Science.gov

Sample records for adverse incident reporting

  1. Developing a departmental culture for reporting adverse incidents.

    PubMed

    Bhatia, R; Blackshaw, G; Rogers, A; Grant, A; Kulkarni, R

    2003-01-01

    A simple, reproducible model for reporting adverse events was developed in order to promote cultural awareness and acceptance of risk management within the authors' department. A departmental proforma was created and prospective reporting of adverse events was encouraged. In the six months prior to commencing this study only four adverse incidents were reported. Following the introduction of the proforma 64 critical incidents and near-misses were reported in the one-year period. In conclusion a simple model for reporting critical incidents and near-misses has been established. This has fostered a cultural change within the department and all members of staff feel more comfortable with reporting such incidents. The process is seen as educational and an important part of continuing professional and departmental development. Protocols and changes in organisational practice have been developed to reduce and prevent the occurrence of adverse events and offer patients continuous improvement in care. PMID:12870255

  2. Incidence and pattern of 12 years of reported transfusion adverse events in Zimbabwe: a retrospective analysis

    PubMed Central

    Mafirakureva, Nyashadzaishe; Khoza, Star; Mvere, David A.; Chitiyo, McLeod E.; Postma, Maarten J.; van Hulst, Marinus

    2014-01-01

    Background Haemovigilance hinges on a systematically structured reporting system, which unfortunately does not always exist in resource-limited settings. We determined the incidence and pattern of transfusion-related adverse events reported to the National Blood Service Zimbabwe. Materials and methods A retrospective review of the transfusion-event records of the National Blood Service Zimbabwe was conducted covering the period from 1 January 1999 to 31 December 2011. All transfusion-related event reports received during the period were analysed. Results A total of 308 transfusion adverse events (0.046%) were reported for 670,625 blood components distributed. The majority (61.6%) of the patients who experienced an adverse event were female. The median age was 36 years (range, 1–89 years). The majority (68.8%) of the adverse events were acute transfusion reactions consisting of febrile non-haemolytic transfusion reactions (58.5%), minor allergies (31.6%), haemolytic reactions (5.2%), severe allergic reactions (2.4%), anaphylaxis (1.4%) and hypotension (0.9%). Two-thirds (66.6%) of the adverse events occurred following administration of whole blood, although only 10.6% of the blood was distributed as whole blood. Packed cells, which accounted for 75% of blood components distributed, were associated with 20.1% of the events. Discussion The incidence of suspected transfusion adverse events was generally lower than the incidences reported globally in countries with well-established haemovigilance systems. The administration of whole blood was disproportionately associated with transfusion adverse events. The pattern of the transfusion adverse events reported here highlights the probable differences in practice between different settings. Under-reporting of transfusion events is rife in passive reporting systems. PMID:24887217

  3. What Can Hospitalized Patients Tell Us About Adverse Events? Learning from Patient-Reported Incidents

    PubMed Central

    Weingart, Saul N; Pagovich, Odelya; Sands, Daniel Z; Li, Joseph M; Aronson, Mark D; Davis, Roger B; Bates, David W; Phillips, Russell S

    2005-01-01

    Purpose Little is known about how well hospitalized patients can identify errors or injuries in their care. Accordingly, the purpose of this study was to elicit incident reports from hospital inpatients in order to identify and characterize adverse events and near-miss errors. Subjects We conducted a prospective cohort study of 228 adult inpatients on a medicine unit of a Boston teaching hospital. Methods Investigators reviewed medical records and interviewed patients during the hospitalization and by telephone 10 days after discharge about “problems,”“mistakes,” and “injuries” that occurred. Physician investigators classified patients' reports. We calculated event rates and used multivariable Poisson regression models to examine the factors associated with patient-reported events. Results Of 264 eligible patients, 228 (86%) agreed to participate and completed 528 interviews. Seventeen patients (8%) experienced 20 adverse events; 1 was serious. Eight patients (4%) experienced 13 near misses; 5 were serious or life threatening. Eleven (55%) of 20 adverse events and 4 (31%) of 13 near misses were documented in the medical record, but none were found in the hospital incident reporting system. Patients with 3 or more drug allergies were more likely to report errors compared with patients without drug allergies (incidence rate ratio 4.7, 95% CI 1.7, 13.4). Conclusion Inpatients can identify adverse events affecting their care. Many patient-identified events are not captured by the hospital incident reporting system or recorded in the medical record. Engaging hospitalized patients as partners in identifying medical errors and injuries is a potentially promising approach for enhancing patient safety. PMID:16117751

  4. 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

  5. Incident reporting.

    PubMed

    Wilson, J

    Healthcare delivery is a risky business. People view the NHS in the same light as other commercial businesses such as the hotel, retail and airline industries. The White Paper 'The New NHS: Modern, Dependable' (Secretary of State for Health, 1997) places statutory responsibilities on managers and clinicians to provide a quality service and to have accountability for clinical governance and performance management. Quality and risk are two sides of the same coin, i.e. if you have good quality you have low risk, and this firmly supports the clinical effectiveness agenda. Healthcare organizations in all sectors of care delivery need to demonstrate their high levels of achievement and commitment to continuous quality improvements. Risk management is a process for identifying, assessing and evaluating risks which have adverse effects on the quality, safety and effectiveness of service delivery, and taking positive action to eliminate or reduce them. Having an open, honest and blame-free organization which is open to improving processes and systems of care is a big step towards having staff who are committed to quality and getting things right. Near-miss, incident and indicator recording and reporting are cornerstones of any quality and risk management system.

  6. From Blaming to Learning: Re-Framing Organisational Learning from Adverse Incidents

    ERIC Educational Resources Information Center

    Gray, Dee; Williams, Sion

    2011-01-01

    Purpose: This paper aims to discuss and present research findings from a proof of concept pilot, set up to test whether a teaching intervention which incorporated a dual reporting and learning approach from adverse incidents, could contribute towards individual and organisational approaches to patient safety. Design/methodology/approach: The study…

  7. 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.

  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. PMID:26246282

  9. Adverse incidents resulting in exposure to body fluids at a UK dental teaching hospital over a 6-year period

    PubMed Central

    Hughes, A; Davies, L; Hale, R; Gallagher, JE

    2012-01-01

    Background: The safety and protection of patients and health care workers is of paramount importance in dentistry, and this includes students in training who provide clinical care. Given the nature of dental care, adverse incidents can and do occur, exposing health care workers to body fluids and putting them at risk of infection, including contracting a blood-borne virus. The aim of this research was to analyze trends in the volume, rate, nature, management, and outcome of adverse incidents reported at one dental teaching hospital from 2005 to 2010. Methods: Descriptive analysis of trends in the volume, rate, nature, management, and outcome of adverse incidents reported at one dental teaching hospital over a six-year period was undertaken in relation to the level of outpatient and day surgery activity. Results: In total, 287 incidents were reported over a six-year period, which amounted to 0.039% of outpatient or day surgery appointments. Nearly three quarters of all the incidents (n = 208, 72%) took place during treatment or whilst clearing away after the appointment. The most frequent incidents were associated with administration of local anesthetic (n = 63, 22%), followed by burs used in dental hand pieces (n = 51, 18%). Conclusion: This research confirms that adverse incidents are a feature of dental hospitals and reports the common sources. The importance of accurate and consistent reporting of data to ensure that these issues are monitored to inform action and reduce risks to staff, students, and patients are highlighted. PMID:23118545

  10. Encouraging spontaneous reporting of adverse effects.

    PubMed

    2015-02-01

    One priority when organising surveillance of health products is to remove barriers to reporting adverse effects. One way to encourage reporting is by providing regular feedback, as practised by the German drug bulletin arznei-telegramm, for example. PMID:25802925

  11. Incidence and nature of adverse reactions to antibiotics used as endocarditis prophylaxis

    PubMed Central

    Thornhill, Martin H.; Dayer, Mark J.; Prendergast, Bernard; Baddour, Larry M.; Jones, Simon; Lockhart, Peter B.

    2015-01-01

    Objectives Antibiotic prophylaxis (AP) administration prior to invasive dental procedures has been a leading focus of infective endocarditis prevention. However, there have been long-standing concerns about the risk of adverse drug reactions as a result of this practice. The objective of this study was to identify the incidence and nature of adverse reactions to amoxicillin and clindamycin prophylaxis to prevent infective endocarditis. Methods We obtained AP prescribing data for England from January 2004 to March 2014 from the NHS Business Services Authority, and adverse drug reaction data from the Medicines and Healthcare Products Regulatory Agency's Yellow Card reporting scheme for prescriptions of the standard AP protocol of a single 3 g oral dose of amoxicillin or a single 600 mg oral dose of clindamycin for those allergic to penicillin. Results The reported adverse drug reaction rate for amoxicillin AP was 0 fatal reactions/million prescriptions (in fact 0 fatal reactions for nearly 3 million prescriptions) and 22.62 non-fatal reactions/million prescriptions. For clindamycin, it was 13 fatal and 149 non-fatal reactions/million prescriptions. Most clindamycin adverse drug reactions were Clostridium difficile infections. Conclusions AP adverse drug reaction reporting rates in England were low, particularly for amoxicillin, and lower than previous estimates. This suggests that amoxicillin AP is comparatively safe for patients without a history of amoxicillin allergy. The use of clindamycin AP was, however, associated with significant rates of fatal and non-fatal adverse drug reactions associated with C. difficile infections. These were higher than expected and similar to those for other doses, durations and routes of clindamycin administration. PMID:25925595

  12. 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.

  13. 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.

  14. [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.

  15. 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

  16. Whose Voices are Heard in Patient Safety Incident Reports?

    PubMed Central

    Saranto, Kaija; Bates, David W.; Mykkänen, Minna; Härkönen, Mikko; Miettinen, Merja

    2012-01-01

    Patient safety incident reporting systems are used to monitor adverse events, generate information for risk management and to improve patient safety. A number of electronic reporting systems have been developed, but their data elements appear relatively similar. An inductive data analysis was carried out to find out especially what is the content of descriptions of contributing factors of adverse events. The data consisted of incident reports entered in a hospital based reporting system in the years 2008–2010. Overall, 82 reports of 785 contained free text information about patients’ and relatives’ involvement in the events reported by staff. We found that patients themselves noticed almost half of these incidents. Of the incidents they noticed, most resulted in moderate harm. PMID:24199120

  17. [Incidence rate of adverse reaction/event by Qingkailing injection: a Meta-analysis of single rate].

    PubMed

    Ai, Chun-ling; Xie, Yan-ming; Li, Ming-quan; Wang, Lian-xin; Liao, Xing

    2015-12-01

    To systematically review the incidence rate of adverse drug reaction/event by Qingkailing injection. Such databases as the PubMed, EMbase, the Cochrane library, CNKI, VIP WanFang data and CBM were searched by computer from foundation to July 30, 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and cross check data. Then, Meta-analysis was performed by using the R 3.2.0 software, subgroup sensitivity analysis was performed based on age, mode of medicine, observation time and research quality. Sixty-three studies involving 9,793 patients with Qingkailing injection were included, 367 cases of adverse reactions/events were reported in total. The incidence rate of adverse reaction in skin and mucosa group was 2% [95% CI (0.02; 0.03)]; the digestive system adverse reaction was 6% [95% CI(0.05; 0.07); the injection site adverse reaction was 4% [95% CI (0.02; 0.07)]. In the digestive system as the main types of adverse reactions/events, incidence of children and adults were 4.6% [0.021 1; 0.097 7] and 6.9% [0.053 5; 0.089 8], respectively. Adverse reactions to skin and mucous membrane damage as the main performance/event type, the observation time > 7 days and ≤ 7 days incidence of 3% [0.012 9; 0.068 3] and 1.9% [0.007 8; 0.046 1], respectively. Subgroup analysis showed that different types of adverse reactions, combination in the incidence of adverse reactions/events were higher than that of single drug, the difference was statistically significant (P < 0.05). This study suggested the influence factors of adverse reactions occur, and clinical rational drug use, such as combination, age and other fators, and the influence factors vary in different populations. Therefore, clinical doctors for children and the elderly use special care was required for a clear and open spirit injection, the implementation of individualized medication.

  18. [Incidence rate of adverse reaction/event by Qingkailing injection: a Meta-analysis of single rate].

    PubMed

    Ai, Chun-ling; Xie, Yan-ming; Li, Ming-quan; Wang, Lian-xin; Liao, Xing

    2015-12-01

    To systematically review the incidence rate of adverse drug reaction/event by Qingkailing injection. Such databases as the PubMed, EMbase, the Cochrane library, CNKI, VIP WanFang data and CBM were searched by computer from foundation to July 30, 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and cross check data. Then, Meta-analysis was performed by using the R 3.2.0 software, subgroup sensitivity analysis was performed based on age, mode of medicine, observation time and research quality. Sixty-three studies involving 9,793 patients with Qingkailing injection were included, 367 cases of adverse reactions/events were reported in total. The incidence rate of adverse reaction in skin and mucosa group was 2% [95% CI (0.02; 0.03)]; the digestive system adverse reaction was 6% [95% CI(0.05; 0.07); the injection site adverse reaction was 4% [95% CI (0.02; 0.07)]. In the digestive system as the main types of adverse reactions/events, incidence of children and adults were 4.6% [0.021 1; 0.097 7] and 6.9% [0.053 5; 0.089 8], respectively. Adverse reactions to skin and mucous membrane damage as the main performance/event type, the observation time > 7 days and ≤ 7 days incidence of 3% [0.012 9; 0.068 3] and 1.9% [0.007 8; 0.046 1], respectively. Subgroup analysis showed that different types of adverse reactions, combination in the incidence of adverse reactions/events were higher than that of single drug, the difference was statistically significant (P < 0.05). This study suggested the influence factors of adverse reactions occur, and clinical rational drug use, such as combination, age and other fators, and the influence factors vary in different populations. Therefore, clinical doctors for children and the elderly use special care was required for a clear and open spirit injection, the implementation of individualized medication. PMID:27245021

  19. 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

  20. Development of an incident reporting system.

    PubMed

    Puetz, K

    1988-08-01

    Incident reports document occurrences that are not consistent with routine hospital procedures or routine patient care; they are one measure of the quality of patient care. Waukesha (Wisconsin) Memorial Hospital has developed an incident reporting system that allows analysis of incidents by type and location of occurrence so trends can be identified. The hospital has also developed an "incident rate," which is useful for analyzing incident occurrences in relation to patient census.

  1. Improving incident reporting among junior doctors.

    PubMed

    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.

  2. Adverse drug reactions: classification, susceptibility and reporting.

    PubMed

    Kaufman, Gerri

    2016-08-10

    Adverse drug reactions (ADRs) are increasingly common and are a significant cause of morbidity and mortality. Historically, ADRs have been classified as type A or type B. Type A reactions are predictable from the known pharmacology of a drug and are associated with high morbidity and low mortality. Type B reactions are idiosyncratic, bizarre or novel responses that cannot be predicted from the known pharmacology of a drug and are associated with low morbidity and high mortality. Not all ADRs fit into type A and type B categories; therefore, additional categories have been developed. These include type C (continuing), type D (delayed use), and type E (end of use) reactions. Susceptibility to ADRs is influenced by age, gender, disease states, pregnancy, ethnicity and polypharmacy. Drug safety is reliant on nurses and other healthcare professionals being alert to the possibility of ADRs, working with patients to optimise medicine use and exercising vigilance in the reporting of ADRs through the Yellow Card Scheme. PMID:27507394

  3. 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

  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 and predictors of adverse drug events in an African cohort of HIV-infected adults treated with efavirenz

    PubMed Central

    Abah, Isaac Okoh; Akanbi, Maxwell; Abah, Mercy Enuwa; Finangwai, Amos Istifanus; Dady, Christy W; Falang, Kakjing Dadul; Ebonyi, Augustine Odoh; Okopi, Joseph Anejo; Agbaji, Oche Ochai; Sagay, Altiene Solomon; Okonkwo, Prosper; Idoko, John A; Kanki, Phyllis J

    2015-01-01

    Introduction Adverse drug reactions associated with efavirenz (EFV) therapy are poorly described beyond the first year of treatment. We aimed to describe the incidence and predictors of EFV-related adverse drug reactions (ADRs) in a cohort of adult Nigerian HIV-infected patients on antiretroviral therapy (ART). Methods This retrospective cohort study utilized clinical data of HIV-1 infected adults (aged ≥15 years), commenced on efavirenz containing-regimen between January 2004 and December 2011. The time-dependent occurrence of clinical adverse events as defined by the World Health Organization was analyzed by Cox regression analysis. Results A total of 2920 patients with baseline median (IQR) age of 39 (33-46) years, largely made up of men (78%) were included in the study. During 8834 person-years of follow up, 358 adverse drug events were reported; the incidence rate was 40.3 ADRs per 1000 person-years of treatment. Lipodystrophy and neuropsychiatric disorders were the most common ADRs with incidences of 63 and 30 per 1000 patients respectively. About one-third of the neuropsychiatric adverse events were within 12 months of commencement of ART. The risk of neuropsychiatric ADRs was independently predicted for women [adjusted hazard ratio (aHR) 9.05; 95% CI: 5.18-15.82], those aged <40 years (aHR 2.59; 95% CI: 1.50-4.45), advanced HIV disease (WHO stage 3 or 4) [aHR 2.26; 95% CI: 1.37-3.72], and zidovudine [aHR 2.21; 95% CI: 1.27-3.83] or stavudine [aHR 4.22; 95% CI: 1.99-8.92] containing regimen compared to tenofovir. Conclusion Neuropsychiatric adverse drug events associated with efavirenz-based ART had both early and late onset in our clinical cohort of patients on chronic EFV therapy. Continuous neuropsychiatric assessment for improved detection and management of neuropsychiatric ADRs is recommended in resource-limited settings where the use of efavirenz-based regimens has been scaled up. PMID:26405676

  6. 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

  7. 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

  8. 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. PMID:26647506

  9. Recent adverse trends in semen quality and testis cancer incidence among Finnish men

    PubMed Central

    Jørgensen, N; Vierula, M; Jacobsen, R; Pukkala, E; Perheentupa, A; Virtanen, H E; Skakkebæk, N E; Toppari, J

    2011-01-01

    Impaired semen quality and testicular cancer may be linked through a testicular dysgenesis syndrome of foetal origin. The incidence of testis cancer has been shown to increase among Finnish men, whereas there is no recent publication describing temporal trends in semen quality. Therefore, we carried out a prospective semen quality study and a registry study of testis cancer incidence among Finnish men to explore recent trends. A total of 858 men were investigated in the semen quality study during 1998–2006. Median sperm concentrations were 67 (95% CI 57–80) million/mL, 60 (51–71) and 48 (39–60) for birth cohorts 1979–81, 1982–83 and 1987; total sperm counts 227 (189–272) million, 202 (170–240) and 165 (132–207); total number of morphologically normal spermatozoa 18 (14–23) million, 15 (12–19) and 11 (8–15). Men aged 10–59 years at the time of diagnosis with testicular cancer during 1954–2008 were included in the registry study, which confirmed the increasing incidence of testicular cancer in recent cohorts. These simultaneous and rapidly occurring adverse trends suggest that the underlying causes are environmental and, as such, preventable. Our findings necessitate not only further surveillance of male reproductive health but also research to detect and remove the underlying factors. PMID:21366607

  10. 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. PMID:26098967

  11. Low incidence of severe adverse effects after mandibular ridge reconstruction using hydroxylapatite.

    PubMed

    Mercier, P; Bellavance, F

    1999-08-01

    The short and long term adverse effects after ridge reconstruction using hydroxylapatite (HA) are presented in this study. The HA was inserted using a modified tunnelling technique, followed by a lowering of the floor of the mouth and a vestibuloplasty using split thickness skin graft, 4-6 weeks later. The study comprised 637 patients followed for a period of 1 to 10 years (mean 6.0+/-2.6 years). Major loss of HA was seen in 17 patients (2.7%). Donor site visibility (skin graft) appeared to improve greatly over the years from 29.2% to 8.8% at the latest follow-up. Neurosurgery deficits also improved from 11.6% (paraesthesia and dysaesthesia) to 4.6%. Long term follow-up revealed a high percentage of patient satisfaction (97%), indicating that the low incidence of severe adverse effects of the procedure does play a significant role in the appreciation of the procedure and prosthetic care. PMID:10416894

  12. Multiple adverse effects of pyridium: a case report.

    PubMed

    Haigh, Charles; Dewar, James C

    2006-01-01

    Pyridium (phenazopyridine hydrochloride) is often prescribed as an analgesic in patients following trauma, surgery, or infections of the urinary tract. Pyridium toxicity has been previously reported, however, most cases result in a single adverse effect. Herein the authors describe an elderly patient who presented with simultaneous multiple adverse effects, including a previously undocumented myelosuppressive pancytopenia.

  13. 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

  14. Active Hemovigilance Significantly Improves Reporting of Acute Non-infectious Adverse Reactions to Blood Transfusion.

    PubMed

    Agnihotri, Naveen; Agnihotri, Ajju

    2016-09-01

    One of the key purposes of a hemovigilance program is to improve reporting of transfusion related adverse events and subsequent data-driven improvement in blood transfusion (BT) practices. We conducted a study over 3 years to assess the impact of healthcare worker training and an active feedback programme on reporting of adverse reactions to BTs. All hospitalized patients who required a BT were included in the study. Healthcare workers involved in BT to patients were sensitized and trained in adverse reaction reporting by conducting training sessions and meetings. All the transfused patients were 'actively' monitored for any acute adverse reaction by using a uniquely coded blood issue form. A total of 18,914 blood components transfused to 5785 different patients resulted in 61 adverse reaction episodes. This incidence of 0.32 % in our study was found to be significantly higher (p < 0.005) than that reported from the same region in the past. Red blood cell units were the most frequently transfused component and thus most commonly involved in an adverse reaction (42.6 %), however apheresis platelets had the highest chance of reaction per unit transfused (0.66 %). There was no mortality associated with the BT during the study period. An active surveillance program significantly improves reporting and management of adverse reactions to BTs. PMID:27429527

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... reports or as the result of a formal clinical trial. (2) As with all reports submitted under paragraph (c... manufacturer should not include in reports under this section any adverse experience that occurred in clinical trials if they were previously submitted as part of the biologics license application. If a report...

  16. 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.

  17. 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

  18. Anaesthesia Incident Monitoring Study in Hospital Kuala Lumpur--the second report.

    PubMed

    Choy, Y C; Lee, C Y; Inbasegaran, K

    1999-03-01

    Critical incident reporting is a useful quality improvement technique for reducing morbidity and mortality in anaesthesia. This study analyses 93 cases in Kuala Lumpur Hospital from July 1995 to January 1997. The main incidents during anaesthesia in this study were airway incidents. While human error was identified as the main factor contributing to the occurrence of adverse incidents. Critical incident monitoring plays an important role in identifying potential problems, which may lead to disaster. The findings from this report of the anaesthesia incident monitoring study continued to indicate the occurrence of similar problems seen in an earlier report. The identification of common incidents can be used to identify risk factors and minimise repetition of such incidents.

  19. [Direct reporting by patients of adverse drug reactions in Spain].

    PubMed

    Esther Salgueiro, M; Jimeno, Francisco J; Aguirre, Carmelo; García, Montserrat; Ordóñez, Lucía; Manso, Gloria

    2013-01-01

    The Spanish Pharmacovigilance System for Medicinal Products for Human Use, integrated by regional centers of pharmacovigilance coordinated by the Spanish Agency for Medicines and Health Products, is responsible for developing the Program of Spontaneous Reporting of Suspected Adverse Drug Reactions in our country. Although, until now, reports were only requesting to health professionals, the current understanding of the role of patients in the clinical setting and the experience gained in other countries of our environment, have demonstrated the convenience of developing active participation systems to patients in the reporting of suspected adverse drug reactions. In addition, this is taking into account in the new European legislation on pharmacovigilance. PMID:23461502

  20. [Direct reporting by patients of adverse drug reactions in Spain].

    PubMed

    Esther Salgueiro, M; Jimeno, Francisco J; Aguirre, Carmelo; García, Montserrat; Ordóñez, Lucía; Manso, Gloria

    2013-01-01

    The Spanish Pharmacovigilance System for Medicinal Products for Human Use, integrated by regional centers of pharmacovigilance coordinated by the Spanish Agency for Medicines and Health Products, is responsible for developing the Program of Spontaneous Reporting of Suspected Adverse Drug Reactions in our country. Although, until now, reports were only requesting to health professionals, the current understanding of the role of patients in the clinical setting and the experience gained in other countries of our environment, have demonstrated the convenience of developing active participation systems to patients in the reporting of suspected adverse drug reactions. In addition, this is taking into account in the new European legislation on pharmacovigilance.

  1. Reliability of adverse symptom event reporting by clinicians

    PubMed Central

    Li, Yuelin; Coffey, Charles W.; Sit, Laura; Shaw, Mary; Lavene, Dawn; Bennett, Antonia V.; Fruscione, Mike; Rogak, Lauren; Hay, Jennifer; Gönen, Mithat; Schrag, Deborah; Basch, Ethan

    2013-01-01

    Purpose Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk–benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit. Methods A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26–91, M = 62.39) from lung (n = 134), prostate (n = 113), and Ob/Gyn (n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials. Results The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation (0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%). Conclusion Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches to adverse symptom reporting, such as patient self-reporting, should be considered. PMID:21984468

  2. [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. PMID:24927508

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

    PubMed

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

    2016-04-22

    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.

  4. 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

  5. [Neonatal adverse events and near misses reported in Brazil from 2007 to 2013].

    PubMed

    Lanzillotti, Luciana da Silva; Andrade, Carla Lourenço Tavares de; Mendes, Walter; Seta, Marismary Horsth De

    2016-01-01

    This study aimed to analyze adverse events and near misses in newborns up to 28 days of life, reported to the Brazilian National Notification System for Sanitary Surveillance (NOTIVISA) system from 2007 to 2013. This was a quantitative, descriptive, retrospective study with analysis of secondary data. A total of 355 incidents were reported: 118 (33.3%) related to medical devices, 4 (1.1%) medical equipment, and 233 (65.6%) medicines. Silver nitrate and antibiotics were the most frequently reported medicines, and among medical devices and equipment, phlebitis associated with IV lines was the most frequently reported adverse event. The study unveils the reporting of adverse events and near misses, fostering discussion on what actually constitutes harm according to the person that reports the event. The challenge for NOTIVISA is to improve the system, and as with other information systems, this results from its use, critical analysis, and interaction with users - incident reporters and interested parties like teaching and research institutions. PMID:27653193

  6. 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

  7. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)

    PubMed Central

    Shimabukuro, Tom T.; Nguyen, Michael; Martin, David; DeStefano, Frank

    2015-01-01

    The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination. PMID:26209838

  8. Evaluation of adverse reaction reports for a newly laundry product.

    PubMed

    Weaver, J E; Herrmann, K W

    1981-05-01

    The marketing of widely used consumer products inevitably results in some reports of adverse dermatologic reactions which are tentatively attributable through medical history to the use of these products. Just as it is important for manufacturers to perform thorough premarket safety testing, it also is important for them to investigate these reported reactions to confirm the safety of the product under widespread use conditions. This report describes the results of such a follow-up investigation into 300 adverse reaction reports obtained during the first year of marketing of new laundry product. The results of diagnostic patch and prick tests, controlled reuse testing, and definitive diagnoses by physicians (mostly allergists and dermatologists) demonstrated that this product was highly unlikely to have caused the reported dermatologic conditions. Widespread distribution of free samples of the new product appeared to be largely responsible for the frequency of anecdotal association of adverse reactions to use of the product. The diagnostic follow-up program is described. PMID:7240466

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

    PubMed

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

    1989-07-01

    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

  10. 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

  11. Adverse reactions to benzodiazepine hypnotics: spontaneous reporting system.

    PubMed

    Bixler, E O; Kales, A; Brubaker, B H; Kales, J D

    1987-01-01

    The rates of reported adverse drug reactions involving the central nervous system were compared among patients taking any of three benzodiazepine hypnotics: flurazepam, temazepam, and triazolam. These rates, based upon data collected through the spontaneous reporting system of the Food and Drug Administration, were controlled for the number and size of new prescriptions for each drug. In general, triazolam had much higher overall rates than did the other two drugs. Hyperexcitability and withdrawal effects were greatest for triazolam and least for flurazepam. Amnesia was reported almost exclusively with triazolam. Rates for other cognitive as well as affective and other behavioral effects were also much greater for triazolam and about equal for the other two drugs. Finally, daytime sedation was reported slightly more for flurazepam than triazolam and least for temazepam which was also reported most frequently as lacking hypnotic effect. PMID:2892212

  12. 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.

  13. Improving reporting of critical incidents through education and involvement.

    PubMed Central

    Donnelly, Peter

    2015-01-01

    Critical incident reporting involves highlighting events and near-misses which have a potential impact on patient care and patient safety. Reporting of critical incidents is a recognised tool in improving patient safety. Within the community paediatric setting in the Belfast Health & Social Care Trust (BHSCT) there is a paucity of incident report forms. The purpose of this quality improvement project was to establish the barriers to reporting critical incidents and to implement plan-do-study-act (PDSA) cycles to create a climate for change. The methodology for this project was to firstly perform a baseline audit to review all submitted critical incident reports for the Community Paediatric team in the BHSCT for a six month period. A questionnaire was distributed to staff within the multidisciplinary team to establish examples of barriers to reporting. Interventions performed included introducing an agreed definition of a critical incident, distributing/presenting questionnaire findings to senior members of the various management teams and providing feedback to healthcare workers after presentation of a critical incident presentation. A review of incident reports was performed over the subsequent six month period to assess how the interventions impacted on incident reporting. Over 12 questionnaires 28 barriers to reporting critical incidents were reported which fell into five separate categories. Staff members were twice as likely to report negativity after reporting a critical incident. Overall critical incident reporting within the BHSCT Community Paediatric team improved from 11 incident reports (1.8 per month) to 22 incident reports (3.7 per month) after completion of the quality improvement project. This represents an increase of 100%. PMID:26734409

  14. 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 §§...

  15. 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 §§...

  16. 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 §§...

  17. 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 §§...

  18. 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 §§...

  19. Unit-based incident reporting and root cause analysis: variation at three hospital unit types

    PubMed Central

    Wagner, Cordula; Merten, Hanneke; Zwaan, Laura; Lubberding, Sanne; Timmermans, Danielle; Smits, Marleen

    2016-01-01

    Objectives To minimise adverse events in healthcare, various large-scale incident reporting and learning systems have been developed worldwide. Nevertheless, learning from patient safety incidents is going slowly. Local, unit-based reporting systems can help to get faster and more detailed insight into unit-specific safety issues. The aim of our study was to gain insight into types and causes of patient safety incidents in hospital units and to explore differences between unit types. Design Prospective observational study. Setting 10 emergency medicine units, 10 internal medicine units and 10 general surgery units in 20 hospitals in the Netherlands participated. Patient safety incidents were reported by healthcare providers. Reports were analysed with root cause analysis. The results were compared between the 3 unit types. Results A total of 2028 incidents were reported in an average reporting period of 8 weeks per unit. More than half had some consequences for patients, such as a prolonged hospital stay or longer waiting time, and a small number resulted in patient harm. Significant differences in incident types and causes were found between unit types. Emergency units reported more incidents related to collaboration, whereas surgical and internal medicine units reported more incidents related to medication use. The distribution of root causes of surgical and emergency medicine units showed more mutual similarities than those of internal medicine units. Conclusions Comparable incidents and causes have been found in all units, but there were also differences between units and unit types. Unit-based incident reporting gives specific information and therefore makes improvements easier. We conclude that unit-based incident reporting has an added value besides hospital-wide or national reporting systems that already exist in various countries. PMID:27329443

  20. Adverse childhood experiences reported by adults --- five states, 2009.

    PubMed

    2010-12-17

    Adverse childhood experiences (ACEs) include verbal, physical, or sexual abuse, as well as family dysfunction (e.g., an incarcerated, mentally ill, or substance-abusing family member; domestic violence; or absence of a parent because of divorce or separation). ACEs have been linked to a range of adverse health outcomes in adulthood, including substance abuse, depression, cardiovascular disease, diabetes, cancer, and premature mortality. Furthermore, data collected from a large sample of health maintenance organization members indicated that a history of ACEs is common among adults and ACEs are themselves interrelated. To examine whether a history of ACEs was common in a randomly selected population, CDC analyzed information from 26,229 adults in five states using the 2009 ACE module of the Behavioral Risk Factor Surveillance System (BRFSS). This report describes the results of that analysis, which indicated that, overall, 59.4% of respondents reported having at least one ACE, and 8.7% reported five or more ACEs. The high prevalence of ACEs underscores the need for 1) additional efforts at the state and local level to reduce and prevent child maltreatment and associated family dysfunction and 2) further development and dissemination of trauma-focused services to treat stress-related health outcomes associated with ACEs.

  1. Care Staff Perceptions of Choking Incidents: What Details Are Reported?

    ERIC Educational Resources Information Center

    Guthrie, Susan; Lecko, Caroline; Roddam, Hazel

    2015-01-01

    Background: Following a series of fatal choking incidents in one UK specialist service, this study evaluated the detail included in incident reporting. This study compared the enhanced reporting system in the specialist service with the national reporting and learning system. Methods: Eligible reports were selected from a national organization and…

  2. Use and reported adverse effects of new chemical entities.

    PubMed

    Kennedy, D L; Goetsch, R A; Dreis, M W

    1989-03-01

    Reports submitted to the FDA through 1987 of adverse drug reactions (ADRs) to new chemical entities (NCEs) approved after 1983 are described, and estimates of each NCE's proportionate use in hospitals and within its therapeutic class are reported. This review was limited to those domestic spontaneous ADR reports submitted to the FDA by healthcare professionals. NCEs accounted for approximately 20% of the total number of domestic spontaneous ADR reports received in 1987, 22% of the reports of serious ADRs, and 24% of the reports that listed death as an outcome. Data on the use of these NCEs were obtained through the U.S. Pharmaceutical Market--Drugstores and Hospitals and the National Prescription Audit. Of the 93 drugs designated as NCEs in 1987, 65 had measurable use, with 41% of those used principally in hospitals. Most hospital-use NCEs were injectable antimicrobial agents, surgical drugs, and radioactive diagnostic agents. Because NCEs account for a disproportionate share of the ADRs reported to the FDA, and because of the high use of NCEs in hospitals, hospital pharmacists should be aware of the importance of monitoring and reporting serious ADRs associated with NCEs. PMID:2719041

  3. 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

  4. Rating and Classification of Incident Reporting in Radiology in a Large Academic Medical Center.

    PubMed

    Mansouri, Mohammad; Aran, Shima; Shaqdan, Khalid W; Abujudeh, Hani H

    2016-01-01

    The purpose of this article is to provide a rate of safety incident report of adverse events in a large academic radiology department and to share the various types that may occur. This is a Health Insurance Portability and Accountability Act compliant, institutional review board-approved study. Consent requirement was waived. All incident reports from April 2006-September 2012 were retrieved. Events were further classified as follows: diagnostic test orders, identity document or documentation or consent, safety or security or conduct, service coordination, surgery or procedure, line or tube, fall, medication or intravenous safety, employee general incident, environment or equipment, adverse drug reaction (ADR), skin or tissue, and diagnosis or treatment. Overall rates and subclassification rates were calculated. There were 10,224 incident reports and 4,324,208 radiology examinations (rate = 0.23%). The highest rates of the incident reports were due to diagnostic test orders (34.3%; 3509/10,224), followed by service coordination (12.2%; 1248/10,224) and ADR (10.3%; 1052/4,324,208). The rate of incident reporting was highest in inpatient (0.30%; 2949/970,622), followed by emergency radiology (0.22%; 1500/672,958) and outpatient (0.18%; 4957/2,680,628). Approximately 48.5% (4947/10,202) of incidents had no patient harm and did not affect the patient, followed by no patient harm, but did affect the patient (35.2%, 3589/10,202), temporary or minor patient harm (15.5%, 1584/10,202), permanent or major patient harm (0.6%, 62/10,202), and patient death (0.2%, 20/10,202). Within an academic radiology department, the rate of incident reports was only 0.23%, usually did not harm the patient, and occurred at higher rates in inpatients. The most common incident type was in the category of diagnostic test orders, followed by service coordination, and ADRs.

  5. 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.

  6. Perception of Nigerian medical students on adverse drug reaction reporting.

    PubMed

    Abubakar, Abdullahi Rabiu; Chedi, Bashir A Z; Mohammed, Khalid Garba; Haque, Mainul

    2015-01-01

    Spontaneous reporting (SPR) and intensive monitoring are the conventional systems used for detecting, recording, and reporting adverse drug reactions (ADRs). Using spontaneous reporting a lot of successes has been made as existing ADRs were identified and new ones prevented through this methods. The aim of this appraisal was to evaluate the knowledge, attitude, and the practice of medical students with regards to ADRs reporting and to see if differences exist between the level of study and genders. The questionnaire was adopted, modified, and validated from previous studies. It comprised of 25 questions. It was administered year-IV and V medical students of Bayero University Kano, Nigeria. The data collected were coded and analyzed using the Statistical Package for the Social Sciences (SPSS) version 20, currently known as IBM SPSS Statistics. The response rate was 74%. Among the 108 participants, 80% got the definition of ADRs correct; 63% of them knew the precise functions of pharmacovigilance (PV). In addition, 82% strongly agreed that ADR reporting is health care workers responsibility; 82% also said PV should be taught in detail. Meanwhile, 99% have noticed patient experiencing ADRs; 67% said even mild ADRs should be reported. The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students surveyed. Unfortunately, the practice of medical students was found to be unsatisfactory. There is a need to upgrade the students teaching the curriculum with respect to ADRs monitoring. PMID:26605155

  7. Incidence, Severity, and Association With Adverse Outcome of Hyponatremia in Children Hospitalized With Heart Failure.

    PubMed

    Price, Jack F; Kantor, Paul F; Shaddy, Robert E; Rossano, Joseph W; Goldberg, Jason F; Hagan, Joseph; Humlicek, Timothy J; Cabrera, Antonio G; Jeewa, Aamir; Denfield, Susan W; Dreyer, William J; Akcan-Arikan, Ayse

    2016-10-01

    Hyponatremia is a common finding in adults hospitalized with heart failure (HF) and is associated with longer hospital stays and increased mortality. The significance of hyponatremia in children with HF is not known. We sought to determine the incidence of hyponatremia and association with clinical outcome in children hospitalized with HF. Admission and inpatient serum sodium concentrations were analyzed in 141 consecutive children hospitalized with acute decompensated HF. Inclusion criteria include patients (age, birth to 21 years) with biventricular hearts who were hospitalized for HF from January 2007 to December 2012. The primary composite end point was death, cardiac transplantation, or the use of mechanical circulatory support (MCS) during hospitalization. Data for 141 patients were included in the analysis. The cohort included 48 patients (34%) with preexisting HF. Mean serum sodium at admission was 136 ± 4 mmol/L (range 124 to 150 mmol/L). Hyponatremia (serum sodium <135 mmol/L) was present in 45 patients (32%) at admission. Seventy-one patients (75%) with normal serum sodium concentrations at admission subsequently developed acquired hyponatremia during their hospitalization. Hyponatremia persisted at discharge in 17 of 66 patients (26%). Fifty-eight patients (41%) reached the composite end point during hospitalization (death, n = 15; cardiac transplantation, n = 27; MCS, n = 46). Hyponatremia at admission was independently associated with death, cardiac transplantation, or the use of MCS during hospitalization (odds ratio 3.1, p = 0.02). In conclusion, hyponatremia occurs commonly in children hospitalized with acute decompensated HF and is associated with increased risk of in-hospital mortality, cardiac transplantation, and need for MCS. PMID:27530824

  8. Adverse Events of Acupuncture: A Systematic Review of Case Reports

    PubMed Central

    Xu, Shifen; Wang, Lizhen; Cooper, Emily; Zhang, Ming; Manheimer, Eric; Berman, Brian; Shen, Xueyong; Lao, Lixing

    2013-01-01

    Acupuncture, moxibustion, and cupping, important in traditional Eastern medicine, are increasingly used in the West. Their widening acceptance demands continual safety assessment. This review, a sequel to one our team published 10 years ago, is an evaluation of the frequency and severity of adverse events (AEs) reported for acupuncture, moxibustion, and cupping between 2000 and 2011. Relevant English-language reports in six databases were identified and assessed by two reviewers. During this 12-year period, 117 reports of 308 AEs from 25 countries and regions were associated with acupuncture (294 cases), moxibustion (4 cases), or cupping (10 cases). Country of occurrence, patient's sex and age, and outcome were extracted. Infections, mycobacterial, staphylococcal, and others, were the main complication of acupuncture. In the previous review, we found the main source of infection to be hepatitis, caused by reusable needles. In this review, we found the majority of infections to be bacterial, caused by skin contact at acupoint sites; we found no cases of hepatitis. Although the route of infection had changed, infections were still the major complication of acupuncture. Clearly, guidelines such as Clean Needle Technique must be followed in order to minimize acupuncture AEs. PMID:23573135

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

    PubMed

    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.

  10. [Adverse events following influenza vaccination: reaction to specific reports and the necessity of a central registration system].

    PubMed

    Swaan, C M; van der Sande, M A B; Speelman, P; Conyn-van Spaendonck, M A E; Straus, S M J M; Coutinho, R A

    2007-09-29

    The influenza vaccine is considered safe, but information on vaccine-related adverse events is limited and a nationwide overview of adverse events is lacking. In 2006, after deaths occurred in Israel and the Netherlands following influenza vaccination, the Dutch Ministry of Health, Welfare and Sport (VWS) asked the National Institute for Public Health and the Environment (RIVM) twice for a recommendation regarding the continuation of the national vaccination campaign. After 4 deaths were reported in Israel in October 2006 following administration of Vaxigrip, the Dutch vaccination campaign was suspended for one week. One month later, 4 additional deaths were reported after influenza vaccination in the Netherlands. The newly appointed outbreak management team concluded that a causal relationship between vaccination and the deaths was highly unlikely, based on data regarding the individual cases, background mortality rates and prior reports of adverse events. Further suspension of the vaccination campaign was deemed unnecessary this time. A centralised nationwide registry of adverse events has since been established to provide further insight into the incidence of adverse events following influenza vaccination. Physicians are advised to report potential adverse events following influenza vaccination to the Netherlands Pharmacovigilance Centre Lareb (www.lareb.nl). PMID:17957995

  11. 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

  12. 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

  13. 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

  14. Incidence of weak opioids adverse events in the management of cancer pain: a double-blind comparative trial.

    PubMed

    Rodriguez, Rene Fernando; Bravo, Luis Eduardo; Castro, Fernando; Montoya, Olga; Castillo, Javier Mauricio; Castillo, María Pilar; Daza, Paola; Restrepo, José Manuel; Rodriguez, Mario Fernando

    2007-02-01

    With the objective of comparing incidence of adverse events of the opioids codeine, hydrocodone, and tramadol in the relief of cancer pain, we conducted a randomized controlled trial in which patients with cancer were randomly assigned according to a computer-generated schedule to receive one of the three opioids. Of the 177 patients who participated, 62 patients received hydrocodone, 59 patients received codeine, and 56 patients received tramadol. The pain experienced by the participants originated most frequently from the stomach, breast, or prostate gland and was classified as either somatic (33%), visceral (52%), mixed (6%), or neuropathic (9%). At the first visit, 60% of the patients described their pain intensity as moderate (4-6/10), with the remaining 40% of the patients describing their pain as severe (7-10/10). The symptoms most associated with pain were weakness, insomnia. and anorexia. In 77% of the total number of cases, the patient was aware of his/her diagnosis prior to admittance to the palliative care unit. Of the total number of cases, 57% fell in the age range of 60-89 years old and 50% of the participants were female. No significant statistical difference in the analgesic efficacy of the three opioids was found (p: 0.69; chi(2): 0.73). Use of tramadol produced higher rates of adverse events than codeine and hydrocodone: vomiting, dizziness, loss of appetite, and weakness (p < 0.05).

  15. Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting.

    PubMed

    Nebeker, Jonathan R; Barach, Paul; Samore, Matthew H

    2004-05-18

    Adverse drug events cause substantial morbidity and mortality, yet they remain underappreciated and misunderstood. The terminology to describe errors and patient harm associated with medications causes much confusion. This article uses the case study of a patient with multiple adverse drug events to clarify key terms, such as adverse event, adverse drug reaction, adverse drug event, medication error, and side effect. The case discussion illustrates clinical approaches to analyzing the causal connection between a suspect drug and an adverse event. Examples and rationale for meaningful documentation of adverse drug events are provided, along with an outline of the types of events that should be reported to regulatory agencies.

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... substantial disruption of a person's ability to conduct normal life functions. Life-threatening adverse... only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... substantial disruption of a person's ability to conduct normal life functions. Life-threatening adverse... only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... substantial disruption of a person's ability to conduct normal life functions. Life-threatening adverse... only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism...

  19. 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…

  20. 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.

  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. Concealment of drugs by police detainees: lessons learned from adverse incidents and from 'routine' clinical practice.

    PubMed

    Havis, Siobhan; Best, David; Carter, Jane

    2005-10-01

    This is a collaborative piece of work undertaken between the PCA and a Principal FME. The study is based on 16 cases of internal drug concealment drawn from 43 drug-related deaths in custody in England and Wales between 1997 and 2002. These data are supplemented by three case studies from a county force involving non-fatal drug concealment to illustrate practical custody issues. The majority of the 16 deaths were white (n = 12) and male (n = 13) with a mean age of 34 years. In half of the cases, the deceased was known or believed to have concealed drugs orally at the point of initial contact with police. In 4/16 cases, the individual first showed signs of medical distress in a public place, a further 4 collapsed on arrival at the police station and two more detainees were subsequently found collapsed in their cell. Drug toxicity was the most common cause of death (10/16). In 5 cases death was caused by airway obstruction by swallowed packages. Both cocaine (14/16) and cannabis (8/16) traces were found in post-mortem samples. The report emphasises the need for a safety first approach.

  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. 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...

  5. 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

  6. A national incident reporting and learning system in England and Wales, but at what cost?

    PubMed

    Carter, Alexander W; Mossialos, Elias; Darzi, Ara

    2015-06-01

    Recent high-profile failures in healthcare highlight the ongoing need for improvements in patient safety. Moreover, the fiscal challenge facing many health systems has brought the costs and economic efficiencies associated with improving quality (and safety) to bear. Currently, there is a lack of economic evidence underpinning resource allocation decisions in patient safety. Incident reporting systems are considered an important means of addressing these challenges by monitoring incident rates over time, identifying new threats to patient care and ultimately preventing repetition of costly adverse events. Uniquely, for more than a decade, the UK has been developing a National Reporting and Learning System to provide these functions for the English and Welsh health system(s), in addition to pre-existing local systems. The need to evaluate the impact of national incident reporting, and learning systems in terms of effectiveness and efficiency is argued and the methodological challenges that must be considered in an economic analysis are outlined. PMID:25834922

  7. A national incident reporting and learning system in England and Wales, but at what cost?

    PubMed

    Carter, Alexander W; Mossialos, Elias; Darzi, Ara

    2015-06-01

    Recent high-profile failures in healthcare highlight the ongoing need for improvements in patient safety. Moreover, the fiscal challenge facing many health systems has brought the costs and economic efficiencies associated with improving quality (and safety) to bear. Currently, there is a lack of economic evidence underpinning resource allocation decisions in patient safety. Incident reporting systems are considered an important means of addressing these challenges by monitoring incident rates over time, identifying new threats to patient care and ultimately preventing repetition of costly adverse events. Uniquely, for more than a decade, the UK has been developing a National Reporting and Learning System to provide these functions for the English and Welsh health system(s), in addition to pre-existing local systems. The need to evaluate the impact of national incident reporting, and learning systems in terms of effectiveness and efficiency is argued and the methodological challenges that must be considered in an economic analysis are outlined.

  8. Incidents/accidents classification and reporting in Statoil.

    PubMed

    Berentsen, Rune; Holmboe, Rolf H

    2004-07-26

    Based on requirements in the new petroleum regulations from Norwegian Petroleum Directorate (NPD) and the realisation of a need to improve and rationalise the routines for reporting and follow up of incidents, Statoil Exploration & Production Norway (Statoil E&P Norway) has formulated a new strategy and process for handling of incidents/accidents. The following past experiences serve as basis for the changes made to incident reporting in Statoil E&P Norway; too much resources were spent on a comprehensive handling and analysis of a vast amount of incidents with less importance for the safety level, taking the focus away from the more severe and important issues at hand, the assessment of "Risk Factor", i.e. the combination of recurrence frequency and consequence, was difficult to use. The high degree of subjectivity involved in the determination of the "Risk Factor" (in particular the estimation of the recurrence frequency) resulted in poor data quality and lack of consistency in the data material. The new system for categorisation and handling of undesirable incidents was established in January 2002. The intention was to get a higher degree of focus on serious incidents (injuries, damages, loss and near misses), with a thorough handling and follow-up. This is reflected throughout the handling of the serious incidents, all the way from immediate notification of the incident, through investigation and follow-up of corrective and preventive actions. Simultaneously, it was also an objective to rationalise/simplify the handling of less serious incidents. These incidents are, however, subjected to analyses twice a year in order to utilize the learning opportunity that they also provide. A year after the introduction of this new system for categorisation and follow-up of undesirable incidents, Statoil's experiences are predominantly good; the intention to get a higher degree of focus on serious incidents (injuries, damages, loss and near misses), has been met, the data

  9. 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

  10. 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.

  11. Incidence and risk factors of bleeding-related adverse events in patients with chronic lymphocytic leukemia treated with ibrutinib

    PubMed Central

    Lipsky, Andrew H.; Farooqui, Mohammed Z.H.; Tian, Xin; Martyr, Sabrina; Cullinane, Ann M.; Nghiem, Khanh; Sun, Clare; Valdez, Janet; Niemann, Carsten U.; Herman, Sarah E. M.; Saba, Nakhle; Soto, Susan; Marti, Gerald; Uzel, Gulbu; Holland, Steve M.; Lozier, Jay N.; Wiestner, Adrian

    2015-01-01

    Ibrutinib is associated with bleeding-related adverse events of grade ≤2 in severity, and infrequently with grade ≥3 events. To investigate the mechanisms of bleeding and identify patients at risk, we prospectively assessed platelet function and coagulation factors in our investigator-initiated trial of single-agent ibrutinib for chronic lymphocytic leukemia. At a median follow-up of 24 months we recorded grade ≤2 bleeding-related adverse events in 55% of 85 patients. No grade ≥3 events occurred. Median time to event was 49 days. The cumulative incidence of an event plateaued by 6 months, suggesting that the risk of bleeding decreases with continued therapy. At baseline, von Willebrand factor and factor VIII levels were often high and normalized on treatment. Platelet function measured via the platelet function analyzer (PFA-100™) was impaired in 22 patients at baseline and in an additional 19 patients on ibrutinib (often transiently). Collagen and adenosine diphosphate induced platelet aggregation was tested using whole blood aggregometry. Compared to normal controls, response to both agonists was decreased in all patients with chronic lymphocytic leukemia, whether on ibrutinib or not. Compared to untreated chronic lymphocytic leukemia patients, response to collagen showed a mild further decrement on ibrutinib, while response to adenosine diphosphate improved. All parameters associated with a significantly increased risk of bleeding-related events were present at baseline, including prolonged epinephrine closure time (HR 2.74, P=0.012), lower levels of von Willebrand factor activity (HR 2.73, P=0.009) and factor VIII (HR 3.73, P=0.0004). In conclusion, both disease and treatment-related factors influence the risk of bleeding. Patients at greater risk for bleeding of grade ≤2 can be identified by clinical laboratory tests and counseled to avoid aspirin, non-steroidal anti-inflammatory drugs and fish oils. ClinicalTrials.gov identifier NCT01500733 PMID

  12. Incidence and risk factors of bleeding-related adverse events in patients with chronic lymphocytic leukemia treated with ibrutinib.

    PubMed

    Lipsky, Andrew H; Farooqui, Mohammed Z H; Tian, Xin; Martyr, Sabrina; Cullinane, Ann M; Nghiem, Khanh; Sun, Clare; Valdez, Janet; Niemann, Carsten U; Herman, Sarah E M; Saba, Nakhle; Soto, Susan; Marti, Gerald; Uzel, Gulbu; Holland, Steve M; Lozier, Jay N; Wiestner, Adrian

    2015-12-01

    Ibrutinib is associated with bleeding-related adverse events of grade ≤ 2 in severity, and infrequently with grade ≥ 3 events. To investigate the mechanisms of bleeding and identify patients at risk, we prospectively assessed platelet function and coagulation factors in our investigator-initiated trial of single-agent ibrutinib for chronic lymphocytic leukemia. At a median follow-up of 24 months we recorded grade ≤ 2 bleeding-related adverse events in 55% of 85 patients. No grade ≥ 3 events occurred. Median time to event was 49 days. The cumulative incidence of an event plateaued by 6 months, suggesting that the risk of bleeding decreases with continued therapy. At baseline, von Willebrand factor and factor VIII levels were often high and normalized on treatment. Platelet function measured via the platelet function analyzer (PFA-100™) was impaired in 22 patients at baseline and in an additional 19 patients on ibrutinib (often transiently). Collagen and adenosine diphosphate induced platelet aggregation was tested using whole blood aggregometry. Compared to normal controls, response to both agonists was decreased in all patients with chronic lymphocytic leukemia, whether on ibrutinib or not. Compared to untreated chronic lymphocytic leukemia patients, response to collagen showed a mild further decrement on ibrutinib, while response to adenosine diphosphate improved. All parameters associated with a significantly increased risk of bleeding-related events were present at baseline, including prolonged epinephrine closure time (HR 2.74, P=0.012), lower levels of von Willebrand factor activity (HR 2.73, P=0.009) and factor VIII (HR 3.73, P=0.0004). In conclusion, both disease and treatment-related factors influence the risk of bleeding. Patients at greater risk for bleeding of grade ≤ 2 can be identified by clinical laboratory tests and counseled to avoid aspirin, non-steroidal anti-inflammatory drugs and fish oils. ClinicalTrials.gov identifier NCT01500733.

  13. The meaning of justice in safety incident reporting.

    PubMed

    Weiner, Bryan Jeffrey; Hobgood, Cherri; Lewis, Megan A

    2008-01-01

    Safety experts contend that to make incident reporting work, healthcare organizations must establish a "just" culture-that is, an organizational context in which health professionals feel assured that they will receive fair treatment when they report safety incidents. Although healthcare leaders have expressed keen interest in establishing a just culture in their institutions, the patient safety literature offers little guidance as to what the term "just culture" really means or how one goes about creating a just culture. Moreover, the safety literature does not indicate what constitutes a just incident reporting process in the eyes of the health professionals who provide direct patient care. This gap is unfortunate, for knowing what constitutes a just incident reporting process in the eyes of front-line health professionals is essential for designing useful information systems to detect, monitor, and correct safety problems. In this article, we seek to clarify the conceptual meaning of just culture and identify the attributes of incident reporting processes that make such systems just in the eyes of health professionals. To accomplish these aims, we draw upon organizational justice theory and research to develop a conceptual model of perceived justice in incident reporting processes. This model could assist those healthcare leaders interested in creating a just culture by clarifying the multiple meanings, antecedents, and consequences of justice.

  14. [Contemplation and suggestion on the medical device adverse event reporting program].

    PubMed

    Yu, Baodong; Guan, Yingjie; Mo, Xiaomei

    2014-01-01

    The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.

  15. Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009-January 31, 2010.

    PubMed

    Vellozzi, Claudia; Broder, Karen R; Haber, Penina; Guh, Alice; Nguyen, Michael; Cano, Maria; Lewis, Paige; McNeil, Michael M; Bryant, Marthe; Singleton, James; Martin, David; DeStefano, Frank

    2010-10-21

    The United States (US) influenza A (H1N1) 2009 monovalent (2009-H1N1) vaccination program began in October 2009. Reports to the vaccine adverse event reporting system (VAERS), a US spontaneous reporting system, were reviewed to identify potential rare events or unusual adverse event (AE) patterns after 2009-H1N1 vaccination. The adverse event profile after 2009-H1N1 vaccine in VAERS (∼10,000 reports) was consistent with that of seasonal influenza vaccines, although the reporting rate was higher after 2009-H1N1 than seasonal influenza vaccines, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain-Barré syndrome and anaphylaxis reports after 2009-H1N1 vaccination were rare (each <2 per million doses administered).

  16. The Australian Incident Monitoring Study. Difficult intubation: an analysis of 2000 incident reports.

    PubMed

    Williamson, J A; Webb, R K; Szekely, S; Gillies, E R; Dreosti, A V

    1993-10-01

    The first 2000 incidents reported to the Australian Incident Monitoring Study were analysed with respect to the incidence and circumstances of problems with endotracheal intubation; 85 (4%) indicated difficulties with intubation. One third of these were emergency cases, one third involved an initially unassisted trainee and one fifth were outside normal working hours. Failure to predict a difficult intubation was reported in one third of the cases, with another quarter presenting serious difficulty despite preoperative prediction. Difficulties with ventilation were experienced in 1 in 7 of the 85 reports; there was one cardiac arrest, but no death. Endotracheal intubation was not achieved in one fifth of the cases. The commonest complications reported amongst the 85 incidents were oesophageal intubation (18 cases), arterial desaturation (15 cases), and reflux of gastric contents (7 cases). Emergency trans-tracheal airways were required in 5 cases. Obesity, limited neck mobility and mouth opening, and inadequate assistance together accounted for two thirds of all the contributing factors. The most successful intubation aid in this series was a gum elastic bougie. A capnograph contributed to management in 28% and a pulse oximeter in 12% of the cases in which they were used. The most serious desaturations were associated with accidental oesophageal intubation. These data suggest a lack of reliable preoperative assessment techniques and skills for the prediction of difficult intubations. They also suggest the need for a greater emphasis on ensuring that the necessary equipment is available, and on teaching and learning drills for difficult intubation and any associated difficulty with ventilation.

  17. 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

  18. 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

  19. 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

  20. 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.

  1. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2

    PubMed Central

    Rugo, H. S.; Pritchard, K. I.; Gnant, M.; Noguchi, S.; Piccart, M.; Hortobagyi, G.; Baselga, J.; Perez, A.; Geberth, M.; Csoszi, T.; Chouinard, E.; Srimuninnimit, V.; Puttawibul, P.; Eakle, J.; Feng, W.; Bauly, H.; El-Hashimy, M.; Taran, T.; Burris, H. A.

    2014-01-01

    Background In the BOLERO-2 trial, everolimus (EVE), an inhibitor of mammalian target of rapamycin, demonstrated significant clinical benefit with an acceptable safety profile when administered with exemestane (EXE) in postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer. We report on the incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs) as well as incidence of dose modifications during the extended follow-up of this study. Patients and methods Patients were randomized (2:1) to receive EVE 10 mg/day or placebo (PBO), with open-label EXE 25 mg/day (n = 724). The primary end point was progression-free survival. Secondary end points included overall survival, objective response rate, and safety. Safety evaluations included recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations. Results The safety population comprised 720 patients (EVE + EXE, 482; PBO + EXE, 238). The median follow-up was 18 months. Class-effect toxicities, including stomatitis, pneumonitis, and hyperglycemia, were generally of mild or moderate severity and occurred relatively early after treatment initiation (except pneumonitis); incidence tapered off thereafter. EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age. The median duration of dose interruption was 7 days. Discontinuation of both study drugs because of AEs was higher with EVE + EXE (9%) versus PBO + EXE (3%). Conclusions Most EVE-associated AEs occur soon after initiation of therapy, are typically of mild or moderate severity, and are generally manageable with dose reduction and interruption. Discontinuation due to toxicity was uncommon. Understanding the time course of class-effect AEs will help inform preventive and monitoring strategies as well as patient education. Trial registration number NCT00863655. PMID:24615500

  2. 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

  3. 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.

  4. Endocrine disrupters and human health: could oestrogenic chemicals in body care cosmetics adversely affect breast cancer incidence in women?

    PubMed

    Harvey, Philip W; Darbre, Philippa

    2004-01-01

    In the decade that has elapsed since the suggestion that exposure of the foetal/developing male to environmental oestrogens could be the cause of subsequent reproductive and developmental effects in men, there has been little definitive research to provide conclusions to the hypothesis. Issues of exposure and low potency of environmental oestrogens may have reduced concerns. However, the hypothesis that chemicals applied in body care cosmetics (including moisturizers, creams, sprays or lotions applied to axilla or chest or breast areas) may be affecting breast cancer incidence in women presents a different case scenario, not least in the consideration of the exposure issues. The specific cosmetic type is not relevant but the chemical ingredients in the formulations and the application to the skin is important. The most common group of body care cosmetic formulation excipients, namely p-hydroxybenzoic acid esters or parabens, have been shown recently to be oestrogenic in vitro and in vivo and now have been detected in human breast tumour tissue, indicating absorption (route and causal associations have yet to be confirmed). The hypothesis for a link between oestrogenic ingredients in underarm and body care cosmetics and breast cancer is forwarded and reviewed here in terms of: data on exposure to body care cosmetics and parabens, including dermal absorption; paraben oestrogenicity; the role of oestrogen in breast cancer; detection of parabens in breast tumours; recent epidemiology studies of underarm cosmetics use and breast cancer; the toxicology database; the current regulatory status of parabens and regulatory toxicology data uncertainties. Notwithstanding the major public health issue of the causes of the rising incidence of breast cancer in women, this call for further research may provide the first evidence that environmental factors may be adversely affecting human health by endocrine disruption, because exposure to oestrogenic chemicals through application

  5. 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

  6. 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

  7. Quality check of spontaneous adverse drug reaction reporting forms of different countries.

    PubMed

    Bandekar, M S; Anwikar, S R; Kshirsagar, N A

    2010-11-01

    Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment.

  8. The social dimensions of safety incident reporting in maternity care: the influence of working relationships and group processes.

    PubMed

    Lindsay, Patricia; Sandall, Jane; Humphrey, Charlotte

    2012-11-01

    Over the past twenty years there has been a growing awareness of the scale and cost of adverse events in health care. In this paper we discuss findings from a study, undertaken in 2008, investigating social and cultural influences on incident reporting in maternity care in one U.K. National Health Service hospital. Maternity claims account for 50% of NHS compensation expenditure, with claims arising from poor fetal heart monitoring alone amounting to £85.8 million in 2010. Earlier studies on incident reporting used case note review and staff self-reports. We used ethnographic methods to highlight the social nature of, and social processes around, incident reporting, and the use of the collegial work group as an aid to decision-making. Incident reporting was rarely an isolated, private event, but the result of a process involving group deliberation. We suggest that incident reporting in health care should be regarded as a process rather than an event and reporting policies adjusted to accommodate group processes in order to improve reporting rates. While the paper presents findings from a single site we suggest these may add to the understanding of reporting in other care areas of health care. The key contribution this paper makes is to report the existence of a process of worker peer conferral as a decision-making aid prior to incident reporting. PMID:22884941

  9. 36 CFR 1230.14 - How do agencies report incidents?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false How do agencies report incidents? 1230.14 Section 1230.14 Parks, Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION RECORDS MANAGEMENT UNLAWFUL OR ACCIDENTAL REMOVAL, DEFACING, ALTERATION, OR DESTRUCTION OF...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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.

  16. 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…

  17. 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.

  18. 30 CFR 285.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... must I report them? (a) You must report the following incidents to us immediately via oral communication, and provide a written follow-up report (paper copy or electronically transmitted) within...

  19. Patient-reported outcomes and the evolution of adverse event reporting in oncology.

    PubMed

    Trotti, Andy; Colevas, A Dimitrios; Setser, Ann; Basch, Ethan

    2007-11-10

    Adverse event (AE) reporting in oncology has evolved from informal descriptions to a highly systematized process. The Common Terminology Criteria for Adverse Events (CTCAE) is the predominant system for describing the severity of AEs commonly encountered in oncology clinical trials. CTCAE clinical descriptors have been developed empirically during more than 30 years of use. The method of data collection is clinician based. Limitations of the CTC system include potential for incomplete reporting and limited guidance on data analysis and presentation methods. The Medical Dictionary for Regulatory Activities (MedDRA) is a comprehensive medical terminology system used for regulatory reporting and drug labeling. MedDRA does not provide for severity ranking of AEs. CTC-based data presentations are the primary method of AE data reporting used in scientific journals and oncology meetings. Patient-reported outcome instruments (PROs) cover the subjective domain of AEs. Exploratory work suggests PROs can be used with a high degree of patient engagement and compliance. Additional studies are needed to determine how PROs can be used to complement current AE reporting systems. Potential models for integrating PROs into AE reporting are described in this review. AE reporting methods will continue to evolve in response to changing therapies and growing interest in measuring the impact of cancer treatment on health status. Although integration of PROs into AE reporting may ultimately improve the comprehensiveness and quality of collected data, it may also increase the administrative burden and cost of conducting trials. Therefore, care must be used when developing health outcomes and safety data collection plans. PMID:17991931

  20. MEADERS: Medication Errors and Adverse Drug Event Reporting system.

    PubMed

    Zafar, Atif

    2007-10-11

    The Agency for Healthcare Research and Quality (AHRQ) recently funded the PBRN Resource Center to develop a system for reporting ambulatory medication errors. Our goal was to develop a usable system that practices could use internally to track errors. We initially performed a comprehensive literature review of what is currently available. Then, using a combination of expert panel meetings and iterative development we designed an instrument for ambulatory medication error reporting and createad a reporting system based both in MS Access 2003 and on the web using MS ASP.NET 2.0 technologies.

  1. 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

  2. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... scientific and medical journals either as case reports or as the result of a formal clinical trial. (2) As... adverse drug experiences that occurred in clinical trials if they were previously submitted as part of...

  3. 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

  4. A Systematic Review of the Reporting of Adverse Events Associated With Medical Herb Use Among Children

    PubMed Central

    Adams, Denise; Filippelli, Amanda C.; Nasser, Hafsa; Saper, Robert; White, Laura; Vohra, Sunita

    2013-01-01

    Purpose: Information about the safety of herbal medicine often comes from case reports published in the medical literature, thus necessitating good quality reporting of these adverse events. The purpose of this study was to perform a systematic review of the comprehensiveness of reporting of published case reports of adverse events associated with herb use in the pediatric population. Methods: Electronic literature search included 7 databases and a manual search of retrieved articles from inception through 2010. We included published case reports and case series that reported an adverse event associated with exposure to an herbal product by children under the age of 18 years old. We used descriptive statistics. Based on the International Society of Epidemiology's “Guidelines for Submitting Adverse Events Reports for Publication,” we developed and assigned a guideline adherence score (0-17) to each case report. Results: Ninety-six unique journal papers were identified and represented 128 cases. Of the 128 cases, 37% occurred in children under 2 years old, 38% between the ages of 2 and 8 years old, and 23% between the ages of 9 and 18 years old. Twenty-nine percent of cases were the result of an intentional ingestion while 36% were from an unintentional ingestion. Fifty-two percent of cases documented the Latin binomial of the herb ingredients; 41% documented plant part. Thirty-two percent of the cases reported laboratory testing of the herb, 20% documented the manufacturer of the product, and 22% percent included an assessment of the potential concomitant therapies that could have been influential in the adverse events. Mean guideline adherence score was 12.5 (range 6-17). Conclusions: There is considerable need for improvement in reporting adverse events in children following herb use. Without better quality reporting, adverse event reports cannot be interpreted reliably and do not contribute in a meaningful way to guiding recommendations for medicinal herb use

  5. The Logic of Surveillance Guidelines: An Analysis of Vaccine Adverse Event Reports from an Ontological Perspective

    PubMed Central

    Courtot, Mélanie; Brinkman, Ryan R.; Ruttenberg, Alan

    2014-01-01

    Background When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated processing can make this process more efficient. Methods and Findings Using the Brighton anaphylaxis case definition, we show that existing clinical guidelines used as standards in pharmacovigilance can be logically encoded using a formal representation such as the Adverse Event Reporting Ontology we developed. We validated the classification of vaccine adverse event reports using the ontology against existing rule-based systems and a manually curated subset of the Vaccine Adverse Event Reporting System. However, we encountered a number of critical issues in the formulation and application of the clinical guidelines. We report these issues and the steps being taken to address them in current surveillance systems, and in the terminological standards in use. Conclusions By standardizing and improving the reporting process, we were able to automate diagnosis confirmation. By allowing medical experts to prioritize reports such a system can accelerate the identification of adverse reactions to vaccines and the response of regulatory agencies. This approach of combining ontology and semantic technologies can be used to improve other areas of vaccine adverse event reports analysis and should inform both the design of clinical guidelines and how they are used in the future. Availability Sufficient material to reproduce our results is available, including documentation, ontology, code and datasets, at http://purl.obolibrary.org/obo/aero. PMID:24667848

  6. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... products to the Center for Biologics Evaluation and Research (HFM-210), or to the Center for Drug... Consolidated Forms and Publications Distribution Center, 3222 Hubbard Rd., Landover, MD 20785. Supplies of the VAERS form may be obtained from VAERS by calling 1-800-822-7967. (g) Multiple reports. A...

  7. Application of a human factors classification framework for patient safety to identify precursor and contributing factors to adverse clinical incidents in hospital.

    PubMed

    Mitchell, Rebecca J; Williamson, Ann; Molesworth, Brett

    2016-01-01

    This study aimed to identify temporal precursor and associated contributing factors for adverse clinical incidents in a hospital setting using the Human Factors Classification Framework (HFCF) for patient safety. A random sample of 498 clinical incidents were reviewed. The framework identified key precursor events (PE), contributing factors (CF) and the prime causes of incidents. Descriptive statistics and correspondence analysis were used to examine incident characteristics. Staff action was the most common type of PE identified. Correspondence analysis for all PEs that involved staff action by error type showed that rule-based errors were strongly related to performing medical or monitoring tasks or the administration of medication. Skill-based errors were strongly related to misdiagnoses. Factors relating to the organisation (66.9%) or the patient (53.2%) were the most commonly identified CFs. The HFCF for patient safety was able to identify patterns of causation for the clinical incidents, highlighting the need for targeted preventive approaches, based on an understanding of how and why incidents occur. PMID:26360210

  8. EMS helicopter incidents reported to the NASA Aviation Safety Reporting System

    NASA Technical Reports Server (NTRS)

    Connell, Linda J.; Reynard, William D.

    1993-01-01

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

  9. 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.

  10. Adverse event reporting for herbal medicines: a result of market forces.

    PubMed

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

    2009-05-01

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

  11. Manual therapy for the cervical spine and reported adverse effects: a survey of Irish manipulative physiotherapists.

    PubMed

    Sweeney, Aoife; Doody, Catherine

    2010-02-01

    The purpose of this study was to determine the use of manipulation and mobilisation by the Chartered Physiotherapists (CMPT) in Manipulative Therapy Ireland and to describe adverse effects associated with the use of these techniques. A 44 item postal survey was sent to all 259 members of the CPMT (response rate 49%, n=127). All 127 respondents used non-High Velocity Thrust Techniques (HVTT) and 27% (n=34) used HVTT. Nine percent (n=12) used HVTT on the upper cervical spine. Twenty six percent (n=33) reported an adverse effect in the previous 2 years. The adverse effects were associated with the use of HVTT (4%, n=5), non-HVTT (20%, n=26) and cervical traction (2%, n=2). The most serious adverse effects were associated with non-HVTT and included 1 drop attack, 1 fainting episode and 1 Transient Ischemic Attack (TIA) 4 days post treatment. Fifty three percent (n=18) of HVTT users and 40% (n=44) of non-HVTT users reported carrying out a vertebrobasilar insufficiency (VBI) assessment. The study shows that VBI assessment may not detect every patient at risk of adverse effects. Large scale studies to investigate the risk of serious adverse reactions are needed. A system of reporting adverse effects on a routine basis could be considered.

  12. 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…

  13. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... first person or entity who reported the information to you). (2) If you are a user facility, importer... you are correcting or supplying information that is missing from another reporter's Form 3500A, you... do not have to report an adverse event if you have information that would lead a person who...

  14. Consumer reporting of adverse events following immunization (AEFI): identifying predictors of reporting an AEFI.

    PubMed

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

    2014-01-01

    Passive reporting of adverse events following immunization (AEFI) by consumers or healthcare professionals is the primary mechanism for post-marketing surveillance of vaccine safety. Although recent initiatives have promoted consumer reporting, there is a lack of research concerning consumer reporters. Computer assisted telephone interviews (CATI) were conducted in 2011 of a cross-sectional, random, general population sample of 191 South Australian parents who stated that their children had previously experienced an AEFI. We compared awareness of surveillance, vaccine safety opinions, and demographics of parents reporting an AEFI to either healthcare professionals or surveillance authorities with those who did not report their children's AEFI. Multivariate regression analyses measured: the association between reporting and safety views; and demographic predictors of reporting an AEFI. Reporting an AEFI to a healthcare professional or a surveillance authority was not significantly associated with awareness of a surveillance system. AEFI reporters, when compared with non-reporters, were more likely to be Australian-born (OR = 4.58, [1.64, 12.78], P = 0.004); were associated with the perception that a serious reaction was more likely to occur at their children's last immunization (OR = 2.54 [95%CI 1.22, 5.30], P = 0.013); and were less accepting of the risk of febrile convulsion, (OR = 3.59 [95%CI 1.50, 8.57], P = 0.004). Although reporting an AEFI was not associated with awareness of surveillance or most socio-demographics, the results suggest some difference in safety opinions. Further studies are required to ascertain if these differences pre-date the occurrence of an AEFI or are a consequence of the AEFI and how consumers can contribute further to vaccine safety surveillance. PMID:24406315

  15. 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.

  16. 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

  17. Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting

    PubMed Central

    Protić, Dragana; Vujasinović-Stupar, Nada; Bukumirić, Zoran; Pavlov-Dolijanović, Slavica; Baltić, Snežana; Mutavdžin, Slavica; Marković-Denić, Ljiljana; Zdravković, Marija; Todorović, Zoran

    2016-01-01

    Background Adverse drug reactions (ADRs) have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system. Methods Semi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261) completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history. Results Group 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found between rheumatology patients with and without neurological comorbidities regarding their awareness of ADRs. The majority of patients reported ADRs of cytotoxic drugs. The most reported ADRs were moderate gastrointestinal discomforts. Conclusion We may draw a profile of rheumatological patients willing to report ADRs: 1) The majority of them suffer from systemic inflammatory diseases and are slightly more prone to neurological comorbidities. 2) They are predominantly aware of their diagnosis but less able to identify the drugs that may cause their ADRs. 3) They tend to report mainly moderate gastrointestinal ADRs; that is, other cohorts of patients and other types of ADRs remain mainly undetected in such a reporting, which could represent a bias. Counseling and education of patients as well as developing a network for online communication might improve patients’ reporting of potential ADRs. PMID:26893547

  18. Committee's report on ruthenium fall-out incident

    SciTech Connect

    Borkowski, C.J.; Crawford, J.H.; Livingston, R.; Ritchie, R.H.; Rupp, A.F.; Taylor, E.H.

    1983-07-01

    Investigations of the fall-out incident of November 11 and 12, 1959, by responsible parties (Health Physics Division and Operations Division personnel) established beyond reasonable doubt that the incident had its origin in the expulsion of particles, heavily contaminated with ruthenium, which had been detached from the walls of the electric fan housing and ducts in the off-gas system associated with the brick stack. All available evidence indicates that the particles were loosened during maintenance work on the exhaust damper and the bearings of the electric fan and were carried up the stack in two bursts as particulate fall-out when this fan was put back into service. Radiographic and chemical analysis showed the activity to be almost entirely ruthenium (Ru/sup 106/) and its daughter rhodium (Rh/sup 106/) with very little, if any, strontium being present. This report summarizes the findings and sets forth the conclusions and recommendations of the Committee asked to investigate the incident.

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

    PubMed

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

    2015-11-01

    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. PMID:26685652

  20. 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. PMID:23360751

  1. Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System

    PubMed Central

    Gnädinger, Markus; Ceschi, Alessandro; Conen, Dieter; Herzig, Lilli; Puhan, Milo; Staehelin, Alfred; Zoller, Marco

    2015-01-01

    Background/rationale Patient safety is a major concern in healthcare systems worldwide. Although most safety research has been conducted in the inpatient setting, evidence indicates that medical errors and adverse events are a threat to patients in the primary care setting as well. Since information about the frequency and outcomes of safety incidents in primary care is required, the goals of this study are to describe the type, frequency, seasonal and regional distribution of medication incidents in primary care in Switzerland and to elucidate possible risk factors for medication incidents. Methods and analysis Study design and setting: We will conduct a prospective surveillance study to identify cases of medication incidents among primary care patients in Switzerland over the course of the year 2015. Participants: Patients undergoing drug treatment by 167 general practitioners or paediatricians reporting to the Swiss Federal Sentinel Reporting System. Inclusion criteria: Any erroneous event, as defined by the physician, related to the medication process and interfering with normal treatment course. Exclusion criteria: Lack of treatment effect, adverse drug reactions or drug–drug or drug–disease interactions without detectable treatment error. Primary outcome: Medication incidents. Risk factors: Age, gender, polymedication, morbidity, care dependency, hospitalisation. Statistical Analysis: Descriptive statistics to assess type, frequency, seasonal and regional distribution of medication incidents and logistic regression to assess their association with potential risk factors. Estimated sample size: 500 medication incidents. Limitations: We will take into account under-reporting and selective reporting among others as potential sources of bias or imprecision when interpreting the results. Ethics and dissemination No formal request was necessary because of fully anonymised data. The results will be published in a peer-reviewed journal. Trial registration number

  2. Influence of dexmedetomidine on incidence of adverse reactions introduced by hemabate in postpartum hemorrhage during cesarean section

    PubMed Central

    Liu, Yang; Chen, Hong-Xia; Kang, Dao-Lin; Kuang, Xiao-Hua; Liu, Wen-Xing; Ni, Jin

    2015-01-01

    Objective: The purpose of our study was to observe the influence of dexmedetomidine on complications caused by hemabate in patients undergoing caesarean section. Methods: A total of 120 females (age range, 20-40 years) at 35-40 weeks gestation who delivered by cesarean between September, 2014 and December, 2014 were enrolled in our study. Patients were randomly allocated into three groups that received intravenously physiological saline 20 mL (placebo group), lower dose (0.5 μg kg-1) of dexmedetomidine (low-dex gruop) and higher dose (1 μg kg-1) of dexmedetomidine (high-dex group) during cesarean section, following the delivery of the infant and intramuscular hemabate injection. Results: Nausea, vomiting, chest congestion and elevated blood pressure were the most common adverse events of placebo group. Compared with placebo group, the above mentioned adverse reactions decreased significantly in both low-dex group and high-dex group (P<0.05), whereas there were no significant difference between low-dex group and high-dex group (P>0.05). As to patient satisfaction score, low-dex group and high-dex group were all higher than placebo group (P<0.05). Furthermore, there were more patients satisfied with high-dex group than low-dex group (P<0.05). Conclusion: Dexmedetomidine (0.5 μg kg-1 and 1 μg kg-1) were all effective in preventing adverse reactions introduced by hemabate and improve parturients’ satisfaction in patients undergoing cesarean delivery. And higher dose (1 μg kg-1) of dexmedetomidine is superior to lower dose (0.5 μg kg-1) in patient satisfaction. PMID:26550325

  3. 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...

  4. 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.

  5. New thoughts on the "forgotten" aspect of antimicrobial stewardship: adverse event reporting.

    PubMed

    Hoffmann, Charles; Khadem, Tina; Schweighardt, Anne; Brown, Jack

    2015-01-01

    Antimicrobial stewardship is an activity that optimizes patient care through selection of the most appropriate antimicrobial therapy. Antimicrobial stewardship programs strive to enhance patient care and reduce preventable consequences of antimicrobial use. They are also vital in monitoring for the development of adverse events occurring as a result of antimicrobial therapy, although literature reviews of this activity are scarce. Although randomized controlled trials are considered the gold standard to study the efficacy of a medication, these trials are not designed to test safety end points and often are only able to identify the most commonly occurring and acute adverse events. In addition, prior to a drug going to market, it is difficult to detect rare adverse events because the associated costs are economically untenable given the limited pipeline of novel agents. These limitations in some ways may be resolved with the use of postmarketing surveillance and spontaneous reporting systems such as the United States Food and Drug Administration Adverse Event Reporting System. The focus of this commentary is to highlight the importance of adverse event reporting by antimicrobial stewardship programs to spontaneous reporting systems as a means to improve patient care.

  6. Adverse Drug Reaction Reporting Program of the Ontario Medical Association: the first 3 years.

    PubMed Central

    Gowdey, C W; Brennan, M

    1985-01-01

    This paper describes the Adverse Drug Reaction Reporting Program developed and operated by the Committee on Drugs and Pharmaco-therapy of the Ontario Medical Association. Analyses were done to demonstrate some of the trends derived from the reports. Some of the clinical observations based on the reports, which are published quarterly and circulated to physicians and to pharmacy, nursing and hospital organizations, are also reviewed. PMID:3871167

  7. Systematic Review of Adverse Effects from Herbal Drugs Reported in Randomized Controlled Trials.

    PubMed

    Lee, Ji Young; Jun, Seung Ah; Hong, Sung Shin; Ahn, Yo Chan; Lee, Dong Soo; Son, Chang Gue

    2016-09-01

    Herbal drugs have become a popular form of healthcare, raising concerns about their safety. This study aimed to characterize the adverse effects of herbal drugs through a systematic review of results reported in randomized controlled trials (RCTs). Using eight electronic databases including PubMed, the Cochrane library and six Korean medical databases, the frequency of reported toxicity was recorded based on drug composition and indication. Among 4957 potentially relevant articles, 242 papers comprised of 244 studies met our inclusion criteria; these included 111 studies of a single herb and 133 of multiple herbs. These studies accounted for a total 15 441 participants (male = 5590; female = 9851; 7383 for single and 8058 for multiple herb studies). There were 480 cases (3.1%) of adverse events (344 for single, 136 for multiple herb studies; p < 0.01). A total of 259 cases reported blood test abnormalities, including five cases of abnormality in hepatic functional enzymes. The most frequently reported adverse event was digestive symptoms (44.3%), followed by nervous system symptoms (17.3%) and behaviors such as loss of appetite (16.3%). This is the first systematic review of adverse effects of herbal drugs among clinical studies, and the results indicate that herbal drugs are relatively safe. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27196988

  8. 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…

  9. [Analysis of the cardiac side effects of antipsychotics: Japanese Adverse Drug Event Report Database (JADER)].

    PubMed

    Ikeno, Takashi; Okumara, Yasuyuki; Kugiyama, Kiyotaka; Ito, Hiroto

    2013-08-01

    We analyzed the cases of side effects due to antipsychotics reported to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) from Jan. 2004 to Dec. 2012. We used the Japanese Adverse Drug Event Report Database (JADER) and analyzed 136 of 216,945 cases using the defined terms. We also checked the cardiac adverse effects listed in the package inserts of the antipsychotics involved. We found cases of Ikr blockade resulting in sudden death (49 cases), electrocardiogram QT prolonged (29 cases), torsade de pointes (TdP, 19 cases), ventricular fibrillation (VF, 10 cases). M2 receptor blockade was observed in tachycardia (8 cases) and sinus tachycardia (3 cases). Calmodulin blockade was involved in reported cardiomyopathy (3 cases) and myocarditis (1 case). Multiple adverse events were reported simultaneously in 14 cases. Our search of package inserts revealed warnings regarding electrocardiogram QT prolongation (24 drugs), tachycardia (23), sudden death (18), TdP (14), VF (3), myocarditis (1) and cardiomyopathy (1). We suggest that when an antipsychotic is prescribed, the patient should be monitored regularly with ECG, blood tests, and/or biochemical tests to avoid adverse cardiac effects. PMID:25069255

  10. 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. PMID:26269465

  11. 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.

  12. [Incidence and therapeutic relevance of the adverse effects of antidepressive agents within the scope of ambulatory neurologic treatment].

    PubMed

    Schmidt, L G; Schüssler, G; Linden, M; Müller-Oerlinghausen, B

    1988-04-01

    Within a postmarketing drug surveillance study the incidence and relevance of ADRs leading to drug discontinuation in therapy of depressed outpatients were examined. In addition, corresponding drug prescribing patterns of patients under routine treatment conditions were recorded. It was found that most psychiatric outpatients were able to identify common ADRs and to differentiate them from the underlying illnesses and comedication. Low-dose therapy was confirmed as routine treatment in the majority of psychiatric outpatients. No differences regarding age, sex, and dosage could be found between patients with further drug intake and those who stopped their antidepressant medication because of ADRs. Such events had been recorded in 11.5% of patients with first prescriptions made by the treating physicians in a monitoring of three months. However, only 0.3% of patients on long-term therapy (that had been initiated at treatment terms preceding the monitoring period) experienced an ADR indicating a decreased risk for drug discontinuation (because of ADR) the longer the patient was on treatment. Knowing ADR(-profiles) of prescribed drugs by treating psychiatrist may aid the treatment of compliance or prevention of ADRs. PMID:3384381

  13. Incidence et Caracteristiques des Signalements d'Enfants Maltraites: Comparaison Interculturelle (Incidence and Characteristics of Reported Child Abuse: Intercultural Comparisons).

    ERIC Educational Resources Information Center

    Tourigny, Marc; Bouchard, Camil

    1994-01-01

    Analysis of 953 reports of child abuse in Montreal (Quebec) found the incidence slightly higher among Haitians than French-Canadians. Among Haitians, reporting tended to originate with police or school personnel, and cases consisted mainly of physical abuse. Results suggest that child-rearing practices of Haitian families are in conflict with…

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

    PubMed Central

    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. PMID:26798528

  15. 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.

  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. 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

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

    2016-03-01

    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 higher with Ultravist

  18. 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

  19. 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...

  20. 40 CFR 159.184 - Toxic or adverse effect incident reports.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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...

  1. 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...

  2. 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...

  3. 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...

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

    PubMed

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

    2009-01-01

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

  5. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... Reaction, Lack of Effectiveness, Product Defect Report,'' as required by FDA regulations. DATES: Although.../ manufacturing defects on Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness,...

  6. 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

  7. 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

  8. 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.

  9. 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

    ... Incident Report--Natural and Other Gas Transmission and Gathering Pipeline Systems; PHMSA F 7100.2-1 Annual Report for Calendar Year 20-- Natural and 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...

  10. 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.

  11. Reporter sex and newspaper coverage of the adverse health effects of hormone therapy.

    PubMed

    Nelson, David E; Signorielli, Nancy

    2007-01-01

    Women have used hormone therapy (HT) to relieve menopausal symptoms for decades. Major studies published in JAMA in July 2002 demonstrated adverse health effects from hormone therapy, and the National Institutes of Health halted the Women's Health Initiative clinical trial several years early. We conducted a content analysis of 10 U.S. newspapers in July and August 2002 to examine the role of reporter sex on news coverage on HT. We found substantial sex differences in reporting about HT. Female reporters were much more likely than male reporters to include a self-help frame (66.7% vs. 30.8%, p = 0.002). Female reporters were also much more likely to use women in the public as sources in HT-related articles (33.9% vs. 10.0%, p = 0.039). Reporter sex may play a role in the selection and content of health news articles. PMID:17613459

  12. Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes

    PubMed Central

    Jia, Xiaoyu; Heller, Glenn; Barz, Allison; Sit, Laura; Fruscione, Michael; Appawu, Mark; Iasonos, Alexia; Atkinson, Thomas; Goldfarb, Shari; Culkin, Ann; Kris, Mark G.; Schrag, Deborah

    2009-01-01

    Background In cancer treatment trials, the standard source of adverse symptom data is clinician reporting by use of items from the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). Patient self-reporting has been proposed as an additional data source, but the implications of such a shift are not understood. Methods Patients with lung cancer receiving chemotherapy and their clinicians independently reported six CTCAE symptoms and Karnofsky Performance Status longitudinally at sequential office visits. To compare how patient's vs clinician's reports relate to sentinel clinical events, a time-dependent Cox regression model was used to measure associations between reaching particular CTCAE grade severity thresholds with the risk of death and emergency room visits. To measure concordance of CTCAE reports with indices of daily health status, Kendall tau rank correlation coefficients were calculated for each symptom with EuroQoL EQ-5D questionnaire and global question scores. Statistical tests were two-sided. Results A total of 163 patients were enrolled for an average of 12 months (range = 1–28 months), with a mean of 11 visits and 67 (41%) deaths. CTCAE reports were submitted by clinicians at 95% of visits and by patients at 80% of visits. Patients generally reported symptoms earlier and more frequently than clinicians. Statistically significant associations with death and emergency room admissions were seen for clinician reports of fatigue (P < .001), nausea (P = .01), constipation (P = .038), and Karnofsky Performance Status (P < .001) but not for patient reports of these items. Higher concordance with EuroQoL EQ-5D questionnaire and global question scores was observed for patient-reported symptoms than for clinician-reported symptoms. Conclusions Longitudinally collected clinician CTCAE assessments better predict unfavorable clinical events, whereas patient reports better reflect daily health status. These perspectives are

  13. 28 CFR 541.14 - Incident report and investigation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... INMATE DISCIPLINE AND SPECIAL HOUSING UNITS Inmate Discipline and Special Housing Units § 541.14 Incident... Discipline Hearing Officer, the DHO shall give a copy of the investigation and other relevant materials...

  14. 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

  15. Learning from defects using a comprehensive management system for incident reports in critical care.

    PubMed

    Arabi, Y M; Al Owais, S M; Al-Attas, K; Alamry, A; AlZahrani, K; Baig, B; White, D; Deeb, A M; Al-Dozri, H D; Haddad, S; Tamim, H M; Taher, S

    2016-03-01

    Incident reporting systems are often used without a structured review process, limiting their utility to learn from defects and compromising their impact on improving the healthcare system. The objective of this study is to describe the experience of implementing a Comprehensive Management System (CMS) for incident reports in the ICU. A physician-led multidisciplinary Incident Report Committee was created to review, analyse and manage the department incident reports. New protocols, policies and procedures, and other patient safety interventions were developed as a result. Information was disseminated to staff through multiple avenues. We compared the pre- and post-intervention periods for the impact on the number of incident reports, level of harm, time needed to close reports and reporting individuals. A total of 1719 incidents were studied. ICU-related incident reports increased from 20 to 36 incidents per 1000 patient days (P=0.01). After implementing the CMS, there was an increase in reporting 'no harm' from 14.2 to 28.1 incidents per 1000 patient days (P<0.001). There was a significant decrease in the time needed to close incident report after implementing the CMS (median of 70 days [Q1-Q3: 26-212] versus 13 days [Q1-Q3: 6-25, P<0.001]). A physician-led multidisciplinary CMS resulted in significant improvement in the output of the incident reporting system. This may be important to enhance the effectiveness of incident reporting systems in highlighting system defects, increasing learning opportunities and improving patient safety. PMID:27029653

  16. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience

    PubMed Central

    Blenkinsopp, A; Wilkie, P; Wang, M; Routledge, P A

    2007-01-01

    Aims To synthesize data from published studies and international experience to identify evidence of potential benefits and drawbacks of direct patient reporting of suspected adverse drug reactions (ADRs) by patients. Methods Structured search of MEDLINE, CINAHL and PsycINFO supplemented by internet searches and requests for information to key contacts. Results Seven studies (eight papers) were included in the review. None of the studies concerned spontaneous reporting by patients. Information on patient reporting systems was obtained for six countries, with summary data reported by four. Patient reports identified possible new ADRs that had not previously been reported by health professionals. The quality of patient reports appears to be similar to that of health professional reports. There is some evidence that patients report an ADR when they consider their health professional has not paid attention to their concerns. Patient reports may, at least initially, be more time consuming to process. Conclusions Overall, the evidence indicates that patient reporting of suspected ADRs has more potential benefits than drawbacks. Evaluation of patient reporting systems is needed to provide further evidence. PMID:17274788

  17. Combing signals from spontaneous reports and electronic health records for detection of adverse drug reactions

    PubMed Central

    Harpaz, Rave; Vilar, Santiago; DuMouchel, William; Salmasian, Hojjat; Haerian, Krystl; Shah, Nigam H; Chase, Herbert S; Friedman, Carol

    2013-01-01

    Objective Data-mining algorithms that can produce accurate signals of potentially novel adverse drug reactions (ADRs) are a central component of pharmacovigilance. We propose a signal-detection strategy that combines the adverse event reporting system (AERS) of the Food and Drug Administration and electronic health records (EHRs) by requiring signaling in both sources. We claim that this approach leads to improved accuracy of signal detection when the goal is to produce a highly selective ranked set of candidate ADRs. Materials and methods Our investigation was based on over 4 million AERS reports and information extracted from 1.2 million EHR narratives. Well-established methodologies were used to generate signals from each source. The study focused on ADRs related to three high-profile serious adverse reactions. A reference standard of over 600 established and plausible ADRs was created and used to evaluate the proposed approach against a comparator. Results The combined signaling system achieved a statistically significant large improvement over AERS (baseline) in the precision of top ranked signals. The average improvement ranged from 31% to almost threefold for different evaluation categories. Using this system, we identified a new association between the agent, rasburicase, and the adverse event, acute pancreatitis, which was supported by clinical review. Conclusions The results provide promising initial evidence that combining AERS with EHRs via the framework of replicated signaling can improve the accuracy of signal detection for certain operating scenarios. The use of additional EHR data is required to further evaluate the capacity and limits of this system and to extend the generalizability of these results. PMID:23118093

  18. The state of adverse event reporting and signal generation of dietary supplements in Korea.

    PubMed

    Park, Kyoung Sik; Kwon, Oran

    2010-06-01

    One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Since 2006, the Korea Food & Drug Administration (KFDA) has established an AE monitoring system for dietary supplements with emphases on the facilitation of AE reporting from consumers, the creation of a new database for aggregating information from multiple sources, and the proposition of appropriate tools for analyzing the likelihood that a product or an ingredient caused an adverse reaction. During the 3-year period from 2006 through 2008, 1430 AE reports had been collected from consumers and 222 AE reports providing complete case details were extracted by integrating AE reports into the product information. The 'relative AE profile' method was applied first to detect statistically significant signals, resulting in only one substrate-event pair (dietary fiber and vomiting) as a signal. Subsequently, the WHO scale was used to estimate the likelihood that dietary fiber caused vomiting. Due to the limited information available, the KFDA determined that no conclusion could be drawn to support any regulatory action, but that the relationship between dietary fiber and vomiting is an area of concern warranting further investigation. PMID:20074608

  19. 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. PMID:25526960

  20. 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.

  1. Suspected adverse drug reactions in elderly patients reported to the Committee on Safety of Medicines.

    PubMed

    Castleden, C M; Pickles, H

    1988-10-01

    1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age group. 4. The reported ADR was more likely to be serious or fatal in the elderly. 5. The commonest ADRs reported for the elderly affected the gastrointestinal (GIT) and haemopoietic systems, where more reports were received than would be expected from prescription figures. 6. The drug suspected of causing a GIT reaction was a NSAI in 75% of the reports. 7. Ninety-one per cent of fatal reports of GIT bleeds and perforations associated with NSAI drugs were in patients over 60 years of age. PMID:3263875

  2. Using self-report and adverse event measures to track health's impact on productivity in known groups.

    PubMed

    Allen, Harris M; Bunn, William B

    2003-09-01

    The use of survey data to measure and monitor health and productivity differences between groups is an issue of increasing importance. This article examines the capacity of productivity self-reports (derived from surveys) and adverse event measures (derived from administrative sources) to differentiate groups with a priori known characteristics. A replication strategy is used to test the contributions that productivity self-reports make, alone as well as above and beyond measures of adverse events, to the discrimination of 5 pairs of groups classified by clinical, job type, and demographic criteria. These tests are conducted on representative samples of the active, largely blue-collar employee population at International Truck and Engine Corporation. The results show that both productivity self-reports and adverse event measures differentiate and track known groups. Even in the presence of highly significant effects from adverse event measures, self-reports improve the assessment of productivity. We conclude that: 1) although the joint use of self-reports and adverse event measures is the better approach, practitioners can use self-reports with the expectation that this method will track group differences in health and productivity when adverse event measures are not available; and 2) survey self-reports make unique and independent contributions when adverse events measures are used.

  3. [Incidence of pleural mesotheliomas in Poland (preliminary report)].

    PubMed

    Szturmowicz, M; Vertun-Baranowska, B; Rowińska-Zakrzewska, E; Szymańska, D

    1991-01-01

    Mesothelioma is a rare malignancy, difficult to diagnose and rarely found in a population not exposed to asbestos. In the immediate past incidence rates of this disease have increased due to extensive use of this mineral in the industry of the 1950's. The aim of this study was to assess the incidence of mesotheliomas basing on results of a questionnaire posted in 1987 to all pneumonology clinics, oncological departments in Poland, and data from the Central Oncological Register from the years 1970-1985. Incidence of this malignant disease was 1-2 cases per 1,000,000 of general population during the years 1970-1985 and did not rise in 1986. Regional differences were observed, in some areas the incidence rate was 5-6 per 1,000,000. Data from the Occupational Medicine Institute disclosed in these regions more extensive industrial use of this mineral. The authors have also concluded that "at-life" diagnosis of mesothelioma rises, mainly due to the use of open pleural biopsy.

  4. 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…

  5. 46 CFR 148.115 - Report of incidents.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) DANGEROUS CARGOES CARRIAGE OF BULK SOLID.... (a) When a fire or other hazardous condition occurs on a vessel transporting a material covered by... any instructions given. (b) Any incident or casualty occurring while transporting a material...

  6. 46 CFR 148.115 - Report of incidents.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) DANGEROUS CARGOES CARRIAGE OF BULK SOLID.... (a) When a fire or other hazardous condition occurs on a vessel transporting a material covered by... any instructions given. (b) Any incident or casualty occurring while transporting a material...

  7. 46 CFR 148.115 - Report of incidents.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) DANGEROUS CARGOES CARRIAGE OF BULK SOLID.... (a) When a fire or other hazardous condition occurs on a vessel transporting a material covered by... any instructions given. (b) Any incident or casualty occurring while transporting a material...

  8. 46 CFR 148.115 - Report of incidents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) DANGEROUS CARGOES CARRIAGE OF BULK SOLID.... (a) When a fire or other hazardous condition occurs on a vessel transporting a material covered by... any instructions given. (b) Any incident or casualty occurring while transporting a material...

  9. 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

  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. 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

  12. 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... Generally Applicable Requirements for Individual Adverse Event Reports § 803.21 Where can I find...

  13. 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... Generally Applicable Requirements for Individual Adverse Event Reports § 803.21 Where can I find...

  14. 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... Generally Applicable Requirements for Individual Adverse Event Reports § 803.21 Where can I find...

  15. Incident reporting in post-operative patients managed by acute pain service

    PubMed Central

    Hasan, Syeda Fauzia; Hamid, Mohammad

    2015-01-01

    Background and Aims: Incident reporting is a reliable and inexpensive tool used in anaesthesia to identify errors in patient management. A hospital incident reporting system was already present in our hospital, but we were unable to find any incident related to acute pain management. Hence, acute pain service (APS) was started for voluntary incident reporting in post-operative patients to identify critical incidents, review the root cause and suggest remedial measures. Methods: All post-operative patients managed by APS were included in this observational study. A proforma was developed by APS, which included information about the type of incident (equipment and patient-related, human errors), severity of incident, person responsible and suggestions to prevent the same incident in the future. Patients and medical staff were informed about the reporting system. Whenever an incident was identified, a proforma was filled out by APS resident and data entered in SPSS programme. Results: Total of 98 (1.80%) incidents were reported in 5432 patients managed by APS during 3 years period. Average age of the patients was 46 ± 17 years. Majority of incidents were related to epidural care (71%) and occurred in surgical wards (87%). Most of the incidents occurred due to human error and infusion delivery set-related defects. Conclusion: Incident reporting proved to be a feasible method of improving quality care in developing countries. It not only provides valuable information about areas which needed improvement, but also helped in developing strategies to improve care. Knowledge and attitudes of medical and paramedical staff are identified as the targeted area for improvement. PMID:26903672

  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. 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

  18. Developing and integrating an adverse drug reaction reporting system with the hospital information system.

    PubMed

    Kataoka, Satoshi; Ohe, Kazuhiko; Mochizuki, Mayumi; Ueda, Shiro

    2002-01-01

    We have developed an adverse drug reaction (ADR) reporting system integrating it with Hospital Information System (HIS) of the University of Tokyo Hospital. Since this system is designed with JAVA, it is portable without re-compiling to any operating systems on which JAVA virtual machines work. In this system, we implemented an automatic data filling function using XML-based (extended Markup Language) files generated by HIS. This new specification would decrease the time needed for physicians and pharmacists to fill the spontaneous ADR reports. By clicking a button, the report is sent to the text database through Simple Mail Transfer Protocol (SMTP) electronic mails. The destination of the report mail can be changed arbitrarily by administrators, which adds this system more flexibility for practical operation. Although we tried our best to use the SGML-based (Standard Generalized Markup Language) ICH M2 guideline to follow the global standard of the case report, we eventually adopted XML as the output report format. This is because we found some problems in handling two bytes characters with ICH guideline and XML has a lot of useful features. According to our pilot survey conducted at the University of Tokyo Hospital, many physicians answered that our idea, integrating ADR reporting system to HIS, would increase the ADR reporting numbers.

  19. 30 CFR 285.832 - How do I report incidents requiring immediate notification?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... notification? 285.832 Section 285.832 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR... Environmental and Safety Management, Inspections, and Facility Assessments for Activities Conducted Under SAPs, COPs and GAPs Incident Reporting and Investigation § 285.832 How do I report incidents...

  20. Enhancing the Safety of Children in Foster Care and Family Support Programs: Automated Critical Incident Reporting

    ERIC Educational Resources Information Center

    Brenner, Eliot; Freundlich, Madelyn

    2006-01-01

    The Adoption and Safe Families Act of 1997 has made child safety an explicit focus in child welfare. The authors describe an automated critical incident reporting program designed for use in foster care and family-support programs. The program, which is based in Lotus Notes and uses e-mail to route incident reports from direct service staff to…

  1. 30 CFR 250.190 - Reporting requirements for incidents requiring written notification.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... written notification. 250.190 Section 250.190 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF... notification. (a) For any incident covered under § 250.188, you must submit a written report within 15 calendar days after the incident to the District Manager. The report must contain the following information:...

  2. 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…

  3. 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...

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Internal safety reporting and incident... RULES Fractional Ownership Operations Program Management § 91.1021 Internal safety reporting and incident/accident response. (a) Each program manager must establish an internal anonymous safety...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Internal safety reporting and incident... RULES Fractional Ownership Operations Program Management § 91.1021 Internal safety reporting and incident/accident response. (a) Each program manager must establish an internal anonymous safety...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... RULES Fractional Ownership Operations Program Management § 91.1021 Internal safety reporting and 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. 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... report within 15 calendar days after the incident to the District Manager. The report must contain the... name and number, or pipeline segment number; (6) Type of incident or injury; (7) Operation or...

  8. 14 CFR 91.1021 - Internal safety reporting and incident/accident response.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... RULES Fractional Ownership Operations Program Management § 91.1021 Internal safety reporting and 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....

  9. 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... report within 15 calendar days after the incident to the District Manager. The report must contain the... name and number, or pipeline segment number; (6) Type of incident or injury; (7) Operation or...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

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

    PubMed Central

    2013-01-01

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

  15. Surface Movement Incidents Reported to the NASA Aviation Safety Reporting System

    NASA Technical Reports Server (NTRS)

    Connell, Linda J.; Hubener, Simone

    1997-01-01

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

  16. 41 CFR 102-33.450 - How must we report accident and incident data?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 33-MANAGEMENT OF GOVERNMENT AIRCRAFT Reporting Information on Government Aircraft Accident and Incident Data... reporting are available through the system or from GSA, Aircraft Management Policy Division (MTA), 1800...

  17. 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…

  18. 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.

  19. 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. PMID:27029662

  20. 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%).

  1. Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children – a prospective observational cohort study of 6,601 admissions

    PubMed Central

    2013-01-01

    Background Adverse drug reactions (ADRs) are an important cause of harm in children. Current data are incomplete due to methodological differences between studies: only half of all studies provide drug data, incidence rates vary (0.6% to 16.8%) and very few studies provide data on causality, severity and risk factors of pediatric ADRs. We aimed to determine the incidence of ADRs in hospitalized children, to characterize these ADRs in terms of type, drug etiology, causality and severity and to identify risk factors. Methods We undertook a year-long, prospective observational cohort study of admissions to a single UK pediatric medical and surgical secondary and tertiary referral center (Alder Hey, Liverpool, UK). Children between 0 and 16 years 11 months old and admitted for more than 48 hours were included. Observed outcomes were occurrence of ADR and time to first ADR for the risk factor analysis. Results A total of 5,118 children (6,601 admissions) were included, 17.7% of whom experienced at least one ADR. Opiate analgesics and drugs used in general anesthesia (GA) accounted for more than 50% of all drugs implicated in ADRs. Of these ADRs, 0.9% caused permanent harm or required admission to a higher level of care. Children who underwent GA were at more than six times the risk of developing an ADR than children without a GA (hazard ratio (HR) 6.40; 95% confidence interval (CI) 5.30 to 7.70). Other factors increasing the risk of an ADR were increasing age (HR 1.06 for each year; 95% CI 1.04 to 1.07), increasing number of drugs (HR 1.25 for each additional drug; 95% CI 1.22 to 1.28) and oncological treatment (HR 1.90; 95% CI 1.40 to 2.60). Conclusions ADRs are common in hospitalized children and children who had undergone a GA had more than six times the risk of developing an ADR. GA agents and opiate analgesics are a significant cause of ADRs and have been underrepresented in previous studies. This is a concern in view of the increasing number of pediatric short

  2. [Vigilance for veterinary medicinal products: reports of adverse reactions in the year 2012].

    PubMed

    Müntener, C R; Bruckner, L; Kupper, J; Althaus, F R; Schäublin, M

    2013-11-01

    197 adverse reactions of Swissmedic-authorized veterinary medicinal products were reported during the year 2012 (2011: 167). Species and drug classes remain unchanged over the years: most of the reports related to reactions following the use of antiparasitic products (37.6 %), antiinfectives (15.7 %) or non-steroidal antiinflammatory drugs (11.7 %) in companion animals (94 dogs and 53 cats) followed by cattle/calves (29). Additionally, 45 cases transmitted by the Swiss Toxicological Information Centre in Zürich were processed. We discuss a paradoxical reaction under the potential influence of acepromazine as well as a modified protocol for treating permethrin intoxication in cats. Finally, the vaccinovigilance program received 95 declarations following the application of various vaccines, mainly to dogs or cats.

  3. 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.

  4. [Vigilance for veterinary medicinal products: reports of adverse reactions in the year 2012].

    PubMed

    Müntener, C R; Bruckner, L; Kupper, J; Althaus, F R; Schäublin, M

    2013-11-01

    197 adverse reactions of Swissmedic-authorized veterinary medicinal products were reported during the year 2012 (2011: 167). Species and drug classes remain unchanged over the years: most of the reports related to reactions following the use of antiparasitic products (37.6 %), antiinfectives (15.7 %) or non-steroidal antiinflammatory drugs (11.7 %) in companion animals (94 dogs and 53 cats) followed by cattle/calves (29). Additionally, 45 cases transmitted by the Swiss Toxicological Information Centre in Zürich were processed. We discuss a paradoxical reaction under the potential influence of acepromazine as well as a modified protocol for treating permethrin intoxication in cats. Finally, the vaccinovigilance program received 95 declarations following the application of various vaccines, mainly to dogs or cats. PMID:24168771

  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. 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

  7. Sexual Assault of Young Children as Reported to Law Enforcement: Victim, Incident, and Offender Characteristics. A NIBRS Statistical Report.

    ERIC Educational Resources Information Center

    Snyder, Howard N.

    Until recently, law enforcement and policymakers had few hard data on the child victims of sexual abuse, offenders, and other characteristics of these crimes on which to base a response. The National Incident-Based Reporting System (NIBRS), capturing a wide range of information on each sexual assault incident reported to law enforcement, can…

  8. 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.

  9. Toxic shock syndrome: incidence and geographic distribution from a hospital medical records reporting system.

    PubMed

    Miday, R K; Wilson, E R

    1988-05-01

    A large database of hospital records maintained by the Commission on Professional and Hospital Activities Professional Activity Study (CPHA-PAS) was used to estimate the temporal incidence and geographic distribution of toxic shock syndrome (TSS). The CPHA-PAS hospital-diagnosed incidence was 3.5 times the reported TSS incidence, with a gradual decrease over the time period 1981-83. Marked differences in the regional occurrence of cases may provide clues to the etiology of this complex disease.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 30 CFR 285.833 - What are the reporting requirements for incidents requiring written notification?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... incidents requiring written notification? 285.833 Section 285.833 Mineral Resources MINERALS MANAGEMENT... OUTER CONTINENTAL SHELF Environmental and Safety Management, Inspections, and Facility Assessments for Activities Conducted Under SAPs, COPs and GAPs Incident Reporting and Investigation § 285.833 What are...

  15. 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)

  16. 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

  17. A consensus based template for reporting of pre-hospital major incident medical management

    PubMed Central

    2014-01-01

    Background Structured reporting of major incidents has been advocated to improve the care provided at future incidents. A systematic review identified ten existing templates for reporting major incident medical management, but these templates are not in widespread use. We aimed to address this challenge by designing an open access template for uniform reporting of data from pre-hospital major incident medical management that will be tested for feasibility. Methods An expert group of thirteen European major incident practitioners, planners or academics participated in a four stage modified nominal group technique consensus process to design a novel reporting template. Initially, each expert proposed 30 variables. Secondly, these proposals were combined and each expert prioritized 45 variables from the total of 270. Thirdly, the expert group met in Norway to develop the template. Lastly, revisions to the final template were agreed via e-mail. Results The consensus process resulted in a template consisting of 48 variables divided into six categories; pre-incident data, Emergency Medical Service (EMS) background, incident characteristics, EMS response, patient characteristics and key lessons. Conclusions The expert group reached consensus on a set of key variables to report the medical management of pre-hospital major incidents and developed a novel reporting template. The template will be freely available for downloading and reporting on http://www.majorincidentreporting.org. This is the first global open access database for pre-hospital major incident reporting. The use of a uniform dataset will allow comparative analysis and has potential to identify areas of improvement for future responses. PMID:24517242

  18. 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.

  19. 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

  20. Vaccine Risk Perception Among Reporters of Autism After Vaccination: Vaccine Adverse Event Reporting System 1990–2001

    PubMed Central

    Woo, Emily Jane; Ball, Robert; Bostrom, Ann; Shadomy, Sean V.; Ball, Leslie K.; Evans, Geoffrey; Braun, Miles

    2004-01-01

    Objectives. We investigated vaccine risk perception among reporters of autism to the Vaccine Adverse Event Reporting System (VAERS). Methods. We conducted structured interviews with 124 parents who reported autism and related disorders to VAERS from 1990 to 2001 and compared results with those of a published survey of parents in the general population. Results. Respondents perceived vaccine-preventable diseases as less serious than did other parents. Only 15% of respondents deemed immunization extremely important for children’s health; two thirds had withheld vaccines from their children. Conclusions. Views of parents who believe vaccines injured their children differ significantly from those of the general population regarding the benefits of immunization. Understanding the factors that shape this perspective can improve communication among vaccine providers, policymakers, and parents/patients. PMID:15249304

  1. Incidence of Self-Reported Diabetes in New York City, 2002, 2004, and 2008

    PubMed Central

    Chamany, Shadi; Driver, Cynthia R.; Kerker, Bonnie; Silver, Lynn

    2012-01-01

    Introduction Prevalence and incidence of diabetes among adults are increasing in the United States. The purpose of this study was to estimate the incidence of self-reported diabetes in New York City, examine factors associated with diabetes incidence, and estimate changes in the incidence over time. Methods We used data from the New York City Community Health Survey in 2002, 2004, and 2008 to estimate the age-adjusted incidence of self-reported diabetes among 24,384 adults aged 18 years or older. Multiple logistic regression analysis was performed to examine factors associated with incident diabetes. Results Survey results indicated that the age-adjusted incidence of diabetes per 1,000 population was 9.4 in 2002, 11.9 in 2004, and 8.6 in 2008. In multivariable-adjusted analysis, diabetes incidence was significantly associated with being aged 45 or older, being black or Hispanic, being overweight or obese, and having less than a high school diploma. Conclusion Our results suggest that the incidence of diabetes in New York City may be stabilizing. Age, black race, Hispanic ethnicity, elevated body mass index, and low educational attainment are risk factors for diabetes. Large-scale implementation of prevention efforts addressing obesity and sedentary lifestyle and targeting racial/ethnic minority groups and those with low educational attainment are essential to control diabetes in New York City. PMID:22698175

  2. 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.

  3. 33 CFR 156.220 - Reporting of incidents.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) POLLUTION OIL AND HAZARDOUS MATERIAL TRANSFER OPERATIONS Special Requirements for Lightering of Oil and... discharge of oil or hazardous material into the water shall be reported, by the service vessel,...

  4. 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.

  5. Predictive Factors of Spontaneous Reporting of Adverse Drug Reactions among Community Pharmacists

    PubMed Central

    Yu, Yun Mi; Lee, Euni; Koo, Bon Sun; Jeong, Kyeong Hye; Choi, Kyung Hee; Kang, Lee Kyung; Lee, Mo Se; Choi, Kwang Hoon; Oh, Jung Mi; Shin, Wan Gyoon

    2016-01-01

    Purpose To evaluate the association between spontaneous reporting (SR) and the knowledge, attitude, and needs of community pharmacists (CPs), using a questionnaire following a conceptual model known as the mixed model of knowledge-attitude-practices and the satisfaction of needs. Methods Self-administered questionnaires were used with a nationwide convenience sample of CPs between September 1, 2014 and November 25, 2014 in Korea. The association between SR and the predictive factors was evaluated using multivariate logistic regression analysis. Results In total, 1,001 questionnaires were analyzed. The mean age of the respondents and the number of years spent in community pharmacy practice were 45.6 years and 15.3 years, respectively. CPs with experience of SR was 29.4%. Being older than 60 (ORadj, 0.16; 95% CI, 0.06–0.42), having prior experience with adverse drug reactions (ADR) (ORadj, 6.46; 95% CI, 2.46–16.98), having higher specific knowledge of SR (ORadj, 3.58; 95% CI, 1.96–6.56), and having less concern about the obstacles to SR (ORadj, 0.36; 95% CI, 0.23–0.57) were significant contributing factors to SR. The main obstacles to SR included perception of ADRs as ‘not serious ADR’ (77.9%), ‘already well known ADR’ (81.5%), and ‘uncertain about causality’ (73.3%). CPs without reporting experience had greater concerns related to the reporting method and the liability of the pharmacy than those with reporting experience (p<0.05). Conclusions Findings from our study showed around one in three CPs had ADR reporting experience in Korea, while 87.1% had prior experience with ADR cases. The knowledge of SR, prior experience of ADR, and less concern about the obstacles to SR were contributing factors for reporting levels. PMID:27192159

  6. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India

    PubMed Central

    Tandon, Vishal R.; Mahajan, Vivek; Khajuria, Vijay; Gillani, Zahid

    2015-01-01

    Aim: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India. Materials and Methods: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance. Results: At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students. Conclusion: UR is a matter of concern PvPI. Multiple

  7. 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.

  8. Do we need a national incident reporting system for medical imaging?

    PubMed

    Itri, Jason N; Krishnaraj, Arun

    2012-05-01

    The essential role of an incident reporting system as a tool to improve safety and reliability has been described in high-risk industries such as aviation and nuclear power, with anesthesia being the first medical specialty to successfully integrate incident reporting into a comprehensive quality improvement strategy. Establishing an incident reporting system for medical imaging that effectively captures system errors and drives improvement in the delivery of imaging services is a key component of developing and evaluating national quality improvement initiatives in radiology. Such a national incident reporting system would be most effective if implemented as one piece of a comprehensive quality improvement strategy designed to enhance knowledge about safety, identify and learn from errors, raise standards and expectations for improvement, and create safer systems through implementation of safe practices. The potential benefits of a national incident reporting system for medical imaging include reduced morbidity and mortality, improved patient and referring physician satisfaction, reduced health care expenses and medical liability costs, and improved radiologist satisfaction. The purposes of this article are to highlight the positive impact of external reporting systems, discuss how similar advancements in quality and safety can be achieved with an incident reporting system for medical imaging in the United States, and describe current efforts within the imaging community toward achieving this goal. PMID:22554630

  9. 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.

  10. 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

  11. Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales

    PubMed Central

    Karayal, Onur N.; Kolluri, Sheela; Vanderburg, Douglas; Kemmler, Georg; Fleischhacker, W. Wolfgang

    2015-01-01

    Background: While antipsychotic-induced extrapyramidal symptoms (EPS) and akathisia remain important concerns in the treatment of patients with schizophrenia, the relationship between movement disorder rating scales and spontaneously reported EPS-related adverse events (EPS-AEs) remains unexplored. Methods: Data from four randomized, placebo- and haloperidol-controlled ziprasidone trials were analyzed to examine the relationship between spontaneously reported EPS-AEs with the Simpson Angus Scale (SAS) and Barnes Akathisia Rating Scale (BARS). Categorical summaries were created for each treatment group to show the frequencies of subjects with EPS-AEs in each of the SAS and BARS categories at weeks 1, 3, and 6, and agreement between ratings was quantified by means of weighted kappa (κ). Results: In general, we found greater frequencies of EPS-AEs with increasing severity of the SAS and BARS scores. The EPS-AEs reported with a “none” SAS score ranged from 0 to 22.2%, with a “mild” SAS score from 3.3 to 29.0%, and with a “moderate” SAS score from 0 to 100%. No subjects in any treatment group reported “severe” SAS scores or corresponding EPS-AEs. Agreement between SAS scores and EPS-AEs was poor for ziprasidone and placebo (κ < 0.2) and only slightly better for haloperidol. The EPS-AEs reported with “non questionable” BARS scores ranged from 1.9 to 9.8%, with “mild moderate” BARS scores from 12.8 to 54.6%, and with “marked severe” scores from 0 to 100%. Agreement was modest for ziprasidone and placebo (κ < 0.4) and moderate for haloperidol (κ < 0.6). Conclusions: These findings may reflect either underreporting of AEs by investigators and subjects or erroneous rating scale evaluations. PMID:26116494

  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. Recognition and reporting of suspected adverse drug reactions by surveyed healthcare professionals in Uganda: key determinants

    PubMed Central

    Kiguba, Ronald; Karamagi, Charles; Waako, Paul; Ndagije, Helen B; Bird, Sheila M

    2014-01-01

    Objective To assess extent and determinants of past-month recognition of suspected adverse drug reactions (ADR) and past-year ADR reporting among healthcare professionals (HCPs) in Uganda. Setting Geographically diverse health facilities (public, private for-profit, private not-for-profit). Participants Of 2000 questionnaires distributed, 1345 were completed: return rate of 67%. Primary and secondary outcome measures Per cent HCPs who suspected ADR in the past month; reported ADR in the past year. Results Nurses were the majority (59%, 792/1345). Only half the respondents had heard about pharmacovigilance: 39% of nurses (295/763; 95% CI 35% to 42%), 70% otherwise (383/547; 95% CI 66% to 74%). One fifth (268/1289 or 21%; 95% CI 19% to 23%) had suspected an ADR in the previous 4 weeks, 111 of them were nurses; 15% (190/1296) had reported a suspected ADR in the past year, 103 of them were nurses. Past-month ADR suspicion was more likely by non-nurses (OR=1.7, 95% CI 1.16 to 2.40) and with medical research involvement (OR=1.5, 95% CI 1.05 to 2.15) but past-month receipt of patient ADR-complaint predominated (OR=19, 95% CI 14 to 28). Past-year ADR reporting was higher by hospital staff (OR=1.9, 95% CI 1.18 to 3.10), especially in medicine (OR=2.3, 95% CI 1.08 to 4.73); but lower from private for-profit health facilities (OR=0.5, 95% CI 0.28 to 0.77) and by older staff (OR=0.6, 95% CI 0.43 to 0.91); more likely by HCPs who had ever encountered a fatal ADR (OR=2.9, 95% CI 1.94 to 4.25), knew to whom to report (OR=1.7, 95% CI 1.18 to 2.46), or suggested how to improve ADR reporting (OR=1.6, 95% CI 1.04 to 2.49). Two attitudinal factors were important: diffidence and lethargy. Conclusions One in five HCPs suspected an ADR in the past-month and one in seven reported ADR in the previous year. Empowering patients could strengthen ADR detection and reporting in Africa. PMID:25421337

  14. Melanoma Associated with TNFα Inhibitors: a Research on Adverse Drug events And Reports (RADAR) Project

    PubMed Central

    Nardone, B.; Hammel, J.A.; Raisch, D.W.; Weaver, L.L.; Schneider, D.; West, D.P.

    2014-01-01

    Background Tumor necrosis factor-alpha inhibitors (TNFαIs) are used for treatment of inflammatory disorders. There is evidence linking these agents with occurrence of malignancies. For four out of five TNFαIs the Food and Drug Administration (FDA) label states, “melanoma has been reported in patients treated with these agents.” Objectives Determine whether a statistically-significant association exists between administration of TNFαIs and development of malignant melanoma. Methods We searched the FDA Adverse Events Reporting System (FAERS) database for terms related to melanoma and TNFαIs for detection of safety signals. We also searched a large urban academic electronic medical record (EMR) database for which we calculated the relative risk (RR) of melanoma in subjects exposed to TNFαIs vs. non-exposed subjects. Results There were 972 reports of melanoma associated with a TNFαIs identified in the FAERS database, with 69 reports among individuals using more than one TNFαI. A safety signal was detected for infliximab (I) golimumab (G), etanercept (E), and adalimumab (A). Cetrolizumab pegol (CP) had no detectible safety signal. For TNFαIs as a class of drugs, a safety signal was detectable in the FAERS database, and RR was significant in the EMR database. For the EMR cohort, 6,045 patients were exposed to TNFαIs and 35 cases of melanoma were detected. Significance for RR was detected for A (RR = 1.8, p = 0.02) and E (RR 2.35, p = 0.0004). Conclusions We identified a significant association between exposure to TNFαIs and malignant melanoma in two different analyses. Our findings add to existing evidence linking these agents with the occurrence of malignant melanoma. Additional investigations are required to further explore this association and the risk of melanoma with TNFαI therapy. PMID:24328939

  15. 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

  16. 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.

  17. 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... Department to conduct an assessment to improve the collection, analysis, reporting, and use of data related... improving the collection, analysis, reporting, and use of data related to accidents and incidents...

  18. Estimating HIV incidence from case-report data: method and an application in Colombia

    PubMed Central

    Vesga, Juan Fernando; Cori, Anne; van Sighem, Ard; Hallett, Timothy B.

    2014-01-01

    Objective: Quantifying HIV incidence is essential for tracking epidemics but doing this in concentrated epidemic can be a particular challenge because of limited consistent high-quality data about the size, behaviour and prevalence of HIV among key populations. Here, we examine a method for estimating HIV incidence from routinely collected case-reporting data. Methods: A flexible model of HIV infection, diagnosis and survival is constructed and fit to time-series data on the number of reported cases in a Bayesian framework. The time trend in the hazard of infection is specified by a penalized B-spline. We examine the performance of the model by applying it to synthetic data and determining whether the method is capable of recovering the input incidence trend. We then apply the method to real data from Colombia and compare our estimates of incidence with those that have been derived using alternative methods. Results: The method can feasibly be applied and it successfully recovered a range of incidence trajectories in synthetic data experiments. However, estimates for incidence in the recent past are highly uncertain. When applied to data from Colombia, a credible trajectory of incidence is generated which indicates a much lower historic level of HIV incidence than has previously been estimated using other methods. Conclusion: It is feasible, though not satisfactory, to estimate incidence using case-report data in settings with good data availability. Future work should examine the impact on missing or biased data, the utility of alternative formulations of flexible functions specifying incidence trends, and the benefit of also including data on deaths and programme indicators such as the numbers receiving antiretroviral therapy. PMID:25406752

  19. Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome

    PubMed Central

    Dougall, Dominic; Johnson, Anthony; Goldsmith, Kimberley; Sharpe, Michael; Angus, Brian; Chalder, Trudie; White, Peter

    2014-01-01

    Objective Adverse events (AEs) are health related events, reported by participants in clinical trials. We describe AEs in the PACE trial of treatments for chronic fatigue syndrome (CFS) and baseline characteristics associated with them. Methods AEs were recorded on three occasions over one year in 641 participants. We compared the numbers and nature of AEs between treatment arms of specialist medical care (SMC) alone, or SMC supplemented by adaptive pacing therapy (APT), cognitive behaviour therapy (CBT) or graded exercise therapy (GET). We examined associations with baseline measures by binary logistic regression analyses, and compared the proportions of participants who deteriorated by clinically important amounts. Results Serious adverse events and reactions were infrequent. Non-serious adverse events were common; the median (quartiles) number was 4 (2, 8) per participant, with no significant differences between treatments (P = .47). A greater number of NSAEs were associated with recruitment centre, and baseline physical symptom count, body mass index, and depressive disorder. Physical function deteriorated in 39 (25%) participants after APT, 15 (9%) after CBT, 18 (11%) after GET, and 28 (18%) after SMC (P < .001), with no significant differences in worsening fatigue. Conclusions The numbers of adverse events did not differ significantly between trial treatments, but physical deterioration occurred most often after APT. The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments. Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data. PMID:24913337

  20. Statistical analysis of incidents reported in the Greek Petrochemical Industry for the period 1997-2003.

    PubMed

    Konstandinidou, Myrto; Nivolianitou, Zoe; Markatos, Nikolaos; Kiranoudis, Chris

    2006-07-31

    This paper makes an analysis of all reported accidents and incidents in the Greek Petrochemical Industry for the period spanning from 1997 to 2003. The work performed is related to the analysis of important parameters of the incidents, their inclusion in a database adequately designed for the purposes of this analysis and an importance assessment of this reporting scheme. Indeed, various stakeholders have highlighted the importance of a reporting system for industrial accidents and incidents. The European Union has established for this purpose the Major Accident Reporting System (MARS) for the reporting of major accidents in the Member States. However, major accidents are not the only measure that can characterize the safety status of an establishment; neither are the former the only events from which important lessons can be learned. Near misses, industrial incidents without major consequences, as well as occupational accidents could equally supply with important findings the interested analyst, while statistical analysis of these incidents could give significant insight in the understanding and the prevention of similar incidents or major accidents in the future. This analysis could be more significant, if each industrial sector was separately analyzed, as the authors do for the petrochemical sector in the present article.

  1. 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

  2. The folly of rewarding silence while hoping for open reporting of adverse medical events--how to realign the rewards.

    PubMed

    Chamberlain, Nick

    2008-09-22

    The recent release under the Official Information Act (OIA) of Capital and Coast District Health Board's (CandC DHB) Serious and Sentinel Event Report, the subsequent national report, and the commitment to fund a New Zealand-wide incident reporting system raise a number of important issues. This paper discusses the barriers to incident reporting and the folly of attempting to reward system improvements while the barriers are still in place. Suggestions are also made to help guide the development of appropriate systems which will eliminate barriers and realign the rewards.

  3. 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

  4. 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.

  5. Patient safety in primary care: incident reporting and significant event reviews in British general practice.

    PubMed

    Rea, David; Griffiths, Sarah

    2016-07-01

    Over the past 20 years, healthcare has adapted to the 'quality revolution' by moving away from direct provision and hierarchical control mechanisms. In their place, new structures based on contractual relationships are being developed coupled with attempts to create an organisational culture that shares learning and that scrutinises existing practice so that it can be improved. The issue here is that contractual arrangements require surveillance, monitoring, regulation and governance systems that can be perceived as antipathetic to the examination of practice and subsequent learning. Historically, reporting levels from general practice have remained low; little information is shared and consequently lessons are not shared across the general practice community. Given large-scale under-engagement of general practitioners (GPs) in incident reporting systems, significant event analysis is advocated to encourage sharing of information about incidents to inform the patient safety agenda at a local and national level. Previous research has concentrated on the secondary care environment and little is known about the situation in primary care, where the majority of patient contacts with healthcare occur. To explore attitudes to incident reporting, the study adopted a qualitative approach to GPs working in a mixture of urban and rural practices reporting to a Welsh Local Health Board. The study found that GPs used significant event analysis methodology to report incidents within their practice, but acknowledged under-reporting. They were less enthusiastic about reporting externally. A number of barriers exist to reporting, including insufficient time to report, lack of feedback, fear of blame, and damage to reputations and patient confidence in a competitive environment. If incident reporting processes are perceived as supportive and formative, and where protected time is allocated to discuss incidents, then GPs are willing to participate. They also need to know how the

  6. Patient safety in primary care: incident reporting and significant event reviews in British general practice.

    PubMed

    Rea, David; Griffiths, Sarah

    2016-07-01

    Over the past 20 years, healthcare has adapted to the 'quality revolution' by moving away from direct provision and hierarchical control mechanisms. In their place, new structures based on contractual relationships are being developed coupled with attempts to create an organisational culture that shares learning and that scrutinises existing practice so that it can be improved. The issue here is that contractual arrangements require surveillance, monitoring, regulation and governance systems that can be perceived as antipathetic to the examination of practice and subsequent learning. Historically, reporting levels from general practice have remained low; little information is shared and consequently lessons are not shared across the general practice community. Given large-scale under-engagement of general practitioners (GPs) in incident reporting systems, significant event analysis is advocated to encourage sharing of information about incidents to inform the patient safety agenda at a local and national level. Previous research has concentrated on the secondary care environment and little is known about the situation in primary care, where the majority of patient contacts with healthcare occur. To explore attitudes to incident reporting, the study adopted a qualitative approach to GPs working in a mixture of urban and rural practices reporting to a Welsh Local Health Board. The study found that GPs used significant event analysis methodology to report incidents within their practice, but acknowledged under-reporting. They were less enthusiastic about reporting externally. A number of barriers exist to reporting, including insufficient time to report, lack of feedback, fear of blame, and damage to reputations and patient confidence in a competitive environment. If incident reporting processes are perceived as supportive and formative, and where protected time is allocated to discuss incidents, then GPs are willing to participate. They also need to know how the

  7. 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

  8. 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

  9. 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.

  10. 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. PMID:27331907

  11. 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.

  12. Quantitative evaluation of initial symptoms as predictors to detect adverse drug reactions using Bayes' theory: expansion and evaluation of drug-adverse drug reaction-initial symptom combinations using adverse event reporting system database.

    PubMed

    Kobayashi, Daisuke; Hosaka, Shigeru; Inoue, Emiko; Ohshima, Kimie; Kutsuma, Nobuaki; Oshima, Shinji; Okuno, Yasushi

    2013-01-01

    In prescription dispensing in Japan, to avoid adverse drug reactions (ADR) pharmacists provide patients with information concerning the initial symptoms (IS) of any ADR that might be caused by the drugs they have been prescribed. However, the usefulness of such information for preventing ADR has not been quantitatively evaluated. We previously performed a trial calculation of the usefulness of rash as a predictor of drug-induced liver disorders by applying Bayes' theorem and showed that the predictive utility of IS can be quantitatively evaluated using likelihood ratios. However, for other drug-ADR-IS combinations it was difficult to obtain the information required for the calculations from Japanese data alone. In this study, using the Adverse Event Reporting System (AERS) database of the U.S. Food and Drug Administration (FDA), we evaluated 132 drug-ADR-IS combinations that were considered to be potentially clinical significant. Regarding bezafibrate-associated rhabdomyolysis and cibenzoline-associated hypoglycemia, these ADR were not detected in cases involving monotherapy. For 58 combinations, no events that were considered to be IS of the target ADR developed. Fever, nausea, and decreased appetite were the IS of many ADR, making them very useful predictors. In contrast, pruritus and rash were not very useful. Fever might be a predictor of thiamazole-induced agranulocytosis or levofloxacin- or terbinafine-induced liver disorder, tremors might be useful for predicting paroxetine-induced serotonin syndrome, and decreased appetite might be a useful indicator of terbinafine-induced liver dysfunction. PMID:24292049

  13. Seasonal effects on the reported incidence of acute diarrhoeal disease in northeast Thailand.

    PubMed

    Pinfold, J V; Horan, N J; Mara, D D

    1991-09-01

    This paper examines the seasonal variation in the reported incidence of acute diarrhoea for selected areas in the northeast of Thailand. Charts are presented which show rainfall, temperature and reported incidence of acute diarrhoea for the period 1982 to 1987. Incidence of diarrhoea appears to be inversely related to a sharp decrease in temperature around January each year. Although rainfall does not appear to have a direct effect on the relative incidence of acute diarrhoea, there is always a consistent reduction during July or August, after the rains have begun. Seasonal changes in climate may be indirectly related to other factors which have an important bearing on diarrhoeal disease. Rainwater collection is an important water source in this region and the affect this has on water use is discussed in relation to faeco-oral disease transmission.

  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. Using a survey of incident reporting and learning practices to improve organisational learning at a cancer care centre

    PubMed Central

    Cooke, David L; Dunscombe, Peter B; Lee, Robert C

    2007-01-01

    Objectives To motivate improvements in an organisational system by measuring staff perceptions of the organisation's ability to learn from incidents and by analysing their personal experience of incidents. Methods Respondents were questioned on the components of the incident learning system from both a personal and an organisational perspective. The respondents (n = 125) were radiotherapists, nurses, dosimetrists, doctors, and other staff at a major academic cancer centre. Responses were analysed in terms of per cent positive responses and response rate, differences between “frontline” and “support” staff, and the respondent's experience with incidents. Results Respondents were more familiar with and more positive about incident identification and reporting—the first two stages of incident learning. Their overall perception of incident learning was most influenced by the investigation and learning components of the system. Respondents in frontline positions were more positive than those in support positions about responding to, identifying and reporting incidents. Respondents reported having experienced a mean of three incidents per year, of which two were reported and two out of three of the reported incidents were investigated, and a median of two incidents being experienced and reported, but none investigated. Most incidents experienced were not captured by the organisation's existing incident reporting system. Conclusion The survey tool was effective in measuring the ability of the organisation to learn from incidents. Implications of the survey results for improving organisational learning are discussed. PMID:17913774

  16. 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.

  17. 30 CFR 250.188 - What incidents must I report to MMS and when must I report them?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false What incidents must I report to MMS and when must I report them? 250.188 Section 250.188 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT... surface equipment or procedures. (4) All fires and explosions. (5) All reportable releases of...

  18. [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.

  19. [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. PMID:21877221

  20. 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…

  1. 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

    ... of proposed rulemaking (NPRM), published in the Federal Register (FR), is available for inspection...'' in 73 FR 58520. This NPRM proposed and the final rule herein codifies the addition of five reportable... SAFETY BOARD 49 CFR Part 830 Notification and Reporting of Aircraft Accidents or Incidents and...

  2. 40 CFR 1612.3 - Published reports and material contained in the public incident investigation dockets.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Published reports and material... CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD PRODUCTION OF RECORDS IN LEGAL PROCEEDINGS § 1612.3 Published reports and material contained in the public incident investigation dockets. (a) Demands...

  3. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

    PubMed Central

    Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

    2015-01-01

    Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. Method The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. Results The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Conclusion Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. PMID:25918337

  4. 21 CFR 803.40 - If I am an importer, what kinds of individual adverse event reports must I submit, when must I...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... adverse event reports must I submit, when must I submit them, and to whom must I submit them? 803.40... importer, what kinds of individual adverse event reports must I submit, when must I submit them, and to whom must I submit them? (a) Reports of deaths or serious injuries. You must submit a report to us,...

  5. 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.

  6. 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.

  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. PMID:26518315

  8. 21 CFR 803.19 - Are there exemptions, variances, or alternative forms of adverse event reporting requirements?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Are there exemptions, variances, or alternative forms of adverse event reporting requirements? 803.19 Section 803.19 Food and Drugs FOOD AND DRUG..., semiannually, annually or other appropriate time period. We may grant these modifications in response to...

  9. 21 CFR 803.19 - Are there exemptions, variances, or alternative forms of adverse event reporting requirements?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Are there exemptions, variances, or alternative forms of adverse event reporting requirements? 803.19 Section 803.19 Food and Drugs FOOD AND DRUG... modifications in response to your request, as described in paragraph (b) of this section, or at our...

  10. 21 CFR 803.19 - Are there exemptions, variances, or alternative forms of adverse event reporting requirements?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Are there exemptions, variances, or alternative forms of adverse event reporting requirements? 803.19 Section 803.19 Food and Drugs FOOD AND DRUG..., semiannually, annually or other appropriate time period. We may grant these modifications in response to...

  11. 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

  12. Rare, Serious, and Comprehensively Described Suspected Adverse Drug Reactions Reported by Surveyed Healthcare Professionals in Uganda

    PubMed Central

    Kiguba, Ronald; Karamagi, Charles; Waako, Paul; Ndagije, Helen B.; Bird, Sheila M.

    2015-01-01

    Background Lack of adequate detail compromises analysis of reported suspected adverse drug reactions (ADRs). We investigated how comprehensively Ugandan healthcare professionals (HCPs) described their most recent previous-month suspected ADR, and determined the characteristics of HCPs who provided comprehensive ADR descriptions. We also identified rare, serious, and unanticipated suspected ADR descriptions with medication safety-alerting potential. Methods During 2012/13, this survey was conducted in purposively selected Ugandan health facilities (public/private) including the national referral and six regional referral hospitals representative of all regions. District hospitals, health centres II to IV, and private health facilities in the catchment areas of the regional referral hospitals were conveniently selected. Healthcare professionals involved in prescribing, transcribing, dispensing, and administration of medications were approached and invited to self-complete a questionnaire on ADR reporting. Two-thirds of issued questionnaires (1,345/2,000) were returned. Results Ninety per cent (241/268) of HCPs who suspected ADRs in the previous month provided information on five higher-level descriptors as follows: body site (206), drug class (203), route of administration (127), patient age (133), and ADR severity (128). Comprehensiveness (explicit provision of at least four higher-level descriptors) was achieved by at least two-fifths (46%, 124/268) of HCPs. Received descriptions were more likely to be comprehensive from HCPs in private health facilities, regions other than central, and those not involved in teaching medical students. Overall, 106 serious and 51 rare previous-month suspected ADRs were described. The commonest serious and rare ADR was Stevens-Johnson syndrome (SJS); mostly associated with oral nevirapine or cotrimoxazole, but haemoptysis after diclofenac analgesia and paralysis after quinine injection were also described. Conclusion Surveyed Ugandan

  13. 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

  14. Adult Perpetrator Gender Asymmetries in Child Sexual Assault Victim Selection: Results from the 2000 National Incident-Based Reporting System

    ERIC Educational Resources Information Center

    McCloskey, Kathy A.; Raphael, Desreen N.

    2005-01-01

    Data from the 2000 National Incident-Based Reporting System (NIBRS) show that while males make up about nine out of every 10 adult sexual assault perpetrators, totaling about 26,878 incidents within the reporting period, females account for about one out of 10 perpetrators, totaling about 1,162 incidents. Male sexual assault perpetrators offend…

  15. 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... the reporting forms or modify the existing codes. If we do make modifications, we will ensure that...

  16. 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.

  17. 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

  18. Self-reported incidence of skin and soft tissue infections among deployed US military.

    PubMed

    May, Larissa; Porter, Chad; Tribble, David; Armstrong, Adam; Mostafa, Manal; Riddle, Mark

    2011-07-01

    The incidence of skin and soft tissue infections has steadily increased over the past decade, and military populations, particularly recruits, have been affected. However, the epidemiology of skin and soft tissue infections in deployed personnel has not previously been described. We conducted a cross-sectional study of United States military personnel in mid-deployment using self-reported questionnaire data containing 11 demographic questions and 20 questions related to skin and soft tissue infections. The primary outcome was self-reported incident SSTI. Descriptive analyses were conducted and incidence estimates calculated. Multivariable regression models were developed to evaluate the association between SSTI and important covariates. Self-reported treatment modalities and effect on work performance were also assessed. The study was approved by the Institutional Review Board. 2125 questionnaires were completed over 12 months using convenience sampling. 110 personnel (5%) reported one or more skin and soft tissue infection during their most recent employment, for an incidence of 52 cases per 100,000 person-days. The majority reported a single infection. A higher proportion of individuals reporting skin and soft tissue infection were female, reported antibiotic use in the 6 months prior to completing the survey, had a family member in the healthcare occupation, and were senior enlisted or officers. 40 (36%) were treated with antibiotics and 24 (22%) underwent incision and drainage. Less than 5% (3 patients) required admission. Eighty eight respondents (81%), reported no days of lost job performance. There is a higher than expected incidence of skin and soft tissue infections in deployed military personnel. Although fewer than 20% of patients report missing at least one day of work, this can have a significant impact on the military mission. Further study should be conducted into how to prevent skin and soft tissue infections in military populations. PMID:21917525

  19. 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.

  20. 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. PMID:21462790

  1. 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. PMID:23660010

  2. 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.

  3. Variation in reported neonatal group B streptococcal disease incidence in developing countries.

    PubMed

    Dagnew, Alemnew F; Cunnington, Marianne C; Dube, Queen; Edwards, Morven S; French, Neil; Heyderman, Robert S; Madhi, Shabir A; Slobod, Karen; Clemens, Sue Ann Costa

    2012-07-01

    Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed countries. Its burden in the developing world is less clear. Studies reporting neonatal GBS disease incidence from developing countries were identified from 5 literature databases. Studies were assessed with respect to case finding and culture methods. Only 20 studies were identified. The GBS incidence ranged 0-3.06 per 1000 live births with variation within and between geographic regions. All but 1 study identified GBS cases within a hospital setting, despite the potential for births in the community. Possible case under-ascertainment was only discussed in 2 studies. A higher GBS incidence was reported when using automated culture methods. Prospective, population-based surveillance is urgently needed in developing countries to provide an accurate assessment of the neonatal GBS disease burden. This will be crucial for the design of interventions, including novel vaccines, and the understanding of their potential to impact mortality from neonatal sepsis. PMID:22523262

  4. Critical steps in learning from incidents: using learning potential in the process from reporting an incident to accident prevention.

    PubMed

    Drupsteen, Linda; Groeneweg, Jop; Zwetsloot, Gerard I J M

    2013-01-01

    Many incidents have occurred because organisations have failed to learn from lessons of the past. This means that there is room for improvement in the way organisations analyse incidents, generate measures to remedy identified weaknesses and prevent reoccurrence: the learning from incidents process. To improve that process, it is necessary to gain insight into the steps of this process and to identify factors that hinder learning (bottlenecks). This paper presents a model that enables organisations to analyse the steps in a learning from incidents process and to identify the bottlenecks. The study describes how this model is used in a survey and in 3 exploratory case studies in The Netherlands. The results show that there is limited use of learning potential, especially in the evaluation stage. To improve learning, an approach that considers all steps is necessary. PMID:23498711

  5. Groups with Historically High Incidences of Unemployment. A Report to the Congress.

    ERIC Educational Resources Information Center

    Helmeke, Kerry; And Others

    This report dealing with groups with historically high incidences of unemployment is made in response to Section 4 (d) (3) of the Fair Labor Standards Act. (These groups include teenagers; 20-24 year-olds; veterans [20-24 year-olds]; females; blacks and other minorities; persons of Hispanic origin; and the elderly [65 years and older]). The report…

  6. 30 CFR 285.830 - What are my incident reporting requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... accordance with 30 CFR 254.46. ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What are my incident reporting requirements? 285.830 Section 285.830 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE...

  7. 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....

  8. 30 CFR 250.187 - What are BSEE's incident reporting requirements?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... may be required by other regulatory agencies. (d) You must report all spills of oil or other liquid... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF General... apply to incidents that occur on the area covered by your lease, right-of-use and easement,...

  9. 30 CFR 250.187 - What are BSEE's incident reporting requirements?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... may be required by other regulatory agencies. (d) You must report all spills of oil or other liquid... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF General... apply to incidents that occur on the area covered by your lease, right-of-use and easement,...

  10. 30 CFR 250.187 - What are MMS' incident reporting requirements?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... incidents that may be required by other regulatory agencies. (d) You must report all spills of oil or other... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL... easement, pipeline right-of-way, or other permit issued by MMS, and that are related to...

  11. 30 CFR 250.187 - What are BSEE's incident reporting requirements?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... may be required by other regulatory agencies. (d) You must report all spills of oil or other liquid... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF General... apply to incidents that occur on the area covered by your lease, right-of-use and easement,...

  12. 30 CFR 250.187 - What are MMS' incident reporting requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... regulatory agencies. (d) You must report all spills of oil or other liquid pollutants in accordance with 30... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF General Information and... incidents that occur on the area covered by your lease, right-of-use and easement, pipeline right-of-way,...

  13. 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...

  14. Major Findings from the Canadian Incidence Study of Reported Child Abuse and Neglect

    ERIC Educational Resources Information Center

    Trocme, Nico M.; Tourigny, Marc; MacLaurin, Bruce; Fallon, Barbara

    2003-01-01

    Objective: To present key findings from the Canadian Incidence Study of Reported Child Maltreatment (CIS) in sufficient detail to provide a basis for international comparisons in terms of forms and severity of maltreatment and the age and sex of victims. Method: A survey conducted in a random sample of 51 child welfare service areas across Canada…

  15. Reporting of Child Maltreatment: A Secondary Analysis of the National Incidence Surveys.

    ERIC Educational Resources Information Center

    Ards, Sheila; Harrell, Adele

    1993-01-01

    Data from the National Study of the Incidence and Prevalence of Child Abuse and Neglect were analyzed concerning kinds of cases underreported, overreported, or not reported. The analysis examined age, family income, sex, race, urban or rural, and type of abuse from sexual abuse to educational neglect. (JDD)

  16. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Reports by air carriers on incidents involving animals during air transport. 234.13 Section 234.13 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC REGULATIONS AIRLINE SERVICE QUALITY...

  17. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Reports by air carriers on incidents involving animals during air transport. 234.13 Section 234.13 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC REGULATIONS AIRLINE SERVICE QUALITY...

  18. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Reports by air carriers on incidents involving animals during air transport. 234.13 Section 234.13 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC REGULATIONS AIRLINE SERVICE QUALITY...

  19. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Reports by air carriers on incidents involving animals during air transport. 234.13 Section 234.13 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC REGULATIONS AIRLINE SERVICE QUALITY...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Reports by air carriers on incidents involving animals during air transport. 234.13 Section 234.13 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC REGULATIONS AIRLINE SERVICE QUALITY...

  1. 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 existing codes. If we do make modifications, we will ensure that we make the new...

  2. Improvement in the incident reporting and investigation procedures using process excellence (DMAI2C) methodology.

    PubMed

    Miles, Elizabeth N

    2006-03-17

    In 1996, Health & Safety introduced an incident investigation process called Learning to Look to Johnson & Johnson. This process provides a systematic way of analyzing work-related injuries and illness, uncovers root cause that leads to system defects, and points to viable solutions. The process analyzed involves three steps: investigation and reporting of the incident, determination of root cause, and development and implementation of a corrective action plan. The process requires the investigators to provide an initial communication for work-related serious injuries and illness as well as lost workday cases to Corporate Headquarters within 72 h of the incident with a full investigative report to follow within 10 days. A full investigation requires a written report, a cause-result logic diagram (CRLD), a corrective action plan (CAP) and a report of incident costs (SafeCost) all due to be filed electronically. It is incumbent on the principal investigator and his or her investigative teams to assemble the various parts of the investigation and to follow up with the relevant parties to ensure corrective actions are implemented, and a full report submitted to Corporate executives. Initial review of the system revealed that the process was not working as designed. A number of reports were late, not signed by the business leaders, and in some instances, all cause were not identified. Process excellence was the process used to study the issue. The team used six sigma DMAI2C methodologies to identify and implement system improvements. The project examined the breakdown of the critical aspects of the reporting and investigation process that lead to system errors. This report will discuss the study findings, recommended improvements, and methods used to monitor the new improved process. PMID:16225990

  3. Improvement in the incident reporting and investigation procedures using process excellence (DMAI2C) methodology.

    PubMed

    Miles, Elizabeth N

    2006-03-17

    In 1996, Health & Safety introduced an incident investigation process called Learning to Look to Johnson & Johnson. This process provides a systematic way of analyzing work-related injuries and illness, uncovers root cause that leads to system defects, and points to viable solutions. The process analyzed involves three steps: investigation and reporting of the incident, determination of root cause, and development and implementation of a corrective action plan. The process requires the investigators to provide an initial communication for work-related serious injuries and illness as well as lost workday cases to Corporate Headquarters within 72 h of the incident with a full investigative report to follow within 10 days. A full investigation requires a written report, a cause-result logic diagram (CRLD), a corrective action plan (CAP) and a report of incident costs (SafeCost) all due to be filed electronically. It is incumbent on the principal investigator and his or her investigative teams to assemble the various parts of the investigation and to follow up with the relevant parties to ensure corrective actions are implemented, and a full report submitted to Corporate executives. Initial review of the system revealed that the process was not working as designed. A number of reports were late, not signed by the business leaders, and in some instances, all cause were not identified. Process excellence was the process used to study the issue. The team used six sigma DMAI2C methodologies to identify and implement system improvements. The project examined the breakdown of the critical aspects of the reporting and investigation process that lead to system errors. This report will discuss the study findings, recommended improvements, and methods used to monitor the new improved process.

  4. Reported incidence of occupational asthma in the United Kingdom, 1989-90.

    PubMed Central

    Meredith, S

    1993-01-01

    STUDY OBJECTIVE--To estimate the incidence of occupational asthma seen by respiratory and occupational physicians in the UK in 1989 and 1990. DESIGN--New cases of occupational asthma were taken from a national reporting scheme, the Surveillance of Work-related and Occupational Respiratory Disease Project (SWORD). Estimates of the working population from the Labour Force Survey were used to calculate reported incidence by age group, sex, occupation, and region. SETTING--The SWORD project is a scheme for the reporting of new cases of work-related respiratory disease by thoracic and occupational physicians from throughout the UK which began in 1989. PATIENTS--In 1989 and 1990, of 4229 cases reported, 1085 (26%) were in patients with occupational asthma. MAIN RESULTS--Only half the reported cases were attributed to agents prescribed under the Industrial Injuries Scheme. There was considerable diversity in risk by occupation, with highest annual rates in welders, solderers, and electronic assemblers (175/million), laboratory workers (188/million), metal treaters (267/million), bakers (334/million), plastics workers (337/million), chemical processors (364/million), and spray painters (658/million). Crude rates in men were higher than in women, but rates within occupations were similar in both sexes. Rates of disease rose with age; adjustment for occupation increased the gradient. Regional differences were only partly explained by diversity of industry and were probably mainly due to variation in levels of ascertainment and reporting. CONCLUSIONS--Asthma is the most commonly reported occupational lung disease in the UK. The incidence in the general population is unknown, but it was estimated that the incidence of new cases seen by respiratory and occupational physicians was about three times that reported. High relative risks were found in a number of occupations in which effective control of the work environment is urgently required. PMID:8120500

  5. Incidence and severity of sediment contamination in surface waters of the United States. Volume 1. National sediment quality survey. Report to the Congress

    SciTech Connect

    1997-09-01

    This report describes the accumulation of chemical contaminants in river, lake, ocean, and estuary bottoms and includes a screening assessment of the potential for associated adverse effects to human and environmental health. It represents the first comprehensive EPA analysis of sediment chemistry and related biological data to assess what is known about the national incidence and severity of sediment contamination. EPA studied available data from sixty-five percent of the 2,111 watersheds in the continental United States and identified ninety-six watersheds that contain `areas of probable concern.`

  6. Incidence and relative risk of adverse events of special interest in patients with castration resistant prostate cancer treated with CYP-17 inhibitors: A meta-analysis of published trials.

    PubMed

    Roviello, Giandomenico; Sigala, Sandra; Danesi, Romano; Re, Marzia Del; Bonetta, Alberto; Cappelletti, Maria Rosa; Zanotti, Laura; Bottini, Alberto; Generali, Daniele

    2016-05-01

    Abiraterone acetate and orteronel are two CYP-17 inhibitors that have been studied in prostate cancer. They have shown relevant toxicities, including fluid retention/oedema, hypokalaemia, hypertension, liver function test abnormalities and cardiac events. The goal of this study was to determine the risk of special adverse events related to CYP- 17 inhibitor in patients with metastatic castration-resistant prostate cancer (CRCP). Summary data from four randomized phase III trials comparing CYP-17 inhibitors and prednisone versus placebo and prednisone in metastatic CRCP patients were meta-analysed. Pooled risk ratios (RRs) for the risk of all-grade and grade 3-4 adverse events of special interest were calculated. Data from 4916 patients (2849 in the AA experimental arm; 2067 in the control arm) were analysed. The incidence of grade 3-4 adverse events was never more than 10% of the patients. However, compared with placebo, the CYP-17 inhibitor significantly increased the all-grade events of hypertension (RR=1.53; 95% CI=1.3-1.8; p<0.00001), hypokalaemia (RR=1.56; 95% CI=1.29-1.89; p<0.00001), cardiac disorders (RR=1.47; 95% CI=1.27-1.7; p<0.00001) liver function test abnormalities (RR=1.93; 95% CI=1.15-3.24; p=0.01) grade≥3 adverse events, hypokalaemia (RR=4.23; 95% CI=1.28-13.99; p=0.02) and cardiac disorders (RR=1.55; 95% CI=1.18-2.05; p=0.002). A lot of adverse events such as hypertension, hypokalaemia, cardiac disorders and liver function test abnormalities are increased during CYP-17 inhibitor based therapy. Strict monitoring of these side effects should be considered during CYP- 17 inhibitor therapy in prostate cancer patients.

  7. Does an allergy to fish pre-empt an adverse protamine reaction? A case report and a literature review.

    PubMed

    Collins, C; O'Donnell, A

    2008-11-01

    The operating theatre exposes patients to myriad potential agents which could result in a life-threatening anaphylactic reaction. Anaesthetic drugs, blood products, and latex are only some of the possible allergens. Reactions are deemed to be anaphylactic when immediate sensitivity is combined with cardiovascular collapse. A patient who had a known allergy to shellfish presented for first time cardiopulmonary bypass. The perfusion team were concerned that there was a realistic possibility that an adverse reaction to protamine could occur. Anaphylactic reactions to protamine in patients allergic to fish have been reported. The anaesthetic team were informed and the necessary precautions taken. We report on the outcome for our patient and also discuss other risk factors and the types of reactions that can result when an adverse reaction to protamine occurs.

  8. 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.

  9. 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

  10. 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.

  11. 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

  12. 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…

  13. 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.

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

    PubMed Central

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

    2015-01-01

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

  15. 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

  16. Systematic literature review of templates for reporting prehospital major incident medical management

    PubMed Central

    Fattah, Sabina; Rehn, Marius; Reierth, Eirik; Wisborg, Torben

    2013-01-01

    Objective To identify and describe the content of templates for reporting prehospital major incident medical management. Design Systematic literature review according to PRISMA guidelines. Data sources PubMed/MEDLINE, EMBASE, CINAHL, Scopus and Web of Knowledge. Grey literature was also searched. Eligibility criteria for selected studies Templates published after 1 January 1990 and up to 19 March 2012. Non-English language literature, except Scandinavian; literature without an available abstract; and literature reporting only psychological aspects were excluded. Results The main database search identified 8497 articles, among which 8389 were excluded based on title and abstract. An additional 96 were excluded based on the full-text. The remaining 12 articles were included in the analysis. A total of 107 articles were identified in the grey literature and excluded. The reference lists for the included articles identified five additional articles. A relevant article published after completing the search was also included. In the 18 articles included in the study, 10 different templates or sets of data are described: 2 methodologies for assessing major incident responses, 3 templates intended for reporting from exercises, 2 guidelines for reporting in medical journals, 2 analyses of previous disasters and 1 Utstein-style template. Conclusions More than one template exists for generating reports. The limitations of the existing templates involve internal and external validity, and none of them have been tested for feasibility in real-life incidents. Trial registration The review is registered in PROSPERO (registration number: CRD42012002051). PMID:23906946

  17. 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

  18. 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

  19. 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

  20. 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.

  1. 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.

  2. 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…

  3. Harassment and Intimidation (Bullying) in Maryland Public Schools. A Report to the Maryland General Assembly on Incidents Reported under the Safe Schools Reporting Act of 2005

    ERIC Educational Resources Information Center

    Maryland State Department of Education, 2008

    2008-01-01

    The Safe Schools Reporting Act of 2005 requires that county boards of education and the Baltimore City Board of School Commissioners report incidents of harassment or intimidation against students in public schools under the county board's and commission's jurisdiction. The reporting period for the third report encompasses the 2006-2007 school…

  4. The implementation and utility of fire incident reporting systems: the Delaware experience.

    PubMed

    Bergen, Gwendolyn; Frattaroli, Shannon; Ballesteros, Michael F; Ta, Van M; Beach, Crystal; Gielen, Andrea C

    2008-04-01

    Fires and burns are the fifth most common cause of unintentional injury deaths in the United States. To address fires and fire deaths, the National Fire Data Center (NFDC) established the National Fire Incident Reporting System (NFIRS) as a surveillance system for fires. Delaware implemented NFIRS as the Delaware Fire Incident Reporting System (DFIRS), and is currently capturing all fires reported in the system. The objectives of this study are to: 1) understand the implementation of DFIRS; 2) analyze data from DFIRS to describe fire incidents; and 3) inform other states' fire surveillance efforts. We interviewed Delaware State Fire Marshal's Office personnel to understand the implementation of DFIRS and analyzed DFIRS data from May 2003 to December 2004 to examine data completeness, and characteristics of fires, smoke alarms, and fire injuries and deaths. DFIRS captures 100% of Delaware fires reported to fire departments. Data completeness for the fields examined ranged from 33% to 100%. Fires in which smoke alarms alerted occupants were significantly less likely to result in injury or death than fires in which smoke alarms did not. DFIRS has the potential to serve as a valuable fire prevention and fire analysis tool. For DFIRS to reach its full potential as a surveillance system, increased attention to data completeness is necessary. PMID:18074209

  5. 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. PMID:27354959

  6. 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

  7. 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

  8. 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

  9. Reporting of adverse events related to dietary supplements to a public health center by medical staff: a survey of clinics and pharmacies

    PubMed Central

    Ide, Kazuki; Yamada, Hiroshi; Kawasaki, Yohei; Noguchi, Marika; Kitagawa, Mamoru; Chiba, Tsuyoshi; Kagawa, Yoshiyuki; Umegaki, Keizo

    2016-01-01

    Background Dietary supplements are used by >50% of the adult population in Japan, and adverse events related to these products have been reported with their increased use. Thus, an efficient system to gather and report data on these adverse events is essential. To date, however, reporting has been limited. The aim of this study was to address this deficiency by exploring the routine reporting practices of the medical staff employed at clinics or pharmacies in Japan. Methods We conducted a survey of the procedures used by the medical staff to report adverse events related to dietary supplement intake to public health centers in Japan. The survey was conducted in Japan between November 2015 and January 2016. Based on a sample size calculation, questionnaires were administered to 1,700 potential respondents (850 pharmacists and 850 physicians). The questionnaire inquired about the sociodemographic characteristics and dietary supplement-related adverse event-reporting practices. Results The response rate was 34.7%, including 286 pharmacists and 304 physicians. Although >30% of the pharmacists and physicians had prior experience dealing with such adverse events, <5% had reported these to a public health center. The survey identified several barriers to reporting, such as “difficulty judging the relationship between an adverse event and the dietary supplement” and “lack of clarity regarding the severity of an adverse event”. Conclusion This is the first study to explore the routine reporting practices of physicians and pharmacists in terms of adverse events related to dietary supplements. Further studies are required to elucidate the severity of these adverse events. Moreover, standard reporting criteria ought to be introduced to improve public health. PMID:27672326

  10. Automating patient safety incident reporting to improve healthcare quality in the defence medical services.

    PubMed

    Lamb, Di; Piper, N

    2015-12-01

    There are many reasons for poor compliance with patient safety incident reporting in the UK. The Defence Medical Services has made a significant investment to address the culture and process by which risk to patient safety is managed within its organisation. This paper describes the decision process and technical considerations in the design of an automated reporting system together with the implementation procedure aimed to maximise compliance. The elimination of inherent weaknesses in feedback mechanisms from the three Armed Forces, which had been uniquely different, ensured the quality of data improved, which enabled resources to be prioritised that would also have a direct impact upon the quality of patient care.

  11. Results From the First Decade of Research Conducted by the Research on Adverse Drug events And Reports (RADAR) Project

    PubMed Central

    McKoy, June M.; Fisher, Matthew J.; Courtney, D. Mark; Raisch, Dennis W.; Edwards, Beatrice J.; Scheetz, Marc H.; Belknap, Steven M.; Trifilio, Steven M.; Samaras, Athena T.; Liebling, Dustin B.; Nardone, Beatrice; Tulas, Katrina Marie; West, Dennis P.

    2013-01-01

    Introduction In 1998, a multidisciplinary team of investigators initiated the Research on Adverse Drug events And Reports (RADAR) project, a post-marketing surveillance effort that systematically investigates and disseminates information describing serious and previously unrecognized serious adverse drug and device reactions (sADRs). Objective Herein, we describe the findings, dissemination efforts, and lessons learned from the first decade of the RADAR project. Methods After identifying serious and unexpected clinical events suitable for further investigation, RADAR collaborators derived case information from physician queries, published and unpublished clinical trials, case reports, US FDA databases and manufacturer sales figures. Study Selection All major RADAR publications from 1998 to the present are included in this analysis. Data Extraction For each RADAR publication, data were abstracted on data source, correlative basic science findings, dissemination and resultant safety information. Results RADAR investigators reported 43 serious ADRs. Data sources included case reports (17 sADRs), registries (5 sADRs), referral centers (8 sADRs) and clinical trial reports (13 sADRs). Correlative basic science findings were reported for ten sADRs. Thirty-seven sADRS were described as published case reports (5 sADRs) or published case-series (32 sADRs). Related safety information was disseminated as warnings or boxed warnings in the package insert (17 sADRs) and/or `Dear Healthcare Professional' letters (14 sADRs). Conclusion An independent National Institutes of Health-funded post-marketing surveillance programme can supplement existing regulatory and pharmaceutical manufacturer supported drug safety initiatives. PMID:23553448

  12. 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

  13. Cardiovascular Adverse Reactions During Antidepressant Treatment: A Drug Surveillance Report of German-Speaking Countries Between 1993 and 2010

    PubMed Central

    Spindelegger, Christoph Josef; Papageorgiou, Konstantinos; Grohmann, Renate; Engel, Rolf; Greil, Waldemar; Konstantinidis, Anastasios; Agelink, Marcus Willy; Bleich, Stefan; Ruether, Eckart; Toto, Sermin

    2015-01-01

    Background: Antidepressants (ADs) are known to have the potential to cause various cardiovascular adverse drug reactions (ADRs). The tricyclic antidepressants (TCAs) were first revealed to be a possible source of cardiovascular ADRs. In recent years, newer classes of ADs were also suggested to have a higher risk of cardiovascular adverse effects. In particular, the selective serotonin reuptake inhibitors (SSRIs) were suspected to have the potential to induce QTc interval prolongation, and therefore increase the risk of ventricular arrhythmia. This descriptive study is based on the continuous pharmacovigilance program of German-speaking countries (Austria, Germany, and Switzerland), the Arzneimittelsicherheit in der Psychiatrie (AMSP), which assesses severe ADRs occurring in clinical routine situations. Methods: Of 169 278 psychiatric inpatients treated with ADs between 1993 and 2010, 198 cases of cardiovascular ADRs (0.12%) were analyzed. Results: Our study showed that the incidence rates of cardiovascular ADRs were highest during treatment with monoamine oxidase inhibitors (0.27%), TCAs (0.15%), and serotonin noradrenaline reuptake inhibitors (0.14%); the risk of occurring during treatment with SSRIs (0.08%) was significantly lower. The noradrenergic and specific serotonergic AD mirtazapine (0.07%) had a significantly lower risk of cardiovascular ADRs than all other ADs. Severe hypotension was the most frequent ADR, followed by hypertension, arrhythmia, and in some rare cases heart failure. Conclusions: Despite certain limitations due to the AMSP study design, our observations on cardiovascular ADRs can contribute to a better knowledge of the cardiovascular risk profiles of antidepressants in the clinical routine setting. However, prospective studies are needed to verify our findings. PMID:25522416

  14. Guillain-Barré syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006-2009.

    PubMed

    Souayah, Nizar; Michas-Martin, P A; Nasar, Abu; Krivitskaya, Nataliya; Yacoub, Hussam A; Khan, Hafiz; Qureshi, Adnan I

    2011-01-29

    Using data from Vaccine Adverse Event Reporting System, we identified 69 reports of Guillain-Barré Syndrome (GBS) after Gardasil vaccination that occurred in the United States between 2006 and 2009. The onset of symptoms was within 6 weeks after vaccination in 70% of the patients in whom the date of vaccination was known. The estimated weekly reporting rate of post-Gardasil GBS within the first 6 weeks (6.6 per 10,000,000) was higher than that of the general population, and higher than post-Menactra and post-influenza vaccinations. Further prospective active surveillance for accurate ascertainment and identification of high-risk groups of GBS after Gardasil vaccination is warranted.

  15. Network analysis of possible anaphylaxis cases reported to the US vaccine adverse event reporting system after H1N1 influenza vaccine.

    PubMed

    Botsis, Taxiarchis; Ball, Robert

    2011-01-01

    The identification of signals from spontaneous reporting systems plays an important role in monitoring the safety of medical products. Network analysis (NA) allows the representation of complex interactions among the key elements of such systems. We developed a network for a subset of the US Vaccine Adverse Event Reporting System (VAERS) by representing the vaccines/adverse events (AEs) and their interconnections as the nodes and the edges, respectively; this subset we focused upon included possible anaphylaxis reports that were submitted for the H1N1 influenza vaccine. Subsequently, we calculated the main metrics that characterize the connectivity of the nodes and applied the island algorithm to identify the densest region in the network and, thus, identify potential safety signals. AEs associated with anaphylaxis formed a dense region in the 'anaphylaxis' network demonstrating the strength of NA techniques for pattern recognition. Additional validation and development of this approach is needed to improve future pharmacovigilance efforts. PMID:21893812

  16. Medication incident reporting in residential aged care facilities: Limitations and risks to residents’ safety

    PubMed Central

    2012-01-01

    Background Medication incident reporting (MIR) is a key safety critical care process in residential aged care facilities (RACFs). Retrospective studies of medication incident reports in aged care have identified the inability of existing MIR processes to generate information that can be used to enhance residents’ safety. However, there is little existing research that investigates the limitations of the existing information exchange process that underpins MIR, despite the considerable resources that RACFs’ devote to the MIR process. The aim of this study was to undertake an in-depth exploration of the information exchange process involved in MIR and identify factors that inhibit the collection of meaningful information in RACFs. Methods The study was undertaken in three RACFs (part of a large non-profit organisation) in NSW, Australia. A total of 23 semi-structured interviews and 62 hours of observation sessions were conducted between May to July 2011. The qualitative data was iteratively analysed using a grounded theory approach. Results The findings highlight significant gaps in the design of the MIR artefacts as well as information exchange issues in MIR process execution. Study results emphasized the need to: a) design MIR artefacts that facilitate identification of the root causes of medication incidents, b) integrate the MIR process within existing information systems to overcome key gaps in information exchange execution, and c) support exchange of information that can facilitate a multi-disciplinary approach to medication incident management in RACFs. Conclusions This study highlights the advantages of viewing MIR process holistically rather than as segregated tasks, as a means to identify gaps in information exchange that need to be addressed in practice to improve safety critical processes. PMID:23122411

  17. 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

  18. 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

  19. 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. PMID:27249687

  20. 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...

  1. 30 CFR 585.833 - What are the reporting requirements for incidents requiring written notification?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... number; (6) Type of incident or injury; (7) Activity at time of incident; (8) Description of incident, damage, or injury (including days away from work, restricted work, or job transfer), and any...

  2. 30 CFR 585.833 - What are the reporting requirements for incidents requiring written notification?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... number; (6) Type of incident or injury; (7) Activity at time of incident; (8) Description of incident, damage, or injury (including days away from work, restricted work, or job transfer), and any...

  3. 30 CFR 585.833 - What are the reporting requirements for incidents requiring written notification?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... number; (6) Type of incident or injury; (7) Activity at time of incident; (8) Description of incident, damage, or injury (including days away from work, restricted work, or job transfer), and any...

  4. [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.

  5. Pre-adoption adversity and self-reported behavior problems in 7 year-old international adoptees.

    PubMed

    Gagnon-Oosterwaal, Noémi; Cossette, Louise; Smolla, Nicole; Pomerleau, Andrée; Malcuit, Gérard; Chicoine, Jean-François; Jéliu, Gloria; Belhumeur, Céline; Berthiaume, Claude

    2012-08-01

    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 soon after arrival in their adoptive family. At age 7, the Dominic Interactive, a self-report measure, was used to evaluate externalizing and internalizing symptoms while mothers completed the CBCL. Children's self-reports were compared to their non-adopted peers'. Adopted children reported more symptoms of specific phobia than their peers. A significant correlation was found between mothers' and children's reports but only for externalizing symptoms. Self-reported symptoms were related to indices of nutritional and psychosocial deprivation at arrival, such as low height/age and weight/height ratios. Our results emphasize the importance of considering international adoptees' perception of their psychological adjustment and the long-term impact of early risk factors.

  6. 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

  7. 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.

  8. [Pressure ulcer care quality indicator: analysis of medical records and incident report].

    PubMed

    dos Santos, Cássia Teixeira; Oliveira, Magáli Costa; Pereira, Ana Gabriela da Silva; Suzuki, Lyliam Midori; Lucena, Amália de Fátima

    2013-03-01

    Cross-sectional study that aimed to compare the data reported in a system for the indication of pressure ulcer (PU) care quality, with the nursing evolution data available in the patients' medical records, and to describe the clinical profile and nursing diagnosis of those who developed PU grade 2 or higher Sample consisted of 188 patients at risk for PU in clinical and surgical units. Data were collected retrospectively from medical records and a computerized system of care indicators and statistically analyzed. Of the 188 patients, 6 (3%) were reported for pressure ulcers grade 2 or higher; however, only 19 (10%) were recorded in the nursing evolution records, thus revealing the underreporting of data. Most patients were women, older adults and patients with cerebrovascular diseases. The most frequent nursing diagnosis was risk of infection. The use of two or more research methodologies such as incident reporting data and retrospective review of patients' records makes the results trustworthy.

  9. Identifying medication error chains from critical incident reports: a new analytic approach.

    PubMed

    Huckels-Baumgart, Saskia; Manser, Tanja

    2014-10-01

    Research into the distribution of medication errors usually focuses on isolated stages within the medication use process. Our study aimed to provide a novel process-oriented approach to medication incident analysis focusing on medication error chains. Our study was conducted across a 900-bed teaching hospital in Switzerland. All reported 1,591 medication errors 2009-2012 were categorized using the Medication Error Index NCC MERP and the WHO Classification for Patient Safety Methodology. In order to identify medication error chains, each reported medication incident was allocated to the relevant stage of the hospital medication use process. Only 25.8% of the reported medication errors were detected before they propagated through the medication use process. The majority of medication errors (74.2%) formed an error chain encompassing two or more stages. The most frequent error chain comprised preparation up to and including medication administration (45.2%). "Non-consideration of documentation/prescribing" during the drug preparation was the most frequent contributor for "wrong dose" during the administration of medication. Medication error chains provide important insights for detecting and stopping medication errors before they reach the patient. Existing and new safety barriers need to be extended to interrupt error chains and to improve patient safety.

  10. The Canadian Incidence Study of Reported Child Abuse and Neglect: a partnership.

    PubMed

    Tonmyr, L

    2015-01-01

    In the mid-1990s, Health Canada's Family Violence Prevention Unit commissioned a study to assess the possibility of collecting child maltreatment data from child welfare agencies across Canada. A Health Canada group responsible for maternal and child health surveillance built on the results of this study. This group consulted widely with provincial and territorial partners to build a surveillance system, resulting in a truly collaborative effort that led to the implementation of the Canadian Incidence Study of Reported Child Abuse and Neglect (CIS). This was a remarkable accomplishment considering the challenge of working with multiple partners, different legislative frameworks and the stigma that often accompanies the experience of child maltreatment.

  11. 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

    ... Influenza Pandemic.'' In the Federal Register of December 16, 2008 (73 FR 76364), FDA published notice of... 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...

  12. Cost of illness of patient-reported adverse drug events: a population-based cross-sectional survey

    PubMed Central

    Gyllensten, Hanna; Rehnberg, Clas; Jönsson, Anna K; Petzold, Max; Carlsten, Anders; Andersson Sundell, Karolina

    2013-01-01

    Objectives To estimate the cost of illness (COI) of individuals with self-reported adverse drug events (ADEs) from a societal perspective and to compare these estimates with the COI for individuals without ADE. Furthermore, to estimate the direct costs resulting from two ADE categories, adverse drug reactions (ADRs) and subtherapeutic effects of medication therapy (STE). Design Cross-sectional study. Setting The adult Swedish general population. Participants The survey was distributed to a random sample of 14 000 Swedish residents aged 18 years and older, of which 7099 responded, 1377 reported at least one ADE and 943 reported an ADR or STE. Main outcome measures Societal COI, including direct and indirect costs, for individuals with at least one self-reported ADE, and the direct costs for prescription drugs and healthcare use resulting from self-reported ADRs and STEs were estimated during 30 days using a bottom-up approach. Results The economic burden for individuals with ADEs were (95% CI) 442.7 to 599.8 international dollars (Int$), of which direct costs were Int$ 279.6 to 420.0 (67.1%) and indirect costs were Int$ 143.0 to 199.8 (32.9%). The average COI was higher among those reporting ADEs compared with other respondents (COI: Int$ 442.7 to 599.8 versus Int$ 185.8 to 231.2). The COI of respondents reporting at least one ADR or STE was Int$ 468.9 to 652.9. Direct costs resulting from ADRs or STEs were Int$ 15.0 to 48.4. The reported resource use occurred both in hospitals and outside in primary care. Conclusions Self-reported ADRs and STEs cause resource use both in hospitals and in primary care. Moreover, ADEs seem to be associated with high overall COI from a societal perspective when comparing respondents with and without ADEs. There is a need to further examine this relationship and to study the indirect costs resulting from ADEs. PMID:23794552

  13. 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

  14. [Need for innovation in working with adverse events].

    PubMed

    Viskum, Birgit; Juhl, Andreas Granhof; Pedersen, Inge; Stæhr, Michael Dyre

    2011-10-10

    Patient safety has been in focus in the Danish health care for the past five years, with a mandatory reporting system for adverse events/incidents at hospitals. The incidents have been analysed with the Root Cause Analysis. This analysis is a relatively simple linear cause effect analysis, however, not suitable for the use in a complex sociotechnic health-care system. There is a need for other methods and approaches, which can reflect this complexity and focus on the future prospective prevention.

  15. 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. PMID:24112316

  16. An evaluation of potential signals for ventricular arrhythmia and cardiac arrest with dolasetron, ondansetron, and granisetron in the fda combined spontaneous reporting system/adverse event reporting system

    PubMed Central

    Schnell, Frederick M.; Coop, Andrew J.

    2005-01-01

    Background: Of the US Food and Drug Administration (FDA)-approved5-hydroxytryptamine type 3 (5-HT3)-receptor antagonists, dolasetron, ondan-setron, granisetron, and palonosetron, only dolasetron and palonosetron have a precaution in their FDA labeling concerning corrected QT interval (QTc) prolongation. At FDA approved doses, QTc prolongation has been observed in clinical trials with some 5-HT3 receptor antagonists (however, palonosetron has been only recently approved, with few published clinical data available). However, due to patient exclusion criteria, such trials with 5-HT3 receptor antagonists may have failed to examine the risk of these agents in “real world” patients with cancer. Objective: The aim of this analysis was to assess the potential risk for selected cardiac adverse events associated with dolasetron, ondansetron, and granisetron use. Methods: The FDA combined Spontaneous Reporting System/Adverse Event Reporting System database was analyzed. The process of analyzing such a database for early warnings of potential hazards is known as signal generation. The statistical technique proportional reporting ratio (PRR) was used to aid detection of a potential signal within the database. PRR is the observed proportion of a given adverse event for the drug of interest (the number of events of interest for the drug divided by the total number of reports for the drug) divided by the expected proportion. Through the third quarter of 2002, the database was searched using the preferred term electrocardiogram qt corrected interval prolonged. Results: One, 3, and 0 cases were reported for dolasetron, ondansetron, andgranisetron, respectively. The number of cases did not satisfy 1 of the 3 criteria we utilized to define a potential signal, the 3 criteria being: 3 or more reported cases of the adverse event, a PRR value of at least 2, and a χ2 value of >4. As this term may be unlikely to be reported, the database was also searched using the term ventricular

  17. 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.

  18. Incident reporting to BfArM - regulatory framework, results and challenges.

    PubMed

    Seidel, Robin; Stößlein, Ekkehard; Lauer, Wolfgang

    2016-04-01

    Medical devices are manifold and one of the most innovative fields of technology. As technologies advance, former limits cease to exist and complex devices become reality. Medical devices represent a very dynamic field with high economic relevance. The manufacturer of a medical device is obliged to minimize product-related risks as well as to demonstrate compliance with the so-called "essential requirements" regarding safety and performance before placing the device on the market. Any critical incident in relation to the application of a medical device has to be reported to the competent authority for risk assessment, which in Germany is either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) depending on the type of device. In this article, the German regulatory framework for medical devices and the resulting tasks for BfArM are described as well as the topics of its recently installed research and development group on prospective risk identification and application safety for medical devices. Results of failure mode and root cause analyses of incident data are presented as well as further data on cases with the result "root-cause analysis not possible". Finally an outlook is given on future challenges regarding risk assessment for medical devices. PMID:27028733

  19. Incident reporting to BfArM - regulatory framework, results and challenges.

    PubMed

    Seidel, Robin; Stößlein, Ekkehard; Lauer, Wolfgang

    2016-04-01

    Medical devices are manifold and one of the most innovative fields of technology. As technologies advance, former limits cease to exist and complex devices become reality. Medical devices represent a very dynamic field with high economic relevance. The manufacturer of a medical device is obliged to minimize product-related risks as well as to demonstrate compliance with the so-called "essential requirements" regarding safety and performance before placing the device on the market. Any critical incident in relation to the application of a medical device has to be reported to the competent authority for risk assessment, which in Germany is either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) depending on the type of device. In this article, the German regulatory framework for medical devices and the resulting tasks for BfArM are described as well as the topics of its recently installed research and development group on prospective risk identification and application safety for medical devices. Results of failure mode and root cause analyses of incident data are presented as well as further data on cases with the result "root-cause analysis not possible". Finally an outlook is given on future challenges regarding risk assessment for medical devices.

  20. 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

  1. Reported tailings dam failures. A review of the European incidents in the worldwide context.

    PubMed

    Rico, M; Benito, G; Salgueiro, A R; Díez-Herrero, A; Pereira, H G

    2008-04-01

    A detailed search and re-evaluation of the known historical cases of tailings dam failure was carried out. A corpus of 147 cases of worldwide tailings dam disasters, from which 26 located in Europe, was compiled in a database. This contains six sections, including dam location, its physical and constructive characteristics, actual and putative failure cause, sludge hydrodynamics, socio-economical consequences and environmental impacts. Europe ranks in second place in reported accidents (18%), more than one third of them in dams 10-20 m high. In Europe, the most common cause of failure is related to unusual rain, whereas there is a lack of occurrences associated with seismic liquefaction, which is the second cause of tailings dam breakage elsewhere in the world. Moreover, over 90% of incidents occurred in active mines, and only 10% refer to abandoned ponds. The results reached by this preliminary analysis show an urgent need for EU regulations regarding technical standards of tailings disposal.

  2. Parent-reported adverse food reactions in Hong Kong Chinese pre-schoolers: epidemiology, clinical spectrum and risk factors.

    PubMed

    Leung, Ting Fan; Yung, Edmund; Wong, Yun Sze; Lam, Christopher W K; Wong, Gary W K

    2009-06-01

    The epidemiology of adverse food reactions (AFRs), including the potentially life-threatening food allergy (FA), in Asia is unclear. AFR is believed to be less prevalent than in Caucasians. This study determines the prevalence, clinical features and risk factors for parent-reported AFR in Chinese pre-school children in Hong Kong. Children aged 2-7 yr living in Hong Kong were recruited through local nurseries and kindergartens to ascertain the occurrence and clinical spectrum of AFR and other atopic disorders. Subjects' parents answered a self-administered questionnaire that was modified and validated based on the International Study of Asthma and Allergy in Childhood. A total of 3827 children from 21 nurseries and kindergartens returned the study questionnaires, and information on AFR was analyzable for 3677 (96.1%) children. The prevalence rates of parent-reported AFR and parent-reported, doctor-diagnosed AFR were 8.1% and 4.6%, respectively, whereas 5.0% of pre-schoolers had doctor-diagnosed asthma. The six leading causes of AFR were shellfish (15.8%), egg (9.1%), peanut (8.1%), beef (6.4%), cow's milk (5.7%), and tree nuts (5.0%). When compared with children born and raised in Hong Kong, children born in mainland China (n = 253) had less parent-reported AFR (4.0% vs. 6.7%; p = 0.016). On logistic regression, parent-reported AFR was associated with younger age (p = 0.010), born in mainland China (p = 0.038), and AFR history in father (p = 0.001), mother (p < 0.001), siblings (p = 0.020), and paternal history of rhinitis (p = 0.044). This study shows that AFR is a common atopic disorder in Hong Kong pre-school children, and prevalence rates are comparable to the Caucasians.

  3. Adverse Event Recording and Reporting in Clinical Trials Comparing Lumbar Disk Replacement with Lumbar Fusion: A Systematic Review.

    PubMed

    Hiratzka, Jayme; Rastegar, Farbod; Contag, Alec G; Norvell, Daniel C; Anderson, Paul A; Hart, Robert A

    2015-12-01

    Study Design Systematic review. Objectives (1) To compare the quality of adverse event (AE) methodology and reporting among randomized trials comparing lumbar fusion with lumbar total disk replacement (TDR) using established AE reporting systems; (2) to compare the AEs and reoperations of lumbar spinal fusion with those from lumbar TDR; (3) to make recommendations on how to report AEs in randomized controlled trials (RCTs) so that surgeons and patients have more-detailed and comprehensive information when making treatment decisions. Methods A systematic search of PubMed, the Cochrane collaboration database, and the National Guideline Clearinghouse through May 2015 was conducted. Randomized controlled trials with at least 2 years of follow-up comparing lumbar artificial disk replacement with lumbar fusion were included. Patients were required to have axial or mechanical low back pain of ≥3 months' duration due to degenerative joint disease defined as degenerative disk disease, facet joint disease, or spondylosis. Outcomes included the quality of AE acquisition methodology and results reporting, and AEs were defined as those secondary to the procedure and reoperations. Individual and pooled relative risks and their 95% confidence intervals comparing lumbar TDR with fusion were calculated. Results RCTs demonstrated a generally poor description of methods for assessing AEs. There was a consistent lack of clear definition or grading for these events. Furthermore, there was a high degree of variation in reporting of surgery-related AEs. Most studies lacked adequate reporting of the timing of AEs, and there were no clear distinctions between acute or chronic AEs. Meta-analysis of the pooled data demonstrated a twofold increased risk of AEs in patients having lumbar fusion compared with patients having lumbar TDR at 2-year follow-up, and this relative risk was maintained at 5 years. Furthermore, the pooled data demonstrated a 1.7 times greater relative risk of

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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...

  9. 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...

  10. 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

  11. Patient views of adverse events: comparisons of self-reported healthcare staff attitudes with disclosure of accident information.

    PubMed

    Itoh, Kenji; Andersen, Henning Boje; Madsen, Marlene Dyrløv; Østergaard, Doris; Ikeno, Masaaki

    2006-07-01

    In the present paper, we report results of surveys in 2003 in Japan and Denmark about patients' views about adverse events, focusing on the actions of healthcare staff involved in a medical accident. Results show that patients were more likely to indicate negative expectations to a doctor's reactions after a medical accident when asked in general terms than when asked in relation to concrete case stories. When asked in general terms, 66% (47%) of Japanese (Danish) respondents expected that doctors sometimes hold back on providing information to patients about a medical accident, while 37% (7%) did so when asked about a concrete, mild-outcome case. We examine some possible reasons for the relatively high level of distrust of Japanese patients, and we discuss whether the seemingly lower level of disclosure in Japan than in Denmark and the negative stories in the Japanese press may have an impact. We also suggest some implications for introducing a patient-centred or customer-centred approach to risk management in healthcare and other domains. PMID:16759631

  12. Delayed immune mediated adverse effects to hyaluronic Acid fillers: report of five cases and review of the literature.

    PubMed

    Bitterman-Deutsch, Ora; Kogan, Leonid; Nasser, Faris

    2015-03-16

    Hyaluronic acid (HA) fillers in cosmetic medicine have been considered relatively safe, though fillers used in European countries and throughout the world are not necessarily approved by the Food and Drug Administration. As their use continues to expand worldwide, physicians in a wide range of medical specialties are authorized to perform HA injections, including general medicine practitioners and even dentists. An increasing number of reports have appeared regarding side effects to these products. It is now known that reactions to Hyaluronic acid are related not only to technical faults of the injections, but also to immune responses, including delayed hypersensitivity and granulomatous reactions. Herein, we describe five cases treated by a variety of treatment modalities, all with delayed reactions to different brands of hyaluronic acid fillers. As there is currently no standardization of treatment options of adverse effects, these cases accentuate the debate regarding the approach to the individual patient and the possible need for pre-testing in patients with an atopic tendency. PMID:25918619

  13. 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. PMID:27489574

  14. 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

  15. Incidence of Type 1 Diabetes Mellitus in Turkish Children from the Southeastern Region of the Country: A Regional Report

    PubMed Central

    Demirbilek, Hüseyin; Özbek, Mehmet Nuri; Baran, Rıza Taner

    2013-01-01

    Objective: Variability in the incidence of type 1 diabetes mellitus (T1DM) related to geographical region, ethnic background, gender, and age indicates a need for further epidemiological studies. To date, there are no reported studies on the incidence of T1DM in the pediatric age group from the Southeastern region of Turkey. To define the incidence, demographic and clinical characteristics of T1DM in children 0-14 years of age in Diyarbakir, one of the largest cities in the Southeast region of Turkey. Methods: Hospital files of patients with the diagnosis of T1DM were reviewed. Data of all patients diagnosed between 1 June 2010 and 31 May 2011 were evaluated. Population data on the 0-14 age group were obtained from the Turkish Statistical Institute (TSI) reports. Results: From a total of 41 T1DM patients, 24 (58.5%) were female (male: 41.5%) with a male/female ratio of 1.4. The overall annual incidence of T1DM was 7.2/105, being 8.7/105 in females and 5.7/105 in males. The peak incidence was found to occur at age 5-9 years in the girls and 10-14 years in the boys. Mean age at diagnosis was 8.1±3.8 years. Rate of presentation with diabetic ketoacidosis was 65.9%. Patients applied most frequently in spring and winter months. Conclusions: In this first T1DM incidence study on the pediatric age group in Diyarbakir, Turkey, T1DM incidence was found to be similar to that in countries with low-middle incidence. Conflict of interest:None declared. PMID:23748062

  16. 29 CFR 1904.39 - Reporting fatalities and multiple hospitalization incidents to OSHA.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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 =…

  2. 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

    ... the Federal Register of May 25, 2010 (75 FR 29352), FDA published the notice of availability for a...-applicants with filling out Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness,...

  3. Enhancing the National Incident-Based Reporting System: A Policy Proposal.

    PubMed

    Bierie, David M

    2015-09-01

    The National Incident-Based Reporting System (NIBRS) is an important data set serving social scientists, policy makers, the business community, and the press. However, it is hampered by low participation rates among the nation's police agencies. This article outlines a strategy for enhancing NIBRS by (a) providing police agencies free and supported software to extract and transmit an agency's Record Management System (RMS) data in NIBRS format (or a data-entry system if an RMS does not exist), (b) including personal identifiers of arrestees, and (c) allowing police agencies to access the national data for routine police work. The article describes how taking these steps would decrease the costs of implementing and maintaining NIBRS, encourage widespread adoption, and increase data quality. These enhancements could foster substantial improvements in policing as well as other aspects of the criminal justice system. These changes would also open up new and exciting areas for academics and analysts, including the ability to study criminal careers over time as well as criminal networks within NIBRS.

  4. [Adverse drug reactions in pregnant women].

    PubMed

    Lacroix, Isabelle; Cabou, Cendrine; Montastruc, Jean-Louis; Damase-Michel, Christine

    2007-01-01

    A Prospective pharmacovigilance survey of adverse drug reactions (ADRs) in pregnant women was performed in collaboration with gynaecologists and obstetricians of Midi-Pyrenees area (south west of france). The aim of the study was to evaluate the incidence of adverse drug reactions in pregnant women. The incidence of ADRs in pregnant women was low: 0.3%. Moreover, a retrospective pharmacoepidemiological study was conducted to characterize ADRs in pregnant women. Reports of ADRs collected in the Midi-Pyrenees pharmacovigilance centre from 1982 to 2002 were used: type of ADRs, drugs involved and potential risk factors were compared for pregnant women and for age-matched non pregnant women. Forty seven and 94 reports of ADRs were collected in pregnant and non-pregnant women respectively. Anaphylactic reactions were only observed in pregnant women (3 cases, p = 0.04). We observed 1 ADR related stillbirth (due to anaphylactic reaction) in pregnant women. Drugs for gynaecological and cardiovascular systems were more frequently involved in ADRs in pregnant women than in controls. ADRs mainly occurred during the third trimester of pregnancy. The incidence of ADRs is very low in pregnant women. However, one must pay attention on the risk of anaphylactic reactions in pregnant women. PMID:18206108

  5. Analysis of general aviation single-pilot IFR incident data obtained from the NASA Aviation Safety Reporting System

    NASA Technical Reports Server (NTRS)

    Bergeron, H. P.

    1983-01-01

    An analysis of incident data obtained from the NASA Aviation Safety Reporting System (ASRS) has been made to determine the problem areas in general aviation single-pilot IFR (SPIFR) operations. The Aviation Safety Reporting System data base is a compilation of voluntary reports of incidents from any person who has observed or been involved in an occurrence which was believed to have posed a threat to flight safety. This paper examines only those reported incidents specifically related to general aviation single-pilot IFR operations. The frequency of occurrence of factors related to the incidents was the criterion used to define significant problem areas and, hence, to suggest where research is needed. The data was cataloged into one of five major problem areas: (1) controller judgment and response problems, (2) pilot judgment and response problems, (3) air traffic control (ATC) intrafacility and interfacility conflicts, (4) ATC and pilot communication problems, and (5) IFR-VFR conflicts. In addition, several points common to all or most of the problems were observed and reported. These included human error, communications, procedures and rules, and work load.

  6. Adverse reactions to cosmetics.

    PubMed

    Dogra, A; Minocha, Y C; Kaur, S

    2003-01-01

    Adverse reaction to cosmetics constitute a small but significant number of cases of contact dermatitis with varied appearances. These can present as contact allergic dermatitis, photodermatitis, contact irritant dermatitis, contact urticaria, hypopigmentation, hyperpigmentation or depigmentation, hair and nail breakage. Fifty patients were included for the study to assess the role of commonly used cosmetics in causing adverse reactions. It was found that hair dyes, lipsticks and surprisingly shaving creams caused more reaction as compared to other cosmetics. Overall incidence of contact allergic dermatitis seen was 3.3% with patients own cosmetics. Patch testing was also done with the basic ingredients and showed positive results in few cases where casual link could be established. It is recommended that labeling of the cosmetics should be done to help the dermatologists and the patients to identify the causative allergen in cosmetic preparation.

  7. "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. PMID:23763113

  8. 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

  9. 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

  10. 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

  11. [Adverse reaction induced by licorice preparations: clinical analysis of 93 cases].

    PubMed

    Mao, Min; Li, Wei; Wang, Wei; Wang, Shu-Xia; Lu, Jin; Chang, Zhang-Fu

    2013-11-01

    Licorice is a traditional Chinese medicine commonly used in clinic. The products,what contain licorice or licorice extract, has early been involved in the field of cosmetics except for the field of pharmaceuticals and food. Consequently, the reporting on adverse reactions induced by licorice preparations are more frequent. Based on the clinical data of licorice preparations adverse reactions, we described the characteristics of the licorice-related adverse reactions, and proposed specific measures to reduce the incidence of adverse reactions, provided a reference for the rational use of licorice preparations. PMID:24494570

  12. 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...

  13. 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...

  14. 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…

  15. 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…

  16. 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

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human Factor Attachment; notice to employee; employee supplement. 225.12 Section 225.12 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT...

  17. 30 CFR 250.190 - Reporting requirements for incidents requiring written notification.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... name and number, or pipeline segment number; (6) Type of incident or injury; (7) Operation or activity...), and any corrective action taken; and (9) Property or equipment damage estimate (in U.S. dollars)....

  18. 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

  19. Systemic glucocorticoid therapy: risk factors for reported adverse events and beliefs about the drug. A cross-sectional online survey of 820 patients.

    PubMed

    Morin, Clément; Fardet, Laurence

    2015-12-01

    Despite systemic glucocorticoids are widely used, risk factors for most of their adverse events and patients' beliefs about the drug are poorly known. An online survey was conducted between February and July 2013 through the website www.cortisone-info.fr . Demographic (e.g., age, gender) and therapeutic (e.g., type of prescribed glucocorticoid, duration of prescription) data were collected. Patients were further asked to answer questions about glucocorticoid-induced adverse events and their beliefs about efficacy and safety of the drug. Risk factors for adverse events and efficacy/safety beliefs were assessed using multivariate logistic regression models. Eight hundred twenty questionnaires were analyzed (women 74.3 %; median age 49 [34-62] years, median equivalent prednisone dosage 20 [10-48] mg/day). The most frequently reported adverse events were insomnia (n = 477, 58.2 %), mood disturbances (n = 411, 50.1 %), hyperphagia (n = 402, 49.0 %), and lipodystrophy (n = 387, 47.2 %). The risk of some adverse events (e.g., weight gain, easy bruising) increased with the duration of exposure while other adverse events (e.g., insomnia, mood disorders, epigastric pain) were present since the first days of exposure. The risk of hirsutism, altered wound healing, mood disturbances, weight gain, lipodystrophy, hyperphagia, and epigastric pain decreased with age. Cutaneous disorders, morphological changes, and epigastric pain were more frequently reported by women. Interestingly, patients prescribed prednisolone reported less adverse events than those prescribed prednisone. No adverse event, demographical or prescribing characteristics were associated with beliefs about efficacy while factors associated with safety concerns were age (OR: 1.2 [1.1-1.3] per 10-year increase), osteoporosis (OR: 3.3 [1.4-7.9]), easy bruising (OR: 1.6 [1.1-2.3]), insomnia (OR: 1.7 [1.2-2.4]), and weight gain (OR: 1.6 [1.1-2.2]). These results may help clinicians to adapt information

  20. 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.

  1. 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.

  2. 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

  3. Social determinants of health predict state incidence of HIV and AIDS: a short report.

    PubMed

    Zeglin, Robert J; Stein, J Paul

    2015-01-01

    There are approximately 1.2 million people living with HIV/AIDS (PLWHA) in the USA. Each year, there are roughly 50,000 new HIV diagnoses. The World Health Organization Commission on Social Determinants of Health (CSDH) identified several social determinants of health and health inequity (SDH) including childcare, education, employment, gender equality, health insurance, housing, and income. The CSDH also noted the significant impact the SDH can have on advocacy for social change, social interventions to reduce HIV prevalence, and health monitoring. The current analysis evaluated the predictive ability of five SDH for HIV and AIDS incidence on the state level. The SDH used in the analysis were education, employment, housing, income, and insurance; other SDH were not included because reliable and appropriate state-level data were not available. The results of multiple regression analyses indicate that the use of these five SDH create statistically significant models predicting HIV incidence (adjusted R(2) = .54) and AIDS incidence (adjusted R(2) = .37) and account for a sizable portion of the variance for each. Stepwise variable selection reduced the necessary SDH to two: (1) education and (2) housing. These models are also statistically significant and account for a notable portion of variance in HIV incidence (adjusted R(2) = .55) and AIDS incidence (adjusted R(2) = .40). These outcomes demonstrate that state-level SDH, particularly education and housing, offer significant explanatory power regarding HIV and AIDS incidence rates. Congruent with the recommendations of the CSDH, the results of the current analysis suggest that state-sponsored policy and social interventions should consider and target SDH, especially education and housing, in attempts to reduce HIV and AIDS incidence rates.

  4. Social determinants of health predict state incidence of HIV and AIDS: a short report.

    PubMed

    Zeglin, Robert J; Stein, J Paul

    2015-01-01

    There are approximately 1.2 million people living with HIV/AIDS (PLWHA) in the USA. Each year, there are roughly 50,000 new HIV diagnoses. The World Health Organization Commission on Social Determinants of Health (CSDH) identified several social determinants of health and health inequity (SDH) including childcare, education, employment, gender equality, health insurance, housing, and income. The CSDH also noted the significant impact the SDH can have on advocacy for social change, social interventions to reduce HIV prevalence, and health monitoring. The current analysis evaluated the predictive ability of five SDH for HIV and AIDS incidence on the state level. The SDH used in the analysis were education, employment, housing, income, and insurance; other SDH were not included because reliable and appropriate state-level data were not available. The results of multiple regression analyses indicate that the use of these five SDH create statistically significant models predicting HIV incidence (adjusted R(2) = .54) and AIDS incidence (adjusted R(2) = .37) and account for a sizable portion of the variance for each. Stepwise variable selection reduced the necessary SDH to two: (1) education and (2) housing. These models are also statistically significant and account for a notable portion of variance in HIV incidence (adjusted R(2) = .55) and AIDS incidence (adjusted R(2) = .40). These outcomes demonstrate that state-level SDH, particularly education and housing, offer significant explanatory power regarding HIV and AIDS incidence rates. Congruent with the recommendations of the CSDH, the results of the current analysis suggest that state-sponsored policy and social interventions should consider and target SDH, especially education and housing, in attempts to reduce HIV and AIDS incidence rates. PMID:25225050

  5. 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…

  6. Adverse reactions of Methylphenidate in children with attention deficit-hyperactivity disorder: Report from a referral center

    PubMed Central

    Khajehpiri, Zahra; Mahmoudi-Gharaei, Javad; Faghihi, Toktam; Karimzadeh, Iman; Khalili, Hossein; Mohammadi, Mostafa

    2014-01-01

    Objective: The aim of the current study was to determine various aspects of methylphenidate adverse reactions in children with attention deficit-hyperactivity disorder (ADHD) in Iran. Methods: During the 6 months period, all children under methylphenidate treatment alone or along with other agents attending a university-affiliated psychology clinic were screened regarding all subjective and objective adverse drug reactions (ADRs) of methylphenidate. Causality and seriousness of detected ADRs were assessed by relevant World Health Organization definitions. The Schumock and Thornton questionnaire was used to determine preventability of ADRs. Findings: Seventy-one patients including 25 girls and 46 boys with ADHD under methylphenidate treatment were enrolled within the study period. All (100%) ADHD children under methylphenidate treatment developed at least one ADR. Anorexia (74.3%), irritability (57.1%), and insomnia (47.2%) were the most frequent methylphenidate-related adverse reactions. Except for one, all other detected ADRs were determined to be mild. In addition, no ADR was considered to be preventable and serious. Conclusion: Our data suggested that although methylphenidate related adverse reactions were common in children with ADHD, but they were mainly mild and nonserious. PMID:25535621

  7. Analysis of general aviation single-pilot IFR incident data obtained from the NASA aviation safety reporting system

    NASA Technical Reports Server (NTRS)

    Bergeron, H. P.

    1980-01-01

    Data obtained from the NASA Aviation Safety Reporting System (ASRS) data base were used to determine problems in general aviation single pilot IFR operations. The data examined consisted of incident reports involving flight safety in the National Aviation System. Only those incidents involving general aviation fixed wing aircraft flying under IFR in instrument meteorological conditions were analyzed. The data were cataloged into one of five major problem areas: (1) controller judgement and response problems; (2) pilot judgement and response problems; (3) air traffic control intrafacility and interfacility conflicts; (4) ATC and pilot communications problems; and (5) IFR-VFR conflicts. The significance of the related problems, and the various underlying elements associated with each are discussed. Previous ASRS reports covering several areas of analysis are reviewed.

  8. 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

  9. 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.

  10. Self-Reported Prevalence of Symptomatic Adverse Reactions to Gluten and Adherence to Gluten-Free Diet in an Adult Mexican Population

    PubMed Central

    Ontiveros, Noe; López-Gallardo, Jesús A.; Vergara-Jiménez, Marcela J.; Cabrera-Chávez, Francisco

    2015-01-01

    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. PMID:26197336

  11. 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

    2015-07-01

    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. PMID:26197336

  12. 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.

  13. 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

  14. 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...

  15. Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea

    PubMed Central

    Holmes, Anna D.; Waite, Kimberly A.; Chen, Michael C.; Palaniswamy, Kiruthi; Wiser, Thomas H.; Draelos, Zoe D.; Rafal, Elyse S.; Werschler, W. Philip; Harvey, Alison E.

    2015-01-01

    Background: The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse events of worsened redness have occasionally been reported with its use. Objective: A detailed analysis of adverse events is needed to accurately define worsening erythema and the adverse-events profile associated with brimonidine gel treatment. Methods and measurements: A retrospective review of related dermatological adverse events occurring in subjects enrolled in the two pivotal four-week Phase 3 studies and the 52-week long-term safety study for brimonidine gel was conducted. Measurements included total adverse-event incidences; number of subjects experiencing adverse events; study discontinuation due to adverse events, severity, onset, episodic duration period; and correlation of adverse events to subject disposition, and rosacea profile. Results: Flushing and erythema were the most commonly reported adverse events, occurring in a total of 5.4 percent of subjects in the Phase 3 studies and in 15.4 percent in the long-term study. Most adverse events were mild or moderate in severity, transient, and intermittent. Adverse events occurred early in treatment, and duration was short-lived in the majority of cases. Adverse-event patterns were not remarkably altered with regard to subject disposition in the long-term study. Conclusion: Adverse events of worsening redness are not frequent, are transient in nature, and occur early in the course of treatment with brimonidine gel. PMID:26345379

  16. 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.

  17. 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.

  18. 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.

  19. The evolution of HPV-related anogenital cancers reported in Quebec - incidence rates and survival probabilities.

    PubMed

    Louchini, R; Goggin, P; Steben, M

    2008-01-01

    Non-cervical anogenital cancers (i.e. anal, vulvar, vaginal and penile cancers) associated with the human papillomavirus (HPV), for which HPV is known to be the necessary cause of carcinogenesis, are poorly documented due to their relatively low incidence rate. The aim of this study is to describe the incidence rates of these cancers between 1984 and 2001, and their relative survival probabilities, in Quebec (Canada) between 1984 and 1998. The incidence of these cancers is on the rise, particularly anal cancer in women and, more recently (since 1993-95), vulvar cancer. Between 1984-86 and 1993-95, the 5-year relative survival probability for men with anal cancer decreased from 57% to 46%, while that for penile cancer dropped from 75% to 59%. However, during the same period, the 5-year relative survival probability for women with anal cancer rose from 56% to 65%, and remained stable for cervical and vulvar cancers, at 74% and 82%, respectively. PMID:18341764

  20. 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…

  1. 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. PMID:25988866

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

    PubMed Central

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

    2014-01-01

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

  3. 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.

  4. 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. PMID:26068566

  5. 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

  6. Neighbourhood and dwelling characteristics associated with the self-reported adverse health effects of heat in most deprived urban areas: a cross-sectional study in 9 cities.

    PubMed

    Bélanger, Diane; Gosselin, Pierre; Valois, Pierre; Abdous, Belkacem

    2015-03-01

    Dwelling and neighbourhood characteristics associated with the prevalence of self-reported heat-induced adverse health effects are not well known. We interviewed 3485 people in the most disadvantaged neighbourhoods of the nine largest cities in Québec, Canada. The prevalence of heat-induced adverse health effects was 46%, out of which one fourth led to medical consultation. Multivariate analyses showed that dissatisfaction with the summer dwelling temperature, which refers to home heat exposure, and perception that the neighbourhood is polluted due to traffic, were determinant, even after adjusting for current health status. These risk indicators can be used to identify subgroups at high risk and as priority-setting criteria for urban renewal programs for the hotter climate to come.

  7. Neighbourhood and dwelling characteristics associated with the self-reported adverse health effects of heat in most deprived urban areas: a cross-sectional study in 9 cities.

    PubMed

    Bélanger, Diane; Gosselin, Pierre; Valois, Pierre; Abdous, Belkacem

    2015-03-01

    Dwelling and neighbourhood characteristics associated with the prevalence of self-reported heat-induced adverse health effects are not well known. We interviewed 3485 people in the most disadvantaged neighbourhoods of the nine largest cities in Québec, Canada. The prevalence of heat-induced adverse health effects was 46%, out of which one fourth led to medical consultation. Multivariate analyses showed that dissatisfaction with the summer dwelling temperature, which refers to home heat exposure, and perception that the neighbourhood is polluted due to traffic, were determinant, even after adjusting for current health status. These risk indicators can be used to identify subgroups at high risk and as priority-setting criteria for urban renewal programs for the hotter climate to come. PMID:25598449

  8. 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.

  9. 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

  10. 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

  11. 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

  12. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

    PubMed

    Basch, Ethan; 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

    2014-09-01

    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

  13. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

    PubMed

    Basch, Ethan; 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

    2014-09-01

    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.

  14. Risk of Anaphylaxis with Repeated Courses of Rasburicase: A Research on Adverse Drug Events and Reports (RADAR) Project

    PubMed Central

    Allen, Katherine C.; Champlain, Amanda H.; Cotliar, Jonathan A.; Belknap, Steven M.; West, Dennis P.; Mehta, Jayesh; Trifilio, Steven M.

    2015-01-01

    Background Rasburicase, a recombinant urate oxidase, is used to rapidly metabolize uric acid in patients with hyperuricaemia. Rasburicase is an immunogenic therapeutic protein, which has been shown to elicit antibody response in 64 % of healthy volunteers within 1–6 weeks after the initial course, with persistent antibodies for over 1 year. Drug labelling indicates that anaphylaxis rarely occurs (in <1 % of patients) after a single course of therapy with rasburicase, but there are no data available on the incidence of anaphylaxis in patients receiving a subsequent rasburicase course. Objective To determine the incidence of anaphylaxis after multiple treatment courses of rasburicase. Methods A retrospective chart review was performed on 97 consecutively treated patients who received repeated courses of rasburicase for hyperuricaemia, to determine whether the risk of anaphylaxis is increased with repeated exposure to rasburicase. Results None of the 97 patients who were reviewed experienced anaphylaxis during the first rasburicase course; however, six patients (6.2 %) experienced anaphylaxis during a subsequent rasburicase treatment course (p = 0.03). Conclusion Anaphylaxis after a second course of rasburicase appears to occur more frequently than described in the US Food and Drug Administration-approved package insert for initial treatment courses. Given the serious nature of anaphylactic events, caution is advised when administering repeated courses of rasburicase. PMID:25566825

  15. Anthrax threats: a report of two incidents from Salt Lake City.

    PubMed

    Swanson, E R; Fosnocht, D E

    2000-02-01

    The threat of anthrax as an agent of bioterrorism in the U.S. is very real, with 47 incidents of possible exposure involving 5664 persons documented by the Federal Bureau of Investigation over a 14-month period in 1998 and 1999. The highly visible and potentially devastating effects of these threats require a well-coordinated and well-organized Emergency Medical Services (EMS) and Emergency Department (ED) response to minimize panic and reduce the potential spread of an active and deadly biologic agent. This requires planning and education before the event. We describe the events of two anthrax threats in a major metropolitan area. The appropriate EMS and ED response to these threats is outlined. PMID:10699528

  16. Self-reporting compared to prospective surveillance to evaluate the incidence of diarrhea among French Army personnel deployed to N'djamena, Chad.

    PubMed

    Marimoutou, Catherine; Pommier de Santi, Vincent; Attrait, Xavier; Ollivier, Lénaïck; Michel, Rémy; Boutin, Jean-Paul

    2011-01-01

    Self-reporting seems more appropriate than medical-based surveillance to estimate true incidence of diarrhea during deployment of military troops. Most soldiers self-reported multiple episodes, 42% leading to medical care, mainly the first episode, resulting in a threefold higher incidence. Mathematical models integrating self-reported data should better predict outbreaks during military deployments and define a more complete assessment of disease burden.

  17. All-time high tularaemia incidence in Norway in 2011: report from the national surveillance.

    PubMed

    Larssen, K W; Bergh, K; Heier, B T; Vold, L; Afset, J E

    2014-11-01

    Tularaemia has mainly been a sporadic disease in Norway. In 2011, 180 persons (3.7 per 100,000 population) were diagnosed with tularaemia. This article describes the epidemiological and clinical features of tularaemia cases during a year with exceptionally high tularaemia incidence. Data from the national reference laboratory for tularaemia combined with epidemiological data from the Norwegian Surveillance System for Communicable Diseases (MSIS) were used. The incidence of tularaemia varied greatly between counties, but almost every county was involved. The majority (77.8 %) of the cases were diagnosed during the autumn and winter months. The geographic distribution also showed seasonal patterns. Overall, oropharyngeal tularaemia (41.1 %) was the most common clinical presentation, followed by glandular (14.4 %), typhoidal (14.4 %), respiratory (13.3 %) and ulceroglandular (12.8 %) tularaemia. From January to April, oropharyngeal tularaemia dominated, from May to September, ulceroglandular tularaemia was most common, whereas from October to December, there was an almost even distribution between several clinical forms of tularaemia. Eighty-five (47.2 %) of all tularaemia cases were admitted to, or seen as outpatients in, hospitals. An unexpectedly high number (3.9 %) of the patients had positive blood culture with Francisella tularensis. The clinical manifestations of tularaemia in Norway in 2011 were diverse, and changing throughout the year. Classification was sometimes difficult due to uncharacteristic symptoms and unknown mode of transmission. In rodent years, tularaemia is an important differential diagnosis to keep in mind at all times of the year for a variety of clinical symptoms.

  18. Analysis of Adverse Events in Identifying GPS Human Factors Issues

    NASA Technical Reports Server (NTRS)

    Adams, Catherine A.; Hwoschinsky, Peter V.; Adams, Richard J.

    2004-01-01

    The purpose of this study was to analyze GPS related adverse events such as accidents and incidents (A/I), Aviation Safety Reporting System (ASRS) reports and Pilots Deviations (PDs) to create a framework for developing a human factors risk awareness program. Although the occurrence of directly related GPS accidents is small the frequency of PDs and ASRS reports indicated there is a growing problem with situational awareness in terminal airspace related to different types of GPs operational issues. This paper addresses the findings of the preliminary research and a brief discussion of some of the literature on related GPS and automation issues.

  19. Reasons for Not Reporting Victimizations to the Police: Do They Vary for Physical and Sexual Incidents?

    ERIC Educational Resources Information Center

    Thompson, Martie; Sitterle, Dylan; Clay, George; Kingree, Jeffrey

    2007-01-01

    Victimization is a significant problem among college students, but it is less likely to be reported to the police than are victimizations in the general population. Objective: In this study, the authors examined (1) whether reasons for not reporting varied by type of victimization (sexual or physical) and (2) victim-, offender-, and…

  20. 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

    ... current data structure of the form allows the collection of one set of C3(a) through C3(h) data for each... the data structure to accommodate multiple C3(a) through C3(h) data per report and there is no... Report instructions to improve clarity. Significant differences exist in the scope of data collected...

  1. 75 FR 68861 - Miscellaneous Amendments to the Federal Railroad Administration's Accident/Incident Reporting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-09

    ... railroads and require reporting of occupational illnesses. 39 FR 43222, December 11, 1974. The third major... of railroad operations, 43 FR 10584, March 14, 1978. With respect to employee injury and illness... reporting regulations. 61 FR 30940, June 18, 1996; 61 FR 67477, December 23, 1996. This was the first...

  2. Parental reports of adverse events following simultaneously given dT-IPV and MMR vaccines in healthy 9-year-old children.

    PubMed

    Kemmeren, Jeanet M; van der Maas, Nicoline A T; de Melker, Hester E

    2011-03-01

    In the Netherlands, children at 9 years of age receive a booster dT-IPV together with their second measles, mumps, and rubella (MMR) vaccination within the national immunization program. Safety is monitored continuously by enhanced passive surveillance. This population-based study was conducted to obtain more information on adverse events after vaccination at 9 years of age. Questionnaires on local and systemic reactions were distributed 1 and 3 weeks after vaccination, respectively, to parents of 1,250 healthy children who received their MMR and diphtheria, tetanus, and inactivated poliovirus injection (dT-IPV) vaccination as scheduled. Response to the questionnaires was 57.0% and 46.5%, respectively. Local reactions occurred in 86.5% of the children within 7 days after vaccination, more often at the dT-IPV (83.4%) than at the MMR site (32.7%). Pain was the most reported symptom (80.8% at the dT-IPV site; 29.1% at the MMR site). Systemic events occurred in 33.4% children within 7 days after vaccination, with headache as the most frequently reported (20.8%). Systemic events occurred in 20.8% children 8-21 days after vaccination. Children with local reactions at only the dT-IPV site had significantly more systemic events (19.3%) than those without local reactions (3.4%, p < 0.01). Such difference was not found for the MMR site. No serious adverse events were reported. Medical intervention was applied to 133 children (130 used analgesics and for three children the GP was consulted by phone). In conclusion, the frequency of reported local reactions is high, especially at the dT-IPV site, but all symptoms were transient. However, the use of reduced antigen content vaccines in association with the occurrence of adverse events is meaningful to explore. Furthermore, the overall rates are useful for monitoring variations in adverse events rates in the general population.

  3. Adverse Interaction between Capecitabine and Warfarin Resulting in Altered Coagulation Parameters: A Review of the Literature Starting from a Case Report.

    PubMed

    Giunta, Giovanni

    2010-01-01

    Capecitabine is an orally active prodrug of fluorouracil and is extensively used as an antineoplastic agent. It is converted to 5-Fluorouracil in the liver and tumor tissues. Warfarin is an anticoagulant agent for preventing and treating venous and arterial thrombosis and embolism and is metabolized by cytochrome P450 isoenzymes in the liver. Preclinical in vitro studies using human liver microsomes report no inhibitory effects between capecitabine and substrates of cytochrome P. However, the concomitant administration of capecitabine and warfarin resulted in INR elevation in the cases previously reported in the literature. The exact mechanism of this interaction is unknown but may be related to downregulation of cytochrome P450 2C9 by capecitabine or its metabolites. We report on the possible adverse interaction between capecitabine and warfarin in a patient with metastatic breast cancer and critically review the existing literature on this topic. Physicians should be aware of adverse reactions arising from the combined use of capecitabine and warfarin. In the light of the current data, INR levels should be closely monitored in patients using these drugs together. PMID:20671989

  4. Incidence of primary breast cancer in Iran: Ten-year national cancer registry data report.

    PubMed

    Jazayeri, Seyed Behzad; Saadat, Soheil; Ramezani, Rashid; Kaviani, Ahmad

    2015-08-01

    Breast cancer is the leading type of malignancy and the leading cause of cancer-related deaths in women worldwide. The screening programs and advances in the treatment of patients with breast cancer have led to an increase in overall survival. Cancer registry systems play an important role in providing basic data for research and the monitoring of the cancer status. In this study, the results of the 10-year national cancer registry (NCR) of Iran in breast cancer are reviewed. NCR database records were searched for primary breast cancer records according to ICD-O-3 coding and the cases were reviewed. A total of 52,068 cases were found with the coding of primary breast cancer. Females constituted 97.1% of the cases. Breast cancer was the leading type of cancer in Iranian females, accounting for 24.6% of all cancers. The mean age of the women with breast cancer was 49.6 years (95%CI 49.5-49.6). Most of the cases (95.7%) were registered as having invasive pathologies (behavior code 3). The most common morphology of primary breast cancer was invasive ductal carcinoma (ICD-O 8500/3) followed by invasive lobular carcinoma (ICD-O 8520/3) with relative frequencies of 77.8% and 5.2%, respectively. The average annual crude incidence of primary breast cancer in females was 22.6 (95%CI 22.1-23.1) per 100,000 females, with an age-standardized rate (ASR) of 27.4 (95%CI 22.5-35.9). There were no data on survival, staging or immunohistochemical marker(s) of the breast-cancer-registered cases. The incidence of breast cancer in Iran is lower than in low-middle-income neighboring countries. The NCR data registry of breast cancer is not accurate in monitoring the effect of screening programs or determining the current status of breast cancer in Iran. Screening programs of breast cancer in Iran have failed to enhance the detection of the patients with in situ lesion detection. A quality breast cancer registry and a screening program for breast cancer are both needed.

  5. Limiting risk of hospital adverse events: avoiding train wrecks is more important than counting and reporting them.

    PubMed

    Morton, A; Cook, D; Mengersen, K; Waterhouse, M

    2010-12-01

    Targets implemented at national or state levels have been employed in response to excessive numbers of adverse events (AEs) such as multiple antibiotic-resistant Staphylococcus aureus bacteraemias. Hospital resources are limited and setting such targets can result in resource diversion to dealing with the targeted AEs. There may be initial success as judged by decreasing counts but underlying problems are not necessarily addressed, and there is evidence that other non-targeted AEs may increase. Moreover, the values of individual observations can be greatly influenced by random variation. This can make it difficult using comparisons and targets to draw conclusions about the work of an institution. Although counting AEs is essential, the key to avoiding episodes of patient harm is prevention. This requires the implementation of evidence-based systems. These are already available for many AEs in the form of 'bundles' and checklists. When these systems are properly implemented and sustained, AE rates tend to occur at minimum predictable levels. Unfortunately, in spite of widespread knowledge and aggressive promotion, high levels of compliance have often been difficult to achieve and sustain. Better understanding and implementation of methods to sustain evidence-based systems are needed. Checklists, used as part of an overall system involving leadership and empowerment, application of evidence, culture change and measurement, may help to overcome this problem.

  6. Report on state liability for radioactive materials transportation incidents: A survey of laws

    SciTech Connect

    Not Available

    1989-10-01

    The purpose of this report is to provide a synopsis of the liability laws of the Southern States Energy Board`s (SSEB`s) 16 member states. It begins by briefly reviewing potential sources of liability, immunity from liability, waiver of immunity, and statutes of limitation, followed by liability laws of member states. The report was prepared by reviewing legal literature pertaining to governmental liability, with particular emphasis on nuclear waste transportation, including law review articles, legal treatises, technical reports, state statutes and regulations.

  7. The Role of Adverse Event Reporting in the FDA Response to a Multistate Outbreak of Liver Disease Associated with a Dietary Supplement

    PubMed Central

    DeBeck, Heidi J.; LeBlanc, Pamela; Mogen, Kathryn M.; Wolpert, Beverly J.; Sabo, Jonathan L.; Salter, Monique; Seelman, Sharon L.; Lance, Susan E.; Monahan, Caitlin; Steigman, David S.; Gensheimer, Kathleen

    2015-01-01

    Objective Liver disease is a potential complication from using dietary supplements. This study investigated an outbreak of non-viral liver disease associated with the use of OxyELITE ProTM, a dietary supplement used for weight loss and/or muscle building. Methods Illness details were ascertained from MedWatch reports submitted to the U.S. Food and Drug Administration (FDA) describing consumers who ingested OxyELITE Pro alone or in combination with other dietary supplements. FDA's Forensic Chemistry Center analyzed samples of OxyELITE Pro. Results From February 2012 to February 2014, FDA received 114 reports of adverse events of all kinds involving consumers who ingested OxyELITE Pro. The onset of illness for the first report was December 2010 and for the last report was January 2014. Thirty-three states, two foreign nations, and Puerto Rico submitted reports. Fifty-five of the reports (48%) described liver disease in the absence of viral infection, gallbladder disease, autoimmune disease, or other known causes of liver damage. A total of 33 (60%) of these patients were hospitalized, and three underwent liver transplantation. In early 2013, OxyELITE Pro products entered the market with a formulation distinct from products sold previously. The new formulation replaced 1,3-dimethylamylamine with aegeline. However, the manufacturer failed to submit to FDA a required “new dietary ingredient” notice for the use of aegeline in OxyELITE Pro products. Laboratory analysis identified no drugs, poisons, pharmaceuticals, toxic metals, usnic acid, N-Nitroso-fenfluramine, pyrrolizidine alkaloids, aristocholic acid, or phenethylamines in the products. Conclusions Vigilant surveillance is required for adverse events linked to the use of dietary supplements. PMID:26327730

  8. Tobacco-related cancers in India: A review of incidence reported from population-based cancer registries

    PubMed Central

    Asthana, Smita; Patil, Rakshit S.; Labani, Satyanarayana

    2016-01-01

    Background: Tobacco related cancers (TRC) account for major share of all cancers and updated of incidence data are helpful in policy changes. The aim was to present an update of TRCs on age-adjusted incidence data and corresponding lifetime risk of developing TRC for different regions of the country. Methods: The data for this study were obtained from published reports of 25 population-based cancer registries (PBCRs) in India. The PBCRs in different parts of India were divided into seven regions such as North, South, Central, Northeast, West, Rural West, and East. Data indicators such as age-adjusted rates (AARs) of incidence and the cumulative risks of TRCs up to the age of 64 years for each of the 10 TRC sites of either sex in each of 25 registries were obtained from the National Cancer Registry Programme reports. Results: Among all TRCs, esophagus, lung, hypopharynx, and mouth are the leading sites for both males and females. Males in Northeast region had the highest risk 1 in 27 of developing esophageal cancer, 1 in 67 for cancer of lungs and hypopharynx, followed by 1 in 143 for both mouth and tongue cancers. Females also had the highest risk of esophagus and lungs (1 in 63 female) and cancer of mouth (1 in 250) in Northeast region. Proportion of TRC in comparison of all cancer ranged from 11–25% for men and 3–18% for women. Conclusions: Proportion of TRC in relation to all cancers was still high in different registries of India including the Northeast region. PMID:27688608

  9. The measurement of boundary layers on a compressor blade in cascade at high positive incidence angle. 2: Data report

    NASA Technical Reports Server (NTRS)

    Deutsch, S.; Zierke, W. C.

    1986-01-01

    Boundary layer and near-wake velocity measurements have been made in the well documented flow field about a double circular arc compressor blade in cascade, at an incidence angle of 5 deg. and a chord Reynolds number of 500,000. In Part 2 of this report these measurements were analyzed and presented in standard graphical format. The flow geometry, measurement techniques, and physics of the flow field were also discussed. In this, part 2 of the report, raw and analyzed data are presented in tabulated form in an attempt to make this data more accessible to computational comparison. Also included in part 2 is a description of the data analysis employed. A computer tape containing the data is available.

  10. The Use of Fish Oil with Warfarin Does Not Significantly Affect either the International Normalised Ratio or Incidence of Adverse Events in Patients with Atrial Fibrillation and Deep Vein Thrombosis: A Retrospective Study

    PubMed Central

    Pryce, Rebecca; Bernaitis, Nijole; Davey, Andrew K.; Badrick, Tony; Anoopkumar-Dukie, Shailendra

    2016-01-01

    Background: Warfarin is a leading anticoagulant in the management of atrial fibrillation (AF) and deep vein thrombosis (DVT). Drug interactions influence the safety of warfarin use and while extensive literature exists regarding the effect on warfarin control and bleeding incidence with many medicines, there is little evidence on the influence of complementary medicines. The aim of this study was to assess the influence of fish and krill oil supplementation on warfarin control and bleeding incidence in AF and DVT patients. Methods: A retrospective analysis was conducted utilising patient information from a large private pathology clinic. AF and DVT patients receiving long-term warfarin therapy (>30 days) at the clinic and taking fish and krill oil supplements were eligible for study inclusion. Results: Of the 2081 patients assessed, a total of 573 warfarin users met the inclusion criteria with 145 patients in the fish and krill oil group (supplement group) and 428 patients in the control group. Overall, it was found that fish and krill oils did not significantly alter warfarin time in therapeutic range (TTR) or bleeding incidence, even when compared by gender. Conclusion: Omega-3 supplementation with fish and krill oil does not significantly affect long-term warfarin control and bleeding and thromboembolic events when consumed concurrently in patients managed at an anticoagulation clinic. PMID:27657121

  11. Incidence of Seminoma Cancer in Staffs that Worked in Electromagnetic Waves Station; Three Cases Report.

    PubMed

    Houshyari, Mohammad; Jafari, Anya; Mostaar, Ahmad

    2015-01-01

    Physical agents such as ultraviolet or ionizing radiation and repetitive trauma have been related to the causation of cancer in humans. Much less clear is the association between exposure to radiofrequency, such as radar and microwave radiation to the development of cancer. Sporadic case reports and small series suggest that this type of radiation might lead to cancer or contribute to its evolution. The association between radiofrequency and testicular damage and cancer is unproved, but clinical and experimental data are suggestive of such possibility. In this paper we have reported three cases of seminoma in person who worked in the same place that exposed to radio frequency (RF) waves.

  12. Improving community based AEFI (Adverse Events Following Immunization) reporting rate through telephone “beep” in a Cameroon health district: a randomized field trial

    PubMed Central

    Tsafack, Marcellin; Ateudjieu, Jérôme

    2015-01-01

    Introduction AEFIs underreporting is one of different barriers to achieving objectives of pharmaco vigilance of vaccine worldwide. Studies describe it as being related to limited awareness of health personnel and of vaccinees or of their parents. The objective was to assess the effect of telephone “beep” on community based reporting rates of AEFIs during routine immunization sessions in a Cameroon Health District. Methods It was a randomized control trial implemented during routine EPI in Biyem-Assi health district (Cameroon). Parents of vaccinated children were randomly assigned: i) to receive the telephone contact of the investigation team and was advised to ‘'beep’‘(short phone call not picked up) the investigators team in the case any medical incidence occurs within the 30 days following the immunization (intervention group) or; ii) to return to the health facility in case any medical incidence occurs within the same period (control group). The main outcome was AEFI incidence rate. Results 236 parents were assigned to the intervention group and 235 to the control group. Of 1192 doses of EPI vaccines administered, 20 AEFIs (392 AEFIs/100000 doses/week) were reported within 30 days after vaccine administration. These included 19 (829 AEFIs/100000 doses/week) AEFIs in the intervention group and 1 (43 AEFIs/100000 doses/week) AEFI in the control group. The AEFIs reporting rate in the intervention group was significantly higher than that in the control group [RR = 18.9; CI95 (2.5; 140.0) (P=0.0004)]. Conclusion The use of telephone “beep” significantly increases at affordable cost community based AEFI reporting rate in routine EPI. PMID:26985269

  13. 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

    ... 61 FR 60632 (Nov. 29, 1996). In 2005, FRA again amended its method for calculating the reporting... Surface Transportation Board for the BLS data that was no longer collected (70 FR 75414 (Dec. 20, 2005... threshold was revised. 77 FR 71354 (November 30, 2012). Consequently, FRA has recalculated the threshold,...

  14. 76 FR 72850 - Adjustment of Monetary Threshold for Reporting Rail Equipment Accidents/Incidents for Calendar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... reporting threshold was revised. 75 FR 75911 (December 7, 2010). Consequently, FRA has recalculated the... published December 20, 2005, 70 FR 75414. FRA has found that both the current cost data inserted into this... addition to DOT policies and procedures (44 FR 11034 (Feb. 26, 1979)). Regulatory Flexibility Act...

  15. 77 FR 71354 - Adjustment of Monetary Threshold for Reporting Rail Equipment Accidents/Incidents for Calendar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ... reporting threshold was revised. 76 FR 72850 (November 28, 2011). Consequently, FRA has recalculated the... final rule published December 20, 2005, 70 FR 75414. FRA has found that both the current cost data... 12866 and 13563 in addition to DOT policies and procedures (44 FR 11034 (Feb. 26, 1979))....

  16. 77 FR 53779 - Reports by Air Carriers on Incidents Involving Animals During Air Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-04

    ... published in the Federal Register on June 29, 2012. See 77 FR 38747. The Department of Transportation is... Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://DocketsInfo.dot.gov . Docket...; ] DEPARTMENT OF TRANSPORTATION Office of the Secretary 14 CFR Part 235 RIN 2105-AE07 Reports by Air Carriers...

  17. School Technology Leadership: Incidence and Impact. Teaching, Learning, and Computing: 1998 National Survey, Report #6.

    ERIC Educational Resources Information Center

    Anderson, Ronald E.; Dexter, Sara L.

    This report examines the relationship between school leadership and effective utilization of technology. As an aid to identifying a wide variety of technology policy decisions, a taxonomy of educational technology leadership decisions was constructed. Decisions that pertain primarily to the infrastructure are distinguished from those that deal…

  18. 49 CFR 225.9 - Telephonic reports of certain accidents/incidents and other events.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... of rail accidents for the National Transportation Safety Board (49 CFR part 840) and the Research and..., 49 CFR 171.15). FRA Locomotive Safety Standards require certain locomotive accidents to be reported by telephone to the NRC at the same toll-free number (800-424-0201). 49 CFR 229.17. (c) Contents...

  19. 49 CFR 225.9 - Telephonic reports of certain accidents/incidents and other events.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... of rail accidents for the National Transportation Safety Board (49 CFR part 840) and the Research and..., 49 CFR 171.15). FRA Locomotive Safety Standards require certain locomotive accidents to be reported by telephone to the NRC at the same toll-free number (800-424-0201). 49 CFR 229.17. (c) Contents...

  20. 75 FR 75911 - Adjustment of Monetary Threshold for Reporting Rail Equipment Accidents/Incidents for Calendar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-07

    ... reporting threshold was revised. 74 FR 65458 (December 10, 2009). Consequently, FRA has recalculated the... final rule published December 20, 2005, 70 FR 75414. FRA has found that both the current cost data... both Executive Order 12866 and DOT policies and procedures (44 FR 11034 (Feb. 26, 1979))....

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 33-MANAGEMENT OF GOVERNMENT AIRCRAFT Reporting Information on Government Aircraft Accident and... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What accident...

  2. 49 CFR 225.15 - Accidents/incidents not to be reported.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... considered work-related if the employee is infected at work); or (7) The illness is a mental illness. Mental... mental illness that is work-related. (d) With respect to contractors and volunteers. A railroad is not to... respect to railroad employees on duty. A railroad is not to report the following injuries to or...

  3. 49 CFR 225.15 - Accidents/incidents not to be reported.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... considered work-related if the employee is infected at work); or (7) The illness is a mental illness. Mental... mental illness that is work-related. (d) With respect to contractors and volunteers. A railroad is not to... respect to railroad employees on duty. A railroad is not to report the following injuries to or...

  4. 49 CFR 225.15 - Accidents/incidents not to be reported.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... considered work-related if the employee is infected at work); or (7) The illness is a mental illness. Mental... mental illness that is work-related. (d) With respect to contractors and volunteers. A railroad is not to... respect to railroad employees on duty. A railroad is not to report the following injuries to or...

  5. 49 CFR 225.15 - Accidents/incidents not to be reported.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... considered work-related if the employee is infected at work); or (7) The illness is a mental illness. Mental... mental illness that is work-related. (d) With respect to contractors and volunteers. A railroad is not to... respect to railroad employees on duty. A railroad is not to report the following injuries to or...

  6. 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

    ... Aircraft Wreckage, Mail, Cargo, and Records,'' in the Federal Register (73 FR 16826). This NPRM proposed... Register (FR), is available for inspection and copying in the NTSB's public reading room, located at 490 L... Authorization (COA). See 72 FR 6689 (Feb. 13, 2007). The FAA COA Guidance Manual 08-01 notes that reports...

  7. Live attenuated measles and mumps viral strain-containing vaccines and hearing loss: Vaccine Adverse Event Reporting System (VAERS), United States, 1990--2003.

    PubMed

    Asatryan, Armenak; Pool, Vitali; Chen, Robert T; Kohl, Katrin S; Davis, Robert L; Iskander, John K

    2008-02-26

    Hearing loss (HL) is a known complication of wild measles and mumps viral infections. As vaccines against measles and mumps contain live attenuated viral strains, it is biologically plausible that in some individuals HL could develop as a complication of vaccination against measles and/or mumps. Our objectives for this study were: to find and describe all cases of HL reported in the scientific literature and to the US Vaccine Adverse Events Reporting System (VAERS) for the period 1990--2003; and to determine reporting rate of HL after live attenuated measles and/or mumps viral strain-containing vaccines (MMCV) administration. We searched published reports for cases of HL identified after vaccination with MMCV. We also searched for reports of HL after MMCV administration submitted to VAERS from 1990 through 2003 and determined the dose-adjusted reporting rate of HL. Our main outcome measure was reported cases of HL after immunization with MMCV which were classified as idiopathic. We found 11 published case reports of HL following MMCV. The review of the VAERS reports identified 44 cases of likely idiopathic sensorineural HL after MMCV administration. The onset of HL in the majority of VAERS and published cases was consistent with the incubation periods of wild measles and mumps viruses. Based on the annual usage of measles-mumps-rubella (MMR) vaccine, we estimated the reporting rate of HL to be 1 case per 6-8 million doses. Thus, HL following MMCV has been reported in the literature and to the VAERS. Further studies are needed to better understand if there is a causal relationship between MMCV and HL.

  8. Preliminary report on operational guidelines developed for use in emergency preparedness and response to a radiological dispersal device incident.

    SciTech Connect

    Yu, C.; Cheng, J.-J.; Kamboj, S.; Domotor, S.; Wallo, A.; Environmental Science Division; DOE

    2006-12-15

    This report presents preliminary operational guidelines and supporting work products developed through the interagency Operational Guidelines Task Group (OGT). The report consolidates preliminary operational guidelines, all ancillary work products, and a companion software tool that facilitates their implementation into one reference source document. The report is intended for interim use and comment and provides the foundation for fostering future reviews of the operational guidelines and their implementation within emergency preparedness and response initiatives in the event of a radiological dispersal device (RDD) incident. The report principally focuses on the technical derivation and presentation of the operational guidelines. End-user guidance providing more details on how to apply these operational guidelines within planning and response settings is being considered and developed elsewhere. The preliminary operational guidelines are categorized into seven groups on the basis of their intended application within early, intermediate, and long-term recovery phases of emergency response. We anticipate that these operational guidelines will be updated and refined by interested government agencies in response to comments and lessons learned from their review, consideration, and trial application. This review, comment, and trial application process will facilitate the selection of a final set of operational guidelines that may be more or less inclusive of the preliminary operational guidelines presented in this report. These and updated versions of the operational guidelines will be made available through the OGT public Web site (http://ogcms.energy.gov) as they become finalized for public distribution and comment.

  9. ISMP Adverse Drug Reactions

    PubMed Central

    2013-01-01

    The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration’s (FDA’s) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA’s MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner. PMID:24421544

  10. Determinants of self-reported bystander behavior in cyberbullying incidents amongst adolescents.

    PubMed

    DeSmet, Ann; Veldeman, Charlene; Poels, Karolien; Bastiaensens, Sara; Van Cleemput, Katrien; Vandebosch, Heidi; De Bourdeaudhuij, Ilse

    2014-04-01

    This study explores behavioral determinants of self-reported cyberbullying bystander behavior from a behavioral change theoretical perspective, to provide levers for interventions. Nine focus groups were conducted with 61 young adolescents (aged 12-16 years, 52% girls). Assertive defending, reporting to others, providing advice, and seeking support were the most mentioned behaviors. Self-reported bystander behavior heavily depended on contextual factors, and should not be considered a fixed participant role. Bystanders preferred to handle cyberbullying offline and in person, and comforting the victim was considered more feasible than facing the bully. Most prevailing behavioral determinants to defend or support the victim were low moral disengagement, that the victim is an ingroup member, and that the bystander is popular. Youngsters felt they received little encouragement from their environment to perform positive bystanding behavior, since peers have a high acceptance for not defending and perceived parental support for defending behavior is largely lacking. These results suggest multilevel models for cyberbullying research, and interventions are needed. With much previous research into cyberbullying insufficiently founded in theoretical models, the employed framework of the Integrative Model and Social Cognitive Theory may inspire future studies into bystander behavior.

  11. Determinants of self-reported bystander behavior in cyberbullying incidents amongst adolescents.

    PubMed

    DeSmet, Ann; Veldeman, Charlene; Poels, Karolien; Bastiaensens, Sara; Van Cleemput, Katrien; Vandebosch, Heidi; De Bourdeaudhuij, Ilse

    2014-04-01

    This study explores behavioral determinants of self-reported cyberbullying bystander behavior from a behavioral change theoretical perspective, to provide levers for interventions. Nine focus groups were conducted with 61 young adolescents (aged 12-16 years, 52% girls). Assertive defending, reporting to others, providing advice, and seeking support were the most mentioned behaviors. Self-reported bystander behavior heavily depended on contextual factors, and should not be considered a fixed participant role. Bystanders preferred to handle cyberbullying offline and in person, and comforting the victim was considered more feasible than facing the bully. Most prevailing behavioral determinants to defend or support the victim were low moral disengagement, that the victim is an ingroup member, and that the bystander is popular. Youngsters felt they received little encouragement from their environment to perform positive bystanding behavior, since peers have a high acceptance for not defending and perceived parental support for defending behavior is largely lacking. These results suggest multilevel models for cyberbullying research, and interventions are needed. With much previous research into cyberbullying insufficiently founded in theoretical models, the employed framework of the Integrative Model and Social Cognitive Theory may inspire future studies into bystander behavior. PMID:24359305

  12. Severe sustained cholestatic hepatitis following temozolomide in a patient with glioblastoma multiforme: case study and review of data from the FDA adverse event reporting system.

    PubMed

    Sarganas, Giselle; Orzechowski, Hans D; Klimpel, Andreas; Thomae, Michael; Kauffmann, Wolfgang; Herbst, Hermann; Bronder, Elisabeth; Garbe, Edeltraut

    2012-05-01

    Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor in adults. Its established first-line adjuvant treatment is radiotherapy in combination with temozolomide (TZM). Hematotoxicity is listed as a frequent adverse drug reaction in the US prescribing information and hepatotoxicity has been reported infrequently in the postmarketing period. We here present the case of a patient diagnosed with GBM who developed severe sustained cholestatic hepatitis following treatment with TZM. The cholestasis was not reversible after withdrawal of TZM during 6 months before the patient's death. Another 2 published case reports of sustained cholestasis following TZM treatment were identified; however, the sustained nature of cholestasis was not emphasized in these reports. Sixteen cases of cholestatic hepatitis/cholestasis associated with TZM were identified in the FDA spontaneous reporting system between 2007 and 2010. Information on the course of the cholestasis in these cases could not be retrieved. In the literature there are other published reports of hepatotoxicity associated with TZM that have reported reversibility upon withdrawal of the drug. Thus, TZM appears to cause different types of hepatotoxicity. Particular attention should be paid to sustained cholestasis as a very serious type of TZM-associated liver toxicity. PMID:22394496

  13. Severe sustained cholestatic hepatitis following temozolomide in a patient with glioblastoma multiforme: case study and review of data from the FDA adverse event reporting system

    PubMed Central

    Sarganas, Giselle; Orzechowski, Hans D.; Klimpel, Andreas; Thomae, Michael; Kauffmann, Wolfgang; Herbst, Hermann; Bronder, Elisabeth; Garbe, Edeltraut

    2012-01-01

    Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor in adults. Its established first-line adjuvant treatment is radiotherapy in combination with temozolomide (TZM). Hematotoxicity is listed as a frequent adverse drug reaction in the US prescribing information and hepatotoxicity has been reported infrequently in the postmarketing period. We here present the case of a patient diagnosed with GBM who developed severe sustained cholestatic hepatitis following treatment with TZM. The cholestasis was not reversible after withdrawal of TZM during 6 months before the patient's death. Another 2 published case reports of sustained cholestasis following TZM treatment were identified; however, the sustained nature of cholestasis was not emphasized in these reports. Sixteen cases of cholestatic hepatitis/cholestasis associated with TZM were identified in the FDA spontaneous reporting system between 2007 and 2010. Information on the course of the cholestasis in these cases could not be retrieved. In the literature there are other published reports of hepatotoxicity associated with TZM that have reported reversibility upon withdrawal of the drug. Thus, TZM appears to cause different types of hepatotoxicity. Particular attention should be paid to sustained cholestasis as a very serious type of TZM-associated liver toxicity. PMID:22394496

  14. How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials

    PubMed Central

    2013-01-01

    Background Accurately characterizing a drug’s safety profile is essential. Trial harm and tolerability assessments rely, in part, on participants’ reports of medical histories, adverse events (AEs), and concomitant medications. Optimal methods for questioning participants are unclear, but different methods giving different results can undermine meta-analyses. This study compared methods for eliciting such data and explored reasons for dissimilar participant responses. Methods Participants from open-label antimalarial and antiretroviral interaction trials in two distinct sites (South Africa, n = 18 [all HIV positive]; Tanzania, n = 80 [86% HIV positive]) were asked about ill health and treatment use by sequential use of (1) general enquiries without reference to particular conditions, body systems or treatments, (2) checklists of potential health issues and treatments, (3) in-depth interviews. Participants’ experiences of illness and treatment and their reporting behaviour were explored qualitatively, as were trial clinicians’ experiences with obtaining participant reports. Outcomes were the number and nature of data by questioning method, themes from qualitative analyses and a theoretical interpretation of participants’ experiences. Results There was an overall cumulative increase in the number of reports from general enquiry through checklists to in-depth interview; in South Africa, an additional 12 medical histories, 21 AEs and 27 medications; in Tanzania an additional 260 medical histories, 1 AE and 11 medications. Checklists and interviews facilitated recognition of health issues and treatments, and consideration of what to report. Information was sometimes not reported because participants forgot, it was considered irrelevant or insignificant, or they feared reporting. Some medicine names were not known and answers to questions were considered inferior to blood tests for detecting ill health. South African inpatient volunteers exhibited a

  15. The reported incidence of work-related musculoskeletal disease in the UK: MOSS 1997-2000.

    PubMed

    Cherry, N M; Meyer, J D; Chen, Y; Holt, D L; McDonald, J C

    2001-10-01

    Consultant rheumatologists participate in surveillance of work-related musculoskeletal conditions under the Musculoskeletal Occupational Surveillance Scheme (MOSS), which has been in operation since 1997. During the first 3 years of the scheme, an estimated total of 8070 cases and 8442 diagnoses were obtained, an average of slightly less than 2700 estimated cases each year. Disorders of the upper limb accounted for approximately 66% (5502) of the total, with hand/wrist/arm conditions (3693 cases) comprising the majority of these. Conditions of the lumbar spine and trunk (13% of cases), the cervical spine (12%) and the shoulder (12%) were also frequently reported. Pain with ill-defined pathology was reported in 35% of cases with hand and forearm disorders. Overall, 82% of cases were related to repetitive rather than single injury. The largest numbers of cases were seen in workers in craft occupations (1659) and in clerical and secretarial workers (1524). High rates of musculoskeletal conditions, particularly of upper limb disorders, are notable in mining. In most occupations, and overall, women were at greater risk than men.

  16. Data Mining and the Twitter Platform for Prescribed Burn and Wildfire Incident Reporting with Geospatial Applications

    NASA Astrophysics Data System (ADS)

    Endsley, K.; McCarty, J. L.

    2012-12-01

    Data mining techniques have been applied to social media in a variety of contexts, from mapping the evolution of the Tahrir Square protests in Egypt to predicting influenza outbreaks. The Twitter platform is a particular favorite due to its robust application programming interface (API) and high throughput. Twitter, Inc. estimated in 2011 that over 2,200 messages or "tweets" are generated every second. Also helpful is Twitter's semblance in operation to the short message service (SMS), better known as "texting," available on cellular phones and the most popular means of wide telecommunications in many developing countries. In the United States, Twitter has been used by a number of federal, state and local officials as well as motivated individuals to report prescribed burns in advance (sometimes as part of a reporting obligation) or to communicate the emergence, response to, and containment of wildfires. These reports are unstructured and, like all Twitter messages, limited to 140 UTF-8 characters. Through internal research and development at the Michigan Tech Research Institute, the authors have developed a data mining routine that gathers potential tweets of interest using the Twitter API, eliminates duplicates ("retweets"), and extracts relevant information such as the approximate size and condition of the fire. Most importantly, the message is geocoded and/or contains approximate locational information, allowing for prescribed and wildland fires to be mapped. Natural language processing techniques, adapted to improve computational performance, are used to tokenize and tag these elements for each tweet. The entire routine is implemented in the Python programming language, using open-source libraries. As such, it is demonstrated in a web-based framework where prescribed burns and/or wildfires are mapped in real time, visualized through a JavaScript-based mapping client in any web browser. The practices demonstrated here generalize to an SMS platform (or any short

  17. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  18. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  19. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  20. Toxic Epidermal Necrolysis During Dronedarone Treatment: First Report of a Severe Serious Adverse Event Of A New Antiarrhythmic Drug.

    PubMed

    Gecks, Thomas; Prochnau, Dirk; Franz, Marcus; Jung, Christian; Kühnert, Helmut; Schliemann, Sibylle; Figulla, Hans Rainer

    2015-10-01

    A 77-year-old female patient with symptomatic atrial fibrillation with fast ventricular rate despite conventional antiarrhythmic therapy was treated with dronedarone. Five days later, she developed a maculopapulous exanthema and small flaccid blisters, which spread over the common integument predominantly located on the dorsal trunk. Over few days, the patient showed a severe epidermal necrolysis of approximately 30 % of the body area and ultimately died in multiorgan failure. Here, we report a rare case of toxic epidermal necrolysis during treatment with dronedarone leading to patient death.