contamination and its effects of aerodynamics, and to the effects of heavy rain and deicing/anti-icing fluids.

  10. Space shuttle orbit maneuvering engine reusable thrust chamber: Adverse operating conditions test report

    NASA Technical Reports Server (NTRS)

    Tobin, R. D.

    1974-01-01

    Test hardware, facilities, and procedures are described along with results of electrically heated tube and channel tests conducted to determine adverse operating condition limits for convectively cooled chambers typical of Space Shuttle Orbit Manuevering Engine designs. Hot-start tests were conducted with corrosion resistant steel and nickel tubes with both monomethylhydrazine and 50-50 coolants. Helium ingestion, in both bubble and froth form, was studied in tubular test sections. Helium bubble ingestion and burn-out limits in rectangular channels were also investigated.

  11. Mediterranean Diet Reduces the Adverse Effect of the TCF7L2-rs7903146 Polymorphism on Cardiovascular Risk Factors and Stroke Incidence

    PubMed Central

    Corella, Dolores; Carrasco, Paula; Sorlí, Jose V.; Estruch, Ramón; Rico-Sanz, Jesús; Martínez-González, Miguel Ángel; Salas-Salvadó, Jordi; Covas, M. Isabel; Coltell, Oscar; Arós, Fernando; Lapetra, José; Serra-Majem, Lluís; Ruiz-Gutiérrez, Valentina; Warnberg, Julia; Fiol, Miquel; Pintó, Xavier; Ortega-Azorín, Carolina; Muñoz, Miguel Ángel; Martínez, J. Alfredo; Gómez-Gracia, Enrique; González, José I.; Ros, Emilio; Ordovás, José M.

    2013-01-01

    OBJECTIVE Transcription factor 7-like 2 (TCF7L2) polymorphisms are strongly associated with type 2 diabetes, but controversially with plasma lipids and cardiovascular disease. Interactions of the Mediterranean diet (MedDiet) on these associations are unknown. We investigated whether the TCF7L2-rs7903146 (C>T) polymorphism associations with type 2 diabetes, glucose, lipids, and cardiovascular disease incidence were modulated by MedDiet. RESEARCH DESIGN AND METHODS A randomized trial (two MedDiet intervention groups and a control group) with 7,018 participants in the PREvención con DIetaMEDiterránea study was undertaken and major cardiovascular events assessed. Data were analyzed at baseline and after a median follow-up of 4.8 years. Multivariable-adjusted Cox regression was used to estimate hazard ratios (HRs) for cardiovascular events. RESULTS The TCF7L2-rs7903146 polymorphism was associated with type 2 diabetes (odds ratio 1.87 [95% CI 1.62–2.17] for TT compared with CC). MedDiet interacted significantly with rs7903146 on fasting glucose at baseline (P interaction = 0.004). When adherence to the MedDiet was low, TT had higher fasting glucose concentrations (132.3 ± 3.5 mg/dL) than CC+CT (127.3 ± 3.2 mg/dL) individuals (P = 0.001). Nevertheless, when adherence was high, this increase was not observed (P = 0.605). This modulation was also detected for total cholesterol, LDL cholesterol, and triglycerides (P interaction < 0.05 for all). Likewise, in the randomized trial, TT subjects had a higher stroke incidence in the control group (adjusted HR 2.91 [95% CI 1.36–6.19]; P = 0.006 compared with CC), whereas dietary intervention with MedDiet reduced stroke incidence in TT homozygotes (adjusted HR 0.96 [95% CI 0.49–1.87]; P = 0.892 for TT compared with CC). CONCLUSIONS Our novel results suggest that MedDiet may not only reduce increased fasting glucose and lipids in TT individuals, but also stroke incidence. PMID:23942586

  12. Department of the Navy Suicide Incident Report (DONSIR): Summary of Findings, 1999-2007

    DTIC Science & Technology

    2009-03-24

    in body weight (p < .01), with 25 out of 330 decedents evidencing recent change. This is possibly a spurious result based on over- or under- eating ...acute than chronic, with major psychological disorders and physical 1999–2007 DON Suicide Incident Report 35 illnesses less prevalent in comparison...performance histories than other personnel, and that perfectionism may distinguish certain types of suicidal behavior such as completed versus attempted

  13. 45 CFR 60.11 - Reporting adverse actions on clinical privileges.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Board of Medical Examiners—(1) Actions that must be reported and to whom the report must be made. Each health care entity must report to the Board of Medical Examiners in the State in which the health care... practitioners. A health care entity may report to the Board of Medical Examiners information as described...

  14. Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update

    PubMed Central

    Naeem, Farooq; Gire, Nadeem; Xiang, Shuo; Yang, Megan; Syed, Yumeen; Shokraneh, Farhad; Adams, Clive; Farooq, Saeed

    2016-01-01

    Recent years have seen a rapidly increasing trend towards the delivery of health technology through mobile devices. Smartphones and tablet devices are thus becoming increasingly popular for accessing information and a wide range of services, including health care services. Modern mobile apps can be used for a variety of reasons, ranging from education for the patients and assistance to clinicians to delivery of interventions. Mobile phone apps have also been established to benefit patients in a scope of interventions across numerous medical specialties and treatment modalities. Medical apps have their advantages and disadvantages. It is important that clinicians have access to knowledge to make decisions regarding the use of medical apps on the basis of risk-benefit ratio. Mobile apps that deliver psycho social interventions offer unique challenges and opportunities. A number of reviews have highlighted the potential use of such apps. There is a need to describe, report and study their side effects too. The adverse effects associated with these apps can broadly be divided into: (1) those resulting from the security and safety concerns; (2) those arising from the use of a particular psycho social intervention; and (3) those due to the interaction with digital technology. There is a need to refine and reconsider the safety and adverse effects in this area. The safety profile of a mobile PSI app should describe its safety profile in: (1) privacy and security; (2) adverse effects of psychotherapy; and (3) adverse effects unique to the use of apps and the internet. This is, however, a very new area and further research and reporting is required to inform clinical decision making. PMID:27354959

  15. Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update.

    PubMed

    Naeem, Farooq; Gire, Nadeem; Xiang, Shuo; Yang, Megan; Syed, Yumeen; Shokraneh, Farhad; Adams, Clive; Farooq, Saeed

    2016-06-22

    Recent years have seen a rapidly increasing trend towards the delivery of health technology through mobile devices. Smartphones and tablet devices are thus becoming increasingly popular for accessing information and a wide range of services, including health care services. Modern mobile apps can be used for a variety of reasons, ranging from education for the patients and assistance to clinicians to delivery of interventions. Mobile phone apps have also been established to benefit patients in a scope of interventions across numerous medical specialties and treatment modalities. Medical apps have their advantages and disadvantages. It is important that clinicians have access to knowledge to make decisions regarding the use of medical apps on the basis of risk-benefit ratio. Mobile apps that deliver psycho social interventions offer unique challenges and opportunities. A number of reviews have highlighted the potential use of such apps. There is a need to describe, report and study their side effects too. The adverse effects associated with these apps can broadly be divided into: (1) those resulting from the security and safety concerns; (2) those arising from the use of a particular psycho social intervention; and (3) those due to the interaction with digital technology. There is a need to refine and reconsider the safety and adverse effects in this area. The safety profile of a mobile PSI app should describe its safety profile in: (1) privacy and security; (2) adverse effects of psychotherapy; and (3) adverse effects unique to the use of apps and the internet. This is, however, a very new area and further research and reporting is required to inform clinical decision making.

  16. Reporting Crime Victimizations to the Police and the Incidence of Future Victimizations: A Longitudinal Study

    PubMed Central

    Ranapurwala, Shabbar I.; Berg, Mark T.; Casteel, Carri

    2016-01-01

    Background Law enforcement depends on cooperation from the public and crime victims to protect citizens and maintain public safety; however, many crimes are not reported to police because of fear of repercussions or because the crime is considered trivial. It is unclear how police reporting affects the incidence of future victimization. Objective To evaluate the association between reporting victimization to police and incident future victimization. Methods We conducted a retrospective cohort study using National Crime Victimization Survey 2008–2012 data. Participants were 12+ years old household members who may or may not be victimized, were followed biannually for 3 years, and who completed at least one follow-up survey after their first reported victimization between 2008 and 2012. Crude and adjusted generalized linear mixed regression for survey data with Poisson link were used to compare rates of future victimization. Results Out of 18,657 eligible participants, 41% participants reported to their initial victimization to police and had a future victimization rate of 42.8/100 person-years (PY) (95% CI: 40.7, 44.8). The future victimization rate of those who did not report to the police (59%) was 55.0/100 PY (95% CI: 53.0, 57.0). The adjusted rate ratio comparing police reporting to not reporting was 0.78 (95%CI: 0.72, 0.84) for all future victimizations, 0.80 (95% CI: 0.72, 0.90) for interpersonal violence, 0.73 (95% CI: 0.68, 0.78) for thefts, and 0.95 (95% CI: 0.84, 1.07) for burglaries. Conclusions Reporting victimization to police is associated with fewer future victimization, underscoring the importance of police reporting in crime prevention. This association may be attributed to police action and victim services provisions resulting from reporting. PMID:27466811

  17. FDA regulation of dietary supplements and requirements regarding adverse event reporting.

    PubMed

    Frankos, V H; Street, D A; O'Neill, R K

    2010-02-01

    In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to set up a distinct regulatory framework for what we now call dietary supplements. The DSHEA was passed with the intent of striking a balance between providing consumers access to safe dietary supplements to help maintain or improve their health and giving the US Food and Drug Administration (FDA) authority to regulate and take action against manufacturers of supplements or supplement ingredients that present safety problems, are presented with false or misleading claims, or are adulterated or misbranded. This article will present FDA's recent experience in collecting and evaluating dietary supplement adverse event data for the purpose of assuring the public that the dietary supplements they purchase are safe.

  18. Introduction to Pesticide Incidents

    EPA Pesticide Factsheets

    Pesticides incidents must be reported by pesticide registrants. Others, such as members of the public and environmental professionals, would like to report pesticide incidents. This website will explain and facilitate such incident reporting.

  19. Critical Incident Reporting System in Teaching Hospitals in Turkey: A Survey Study

    PubMed Central

    Şalvız, Emine Aysu; Edipoğlu, Saadet İpek; Sungur, Mukadder Orhan; Altun, Demet; Büget, Mehmet İlke; Seyhan, Tülay Özkan

    2016-01-01

    Objective Critical incident reporting systems (CIRS) and morbidity–mortality meetings (MMMs) offer the advantages of identifying potential risks in patients. They are key tools in improving patient safety in healthcare systems by modifying the attitudes of clinicians, nurses and staff (human error) and also the system (human and/or technical error) according to the analysis and the results of incidents. Methods One anaesthetist assigned to an administrative and/or teaching position from all university hospitals (UHs) and training and research hospitals (TRHs) of Turkey (n=114) was contacted. In this survey study, we analysed the facilities of anaesthetists in Turkish UHs and TRHs with respect to CIRS and MMMs and also the anaesthetists’ knowledge, experience and attitudes regarding CIs. Results Anaesthetists from 81 of 114 teaching hospitals replied to our survey. Although 96.3% of anaesthetists indicated CI reporting as a necessity, only 37% of departments/hospitals were reported to have CIRS. True definition of CI as “an unexpected /accidental event” was achieved by 23.3% of anaesthetists with CIRS. MMMs were reported in 60.5% of hospitals. Nevertheless, 96% of anaesthetists believe that CIRS and MMMs decrease the incidence of CI occurring. CI occurrence was attributed to human error as 4 [1–5]/10 and 3 [1–5]/10 in UHs and TRHs, respectively (p=0.005). In both hospital types, technical errors were evaluated as 3 [1–5]/10 (p=0.498). Conclusion This first study regarding CIRS in the Turkish anaesthesia departments/hospitals highlights the lack of CI knowledge and CIRS awareness and use in anaesthesia departments/teaching hospitals in Turkey despite a safety reporting system set up by the Turkish Ministry of Health. PMID:27366560

  20. Incidence of adverse events in antipsychotic-naïve children and adolescents treated with antipsychotic drugs: a French multicentre naturalistic study protocol (ETAPE)

    PubMed Central

    Menard, Marie-Line; Thümmler, Susanne; Giannitelli, Marianna; Olliac, Bertrand; Bonnot, Olivier; Cohen, David; Askenazy, Florence

    2016-01-01

    Introduction In France, over recent years, the prescription rate of antipsychotic (AP) remained stable in children and adolescents. Prescription of second-generation antipsychotics increased, whereas prescription of first-generation antipsychotics decreased. Off-label prescriptions are very frequent in this population. Adverse events (AEs) in youth treated with AP are common and may be severe. AEs have hitherto been poorly monitored in naturalistic studies independent from industry. Method and analysis We describe a French prospective multicentre study in an AP-naïve paediatric population named Etude de la Tolérance des AntiPsychotique chez l'Enfant (ETAPE). The study started in April 2013. So far, 200 patients have been included. The inclusion criteria are: male or female inpatients aged from 6 to 18 years, treated with an AP drug for less than 28 days, never been treated or having received AP for less than 3 months, discontinued at least 6 months prior to inclusion. These assessments of AE are performed at inclusion, as well as at 3, 6, 9 and 12 months after the introduction of the AP. The monitoring period will end in May 2016. Ethics and dissemination The study protocol was approved by the Ethics Committee ‘Sud Méditerrané V’ (number 12.082) and by the French National Agency for Medicines and Health Products Safety (number 2012-004546-15). All patients and their parents signed informed consent on enrolment in the study. We will submit the results of the study to relevant journals and offer national and international presentations. This study will enable better characterisation of the prescription of AP drugs. The results will further help to develop quality standards and recommendations for monitoring AE during the prescription of AP. Trial registration number NCT02007928. PMID:27053275

  1. Food and Drug Administration (FDA) postmarket reported side effects and adverse events associated with pulmonary hypertension therapy in pediatric patients.

    PubMed

    Maxey, Dawn M; Ivy, D Dunbar; Ogawa, Michelle T; Feinstein, Jeffrey A

    2013-10-01

    Because most medications for pediatric pulmonary hypertension (PH) are used off label and based on adult trials, little information is available on pediatric-specific adverse events (AEs). Although drug manufacturers are required to submit postmarket AE reports to the Food and Drug Administration (FDA), this information is rarely transmitted to practitioners. In the setting of a recent FDA warning for sildenafil, the authors sought to give a better description of the AEs associated with current therapies in pediatric PH. In January 2010, a written request was made to the Food and Drug Administration for AE records of commonly used PH medications. Reports were screened for pediatric patients, analyzed in terms of AEs, and compared with the medical literature. Arbitrarily, AEs that could be attributed to concomitant medications were not attributed to the PH medication in question. Adverse events occurring in more than 5 % of events for each drug were assumed to be associated with the targeted PH medication. Between November 1997 and December 2009, 588 pediatric AE reports (death in 257 cases) were reported for the three most commonly used therapies: bosentan, epoprostenol, and sildenafil. Many of the AEs were similar to those reported previously. However, 27 AEs not previously reported in the literature (e.g., pulmonary hemorrhage, hemoptysis, and pneumonia) were found. The FDA postmarket records for PH medications in pediatric patients show a significant number of AEs. The discovery of AEs not previously reported will better inform those caring for these complex and critically ill children, and the large number of deaths suggest they may be underreported in current literature.

  2. Eliciting the child’s voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative

    PubMed Central

    Reeve, Bryce B.; McFatrich, Molly; Pinheiro, Laura C.; Weaver, Meaghann S.; Sung, Lillian; Withycombe, Janice S.; Baker, Justin N.; Mack, Jennifer W.; Waldron, Mia K.; Gibson, Deborah; Tomlinson, Deborah; Freyer, David R.; Mowbray, Catriona; Jacobs, Shana; Palma, Diana; Martens, Christa E.; Gold, Stuart H.; Jackson, Kathryn D.; Hinds, Pamela S.

    2017-01-01

    Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child’s voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child’s/adolescent’s understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were interviewed independently. Results Two rounds of interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive. PMID:27650708

  3. Desensitization and immune tolerance induction in children with severe factor IX deficiency; inhibitors and adverse reactions to replacement therapy: a case-report and literature review.

    PubMed

    Bon, Andrea; Morfini, Massimo; Dini, Alessandro; Mori, Francesca; Barni, Simona; Gianluca, Sottilotta; de Martino, Maurizio; Novembre, Elio

    2015-02-19

    Hemophilia B is a rare X-linked recessive disorder with plasma factor IX (FIX) deficiency. 1-3% of patients treated with exogenous FIX-containing products develop inhibitors (i.e. polyclonal high affinity immunoglobulins) that neutralize the procoagulant activity of a specific coagulation factor. Although the incidence of inhibitors in hemophilia B patients is low, most are "high titer" and frequently associated with the development of severe allergic or anaphylactic reactions. Immune tolerance induction as a strategy for inhibitor eradication was first described in 1984. Unfortunately, the overall reported success of immune tolerance induction in FIX deficiency with inhibitors is approximately 25-40%.We report the case of a 2-year-old boy with hemophilia B severe FIX deficiency (<1%), inhibitor antibodies to FIX development, and a history of adverse reactions to FIX infusions, who underwent a successful desensitization and immune tolerance induction with a daily FIX infusion. With this regimen the inhibitor titer decreased with effective bleeding prevention.

  4. Pulmonary oedema as a suspected adverse drug reaction following vincristine administration to a cat: a case report.

    PubMed

    Polton, Gerry A; Elwood, Clive M

    2008-07-01

    This report describes recurrent respiratory distress following vincristine administration to a cat with chronic lymphocytic leukaemia. The cat was treated with a combination of vincristine, chlorambucil and prednisolone with initial success. After approximately 4 months, dyspnoea developed within 6 h of vincristine administration. Emergency therapy was instituted resulting in a full recovery. Further vincristine was administered; dyspnoea was similarly noted after all but one of these treatments. Dyspnoeic episodes were not attributable to alterations in vincristine dose or method of administration. The repeated temporal association was consistent with a suspected adverse drug reaction to vincristine.

  5. 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

  6. Early Adverse Events and Attrition in SSRI Treatment: A Suicide Assessment Methodology Study (SAMS) Report

    PubMed Central

    Warden, Diane; Trivedi, Madhukar H.; Wisniewski, Stephen R.; Kurian, Benji; Zisook, Sidney; Kornstein, Susan G.; Friedman, Edward S.; Miyahara, Sachiko; Leuchter, Andrew F.; Fava, Maurizio; Rush, John

    2011-01-01

    Adverse events during selective serotonin reuptake inhibitor (SSRI) treatment are frequent and may lead to premature treatment discontinuation. If attrition is associated with early worsening of side effects or the frequency, intensity, or burden of side effects, interventions to maximize retention could be focused on patients with these events. Outpatient participants (n=265) with nonpsychotic major depressive disorder entered an 8-week trial with an SSRI. At baseline and week 2, specific side effects were evaluated with the Systematic Assessment for Treatment Emergent Events – Systematic Inquiry, and at week 2 the Frequency, Intensity, and Burden of Side Effects Rating globally assessed side effects. Attrition was defined by those participants who left treatment after week 2 but before week 8. No specific week 2 side effect, either treatment emergent or with worsening intensity, was independently associated with attrition. Global ratings of side effect frequency, intensity, or burden at week 2 were also not associated with subsequent attrition. Neither global ratings nor specific side effects at week 2 were related to patient attrition during SSRI treatment. Other factors appear to contribute to patient decisions about continuing with treatment. PMID:20473060

  7. [Adverse drug reactions of hydroxymethylglutaryl-CoA reductase inhibitors reported to agency for medicinal products and medical devices].

    PubMed

    Skvrce, Nikica Mirosević; Bozina, Nada; Sarinić, Viola Macolić; Tomić, Sinisa

    2010-01-01

    Hydroxymethylglutaryl-CoA reductase inhibitors (statins) are drugs used in the treatment of chronic diseases and frequently in concomitant therapy with many other drugs. Therefore, the risk of adverse drug reactions (ADRs), especially those caused by interactions is high. Aim of the study was to describe and analyze ADRs caused by statins reported to Croatian Agency from March 2005 to December 2008, and to emphasize reasons of their occurrence. 136 of statin ADRs were reported. 12 % of all reported statins' ADRs were caused by interactions, which is higher than percent (5.6%) of interactions caused by all other drugs in 2005 and 2006. Proportion of serious ADRs related to administered dose and thus preventable was higher than proportion of all ADRs caused by statins (p = 0.003). Most serious ADRs could have been prevented with better understanding of interactions and by use of pharmacogenomics in identifying patients that are because of genetic predisposition more sensitive to standard doses.

  8. Seeking Quality in the Face of Adversity: Fordham Sponsorship Accountability Report, 2008-09

    ERIC Educational Resources Information Center

    Thomas B. Fordham Foundation, 2009

    2009-01-01

    As a charter school sponsor (authorizer), the Thomas B. Fordham Foundation submits an accountability report to the Ohio Department of Education at the end of November each year. The report includes profiles of each Fordham-sponsored school, as well as graphics comparing the achievement data of its schools, their home districts, and statewide…

  9. Abuse liability of flupirtine revisited: implications of spontaneous reports of adverse drug reactions.

    PubMed

    Gahr, Maximilian; Freudenmann, Roland W; Connemann, Bernhard J; Hiemke, Christoph; Schönfeldt-Lecuona, Carlos

    2013-12-01

    Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP's agonistic effects at the GABAA receptor might prime addictive behaviors, and literature provides some anecdotal reports on FLP abuse/dependence. To shed more light on this topic we acquired and evaluated data obtained from a national German pharmacovigilance database. We analyzed all reports of FLP abuse/dependence that were recorded in the database of the German Federal Institute for Drugs and Medical Devices (BfArM). A total of n = 48 reports of FLP abuse/dependence could be identified (mean age 45 years, 62.5% female). First reports were submitted to BfArM in 1991 with increasing numbers of annual reports from the year 2006 on. Mean daily FLP dosage was 805 mg (range 200-3,000 mg). Current or previous substance abuse/dependence was reported in 21% and 17%, respectively. Mean duration of FLP abuse/dependence until report to BfArM was 23 months (range 1-84 months). Withdrawal syndromes after discontinuation of FLP were reported in n = 9 (19%). Our findings strengthen the hypothesis that FLP features a potential to cause addictive behaviors. Female sex, age >40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence.

  10. Attitude of nurses and pharmacists on adverse drug reactions reporting in selected hospitals in Sokoto, Northwest Nigeria

    PubMed Central

    Umar, Muhammad Tukur; Bello, Shaibu Oricha; Chika, Aminu; Oche, Oche Mansur

    2016-01-01

    Objective: Objective of this study was to assess the attitude of nurses and pharmacists towards adverse drug reactions (ADRs) reporting. Methods: The questionnaire was designed based on extended “Inman seven deadly sins.” Two hundred and seventy-two respondents were selected by stratified sampling technique. The questionnaires were delivered to the respondents at their places of practice. The data generated were analyzed by Sigma XL Software Inc. Findings: There was no statistically significant relationship between demographic profiles and reporting attitude except for qualification. On extended “Inman seven deadly sins” awareness of reporting protocol and nearby center for ADRs reporting were low 27.3 and 7.5%, respectively. However, respondents’ score on components of attitude of ADRs reporting is generally encouraging. On comparative basis, no statistical significance exists between pharmacists and nurses. Conclusion: The study showed that attitude of respondents towards ADRs reporting is good. However, there is a need for targeted health education intervention among these cadres of health-care professionals, especially on aspects of awareness of reporting protocol and reporting center. PMID:27512716

  11. Adverse Events Associated with Immune Checkpoint Blockade in Patients with Cancer: A Systematic Review of Case Reports

    PubMed Central

    Abdel-Wahab, Noha; Shah, Mohsin; Suarez-Almazor, Maria E.

    2016-01-01

    Background Three checkpoint inhibitor drugs have been approved by the US Food and Drug Administration for use in specific types of cancers. While the results are promising, severe immunotherapy-related adverse events (irAEs) have been reported. Objectives To conduct a systematic review of case reports describing the occurrence of irAEs in patients with cancer following checkpoint blockade therapy, primarily to identify potentially unrecognized or unusual clinical findings and toxicity. Data Sources We searched Medline, EMBASE, Web of Science, PubMed ePubs, and Cochrane CENTRAL with no restriction through August 2015. Study Selection Studies reporting cases of cancer develop irAEs following treatment with anti CTLA-4 (ipilimumab) or anti PD-1 (nivolumab or pembrolizumab) antibodies were included. Data Extraction We extracted data on patient characteristics, irAEs characteristics, how irAEs were managed, and their outcomes. Data Synthesis 191 publications met inclusion criteria, reporting on 251 cases. Most patients had metastatic melanoma (95.6%), and the majority were treated with ipilimumab (93.2%). Autoimmune colitis, hepatitis, endocrinopathies, and cutaneous irAEs were the most frequently reported irAEs in ipilimumab treated patients. A broad spectrum of toxicities were reported for almost every body system. Moreover, well-defined diseases such as sarcoidosis, polyarthritis, polymyalgia rheumatica/arteritis, lupus, celiac disease, dermatomyositis, and Vogt-Koyanagi-like syndrome were reported. The most frequent irAEs reported with anti-PD1 agents were dermatitis for pembrolizumab, and thyroid disease and pneumonitis for nivolumab. Complete resolution of adverse events occurred in most cases. However, persistent irAEs and death were reported, mainly in patients treated with ipilimumab. Limitations Our study is limited by information available in the original reports. Conclusions Evidence from case reports shows that cancer patients develop irAEs following

  12. Patient-Safety-Related Hospital Deaths in England: Thematic Analysis of Incidents Reported to a National Database, 2010–2012

    PubMed Central

    Donaldson, Liam J.; Panesar, Sukhmeet S.; Darzi, Ara

    2014-01-01

    Background Hospital mortality is increasingly being regarded as a key indicator of patient safety, yet methodologies for assessing mortality are frequently contested and seldom point directly to areas of risk and solutions. The aim of our study was to classify reports of deaths due to unsafe care into broad areas of systemic failure capable of being addressed by stronger policies, procedures, and practices. The deaths were reported to a patient safety incident reporting system after mandatory reporting of such incidents was introduced. Methods and Findings The UK National Health Service database was searched for incidents resulting in a reported death of an adult over the period of the study. The study population comprised 2,010 incidents involving patients aged 16 y and over in acute hospital settings. Each incident report was reviewed by two of the authors, and, by scrutinising the structured information together with the free text, a main reason for the harm was identified and recorded as one of 18 incident types. These incident types were then aggregated into six areas of apparent systemic failure: mismanagement of deterioration (35%), failure of prevention (26%), deficient checking and oversight (11%), dysfunctional patient flow (10%), equipment-related errors (6%), and other (12%). The most common incident types were failure to act on or recognise deterioration (23%), inpatient falls (10%), healthcare-associated infections (10%), unexpected per-operative death (6%), and poor or inadequate handover (5%). Analysis of these 2,010 fatal incidents reveals patterns of issues that point to actionable areas for improvement. Conclusions Our approach demonstrates the potential utility of patient safety incident reports in identifying areas of service failure and highlights opportunities for corrective action to save lives. Please see later in the article for the Editors' Summary PMID:24959751

  13. Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    PubMed

    Kluetz, Paul G; Chingos, Diana T; Basch, Ethan M; Mitchell, Sandra A

    2016-01-01

    Systematic capture of the patient perspective can inform the development of new cancer therapies. Patient-reported outcomes (PROs) are commonly included in cancer clinical trials; however, there is heterogeneity in the constructs, measures, and analytic approaches that have been used making these endpoints challenging to interpret. There is renewed effort to identify rigorous methods to obtain high-quality and informative PRO data from cancer clinical trials. In this setting, PROs are used to address specific research objectives, and an important objective that spans the product development life cycle is the assessment of safety and tolerability. The U.S. Food and Drug Administration's (FDA) Office of Hematology and Oncology Products (OHOP) has identified symptomatic adverse events (AEs) as a central PRO concept, and a systematic assessment of patient-reported symptomatic AEs can provide data to complement clinician reporting. The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being evaluated by multiple stakeholders, including the FDA, and is considered a promising tool to provide a standard yet flexible method to assess symptomatic AEs from the patient perspective. In this article, we briefly review the FDA OHOP's perspective on PROs in cancer trials submitted to the FDA and focus on the assessment of symptomatic AEs using PRO-CTCAE. We conclude by discussing further work that must be done to broaden the use of PRO-CTCAE as a method to provide patient-centered data that can complement existing safety and tolerability assessments across cancer clinical trials.

  14. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability AGENCY... for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance..., biologics, medical devices, and dietary supplements during an influenza pandemic. The agency...

  15. 77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability AGENCY... Medical Products and Dietary Supplements During an Influenza Pandemic.'' The guidance discusses FDA's... devices, and dietary supplements during an influenza pandemic. The Agency makes recommendations...

  16. Abuse of methylphenidate in Germany: data from spontaneous reports of adverse drug reactions.

    PubMed

    Gahr, Maximilian; Freudenmann, Roland W; Hiemke, Christoph; Kölle, Markus A; Schönfeldt-Lecuona, Carlos

    2014-01-30

    To retrieve insights into abuse/dependence of methylphenidate (MPH) in Germany, a query of a pharmacovigilance database was performed (observation interval: 1993 until 2012). From 1190 reports of any ADR related to MPH, n=23 (2%) cases of MPH abuse were identified (mean age 29 years; male sex 78%; mean daily MPH-dosage 111 ± 126.6 mg). As oral application was predominant (70%), the majority of reported cases of MPH abuse might be due to pharmacologic neuroenhancement.

  17. [Adverse event reporting in an intensive care unit at Tunja, Colombia].

    PubMed

    Riveros, Efraín; Amado, Paula; Zambrano, Paula

    2013-01-01

    Introducción: La seguridad de paciente en áreas hospitalarias críticas ha sido tema de diversas investigaciones. En este sentido, en Colombia está creciendo la conciencia acerca de la gestión de eventos adversos. Este estudio explora la primera fase de dicha gestión: el reporte en la unidad de cuidado intensivo de una institución privada prototipo. Objetivo: Evaluar el reporte de eventos adversos en una clínica colombiana de tercer nivel, a través de la estimación de frecuencias y categorías de los reportes. Material y Métodos: Se hizo un estudio descriptivo sobre la tasa de reporte de eventos adversos en la Clínica de los Andes de Tunja, durante 2011, a través de la estimación de frecuencias y categorías de los reportes.La tasa de reporte se definió como el número de reportes por 1000 días cama. Reportamos las categorías de los eventos adversos comomayores y menores. Resultados: Se registraron 383 admisiones a la UCI, correspondientes a 2374 días paciente. Se presentaron un total de 54 eventos adversos reportados (tasa de 22,74 por 1000 días paciente). El tipo de evento más frecuente fue el relacionado con vías intravenosas (55%)(IC 95% 50,1-58,3), seguido por desviación de procesos (22%)(IC 95% 18,2-26,1). Conclusiones: Se encontróuna tasa de reporte de eventos adversos en el rango superior de lo publicado en la literatura. Posiblemente exista aúnuna proporción no cuantificada de subregistro, que puede atribuirse principalmente a factores culturales.

  18. Pesticide Exposure and Self-Reported Incident Depression among Wives in the Agricultural Health Study

    PubMed Central

    Beard, John D.; Hoppin, Jane A.; Richards, Marie; Alavanja, Michael C. R.; Blair, Aaron; Sandler, Dale P.; Kamel, Freya

    2013-01-01

    Background Depression in women is a public health problem. Studies have reported positive associations between pesticides and depression, but few studies were prospective or presented results for women separately. Objectives We evaluated associations between pesticide exposure and incident depression among farmers’ wives in the Agricultural Health Study, a prospective cohort study in Iowa and North Carolina. Methods We used data on 16,893 wives who did not report physician-diagnosed depression at enrollment (1993-1997) and who completed a follow-up telephone interview (2005-2010). Among these wives, 1,054 reported physician diagnoses of depression at follow-up. We collected information on potential confounders and on ever use of any pesticide, 11 functional and chemical classes of pesticides, and 50 specific pesticides by wives and their husbands via self-administered questionnaires at enrollment. We used inverse probability weighting to adjust for potential confounders and to account for possible selection bias induced by the death or loss of 10,639 wives during follow-up. We used log-binomial regression models to estimate risk ratios and 95% confidence intervals. Results After weighting for age at enrollment, state of residence, education level, diabetes diagnosis, and not dropping out of the cohort, wives’ incident depression was positively associated with diagnosed pesticide poisoning, but was not associated with ever using any pesticide. Use of individual pesticides or functional or chemical classes of pesticides was generally not associated with wives’ depression. Among wives who never used pesticides, husbands’ ever use of individual pesticides or functional or chemical classes of pesticides was generally not associated with wives’ incident depression. Conclusions Our study adds further evidence that high level pesticide exposure, such as pesticide poisoning, is associated with increased risk of depression and sets a lower bound on the level of

  19. Adverse drug reactions reporting : Knowledge and opinion of general public in Penang, Malaysia

    PubMed Central

    Elkalmi, Ramadan; Hassali, Mohamed Azmi; Al-lela, Omar Qutaiba; Jawad Awadh, Ammar Ihsan; Al-Shami, Abdul Kareem; Jamshed, Shazia Qasim

    2013-01-01

    Objective: The objective of this study was to explore the knowledge of the general population towards ADR and their reporting system. Methods: An anonymous, self-administered questionnaire (15 items) was designed. The questionnaire was subjected to face validity and content validity. The reliability coefficient was found to be 0.71. This study recruited proportionately large convenience sample of the general public in Penang. Interviews using a structured questionnaire were conducted over a week period in August 2009. The recommended sample size was calculated to be 368. Results: Three hundred thirty-four responses were received. Slightly more than half of the respondents were in the age group of 18-25 years (53.6%; n = 179). When asked about the sources of their medication majority of them reported medical doctor (85.6%), whereas small number (34.7%) reported community pharmacists as sources of medications. Three-quarter of the respondents (77.2%) get their information about the side-effects of drugs from physicians, followed by pharmacist (44.6%). More than half of the respondents (65.6%, n = 219) reported unawareness about the existence of ADR center set up by the Ministry of Health. Conclusion: Respondents reflected inadequate knowledge on ADR reporting. This needs to be corrected as the trend of future pharmacovigilance is toward the patient. Moreover, the new trend seems to be more appropriate as the patient is the group of the people who are directly affected from the ADR of a particular drug and not the health-care providers. Furthermore, the patient will be informed about the economic implications of not reporting ADR. It is recommended that government agencies, like MADRAC needs to find ways to increase patient- reported ADR cases. PMID:24082699

  20. Report: EPA Could Improve Processes for Managing Contractor Systems and Reporting Incidents

    EPA Pesticide Factsheets

    Report #2007-P-00007, January 11, 2007. Although EPA had defined the specific requirements for contractor systems, EPA had not established procedures to ensure identification of all contractor systems.

  1. Assessing the predictive value of the rodent neurofunctional assessment for commonly reported adverse events in phase I clinical trials.

    PubMed

    Mead, Andy N; Amouzadeh, Hamid R; Chapman, Kathryn; Ewart, Lorna; Giarola, Alessandra; Jackson, Samuel J; Jarvis, Philip; Jordaan, Pierre; Redfern, Will; Traebert, Martin; Valentin, Jean-Pierre; Vargas, Hugo M

    2016-10-01

    Central Nervous System (CNS)-related safety concerns are major contributors to delays and failure during the development of new candidate drugs (CDs). CNS-related safety data on 141 small molecule CDs from five pharmaceutical companies were analyzed to identify the concordance between rodent multi-parameter neurofunctional assessments (Functional Observational Battery: FOB, or Irwin test: IT) and the five most common adverse events (AEs) in Phase I clinical trials, namely headache, nausea, dizziness, fatigue/somnolence and pain. In the context of this analysis, the FOB/IT did not predict the occurrence of these particular AEs in man. For AEs such as headache, nausea, dizziness and pain the results are perhaps unsurprising, as the FOB/IT were not originally designed to predict these AEs. More unexpected was that the FOB/IT are not adequate for predicting 'somnolence/fatigue' nonclinically. In drug development, these five most prevalent AEs are rarely responsible for delaying or stopping further progression of CDs. More serious AEs that might stop CD development occurred at too low an incidence rate in our clinical dataset to enable translational analysis.

  2. Contribution of Therapeutic Monitoring in the Assessment of Toxic Adverse Effects of Mitotane: a Case Report.

    PubMed

    Jebabli, Nadia; Gaïes, Emna; Eljebari, Hanen; Charfi, Rim; Lakhal, Mohamed; Klouz, Anis; Salouage, Issam; Trabelsi, Sameh

    2015-01-01

    Mitotane provided serious side effects and low doses seemed to be tolerated. Determination of mitotane concentration in plasma is recommended. We report the case of toxic plasma levels with low doses of mitotane in a 47-year-old man with adrenocortical cancer.

  3. Accounting for multiplicity in the evaluation of "signals" obtained by data mining from spontaneous report adverse event databases.

    PubMed

    Gould, A Lawrence

    2007-02-01

    Surveillance of drug products in the marketplace continues after approval, to identify rare potential toxicities that are unlikely to have been observed in the clinical trials carried out before approval. This surveillance accumulates large numbers of spontaneous reports of adverse events along with other information in spontaneous report databases. Recently developed empirical Bayes and Bayes methods provide a way to summarize the data in these databases, including a quantitative measure of the strength of the reporting association between the drugs and the events. Determining which of the particular drug-event associations, of which there may be many tens of thousands, are real reporting associations and which random noise presents a substantial problem of multiplicity because the resources available for medical and epidemiologic followup are limited. The issues are similar to those encountered with the evaluation of microarrays, but there are important differences. This report compares the application of a standard empirical Bayes approach with micorarray-inspired methods for controlling the False Discovery Rate, and a new Bayesian method for the resolution of the multiplicity problem to a relatively small database containing about 48,000 reports. The Bayesian approach appears to have attractive diagnostic properties in addition to being easy to interpret and implement computationally.

  4. 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 Central

    2015-01-01

    Background 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. Methods 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. Findings 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

  5. Cross-sectional study exploring barriers to adverse drug reactions reporting in community pharmacy settings in Dhaka, Bangladesh

    PubMed Central

    Amin, Mohammad Nurul; Khan, Tahir Mehmood; Dewan, Syed Masudur Rahman; Islam, Mohammad Safiqul; Moghal, Mizanur Rahman

    2016-01-01

    Objectives To assess community pharmacists'/pharmacy technicians' knowledge and perceptions about adverse drug reactions (ADRs) and barriers towards the reporting of such reactions in Dhaka, Bangladesh. Method A cross-sectional study was planned to approach potential respondents for the study. A self-administered questionnaire was delivered to community pharmacists/pharmacy technicians (N=292) practising in Dhaka, Bangladesh. Results The overall response to the survey was 69.5% (n=203). The majority of the sample was comprised of pharmacy technicians (152, 74.9%) who possessed a diploma in pharmacy, followed by pharmacists (37, 18.2%) and others (12, 5.9%). Overall, 72 (35.5%) of the respondents disclosed that they had experienced an ADR at their pharmacy, yet more than half (105, 51.7%) were not familiar with the existence of an ADR reporting body in Bangladesh. Exploring the barriers to the reporting of ADRs, it was revealed that the top four barriers to ADR reporting were ‘I do not know how to report (Relative Importance Index (RII)=0.998)’, ‘reporting forms are not available (0.996)’, ‘I am not motivated to report (0.997)’ and ‘Unavailability of professional environment to discuss about ADR (RII=0.939)’. In addition to these, a majority (141, 69.46%) were not confident about the classification of ADRs (RII=0.889) and were afraid of legal liabilities associated with reporting ADRs (RII=0.806). Moreover, a lack of knowledge about pharmacotherapy and the detection of ADRs was another major factor hindering their reporting (RII=0.731). Conclusions The Directorate of Drug Administration in Bangladesh needs to consider the results of this study to help it improve and simplify ADR reporting in Bangladeshi community pharmacy settings. PMID:27489151

  6. Understanding patient-to-worker violence in hospitals: a qualitative analysis of documented incident reports

    PubMed Central

    Arnetz, Judith E.; Hamblin, Lydia; Essenmacher, Lynnette; Upfal, Mark J.; Ager, Joel; Luborsky, Mark

    2016-01-01

    Aim To explore catalysts to, and circumstances surrounding, patient-to-worker violent incidents recorded by employees in a hospital system database. Background Violence by patients towards healthcare workers (Type II workplace violence) is a significant occupational hazard in hospitals worldwide. Studies to date have failed to investigate its root causes due to a lack of empirical research based on documented episodes of patient violence. Design Qualitative content analysis. Methods Content analysis was conducted on the total sample of 214 Type II incidents documented in 2011 by employees of an American hospital system with a centralized reporting system. Findings The majority of incidents were reported by nurses (39·8%), security staff (15·9%) and nurse assistants (14·4%). Three distinct themes were identified from the analysis: Patient Behaviour, Patient Care and Situational Events. Specific causes of violence related to Patient Behaviour were cognitive impairment and demanding to leave. Catalysts related to patient care were the use of needles, patient pain/discomfort and physical transfers of patients. Situational factors included the use/presence of restraints; transitions in the care process; intervening to protect patients and/or staff; and redirecting patients. Conclusions Identifying catalysts and situations involved in patient violence in hospitals informs administrators about potential targets for intervention. Hospital staff can be trained to recognize these specific risk factors for patient violence and can be educated in how to best mitigate or prevent the most common forms of violent behaviour. A social–ecological model can be adapted to the hospital setting as a framework for prevention of patient violence towards staff. PMID:25091833

  7. How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review

    PubMed Central

    Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

    2015-01-01

    Context Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however, little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. Methods Our systematic literature review identified 2 groups of studies: (1) those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. Findings In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures, and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. Conclusions The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and led by clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs. PMID:26626987

  8. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting

    PubMed Central

    Kharkar, Mala; Bowalekar, Suresh

    2012-01-01

    Objective: The objective was to assess knowledge, attitude and perceptions/practices (KAP) of medical practitioners (MPs) in India towards Adverse Drug Reaction (ADR) reporting. Materials and Methods: A questionnaire was designed for assessment of KAP of medical practitioners in India toward ADR reporting. This questionnaire was administered to 2-3 medical practitioners from each zone prior to administering final questionnaire which was approved by Disha Independent Ethics Committee, Mumbai. 1200 medical practitioners (about 300 from each zone) from India were selected randomly. Results: 1000 medical practitioners out of 1200 (90%), selected at random were approached. A total of 870 provided responses to the questionnaire, giving a response rate of 73% of 1200 selected randomly. A total of 47.5% respondents reported that they were aware of Government ADR centers. A total of 59.2% reported that they are familiar with the procedure of reporting ADRs to Government centers. However, only 18.5% of MPs have reported the observed ADRs to Government ADR centers. As against this relatively large number of MPs (87.9%) have reported ADRs observed during their routine practice to medical representatives of pharmaceutical company and NGOs (non-Govt. Organizations). A total of 80.5% of respondents agreed that safety plays an important role and 96% reported that ADR centers are useful. However, only 55.6% of respondents have reported that there is a need for ADR centers. Conclusion: The study reveals that practitioners are aware of ADR reporting; their perception toward ADR reporting is right but it is not reflected when it comes to the act of reporting of ADRs. In our sample of 870 respondents only 18.5 % reported ADRs to some organizations. Only 5% of respondents recorded the details of ADR and reported to the manufacturer and 1% of respondents to government health ministry. Thus, medical practitioners in India appear to have a good knowledge about ADR reporting, the right

  9. A critical evaluation of reports associating ayahuasca with life-threatening adverse reactions.

    PubMed

    dos Santos, Rafael Guimarāes

    2013-01-01

    Ayahuasca is a botanical hallucinogenic preparation traditionally consumed by Northwestern Amazonian indigenous groups. Scientific evidence suggests good tolerability after acute administration of ayahuasca and also after years or even decades of its ritual consumption. Nevertheless, some scientific and media reports associate ayahuasca or some of its alkaloids with severe intoxications. The purpose of the present text is to do a critical evaluation of these reports. The evaluation of the cases highlights the fact that some lack accurate forensic/toxicological information, while others are not directly relevant to traditional ayahuasca preparations. These limitations reduce the possibility of an accurate risk assessment, which could indicate potential contraindications and susceptibilities for ayahuasca consumption. Nevertheless, even with these limitations, the cases suggest that previous cardiac and hepatic pathologies and current use of serotonergic drugs/medications are contraindications to ayahuasca use, and that caution should be taken when using different botanical species and extracted/synthetic alkaloids to prepare ayahuasca analogues.

  10. 30 CFR 585.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... report them? 585.831 Section 585.831 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY AND ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER... person(s) from the facility to shore or to another offshore facility; (3) Fires and explosions;...

  11. 30 CFR 585.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... report them? 585.831 Section 585.831 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY AND ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER... person(s) from the facility to shore or to another offshore facility; (3) Fires and explosions;...

  12. 30 CFR 585.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... report them? 585.831 Section 585.831 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY AND ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER... person(s) from the facility to shore or to another offshore facility; (3) Fires and explosions;...

  13. Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination.

    PubMed

    Parretta, Elisabetta; Ianniello, Benedetta; Ferrazin, Fernanda; Rossi, Francesco; Capuano, Annalisa

    2011-05-09

    According to European recommendations, the Italian Medicines Agency (AIFA) required close monitoring of the safety of the MF59-adjuvanted H1N1v vaccine, which was the only vaccine available in Italy for prophylaxis of the A/H1N1 (2009) pandemic influenza. From October 2009 to June 2010, the Italian Pharmacovigilance Adverse Event (AE) Spontaneous Reporting System [Rete Nazionale Farmacovigilanza] (RNF) received 1330 reports of AEs temporally related with the pandemic influenza vaccination out of a total of 924,057 doses administered. Among these, 1,162 (87.37%) AE reports were classified 'non serious', 91 (6.84%) 'serious', 3 (0.23%) had a fatal outcome and 74 (5.56%) did not include the degree of seriousness. Among the serious AE reports, some unexpected AEs emerged. Even though some typical vaccine safety issues which emerged should be further explored, such as vaccination in pregnancy, the analysis of all AE reports sent to RNF shows that the vaccine has a well-tolerated safety profile which resembles that of the already available seasonal influenza vaccines. This contrasts with the widespread public concern about its safety, which has been one of the major causes of the low vaccination rate observed in Italy, as well as in other countries.

  14. How will we get the data and what will we do with it then? Issues in the reporting of adverse healthcare events

    PubMed Central

    Johnson, C

    2003-01-01

    Incident reporting has been proposed as an important means of identifying and addressing the causes of human error in medicine, and initiatives to implement these schemes have been set up in many countries. However, incident reporting has its limitations. Many people have been too ready to believe the overstated claims about the effectiveness of incident reporting in other domains. Others have not listened to the more limited claims made by the operators of existing systems in aviation and in organizational health and safety applications. This paper argues that more attention should be paid to the problems of eliciting incident reports from a broad spectrum of healthcare workers. It is also argued that more sophisticated computation support should be recruited so that clinicians do not have to learn complex command languages when they want to search for common factors in those incidents that are submitted. PMID:14645898

  15. Reported incidence of occupational asthma in France, 1996–99: the ONAP programme

    PubMed Central

    Ameille, J; Pauli, G; Calastreng-Crinqu..., A; Vervloet, D; Iwatsubo, Y; Popin, E; Bayeux-Dunglas, M; Kopferschmitt-Kub..., M

    2003-01-01

    Aims: To estimate the general and specific incidence of occupational asthma in France in 1996–99; and to describe the distribution of cases by age, sex, suspected causal agents, and occupation. Methods: New cases of occupational asthma were collected by a national surveillance programme, based on voluntary reporting, named Observatoire National des Asthmes Professionnels (ONAP), involving a network of occupational and chest physicians. For each case, the reporting form included information on age, sex, location of workplace, occupation, suspected causal agent, and methods of diagnosis. Estimates of the working population, used to calculate incidence rates by age, sex, region, and occupation, were obtained from the Institut National de la Statistique et des Etudes Economiques (INSEE) and from the French Securite Sociale statistics. Results: In 1996–99, 2178 cases of occupational asthma were reported to the ONAP, giving a mean annual rate of 24/million. Rates in men were higher than rates in women (27/million versus 19/million). The highest rate was observed in the 15–29 years age group (30/million). The most frequently incriminated agents were flour (20.3%), isocyanates (14.1%), latex (7.2%), aldehyde (5.9%), persulphate salts (5.8%), and wood dusts (3.7%). The highest risks of occupational asthma were found in bakers and pastry makers (683/million), car painters (326/million), hairdressers (308/million), and wood workers (218/million). Conclusion: Despite likely underreporting, the number of cases of occupational asthma reported to the ONAP was approximately twice the number of compensated cases over the same period. The relevance of the programme is confirmed by the reproducibility of the results year after year, and its consistency with other surveillance programmes. The ONAP programme is useful for the identification of targets for primary prevention. PMID:12554842

  16. Nutravigilance: principles and practices to enhance adverse event reporting in the dietary supplement and natural products industry.

    PubMed

    Schmitz, Stephen M; Lopez, Hector L; MacKay, Douglas

    2014-03-01

    Nutravigilance is defined as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects related to the use of a food, dietary supplement, or medical food". The nutravigilance approach is derived from well-defined principles of pharmacovigilance in the drug and biologics industries, which have been developed and refined over a number of years through expert recommendations. While the primary purpose of nutravigilance is to protect customer/patient safety, it also serves to reduce product liability risks for manufacturers and marketing agents of such products. Compliance with the current FDA adverse event reporting requirements is suboptimal, and FDA oversight and enforcement activities have recently increased. In order to better protect customer and product safety, dietary supplement manufacturers must significantly change their current approach, and demonstrate a proactive, systematic, risk-based, scientific approach to product safety, similar to one utilized successfully in the pharmaceutical industry. While this article focuses on FDA regulations, the principles are widely relevant to the supplement industry in the rest of the world.

  17. "You just don't report that kind of stuff": investigating teens' ambivalence toward peer-perpetrated, unwanted sexual incidents.

    PubMed

    Weiss, Karen G

    2013-01-01

    An investigation of narratives from the National Crime Victimization Survey (NCVS) finds that one in three teenagers--12-18 years old--who experience an unwanted sexual incident perpetrated by another teen trivialize their incidents as minor, unimportant, or normal kid stuff. This study contextualizes these responses within a framework of ambivalence that highlights separately teens' ambiguity of definitions, or uncertainty that incidents perpetrated by other teens (especially dating partners and schoolmates) are "real" crimes or offenses worth reporting, and adaptive indifference, a more tactical response to conflicting norms and allegiances that discourage teens from reporting their peers' sexual misconduct to authorities. The context and consequences of teens' ambivalence are discussed.

  18. Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association

    PubMed Central

    2012-01-01

    Background The new European pharmacovigilance legislation has been suggested as marking the beginning of a new chapter in drug safety, making patients an important part of pharmacovigilance. In Sweden since 2008 it has been possible for consumers to report adverse drug reactions (ADRs) to the Medical Products Agency (MPA), and these reports are now understood as an increasingly valuable contribution in the monitoring of safety aspects in medicines. Already in 2002 it was possible to report experiences with medicines to the non-profit and independent organization Consumer Association for Medicines and Health (KILEN) through a web-based report form with an opportunity to describe ADR experiences in free text comments. The aim of this study was to qualitatively analyze the free text comments appended to consumer reports on antidepressant medication. Methods All reports of suspected adverse reactions regarding antidepressant medications submitted from January 2002 to April 2009 to KILEN’s Internet-based reporting system in Sweden were analyzed according to reported narrative experience(s). Content analysis was used to interpret the content of 181 reports with free text comments. Results Three main categories emerged from the analyzed data material: (1) Experiences of drug treatment with subcategories (a) Severe psychiatric adverse reactions, and (b) Discontinuation symptoms; (2) Lack of communication and (3) Trust and distrust. A majority of the reports to KILEN were from patients experiencing symptoms of mental disturbances (sometimes severe) affecting them in many different ways, especially during discontinuation. Several report included narratives of patients not receiving information of potential ADRs from their doctor, but also that there were no follow-ups of the treatment. Trust was highlighted as especially important and some patients reported losing confidence in their doctor when they were not believed about the suspected ADRs they experienced, making them

  19. Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the Atmospheric Environment Safety Technology Project

    NASA Technical Reports Server (NTRS)

    Withrow, Colleen A.; Reveley, Mary S.

    2014-01-01

    This study analyzed aircraft incidents in the NASA Aviation Safety Reporting System (ASRS) that apply to two of the three technical challenges (TCs) in NASA's Aviation Safety Program's Atmospheric Environment Safety Technology Project. The aircraft incidents are related to airframe icing and atmospheric hazards TCs. The study reviewed incidents that listed their primary problem as weather or environment-nonweather between 1994 and 2011 for aircraft defined by Federal Aviation Regulations (FAR) Parts 121, 135, and 91. The study investigated the phases of flight, a variety of anomalies, flight conditions, and incidents by FAR part, along with other categories. The first part of the analysis focused on airframe-icing-related incidents and found 275 incidents out of 3526 weather-related incidents over the 18-yr period. The second portion of the study focused on atmospheric hazards and found 4647 incidents over the same time period. Atmospheric hazards-related incidents included a range of conditions from clear air turbulence and wake vortex, to controlled flight toward terrain, ground encounters, and incursions.

  20. 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

  1. Neurosyphilis presenting with dementia, chronic chorioretinitis and adverse reactions to treatment: a case report

    PubMed Central

    Raycheva, Margarita Radoslavova; Petrova, Elena Petrova; Tsankov, Nikolay Konstantinov; Traykov, Latchezar Dintchov

    2009-01-01

    Neurosyphilis results from infection of the brain, meninges or spinal cord by Treponema pallidum and develops in about 25%-40% of persons who are not treated for syphilis. This article reports a rare case of active neurosyphilis with mild dementia, chronic chorioretinitis, and hearing loss. During the treatment with Penicillin, a rare combination of complications such as Jarisch-Herxheimer and Hoigné reactions were observed. The clinical feature is characterized by a slow progressive cognitive decline and behavior changes for the last 2 years. Neuropsychological examination revealed mild dementia (MMSE = 23) with impaired memory and attention and executive function. Left sided chronic chorioretinitis and hearing loss were documented. High dose intravenous penicillin therapy was complicated by Jarisch-Herxheimer and Hoigne reactions. During the follow up examinations at 6 and 12 months, the clinical signs, neuropsychological examination, and cerebrospinal fluid (CFS) samples showed improvement of dementia, CSF findings, and hydrocephalus. In conclusion, this atypical presentation of neurosyphilis in combination with rare complications of treatment is worthy of attention. Neurosyphilis should be part of the differential diagnosis of each patient showing cognitive deterioration and behaviour disturbances. PMID:19918420

  2. Finding clusters of similar events within clinical incident reports: a novel methodology combining case based reasoning and information retrieval

    PubMed Central

    Tsatsoulis, C; Amthauer, H

    2003-01-01

    A novel methodological approach for identifying clusters of similar medical incidents by analyzing large databases of incident reports is described. The discovery of similar events allows the identification of patterns and trends, and makes possible the prediction of future events and the establishment of barriers and best practices. Two techniques from the fields of information science and artificial intelligence have been integrated—namely, case based reasoning and information retrieval—and very good clustering accuracies have been achieved on a test data set of incident reports from transfusion medicine. This work suggests that clustering should integrate the features of an incident captured in traditional form based records together with the detailed information found in the narrative included in event reports. PMID:14645892

  3. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice

    PubMed Central

    Carson-Stevens, Andrew; Hibbert, Peter; Avery, Anthony; Butlin, Amy; Carter, Ben; Cooper, Alison; Evans, Huw Prosser; Gibson, Russell; Luff, Donna; Makeham, Meredith; McEnhill, Paul; Panesar, Sukhmeet S; Parry, Gareth; Rees, Philippa; Shiels, Emma; Sheikh, Aziz; Ward, Hope Olivia; Williams, Huw; Wood, Fiona; Donaldson, Liam; Edwards, Adrian

    2015-01-01

    Introduction Incident reports contain descriptions of errors and harms that occurred during clinical care delivery. Few observational studies have characterised incidents from general practice, and none of these have been from the England and Wales National Reporting and Learning System. This study aims to describe incidents reported from a general practice care setting. Methods and analysis A general practice patient safety incident classification will be developed to characterise patient safety incidents. A weighted-random sample of 12 500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified. Insights from exploratory descriptive statistics and thematic analysis will be combined to identify priority areas for future interventions. Ethics and dissemination The need for ethical approval was waivered by the Aneurin Bevan University Health Board research risk review committee given the anonymised nature of data (ABHB R&D Ref number: SA/410/13). The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers. PMID:26628526

  4. A Laboratory Critical Incident and Error Reporting System for Experimental Biomedicine

    PubMed Central

    Dirnagl, Ulrich; Przesdzing, Ingo; Kurreck, Claudia; Major, Sebastian

    2016-01-01

    We here propose the implementation of a simple and effective method to enhance the quality of basic and preclinical academic research: critical incident reporting (CIR). CIR has become a standard in clinical medicine but to our knowledge has never been implemented in the context of academic basic research. We provide a simple, free, open-source software tool for implementing a CIR system in research groups, laboratories, or large institutions (LabCIRS). LabCIRS was developed, tested, and implemented in our multidisciplinary and multiprofessional neuroscience research department. It is accepted by all members of the department, has led to the emergence of a mature error culture, and has made the laboratory a safer and more communicative environment. Initial concerns that implementation of such a measure might lead to a “surveillance culture” that would stifle scientific creativity turned out to be unfounded. PMID:27906976

  5. A Laboratory Critical Incident and Error Reporting System for Experimental Biomedicine.

    PubMed

    Dirnagl, Ulrich; Przesdzing, Ingo; Kurreck, Claudia; Major, Sebastian

    2016-12-01

    We here propose the implementation of a simple and effective method to enhance the quality of basic and preclinical academic research: critical incident reporting (CIR). CIR has become a standard in clinical medicine but to our knowledge has never been implemented in the context of academic basic research. We provide a simple, free, open-source software tool for implementing a CIR system in research groups, laboratories, or large institutions (LabCIRS). LabCIRS was developed, tested, and implemented in our multidisciplinary and multiprofessional neuroscience research department. It is accepted by all members of the department, has led to the emergence of a mature error culture, and has made the laboratory a safer and more communicative environment. Initial concerns that implementation of such a measure might lead to a "surveillance culture" that would stifle scientific creativity turned out to be unfounded.

  6. Isolated Single Umbilical Artery in Twin Pregnancies and its Adverse Pregnancy Outcomes - A Case Report and Review of Literature

    PubMed Central

    Raiz, Iqbal

    2015-01-01

    Single umbilical artery is the most common congenital abnormality of the umbilical cord and is seen in 4-11% of twin pregnancies. It is usually associated with intrauterine growth retardation, preterm labour, small-for-dates and other structural anomalies. There is no significant difference in the incidence between monochorionic and dichorionic twins. The left artery is usually absent more commonly than the right. The female co-twin was predominantly more affected than their male counterparts. Single umbilical artery is found twice more common in white women than in Afro-Asians and Americans. The hemodynamic disturbances occur early in the embryonic development, influence greatly in the development of single umbilical artery. Genetic and environmental factors also play a major role in the development of this anomaly. The pregnancies with single umbilical artery were classified as high risk group, because the overall perinatal mortality rate was estimated to be as high as 20%. There is a significant increase in the occurrence of single umbilical artery in pregnancies due to artificial reproductive technologies, as well as in spontaneous miscarriages. Prenatal ultrasonography is the principal diagnostic technique employed to identify single umbilical artery during 3rd trimester of pregnancy. The present case, reports the presence of a single umbilical artery in a monozygotic, monochorionic twin pregnancy, which is acardiac-acephalic fetus, small for dates, female sex, associated with other major structural anomalies, and was still born. Authors analyse its incidence, clinical presentations and pregnancy outcome and also review the pertinent literature. PMID:25737967

  7. First Annual Report: NASA-ONERA Collaboration on Human Factors in Aviation Accidents and Incidents

    NASA Technical Reports Server (NTRS)

    Srivastava, Ashok; Fabiani, Patrick

    2012-01-01

    This is the first annual report jointly prepared by NASA and ONERA on the work performed under the agreement to collaborate on a study of the human factors entailed in aviation accidents and incidents particularly focused on consequences of decreases in human performance associated with fatigue. The objective of this Agreement is to generate reliable, automated procedures that improve understanding of the levels and characteristics of flight-crew fatigue factors whose confluence will likely result in unacceptable crew performance. This study entails the analyses of numerical and textual data collected during operational flights. NASA and ONERA are collaborating on the development and assessment of automated capabilities for extracting operationally significant information from very large, diverse (textual and numerical) databases much larger than can be handled practically by human experts. This report presents the approach that is currently expected to be used in processing and analyzing the data for identifying decrements in aircraft performance and examining their relationships to decrements in crewmember performance due to fatigue. The decisions on the approach were based on samples of both the numerical and textual data that will be collected during the four studies planned under the Human Factors Monitoring Program (HFMP). Results of preliminary analyses of these sample data are presented in this report.

  8. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: An observational study

    PubMed Central

    Khan, Sarfaraz Alam; Goyal, Chhaya; Chandel, Nitibhushansingh; Rafi, Mohammed

    2013-01-01

    Background: Underreporting of spontaneous adverse drug reaction (ADR) is a threat to pharmacovigilance. Various factors related with the knowledge and attitudes are responsible for underreporting of ADRs. Aims: The study was aimed at investigating the knowledge and attitudes of doctors to ADR reporting. Materials and Methods: It was a questionnaire-based cross-sectional study. One hundred and eight questionnaires were administered to doctors working in a teaching hospital with an ADR monitoring center. Statistical Analysis Used: The descriptive statistics were used for responses to evaluate the knowledge and attitudes toward ADR reporting. Pearson's Chi-square test was used to observe the association of knowledge and attitude with experience and position. Results: The response rate was 62.9%. Spontaneous reporting rate was found to be 19.1%. The major factors found to be responsible for underreporting of ADR include inadequate risk perception about newly marketed drugs (77.9%), fear factor (73.5%), diffidence (67.7%), lack of clarity of information on ADR form about reporting (52.9%), lethargy (42.7%), insufficient training to identify ADRs (41.2%), lack of awareness about existence of pharmacovigilance program (30.9%) and ADR monitoring center in the institute (19.1%), and inadequate risk perception of over-the-counter (OTC) product (20.6%) and herbal medicines (13.2%). Experience and position did not influence the knowledge and attitudes of doctors. Conclusion: The deficiencies in knowledge and attitudes require urgent attention not only to improve the rate of spontaneous reporting, but also for enhanced safety of the patients and society at large. PMID:23633861

  9. Sterile Seroma Resulting from Multilevel XLIF Procedure as Possible Adverse Effect of Prophylactic Vancomycin Powder: A Case Report

    PubMed Central

    Youssef, Jim A.; Orndorff, Douglas G.; Scott, Morgan A.; Ebner, Rachel E.; Knewitz, Allison P.

    2014-01-01

    Study Design Case report. Objective The objective of this study was to present the unusual case of a 59-year-old woman with a reoccurring sterile postoperative seroma. Methods A patient was observed postoperatively for any complications or adverse side effects resulting from an initial multilevel anterior/posterior lumbar fusion surgery where 2 g (1 g combined with the bone graft used for posterolateral fusion and 1 g placed in the soft tissues) of prophylactic vancomycin powder was placed within the soft tissues posteriorly before wound closure. The patient's progress was monitored through 6 months following the initial procedure. Six weeks postoperatively, the patient sustained a fall and had increased pain. Magnetic resonance imaging, computed tomography, and X-rays demonstrated a displaced sacral fracture, a large epidural fluid collection, and severe compression of the thecal sac at the lumbar operative sites (L3–5). Results On the basis of the aforementioned imaging studies and the patient's progressive neurologic deficit, it was apparent at the 6-week follow-up that emergent surgical intervention was necessary. Drainage and examination of an epidural fluid collection along with treatment of a displaced sacral fracture (S1–S2) were performed. The patient had an uneventful postoperative course with resolution of her back pain and neurologic deficit; however, recurrence of the epidural fluid collection requiring serial aspirations confounded the patients' clinical presentation. Conclusions With the recurrent nature of the seroma being unusual, the cause of the fluid collection and formation is undetermined. With lack of bone morphogenetic protein usage, and few confounding variables accountable, an acute allergic response to topical vancomycin powder is a possible etiology. Analysis with larger patient populations comparing postoperative adverse effects of prophylactic vancomycin powder is recommended. PMID:25364326

  10. What Happened, and Why: Toward an Understanding of Human Error Based on Automated Analyses of Incident Reports. Volume 1

    NASA Technical Reports Server (NTRS)

    Maille, Nicolas P.; Statler, Irving C.; Ferryman, Thomas A.; Rosenthal, Loren; Shafto, Michael G.; Statler, Irving C.

    2006-01-01

    The objective of the Aviation System Monitoring and Modeling (ASMM) project of NASA s Aviation Safety and Security Program was to develop technologies that will enable proactive management of safety risk, which entails identifying the precursor events and conditions that foreshadow most accidents. This presents a particular challenge in the aviation system where people are key components and human error is frequently cited as a major contributing factor or cause of incidents and accidents. In the aviation "world", information about what happened can be extracted from quantitative data sources, but the experiential account of the incident reporter is the best available source of information about why an incident happened. This report describes a conceptual model and an approach to automated analyses of textual data sources for the subjective perspective of the reporter of the incident to aid in understanding why an incident occurred. It explores a first-generation process for routinely searching large databases of textual reports of aviation incident or accidents, and reliably analyzing them for causal factors of human behavior (the why of an incident). We have defined a generic structure of information that is postulated to be a sound basis for defining similarities between aviation incidents. Based on this structure, we have introduced the simplifying structure, which we call the Scenario as a pragmatic guide for identifying similarities of what happened based on the objective parameters that define the Context and the Outcome of a Scenario. We believe that it will be possible to design an automated analysis process guided by the structure of the Scenario that will aid aviation-safety experts to understand the systemic issues that are conducive to human error.

  11. Adverse reaction to metal bearing leading to femoral stem fractures: a literature review and report of two cases

    PubMed Central

    Al-Azzani, Waheeb A.K.; Iqbal, Hafiz J.; John, Alun

    2016-01-01

    Metal-on-metal (MoM) bearing in total hip replacement (THR) has a high failure rate due to adverse reaction to metal debris (ARMD). There is a spectrum of soft tissue and bony changes in ARMD including muscle necrosis and osteolysis. In our institution, more than 1500 MoM THRs were implanted since 2003. Recently, we have revised significant numbers of these. We report our experience and management of a mode of failure of MoM THR that has been infrequently reported—the distal femoral stem fracture. We report on two patients who presented with worsening pain attributable to fracture of the femoral stem. Severe femoral osteolysis led to loss of proximal stem support and eventual fatigue fracture of the component. Both patients were revised employing a posterior approach. Bone trephine was used to extract a well-fixed distal stem fragment without any windows. Both patients had successful outcome after revision with excellent pain relief and no complications. PMID:26846269

  12. Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries

    PubMed Central

    Restani, Patrizia; Di Lorenzo, Chiara; Garcia-Alvarez, Alicia; Badea, Mihaela; Ceschi, Alessandro; Egan, Bernadette; Dima, Lorena; Lüde, Saskia; Maggi, Franco M.; Marculescu, Angela; Milà-Villarroel, Raimon; Raats, Monique M.; Ribas-Barba, Lourdes; Uusitalo, Liisa; Serra-Majem, Lluís

    2016-01-01

    Background The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS) have been described. Objectives To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011–2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey. Subjects/Setting From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS. Results Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8%) and 4 as probable (4.6%). Considering the most frequently cited botanicals, eight cases were due to Valeriana officinalis (garden valerian); seven to Camellia sinensis (tea); six to Ginkgo biloba (Maidenhair tree) and Paullinia cupana (guarana). Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems. Conclusions Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors) to become aware of possible new problems associated with the increasing use of food supplements containing botanicals. PMID:26928206

  13. Serious Adverse Transfusion Reactions Reported in the National Recipient-Triggered Trace Back System in Korea (2006-2014)

    PubMed Central

    Kwon, Jeong Ran; Won, Eun Jeong; Jo, Hyun Jung; Choi, Sae Rom; Lee, Kyoungyul; Kim, Sinyoung; Ahn, Hyeong Sik; Choi, Young Sill

    2016-01-01

    Background Adverse transfusion reactions (ATRs) are clinically relevant to patients with significant morbidity and mortality. This study aimed to review the cases of ATR reported in the recipient-triggered trace back system for a recent nine-year period in Korea. Methods Nine-year data obtained from 2006 to 2014 by the trace back system at the Division of Human Blood Safety Surveillance of the Korean Centers for Disease Control (KCDC) were reviewed. The suspected cases were assessed according to six categories: (i) related to, (ii) probably related to, (iii) probably not related to, (iv) not related to transfusion, (v) unable to investigate, and (vi) under investigation. Results Since 2006, 199 suspected serious ATRs were reported in hospitals and medical institutions in Korea, and these ATRs were reassessed by the division of Human Blood Safety Surveillance of the KCDC. Among the reported 193 cases as transfusion related infections, hepatitis C virus (HCV) infection (135, 67.8%) was reported most frequently, followed by hepatitis B virus (HBV) infection (27, 13.6%), HIV infection (13, 6.5%), syphilis (9, 4.5%), malarial infection (4, 2.0%), other bacterial infections (3, 1.5%), HTLV infection (1, 0.5%), and scrub typhus infection (1, 0.5%), respectively. Of the 199 cases, 13 (6.5%) cases were confirmed as transfusion-related (3 HCV infections, 3 malarial infections, 1 HBV infection, 2 Staphylococcus aureus sepsis, 3 transfusion-related acute lung injuries, and 1 hemolytic transfusion reaction). Conclusions This is the first nationwide data regarding serious ATRs in Korea and could contribute to the implementation of an effective hemovigilance system. PMID:27139606

  14. Incidence of Self-Reported Interpersonal Violence Related Physical Injury in Iran

    PubMed Central

    Salamati, Payman; Rahimi-Movaghar, Afarin; Motevalian, Seyed Abbas; Amin-Esmaeili, Masoumeh; Sharifi, Vandad; Hajebi, Ahmad; Rad Goodarzi, Reza; Hefazi, Mitra; Naji, Zohrehsadat; Saadat, Soheil; Rahimi-Movaghar, Vafa

    2015-01-01

    Background: Violence is the cause of death for 1.5 million people in a year. Objectives: Our study aimed to estimate the incidence rate of self-reported interpersonal violence related physical injury (VRPI) and its associated factors in Iran. Patients and Methods: The sample included people ranged from 15 to 64 years old who were residing in Iran. A total of 1525 clusters were selected from the whole country. Six families were selected from each cluster via a systematic random sampling method. Then, the residential units were identified and the interviewers contacted the inhabitants. In the next step, one of the family members was selected by using Kish grid method. The instrument was a researcher-made questionnaire and consisted of two sections; demographics and project related data. Face validity and content validity of our questionnaire were investigated based on expert opinions and the reliability was confirmed by a pilot study, as well. The inclusion criteria were considered for choosing the interviewers. An interviewer was assigned for each 42 participants (7 clusters). An educational seminar was held for the administrative managers (54 persons) and interviewers (230 persons) for a week. The field work was distributed among all 46 Medical Sciences universities in Iran. In each university, administrative issues were related to an executive director. Mann-Whitney U test and odds ratio were used to analyze the data with 95% confidence interval. α value was considered less than 5%. Results: The frequency of VRPI among 7886 participants was 24 during the last three months. The incidence rate of interpersonal VRPI was estimated at 3.04 per 1000 population (95% CI: 2.66-3.42) during a three-month interval in Iran. The incidence was 4.72 per 1000 population (95% CI: 4.01-5.43) for males and 1.78 per 1000 population (95% CI: 1.39-2.17) for females during a three-month interval. The mean (SD) of age of the participants with and without a history of VRPI were 26.5 (7

  15. 12 CFR 250.181 - Reports of change in control of bank management incident to a merger.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Reports of change in control of bank management... change in control of bank management incident to a merger. (a) A State member bank has inquired whether Pub. L. 88-593 (78 Stat. 940) requires reports of change in control of bank management in...

  16. 12 CFR 250.181 - Reports of change in control of bank management incident to a merger.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Reports of change in control of bank management... change in control of bank management incident to a merger. (a) A State member bank has inquired whether Pub. L. 88-593 (78 Stat. 940) requires reports of change in control of bank management in...

  17. Field evidence of bird poisonings by imidacloprid-treated seeds: a review of incidents reported by the French SAGIR network from 1995 to 2014.

    PubMed

    Millot, Florian; Decors, Anouk; Mastain, Olivier; Quintaine, Thomas; Berny, Philippe; Vey, Danièle; Lasseur, Romain; Bro, Elisabeth

    2017-02-01

    The large-scale use of neonicotinoid insecticides has raised growing concerns about their potential adverse effects on farmland birds, and more generally on biodiversity. Imidacloprid, the first neonicotinoid commercialized, has been identified as posing a risk for seed-eating birds when it is used as seed treatment of some crops since the consumption of a few dressed seeds could cause mortality. But evidence of direct effects in the field is lacking. Here, we reviewed the 103 wildlife mortality incidents reported by the French SAGIR Network from 1995 to 2014, for which toxicological analyses detected imidacloprid residues. One hundred and one incidents totalling at least 734 dead animals were consistent with an agricultural use as seed treatment. Grey partridges (Perdix perdix) and "pigeons" (Columba palumbus, Columba livia and Columba oenas) were the main species found. More than 70% of incidents occurred during autumn cereal sowings. Furthermore, since there is no biomarker for diagnosing neonicotinoid poisonings, we developed a diagnostic approach to estimate the degree of certainty that these mortalities were due to imidacloprid poisoning. By this way, the probability that mortality was due to poisoning by imidacloprid-treated seeds was ranked as at least "likely" in 70% of incidents. As a result, this work provides clear evidence to risk managers that lethal effects due to the consumption by birds of imidacloprid-treated seeds regularly occur in the field. This in turn raises the question of the effectiveness of the two main factors (seed burying and imidacloprid-treated seeds avoidance) that are supposed to make the risk to birds negligible. Risk factors and the relevance of mitigation measures are discussed.

  18. The incidence of stress fracture following peri-acetabular osteotomy: an under-reported complication.

    PubMed

    Malviya, A; Dandachli, W; Beech, Z; Bankes, M J; Witt, J D

    2015-01-01

    Stress fractures occurring in the pubis and ischium after peri-acetabular osteotomy (PAO) are not well recognised, with a reported incidence of 2% to 3%. The purpose of this study was to analyse the incidence of stress fracture after Bernese PAO under the care of two high-volume surgeons. The study included 359 patients (48 men, 311 women) operated on at a mean age of 31.1 years (15 to 56), with a mean follow-up of 26 months (6 to 64). Complete follow-up radiographs were available for 348 patients, 64 of whom (18.4%) developed a stress fracture of the inferior pubic ramus, which was noted at a mean of 9.1 weeks (5 to 55) after surgery. Most (58; 91%) healed. In 40 of the patients with a stress fracture (62.5%), pubic nonunion also occurred. Those with a stress fracture were significantly older (mean 33.9 years (16 to 50) vs 30.5 years (15 to 56), p = 0.002) and had significantly more mean pre-operative deformity: mean centre-edge angle (9.8° (-9.5 to 35) vs 12.4° (-33 to 28), p = 0.04) and mean Tönnis angle (22.8° (0 to 45) vs 18.7° (-2 to 38), p < 0.001). The pubic nonunion rate was significantly higher in those with a stress fracture (62.5% vs 7%, p < 0.001), with regression analysis revealing that these patients had 11.8 times higher risk than those without nonunion.

  19. Corneal transplantation: study of the data of a regional eye bank for the year 2013 and analysis of the evolution of the adverse events reported in France since 2010.

    PubMed

    Gauthier, Anne-Sophie; Castelbou, Marie; Garnier, Mélanie Bidaut; Pizzuto, Joëlle; Roux, Stephan; Gain, Philippe; Pouthier, Fabienne; Delbosc, Bernard

    2017-01-23

    To analyze the data of the adverse events collected in a single major eye bank (EFS Bourgogne Franche Comté, Besançon, France) for the year 2013 and to report the French data of biovigilance provided by the French National Agency for Medicines and Health Products Safety (ANSM) between 2010 and 2013. we have set up a study of adverse events in 2013, in collaboration with a single eye bank (EFS Bourgogne Franche Comté, Besançon, France). A survey was sent to the surgeon for each delivered corneal button by the eye bank in 2013. They were asked for each grafted patient performed in their center, the type of graft (penetrating keratoplasty, anterior keratoplasty or endothelial keratoplasty), the occurrence of adverse events (primary failure, infectious keratis, endophthalmitis, immune rejection, and other events) and the time interval between surgery and events (Less than 1 postoperative month, between 1 month and 1 year postoperatively, >1 year postoperatively). In 2013, 407 corneal buttons were delivered by the eye bank of Besançon in 21 medical centers which performed corneal grafts and we sent 407 surveys. We received 243 completed questionnaires (59.75%) from 11 centers (52.38%). The global reported rate of adverse events was 27.54% of the graft (n = 65/236 corneal grafts performed in 11 centers in 2013; 20% of Primary graft failure, 11% of infectious keratitis, 1% of endophthalmitis, 34% of rejection, 34% of other incidents). 30.16% of complications were noticed before the first month after surgery versus 52.38% of complications noticed between the first month and the first year after surgery and 17.46% of complications noticed after the post-operative first year The most common causes of adverse events after PK were Immune rejection (13.17%), surgical causes (5.98%) and infection (4.79%) and after EK were Primary graft failure (8.2%) and surgical causes (19.67%). In 2013, in France 0.83% of adverse events were notified in ANSM. For the 236 performed

  20. Clinical profiles of adverse drug reactions spontaneously reported at a single Korean hospital dedicated to children with complex chronic conditions

    PubMed Central

    Kim, Bomi; Kim, Sunwha Zara; Lee, Jin; Jung, Ae Hee; Jung, Sun-Hoi; Hahn, Hyeon-Joo; Kang, Hye Ryun

    2017-01-01

    Children with complex chronic conditions (CCC) are presumed to be vulnerable to adverse drug reactions (ADRs). The clinical profiles of ADRs in CCC are not well known. Herein, we aim to describe the ADR profiles in CCC with regard to typical presentations and vulnerable groups. We accessed the ADR yearly reports at a tertiary children's hospital whose practice is mainly dedicated to CCC and descriptively analyzed their clinical profiles according to the presence of a complex chronic condition, ADR severity, and age groups. A total of 1841 cases were analyzed, among which 1258 (68.3%) were mild, 493 (26.8%) moderate, and 90 (4.9%) cases were severe. A total of 1581 (85.9%) cases of complex chronic condition were reported. The proportion of CCC in each severity group increased as the ADR becomes more severe. In CCC, ADRs were most frequently reported by nurses in the adolescent group and in cases where the symptoms involved the gastrointestinal system. The class of antineoplastic and immunomodulating drugs was the most commonly suspected of causing an ADR, followed by one of the antibiotics. When we focus on the trend across the age groups, the ratio of severe-to-total ADRs decreased with older age. Among severe cases, the ratio of off-label prescription-related cases was the highest in the infant/toddler group and decreased as the groups aged. In conclusion, ADRs of CCCs admitted to a tertiary children’s hospital have a unique profile. These groups are vulnerable to ADRs and thus they should be monitored closely, especially when they are infants or toddlers, so that severe ADRs can be identified and treated immediately. PMID:28199420

  1. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER) Database and Association Analysis

    PubMed Central

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Background Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender) has not been proposed. Methods and Findings We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA). We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male. Conclusions Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported

  2. Patient-reported adverse drug reactions and their influence on adherence and quality of life of chronic myeloid leukemia patients on per oral tyrosine kinase inhibitor treatment

    PubMed Central

    Kekäle, Meri; Peltoniemi, Marikki; Airaksinen, Marja

    2015-01-01

    Purpose To evaluate adverse drug reactions (ADRs) experienced by chronic myeloid leukemia (CML) patients during per oral tyrosine kinase inhibitor (TKI) treatment and correlation of ADR symptoms with medication adherence and perceived quality of life (QoL). Patients and methods Eighty-six adult, chronic-phase CML patients who had been on TKI treatment (79% on imatinib, 10.5% dasatinib, and 10.5% nilotinib) for at least 6 months participated in the study (mean age: 57.8 years, 52% males). The mean time from diagnosis was 5.1 years. All patients were interviewed, and patient-reported ADRs were obtained using a structured list. Adherence was assessed using Morisky’s 8-item Medication Adherence Scale (MMAS). The symptoms’ interference with patient’s daily QoL was measured by asking patients about the influence of symptom(s) on their mood, general condition, enjoyment of life, walking, relationships, and work. Results Ninety-seven percent of the patients were suffering from at least one ADR. The mean number of different symptoms was seven (range: 0–15, median 6). The most commonly perceived ADRs were muscle soreness or cramp (69/86, 80%); swelling of hands, legs, feet, or around the eyes (59/86, 69%); and fatigue (43/86, 50%). No correlation was found between adherence and ADRs, because symptoms were equally common in each MMAS adherence class. Half of the patients felt that the ADRs had a negative influence on their daily QoL. A quarter of the patients reported that ADRs affected either their mood, general condition, or enjoyment of life. The incidence of almost all ADRs was much higher among patients reporting negative influence of ADRs on their daily life compared to total study population (P=0.016). Conclusion TKI-related ADRs were common among CML patients irrespective of patient’s adherence level. Patients who reported that ADRs had a negative influence on their daily QoL perceived more ADRs than those who did not experience a negative influence. PMID

  3. Do studies reporting ‘U’-shaped serum 25-hydroxyvitamin D–health outcome relationships reflect adverse effects?

    PubMed Central

    Grant, William B.; Karras, Spyridon N.; Bischoff-Ferrari, Heike A.; Annweiler, Cedric; Boucher, Barbara J.; Juzeniene, Asta; Garland, Cedric F.; Holick, Michael F.

    2016-01-01

    ABSTRACT Several reports describe U-shaped 25-hydroxyvitamin D [25(OH)D] concentration–health outcomes, including musculo-skeletal disorders such as falls and fractures, several cancers, cardiovascular disease (CVD), cognitive function, all-cause mortality rates, birth outcomes, allergic reactions, frailty, and some other disorders. This paper reviews reports of U-shaped outcome associations with vitamin D status for evidence of underlying pathophysiological processes, or of confounding, finding that some U-shaped associations appear to be biologically meaningful, but that many could well reflect confounding by factors such as lifestyle, or hypovitaminosis D-related disease onset being masked by self-supplementation that was begun too late to correct developing health problems but before baseline vitamin D status assessment. However, the various U-shaped associations for allergic reactions may be due to vitamin D modulation of the phenotype of the immune response, shifting the Th1-Th2 balance toward Th2 formation. For prostate cancer, there seems to be little effect of 25(OH)D concentration on incidence; however, there is an inverse correlation between 25(OH)D concentration and mortality rates. Future observational studies, and randomized controlled trial data analyses, should include adjustment for data collected on prior long-term vitamin D supplementation and solar UVB exposure, as well as other potential confounders. PMID:27489574

  4. Do studies reporting 'U'-shaped serum 25-hydroxyvitamin D-health outcome relationships reflect adverse effects?

    PubMed

    Grant, William B; Karras, Spyridon N; Bischoff-Ferrari, Heike A; Annweiler, Cedric; Boucher, Barbara J; Juzeniene, Asta; Garland, Cedric F; Holick, Michael F

    2016-01-01

    Several reports describe U-shaped 25-hydroxyvitamin D [25(OH)D] concentration-health outcomes, including musculo-skeletal disorders such as falls and fractures, several cancers, cardiovascular disease (CVD), cognitive function, all-cause mortality rates, birth outcomes, allergic reactions, frailty, and some other disorders. This paper reviews reports of U-shaped outcome associations with vitamin D status for evidence of underlying pathophysiological processes, or of confounding, finding that some U-shaped associations appear to be biologically meaningful, but that many could well reflect confounding by factors such as lifestyle, or hypovitaminosis D-related disease onset being masked by self-supplementation that was begun too late to correct developing health problems but before baseline vitamin D status assessment. However, the various U-shaped associations for allergic reactions may be due to vitamin D modulation of the phenotype of the immune response, shifting the Th1-Th2 balance toward Th2 formation. For prostate cancer, there seems to be little effect of 25(OH)D concentration on incidence; however, there is an inverse correlation between 25(OH)D concentration and mortality rates. Future observational studies, and randomized controlled trial data analyses, should include adjustment for data collected on prior long-term vitamin D supplementation and solar UVB exposure, as well as other potential confounders.

  5. Detecting Drug Interactions From Adverse-Event Reports: Interaction Between Paroxetine and Pravastatin Increases Blood Glucose Levels

    PubMed Central

    Tatonetti, NP; Denny, JC; Murphy, SN; Fernald, GH; Krishnan, G; Castro, V; Yue, P; Tsau, PS; Kohane, I; Roden, DM; Altman, RB

    2011-01-01

    The lipid-lowering agent pravastatin and the antidepressant paroxetine are among the most widely prescribed drugs in the world. Unexpected interactions between them could have important public health implications. We mined the US Food and Drug Administration’s (FDA’s) Adverse Event Reporting System (AERS) for side-effect profiles involving glucose homeostasis and found a surprisingly strong signal for comedication with pravastatin and paroxetine. We retrospectively evaluated changes in blood glucose in 104 patients with diabetes and 135 without diabetes who had received comedication with these two drugs, using data in electronic medical record (EMR) systems of three geographically distinct sites. We assessed the mean random blood glucose levels before and after treatment with the drugs. We found that pravastatin and paroxetine, when administered together, had a synergistic effect on blood glucose. The average increase was 19 mg/dl (1.0 mmol/l) overall, and in those with diabetes it was 48 mg/dl (2.7 mmol/l). In contrast, neither drug administered singly was associated with such changes in glucose levels. An increase in glucose levels is not a general effect of combined therapy with selective serotonin reuptake inhibitors (SSRIs) and statins. PMID:21613990

  6. 29 CFR 1904.39 - Reporting fatalities and multiple hospitalization incidents to OSHA.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... machine, faxing the area office, or sending an e-mail? No, if you can't talk to a person at the Area... incident. (7) What if I don't learn about an incident right away? If you do not learn of a...

  7. 29 CFR 1904.39 - Reporting fatalities and multiple hospitalization incidents to OSHA.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... machine, faxing the area office, or sending an e-mail? No, if you can't talk to a person at the Area... incident. (7) What if I don't learn about an incident right away? If you do not learn of a...

  8. 29 CFR 1904.39 - Reporting fatalities and multiple hospitalization incidents to OSHA.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... machine, faxing the area office, or sending an e-mail? No, if you can't talk to a person at the Area... incident. (7) What if I don't learn about an incident right away? If you do not learn of a...

  9. Brief Report: A Growth Mixture Model of Occupational Aspirations of Individuals with High-Incidence Disabilities

    ERIC Educational Resources Information Center

    Lee, In Heok; Rojewski, Jay W.

    2013-01-01

    A previous longitudinal study of the occupational aspirations of individuals with high-incidence disabilities revealed multiple longitudinal patterns for individuals with learning disabilities or emotional-behavioral disorders. Growth mixture modeling was used to determine whether individuals in these two high-incidence disabilities groups (N =…

  10. 29 CFR 1904.39 - Reporting fatalities and multiple hospitalization incidents to OSHA.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... machine, faxing the area office, or sending an e-mail? No, if you can't talk to a person at the Area... incident. (7) What if I don't learn about an incident right away? If you do not learn of a...

  11. Incidence of Deep Vein Thrombosis in Patients Undergoing Degenerative Spine Surgery onProphylactic Dalteparin; A Single Center Report

    PubMed Central

    Moayer, AlirezaFarid; Mohebali, Navideh; Razmkon, Ali

    2016-01-01

    Objective: To determine the incidence of deep vein thrombosis (DVT)in patients undergoing spinal surgeries receiving prophylactic doses of Deltaparin in a single center in central Iran. Method: This cross-sectional study was conducted in Shariatee hospital of Isfahan during a 12-month period. We included all the patients undergoing elective spinal surgeries in our center during the study period who received prophylactic dosages of subcutaneous Dalteparin (5000unit daily) thefirst postoperative day. Those with absolute contraindications of anticoagulation therapy were not included in the study. Patients were followed for 3 months clinically and the incidence of DVT was recorded. DVT was suspected clinically and was confirmed by color Doppler sonography. Results: Overall we included 120 patients with mean age of 44.8 ± 12.6years among whom there were 54 (45%) men and 66 (55%) women. Lumbar discectomy (32.9%)and laminectomy (20.2%)were the most common performed procedures. DVT was detected in 1 (0.83%) patient in postoperative period. None of the patients developed pulmonary embolism and none hemorrhagic adverse event was recorded. The patient was treated with therapeutic unfractionated heparin and was discharged with warfarin.  Conclusion: Our results shows the efficacy of LMWH (Dalteparin) in reducing the incidence of DVT to 0.83%. These results also show the safety of Dalteparin in spine surgery because of lack of bleeding complication. PMID:27162925

  12. National Incident Management System (NIMS) Standards Review Panel Workshop Summary Report

    SciTech Connect

    Stenner, Robert D.; Kirk, Jennifer L.; Stanton, James R.; Shebell, Peter; Schwartz, Deborah S.; Judd, Kathleen S.; Gelston, Gariann M.

    2006-02-07

    The importance and need for full compliant implementation of NIMS nationwide was clearly demonstrated during the Hurricane Katrina event, which was clearly expressed in Secretary Chertoff's October 4, 2005 letter addressed to the State's governors. It states, ''Hurricane Katrina was a stark reminder of how critical it is for our nation to approach incident management in a coordinated, consistent, and efficient manner. We must be able to come together, at all levels of government, to prevent, prepare for, respond to, and recover from any emergency or disaster. Our operations must be seamless and based on common incident management doctrine, because the challenges we face as a nation are far greater than capabilities of any one jurisdiction.'' The NIMS is a system/architecture for organizing response on a ''national'' level. It incorporations ICS as a main component of that structure (i.e., it institutionalizes ICS in NIMS). In a paper published on the NIMS Website, the following statements were made: ''NIMS represents a core set of doctrine, principles, terminology, and organizational processes to enable effective, efficient and collaborative incident management at all levels. To provide the framework for interoperability and compatibility, the NIMS is based on a balance between flexibility and standardization.'' Thus the NIC is challenged with the need to adopt quality SDO generated standards to support NIMS compliance, but in doing so maintain the flexibility necessary so that response operations can be tailored for the specific jurisdictional and geographical needs across the nation. In support of this large and complex challenge facing the NIC, the Pacific Northwest National Laboratory (PNNL) was asked to provide technical support to the NIC, through their DHS Science and Technology ? Standards Portfolio Contract, to help identify, review, and develop key standards for NIMS compliance. Upon examining the challenge, the following general process appears to be a

  13. Pro-Arrhythmic Potential of Oral Antihistamines (H1): Combining Adverse Event Reports with Drug Utilization Data across Europe

    PubMed Central

    Poluzzi, Elisabetta; Raschi, Emanuel; Godman, Brian; Koci, Ariola; Moretti, Ugo; Kalaba, Marija; Wettermark, Bjorn; Sturkenboom, Miriam; De Ponti, Fabrizio

    2015-01-01

    Background There is appreciable utilisation of antihistamines (H1) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in ’90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines. Aim To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS) with drug utilization data from 13 European Countries. Methods We identified signals of antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP), QT abnormalities (QTabn), ventricular arrhythmia (VA) and sudden cardiac death/cardiac arrest (SCD/CA). Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance. Results Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, loratadine) and 6 in weaker signals (alimemazine, carbinoxamine, cyclizine, cyproeptadine, dexchlorpheniramine and doxylamine). Exposure to antihistamines with stronger signal was markedly different across European countries and was at least 40% in each Country. Cetirizine was >29 Defined Daily Doses per 1000 inhabitants per day (DID) in Norway, desloratadine >11 DID in France and loratadine >9 DID in Sweden and Croatia. Drugs with weaker signals accounted for no more than 10% (in Sweden) and in most European countries their use was negligible. Conclusions Some second-generation antihistamines are associated with signal of torsadogenicity and largely used in most European countries. Although confirmation by

  14. NY's best not good enough. Despite being a leader in adverse-event reporting, audit reveals some shortcomings, need for reform in N.Y.'s tracking system.

    PubMed

    Becker, Cinda

    2004-10-04

    A New York audit of its well-regarded tracking system for adverse-event reporting drew fire when it revealed some problems with oversight. But state health officials defend the system, which is a model for other states. New Jersey official Marilyn Dahl, left, says New York has "been considered a national leader.

  15. Association between Selective Beta-adrenergic Drugs and Blood Pressure Elevation: Data Mining of the Japanese Adverse Drug Event Report (JADER) Database.

    PubMed

    Ohyama, Katsuhiro; Inoue, Michiko

    2016-01-01

    Selective beta-adrenergic drugs are used clinically to treat various diseases. Because of imperfect receptor selectivity, beta-adrenergic drugs cause some adverse drug events by stimulating other adrenergic receptors. To examine the association between selective beta-adrenergic drugs and blood pressure elevation, we reviewed the Japanese Adverse Drug Event Reports (JADERs) submitted to the Japan Pharmaceuticals and Medical Devices Agency. We used the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms extracted from Standardized MedDRA queries for hypertension to identify events related to blood pressure elevation. Spontaneous adverse event reports from April 2004 through May 2015 in JADERs, a data mining algorithm, and the reporting odds ratio (ROR) were used for quantitative signal detection, and assessed by the case/non-case method. Safety signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. A total of 2021 reports were included in this study. Among the nine drugs examined, significant signals were found, based on the 95%CI for salbutamol (ROR: 9.94, 95%CI: 3.09-31.93) and mirabegron (ROR: 7.52, 95%CI: 4.89-11.55). The results of this study indicate that some selective beta-adrenergic drugs are associated with blood pressure elevation. Considering the frequency of their indications, attention should be paid to their use in elderly patients to avoid adverse events.

  16. Using Critical Incident Reporting to Promote Objectivity and Self-Knowledge in Pre-Service School Psychologists

    ERIC Educational Resources Information Center

    Griffin, Maureen L.; Scherr, Tracey G.

    2010-01-01

    This longitudinal project consisted of exploring the usefulness of Critical Incident Reporting (CIR) as an instructional tool (Griffin, 2003) to first increase objectivity and self-knowledge among practicum students and then to guide practices when those students became interns the following academic year. Analysis included 120 CIRs written by 15…

  17. 49 CFR 225.12 - Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... employee human factor as cause; Employee Human Factor Attachment; notice to employee; employee supplement... cause; Employee Human Factor Attachment; notice to employee; employee supplement. (a) Rail Equipment... Attachment. If, in reporting a rail equipment accident/incident to FRA, a railroad cites an employee...

  18. 49 CFR 225.12 - Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... employee human factor as cause; Employee Human Factor Attachment; notice to employee; employee supplement..., AND INVESTIGATIONS § 225.12 Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human Factor Attachment; notice to employee; employee supplement. (a) Rail...

  19. 49 CFR 225.12 - Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... employee human factor as cause; Employee Human Factor Attachment; notice to employee; employee supplement..., AND INVESTIGATIONS § 225.12 Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human Factor Attachment; notice to employee; employee supplement. (a) Rail...

  20. The Incidence of Crime on the Campuses of U.S. Postsecondary Education Institutions. A Report to Congress.

    ERIC Educational Resources Information Center

    Office of Postsecondary Education (ED), Washington, DC.

    The Higher Education Amendments of 1998 require the Department of Education to collect, analyze, and report to Congress on the incidence of crime on campuses and facilities of postsecondary education institutions, and institutions of postsecondary education that participate in federal student financial assistance programs are required to make…

  1. Predictive Power of Incidents Reporting Rate and Its Dimensions by Job Stress among Workers’ Isfahan Steel Company

    PubMed Central

    Kiani, F; Samavatyan, H; Pourabdian, S; Jafari, E

    2011-01-01

    Background: There is long-term interest in the effects of stress on health, due to the strain that it places on individuals which can lead to an increased risk of disease. The present study examined degree of perceived job stress related to incidents reporting rate and its dimensions among workers’ Isfahan Steel Company. Methods: A self-administered anonymous was distributed to 189 workers. The survey included demographic factors, incidents reporting rate and its components (physical symptoms, psychological symptoms and accidents) and the Job Stress Questionnaire. The data were analyzed by multivariate (MANOVA) and correlation techniques. Results: 1) there was internal significant correlation between perceived job stress with incident reporting rate as well as with its two components namely physical symptoms and psychological symptoms; 2) there was not a significant relationship between perceived job stress and accident; 2) In multivariate analysis, perceived job stress respectively about 12%, 18% and 19% of the variance of variables of incidents reporting rate, physical and psychological symptoms significantly predicted (P< 0.05). Conclusion: Perceived job stress influences to physical and psychological symptoms. Therefore, decreasing job stress can be important to prevent the development of stress-related diseases and to promote workers health. PMID:23113092

  2. The adverse prognostic hallmarks in identical twins with Langerhans cell histiocytosis: a clinical report and literature review.

    PubMed

    Chai, Damin; Tao, Yisheng; Bao, Zhengqi; Yang, Li; Feng, Zhenzhong; Ma, Li; Liang, Limei; Zhou, Xinwen

    2013-01-01

    Langerhans cell histiocytosis (LCH) is characterized by uncontrolled proliferation of Langerhans cells accompanying eosinophils. It often attacks children under 10 years of age. LCH in identical twins is very rare and its prognosis is different. Here we report identical-twin sisters with LCH. Computed tomography (CT) revealed osteolytic change in each twin's skull, and the elder exhibited poor eyesight. There were massive histiocyte-like cells surrounded by eosinophils in pathologic specimen of the abnormal lesions, which is typical pathologic finding in LCH. These pathologic cells were positive for S-100 and the cell surface protein CD1 antigen (CD1α), the known markers of LCH. After treating them with surgery, no symptoms were seen in the younger until now. While the older was found another soft mass (about 2.0 cm in diameter) in the left temporal area 18 months later. The same treatment was given to the older after admission, and she is healthy to date. To explore the relationship between hallmarks and the prognosis of identical-twin patients with LCH, we retrieved the 16 literatures (16 identical-twin pairs, 31 patients) listed in PubMed during the past 60 years. The data revealed all those patients who have disseminated to the bone marrow, spleen and liver with symptoms of fever and hepatosplenomegaly exhibited worse prognosis (9 out of the 31 patients). The other identical-twin subjects without infiltration of those organs recovered well. In conclusion, this study reveals the adverse hallmarks of prognosis in identical-twin patients with LCH by reviewing relevant literatures.

  3. 78 FR 77601 - Adjustment of Monetary Threshold for Reporting Rail Equipment Accidents/Incidents for Calendar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    .../incident'' is a collision, derailment, fire, explosion, act of God, or other event involving the operation... collisions, derailments, fires, explosions, acts of God, and other events involving the operation of...

  4. 30 CFR 250.189 - Reporting requirements for incidents requiring immediate notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., REGULATION, AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE... incident or injury/fatality); (d) Lease number, OCS area, and block; (e) Platform/facility name and...

  5. 30 CFR 250.190 - Reporting requirements for incidents requiring written notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., REGULATION, AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE... number (if a contractor is involved in the incident or injury); (4) Lease number, OCS area, and block;...

  6. 30 CFR 250.190 - Reporting requirements for incidents requiring written notification.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL... is involved in the incident or injury); (4) Lease number, OCS area, and block; (5)...

  7. 30 CFR 250.190 - Reporting requirements for incidents requiring written notification.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL... is involved in the incident or injury); (4) Lease number, OCS area, and block; (5)...

  8. 30 CFR 250.190 - Reporting requirements for incidents requiring written notification.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL... is involved in the incident or injury); (4) Lease number, OCS area, and block; (5)...

  9. Estimating the incidence reporting rates of new influenza pandemics at an early stage using travel data from the source country.

    PubMed

    Chong, K C; Fong, H F; Zee, C Y

    2014-05-01

    During the surveillance of influenza pandemics, underreported data are a public health challenge that complicates the understanding of pandemic threats and can undermine mitigation efforts. We propose a method to estimate incidence reporting rates at early stages of new influenza pandemics using 2009 pandemic H1N1 as an example. Routine surveillance data and statistics of travellers arriving from Mexico were used. Our method incorporates changes in reporting rates such as linearly increasing trends due to the enhanced surveillance. From our results, the reporting rate was estimated at 0·46% during early stages of the pandemic in Mexico. We estimated cumulative incidence in the Mexican population to be 0·7% compared to 0·003% reported by officials in Mexico at the end of April. This method could be useful in estimation of actual cases during new influenza pandemics for policy makers to better determine appropriate control measures.

  10. Patient and procedural factors associated with an increased risk of harm or death in the first 4,000 incidents reported to webAIRS.

    PubMed

    Gibbs, N M; Culwick, M D; Merry, A F

    2017-03-01

    This report describes an analysis of patient and procedural factors associated with a higher proportion of harm or death versus no harm in the first 4,000 incidents reported to webAIRS. The report is supplementary to a previous cross-sectional report on the first 4,000 incidents reported to webAIRS. The aim of this analysis was to identify potential patient or procedural factors that are more common in incidents resulting in harm or death than in incidents with more benign outcomes. There was a >50% higher proportion of harm (versus no harm) for incidents in which the patient's body mass index (BMI) was <18.5 kg/m2, for incidents in post-anaesthesia care units and non-theatre procedural areas, and for incidents under the main category of cardiovascular or neurological. The proportion of incidents associated with death was also higher (risk ratio >1.5) for BMI <18.5 kg/m2, incidents in non-theatre procedural areas, and incidents under the main category of cardiovascular or neurological. In addition, the proportion of incidents associated with death was higher for incidents in which the patient's age was >80 years, the American Society of Anesthesiologists physical status was 4 or 5, incidents involving non-elective procedures, and incidents occurring after hours (1800 to 0800 hours). When faced with incidents with these potential risk factors, anaesthetists should consider earlier interventions and request assistance at an earlier stage. Educational strategies on incident prevention and management should place even further emphasis on scenarios involving these factors.

  11. Analysis of Aviation Safety Reporting System Incident Data Associated With the Technical Challenges of the Vehicle Systems Safety Technology Project

    NASA Technical Reports Server (NTRS)

    Withrow, Colleen A.; Reveley, Mary S.

    2014-01-01

    This analysis was conducted to support the Vehicle Systems Safety Technology (VSST) Project of the Aviation Safety Program (AVsP) milestone VSST4.2.1.01, "Identification of VSST-Related Trends." In particular, this is a review of incident data from the NASA Aviation Safety Reporting System (ASRS). The following three VSST-related technical challenges (TCs) were the focus of the incidents searched in the ASRS database: (1) Vechicle health assurance, (2) Effective crew-system interactions and decisions in all conditions; and (3) Aircraft loss of control prevention, mitigation, and recovery.

  12. [Association between reported annual gold mining extraction and incidence of malaria in Mato Grosso-Brazil, 1985-1996].

    PubMed

    Duarte, Elisabeth Carmen; Fontes, Cor Jesus Fernandes

    2002-01-01

    A secondary data analysis was performed using an ecological design to study the association between malaria incidence rates, the reported annual production of gold mining extraction and monetary investments for the control of malaria from 1985 to 1996 in Mato Grosso, Brazil. A positive and statistically significant (p<0.001) association between the amount of gold extracted and MIR was obtained in multivariate regression analysis, even after allowing for financial investments in malaria control activities. This finding contributes to an understanding of the decrease observed in malaria incidence in Mato Grosso during the last decade, in view of the significant decrease in gold mining within the region during this period.

  13. 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

  14. Extended likelihood ratio test-based methods for signal detection in a drug class with application to FDA's adverse event reporting system database.

    PubMed

    Zhao, Yueqin; Yi, Min; Tiwari, Ram C

    2016-05-02

    A likelihood ratio test, recently developed for the detection of signals of adverse events for a drug of interest in the FDA Adverse Events Reporting System database, is extended to detect signals of adverse events simultaneously for all the drugs in a drug class. The extended likelihood ratio test methods, based on Poisson model (Ext-LRT) and zero-inflated Poisson model (Ext-ZIP-LRT), are discussed and are analytically shown, like the likelihood ratio test method, to control the type-I error and false discovery rate. Simulation studies are performed to evaluate the performance characteristics of Ext-LRT and Ext-ZIP-LRT. The proposed methods are applied to the Gadolinium drug class in FAERS database. An in-house likelihood ratio test tool, incorporating the Ext-LRT methodology, is being developed in the Food and Drug Administration.

  15. Urbanicity, social adversity and psychosis

    PubMed Central

    Heinz, Andreas; Deserno, Lorenz; Reininghaus, Ulrich

    2013-01-01

    In recent years, there has been increasing interest in research on geographical variation in the incidence of schizophrenia and other psychoses. In this paper, we review the evidence on variation in incidence of schizophrenia and other psychoses in terms of place, as well as the individual- and area-level factors that account for this variation. We further review findings on potential mechanisms that link adverse urban environment and psychosis. There is evidence from earlier and more recent studies that urbanicity is associated with an increased incidence of schizophrenia and non-affective psychosis. In addition, considerable variation in incidence across neighbourhoods has been observed for these disorders. Findings suggest it is unlikely that social drift alone can fully account for geographical variation in incidence. Evidence further suggests that the impact of adverse social contexts – indexed by area-level exposures such as population density, social fragmentation and deprivation – on risk of psychosis is explained (confounding) or modified (interaction) by environmental exposures at the individual level (i.e., cannabis use, social adversity, exclusion and discrimination). On a neurobiological level, several studies suggest a close link between social adversity, isolation and stress on the one hand, and monoamine dysfunction on the other, which resembles findings in schizophrenia patients. However, studies directly assessing correlations between urban stress or discrimination and neurobiological alterations in schizophrenia are lacking to date. PMID:24096775

  16. A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000-2013.

    PubMed

    Hoban, Claire L; Byard, Roger W; Musgrave, Ian F

    2015-07-01

    Herbal medicines are perceived to be safe by the general public and medical practitioners, despite abundant evidence from clinical trials and case reports that show herbal preparations can have significant adverse effects. The overall impact of adverse events to herbal medicines in Australia is currently unknown. Post marketing surveillance of medications through spontaneous adverse drug reaction (ADR) reports to the Therapeutic Goods Administration (TGA) is one way to estimate this risk. The patterns of spontaneously reported ADRs provide insight to herbal dangers, especially when compared with patterns of a mechanistically similar conventional drug. The study compared the pattern of spontaneously reported ADRs to St. John's Wort (Hypericum perforatum), a common herbal treatment for depression which contains selective serotonin reuptake inhibitors (SSRI), to fluoxetine, a commonly prescribed synthetic SSRI antidepressant. Spontaneous ADR reports sent to the TGA between 2000-2013 for St. John's Wort (n = 84) and fluoxetine (n = 447) were obtained and analysed. The demographic information, types of interaction, severity of the ADR, and the body systems affected (using the Anatomical Therapeutic Chemical classification system) were recorded for individual ADR cases. The majority of spontaneously reported ADRs for St. John's Wort and fluoxetine were concerning females aged 26-50 years (28.6%, 22.8%). The organ systems affected by ADRs to St John's Wort and fluoxetine have a similar profile, with the majority of cases affecting the central nervous system (45.2%, 61.7%). This result demonstrates that herbal preparations can result in ADRs similar to those of prescription medications.

  17. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015

    PubMed Central

    Moro, Pedro L.; Woo, Emily Jane; Paul, Wendy; Lewis, Paige; Petersen, Brett W.; Cano, Maria

    2016-01-01

    Background In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. Objective To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990–July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. PMID:27410239

  18. Childhood adversities and adult-onset asthma: a cohort study

    PubMed Central

    Korkeila, Jyrki; Lietzen, Raija; Sillanmäki, Lauri H; Rautava, Päivi; Korkeila, Katariina; Kivimäki, Mika; Koskenvuo, Markku; Vahtera, Jussi

    2012-01-01

    Objectives Childhood adversities may be important determinants of later illnesses and poor health behaviour. However, large-scale prospective studies on the associations between childhood adversities and the onset of asthma in adulthood are lacking. Design Prospective cohort study with 7-year follow-up. Setting Nationally representative study. Data were collected from the Health and Social Support (HeSSup) survey and national registers. Participants The participants represent the Finnish population from the following age groups: 20–24, 30–34, 40–44, and 50–54 years at baseline in 1998 (24 057 survey participants formed the final cohort of this study). The occurrence of childhood adversities was assessed at baseline with a six-item survey scale. The analyses were adjusted for sociodemographic characteristics, behavioural health risks and common mental disorders. Primary and secondary outcomes The survey data were linked to data from national health registers on incident asthma during a 7-year follow-up to define new-onset asthma cases with verified diagnoses. Results A total of 12 126 (59%) participants reported that they encountered a childhood adversity. Of them 3677 (18% of all) endured three to six adversities. During a follow-up of 7 years, 593 (2.9%) participants were diagnosed with incident asthma. Those who reported three or more childhood adversities had a 1.6-fold (95% CI 1.31 to 2.01) greater risk of asthma compared to those without childhood adversities. This hazard attenuated but remained statistically significant after adjustment for conventional risk factors (HR 1.33; 95% CI 1.06 to 1.67). Conclusions Adults who report having encountered adversities in childhood may have an increased risk of developing asthma. PMID:23069774

  19. EP&R Standards Project Report: Technical Review of National Incident Management Standards

    SciTech Connect

    Stenner, Robert D.

    2007-04-24

    The importance and necessity for a fully developed and implemented National Incident Management System (NIMS) has been demonstrated in recent years by the impact of national events such as Hurricane Katrina in 2005. Throughout the history of emergency response to major disasters, especially when multiple response organizations are involved, there have been systemic problems in the consistency and uniformity of response operations. Identifying national standards that support the development and implementation of NIMS is key to helping solve these systemic problems. The NIMS seeks to provide uniformity and consistency for incident management by using common terminology and protocols that will enable responders to coordinate their efforts to ensure an efficient response.

  20. Grazing incidence metal optics for the Berkeley Extreme Ultraviolet Explorer satellite - A progress report

    NASA Technical Reports Server (NTRS)

    Finley, D.; Malina, R. F.; Bowyer, S.

    1985-01-01

    The four flight Wolter-Schwarzschild mirrors currently under fabrication for the Extreme Ultraviolet Explorer (EUVE) satellite are described. The principal figuring operation of these grazing incidence metal mirrors (gold over nickel on an aluminum substrate) is carried out by diamond turning at the Lawrence Livermore National Laboratories. Turning has been accomplished and optical testing results analyzed for three of the mirrors. As-turned values of 1.7 arc sec full width at half maximum (FWHM) and half energy width (HEW) of 5 arc seconds in the visible have been achieved. These results illustrate the great potential of precision fabrication technology for the production of large grazing incidence optics.

  1. Parent Report of Antidepressant, Anxiolytic, and Antipsychotic Medication Use in Individuals with Williams Syndrome: Effectiveness and Adverse Effects

    ERIC Educational Resources Information Center

    Martens, Marilee A.; Seyfer, Daisha L.; Andridge, Rebecca R.; Foster, Jessica E. A.; Chowdhury, Monali; McClure, Kelsey E.; Coury, Daniel L.

    2012-01-01

    Williams syndrome (WS) is a neurodevelopmental genetic disorder characterized in part by anxiety and behavioral difficulties. We examine the effectiveness and adverse effects of antidepressant, anxiolytic, and antipsychotic medications in individuals with WS. A total of 513 parents/caregivers completed a survey of psychotropic medication usage…

  2. Can self-reported behavioral factors predict incident sexually transmitted diseases in high-risk African-American men?

    PubMed Central

    Slavinsky, J.; Rosenberg, D. M.; DiCarlo, R. P.; Kissinger, P.

    2000-01-01

    The known link between sexually transmitted diseases (STD) and human immunodeficiency virus (HIV), coupled with the increasing prevalence of HIV in African-American men, makes understanding STD transmission trends in this group important for directing future preventive measures. The goal of this study was to determine if self-reported behavioral factors are predictive of incident sexually transmitted diseases in a group of high risk, HIV-negative African-American men. Five hundred and sixty-two "high risk" (defined as having four or more partners in the last year or having been diagnosed with an STD in the last year) HIV-negative African-American men were administered a baseline behavioral survey and followed to detect an incident STD. Overall, 19% (n = 108) of the patients acquired an incident STD during the study period. In multivariate Cox proportional hazards analysis, the only factor associated with an incident STD was age < or = 19 (hazard ratio, 2.16; 95% confidence interval, 1.03 to 4.54). No other risk factors were statistically significant. In conclusion, self-reported behavioral factors, such as substance use and sexual practices, do not seem to be a good measure of STD risk among a group of high risk, HIV-negative, African-American men. PMID:10946531

  3. Prostate cancer incidence in men with self-reported prostatitis after 15 years of follow-up

    PubMed Central

    Vaarala, Markku H.; Mehik, Aare; Ohtonen, Pasi; Hellström, Pekka A.

    2016-01-01

    Controversy exists regarding a possible association between prostatitis and prostate cancer. To further evaluate the incidence of prostate cancer following prostatitis, a study of prostate cancer incidence in a cohort of Finnish men was performed. The original survey evaluating self-reported prostatitis was conducted in 1996–1997. A database review was conducted focusing on prostate cancer diagnoses in the cohort. In 2012, there were 13 (5.2%) and 27 (1.8%) prostate cancer cases among men with (n=251) and without (n=1,521) prostatitis symptoms, respectively. There were no significant differences in age, primary therapy distribution, prostate-specific antigen levels, Gleason score, clinical T-class at the time of prostate cancer diagnosis, or time lag between the original survey and prostate cancer diagnosis. The standardized incidence ratio (SIR) of prostate cancer was 1.16 [95% confidence interval (CI), 0.62–1.99] and 0.44 (95% CI, 0.29–0.64) among men with and without prostatitis symptoms, respectively. After 15 years of follow-up subsequent to self-reported prostatitis, no evident increase in incidence of prostate cancer was detected among Finnish men with prostatitis symptoms. The higher percentage of prostate cancer among men with prostatitis symptoms appears to be due to coincidentally low SIR of prostate cancer among men without prostatitis symptoms, and may additionally be due to increased diagnostic examinations. Further research is required to confirm this speculation. PMID:27446410

  4. Prostate cancer incidence in men with self-reported prostatitis after 15 years of follow-up.

    PubMed

    Vaarala, Markku H; Mehik, Aare; Ohtonen, Pasi; Hellström, Pekka A

    2016-08-01

    Controversy exists regarding a possible association between prostatitis and prostate cancer. To further evaluate the incidence of prostate cancer following prostatitis, a study of prostate cancer incidence in a cohort of Finnish men was performed. The original survey evaluating self-reported prostatitis was conducted in 1996-1997. A database review was conducted focusing on prostate cancer diagnoses in the cohort. In 2012, there were 13 (5.2%) and 27 (1.8%) prostate cancer cases among men with (n=251) and without (n=1,521) prostatitis symptoms, respectively. There were no significant differences in age, primary therapy distribution, prostate-specific antigen levels, Gleason score, clinical T-class at the time of prostate cancer diagnosis, or time lag between the original survey and prostate cancer diagnosis. The standardized incidence ratio (SIR) of prostate cancer was 1.16 [95% confidence interval (CI), 0.62-1.99] and 0.44 (95% CI, 0.29-0.64) among men with and without prostatitis symptoms, respectively. After 15 years of follow-up subsequent to self-reported prostatitis, no evident increase in incidence of prostate cancer was detected among Finnish men with prostatitis symptoms. The higher percentage of prostate cancer among men with prostatitis symptoms appears to be due to coincidentally low SIR of prostate cancer among men without prostatitis symptoms, and may additionally be due to increased diagnostic examinations. Further research is required to confirm this speculation.

  5. Conflicting calculations of pelvic incidence and pelvic tilt secondary to transitional lumbosacral anatomy (lumbarization of S-1): case report.

    PubMed

    Crawford, Charles H; Glassman, Steven D; Gum, Jeffrey L; Carreon, Leah Y

    2017-01-01

    Advancements in the understanding of adult spinal deformity have led to a greater awareness of the role of the pelvis in maintaining sagittal balance and alignment. Pelvic incidence has emerged as a key radiographic measure and should closely match lumbar lordosis. As proper measurement of the pelvic incidence requires accurate identification of the S-1 endplate, lumbosacral transitional anatomy may lead to errors. The purpose of this study is to demonstrate how lumbosacral transitional anatomy may lead to errors in the measurement of pelvic parameters. The current case highlights one of the potential complications that can be avoided with awareness. The authors report the case of a 61-year-old man who had undergone prior lumbar surgeries and then presented with symptomatic lumbar stenosis and sagittal malalignment. Radiographs showed a lumbarized S-1. Prior numbering of the segments in previous surgical and radiology reports led to a pelvic incidence calculation of 61°. Corrected numbering of the segments using the lumbarized S-1 endplate led to a pelvic incidence calculation of 48°. Without recognition of the lumbosacral anatomy, overcorrection of the lumbar lordosis might have led to negative sagittal balance and the propensity to develop proximal junction failure. This case illustrates that improper identification of lumbosacral transitional anatomy may lead to errors that could affect clinical outcome. Awareness of this potential error may help improve patient outcomes.

  6. Self-Reported Prevalence of Symptomatic Adverse Reactions to Gluten and Adherence to Gluten-Free Diet in an Adult Mexican Population.

    PubMed

    Ontiveros, Noe; López-Gallardo, Jesús A; Vergara-Jiménez, Marcela J; Cabrera-Chávez, Francisco

    2015-07-21

    The prevalence of symptomatic adverse reactions to gluten and adherence to gluten-free diet in Latin American countries is unknown. These measurements are strongly linked to gluten-related disorders. This work aimed to estimate the prevalence of adverse reactions to oral gluten and the adherence to gluten-free diet in the adult Mexican population. To reach this aim, a self-administered questionnaire was designed and tested for clarity/comprehension and reproducibility. Then, a self-administered questionnaire-based cross-sectional study was conducted in the Mexican population. The estimated prevalence rates were (95% CI): 11.9% (9.9-13.5) and 7.8 (6.4-9.4) for adverse and recurrent adverse reactions to gluten respectively; adherence to gluten-free diet 3.7% (2.7-4.8), wheat allergy 0.72% (0.38-1.37); celiac disease 0.08% (0.01-0.45), and NCGS 0.97% (0.55-1.68). Estimated pooled prevalence of self-reported physician-diagnosis of gluten-related disorders was 0.88% (0.49-1.5), and 93.3% respondents reported adherence to gluten-free diet without a physician-diagnosis of gluten-related disorders. Symptom comparisons between those who reported recurrent adverse reactions to gluten and other foods showed statistically significant differences for bloating, constipation, and tiredness (p < 0.05). Gluten-related disorders may be underdiagnosed in the Mexican population and most people adhering to a gluten-free diet are doing it without proper diagnostic work-up of these disorders, and probably without medical/dietician advice.

  7. 49 CFR 225.9 - Telephonic reports of certain accidents/incidents and other events.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the— (i) Death of a rail passenger or a railroad employee; (ii) Death of an employee of a contractor... other events. (a) Types of accidents/incidents and other events to be reported—(1) Certain deaths or... contracting railroad; or (iii) Death or injury of five or more persons. (2) Certain train accidents or...

  8. 49 CFR 225.9 - Telephonic reports of certain accidents/incidents and other events.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... the— (i) Death of a rail passenger or a railroad employee; (ii) Death of an employee of a contractor... other events. (a) Types of accidents/incidents and other events to be reported—(1) Certain deaths or... contracting railroad; or (iii) Death or injury of five or more persons. (2) Certain train accidents or...

  9. 49 CFR 225.9 - Telephonic reports of certain accidents/incidents and other events.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... the— (i) Death of a rail passenger or a railroad employee; (ii) Death of an employee of a contractor... other events. (a) Types of accidents/incidents and other events to be reported—(1) Certain deaths or... contracting railroad; or (iii) Death or injury of five or more persons. (2) Certain train accidents or...

  10. 49 CFR 225.9 - Telephonic reports of certain accidents/incidents and other events.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... and other events. 225.9 Section 225.9 Transportation Other Regulations Relating to Transportation... other events. (a) Types of accidents/incidents and other events to be reported—(1) Certain deaths or... railroad, or an event or exposure that may have arisen from the operation of the railroad, that results...

  11. 49 CFR 225.9 - Telephonic reports of certain accidents/incidents and other events.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... and other events. 225.9 Section 225.9 Transportation Other Regulations Relating to Transportation... other events. (a) Types of accidents/incidents and other events to be reported—(1) Certain deaths or... railroad, or an event or exposure that may have arisen from the operation of the railroad, that results...

  12. 76 FR 54004 - Agency Information Collection (Report of Medical, Legal, and Other Expenses Incident to Recovery...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... for Injury or Death) Activity under OMB Review AGENCY: Veterans Benefits Administration, Department of..., and Other Expenses Incident to Recovery for Injury or Death, VA Form 21-8416b. OMB Control Number... injury or death. Such award is considered as countable income; however, medical, legal or other...

  13. Adverse effects of extra-articular corticosteroid injections: a systematic review

    PubMed Central

    2010-01-01

    Background To estimate the occurrence and type of adverse effects after application of an extra-articular (soft tissue) corticosteroid injection. Methods A systematic review of the literature was made based on a PubMed and Embase search covering the period 1956 to January 2010. Case reports were included, as were prospective and retrospective studies that reported adverse events of corticosteroid injection. All clinical trials which used extra-articular corticosteroid injections were examined. We divided the reported adverse events into major (defined as those needing intervention or not disappearing) and minor ones (transient, not requiring intervention). Results The search yielded 87 relevant studies:44 case reports, 37 prospective studies and 6 retrospective studies. The major adverse events included osteomyelitis and protothecosis; one fatal necrotizing fasciitis; cellulitis and ecchymosis; tendon ruptures; atrophy of the plantar fat was described after injecting a neuroma; and local skin effects appeared as atrophy, hypopigmentation or as skin defect. The minor adverse events effects ranged from skin rash to flushing and disturbed menstrual pattern. Increased pain or steroid flare after injection was reported in 19 studies. After extra-articular injection, the incidence of major adverse events ranged from 0-5.8% and that of minor adverse events from 0-81%. It was not feasible to pool the risk for adverse effects due to heterogeneity of study populations and difference in interventions and variance in reporting. Conclusion In this literature review it was difficult to accurately quantify the incidence of adverse effects after extra-articular corticosteroid injection. The reported adverse events were relatively mild, although one fatal reaction was reported. PMID:20836867

  14. Adverse Drug Reactions Reported to a National HIV & Tuberculosis Health Care Worker Hotline in South Africa: Description and Prospective Follow-Up of Reports

    PubMed Central

    Njuguna, Christine; Stewart, Annemie; Mouton, Johannes P.; Blockman, Marc; Maartens, Gary; Swart, Annoesjka; Chisholm, Briony; Jones, Jackie; Dheda, Mukesh; Igumbor, Ehimario U.

    2015-01-01

    Introduction The National HIV & Tuberculosis Health Care Worker (HCW) Hotline provides advice on the management of suspected adverse drug reactions (ADRs). We describe suspected ADRs reported to the hotline by HCWs, concordance with advice, and patient outcomes. Methods We reviewed suspected ADRs in HIV-infected patients, patients taking antiretrovirals and patients taking anti-tuberculosis therapy reported from May 2013 to October 2014. We performed causality assessment using the World Health Organization Uppsala Monitoring Centre (WHO-UMC) criteria. We included suspected ADRs categorized as certain, probable or possible in further analysis. Results We received 772 ADR reports, of which 87/772 (11.3 %) were classified as certain, 176/772 (22.8 %) as probable, 361/772 (46.8 %) as possible, and 148/772 (19.2 %) as unlikely or unassessable. The most frequent ADRs were rash, drug-induced liver injury (DILI) and kidney injury, comprising 110/624 (17.6 %), 87/624 (13.9 %), and 77/624 (12.3 %), respectively. The ADR was severe in 27.3 % of rashes, 36.4 % of kidney injury reports and 88.5 % of DILI reports. Most frequently implicated drugs, either alone or in combination with other potentially causative drugs, were efavirenz (rashes), efavirenz and anti-tuberculosis drugs (DILI) and tenofovir (kidney injury). In 383 cases with HCW follow-up, 254 (66.3 %) improved, 9 (2.3 %) had complete resolution, 32 (8.4 %) remained unchanged, 6 (1.6 %) deteriorated, 10 (2.6 %) died and 72 (18.8 %) had unknown outcome. Advice provided was followed in 93.2 % of these cases. Of 223 ADRs with preventability data, 40 (17.9 %) were preventable. Conclusion Queries about rashes, DILIs and kidney injuries were common. Detection and management of these ADRs should be included in HCW training. In cases with follow-up, concordance with advice was high, and HCWs reported improvement in the majority. PMID:26547719

  15. What Happened, and Why: Toward an Understanding of Human Error Based on Automated Analyses of Incident Reports. Volume 2

    NASA Technical Reports Server (NTRS)

    Ferryman, Thomas A.; Posse, Christian; Rosenthal, Loren J.; Srivastava, Ashok N.; Statler, Irving C.

    2006-01-01

    The objective of the Aviation System Monitoring and Modeling project of NASA's Aviation Safety and Security Program was to develop technologies to enable proactive management of safety risk, which entails identifying the precursor events and conditions that foreshadow most accidents. Information about what happened can be extracted from quantitative data sources, but the experiential account of the incident reporter is the best available source of information about why an incident happened. In Volume I, the concept of the Scenario was introduced as a pragmatic guide for identifying similarities of what happened based on the objective parameters that define the Context and the Outcome of a Scenario. In this Volume II, that study continues into the analyses of the free narratives to gain understanding as to why the incident occurred from the reporter s perspective. While this is just the first experiment, the results of our approach are encouraging and indicate that it will be possible to design an automated analysis process guided by the structure of the Scenario that can achieve the level of consistency and reliability of human analysis of narrative reports.

  16. Final Report for "Accurate Numerical Models of the Secondary Electron Yield from Grazing-incidence Collisions".

    SciTech Connect

    Seth A Veitzer

    2008-10-21

    Effects of stray electrons are a main factor limiting performance of many accelerators. Because heavy-ion fusion (HIF) accelerators will operate in regimes of higher current and with walls much closer to the beam than accelerators operating today, stray electrons might have a large, detrimental effect on the performance of an HIF accelerator. A primary source of stray electrons is electrons generated when halo ions strike the beam pipe walls. There is some research on these types of secondary electrons for the HIF community to draw upon, but this work is missing one crucial ingredient: the effect of grazing incidence. The overall goal of this project was to develop the numerical tools necessary to accurately model the effect of grazing incidence on the behavior of halo ions in a HIF accelerator, and further, to provide accurate models of heavy ion stopping powers with applications to ICF, WDM, and HEDP experiments.

  17. Leisure-related injuries at the beach: an analysis of lifeguard incident report forms in New Zealand, 2007-12.

    PubMed

    Moran, Kevin; Webber, Jonathon

    2014-01-01

    From 2007-2012, New Zealand lifeguards provided first aid to almost 9,000 beachgoers, an average of 1,772 cases per annum; more than the average number of rescues (n = 1,343) each year. This study describes the aetiology of non-drowning related injuries occurring at surf beaches patrolled by lifeguards. The study design was that of a retrospective analysis of data collated during five summer seasons from 2007-2012. Cases included individuals who sustained recreational injuries while at a patrolled beach in New Zealand. Incident report forms, routinely completed by lifeguards in New Zealand, were the data source for this study. Of the 8,437 incidents evaluated, 57% of the patients were males, one half (52%) were aged less than 16 years. Most injuries (82%) were minor, almost half (43%) were to the lower limbs. Half (54%) of the injuries were sustained in the water, one third (32%) were attributed to land-based activities. Cuts/abrasions accounted for almost half (47%) of all injuries. First aid responses for both water and land-based incidents are indicative of the nature and extent of recreational injuries sustained at the beach. The diversity and frequency of such incidents suggests that public education promoting beach safety is warranted.

  18. Telithromycin: review of adverse effects.

    PubMed

    2014-11-01

    Telithromycin is a macrolide antibiotic that has been marketed since the early 2000s. It has not been shown to be more effective against any bacteria than other macrolide antibiotics. Its antibacterial activity is in no way remarkable. In early 2014, we reviewed its adverse effect profile using data from periodic safety update reports, drug regulatory agencies, and detailed published case reports. In addition to the adverse effect profile telithromycin shares with the other macrolides, it provokes several specific adverse effects: visual disturbances due to impaired accommodation; taste and smell disorders; severe liver damage; worsening of myasthenia gravis; rhabdomyolysis; and loss of consciousness. Prolongation of the QT interval with standard oral doses is a worrisome adverse effect. In practice, it is better not to use telithromycin as it exposes patients to disproportionate, serious adverse effects. When treatment with a macrolide antibiotic appears necessary, it is prudent to choose a different macrolide, such as spiramycin or azithromycin, which have fewer adverse effects.

  19. Incidence and Characteristics of Ventilator-Associated Events Reported to the National Healthcare Safety Network in 2014*

    PubMed Central

    Li, Qunna; Gross, Cindy; Dudeck, Margaret; Allen-Bridson, Katherine; Edwards, Jonathan R.

    2016-01-01

    Objective: Ventilator-associated event surveillance was introduced in the National Healthcare Safety Network in 2013, replacing surveillance for ventilator-associated pneumonia in adult inpatient locations. We determined incidence rates and characteristics of ventilator-associated events reported to the National Healthcare Safety Network. Design, Setting, and Patients: We analyzed data reported from U.S. healthcare facilities for ventilator-associated events that occurred in 2014, the first year during which ventilator-associated event surveillance definitions were stable. We used negative binomial regression modeling to identify healthcare facility and inpatient location characteristics associated with ventilator-associated events. We calculated ventilator-associated event incidence rates, rate distributions, and ventilator utilization ratios in critical care and noncritical care locations and described event characteristics. Measurements and Main Results: A total of 1,824 healthcare facilities reported 32,772 location months of ventilator-associated event surveillance data to the National Healthcare Safety Network in 2014. Critical care unit pooled mean ventilator-associated event incidence rates ranged from 2.00 to 11.79 per 1,000 ventilator days, whereas noncritical care unit rates ranged from 0 to 14.86 per 1,000 ventilator days. The pooled mean proportion of ventilator-associated events defined as infection-related varied from 15.38% to 47.62% in critical care units. Pooled mean ventilator utilization ratios in critical care units ranged from 0.24 to 0.47. Conclusions: We found substantial variability in ventilator-associated event incidence, proportions of ventilator-associated events characterized as infection-related, and ventilator utilization within and among location types. More work is needed to understand the preventable fraction of ventilator-associated events and identify patient care strategies that reduce ventilator-associated events. PMID

  20. German critical incident reporting system database of prehospital emergency medicine: Analysis of reported communication and medication errors between 2005–2015

    PubMed Central

    Hohenstein, Christian; Fleischmann, Thomas; Rupp, Peter; Hempel, Dorothea; Wilk, Sophia; Winning, Johannes

    2016-01-01

    BACKGROUND: Communication failure in prehospital emergency medicine can affect patient safety as it does in other areas of medicine as well. We analyzed the database of the critical incident reporting system for prehospital emergency medicine in Germany retrospectively regarding communication errors. METHODS: Experts of prehospital emergency medicine and risk management screened the database for verbal communication failure, non-verbal communication failure and missing communication at all. RESULTS: Between 2005 and 2015, 845 reports were analyzed, of which 247 reports were considered to be related to communication failure. An arbitrary classification resulted in six different kinds: 1) no acknowledgement of a suggestion; 2) medication error; 3) miscommunication with dispatcher; 4) utterance heard/understood improperly; 5) missing information transfer between two persons; and 6) other communication failure. CONCLUSION: Communication deficits can lead to critical incidents in prehospital emergency medicine and are a very important aspect in patient safety. PMID:27313802

  1. Notes from the Field: Increase in Reported Adverse Health Effects Related to Synthetic Cannabinoid Use - United States, January-May 2015.

    PubMed

    Law, Royal; Schier, Josh; Martin, Colleen; Chang, Arthur; Wolkin, Amy

    2015-06-12

    On April 6, 2015, CDC received notification of an increase in telephone calls to U.S. poison centers related to synthetic cannabinoid use. Monthly calls to all poison centers are tracked by the National Poison Data System, which reported that adverse health effects or concerns about possible adverse health effects related to synthetic cannabinoid use increased 330% from 349 in January 2015 to 1,501 in April 2015. Synthetic cannabinoids include various psychoactive chemicals or a mixture of such chemicals that are sprayed onto plant material, which is then often smoked or ingested to achieve a "high." These products are sold under a variety of names (e.g., synthetic marijuana, spice, K2, black mamba, and crazy clown) and can be sold in retail outlets as herbal products. Law enforcement agencies have regulated a number of these substances; however, manufacturers of synthetic cannabinoids frequently change the formulation to avoid detection and regulation. After the initial notification, CDC analyzed information from the National Poison Data System on reported adverse health effects related to synthetic cannabinoid use for the period January-May 2015.

  2. Meeting Report: Moving Upstream—Evaluating Adverse Upstream End Points for Improved Risk Assessment and Decision-Making

    PubMed Central

    Woodruff, Tracey J.; Zeise, Lauren; Axelrad, Daniel A.; Guyton, Kathryn Z.; Janssen, Sarah; Miller, Mark; Miller, Gregory G.; Schwartz, Jackie M.; Alexeeff, George; Anderson, Henry; Birnbaum, Linda; Bois, Frederic; Cogliano, Vincent James; Crofton, Kevin; Euling, Susan Y.; Foster, Paul M.D.; Germolec, Dori R.; Gray, Earl; Hattis, Dale B.; Kyle, Amy D.; Luebke, Robert W.; Luster, Michael I.; Portier, Chris; Rice, Deborah C.; Solomon, Gina; Vandenberg, John; Zoeller, R. Thomas

    2008-01-01

    Background Assessing adverse effects from environmental chemical exposure is integral to public health policies. Toxicology assays identifying early biological changes from chemical exposure are increasing our ability to evaluate links between early biological disturbances and subsequent overt downstream effects. A workshop was held to consider how the resulting data inform consideration of an “adverse effect” in the context of hazard identification and risk assessment. Objectives Our objective here is to review what is known about the relationships between chemical exposure, early biological effects (upstream events), and later overt effects (downstream events) through three case studies (thyroid hormone disruption, antiandrogen effects, immune system disruption) and to consider how to evaluate hazard and risk when early biological effect data are available. Discussion Each case study presents data on the toxicity pathways linking early biological perturbations with downstream overt effects. Case studies also emphasize several factors that can influence risk of overt disease as a result from early biological perturbations, including background chemical exposures, underlying individual biological processes, and disease susceptibility. Certain effects resulting from exposure during periods of sensitivity may be irreversible. A chemical can act through multiple modes of action, resulting in similar or different overt effects. Conclusions For certain classes of early perturbations, sufficient information on the disease process is known, so hazard and quantitative risk assessment can proceed using information on upstream biological perturbations. Upstream data will support improved approaches for considering developmental stage, background exposures, disease status, and other factors important to assessing hazard and risk for the whole population. PMID:19057713

  3. Masking in reports of “most serious” events: bias in estimators of sports injury incidence in Canadian children

    PubMed Central

    Gupta, A.; Davison, C. M.; McIsaac, M. A.

    2016-01-01

    Abstract Introduction: Surveys that collect information on injuries often focus on the single “most serious” event to help limit recall error and reduce survey length. However, this can mask less serious injuries and result in biased incidence estimates for specific injury subcategories. Methods: Data from the 2002 Health Behaviour in School-aged Children (HBSC) survey and from the Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP) were used to compare estimates of sports injury incidence in Canadian children. Results: HBSC data indicate that 6.7% of children report sustaining a sports injury that required an emergency department (ED) visit. However, details were only collected on a child’s “most serious” injury, so children who had multiple injuries requiring an ED visit may have had sports injuries that went unreported. The rate of 6.7% can be seen to be an underestimate by as much as 4.3%. Corresponding CHIRPP surveillance data indicate an incidence of 9.9%. Potential masking bias is also highlighted in our analysis of injuries attended by other health care providers. Conclusion: The “one most serious injury” line of questioning induces potentially substantial masking bias in the estimation of sports injury incidence, which limits researchers’ ability to quantify the burden of sports injury. Longer survey recall periods naturally lead to greater masking. The design of future surveys should take these issues into account. In order to accurately inform policy decisions and the direction of future research, researchers must be aware of these limitations. PMID:27556918

  4. Reported fried food consumption and the incidence of hypertension in a Mediterranean cohort: the SUN (Seguimiento Universidad de Navarra) project.

    PubMed

    Sayon-Orea, Carmen; Bes-Rastrollo, Maira; Gea, Alfredo; Zazpe, Itziar; Basterra-Gortari, Francisco J; Martinez-Gonzalez, Miguel A

    2014-09-28

    Reported associations between the consumption of fried foods and the incidence of obesity or weight gain make it likely that fried food consumption might also be associated with the development of hypertension. However, evidence from long-term prospective studies is scarce. Therefore, the aim of the present study was to longitudinally evaluate this association in a prospective cohort. The SUN (Seguimiento Universidad de Navarra) project is a Mediterranean cohort study of university graduates conducted in Spain, which started in December 1999 and is still ongoing. In the present study, we included 13,679 participants (5059 men and 8620 women), free of hypertension at baseline with a mean age of 36·5 (SD 10·8) years. Total fried food consumption was estimated at baseline. The outcome was the incidence of a medical diagnosis of self-reported hypertension during the follow-up period. To assess the association between the consumption of fried foods and the subsequent risk of developing incident hypertension during the follow-up period, Cox regression models were used. During a median follow-up period of 6·3 years, 1232 incident cases of hypertension were identified. After adjusting for potential confounders, the adjusted hazard ratios for developing hypertension were 1·18 (95% CI 1·03, 1·36) and 1·21 (95% CI 1·04, 1·41) for those consuming fried foods 2-4 and >4 times/week, respectively, compared with those consuming fried foods < 2 times/week (P for trend = 0·009). In conclusion, frequent consumption of fried foods at baseline was found to be associated with a higher risk of hypertension during the follow-up period in a Mediterranean cohort of university graduates.

  5. Data mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination.

    PubMed

    Niu, M T; Erwin, D E; Braun, M M

    2001-09-14

    The Vaccine Adverse Event Reporting System (VAERS) is the US passive surveillance system monitoring vaccine safety. A major limitation of VAERS is the lack of denominator data (number of doses of administered vaccine), an element necessary for calculating reporting rates. Empirical Bayesian data mining, a data analysis method, utilizes the number of events reported for each vaccine and statistically screens the database for higher than expected vaccine-event combinations signaling a potential vaccine-associated event. This is the first study of data mining in VAERS designed to test the utility of this method to detect retrospectively a known side effect of vaccination-intussusception following rotavirus (RV) vaccine. From October 1998 to December 1999, 112 cases of intussusception were reported. The data mining method was able to detect a signal for RV-intussusception in February 1999 when only four cases were reported. These results demonstrate the utility of data mining to detect significant vaccine-associated events at early date. Data mining appears to be an efficient and effective computer-based program that may enhance early detection of adverse events in passive surveillance systems.

  6. Adverse Reactions to Hallucinogenic Drugs.

    ERIC Educational Resources Information Center

    Meyer, Roger E. , Ed.

    This reports a conference of psychologists, psychiatrists, geneticists and others concerned with the biological and psychological effects of lysergic acid diethylamide and other hallucinogenic drugs. Clinical data are presented on adverse drug reactions. The difficulty of determining the causes of adverse reactions is discussed, as are different…

  7. Structural problems of medical news reports in newspapers: a verification of news reports on an incident of mass nosocomial Serratia infection.

    PubMed

    Mizuno, Yasuhiro; Narimatsu, Hiroto; Kishi, Yukiko; Kodama, Yuko; Murashige, Naoko; Yuji, Koichiro; Matsumura, Tomoko; Kami, Masahiro

    2010-04-01

    It is unclear how changes in the content and number of news reports over time affect the impressions made in the minds of newspaper readers. This study targeted news reports in major newspapers regarding an incident of mass nosocomial Serratia infection that occurred at one clinic. The trends in the total number of articles and total number of characters contained in the articles were congruent, with a peak on the day after the incident was disclosed and a rapid decrease thereafter. The numbers of articles and characters that appeared during the first 3 days corresponded to 45 and 51% of those that appeared during the entire study period. On day 9, it was published that Serratia liquefaciens propagated on medical instruments, and both the number of articles and the number of characters increased by approximately 40% in comparison to those published on the day after the initial report of the incident. The individual articles were deemed to be medically accurate; however, the main problem was that only part of the specific medical issue had been emphasized because of a poor balance in the number of news reports on this topic.

  8. Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study

    PubMed Central

    Hansen, Niels Dalum; Valentiner-Branth, Palle

    2016-01-01

    Background Since 2013 the number of suspected adverse reactions to the quadrivalent human papillomavirus (HPV) vaccine reported to the Danish Medicines Agency (DMA) has increased. Due to the resulting public concerns about vaccine safety, the coverage of HPV vaccinations in the childhood vaccination programme has declined. The aim of the present study was to determine health care-seeking prior to the first HPV vaccination among females who suspected adverse reactions to HPV vaccine. Methods In this registry-based case-control study, we included as cases vaccinated females with reports to the DMA of suspected severe adverse reactions. We selected controls without reports of adverse reactions from the Danish vaccination registry and matched by year of vaccination, age of vaccination, and municipality, and obtained from the Danish National Patient Registry and The National Health Insurance Service Register the history of health care usage two years prior to the first vaccine. We analysed the data by logistic regression while adjusting for the matching variables. Results The study included 316 cases who received first HPV vaccine between 2006 and 2014. Age range of cases was 11 to 52 years, with a peak at 12 years, corresponding to the recommended age at vaccination, and another peak at 19 to 28 years, corresponding to a catch-up programme targeting young women. Compared with 163,910 controls, cases had increased care-seeking in the two years before receiving the first HPV vaccine. A multivariable model showed higher use of telephone/email consultations (OR 1.9; 95% CI 1.2–3.2), physiotherapy (OR 2.1; 95% CI 1.6–2.8) and psychologist/psychiatrist (OR 1.9; 95% CI 1.3–2.7). Cases were more likely to have a diagnosis in the ICD-10 chapters of diseases of the digestive system (OR 1.6; 95% CI 1.0–2.4), of the musculoskeletal system (OR 1.6; 95% CI 1.1–2.2), symptoms or signs not classified elsewhere (OR 1.8; 95% CI 1.3–2.5) as well as injuries (OR 1.5; 95% CI 1

  9. Reports of Perceived Adverse Events of Stimulant Medication on Cognition, Motivation, and Mood: Qualitative Investigation and the Generation of Items for the Medication and Cognition Rating Scale

    PubMed Central

    Kovshoff, Hanna; Banaschewski, Tobias; Buitelaar, Jan K.; Carucci, Sara; Coghill, David; Danckaerts, Marina; Dittmann, Ralf W.; Falissard, Bruno; Grimshaw, Dina Gojkovic; Hollis, Chris; Inglis, Sarah; Konrad, Kerstin; Liddle, Elizabeth; McCarthy, Suzanne; Nagy, Peter; Thompson, Margaret; Wong, Ian C.K.; Zuddas, Alessandro

    2016-01-01

    Abstract Objective: There is no questionnaire to specifically monitor perceived adverse events of methylphenidate (MPH) on cognition, motivation, and mood. The current study therefore had two goals. First, to harvest accounts of such putative events from transcripts of interviews in samples enriched for such potential experiences. Second, to use the derived data to generate items for a new questionnaire that can be used for monitoring such events in medication trials or routine clinical care. Methods: Following a literature search aimed at identifying associations between MPH and cognition and/or motivation, a qualitative semistructured interview was designed to focus specifically on the domains of cognition (i.e., reasoning, depth/breadth of thinking, intellectual capacity, and creativity) and motivation (i.e., drive, effort, and attitudes toward rewards/incentives). Interviews were conducted with 45 participants drawn from the following four groups: (a) clinicians, child and adolescent psychiatrists, and pediatricians specializing in attention-deficit/hyperactivity disorder (ADHD) (n = 15); (2) teachers, with experience of teaching at least 10 medicated children with ADHD (n = 10); (3) parents of children with ADHD (n = 8) treated with MPH; and (4) adolescents/adults with ADHD (n = 12). Purposeful sampling was used to selectively recruit ADHD participants whose histories suggested a degree of vulnerability to MPH adverse events. Data were analyzed using a deductive approach to content analysis. Results: While we probed purposefully for cognitive and motivational adverse events, a third domain, related to mood, emerged from the reports. Therefore, three domains, each with a number of subdomains, were identified from the interview accounts: (i) Cognition (six subdomains; attention/concentration, changes in thinking, reduced creativity, sensory overload, memory, slower processing speed); (ii) motivation (four subdomains; loss of intrinsic motivation

  10. Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    PubMed Central

    Reeve, Bryce B.; Mitchell, Sandra A.; Clauser, Steven B.; Minasian, Lori M.; Dueck, Amylou C.; Mendoza, Tito R.; Hay, Jennifer; Atkinson, Thomas M.; Abernethy, Amy P.; Bruner, Deborah W.; Cleeland, Charles S.; Sloan, Jeff A.; Chilukuri, Ram; Baumgartner, Paul; Denicoff, Andrea; St. Germain, Diane; O’Mara, Ann M.; Chen, Alice; Kelaghan, Joseph; Bennett, Antonia V.; Sit, Laura; Rogak, Lauren; Barz, Allison; Paul, Diane B.; Schrag, Deborah

    2014-01-01

    The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute’s (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research. PMID:25265940

  11. 75 FR 75911 - Adjustment of Monetary Threshold for Reporting Rail Equipment Accidents/Incidents for Calendar...

    Federal Register 2010