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Sample records for adverse incident reporting

  1. Adverse incident reporting in intensive care.

    PubMed

    Hart, G K; Baldwin, I; Gutteridge, G; Ford, J

    1994-10-01

    This prospective, observational, anonymous incident reporting study aimed to identify and correct factors leading to reduced patient safety in intensive care. An incident was any event which caused or had the potential to cause harm to the patient, but included problems in policy or procedure. Reports were discussed at monthly meetings. Of 390 incidents, 106 occasioned "actual" harm and 284 "potential" harm. There was one death, 86 severe complications and 88 complications of minor severity. Most were transient but the effects of 24 lasted up to a week. Most incidents affected cardiovascular and respiratory systems. Incident categories involved drugs, equipment, management or procedures. Incident causes were knowledge-based, rule-based, technical, slip/lapse, no error or unclassifiable. The study has identified some human and equipment performance problems in our intensive care unit. Correction of these should lead to a reduction in the future incidence of those events and hence an increased level of patient safety. PMID:7818059

  2. 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

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Toxic or adverse effect incident... Information § 159.184 Toxic or adverse effect incident reports. (a) General. Information about incidents... organism suffered a toxic or adverse effect, or may suffer a delayed or chronic adverse effect in...

  4. 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

  5. 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

  6. 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

  7. To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?

    PubMed Central

    2011-01-01

    Background Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in which patient safety issues are already reported, such as incidents reported by healthcare professionals and complaints and medico-legal claims filled by patients or their relatives. The aim of the study is to examine to what extent the hospital reporting systems cover the adverse events identified by patient record review. Methods We conducted a retrospective study using a database from a record review study of 5375 patient records in 14 hospitals in the Netherlands. Trained nurses and physicians using a method based on the protocol of The Harvard Medical Practice Study previously reviewed the records. Four reporting systems were linked with the database of reviewed records: 1) informal and 2) formal complaints by patients/relatives, 3) medico-legal claims by patients/relatives and 4) incident reports by healthcare professionals. For each adverse event identified in patient records the equivalent was sought in these reporting systems by comparing dates and descriptions of the events. The study focussed on the number of adverse event matches, overlap of adverse events detected by different sources, preventability and severity of consequences of reported and non-reported events and sensitivity and specificity of reports. Results In the sample of 5375 patient records, 498 adverse events were identified. Only 18 of the 498 (3.6%) adverse events identified by record review were found in one or more of the four reporting systems. There was some overlap: one adverse event had an equivalent in both a complaint and incident report and in three cases a patient/relative used two or three systems to complain about an adverse event. Healthcare professionals reported relatively more

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... water samples, percent surface water source by specific surface water sources to water supply system(s... adverse reproductive effects or in residual disability. (C) H-C: If the person alleged or...

  9. 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... adverse reproductive effects or in residual disability. (C) H-C: If the person alleged or exhibited... of systems supplied. (C) If finished water samples, water supply systems sampled. (D) If...

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... female, pregnant? (J) Exposure data: amount of pesticide; duration of exposure; weight of victim. (K) Was... adverse reproductive effects or in residual disability. (C) H-C: If the person alleged or exhibited... of systems supplied. (C) If finished water samples, water supply systems sampled. (D) If...

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... domestic animal: (A) Type of animal (e.g., livestock, poultry, bird, fish, household pet e.g., dog/cat etc..., submit laboratory report(s). (iii) If fish, wildlife, plants or other non-target organisms: (A) List...., crop, forest, orchard, home garden, ornamental, forage). (G) Formulation of pesticide if not...

  12. Learning from adverse incidents involving medical devices.

    PubMed

    Amoore, John; Ingram, Paula

    While an adverse event involving a medical device is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of incidents involving medical devices are explored using this approach to investigate the various causes of the incident and the protective barriers that minimised or prevented adverse consequences. User factors, including mistakes, omissions and lack of training, conspired with background factors--device controls and device design, storage conditions, hidden device damage and physical layout of equipment when in use--to cause the adverse events. Protective barriers that prevented or minimised the consequences included staff vigilance, operating procedures and alarms. PMID:12715578

  13. 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…

  14. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada

    PubMed Central

    Baker, G. Ross; Norton, Peter G.; Flintoft, Virginia; Blais, Régis; Brown, Adalsteinn; Cox, Jafna; Etchells, Ed; Ghali, William A.; Hébert, Philip; Majumdar, Sumit R.; O'Beirne, Maeve; Palacios-Derflingher, Luz; Reid, Robert J.; Sheps, Sam; Tamblyn, Robyn

    2004-01-01

    Background Research into adverse events (AEs) has highlighted the need to improve patient safety. AEs are unintended injuries or complications resulting in death, disability or prolonged hospital stay that arise from health care management. We estimated the incidence of AEs among patients in Canadian acute care hospitals. Methods We randomly selected 1 teaching, 1 large community and 2 small community hospitals in each of 5 provinces (British Columbia, Alberta, Ontario, Quebec and Nova Scotia) and reviewed a random sample of charts for nonpsychiatric, nonobstetric adult patients in each hospital for the fiscal year 2000. Trained reviewers screened all eligible charts, and physicians reviewed the positively screened charts to identify AEs and determine their preventability. Results At least 1 screening criterion was identified in 1527 (40.8%) of 3745 charts. The physician reviewers identified AEs in 255 of the charts. After adjustment for the sampling strategy, the AE rate was 7.5 per 100 hospital admissions (95% confidence interval [CI] 5.7– 9.3). Among the patients with AEs, events judged to be preventable occurred in 36.9% (95% CI 32.0%–41.8%) and death in 20.8% (95% CI 7.8%–33.8%). Physician reviewers estimated that 1521 additional hospital days were associated with AEs. Although men and women experienced equal rates of AEs, patients who had AEs were significantly older than those who did not (mean age [and standard deviation] 64.9 [16.7] v. 62.0 [18.4] years; p = 0.016). Interpretation The overall incidence rate of AEs of 7.5% in our study suggests that, of the almost 2.5 million annual hospital admissions in Canada similar to the type studied, about 185 000 are associated with an AE and close to 70 000 of these are potentially preventable. PMID:15159366

  15. Nurses must report adverse drug reactions.

    PubMed

    Griffith, Richard

    There is renewed determination throughout the European Union (EU) to reduce the economic cost and high death rate associated with adverse drug reactions through better pharmacovigilance. Timely reporting and sharing of information concerning adverse drug reactions is vital to the success of this initiative. In the UK, the reporting of serious adverse drug reactions is facilitated by the Yellow Card Scheme, yet despite being well placed to monitor the effect of medicines on patients, nurses do not make full use of the scheme. This article sets out the impact of adverse drug reactions in the EU and argues that it is essential that nurses must be at the vanguard of adverse reaction reporting if the EU's pharmacovigilance initiative is to be a success. PMID:23905231

  16. 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.

  17. 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.

  18. [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. PMID:27040337

  19. 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

  20. Standardizing drug adverse event reporting data.

    PubMed

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

    2013-01-01

    Normalizing data in the Adverse Event Reporting System (AERS), an FDA database, would improve the mining capacity of AERS for drug safety signal detection. In this study, we aim to normalize AERS and build a publicly available normalized Adverse drug events (ADE) data source.he drug information in AERS is normalized to RxNorm, a standard terminology source for medication. Drug class information is then obtained from the National Drug File - Reference Terminology (NDF-RT). Adverse drug events (ADE) are aggregated through mapping with the PT (Preferred Term) and SOC (System Organ Class) codes of MedDRA. Our study yields an aggregated knowledge-enhanced AERS data mining set (AERS-DM). The AERS-DM could provide more perspectives to mine AERS database for drug safety signal detection and could be used by research community in the data mining field. PMID:23920875

  1. [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

  2. Adverse incidents and patient safety - improving the learning experience of junior doctors.

    PubMed

    Baruch, Nina

    2014-02-01

    The need to ensure patient safety in the National Health Service (NHS) is a national priority. However, it has long been recognised that a culture of blame impedes learning from previous adverse incidents. It is important to feedback the outcomes of investigations into incidents to NHS staff, but junior doctors have little knowledge of learning points from investigations into adverse incidents. Learning from past mistakes would improve practice and the level of care provided by junior doctors. A forum for learning from mistakes could also provide an opportunity to review past incidents in an open and supportive environment. This could, in turn, start to change the current culture of blame in the NHS and contribute to higher standards of patient safety in the future. PMID:24532743

  3. 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

  4. The incidence of adverse events in Swedish hospitals: a retrospective medical record review study

    PubMed Central

    Soop, Michael; Fryksmark, Ulla; Köster, Max; Haglund, Bengt

    2009-01-01

    Objectives To estimate the incidence, nature and consequences of adverse events and preventable adverse events in Swedish hospitals. Design A three-stage structured retrospective medical record review based on the use of 18 screening criteria. Setting Twenty-eight Swedish hospitals. Population A representative sample (n = 1967) of the 1.2 million Swedish hospital admissions between October 2003 and September 2004. Main Outcome Measures Proportion of admissions with adverse events, the proportion of preventable adverse events and the types and consequences of adverse events. Results In total, 12.3% (n = 241) of the 1967 admissions had adverse events (95% CI, 10.8–13.7), of which 70% (n = 169) were preventable. Fifty-five percent of the preventable events led to impairment or disability, which was resolved during the admission or within 1 month from discharge, another 33% were resolved within 1 year, 9% of the preventable events led to permanent disability and 3% of the adverse events contributed to patient death. Preventable adverse events led to a mean increased length of stay of 6 days. Ten of the 18 screening criteria were sufficient to detect 90% of the preventable adverse events. When extrapolated to the 1.2 million annual admissions, the results correspond to 105 000 preventable adverse events (95% CI, 90 000–120 000) and 630 000 days of hospitalization (95% CI, 430 000–830 000). Conclusions This study confirms that preventable adverse events were common, and that they caused extensive human suffering and consumed a significant amount of the available hospital resources. PMID:19556405

  5. Completeness of adverse drug reactions reports of the Saudi adverse event reporting system

    PubMed Central

    Alshammari, Thamir M.; Al-Kathiri, Wa’ad H.; Louet, Hervé Le; Aljadhey, Hisham S.

    2015-01-01

    Objectives: To assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications. Methods: A cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS. The completeness was assessed by reviewing the components of the adverse drug reactions (ADRs) form, and how many fields were completed. Descriptive statistics are reported. Result: There were 14,783 reports during the study period. Eighty percent of these reports were spontaneous reports. Information related to the drug (99%) and adverse events (98%) of the reports were completed. While the patient’s demographic data were completed only in 38% of all reports, the least completed item in the ADRs form was the reporter information (15%). The most reported drug class was tumor necrosis factor inhibitors (7%), whereas events involving the respiratory organ system were the most frequently reported (4.5%). Conclusion: Although the SAERS is considered new, it has a high number of reports. More efforts are needed to improve the completeness of the SAERS to be a good source to assess the signals between events and suspected drugs, especially when there is a high number of reports. PMID:26108586

  6. Standardizing adverse drug event reporting data

    PubMed Central

    2014-01-01

    Background The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly available normalized ADE data source. The drug information in the AERS is normalized to RxNorm, a standard terminology source for medication, using a natural language processing medication extraction tool, MedEx. Drug class information is then obtained from the National Drug File-Reference Terminology (NDF-RT) using a greedy algorithm. Adverse events are aggregated through mapping with the Preferred Term (PT) and System Organ Class (SOC) codes of Medical Dictionary for Regulatory Activities (MedDRA). The performance of MedEx-based annotation was evaluated and case studies were performed to demonstrate the usefulness of our approaches. Results Our study yields an aggregated knowledge-enhanced AERS data mining set (AERS-DM). In total, the AERS-DM contains 37,029,228 Drug-ADE records. Seventy-one percent (10,221/14,490) of normalized drug concepts in the AERS were classified to 9 classes in NDF-RT. The number of unique pairs is 4,639,613 between RxNorm concepts and MedDRA Preferred Term (PT) codes and 205,725 between RxNorm concepts and SOC codes after ADE aggregation. Conclusions We have built an open-source Drug-ADE knowledge resource with data being normalized and aggregated using standard biomedical ontologies. The data resource has the potential to assist the mining of ADE from AERS for the data mining research community. PMID:25157320

  7. Adverse events during intrahospital transport of critically ill patients: incidence and risk factors

    PubMed Central

    2013-01-01

    Background Transport of critically ill patients for diagnostic or therapeutic procedures is at risk of complications. Adverse events during transport are common and may have significant consequences for the patient. The objective of the study was to collect prospectively adverse events that occurred during intrahospital transports of critically ill patients and to determine their risk factors. Methods This prospective, observational study of intrahospital transport of consecutively admitted patients with mechanical ventilation was conducted in a 38-bed intensive care unit in a university hospital from May 2009 to March 2010. Results Of 262 transports observed (184 patients), 120 (45.8%) were associated with adverse events. Risk factors were ventilation with positive end-expiratory pressure >6 cmH2O, sedation before transport, and fluid loading for intrahospital transports. Within these intrahospital transports with adverse events, 68 (26% of all intrahospital transports) were associated with an adverse event affecting the patient. Identified risk factors were: positive end-expiratory pressure >6 cmH2O, and treatment modification before transport. In 44 cases (16.8% of all intrahospital transports), adverse event was considered serious for the patient. In our study, adverse events did not statistically increase ventilator-associated pneumonia, time spent on mechanical ventilation, or length of stay in the intensive care unit. Conclusions This study confirms that the intrahospital transports of critically ill patients leads to a significant number of adverse events. Although in our study adverse events have not had major consequences on the patient stay, efforts should be made to decrease their incidence. PMID:23587445

  8. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Postmarketing reporting of adverse experiences. 600.80 Section 600.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Reporting of Adverse Experiences § 600.80 Postmarketing reporting of adverse experiences....

  9. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Postmarketing reporting of adverse experiences. 600.80 Section 600.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Reporting of Adverse Experiences § 600.80 Postmarketing reporting of adverse experiences....

  10. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Postmarketing reporting of adverse experiences. 600.80 Section 600.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Reporting of Adverse Experiences § 600.80 Postmarketing reporting of adverse experiences....

  11. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Postmarketing reporting of adverse experiences. 600.80 Section 600.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Reporting of Adverse Experiences § 600.80 Postmarketing reporting of adverse experiences....

  12. 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

  13. 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

  14. Incidence of adverse biological effects within ranges of chemical concentrations in marine and estuarine sediments

    NASA Astrophysics Data System (ADS)

    Long, Edward R.; MacDonald, Donald D.; Smith, Sherri L.; Calder, Fred D.

    1995-01-01

    Matching biological and chemical data were compiled from numerous modeling, laboratory, and field studies performed in marine and estuarine sediments. Using these data, two guideline values (an effects range-low and an effects range-median) were determined for nine trace metals, total PCBs, two pesticides, 13 polynuclear aromatic hydrocarbons (PAHs), and three classes of PAHs. The two values defined concentration ranges that were: (1) rarely, (2) occasionally, or (3) frequently associated with adverse effects. The values generally agreed within a factor of 3 or less with those developed with the same methods applied to other data and to those developed with other effects-based methods. The incidence of adverse effects was quantified within each of the three concentration ranges as the number of cases in which effects were observed divided by the total number of observations. The incidence of effects increased markedly with increasing concentrations of all of the individual PAHs, the three classes of PAHs, and most of the trace metals. Relatively poor relationships were observed between the incidence of effects and the concentrations of mercury, nickel, total PCB, total DDT and p,p'-DDE. Based upon this evaluation, the approach provided reliable guidelines for use in sediment quality assessments. This method is being used as a basis for developing National sediment quality guidelines for Canada and informal, sediment quality guidelines for Florida.

  15. 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

  16. 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.

  17. 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

  18. 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

  19. 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

  20. Adverse events reporting--the tip of an iceberg.

    PubMed

    Shamoo, A E

    2001-01-01

    NIH data indicate that annually seven million human subjects are enrolled in research sponsored by NIH alone. In addition, there are sixteen federal agencies and numerous departments outside NIH conducting experiments with human subjects. Moreover, the pharmaceutical industry spends $26 billion on research (compared to $16 billion for NIH), thus, the total number of human subjects enrolled in research for both the public and private sectors can be estimated as high as nineteen million. I present data on the potential magnitude of adverse events in the United States among human subjects enrolled in research that appear to be unreported and unaccounted for. We obtained data from the Office for Human Research Protections (OHRP) through the Freedom of Information Act for the years 1990 to August 2000 regarding all Institutional Incident Reports (IRPTs) and a list of Compliance Oversight Branch Investigations (COBIs) involving Multiple Project Assurances (MPAs). In the ten years of reporting for nearly seventy million human subjects, there were only 878 IRPTs and 41 investigations. From the incident reports to OHRP, 44% involved adverse events. Those projects investigated for Multiple Project Assurances violations (41 such investigations) showed that 51% were suspended or terminated. The number of deaths reported to OHRP in ten years for the seventy million human subjects is merely eight. The anticipated number of deaths among the general population in seventy million (assuming subject's duration in trials is one month) is 51,000. The number of suicides and attempted suicides alone among the seventy million expected research subjects can be anticipated to be about 5,000. Therefore, the number of expected deaths should have been between 5,000 and 51,000. These numbers and percentages represent minimal numbers since they are not a result of random audits or investigations, but a result of self-reporting or an exogenous complaint. Despite the fact that these are

  1. Major incident in Kent: a case report.

    PubMed

    Hardy, Sophie Elizabeth Jap

    2015-01-01

    A major incident was declared after a road traffic accident involving 150 cars and 200 people in Kent, England. The emergency services oversaw coordination of the scene, recovery and triage of casualties and transfer of patients to hospital. The crash was one of the worst seen on British roads and it has been hailed as a miracle that there were no deaths and very few serious injuries.This case report is a retrospective analysis of the regional health system's response to the crash. The structure is based on the content of a report submitted using an online open access template for major incident reporting (Scand J Trauma Resusc Emerg Med 22: 5, 2014; http://www.majorincidentreporting.org ). A more comprehensive analysis of the incident has also been the theme of a Masters thesis (Hardy S. Reporting Major Incidents in England: Putting Theory into Practice. England: Queen Mary's University of London; 2014). PMID:26391879

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

    PubMed

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

    2015-11-01

    Cutaneous adverse drug reactions (ADRs) are common. However, no prospective study assessing cutaneous ADRs is available for Chinese populations. This study aimed to assess the incidence, manifestations, causative drugs, and other factors related to cutaneous ADRs. A total of 22,866 inpatients were surveyed prospectively from January to April 2012 at the Peking Union Medical College Hospital. Only cutaneous ADRs induced by systemic drugs were considered. Fifty cases were confirmed as cutaneous ADRs, for an estimated incidence of 2.2 per 1000 during this period (95 % confidence interval 1.6-2.8). Cases of cutaneous ADRs comprised 69 % females, while 63 % of all inpatients were female (χ (2) = 0.641, P = 0.427). The department of infectious diseases was the most frequently involved department. Morbilliform exanthema (40 %) was the most frequent cutaneous ADR, followed by urticaria (23.1 %). Anti-infection drugs (36.9 %) caused most cases of cutaneous ADRs, followed by iodinated contrast media (ICM, 18.5 %) and non-steroidal anti-inflammatory drugs (NSAIDs, 18.5 %). The most frequently associated disorders were cancer (24 %), infection (22 %), cardiovascular and cerebrovascular diseases (20 %), and autoimmune diseases (18 %). In this first prospective study assessing the incidence of cutaneous ADRs in China, anti-infection drugs were the most commonly involved drugs, followed by ICM and NSAIDs. No evidence of increased cutaneous ADR incidence in AIDS or SLE patients was observed. Our findings indicate that cancer and its treatments were often related to cutaneous ADRs in China. PMID:26246330

  3. [Patient safety - definition and epidemiology of adverse events, errors and incidents].

    PubMed

    Koppenberg, J

    2012-06-01

    Multiple studies in the last years on patient safety brought this issue into focus for healthcare workers, but also politics and public. It is evident, that patient safety in health care is not longer a "nice to have", but an absolutely "must", analog others high risk industries. This article presents the most important basis principles of patient safety. The development from the error- to the safety culture is described. The terms adverse event, error and incident are defined as well other important terms and possible human pitfalls. At the end epidemiology correlations are presented, to underline the importance of patient safety in medicine. This article should help to understand the terminology of patient safety, to be able to understand the real important ideas and context of patient safety. PMID:22653716

  4. USE OF CASE REPORTS IN ASSESSING ADVERSE OUTCOMES OF HUMAN PRENATAL DRUG EXPOSURES: AN APPROACH

    EPA Science Inventory

    The use of case reports for assessing the developmental consequences of prenatal drug exposure is limited by the inability to determine the incidence of adverse outcomes and by the high likelihood for bias. Yet, because it is impossible to conduct clinical trials for the assessme...

  5. An adverse reaction to local anaesthesia: report of a case.

    PubMed

    Selcuk, E; Ertürk, S; Afrashi, A

    1996-10-01

    The safety of local anaesthetic agents is high but adverse reactions do occur. A common mistake among practitioners is misdiagnosing an adverse reaction to local anaesthesia as a hypersensitivity reaction. Some prospective dental patients are unable to undergo routine dental treatment because they have been mislabelled as allergic to local anaesthetics. This case report illustrates the need for practitioners to be sure of the signs and symptoms of potential adverse reactions and their appropriate management. PMID:9452627

  6. Extraction of potential adverse drug events from medical case reports

    PubMed Central

    2012-01-01

    The sheer amount of information about potential adverse drug events published in medical case reports pose major challenges for drug safety experts to perform timely monitoring. Efficient strategies for identification and extraction of information about potential adverse drug events from free‐text resources are needed to support pharmacovigilance research and pharmaceutical decision making. Therefore, this work focusses on the adaptation of a machine learning‐based system for the identification and extraction of potential adverse drug event relations from MEDLINE case reports. It relies on a high quality corpus that was manually annotated using an ontology‐driven methodology. Qualitative evaluation of the system showed robust results. An experiment with large scale relation extraction from MEDLINE delivered under‐identified potential adverse drug events not reported in drug monographs. Overall, this approach provides a scalable auto‐assistance platform for drug safety professionals to automatically collect potential adverse drug events communicated as free‐text data. PMID:23256479

  7. 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. PMID:16466130

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

    PubMed

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

    2016-09-01

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

  9. 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

  10. 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

  11. Unity from diversity: the evidential use of anecdotal reports of adverse drug reactions and interactions.

    PubMed

    Aronson, Jeffrey K

    2005-04-01

    Anecdotal case reports contribute about one-third of the published literature on adverse drug reactions and interactions, but are regarded as providing poor-quality evidence. However, they can occasionally provide proof of cause and effect, and there are many other reasons for publishing them. Because an anecdote is a narrative, narratological paradigms from literature, art, and music can show how we can make evidential use of anecdotes. Useful paradigms are the dramatic unities (of time, place, and action), comprehensive catalogues, and pattern formations. Here I give examples of each of these types of paradigm and show how they can be used to interpret anecdotes about adverse drug reactions and interactions. The dramatic unities show how a proper classification of adverse drug reactions can be achieved, according to dose-relation, time-course, and susceptibility factors; use of this classification should improve the evidential use of anecdotal reports. A high background incidence of the effect (the medical equivalent of subplots, which violate the unity of action) makes it more difficult to detect adverse drug effects using anecdotal reports. To make best evidential use of the corpus of anecdotal reports of adverse drug reactions, comprehensiveness is important: each suspected adverse reaction should be reported in detail and reactions should be reported in sufficient numbers for proper classification and for patterns to be recognized. One form of pattern recognition, teleoanalysis of data, should, when possible, include not only randomized controlled trials and observational studies, but also case series and anecdotal reports. PMID:15813716

  12. The automation of clinical trial serious adverse event reporting workflow

    PubMed Central

    London, Jack W; Smalley, Karl J; Conner, Kyle; Smith, J Bruce

    2011-01-01

    Background The reporting of serious adverse events (SAEs) is a requirement when conducting a clinical trial involving human subjects, necessary for the protection of the participants. The reporting process is a multi-step procedure, involving a number of individuals from initiation to final review, and must be completed in a timely fashion. Purpose The purpose of this project was to automate the adverse event reporting process, replacing paper-based processes with computer-based processes, so that personnel effort and time required for serious adverse event reporting was reduced, and the monitoring of reporting performance and adverse event characteristics was facilitated. Methods Use case analysis was employed to understand the reporting workflow and generate software requirements. The automation of the workflow was then implemented, employing computer databases, web-based forms, electronic signatures, and email communication. Results In the initial year (2007) of full deployment, 588 SAE reports were processed by the automated system, eSAEy™. The median time from initiation to Principal Investigator electronic signature was less than 2 days (mean 7 ± 0.7 days). This was a significant reduction from the prior paper-based system, which had a median time for signature of 24 days (mean of 45 ± 5.7 days). With eSAEy™, reports on adverse event characteristics (type, grade, etc.) were easily obtained and had consistent values based on standard terminologies. Limitation The automated system described was designed specifically for the work flow at Thomas Jefferson University. While the methodology for system design, and the system requirements derived from common clinical trials adverse reporting procedures are applicable in general, specific work flow details may not relevant at other institutions. Conclusion The system facilitated analysis of individual investigator reporting performance, as well as the aggregation and analysis of the nature of reported adverse

  13. 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

  14. [Reporting adverse reactions and events in randomised clinical trials].

    PubMed

    Hemmingsen, Bianca; Støy, Lina; Wetterslev, Jørn; Tarnow, Lise; Friis, Karin Bach; Christensen, Louise Lundby; Sales, Nader; Gluud, Christian

    2010-08-30

    "Good clinical practice" (GCP) is an international guideline on how to conduct clinical trials on medical products involving human participants. Danish statute follows the EU trial directive (2001/20/EF) including the GCP guidelines. This article summarises the practical implementation of reporting adverse events and adverse reactions to the Danish Medicines Agency and the regional ethics committee based on the protocol of the ongoing Copenhagen Insulin and Metformin Therapy (CIMT) trial. PMID:20825743

  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... derived from commercial marketing experience, postmarketing clinical investigations, postmarketing... adverse experience obtained from a postmarketing clinical study (whether or not conducted under...

  16. 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

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

    PubMed

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

    2012-01-01

    To estimate the incidence of adverse drug reactions (ADRs) in Human immune deficiency virus (HIV) patients on highly active antiretroviral therapy (HAART). To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%). The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52%) was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm(3) with comorbid conditions. PMID:22470896

  18. 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

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

    PubMed

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

    2015-08-26

    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

  20. 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

  1. Attitudinal survey of voluntary reporting of adverse drug reactions

    PubMed Central

    Eland, I A; Belton, K J; van Grootheest, A C; Meiners, A P; Rawlins, M D; Stricker, B H Ch

    1999-01-01

    Aims Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. Methods A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. Results One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34%vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. Conclusions There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions. PMID:10583035

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

    PubMed Central

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

    2015-01-01

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

  3. 49 CFR 225.11 - Reporting of accidents/incidents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  4. 49 CFR 225.11 - Reporting of accidents/incidents.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  5. 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

    ... 10.115). The guidance represents the Agency's current thinking on postmarketing adverse event... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Postmarketing Adverse Event... announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting...

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

    PubMed

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

    2006-04-17

    The adverse event (AE) profiles of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) agents are of great interest, in particular the most recently approved statin, rosuvastatin. The forwarding of reports of AEs has been shown to be influenced by several reporting biases, including secular trend, the new drug reporting effect, product withdrawals, and publicity. Comparative assessments that use AE reporting rates are difficult to interpret under these circumstances, because such effects can themselves lead to marked increases in AE reporting. Consequently, many comparative reporting rate analyses are best carried out in conjunction with other metrics that put reporting burden into context, such as report proportion. All-AE reporting rates showed a temporal profile that resembled those of other statins when marketing cycle and secular trend were taken into account. A before-and-after cerivastatin withdrawal comparison showed a substantial increase in the reporting of AEs of interest for the statin class overall. Report proportion analyses indicated that the burden of rosuvastatin-associated AEs was similar to that for other statin agents. Analyses of monthly reporting rates showed that the reporting of rosuvastatin-associated rhabdomyolysis and renal failure have increased following AE-specific mass media publicity. Postrosuvastatin AE reporting patterns were comparable to those seen with other statins and did not resemble cerivastatin. PMID:16581327

  7. 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

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

    PubMed

    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

  9. 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

  10. 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 §§...

  11. 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 §§...

  12. 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 §§...

  13. 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 §§...

  14. 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 §§...

  15. Elucidating Reasons for Resident Underutilization of Electronic Adverse Event Reporting.

    PubMed

    Hatoun, Jonathan; Suen, Winnie; Liu, Constance; Shea, Sandy; Patts, Gregory; Weinberg, Janice; Eng, Jessica

    2016-07-01

    Reasons for resident underutilization of adverse event (AE) reporting systems are unclear, particularly given frequent resident exposure to AEs and near misses (NMs). Residents at an academic medical center were surveyed about AEs/NMs, barriers to reporting, patient safety climate, and educational interventions. A total of 350 of 527 eligible residents (66%) completed the survey; 77% of respondents reported involvement in an AE/NM, though only 43% had used the reporting system. Top barriers to reporting were not knowing what or how to report. Surgeons reported more than other residents (surgery, 61%; medical, 38%; hospital-based, 15%; P < .01), yet more often felt that systems were unlikely to change after reporting (surgery, 49%; medical, 28%; hospital-based. 18%; P < .01). Residents preferred discussions with supervisors (52%) and department-led conferences (46%) to increased reporting. Efforts to increase resident reporting should address common barriers to reporting as well as department-specific differences in resident knowledge, perceptions of system effectiveness, and educational preferences. PMID:25753451

  16. Automatically Recognizing Medication and Adverse Event Information From Food and Drug Administration’s Adverse Event Reporting System Narratives

    PubMed Central

    Polepalli Ramesh, Balaji; Belknap, Steven M; Li, Zuofeng; Frid, Nadya; West, Dennis P

    2014-01-01

    Background The Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) is a repository of spontaneously-reported adverse drug events (ADEs) for FDA-approved prescription drugs. FAERS reports include both structured reports and unstructured narratives. The narratives often include essential information for evaluation of the severity, causality, and description of ADEs that are not present in the structured data. The timely identification of unknown toxicities of prescription drugs is an important, unsolved problem. Objective The objective of this study was to develop an annotated corpus of FAERS narratives and biomedical named entity tagger to automatically identify ADE related information in the FAERS narratives. Methods We developed an annotation guideline and annotate medication information and adverse event related entities on 122 FAERS narratives comprising approximately 23,000 word tokens. A named entity tagger using supervised machine learning approaches was built for detecting medication information and adverse event entities using various categories of features. Results The annotated corpus had an agreement of over .9 Cohen’s kappa for medication and adverse event entities. The best performing tagger achieves an overall performance of 0.73 F1 score for detection of medication, adverse event and other named entities. Conclusions In this study, we developed an annotated corpus of FAERS narratives and machine learning based models for automatically extracting medication and adverse event information from the FAERS narratives. Our study is an important step towards enriching the FAERS data for postmarketing pharmacovigilance. PMID:25600332

  17. Feedback from reporting patient safety incidents--are NHS trusts learning lessons?

    PubMed

    Wallace, Louise

    2010-01-01

    For the study, first published in 2006, the researchers examined how well NHS organisations had attempted to use the information they gathered from adverse clinical incidents and whether they were learning from it. By looking at existing relevant research worldwide, interviewing experts, surveying NHS organizations (acute, community and ambulance), consulting health care and other high-risk industry safety experts and NHS risk managers, and investigating case studies of good practice, they developed a model to assess how ready NHS systems were to learn from incidents. This is known as Safety Action and Information Feedback from Incident Reporting (SAIFIR). PMID:20075136

  18. 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…

  19. 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

  20. Serious adverse event reporting in investigator-initiated clinical trials.

    PubMed

    Wallace, Sophie; Myles, Paul S; Zeps, Nikolajs; Zalcberg, John R

    2016-04-01

    Reporting adverse events (AEs) and serious AEs (SAEs) are practical steps to ensure safety for volunteers and patients in medical research involving medications, treatments and devices. However, the burden and cost of reporting should be proportionate with the public health benefit of this information. Unfortunately, in Australia there is clear evidence of ever-increasing requirements from sponsors and ethics committees to report AEs and SAEs unnecessarily, leading to a decrease in the uptake of research, particularly less well funded investigator-initiated trials. We believe that individual AE reports to ethics committees serve no useful purpose, because in most cases the study group identity (drug exposure) is not known in studies with blinded treatment arms and their value is limited. Pragmatic, investigator-initiated Phase IV clinical trials of post-marketed drugs or devices are needed to understand their role in everyday clinical practice. In this setting, the workload and costs of systematic, complete reporting of all AEs and SAEs (independent of whether these are treatment-related) is wasteful, and mostly unnecessary. A trial data safety and monitoring committee is in the unique position of being able to review safety information according to the blinded treatment arms of the study. This enables safety data to be analysed appropriately and a summary report provided to the trial steering committee, principal investigators and the relevant ethics committees in a meaningful way. Defined trial endpoints do not need to be reported as safety events (because they are being properly monitored and analysed). PMID:27031396

  1. Patient-reported missed nursing care correlated with adverse events.

    PubMed

    Kalisch, Beatrice J; Xie, Boqin; Dabney, Beverly Waller

    2014-01-01

    The aim of this study was to determine the extent and type of missed nursing care as reported by patients and the association with patient-reported adverse outcomes. A total of 729 inpatients on 20 units in 2 acute care hospitals were surveyed. The MISSCARE Survey-Patient was used to collect patient reports of missed care. Patients reported more missed nursing care in the domain of basic care (2.29 ± 1.06) than in communication (1.69 ± 0.71) and in time to respond (1.52 ± 0.64). The 5 most frequently reported elements of missed nursing care were the following: (a) mouth care (50.3%), (b) ambulation (41.3%), (c) getting out of bed into a chair (38.8%), (d) providing information about tests/procedures (27%), and (e) bathing (26.4%). Patients who reported skin breakdown/pressure ulcers, medication errors, new infections, IVs running dry, IVs infiltrating, and other problems during the current hospitalization reported significantly more overall missed nursing care. PMID:24006031

  2. 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

  3. 49 CFR 191.9 - Distribution system: Incident report.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  4. 49 CFR 191.9 - Distribution system: Incident report.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Distribution system: Incident report. 191.9... CONDITION REPORTS § 191.9 Distribution system: Incident report. (a) Except as provided in paragraph (c) of this section, each operator of a distribution pipeline system shall submit Department of...

  5. Redefining critical incidents: a preliminary report.

    PubMed

    Burns, C; Rosenberg, L

    2001-01-01

    This pilot study was conducted to describe how some traumatic events become "critical incidents" and to generate a new understanding of the term critical incident. The qualitative research design utilized content analysis of structured interviews of six emergency nurses. The nurses were interviewed regarding the ways they think about certain patient care events, the reasons that specific events are remembered and the changes that occurred following the experience of an event they considered to be critical. The definitions of a critical incident as described in the literature--as an event, as a professional's reaction and as a professional's performance--are included in the nurses' comments. None of them, however, offers a comprehensive way of describing a critical incident. The results of this pilot study suggest one, two or all three elements may be present when a traumatic event is experienced. The interaction of these elements helps to produce a fourth "critical" component, the meaning a nurse gives to an event, which can trigger cognitive, affective and/or behavioral changes. This study acknowledges the importance of all the definitions of a critical incident and proposes a more comprehensive definition that results from the interaction among the other components and the generation of personal meaning and change. PMID:11351507

  6. Incidence and Risk Factors of Serious Adverse Events during Antituberculous Treatment in Rwanda: A Prospective Cohort Study

    PubMed Central

    Lorent, Natalie; Sebatunzi, Osee; Mukeshimana, Gloria; Van den Ende, Jef; Clerinx, Joannes

    2011-01-01

    Background Tuberculosis (TB) and TB-human immunodeficiency virus infection (HIV) coinfection is a major public health concern in resource-limited settings. Although TB treatment is challenging in HIV-infected patients because of treatment interactions, immunopathological reactions, and concurrent infections, few prospective studies have addressed this in sub-Saharan Africa. In this study we aimed to determine incidence, causes of, and risk factors for serious adverse events among patients on first-line antituberculous treatment, as well as its impact on antituberculous treatment outcome. Methods and findings Prospective observational cohort study of adults treated for TB at the Internal Medicine department of the Kigali University Hospital from May 2008 through August 2009. Of 263 patients enrolled, 253 were retained for analysis: median age 35 (Interquartile range, IQR 28–40), 55% male, 66% HIV-positive with a median CD4 count 104 cells/mm3 (IQR 44–248 cells/mm3). Forty percent had pulmonary TB, 43% extrapulmonary TB and 17% a mixed form. Sixty-four (26%) developed a serious adverse event; 58/167 (35%) HIV-infected vs. 6/86 (7%) HIV-uninfected individuals. Commonest events were concurrent infection (n = 32), drug-induced hepatitis (n = 24) and paradoxical reactions/TB-IRIS (n = 23). HIV-infection (adjusted Hazard Ratio, aHR 3.4, 95% Confidence Interval, CI 1.4–8.7) and extrapulmonary TB (aHR 2, 95%CI 1.1–3.7) were associated with an increased risk of serious adverse events. For TB/HIV co-infected patients, extrapulmonary TB (aHR 2.0, 95%CI 1.1–3.9) and CD4 count <100 cells/mm3 at TB diagnosis (aHR 1.7, 95%CI 1.0–2.9) were independent predictors. Adverse events were associated with an almost two-fold higher risk of unsuccessful treatment outcome at 6 months (HR 1.89, 95%CI 1.3–3.0). Conclusion Adverse events frequently complicate the course of antituberculous treatment and worsen treatment outcome, particularly in patients with

  7. 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). PMID:17298254

  8. Automatic Analysis of Critical Incident Reports: Requirements and Use Cases.

    PubMed

    Denecke, Kerstin

    2016-01-01

    Increasingly, critical incident reports are used as a means to increase patient safety and quality of care. The entire potential of these sources of experiential knowledge remains often unconsidered since retrieval and analysis is difficult and time-consuming, and the reporting systems often do not provide support for these tasks. The objective of this paper is to identify potential use cases for automatic methods that analyse critical incident reports. In more detail, we will describe how faceted search could offer an intuitive retrieval of critical incident reports and how text mining could support in analysing relations among events. To realise an automated analysis, natural language processing needs to be applied. Therefore, we analyse the language of critical incident reports and derive requirements towards automatic processing methods. We learned that there is a huge potential for an automatic analysis of incident reports, but there are still challenges to be solved. PMID:27139389

  9. Increasing the Number of Adverse Drug Reactions Reporting: the Role of Clinical Pharmacy Residents

    PubMed Central

    Baniasadi, Shadi; Habibi, Maryam; Haghgoo, Roodabeh; Karimi Gamishan, Masoumeh; Dabaghzadeh, Fatemeh; Farasatinasab, Maryam; Farsaei, Shadi; Gharekhani, Afshin; Kafi, Hamidreza; Karimzadeh, Iman; Kharazmkia, Ali; Najmeddin, Farhad; Nikvarz, Naemeh; Oghazian, Mohammad Bagher; Rezaee, Haleh; Sadeghi, Kourosh; Tafazzoli, Ali; Shahsavari, Nahid; Fahimi, Fanak

    2014-01-01

    Detection of adverse drug reactions (ADRs) in hospitals provides an important measure of the burden of drug related morbidity on the healthcare system. Spontaneous reporting of ADRs is scare and several obstacles to such reporting have been identified formerly. This study aimed to determine the role of clinical pharmacy residents in ADR reporting within a hospital setting. Clinical pharmacy residents were trained to report all suspected ADRs through ADR-reporting yellow cards. The incidence, pattern, seriousness, and preventability of the reported ADRs were analyzed. During the period of 12 months, for 8559 patients, 202 ADR reports were received. The most frequently reported reactions were due to anti-infective agents (38.38%). Rifampin accounted for the highest number of the reported ADRs among anti-infective agents. The gastro-intestinal system was the most frequently affected system (21.56%) of all reactions. Fifty four of the ADRs were reported as serious reactions. Eighteen of the ADRs were classified as preventable. Clinical pharmacy residents' involvement in the ADR reporting program could improve the ADR reporting system. PMID:24734083

  10. 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

  11. Detecting medication errors: analysis based on a hospital's incident reports.

    PubMed

    Härkänen, Marja; Turunen, Hannele; Saano, Susanna; Vehviläinen-Julkunen, Katri

    2015-04-01

    The aim of this paper is to analyse how medication incidents are detected in different phases of the medication process. The study design is a retrospective register study. The material was collected from one university hospital's web-based incident reporting database in Finland. In 2010, 1617 incident reports were made, 671 of those were medication incidents and analysed in this study. Statistical methods were used to analyse the material. Results were reported using frequencies and percentages. Twenty-one percent of all medication incidents were detected during documenting or reading the documents. One-sixth of medication incidents were detected during medicating the patients, and approximately one-tenth were detected during verifying of the medicines. It is important to learn how to break the chain of medication errors as early as possible. Findings showed that for nurses, the ability to concentrate on documenting and medicating the patient is essential. PMID:24256158

  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. 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

  14. 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…

  15. 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.

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

    EPA Science Inventory

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

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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

  2. Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs.

    PubMed

    Bohn, J; Kortepeter, C; Muñoz, M; Simms, K; Montenegro, S; Dal Pan, G

    2015-05-01

    Spontaneous adverse event reports constitute an important source of information on previously unknown adverse reactions to marketed medicines. However, the dynamics of such reporting following generic introduction are poorly understood. Using adverse event reports on five antiepileptic drugs from the US Food and Drug Administration's Adverse Event Reporting System, we describe temporal trends in adverse event reporting before and after generic introduction, and survey the quality of product-identifying information contained therein. The majority of reports were sent by innovator drug manufacturers while few were sent by generic manufacturers, even when generics accounted for >90% of dispensed prescriptions. We manually reviewed narratives from 2,500 reports and found that the suspect product type (brand or generic) could not be determined in 84% of reports, while generic products (16%) were identified more often than brand-name products (<1%). These results suggest that pharmacovigilance stakeholders should act to promote more detailed reporting practices. PMID:25670505

  3. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false How do I complete and submit an individual adverse event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING Generally Applicable Requirements for Individual Adverse Event Reports...

  4. 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

  5. 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. PMID:27020256

  6. Incident reporting in one UK accident and emergency department.

    PubMed

    Tighe, Catherine M; Woloshynowych, Maria; Brown, Ruth; Wears, Bob; Vincent, Charles

    2006-01-01

    Greater focus is needed on improving patient safety in modern healthcare systems and the first step to achieving this is to reliably identify the safety issues arising in healthcare. Research has shown the accident and emergency (A&E) department to be a particularly problematic environment where safety is a concern due to various factors, such as the range, nature and urgency of presenting conditions and the high turnover of patients. As in all healthcare environments clinical incident reporting in A&E is an important tool for detecting safety issues which can result in identifying solutions, learning from error and enhancing patient safety. This tool must be responsive and flexible to the local circumstances and work for the department to support the clinical governance agenda. In this paper, we describe the local processes for reporting and reviewing clinical incidents in one A&E department in a London teaching hospital and report recent changes to the system within the department. We used the historical data recorded on the Trust incident database as a representation of the information that would be available to the department in order to identify the high risk areas. In this paper, we evaluate the internal processes, the information available on the database and make recommendations to assist the emergency department in their internal processes. These will strengthen the internal review and staff feedback system so that the department can learn from incidents in a consistent manner. The process was reviewed by detailed examination of the centrally held electronic record (Datix database) of all incidents reported in a one year period. The nature of the incident and the level and accuracy of information provided in the incident reports was evaluated. There were positive aspects to the established system including evidence of positive changes made as a result of the reporting process, new initiatives to feedback to staff, and evolution of the programme for

  7. 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

  8. 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

  9. 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

  10. 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. PMID:27453826

  11. 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.

  12. 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.

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

    PubMed

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

    2016-04-01

    An adverse outcome pathway (AOP) helps to organize existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify knowledge gaps where more research is needed to understand the underlying mechanisms, aid in chemical hazard characterization, and guide the development of new testing approaches that use fewer or no animals. A September 2014 workshop in Bethesda, Maryland considered how the AOP concept could improve regulatory assessments of chemical toxicity. Scientists from 21 countries, representing industry, academia, regulatory agencies, and special interest groups, attended the workshop, titled Adverse Outcome Pathways: From Research to Regulation. Workshop plenary presentations were followed by breakout sessions that considered regulatory acceptance of AOPs and AOP-based tools, criteria for building confidence in an AOP for regulatory use, and requirements to build quantitative AOPs and AOP networks. Discussions during the closing session emphasized a need to increase transparent and inclusive collaboration, especially with disciplines outside of toxicology. Additionally, to increase impact, working groups should be established to systematically prioritize and develop AOPs. Multiple collaborative projects and follow-up activities resulted from the workshop. PMID:26774756

  14. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary......

  15. 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 AND PROJECT WORKS Reports and Records §...

  16. 28 CFR 541.14 - Incident report and investigation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the investigation, and staff may not question the inmate until the Federal Bureau of Investigation or... report and investigation. (a) Incident report. The Bureau of Prisons encourages informal resolution... Section 541.14 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL...

  17. 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

  18. 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. PMID:20845409

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

    PubMed Central

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

    2011-01-01

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

  20. 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

  1. Cardiovascular and pulmonary adverse events in patients treated with BCR-ABL inhibitors: Data from the FDA Adverse Event Reporting System.

    PubMed

    Cortes, Jorge; Mauro, Michael; Steegmann, Juan Luis; Saglio, Giuseppe; Malhotra, Rachpal; Ukropec, Jon A; Wallis, Nicola T

    2015-04-01

    Rare but serious cardiovascular and pulmonary adverse events (AEs) have been reported in patients with chronic myeloid leukemia treated with BCR-ABL inhibitors. Clinical trial data may not reflect the full AE profile of BCR-ABL inhibitors because of stringent study entry criteria, relatively small sample size, and limited duration of follow-up. To determine the utility of the FDA AE Reporting System (FAERS) surveillance database for identifying AEs possibly associated with the BCR-ABL inhibitors imatinib, dasatinib, and nilotinib in the postmarketing patient population, we conducted Multi-Item Gamma Poisson Shrinker disproportionality analyses of FAERS reports on AEs in relevant system organ classes. Signals consistent with the known safety profiles of these agents as well as signals for less well-described AEs were detected. Bone marrow necrosis, conjunctival hemorrhage, and peritoneal fluid retention events were uniquely associated with imatinib. AEs that most commonly reached the threshold for dasatinib consisted of terms relating to hemorrhage and fluid retention, including pleural effusion and pericardial effusion. Most terms that reached the threshold solely with nilotinib were related to peripheral and cardiac vascular events. Although this type of analysis cannot determine AE incidence or establish causality, these findings elucidate the AEs reported in patients treated with BCR-ABL inhibitors across multiple clinical trials and in the community setting for all approved and nonapproved indications, suggesting drug-AE associations warrant further investigation. These findings emphasize the need to consider patient comorbidities when selecting amongst BCR-ABL inhibitors. PMID:25580915

  2. 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…

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 49 CFR 171.16 - Detailed hazardous materials incident reports.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 2 2013-10-01 2013-10-01 false Detailed hazardous materials incident reports. 171.16 Section 171.16 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS GENERAL INFORMATION, REGULATIONS, AND...

  8. 36 CFR 1230.14 - How do agencies report incidents?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 3 2011-07-01 2011-07-01 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...

  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. 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.

  11. Adverse Drug Reactions of Spontaneous Reports in Shanghai Pediatric Population

    PubMed Central

    Du, Wen-Min; Xu, Jin-Fang; Zhang, Xin-Ji; He, Jia

    2014-01-01

    Background Knowledge of drug safety in the pediatric population of China is limited. This study was designed to evaluate ADRs in children reported to the spontaneous reporting system (SRS) of Shanghai in 2009. Methodology and Principal Findings Crude ADR reports submitted to Shanghai SRS in 2009 for individuals aged from birth to 17 years (including 17 years) were included. Data were analyzed with respect to age, gender, category of ADR (System Organ Class [SOC]), the severity of reports and type of reporter. Results A male overrepresentation was observed regarding the total number of reports. The most frequently reported group of drugs were vaccines (42.15%). Skin rash and fever were the commonest symptoms reported in the total pediatric dataset. The proportion of children that suffered from a serious ADR was 2.16% and that for drug related deaths was 0.34%. And we found that the multiple drug exposure experienced a high proportion of serious ADRs compared with the single drug use (χ2 = 15.99, P<0.0001). Sixty-five percent of ADRs were for children less than 6 years of age. And more than half of reports were from doctors. Conclusions In our study, consumers were more likely to report new ADRs though they appear to contribute a relatively small percentage of total reports. We propose that patients would take an active role in reporting ADRs. More researches are needed in order to achieve better understanding the characteristics of ADRs in pediatric population of China. PMID:24587066

  12. 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

  13. 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

  14. 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

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

    PubMed

    Zafar, Atif

    2007-01-01

    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. PMID:18694263

  16. [Research on early warning signals of adverse drug reactions to parenterally administered xiyanping based on spontaneous reporting system (SRS) data].

    PubMed

    Wang, Zhi-Fei; Xiang, Yong-Yang; Xie, Yan-Ming

    2013-09-01

    This article focused on early warning signals regarding the safety of parenterally administered Xiyanping. The study data was obtained from reports made between 2005-2012 from the national spontaneous reporting system (SRS). Proportion reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) algorithms were used to analyse: erythra, pruritus, anaphylactoid reactions and shiver with cold, these 4 adverse drug reactions had a total count of more than 500 events. The article found that Xiyanping's incidence rate of erythra was higher than for background-drugs in every year and in every season. Pruritus was an early warning signal in the second season of 2009, and anaphylactoid reaction was an early warning signal in the fourth season of 2011 and in the second season of 2012. There was however no early warning signal indicated by shiver with cold. This data indicates that erythra maybe an adverse drug reactions to parenterally administered Xiyanping, and if the incidence rate of pruritus and anaphylactoid reaction rises attention should be paid to its safety. PMID:24471321

  17. 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

  18. Creating European guidelines for Chiropractic Incident Reporting and Learning Systems (CIRLS): relevance and structure

    PubMed Central

    2011-01-01

    Background In 2009, the heads of the Executive Council of the European Chiropractors' Union (ECU) and the European Academy of Chiropractic (EAC) involved in the European Committee for Standardization (CEN) process for the chiropractic profession, set out to establish European guidelines for the reporting of adverse reactions to chiropractic treatment. There were a number of reasons for this: first, to improve the overall quality of patient care by aiming to reduce the application of potentially harmful interventions and to facilitate the treatment of patients within the context of achieving maximum benefit with a minimum risk of harm; second, to inform the training objectives for the Graduate Education and Continuing Professional Development programmes of all 19 ECU member nations, regarding knowledge and skills to be acquired for maximising patient safety; and third, to develop a guideline on patient safety incident reporting as it is likely to be part of future CEN standards for ECU member nations. Objective To introduce patient safety incident reporting within the context of chiropractic practice in Europe and to help individual countries and their national professional associations to develop or improve reporting and learning systems. Discussion Providing health care of any kind, including the provision of chiropractic treatment, can be a complex and, at times, a risky activity. Safety in healthcare cannot be guaranteed, it can only be improved. One of the most important aspects of any learning and reporting system lies in the appropriate use of the data and information it gathers. Reporting should not just be seen as a vehicle for obtaining information on patient safety issues, but also be utilised as a tool to facilitate learning, advance quality improvement and to ultimately minimise the rate of the occurrence of errors linked to patient care. Conclusions Before a reporting and learning system can be established it has to be clear what the objectives of the

  19. 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

  20. Paraesthesia after local anaesthetics: an analysis of reports to the FDA Adverse Event Reporting System.

    PubMed

    Piccinni, Carlo; Gissi, Davide B; Gabusi, Andrea; Montebugnoli, Lucio; Poluzzi, Elisabetta

    2015-07-01

    This study was aimed to evaluate the possible alert signals of paraesthesia by local anaesthetics, focusing on those used in dentistry. A case/non-case study of spontaneous adverse events recorded in FAERS (FDA Adverse Event Reporting System) between 2004 and 2011 was performed. Cases were represented by the reports of reactions grouped under the term 'Paraesthesias and dysaesthesias' involving local anaesthetics (ATC: N01B*); non-cases were all other reports of the same drugs. Reporting odds ratios (ROR) with the relevant 95% confidence intervals (95CI) were calculated. Alert signal was considered when number of cases >3 and lower limit of ROR 95CI > 1. To estimate the specificity of signals for dentistry, the analysis was restricted to the specific term "Oral Paraesthesia" and to reports concerning dental practice. Overall, 528 reports of 'Paraesthesias and dysaesthesias' were retrieved, corresponding to 573 drug-reaction pairs (247 lidocaine, 99 bupivacaine, 85 articaine, 30 prilocaine, 112 others). The signal was significant only for articaine (ROR=18.38; 95CI = 13.95-24.21) and prilocaine (2.66; 1.82-3.90). The analysis of the specific term "Oral Paraesthesia" retrieved 82 reports corresponding to 90 drug-reaction pairs (37 articaine, 19 lidocaine, 14 prilocaine, 7 bupivacaine, 13 others) and confirmed the signal for articaine (58.77; 37.82-91.31) and prilocaine (8.73; 4.89-15.57). The analysis of reports concerning dental procedures retrieved a signal for articaine, both for any procedures (8.84; 2.79-27.97) and for non-surgical ones (15.79; 1.87-133.46). In conclusion, among local anaesthetics, only articaine and prilocaine generated a signal of paraesthesia, especially when used in dentistry. PMID:25420896

  1. 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…

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

    PubMed Central

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

    2009-01-01

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

  3. 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.

  4. Medication errors related to transdermal opioid patches: lessons from a regional incident reporting system

    PubMed Central

    2014-01-01

    Objective A few cases of adverse reactions linked to erroneous use of transdermal opioid patches have been reported in the literature. The aim of this study was to describe and characterize medication errors (MEs) associated with use of transdermal fentanyl and buprenorphine. Methods All events concerning transdermal opioid patches reported between 2004 and 2011 to a regional incident reporting system and assessed as MEs were scrutinized and characterized. MEs were defined as “a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient”. Results In the study 151 MEs were identified. The three most common error types were wrong administration time 67 (44%), wrong dose 34 (23%), and omission of dose 20 (13%). Of all MEs, 118 (78%) occurred in the administration stage of the medication process. Harm was reported in 26 (17%) of the included cases, of which 2 (1%) were regarded as serious harm (nausea/vomiting and respiratory depression). Pain was the most common adverse reaction reported. Conclusions Of the reported MEs related to transdermal fentanyl and buprenorphine, most occurred during administration. Improved routines to ascertain correct and timely administration and educational interventions to reduce MEs for these drugs are warranted. PMID:24912424

  5. 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.

  6. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... an individual adverse event report? (a) What form must I complete and submit? There are two versions... must attach a copy of that form to your report form. If you are a manufacturer and the information...

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

    ERIC Educational Resources Information Center

    Hardt, Jochen; Rutter, Michael

    2004-01-01

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

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

    PubMed

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

    2013-01-01

    The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses. PMID:23794943

  9. 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

  10. Acute adverse reactions to radiographic iodinated and gadolinium-based contrast media: incidence, risk factors and premedication: from published evidence to a practical approach.

    PubMed

    Tonolini, M; Bianco, R

    2011-01-01

    Although relatively uncommon especially in their severe manifestations, adverse reactions (ARs) to radiographic contrast media (CM) may represent a source of concern to both physicians and patients because of the large number of CT and MR imaging procedures daily performed. In this paper the current literature is reviewed regarding incidence and risk factors for acute ARs to both iodinated and gadolinium-based CM, and about the usefulness of pharmacological premedication to reduce risk. A practical approach for everyday clinical practice is proposed. PMID:22262334

  11. 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. PMID:26070168

  12. Self-reported adverse reactions among patients initiating antiretroviral therapy in Brazil.

    PubMed

    Pádua, Cristiane A Menezes de; César, Cibele C; Bonolo, Palmira F; Acurcio, Francisco A; Guimarães, Mark Drew C

    2007-02-01

    A cross-sectional analysis was carried out to describe adverse reactions to antiretroviral therapy (ART) reported by HIV-infected patients initiating treatment at two public health AIDS referral centers in Belo Horizonte, Brazil, 2001-2003 and to verify their association with selected variables. Adverse reactions were obtained through interview at the first follow-up visit (first month) after the antiretroviral prescription. Socio-demographic and behavioral variables related to ART were obtained from baseline and follow-up interviews and clinical variables from medical charts. Patients with four or more reactions were compared to those with less than four. Odds ratio with 95% confidence interval were estimated using logistic regression model for both univariate and multivariate analyses. At least one adverse reaction was reported by 92.2% of the participants while 56.2% reported four or more different reactions. Antiretroviral regimens including indinavir/ritonavir, irregular use of antiretrovirals and switch in regimens were independently associated with four or more adverse reactions (OR=7.92, 5.73 and 2.03, respectively). The initial period of ARV treatment is crucial and patients' perception of adverse reactions should be carefully taken into account. Strategies for monitoring and management of adverse reactions including the choice of regimens and the prevention of irregular ART should be developed in AIDS/HIV referral centers in Brazil to promote better adherence to antiretroviral therapy. PMID:17625721

  13. What to do With Healthcare Incident Reporting Systems

    PubMed Central

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

    2013-01-01

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

  14. 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

  15. 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

  16. 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

  17. 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

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

    PubMed Central

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

    2015-01-01

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

  19. 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...

  20. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... individual reports of adverse events. If you are a health professional or consumer, you may use the FDA Form.... Persons qualified to make a medical judgment include physicians, nurses, risk managers, and...

  1. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... individual reports of adverse events. If you are a health professional or consumer, you may use the FDA Form.... Persons qualified to make a medical judgment include physicians, nurses, risk managers, and...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Postmarketing reporting of adverse drug experiences. 314.80 Section 314.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.80 Postmarketing reporting of...

  3. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Postmarketing reporting of adverse drug experiences. 314.80 Section 314.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.80 Postmarketing reporting of...

  4. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Postmarketing reporting of adverse drug experiences. 314.80 Section 314.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.80 Postmarketing reporting of...

  5. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Postmarketing reporting of adverse drug experiences. 314.80 Section 314.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.80 Postmarketing reporting of...

  6. Incident investigation team report: K-reactor D20 spill

    SciTech Connect

    Enis, E.

    1990-12-31

    This report discusses a spill of approximately 20 gallons of D2O (moderator) which occurred on February 7, 1990, at 0008 hours. The spill occurred while construction was removing process water lines from the 5B heat exchanger at a location referred to as a Rams Horn to allow the heat exchanger to be realigned. The heat exchangers in the other systems (loops) had been successfully disconnected (lines broken) during the previous two months and had been realigned without incident under the control of job plans similar to the System 5 job plan. Construction personnel reacted positively at the time the spill and successfully rebolted and tightened the leaking flanges on 5B and later on the 5A heat exchangers. This initial reaction stopped the leak and prevented a more severe incident. The spill incident resulted in a Site Alert declaration by the Shift Manager at 0220 hours when the Stack Tritium Monitor indicated a tritium release which exceeded the limits specified. After the event it was determined that a Temporary Procedure Change (TPC) to this DPSOL, had been approved and issued in April 1989. Had this TPC been available to the Shift Manager, the alert would not have been declared. Although the environmental impact of this event was negligible with no real radiological consequences minimal, the causal factors and programmatic deficiencies identified by this investigation show significant weakness in some critical areas.

  7. Incident investigation team report: K-reactor D20 spill

    SciTech Connect

    Enis, E.

    1990-01-01

    This report discusses a spill of approximately 20 gallons of D2O (moderator) which occurred on February 7, 1990, at 0008 hours. The spill occurred while construction was removing process water lines from the 5B heat exchanger at a location referred to as a Rams Horn to allow the heat exchanger to be realigned. The heat exchangers in the other systems (loops) had been successfully disconnected (lines broken) during the previous two months and had been realigned without incident under the control of job plans similar to the System 5 job plan. Construction personnel reacted positively at the time the spill and successfully rebolted and tightened the leaking flanges on 5B and later on the 5A heat exchangers. This initial reaction stopped the leak and prevented a more severe incident. The spill incident resulted in a Site Alert declaration by the Shift Manager at 0220 hours when the Stack Tritium Monitor indicated a tritium release which exceeded the limits specified. After the event it was determined that a Temporary Procedure Change (TPC) to this DPSOL, had been approved and issued in April 1989. Had this TPC been available to the Shift Manager, the alert would not have been declared. Although the environmental impact of this event was negligible with no real radiological consequences minimal, the causal factors and programmatic deficiencies identified by this investigation show significant weakness in some critical areas.

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

    PubMed Central

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

    2014-01-01

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

  9. [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

  10. 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. PMID:25615401

  11. Establishing national medical imaging incident reporting systems: issues and challenges.

    PubMed

    Jones, D Neil; Benveniste, Klee A; Schultz, Timothy J; Mandel, Catherine J; Runciman, William B

    2010-08-01

    Radiology incident reporting systems provide one source of invaluable patient safety data that, when combined with appropriate analysis and action, can result in significantly safer health care, which is now an urgent priority for governments worldwide. Such systems require integration into a wider safety, quality, and risk management framework because many issues have global implications, and they also require an international classification scheme, which is now being developed. These systems can be used to inform global research activities as identified by the World Health Organization, many of which intersect with the activities of and issues seen in medical imaging departments. How to ensure that radiologists (and doctors in general) report incidents, and are engaged in the process, is a challenge. However, as demonstrated with the example of the Australian Radiology Events Register, this can be achieved when the reporting system is integrated with their professional organization and its other related activities (such as training and education) and administered by a patient safety organization. PMID:20678728

  12. Incident hyperglycemia, parenteral nutrition administration and adverse outcomes in patients with myeloma admitted for initial auto-SCT.

    PubMed

    Sheean, P M; Kilkus, J M; Liu, D; Maciejewski, J; Braunschweig, C A

    2013-08-01

    Parenteral nutrition (PN) exacerbates hyperglycemia, which is associated with increased morbidity and mortality in various cancer populations. By using a retrospective design, we examined incident hyperglycemia in PN and non-PN recipients and the associations with clinical events and 5-year survival in a cohort treated for myeloma with melphalan and auto-SCT (n=112). Clinical comparisons were made at admission, and 'before' and 'after' initiating PN to discern differences and temporality. Actual infusion times were used for PN patients; time frames based on mean PN infusion days were created for the non-PN recipients. Oral intake was lower 'before' in PN vs non-PN patients (P<0.001); however, no differences in mucositis, emesis, infections or transfusions were detected 'before.' Incident hyperglycemia (≥7.0 mmol/L) was significant 'after' PN initiation, and PN recipients experienced delays in WBC (P<0.05) and platelet engraftment (P=0.009), and required significantly greater RBC (P=0.0014) and platelet (P=0.001) support 'after' than non-PN patients. Neutropenic fever and longer hospital stay were more frequent among PN vs non-PN recipients (P<0.001). Differences in 5-year mortality were not apparent. The findings fail to support clinical benefits of PN administration during auto-SCT for myeloma. Further study is needed to discern if hyperglycemia or feeding per se was deleterious in this patient population. PMID:23419432

  13. 49 CFR 225.15 - Accidents/incidents not to be reported.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  14. 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.

  15. Loss of Situation Awareness in Pilots: Analysis of Incident Reports

    NASA Technical Reports Server (NTRS)

    Villeda, Eric B.

    1996-01-01

    Introduction Approximately 75% of all aviation accidents and incidents are attributable to human failures in monitoring, managing, and operating system. Tactical decision errors were found to be a factor in 25 of 37 major US air transport accidents between 1978 and 1990. These two facts demonstrate the inability of some pilots to maintain situation awareness. Situation awareness (SA) is defined as 'the perception of elements in the environment within a volume of time and space, the comprehension of their meaning, and the projection of their status in the near future". Thus, when a pilot loses SA, he or she is unable to ether perceive, comprehend, or project the status of the aircraft. In pilots terms, he or she has 'fallen behind the airplane'. Our study this summer involved an analysis of 190 NASA Aviation Safety Reporting System (ASRS) reports.

  16. Ocular adverse effects after facial cosmetic procedures: a review of case reports.

    PubMed

    Ricci, Lucas H; Navajas, Samia V; Carneiro, Paula R; Söderberg, Stephanie A; Ferraz, Caroline A

    2015-06-01

    To review indexed literature concerning adverse ocular effects of the most common aesthetic facial procedures (light-emitting therapy, dermal fillers injection, and botulinum toxin). Literature search using three online databases - PubMed, SciELO, and Capes - selecting case reports, series of cases and reviews, with no language restriction, published in a period of the last twenty years (1995-2015). After reviewing 48 case reports and most recent reviews, the authors found the most common ocular adverse effects of dermal fillers were related to vascular occlusion; light-emitting therapy was associated with pigmented tissue damage leading to anterior uveitis and iris atrophy, and ptosis presented the higher relative risk associated with botulinum toxin. Even though ocular adverse effects are not very frequent, some of them can lead to permanent ocular dysfunction and visual impairment. Professionals involved in cosmetic procedures should be aware of the risks. PMID:25790150

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

    PubMed Central

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

    2015-01-01

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

  18. 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

  19. 76 FR 57045 - Announcement of Requirements and Registration for “Reporting Device Adverse Events Challenge”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ...Medical devices will play an increasingly large role in the monitoring and collection of patient data with the spread of electronic health records. The United States has a limited system for the post- market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse Events Challenge'' asks multi-disciplinary teams......

  20. 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... experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies... adverse drug experiences that occurred in clinical trials if they were previously submitted as part of...

  1. [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

  2. Insulin Injection Site Dystrophic Calcification with Fat Necrosis: A Case Report of an Uncommon Adverse Effect

    PubMed Central

    Ramdas, Sharad; Ramdas, Anita; Ambroise, Moses

    2014-01-01

    We report a case of an uncommon adverse effect of insulin injection resulting in hard subcutaneous swelling in the lower abdomen of a 47-year-oldfemale with type 1 diabetes. Extensive dystrophic calcification and fat necrosis was revealed on histopathological examination. PMID:25374868

  3. Prospective risk analysis prior to retrospective incident reporting and analysis as a means to enhance incident reporting behaviour: a quasi-experimental field study.

    PubMed

    Kessels-Habraken, Marieke; De Jonge, Jan; Van der Schaaf, Tjerk; Rutte, Christel

    2010-05-01

    Hospitals can apply prospective and retrospective methods to reduce the large number of medical errors. Retrospective methods are used to identify errors after they occur and to facilitate learning. Prospective methods aim to determine, assess and minimise risks before incidents happen. This paper questions whether the order of implementation of those two methods influences the resultant impact on incident reporting behaviour. From November 2007 until June 2008, twelve wards of two Dutch general hospitals participated in a quasi-experimental reversed-treatment non-equivalent control group design. The six units of Hospital 1 first conducted a prospective analysis, after which a sophisticated incident reporting and analysis system was implemented. On the six units of Hospital 2 the two methods were implemented in reverse order. Data from the incident reporting and analysis system and from a questionnaire were used to assess between-hospital differences regarding the number of reported incidents, the spectrum of reported incident types, and the profession of reporters. The results show that carrying out a prospective analysis first can improve incident reporting behaviour in terms of a wider spectrum of reported incident types and a larger proportion of incidents reported by doctors. However, the proposed order does not necessarily yield a larger number of reported incidents. This study fills an important gap in safety management research regarding the order of the implementation of prospective and retrospective methods, and contributes to literature on incident reporting. This research also builds on the network theory of social contagion. The results might indicate that health care employees can disseminate their risk perceptions through communication with their direct colleagues. PMID:20202731

  4. 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

  5. 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

  6. Mixed-effects Poisson regression analysis of adverse event reports: the relationship between antidepressants and suicide.

    PubMed

    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

    2008-05-20

    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. 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

  8. 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. PMID:26798528

  9. 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

  10. 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

  11. 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. PMID:19592912

  12. Medication Incidents Related to Automated Dose Dispensing in Community Pharmacies and Hospitals - A Reporting System Study

    PubMed Central

    Cheung, Ka-Chun; van den Bemt, Patricia M. L. A.; Bouvy, Marcel L.; Wensing, Michel; De Smet, Peter A. G. M.

    2014-01-01

    Introduction Automated dose dispensing (ADD) is being introduced in several countries and the use of this technology is expected to increase as a growing number of elderly people need to manage their medication at home. ADD aims to improve medication safety and treatment adherence, but it may introduce new safety issues. This descriptive study provides insight into the nature and consequences of medication incidents related to ADD, as reported by healthcare professionals in community pharmacies and hospitals. Methods The medication incidents that were submitted to the Dutch Central Medication incidents Registration (CMR) reporting system were selected and characterized independently by two researchers. Main Outcome Measures Person discovering the incident, phase of the medication process in which the incident occurred, immediate cause of the incident, nature of incident from the healthcare provider's perspective, nature of incident from the patient's perspective, and consequent harm to the patient caused by the incident. Results From January 2012 to February 2013 the CMR received 15,113 incidents: 3,685 (24.4%) incidents from community pharmacies and 11,428 (75.6%) incidents from hospitals. Eventually 1 of 50 reported incidents (268/15,113 = 1.8%) were related to ADD; in community pharmacies more incidents (227/3,685 = 6.2%) were related to ADD than in hospitals (41/11,428 = 0.4%). The immediate cause of an incident was often a change in the patient's medicine regimen or relocation. Most reported incidents occurred in two phases: entering the prescription into the pharmacy information system and filling the ADD bag. Conclusion A proportion of incidents was related to ADD and is reported regularly, especially by community pharmacies. In two phases, entering the prescription into the pharmacy information system and filling the ADD bag, most incidents occurred. A change in the patient's medicine regimen or relocation was the immediate causes of an incident

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

    PubMed

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

    2016-01-01

    Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values differed between all reports in the JADER database and those on pregnant women, affecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals [PRR, 159.7; ROR, 669.9; 95% confidence interval (CI), 282.4-1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95%CI, 0.3-15.4). These findings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95%CI, 1.4-3.3). These findings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women. PMID:26935093

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

    ERIC Educational Resources Information Center

    New York State Education Department, 2006

    2006-01-01

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

  15. 30 CFR 585.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 2 2012-07-01 2012-07-01 false What incidents must I report, and when must I report them? 585.831 Section 585.831 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY AND ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Environmental and Safety...

  16. 30 CFR 285.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What incidents must I report, and when must I report them? 285.831 Section 285.831 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Environmental and Safety...

  17. 30 CFR 585.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 2 2014-07-01 2014-07-01 false What incidents must I report, and when must I report them? 585.831 Section 585.831 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY AND ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Environmental and Safety...

  18. 30 CFR 285.831 - What incidents must I report, 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, and when must I report them? 285.831 Section 285.831 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, REGULATION, AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL...

  19. 30 CFR 585.831 - What incidents must I report, and when must I report them?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 2 2013-07-01 2013-07-01 false What incidents must I report, and when must I report them? 585.831 Section 585.831 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY AND ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Environmental and Safety...

  20. A severe dermatologic adverse effect related with gefitinib: case report and review of the literature.

    PubMed

    Li, Yuan-Qing; Sun, Hong; Xue, Dong

    2013-09-01

    Gefitinib, a selective inhibitor of the epidermal growth factor receptor-tyrosine kinase, it's one of the most frequent drug-related adverse effects (AEs) reported in literature is dermatologic AEs. We report, a case of severe cutaneous adverse reactions induced by gefitinib as second-line treatment in a male patient with advanced non-small cell lung cancer after 1 month of treatment. Although tumor shrunk and patient got benefit from the treatment, gefitinib had to be stopped right away. We managed the symptoms of rash with a variety of treatments, including topical ethacridine lactate, antihistamine and so on. After the rash improved, we found his tumor were progress. Then he took gefitinib again without severe skin toxicity or disease progression. We think the development of gefitinib-induced rash may be a sign of effective and administrating it again maybe relieves the degree of rash. PMID:24135241

  1. Non-steroidal anti-inflammatory drugs with adverse psychiatric reactions: five case reports.

    PubMed

    Jiang, H K; Chang, D M

    1999-01-01

    Adverse drug reactions of non-steroidal anti-inflammatory drugs (NSAIDs) are quite prevalent, but there are few reports about possible adverse psychiatric reactions, which may be ignored or underestimated. We describe here five psychiatric outpatients, two with major depressive disorders, one bipolar disorder, one schizophrenic disorder and one anxiety disorder, who were treated with NSAIDs for pain due to rheumatoid arthritis, osteoarthritis or other painful neuromuscular conditions. All five patients developed a moderate to severe depressive state, three patients became obviously paranoid, and four had either thoughts of suicide or an attempt while undergoing co-administration of NSAIDs. The psychiatric symptoms remitted when the NSAIDs were stopped. The depressive and paranoid symptoms returned on seven occasions of re-use or re-challenge with the same or a different type of NSAID in all five patients. When the NSAIDs were stopped again, the patients had another remission of the adverse psychiatric reactions, and eventually recovered to their baseline mental states in clear temporal relationships. The cases presented suggest that NSAIDs can induce or exacerbate idiosyncratic reproducible adverse psychiatric symptoms in certain vulnerable patients, including those with a variety of psychotic or neurotic disorders, and also in elderly persons, but these undesirable side-effects were generally transient and disappeared on withdrawal of the NSAIDs. PMID:10468178

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

    PubMed

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

    2007-05-01

    This study investigated whether self-reported damage, dust, and odors in homes near the World Trade Center (WTC) after September 11, 2001, were related to increased rates of respiratory symptoms among residents and if multiple sources of exposure were associated with greater health risk. We mailed questionnaires to homes within 1.5 km of the WTC site (affected area) and in upper Manhattan (control area). Surveys asked about respiratory symptoms, unplanned medical visits, physician diagnoses, medication use, and conditions in the home after 9/11. Adverse home conditions were associated with new-onset (i.e., began after 9/11) and persistent (i.e., remained 1 year after 9/11) upper and lower respiratory symptoms in the affected area (Cumulative Incidence Ratios [CIRs] 1.20-1.71). Residents reporting longer duration of dust/odors or multiple sources of exposure had greater risk for symptoms compared to those reporting shorter duration and fewer sources. These data suggest that WTC-related contamination in the home after 9/11 was associated with new and persistent respiratory symptoms among residents living near the site. While we cannot eliminate potential biases related to self-reported data, we took strategies to minimize their impact, and the observed effects are biologically plausible. PMID:17530533

  3. 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.

  4. Under-reporting of maternal and perinatal adverse events in New Zealand

    PubMed Central

    Farquhar, Cynthia; Armstrong, Sarah; Kim, Boa; Masson, Vicki; Sadler, Lynn

    2015-01-01

    Objectives To determine the proportion of maternal and perinatal mortality and morbidity cases, identified by the Perinatal and Maternal Mortality Review Committee (PMMRC), that are also reported within the annual serious adverse events (SAEs) reports published by the Health Quality and Safety Commission (HQSC). Setting Nationally collated data from the PMMRC and HQSC, New Zealand. Participants Analysis of maternal and perinatal mortality and morbidity data 2009–2012. Interventions Every SAE report published by the HQSC from 2009 to 2012 was scrutinised for maternal and perinatal cases using the case history provided by district health boards (DHB). Further detail of each case was requested from each DHB to establish whether they had been identified as maternal or perinatal mortalities or morbidities by the PMMRC. Primary outcome measure The proportion of maternal and perinatal mortality and morbidity cases identified by HQSC SAE reports, compared with PMMRC reporting. Results 58 maternal and perinatal SAEs were identified from the SAE reports 2009–2012. Of these, 50 fit under the PMMRC reporting definitions, all of which were also reported by the PMMRC. In the same time frame, the PMMRC captured 536 potentially avoidable maternal and perinatal mortalities and morbidities that fitted the HQSC SAE definition. Fewer than 9% of maternal and perinatal SAEs are captured by the HQSC SAE reporting process. Conclusions The rate of maternal and perinatal adverse event reporting to the HQSC is low and not improving annually, compared with PMMRC reporting of eligible events. This is of concern as these events may not be adequately reviewed locally, and because the SAE report is considered a measure of quality by the DHBs and the HQSC. Currently, the reporting of SAEs to the HQSC cannot be considered a reliable way to monitor or improve the quality of maternity services provided in New Zealand. PMID:26204910

  5. 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

  6. Implementing a template for major incident reporting: experiences from the first year.

    PubMed

    Fattah, Sabina; Rehn, Marius; Wisborg, Torben

    2015-01-01

    Major incidents are resource-demanding situations that require urgent and effective medical management. The possibility to extract learning from them is therefore important. Comparative analysis of information based on uniform data collection from previous incidents may facilitate learning. The Major Incident Reporting Collaborators have developed a template for reporting of the medical pre-hospital response to major incidents. The template is accompanied by an open access webpage ( www.majorincidentreporting.org ) for online reporting and access to published reports. This commentary presents the experiences from the first year of implementing the template including a presentation of the five published reports. PMID:26242290

  7. Biclustering of Adverse Drug Events in FDA’s Spontaneous Reporting System

    PubMed Central

    Harpaz, Rave; Perez, Hector; Chase, Herbert S.; Rabadan, Raul; Hripcsak, George; Friedman, Carol

    2012-01-01

    In this paper we present a new pharmacovigilance data mining technique based on the biclustering paradigm, which is designed to identify drug groups that share a common set of adverse events in FDA’s spontaneous reporting system. A taxonomy of biclusters is developed, revealing that a significant number of bone fide adverse drug event (ADE) biclusters are identified. Statistical tests indicate that it is extremely unlikely that the discovered bicluster structures as well as their content arose by chance. Some of the biclusters classified as indeterminate provide support for previously unrecognized and potentially novel ADEs. In addition, we demonstrate the importance of the proposed methodology to several important aspects of pharmacovigilance such as: providing insight into the etiology of ADEs, facilitating the identification of novel ADEs, suggesting methods and rational for aggregating terminologies, highlighting areas of focus, and as a data exploratory tool. PMID:21191383

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

    PubMed

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

    2010-01-01

    Many adverse drug effects (ADEs) can be attributed to drug interactions. Spontaneous reporting systems (SRS) provide a rich opportunity to detect novel post-marketed drug interaction adverse effects (DIAEs), as they include populations not well represented in clinical trials. However, their identification in SRS is nontrivial. Most existing research have addressed the statistical issues used to test or verify DIAEs, but not their identification as part of a systematic large scale database-wide mining process as discussed in this work. This paper examines the application of a highly optimized and tailored implementation of the Apriori algorithm, as well as methods addressing data quality issues, to the identification of DIAEs in FDAs SRS. PMID:21346985

  9. An Assessment of an Educational Intervention on Resident Physician Attitudes, Knowledge, and Skills Related to Adverse Event Reporting

    PubMed Central

    Jericho, Barbara G.; Tassone, Rosalie F.; Centomani, Nikki M.; Clary, Jennifer; Turner, Crescent; Sikora, Michael; Mayer, David; McDonald, Timothy

    2010-01-01

    Objective Reporting and learning from events linked to patient harm and unsafe conditions is critical to improving patient safety. Programs that engage resident physicians in adverse event reporting can enhance patient safety and simultaneously address all 6 Accreditation Council for Graduate Medical Education competencies. Yet fewer than 60% of physicians know how to report adverse events and near misses, and fewer than 40% know what to report. Our study evaluated the effect of an educational intervention on anesthesiology residents' attitudes, knowledge, and skills related to adverse event reporting and the associated follow-up. Methods In a prospective study, anesthesiology residents participated in a training program focused on the importance of reporting methods and on reporting adverse events for patient safety. Quarterly adverse event reports were analyzed retrospectively for 2 years before the intervention and prospectively for 7 quarters after the intervention. Residents also completed a survey, before and 1 year after the intervention, that evaluated their attitudes, experience, and knowledge regarding adverse event reporting. Results After the intervention, the number of adverse event reports increased from 0 per quarter to almost 30 per quarter. We identified several categories of harm events, near misses, and unsafe conditions, including reports of disruptive providers. Of the harm events associated with invasive procedures, more than half were associated with lack of attending physician supervision. We also observed significant progress in the residents' ability to appropriately file a report, improved attitudes regarding the value of reporting and available emotional support, and a reduction in the perceived impediments to reporting. Conclusions An educational intervention increased the number of adverse event reports submitted by anesthesiology residents, improved their attitudes about the importance of reporting, and produced a source for

  10. 30 CFR 250.190 - Reporting requirements for incidents requiring written notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... written notification. 250.190 Section 250.190 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT... for incidents requiring written 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...

  11. Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting Systems

    PubMed Central

    Perrone, Valentina; Pozzi, Marco; Antoniazzi, Stefania; Clementi, Emilio; Radice, Sonia

    2013-01-01

    Objective To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM) by considering data from different pharmacovigilance surveillance systems. Methods The Vaccine Adverse Event Reporting System (VAERS) database and the EudraVigilance post-authorisation module (EVPM) were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. Results We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. Conclusions This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction. PMID:24147076

  12. Can the vaccine adverse event reporting system be used to increase vaccine acceptance and trust?

    PubMed

    Scherer, Laura D; Shaffer, Victoria A; Patel, Niraj; Zikmund-Fisher, Brian J

    2016-05-01

    Vaccine refusal has an impact on public health, and the human pappillomavirus (HPV) vaccine is particularly underutilized. Research suggests that it may be difficult to change vaccine-related attitudes, and there is currently no good evidence to recommend any particular intervention strategy. One reason for vaccine hesitancy is lack of trust that vaccine harms are adequately documented and reported, yet few communication strategies have explicitly attempted to improve this trust. This study tested the possibility that data from the vaccine adverse event reporting system (VAERS) can be used to increase trust that vaccine harms are adequately researched and that potential harms are disclosed to the public, and thereby improve perceptions of vaccines. In the study, participants were randomly assigned to one of three communication interventions. All participants read the Centers for Disease Control (CDC) vaccine information statement (VIS) for the HPV vaccine. Two other groups were exposed to additional information about VAERS, either summary data or full detailed reports of serious adverse events from 2013. Results showed that the CDC's VIS alone significantly increased perceptions of vaccine benefits and decreased perceived risks. Participants who were also educated about VAERS and given summary data about the serious adverse events displayed more trust in the CDC and greater HPV vaccine acceptance relative to the VIS alone. However, exposure to the detailed VAERS reports significantly reduced trust in the CDC and vaccine acceptance. Hence, general information about the VAERS data slightly increased trust in the CDC and improved vaccine acceptance, but the specific VAERS reports negatively influenced both trust and acceptance. Implications for communicating about vaccines are discussed. PMID:27049120

  13. What are incident reports telling us? A comparative study at two Australian hospitals of medication errors identified at audit, detected by staff and reported to an incident system

    PubMed Central

    Westbrook, Johanna I.; Li, Ling; Lehnbom, Elin C.; Baysari, Melissa T.; Braithwaite, Jeffrey; Burke, Rosemary; Conn, Chris; Day, Richard O.

    2015-01-01

    Objectives To (i) compare medication errors identified at audit and observation with medication incident reports; (ii) identify differences between two hospitals in incident report frequency and medication error rates; (iii) identify prescribing error detection rates by staff. Design Audit of 3291patient records at two hospitals to identify prescribing errors and evidence of their detection by staff. Medication administration errors were identified from a direct observational study of 180 nurses administering 7451 medications. Severity of errors was classified. Those likely to lead to patient harm were categorized as ‘clinically important’. Setting Two major academic teaching hospitals in Sydney, Australia. Main Outcome Measures Rates of medication errors identified from audit and from direct observation were compared with reported medication incident reports. Results A total of 12 567 prescribing errors were identified at audit. Of these 1.2/1000 errors (95% CI: 0.6–1.8) had incident reports. Clinically important prescribing errors (n = 539) were detected by staff at a rate of 218.9/1000 (95% CI: 184.0–253.8), but only 13.0/1000 (95% CI: 3.4–22.5) were reported. 78.1% (n = 421) of clinically important prescribing errors were not detected. A total of 2043 drug administrations (27.4%; 95% CI: 26.4–28.4%) contained ≥1 errors; none had an incident report. Hospital A had a higher frequency of incident reports than Hospital B, but a lower rate of errors at audit. Conclusions Prescribing errors with the potential to cause harm frequently go undetected. Reported incidents do not reflect the profile of medication errors which occur in hospitals or the underlying rates. This demonstrates the inaccuracy of using incident frequency to compare patient risk or quality performance within or across hospitals. New approaches including data mining of electronic clinical information systems are required to support more effective medication error detection and

  14. Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia

    PubMed Central

    Chen, Esa Y. H.; Diug, Basia; Bell, J. Simon; Mc Namara, Kevin P.; Dooley, Michael J.; Kirkpatrick, Carl M.; McNeil, John J.; Caughey, Gillian E.; Ilomäki, Jenni

    2016-01-01

    Objectives: The objective of our study was to describe spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia. Methods: Data were sourced from the Australian Therapeutic Goods Administration (TGA) Database of Adverse Event Notifications between June 2009 and May 2014. Records of haemorrhagic adverse events in which rivaroxaban or dabigatran was considered as a potential cause were analysed. Results: There were 240 haemorrhagic adverse events associated with rivaroxaban and 504 associated with dabigatran. Age was specified for 164 (68%) haemorrhages associated with rivaroxaban, of which 101 occurred in people aged ⩾75 years. Age was specified for 437 (87%) haemorrhages associated with dabigatran, of which 300 occurred in people aged ⩾75 years. Time from treatment initiation to haemorrhage was specified for 122 (51%) haemorrhages associated with rivaroxaban, with 69 (57%) haemorrhages occurring within 30 days of rivaroxaban initiation. Time from treatment initiation to haemorrhage was specified for 253 (50%) haemorrhages associated with dabigatran, with 123 (49%) haemorrhages occurring within 30 days of dabigatran initiation. Gastrointestinal (GI) haemorrhages were the most frequent type of haemorrhages associated with both rivaroxaban (n = 105, 44%) and dabigatran (n = 302, 60%). Data were available on the severity of haemorrhage for 101 (42%) haemorrhages associated with rivaroxaban, with haemorrhage leading to death in 17 people. The severity of haemorrhage was specified for 384 (76%) haemorrhages associated with dabigatran, with haemorrhage leading to death in 61 people. Conclusions: Our study highlights the need for research on the haemorrhagic complications of anticoagulation in clinical care. A considerable proportion of reported haemorrhagic events occurred within 30 days of rivaroxaban and dabigatran initiation. This highlights the importance of considering bleeding risk at the time of treatment

  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. 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

    ... intent to revise six forms under OMB Control Number 2137-0522. These forms include: PHMSA F 7100.1 Incident Report--Gas Distribution System; PHMSA F 7100.1-2 Mechanical Fitting Failure Report Form for Calendar Year 20xx for Distribution Operators; PHMSA F 7100.2 Incident Report-- Natural and Other...

  18. 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

    ...This rule increases the rail equipment accident/incident reporting threshold from $9,500 to $9,900 for certain railroad accidents/incidents involving property damage that occur during calendar year 2013. This action is needed to ensure that FRA's reporting requirements reflect cost increases that have occurred since the reporting threshold was last published in November of...

  19. 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... Incident Report-- Natural and Other Gas Transmission and Gathering Pipeline Systems Form (GTG...

  20. 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

  1. Safety of biologics approved for treating rheumatoid arthritis: analysis of spontaneous reports of adverse events.

    PubMed

    Mendes, Diogo; Alves, Carlos; Batel Marques, Francisco

    2013-08-01

    Despite the effectiveness of biologics approved for the treatment of rheumatoid arthritis, they have been associated with serious adverse events (AEs). Biologics are used under close supervision of health care professionals. In Portugal, they are legally required to report AEs occurring during the treatment. This study aims at investigating post-marketing safety monitoring data of biologics in Portugal by comparing the frequency of spontaneously reported adverse events between 2009 and 2011 with the frequency of such events in the summary of the product characteristics of each biologic. Sales data for biologics were obtained from IMS Health and converted into defined daily doses/1,000 inhabitants/day in order to estimate a proportion of the population treated. The frequency of AEs was estimated as the percentage of patients in which an AE may have occurred. The use of each biologic was estimated for adalimumab at 1,439 patients/year, etanercept 1,944 patients/year, and infliximab 3,211 patients/year. A total of 992 AEs were reported: 207 for adalimumab, 199 for etanercept, and 586 for infliximab. Of the 515 different spontaneously reported AEs, 194 were included for comparisons with the SPCs. Of those, 31 (16 %) were similarly frequent, and 163 (84.0 %) occurred less frequently compared with SPCs' data. These results suggest an insufficient post-marketing safety monitoring of biologics in Portugal. PMID:23604594

  2. Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study

    PubMed Central

    Mirošević Skvrce, Nikica; Macolić Šarinić, Viola; Mucalo, Iva; Krnić, Darko; Božina, Nada; Tomić, Siniša

    2011-01-01

    Aim To analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence. Methods In this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them. Results HALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential drug-drug interactions, 94 of which (7.8% of total reports) were actual drug-drug interactions. Among actual drug-drug interaction reports, the proportion of serious adverse drug reactions (53 out of 94) and the number of drugs (n = 4) was significantly higher (P < 0.001) than among the remaining reports (580 out of 1982; n = 2, respectively). Actual drug-drug interactions most frequently involved nervous system agents (34.0%), and interactions caused by antiplatelet, anticoagulant, and non-steroidal anti-inflammatory drugs were in most cases serious. In only 12 out of 94 reports, actual drug-drug interactions were recognized by the reporter. Conclusion The study confirmed that the Spontaneous Reporting Database was a valuable resource for detecting actual drug-drug interactions. Also, it identified drugs leading to serious adverse drug reactions and deaths, thus indicating the areas which should be in the focus of health care education. PMID:21990078

  3. 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

  4. 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

  5. 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

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

    PubMed

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

    2015-01-01

    The detection of adverse drug events (ADEs) is an important aspect of improving patient safety. The iMedication system employs predefined triggers associated with significant events in a patient's clinical data to automatically detect possible ADEs. We defined four clinically relevant conditions: hyperkalemia, hyponatremia, renal failure, and over-anticoagulation. These are some of the most relevant ADEs in internal medical and geriatric wards. For each patient, ADE risk scores for all four situations are calculated, compared against a threshold, and judged to be monitored, or reported. A ward-based cockpit view summarizes the results. PMID:26262252

  7. 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

  8. 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…

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 77 FR 36008 - Agency Information Collection Activities; Proposed Collection: Cargo Theft Incident Report...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... Incident Report, Revision of a Currently Approved Collection, Comments Requested ACTION: 30-Day notice of... Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the...: Cargo Theft Incident Report. (3) The agency form number, if any, and the applicable component of...

  18. 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...

  19. 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…

  20. 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:...

  1. 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...

  2. 14 CFR 91.1021 - Internal safety reporting and incident/accident response.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 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...

  3. 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...

  4. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 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, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 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...

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

    PubMed Central

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

    2013-01-01

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

  8. Musculoskeletal adverse drug reactions: a review of literature and data from ADR spontaneous reporting databases.

    PubMed

    Conforti, Anita; Chiamulera, Christian; Moretti, Ugo; Colcera, Sonia; Fumagalli, Guido; Leone, Roberto

    2007-01-01

    The musculoskeletal system can be a target organ for adverse drug reactions (ADRs). Drug-induced muscle, bone or connective tissue injuries may be due to, i), primary direct drug action, or, ii), undirected consequence of generalized drug-induced disease. Musculoskeletal ADRs may be only temporarily disabling, such as muscle cramps, as well as in other cases may be serious and life-threatening, such as rhabdomyolysis. In the last few years there has been an increasing awareness of musculoskeletal ADRs. Some recent drug safety issues dealt with serious or uncommon musculoskeletal reactions like rhabdomyolysis associated to statins and tendon rupture associated to fluoroquinolones. In this review, we firstly selected those drug classes having a significantly high percentage of musculoskeletal disorder reports in the WHO adverse drug reaction database, maintained by the Uppsala Monitoring Centre. Secondly, the different musculoskeletal ADRs were closely analyzed through the data obtained from an Italian interregional ADRs spontaneous reporting database. The findings on drugs associated to different musculoskeletal disorders, have been integrated with a review of the epidemiological data available in the literature. For the most involved drugs (HMG-CoA reductase inhibitors, fluoroquinolones, corticosteroids, bisphosphonates, retinoids) the underlying musculoskeletal ADR mechanisms were also reviewed and discussed. PMID:18690950

  9. An educational intervention to improve nurses’ knowledge, attitude, and practice toward reporting of adverse drug reactions

    PubMed Central

    Hanafi, Somayeh; Torkamandi, Hassan; Hayatshahi, Alireza; Gholami, Kheirollah; Shahmirzadi, Nikinaz Ashrafi; Javadi, Mohammad Reza

    2014-01-01

    Background: The reporting of adverse drug reactions (ADRs) by nurses in hospitals is very important. Aims: This study was aimed at investigating the impact of an educational intervention to improve ADR reporting and whether trained nurses had better knowledge, attitude, and practice toward ADR reporting. Materials and Methods: A total of 300 nurses in a tertiary care teaching hospital in Tehran, Iran were evaluated with a knowledge, attitude, and practice (KAP) questionnaire regarding ADR reporting in March 2010. After this, an educational program about ADR was provided to nurses. Then the nurses were re-evaluated by the same questionnaire. Comparisons were made of the attitude and knowledge within nurses, before and after education. Data were analyzed using SPSS software. P < 0.05 was considered as significant level. Independent-sample t-test was used to measure the intervention effect. Results: The response rate was 61.3% (N = 184). Knowledge of nurses before the intervention was significantly less than the knowledge after the intervention (P = 0.001). Also, there was a significant effect on attitude (P = 0.002). During the follow-up period of 4 months after the intervention, 26 spontaneous reports were received. Conclusion: Continuous ADR educational program, training, and integration of ADRs’ reporting into the activities of the nurses would likely improve ADR reporting. PMID:24554968

  10. 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…

  11. 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

  12. 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.

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

    PubMed

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

    2015-10-01

    The epidemiological data are limited for the spontaneous adverse drug reaction (ADR) reporting system in psychiatry and its comparison with intensive monitoring studies in terms of causative drugs, seriousness, preventability and drug interactions. This spontaneous ADR reporting study was carried out over a period of three years in the psychiatry department. We adopted WHO definition for an ADR, Naranjo's algorithm for causality, WHO-ADR terminology for the labeling of involved organ-system, International conference on harmonisation (ICH) E2A guidelines for seriousness, modified Schumock and Thornton's criteria for preventability and Medscape drug interaction checker for drug interactions. Two subgroup analyses were performed to find out the risk factors for the serious and preventable reactions. A total of 97 ADRs from 67 patients were included for analysis. The incidence of 'overall' and 'serious ADRs were 0.69% (95% CI: 0.54%, 0.88%) and 0.18% (95% CI: 0.12-0.29%), respectively. The females experienced more ADRs than males. The most commonly reported ADR, incriminated pharmacology group and drug, were extrapyramidal movement disorders (22.68%), atypical antipsychotics (35.62%) and escitalopram (13.91%), respectively. One out of five and one out three reactions were considered as 'serious' and 'preventable', respectively. The drug interactions contributed in 34.02% reactions. The factors significantly associated with 'serious' reactions were typical antipsychotics [OR: 5.47 (1.68, 17.87)], central and peripheral nervous system disorders [OR: 24.00 (5.12, 112.5)] and extrapyramidal reactions [OR: 14.03 (4.43, 44.43)]. The polypharmacy [OR: 5.85 (1.90, 18.03)] was significantly associated with 'preventable' reactions. The spontaneous reporting system is efficient to detect serious reactions and preventable reactions. PMID:26216702

  14. 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.

  15. [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

  16. Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia

    PubMed Central

    Mahmoud, Mansour Adam; Alswaida, Yazeed; Alshammari, Thamir; Khan, Tahir Mehmood; Alrasheedy, Alian; Hassali, Mohamad Azmi; Aljadhey, Hisham

    2013-01-01

    Objective To assess community pharmacists’ knowledge, behaviors and experiences relating to Adverse Drug Reaction (ADR) reporting in Saudi Arabia. Methods A cross-sectional study was conducted using a validated self-administered questionnaire. A convenience sample of 147 community pharmacists working in community pharmacies in Riyadh, Saudi Arabia. Results The questionnaire was distributed to 147 pharmacists, of whom 104 responded to the survey, a 70.7% response rate. The mean age of participants was 29 years. The majority (n = 101, 98.1%) had graduated with a bachelorette degree and worked in chain pharmacies (n = 68, 66.7%). Only 23 (22.1%) said they were familiar with the ADR reporting process, and only 21 (20.2%) knew that pharmacists can submit ADR reports online. The majority of the participants (n = 90, 86.5%) had never reported ADRs. Reasons for not reporting ADRs most importantly included lack of awareness about the method of reporting (n = 22, 45.9%), misconception that reporting ADRs is the duty of physician and hospital pharmacist (n = 8, 16.6%) and ADRs in community pharmacies are simple and should not be reported (n = 8, 16.6%). The most common approach perceived by community pharmacists for managing patients suffering from ADRs was to refer him/her to a physician (n = 80, 76.9%). Conclusion The majority of community pharmacists in Riyadh have poor knowledge of the ADR reporting process. Pharmacovigilance authorities should take necessary steps to urgently design interventional programs in order to increase the knowledge and awareness of pharmacists regarding the ADR reporting process. PMID:25473329

  17. Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting

    PubMed Central

    Hanafi, Somayeh; Torkamandi, Hassan; Hayatshahi, Alireza; Gholami, Kheirollah; Javadi, Mohammadreza

    2012-01-01

    Background: Adverse drug reactions (ADR) are ranked as some of the major causes of patient morbidity and mortality. Spontaneous reporting of ADRs has remained the cornerstone of pharmacovigilance and is important in maintaining patient safety. This study was conducted to assess the nurses’ knowledge and attitude towards pharmacovigilance, reasons for not reporting ADRs, and their pharmacovigilance practice. Materials and Methods: A questionnaire was prepared to investigate knowledge, attitude and practice (KAP) of nurses regarding ADR reporting. In November 2009, the questionnaires were given to 500 nurses of a teaching hospital in Tehran. Findings: Knowledge and practice of participants were not satisfying; however, their attitude towards pharmacovigilance was at a high level. About 91% of the nurses had never reported an ADR. Most nurses liked to report the ADRs to the physicians (87.1%) and pharmacists in hospital's ADR center (1.8%) rather than the ADR National Center. The main cause of under-reporting of the suspected ADRs was unawareness about the existence of such a national center. Among nurses who had reported ADR for at least once, the majority preferred using phone (10 out of 50) or Yellow Cards (7 out of 50). Only 1 person out of 50 preferred using internet for submitting the reports Conclusions: Since the nurses in this study had little knowledge and poor practice regarding the pharmacovigilance and spontaneous reporting system, interventions such as holding pharmacovigilance workshops in the hospitals focusing on the aims of pharmacovigilance, completing the Yellow Card and clarifying the reporting criteria are strongly recommended. PMID:23492864

  18. 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

  19. 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

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

    PubMed

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

    2015-04-01

    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. PMID:26077519

  1. 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…

  2. 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

  3. 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

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

    PubMed Central

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

    2012-01-01

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

  5. 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

  6. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation.

    PubMed

    Brunoni, Andre Russowsky; Amadera, Joao; Berbel, Bruna; Volz, Magdalena Sarah; Rizzerio, Brenno Gomes; Fregni, Felipe

    2011-09-01

    Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation that has been intensively investigated in clinical and cognitive neuroscience. Although the general impression is that tDCS is a safe technique with mild and transient adverse effects (AEs), human data on safety and tolerability are largely provided from single-session studies in healthy volunteers. In addition the frequency of AEs and its relationship with clinical variables is unknown. With the aim of assessing tDCS safety in different conditions and study designs, we performed a systematic review and meta-analysis of tDCS clinical trials. We assessed Medline and other databases and reference lists from retrieved articles, searching for articles from 1998 (first trial with contemporary tDCS parameters) to August 2010. Animal studies, review articles and studies assessing other neuromodulatory techniques were excluded. According to our eligibility criteria, 209 studies (from 172 articles) were identified. One hundred and seventeen studies (56%) mentioned AEs in the report. Of these studies, 74 (63%) reported at least one AE and only eight studies quantified AEs systematically. In the subsample reporting AEs, the most common were, for active vs. sham tDCS group, itching (39.3% vs. 32.9%, p>0.05), tingling (22.2% vs. 18.3%, p>0.05), headache (14.8% vs. 16.2%, p>0.05), burning sensation (8.7% vs. 10%, p>0.05) and discomfort (10.4% vs. 13.4%, p>0.05). Meta-analytical techniques could be applied in only eight studies for itching, but no definite results could be obtained due to between-study heterogeneity and low number of studies. Our results suggested that some AEs such as itching and tingling were more frequent in the tDCS active group, although this was not statistically significant. Although results suggest that tDCS is associated with mild AEs only, we identified a selective reporting bias for reporting, assessing and publishing AEs of tDCS that hinders further

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

    PubMed Central

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

    2014-01-01

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

  8. Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

    PubMed Central

    Cope, Judith U.; Reaman, Gregory H.; Tonning, Joseph M.

    2015-01-01

    Background. Ewing sarcoma family of tumors (ESFT) are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS) was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT. PMID:26064078

  9. 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

  10. 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)

  11. 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...

  12. 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

  13. 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. PMID:25078411

  14. 46 CFR 148.115 - Report of incidents.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... by this part must also be reported as required under 49 CFR 171.15, if applicable. A copy of the written report required under 49 CFR 171.16 must also be sent to the Commandant (CG-ENG-5), Attn: Hazardous Materials Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE.,...

  15. 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

  16. Discordance between patient and clinician report of multidrug-resistant tuberculosis adverse drug reactions

    PubMed Central

    Kelly, A. M.; Smith, B.; Luo, Z.; Given, B.; Wehrwein, T.; Master, I.; Farley, J. E.

    2016-01-01

    Summary Setting An urban outpatient clinic in Durban, South Africa providing community-based treatment for drug-resistant TB. Objective Describe concordance between patient report and clinician documentation of adverse drug reactions (ADRs) from multidrug-resistant tuberculosis (MDR-TB) treatment. Design ADRs were documented by interview using an 18-item symptom checklist and medical record data abstraction during cross-sectional parent study with 121 MDR-TB patients, 75% co-infected with HIV. Concordance was analyzed using Cohen’s kappa statistic, Gwet’s AC1, and McNemar’s test. Results ADRs were reported much more frequently in the patient interviews (μ = 8.6) compared to medical records (μ = 1.4). Insomnia was most common (67 vs. 2%), followed by peripheral neuropathy (65 vs. 18%), and confusion (61 vs. 4%). Kappa scores were very low, with the highest degree of concordance found in hearing loss (kappa = 0.23), which was the only ADR not found to be significantly different between the two data sources (p = 0.34). Conclusions Our study showed a lack of concordance between patient report and clinician documentation of ADRs. These findings indicate the need for improved documentation of ADRs to better reflect the patient experience during MDR-TB treatment. These data have important implications for country-level pharmacovigilance programs that rely on clinician documentation of ADRs for MDR-TB policy formation. PMID:26970151

  17. 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

  18. 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.

  19. 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

  20. 29 CFR 1904.39 - Reporting fatalities and multiple hospitalization incidents to OSHA.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  1. 29 CFR 1904.39 - Reporting fatalities and multiple hospitalization incidents to OSHA.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  2. 28 CFR 541.7 - Unit Discipline Committee (UDC) review of the incident report.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., 28 CFR part 542, subpart B. ... the incident report. 541.7 Section 541.7 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT INMATE DISCIPLINE AND SPECIAL HOUSING UNITS Inmate Discipline...

  3. 30 CFR 250.187 - What are MMS' incident reporting requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... CFR 254.46. ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What are MMS' incident reporting requirements? 250.187 Section 250.187 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Consumer Protection Division a report on any incidents involving the loss, injury, or death of an animal... of transportation, is being kept as a pet in a family household in the United States....

  5. 14 CFR 234.13 - Reports by air carriers on incidents involving animals during air transport.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Consumer Protection Division a report on any incidents involving the loss, injury, or death of an animal... of transportation, is being kept as a pet in a family household in the United States....

  6. 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.

  7. 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

  8. Spontaneous Reporting of Adverse Drug Reactions through Electronic Submission from Regional Society Healthcare Professionals in Korea

    PubMed Central

    Lee, Jae-Hyun; Park, Kyung Hee; Moon, Hyun Joo; Lee, Yong Won; Park, Jung-Won

    2012-01-01

    Purpose Pharmacovigilance Research Network built a spontaneous reporting system and collected adverse drug reactions (ADRs) by electronic submission (e-sub) in Korea. We analyzed ADRs spontaneously reported through e-sub from regional health professionals. Materials and Methods Nine hundred and thirty three ADR cases were collected and analyzed from January to December in 2008. "A matter" was defined as one symptom matched to one culprit drug included in an ADR case. We collected and analyzed e-sub ADR cases and matters to determine common culprits and organ specified ADR matters. Results There were 3,049 matters in 933 ADR cases for 1 year, and 3.3 matters per case were reported. In organ specific ADR classification, skin reactions which took the first place in 866 matters (28%) included urticaria and rash. The next cases were neurologic symptom (624 matters, 21%) and gastrointestinal symptom (581 matters, 19%). Doctor (53%) and pharmacist (31%) were the most important participants in e-sub spontaneous reporting system, and 3% of ADR cases were reported by patients or their guardians. WHO-Uppsala Monitoring Center causality assessment results showed certain 10.6%, probable 37.7%, possible 41.7% and below unlikely 10.0%. Culprit drugs were antibiotics (23.4%), neurologic agents (14.7%) and non-steroidal anti-inflammatory drugs (9.4%). Conclusion In our study, antibiotic was most common culprit drug, and skin manifestation was most common symptom in e-sub ADRs collected from regional healthcare practitioners in Korea. PMID:22869488

  9. 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. PMID:17917200

  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 ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.19 Are...

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

    ERIC Educational Resources Information Center

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

    2012-01-01

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

  12. An adverse interaction between warfarin and capecitabine: a case report and review of the literature.

    PubMed

    Copur, M S; Ledakis, P; Bolton, M; Morse, A K; Werner, T; Norvell, M; Muhvic, J; Chu, E

    2001-11-01

    Warfarin is one of the most commonly used oral anticoagulants in the clinic. It is well established that a wide range of antineoplastic drugs interact with warfarin, resulting in altered coagulation parameters and/or bleeding sequelae. While altered coagulation parameters have been observed in patients taking the oral 5-fluorouracil prodrug, capecitabine, in combination with warfarin, no report to date has described clinically overt evidence of bleeding. Herein, we report 2 cancer patients who presented with bleeding episodes that most likely resulted from an adverse interaction between capecitabine and warfarin after 6 weeks of concomitant therapy. In each case, there was a marked elevation in both the prothrombin time and international normalized ratio (> 10), with subsequent gastrointestinal bleeding. The exact mechanism of this interaction is yet unknown, but it is possible that capecitabine might, in some manner, reduce the hepatic metabolism of warfarin. Close monitoring of coagulation parameters is recommended for all patients receiving concomitant warfarin and capecitabine, with appropriate adjustment of warfarin dosage. The nature and extent of this interaction requires further investigation. PMID:12450435

  13. 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

  14. Adverse drug events resulting from use of drugs with sulphonamide-containing anti-malarials and artemisinin-based ingredients: findings on incidence and household costs from three districts with routine demographic surveillance systems in rural Tanzania

    PubMed Central

    2013-01-01

    Background Anti-malarial regimens containing sulphonamide or artemisinin ingredients are widely used in malaria-endemic countries. However, evidence of the incidence of adverse drug reactions (ADR) to these drugs is limited, especially in Africa, and there is a complete absence of information on the economic burden such ADR place on patients. This study aimed to document ADR incidence and associated household costs in three high malaria transmission districts in rural Tanzania covered by demographic surveillance systems. Methods Active and passive surveillance methods were used to identify ADR from sulphadoxine-pyrimethamine (SP) and artemisinin (AS) use. ADR were identified by trained clinicians at health facilities (passive surveillance) and through cross-sectional household surveys (active surveillance). Potential cases were followed up at home, where a complete history and physical examination was undertaken, and household cost data collected. Patients were classified as having ‘possible’ or ‘probable’ ADR by a physician. Results A total of 95 suspected ADR were identified during a two-year period, of which 79 were traced, and 67 reported use of SP and/or AS prior to ADR onset. Thirty-four cases were classified as ‘probable’ and 33 as ‘possible’ ADRs. Most (53) cases were associated with SP monotherapy, 13 with the AS/SP combination (available in one of the two areas only), and one with AS monotherapy. Annual ADR incidence per 100,000 exposures was estimated based on ‘probable’ ADR only at 5.6 for AS/SP in combination, and 25.0 and 11.6 for SP monotherapy. Median ADR treatment costs per episode ranged from US$2.23 for those making a single provider visit to US$146.93 for patients with four visits. Seventy-three per cent of patients used out-of-pocket funds or sold part of their farm harvests to pay for treatment, and 19% borrowed money. Conclusion Both passive and active surveillance methods proved feasible methods for anti-malarial ADR

  15. 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...

  16. 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... Published reports and material contained in the public incident investigation dockets. (a) Demands for published investigation reports should be directed to the Office of Congressional and Public Affairs,...

  17. Effectiveness and Sustainability of Education about Incident Reporting at a University Hospital in Japan

    PubMed Central

    Yamashita, Yuichi; Tanihara, Shinichi; Maeda, Chiemi

    2014-01-01

    Objectives The aim of this study was to evaluate the effectiveness and sustainability of educational interventions to encourage incident reporting. Methods This was a quasi-experimental design. The study involved nurses working in two gastroenterology surgical wards at Fukuoka University Hospital, Japan. The number of participants on each ward was 26 nurses at baseline. For the intervention group, we provided 15 minutes of education about patient safety and the importance of incident reporting once per month for six months. After the completion of the intervention, we compared incident reporting in the subsequent 12 months for both groups. Questionnaires about reasons/motives for reporting were administered three times, before the intervention, after the intervention, and six months after the intervention for both the intervention group and the control group. Results For the intervention group, incident reporting during the 6 months after the intervention period increased significantly compared with the baseline. During the same period, the reasons and motives for reporting changed significantly in the intervention group. The increase in reported incidents during the 6- to 12-month period following the intervention was not significant. In the control group, there was no significant difference during follow-up compared with the baseline. Conclusions A brief intervention about patient safety changed the motives for reporting incidents and the frequency of incidents reported by nurses working in surgical wards in a university hospital in Japan. However, the effect of the education decreased after six months following the education. Regular and long-term effort is required to maintain the effect of education. PMID:25152834

  18. 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

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

    NASA Technical Reports Server (NTRS)

    Reynard, W. D.

    1983-01-01

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

  20. 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

  1. 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

  2. 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

    ... events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING... reporting codes for adverse events that I use with medical device reports? (a) The MEDWATCH Medical...

  3. 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

    ... events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING... reporting codes for adverse events that I use with medical device reports? (a) The MEDWATCH Medical...

  4. 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

    ... events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING... Where can I find the reporting codes for adverse events that I use with medical device reports? (a)...

  5. 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

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

    PubMed

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

    2016-01-01

    The Japanese Ministry of Health, Labor, and Welfare lists hand-foot syndrome as a serious adverse drug event. Therefore, we evaluated its association with anticancer drug therapy using case reports in the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In addition, we calculated the reporting odds ratio (ROR) of anticancer drugs potentially associated with hand-foot syndrome, and applied the Weibull shape parameter to time-to-event data from JADER. We found that JADER contained 338224 reports from April 2004 to November 2014, while FAERS contained 5821354 reports from January 2004 to June 2014. In JADER, the RORs [95% confidence interval (CI)] of hand-foot syndrome for capecitabine, tegafur-gimeracil-oteracil, fluorouracil, sorafenib, and regorafenib were 63.60 (95%CI, 56.19-71.99), 1.30 (95%CI, 0.89-1.89), 0.48 (95%CI, 0.30-0.77), 26.10 (95%CI, 22.86-29.80), and 133.27 (95%CI, 112.85-157.39), respectively. Adverse event symptoms of hand-foot syndrome were observed with most anticancer drugs, which carry warnings of the propensity to cause these effects in their drug information literature. The time-to-event analysis using the Weibull shape parameter revealed differences in the time-dependency of the adverse events of each drug. Therefore, anticancer drugs should be used carefully in clinical practice, and patients may require careful monitoring for symptoms of hand-foot syndrome. PMID:26935094

  7. 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

  8. 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

  9. Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria

    PubMed Central

    Agu, Kenneth A.; Oparah, Azuka C.

    2013-01-01

    Aim: This study evaluated the suspected adverse drug reactions (ADR) reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV) positive patients receiving antiretroviral therapy (ART) in Nigeria Materials and Methods: This descriptive study analyzed individual case safety reports (ICSRs) in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval. Results: From 1237 ICSRs collated, only 1119 (90.5%) were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1–35.5) years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD) of 1.5 (± 0.8) ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0%) peripheral neuropathy, (11.4%) skin rash, (10.1%) pruritus and (6.5%) dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05) unlike gender. Anaemia was associated with Zidovudine (AZT)/ Lamivudine (3TC) /Nevirapine (NEV) regimen [Odds ratio, OR = 6.4 (3.0–13.8); P < 0.0001], and peripheral neuropathy with Stavudine (d4T)/3TC/NEV regimen [OR = 8.7 (5.8–30.0), P < 0.0001] and Tenofovir (TDF)/Emtricitabine (FTC)/Efavirenz (EFV) regimen [OR = 2.1 (1.0–4.1), P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3–6.6), P = 0.0056] and 45–59years [OR = 1.9 (1.3–2.7), P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9–349.6), P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS) [OR = 50.2 (0.9–562.1), P = 0.0040] respectively. Conclusion: ADRs were less likely to occur in patients on stavudine-based and tenofovir

  10. 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.

  11. Frequency of reporting of adverse events in randomized controlled trials of psychotherapy vs. psychopharmacotherapy

    PubMed Central

    Vaughan, Barney; Goldstein, Michael H.; Alikakos, Maria; Cohen, Lisa J.; Serby, Michael J.

    2015-01-01

    Background Psychopharmacology and psychotherapy are the two main therapies in mental health. It is common practice to consider adverse events (AEs) of medications, but it’s not clear this occurs with psychotherapy. Aim This study investigates the frequency with which reports of AEs occur in clinical trials using either psychopharmacology alone, psychotherapy alone, or combined approaches. Methods Forty-five articles of randomized trials published in high-impact journals were chosen from a Medline search, and separated into three groups of 15 articles: pharmacotherapy alone (M), psychotherapy alone (T) and combined studies that looked at the effect of both a psychotherapeutic (CT) and psychopharmacologic (CM) intervention. Criteria for what defines an AE were established and the papers were rated for mentions of AEs in papers as a whole and by each section. Results The χ2-analysis of AE mentions showed significant differences between the four study conditions in terms of each paper as a whole (χ2: 10.1, p < 0.018), and by section. Medication (M + CM) and psychotherapy papers (T + CT) were then combined into two groups to compare the odds that one was more likely to mention AEs than the other. Bivariate logistic regression yielded statistically significant odds ratios ranging from 9.33 to 20.99, with medications being far more likely to mention AEs. Conclusion We believe the difference in reports of AEs mirrors the attitudes researchers and providers. It’s critical to consider, and standardize the definition of, AEs in psychotherapy, and imperative to identify and address potential AEs in psychotherapy research. PMID:24630200

  12. Incident reporting by acute pain service at a tertiary care university hospital

    PubMed Central

    Ahmed, Aliya; Yasir, Muhammad

    2015-01-01

    Background and Aims: Provision of effective and safe postoperative pain management is the principal responsibility of acute pain services (APSs). Continuous quality assurance is essential for high-quality patient care. We initiated anonymous reporting of critical incidents by APS to ensure continuous quality improvement and here present prospectively collected data on the reported incidents. Our objective was to analyze the frequency and nature of incidents and to see if any harm was caused to patients. Material and Methods: Data were collected from January 1, 2012 to September 30, 2013. An incident related to pain management was defined as An incident that occurs in a patient receiving pain management supervised by APS, and causes or has the potential to cause harm or affects patient safety. A form was filled including incident type, personnel involved, any harm caused, and steps taken to rectify it. Frequencies and percentages were computed for categorical variables. Results: A total of 2042 patients were seen and 442 (21.64%) incidents reported during the study period, including documentation errors (136/31%), noncompliance with protocols (113/25.56%), wrong combination of drugs (56/12.66%), premature discontinuation (74/16.72%), prolonged delays in change of syringes (27/6.10%), loss to follow-up (19/4.29%), administration of contraindicated drugs (9/2.03%), catheter pull-outs (6/1.35%), and faulty equipment (2/0.45%). Steps were taken to rectify the errors accordingly. No harm was caused to any patient. Conclusion: Reporting of untoward incidents and their regular analysis by APS is recommended to ensure high-quality patient care and to provide guidance in making teaching strategies and guidelines to improve patient safety. PMID:26702208

  13. 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. PMID:20959726

  14. Identification of risk factors for carbamazepine-induced serious mucocutaneous adverse reactions: A case-control study using data from spontaneous adverse drug reaction reports

    PubMed Central

    Bertulyte, Ilma; Schwan, Sofie; Hallberg, Pär

    2014-01-01

    Objectives: To identify risk factors other than genetic for severe carbamazepine-induced mucocutaneous reactions, that is, SJS, TEN, and exfoliative dermatitis (ED). Materials and Methods: We did a case-control study using data from the Swedish national database of spontaneously reported adverse drug reactions (ADRs). We selected all patients who had been reported from January 1, 1965 to March 31, 2010 as having experienced SJS (n = 78), TEN (n = 6), or ED (n = 8), and assessed as at least possibly related to carbamazepine. We also included diagnoses possibly representative of early signs of these serious conditions, that is, erythema multiforme (EM, n = 34) and scaly rash (n = 13). We compared data on demographics, drug treatment, and clinical features for these patients (cases, n = 139) with those from patients who had experienced any other type of ADR from carbamazepine during the same time period (controls, n = 887). Results: After adjustment for multiple comparisons, alcohol abuse was statistically significantly more common among cases than controls (34.5% vs 8.7%, odds ratio 5.5 [95% confidence interval 3.6-8.4], P = 3.14 × 10-14 ). The same was seen for SJS and EM individually. Conclusion: Alcohol abuse is a possible risk factor for serious carbamazepine-induced mucocutaneous reactions. PMID:24799813

  15. [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

  16. 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...

  17. 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

  18. 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... General Provisions § 803.19 Are there exemptions, variances, or alternative forms of adverse event... facility, you may request an exemption or variance from any or all of the reporting requirements in...

  19. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  20. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  1. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  2. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  3. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  4. 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…

  5. 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

  6. 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

  7. 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

  8. 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…

  9. Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies?

    PubMed Central

    Golder, Su; Loke, Yoon K

    2008-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECTIndustry-funded studies tend to emphasize favourable beneficial effects of the sponsor's product, but we do not know if reports of adverse effects are downplayed.Pharmaceutical companies are required to collate and accurately report adverse effects data in order to fulfil regulatory requirements. WHAT THIS STUDY ADDSThe bias found in the studies looking at the association between industry funding and reporting of beneficial effects may not be as prominent when considering adverse effects data.Industry-funded studies do not appear to differ from non-industry-funded studies in reporting the raw adverse effects data, but the interpretation and conclusions may be slanted to favour the sponsor's product.Readers of industry-funded studies should critically examine the raw safety data themselves rather than be swayed by the authors’ interpretation. AIM To investigate whether adverse effects data for the sponsor's product are presented more favourably in pharmaceutical industry-funded studies than in non-industry-funded studies. METHODS We conducted a systematic review of methodological evaluations that had assessed the relationship between industry funding and the reported risk of adverse effects. Searches were undertaken in 10 databases and supplemented with other sources of information such as handsearching, citation searching, checking conference proceedings and discussion with experts. Two reviewers independently screened the records and carried out data extraction for potentially relevant papers. We included studies that compared the results and interpretation of the adverse effects data according to funding source (e.g. adverse effects data in pharmaceutical industry research vs. data from nonprofit organizations, or from one manufacturer vs. another). Methodological evaluations were excluded if categories of funding source were not explicitly specified by the researchers, and if we were uncertain that industry

  10. 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

  11. 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

  12. Adverse events temporally associated with meningococcal vaccines.

    PubMed Central

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

    1996-01-01

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

  13. Problem of small numbers in reporting of cancer incidence and mortality rates in Indian cancer registries.

    PubMed

    Takiar, Ramnath; Nadayil, Deenu; Nandakumar, A

    2009-01-01

    The present paper examines the problem of small numbers (<20 cases) associated with many sites of cancers in Indian cancer registries. The cancer incidence data of 14 Population Based Cancer Registries for the periods of 2001-03 and 2004-05 were utilized for the analysis. Nine out of 14 registries had more than 50% of their sites being associated with small numbers while seven registries had 50% of their sites having as low as 5 cases. Sites associated with small numbers showed a lot of variation and significant differences in their incidence rates within two years duration which are not feasible. The percentage age distribution was also found to vary with different periods. The paper has effectively shown the effect of population size on incidence rates. For a registry of population size 300,000, the incidence rate of 6 can very well be unstable. There are many registries in the world with their population size less than 200,000. Even in the case of registries with high population (>or= 500,000) the practice is to report the cancer incidence by different ethnic groups with populations less than 200,000 and thereby introduce the problem of small numbers in reporting the incidences of various cancer sites. To overcome this problem, pooling of data over broad age groups or ten years age groups or 3 to 5 years periods is one immediate solution. PMID:19827889

  14. Pharmacovigilance Analysis of Serious Adverse Events Reported for Biologic Response Modifiers Used as Prophylaxis against Transplant Rejection: a Real-World Postmarketing Experience from the US FDA Adverse Event Reporting System (FAERS)

    PubMed Central

    Ali, A. K.

    2013-01-01

    Background: Immunosuppression by biologic response modifiers (BRM) is a crucial component for successful organ transplantation. In addition to their variable effectiveness in the prevention of organ rejection, these medications have safety concerns that complicate therapeutic outcomes in organ transplant patients. Objective: This study aims at identifying and characterizing safety signals of serious adverse events associated with exposure to BRM among organ transplant patients in a real-world environment. Methods: The FDA Adverse Event Reporting System was utilized to apply a pharmacovigilance disproportionality analysis to indentify serious adverse events. Associations between drugs and events were measured by empirical Bayes geometric mean (EBGM) and the corresponding 95% confidence intervals (EB05–EB95). Associations with EBGM≥2 were considered significant safety signals. Results: From 1997 to 2012, a total of 12,151 serious adverse event reports for BRM were reported; 15.6% of them (n=1,711) met the safety signal threshold of EB05>1, and 11.6% of these signals (n=199) were significant (EBGM≥2). Sirolimus and mycophenolate accounted for the majority of all signals; antithymocyte immunoglobulin (ATI) and cyclosporine contributed to the majority of significant signals. The following significant signals were identified for ATI (reduced therapeutic response, pulmonary edema, hypotension, serum sickness, infusion-related reaction, and anaphylactic reaction); for azathioprine (alternaria infection, fungal skin infection, and lymphoproliferative disorder); for cyclosporine (neurotoxicity, graft vs. host disease, and thyroid cancer); for cyclophosphamide (disease progression); for daclizumab (cytomegalovirus infection); and for tacrolimus (coma and tremor). 33.6% of these events contributed to patient death (n=67); 6.5% were life-threatening (n=13); 32.1% lead to hospitalization (n=64); and 27.6% resulted in other serious outcomes (n=55). Conclusion: Utilization

  15. 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

  16. 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. PMID:26971992

  17. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  18. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed

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

    2016-04-01

    Acute injuries in sport are still a problem where limited knowledge of incidence and severity in different sports at national level exists. In Sweden, 80% of the sports federations have their mandatory injury insurance for all athletes in the same insurance company and injury data are systematically kept in a national database. The aim of the study was to identify high-risk sports with respect to incidence of acute and severe injuries in 35 sports reported to the database. The number and incidences of injuries as well as injuries leading to permanent medical impairment (PMI) were calculated during 2008-2011. Each year approximately 12,000 injuries and 1,162,660 licensed athletes were eligible for analysis. Eighty-five percent of the injuries were reported in football, ice hockey, floorball, and handball. The highest injury incidence as well as PMI was in motorcycle, handball, skating, and ice hockey. Females had higher risk of a PMI compared with males in automobile sport, handball, floorball, and football. High-risk sports with numerous injuries and high incidence of PMI injuries were motorcycle, handball, ice hockey, football, floorball, and automobile sports. Thus, these sports ought to be the target of preventive actions at national level. PMID:25850826

  20. Preparation of Personnel for Service to Low-Incidence Disability Populations: Final Report.

    ERIC Educational Resources Information Center

    Engleman, Melissa Darrow; Maddox, June I.

    This final report describes the federally-funded Transition Challenge-North Carolina Project (TRAC-NC), a project that prepared 45 newly qualified individuals to serve students with low-incidence disabilities over the last four years. The project provides: (1) add-on certification and/or master's degree training to persons preparing to teach…

  1. 41 CFR 102-33.450 - How must we report accident and incident data?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false How must we report accident and incident data? 102-33.450 Section 102-33.450 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 33-MANAGEMENT OF GOVERNMENT AIRCRAFT...

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false What accident and incident data must we report? 102-33.445 Section 102-33.445 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 33-MANAGEMENT OF GOVERNMENT AIRCRAFT...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false What accident and incident data must we report? 102-33.445 Section 102-33.445 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 33-MANAGEMENT OF GOVERNMENT AIRCRAFT...

  4. 41 CFR 102-33.450 - How must we report accident and incident data?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false How must we report accident and incident data? 102-33.450 Section 102-33.450 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 33-MANAGEMENT OF GOVERNMENT AIRCRAFT...

  5. 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....

  6. Reported and Actual Incidence of Asthma in Teenage Athletes: A Dangerous Discrepancy

    ERIC Educational Resources Information Center

    Swenson, Ruth; Stewart, Craig

    2004-01-01

    Asthma in athletes is a serious concern for coaches, trainers and athletic directors because of its threat to general health and its apparent continued increase in individuals of all ages. Of special concern is the discrepancy between the reported incidence and the actual occurrence of asthma in athletes. The purpose of this study was to continue…

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-MANAGEMENT OF GOVERNMENT AIRCRAFT Reporting Information on Government Aircraft Accident and Incident Data... Street, NW., Washington, DC 20405. Common Aviation Management Information Standard (C-AMIS) ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false How must we...

  8. 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…

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... liquid pollutants in accordance with 30 CFR 254.46. ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false What are MMS' incident reporting requirements? 250.187 Section 250.187 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, REGULATION,...

  10. 41 CFR 102-33.445 - What accident and incident data must we report?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  11. 30 CFR 285.830 - What are my incident reporting requirements?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... liquid pollutants in accordance with 30 CFR 254.46. ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false What are my incident reporting requirements? 285.830 Section 285.830 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, REGULATION,...

  12. 30 CFR 285.832 - How do I report incidents requiring immediate notification?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... notification? 285.832 Section 285.832 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, REGULATION, AND... OUTER CONTINENTAL SHELF 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...

  13. 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...

  14. 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

  15. [Apply association rules to analysis adverse drug reactions of shuxuening injection based on spontaneous reporting system data].

    PubMed

    Yang, Wei; Xie, Yan-Ming; Xiang, Yong-Yang

    2014-09-01

    This research based on the analysis of spontaneous reporting system (SRS) data which the 9 601 case reports of Shuxuening injection adverse drug reactions (ADR) in national adverse drug reaction monitoring center during 2005-2012. Apply to the association rules to analysis of the relationship between Shuxuening injection's ADR and the characteristics of ADR reports were. We found that ADR commonly combination were "nausea + breath + chills + vomiting", "nausea + chills + vomiting + palpitations", and their confidence level were 100%. The ADR and the case reports information commonly combination were "itching, and glucose and sodium chloride Injection, and generally ADR report, and normal dosage", "palpitation, and glucose and sodium chloride injection, and normal dosage, and new report", "chills, and generally ADR report, and normal dosage, and 0.9% sodium chloride injection", and their confidence level were 100% too. The results showed that patients using Shuxuening injection occurred most of ADRs were systemic damage, skin and its accessories damage, digestive system damage, etc. And most of cases were generally and new reports, and patients with normal dosage. The ADR's occurred had little related with solvent. It is showed that the Shuxuening injection occurred of ADR mainly related to drug composition. So Shuxuening injection used in clinical need to closely observation, and focus on the ADR reaction, and to do a good job of drug risk management. PMID:25532406

  16. Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002.

    PubMed

    Begier, Elizabeth M; Burwen, Dale R; Haber, Penina; Ball, Robert

    2004-03-15

    Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis. PMID:14999618

  17. The pattern and risk factors associated with adverse drug reactions induced by Reteplase in patients with acute ST-elevation myocardial infarction: The first report from Iranian population

    PubMed Central

    Aslanabadi, Naser; Safaie, Naser; Shadfar, Faezeh; Taban-Sadeghi, Mohammad Reza; Feizpour, Hossein; Mashayekhi, Simin Ozar; Hamishehkar, Hadi; Aghdam, Naser Khezerlou; Dousti, Samaneh; Namdar, Hossein; Entezari-Maleki, Taher

    2015-01-01

    Objective: Acute myocardial infarction (AMI) is one of the main leading causes of mortality and morbidity. Reteplase is a fibrin-specific thrombolytic which is used in the treatment of AMI. There is a limited number of studies reporting the postmarketing adverse drug reactions (ADRs) induced by reteplase. This study was aimed to examine the reteplase pattern of ADR and its associated risk factors in patients with acute ST-elevation myocardial infarction. Methods: A cross-sectional, prospective study in an 8-month period was done at the University affiliated referral cardiovascular center. The Naranjo probability scale and World Health Organization criteria for severity of ADRs were used for assessing the ADRs. The linear regression and logistic regression tests were used to evaluate the correlation between ADRs and risk factors. Findings: The all 20 patients who received reteplase during the study period were entered. The majority of patients (n = 17) experienced at least one ADR. The results showed that the incidence of ADRs was mainly associated with gender and age, and the number of ADRs was associated with the history of diabetes and taking anti-diabetic agents. The gender was the main predictor in the occurrence of ADRs (odds ratio: 32, 95% confidence interval: 1.38–737.45; P = 0.030). Conclusion: The results showed that gender, age, diabetes mellitus, and using of anti-diabetes medications are the risk factors associated with the incidence of ADRs by reteplase. PMID:26645027

  18. 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

  19. 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

  20. Enhancing Police Responses to Domestic Violence Incidents: Reports From Client Advocates in New South Wales.

    PubMed

    Goodman-Delahunty, Jane; Crehan, Anna Corbo

    2016-07-01

    In an online survey about experiences with the police complaint system, 239 client advocates described a recent incident in which a client with grounds to lodge a complaint declined to do so. Almost one third of those incidents involved domestic violence. Thematic analysis of case descriptions revealed that many police did not take domestic violence reports seriously. A typology of problematic police conduct was developed. Many officers failed to observe current procedures and appeared to lack knowledge of relevant laws. Citizens feared retaliatory victimization by police and/or perceived that complaining was futile. Implications of these findings are reviewed in light of procedural justice theory. PMID:26567295

  1. 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

  2. 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…

  3. 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. PMID:23920604

  4. Does the implementation of an electronic prescribing system create unintended medication errors? A study of the sociotechnical context through the analysis of reported medication incidents

    PubMed Central

    2011-01-01

    Background Even though electronic prescribing systems are widely advocated as one of the most effective means of improving patient safety, they may also introduce new risks that are not immediately obvious. Through the study of specific incidents related to the processes involved in the administration of medication, we sought to find out if the prescribing system had unintended consequences in creating new errors. The focus of this study was a large acute hospital in the Midlands in the United Kingdom, which implemented a Prescribing, Information and Communication System (PICS). Methods This exploratory study was based on a survey of routinely collected medication incidents over five months. Data were independently reviewed by two of the investigators with a clinical pharmacology and nursing background respectively, and grouped into broad types: sociotechnical incidents (related to human interactions with the system) and non-sociotechnical incidents. Sociotechnical incidents were distinguished from the others because they occurred at the point where the system and the professional intersected and would not have occurred in the absence of the system. The day of the week and time of day that an incident occurred were tested using univariable and multivariable analyses. We acknowledge the limitations of conducting analyses of data extracted from incident reports as it is widely recognised that most medication errors are not reported and may contain inaccurate data. Interpretation of results must therefore be tentative. Results Out of a total of 485 incidents, a modest 15% (n = 73) were distinguished as sociotechnical issues and thus may be unique to hospitals that have such systems in place. These incidents were further analysed and subdivided into categories in order to identify aspects of the context which gave rise to adverse situations and possible risks to patient safety. The analysis of sociotechnical incidents by time of day and day of week indicated a trend

  5. 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

  6. The etiology and incidence of anaphylaxis in Rochester, Minnesota: A report from the Rochester Epidemiology Project

    PubMed Central

    Decker, Wyatt W.; Campbell, Ronna L.; Manivannan, Veena; Luke, Anuradha; St. Sauver, Jennifer L.; Weaver, Amy; Bellolio, M. Fernanda; Bergstralh, Eric J.; Stead, Latha G.; Li, James T. C.

    2009-01-01

    Background Reported incidences of anaphylaxis range from 3.2 to 20 per 100,000 population. The incidence and trend over time has meaningful public health implications but has not been well characterized because of a lack of a standard definition and deficiencies in reporting of events. Objective We sought to determine the incidence and cause of anaphylaxis over a 10-year period. Methods We performed a population-based incidence study that was conducted in Rochester, Minnesota, from 1990 through 2000. Anaphylaxis episodes were identified on the basis of symptoms and signs of mast cell and basophil mediator release plus mucocutaneous, gastrointestinal tract, respiratory tract, or cardiovascular system involvement. Results Two hundred eleven cases of anaphylaxis were identified (55.9% in female subjects). The mean age was 29.3 years (SD, 18.2 years; range, 0.8–78.2 years). The overall age-and sex-adjusted incidence rate was 49.8 (95% CI, 45.0–54.5) per 100,000 person-years. Age-specific rates were highest for ages 0 to 19 years (70 per 100,000 person-years). Ingested foods accounted for 33.2% (70 cases), insect stings accounted for 18.5% (39 cases), medication accounted for 13.7% (29 cases), radiologic contrast agent accounted for 0.5% (1 case), “other” causes accounted for 9% (19 cases), and “unknown” causes accounted for 25.1% (53 cases). The “other” group included cats, latex, cleaning agents, environmental allergens, and exercise. There was an increase in the annual incidence rate during the study period from 46.9 per 100,000 persons in 1990 to 58.9 per 100,000 persons in 2000 (P = .03). Conclusion The overall incidence rate is 49.8 per 100,000 person-years, which is higher than previously reported. The annual incidence rate is also increasing. Food and insect stings continue to be major inciting agents for anaphylaxis. PMID:18992928

  7. Adverse effects reported in the use of gastroesophageal reflux disease treatments in children: a 10 years literature review

    PubMed Central

    Cohen, Shlomi; Bueno de Mesquita, Mirjam; Mimouni, Francis B

    2015-01-01

    Gastroesophageal reflux (GER) is commonly observed in children, particularly during the first year of life. Pharmacological therapy is mostly reserved for symptomatic infants diagnosed with GER disease (GERD), usually as defined in a recent consensus statement. The purpose of the present article was to review the reported adverse effects of pharmacological agents used in the treatment of paediatric GERD. We conducted this review using the electronic journal database Pubmed and Cochrane database systematic reviews using the latest 10-year period (1 January 2003 to 31 December 2012). Our search strategy included the following keywords: omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, rantidine, cimetidine, famotidine, nizatidine, domperidone, metoclopramide, betanechol, erythromycin, baclofen, alginate. We used Pubmed’s own filter of: ’child: birth–18 years’. All full articles were reviewed and we only included randomized controlled trials retrieved from our search. We addressed a summary of our search on a drug-by-drug basis with regard to its mechanism of action and clinical applications, and reviewed all of the adverse effects reported and the safety profile of each drug. Adverse effects have been reported in at least 23% of patients treated with histamine H2 receptor antagonists (H2RAs) and 34% of those treated with proton pump inhibitors (PPIs), and mostly include headaches, diarrhoea, nausea (H2RAs and PPIs) and constipation (PPIs). Acid suppression may place immune-deficient infants and children, or those with indwelling catheters, at risk for the development of lower respiratory tract infections and nosocomial sepsis. Prokinetic agents have many adverse effects, without major benefits to support their routine use. PMID:25752807

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update

    PubMed Central

    Naeem, Farooq; Gire, Nadeem; Xiang, Shuo; Yang, Megan; Syed, Yumeen; Shokraneh, Farhad; Adams, Clive; Farooq, Saeed

    2016-01-01

    Recent years have seen a rapidly increasing trend towards the delivery of health technology through mobile devices. Smartphones and tablet devices are thus becoming increasingly popular for accessing information and a wide range of services, including health care services. Modern mobile apps can be used for a variety of reasons, ranging from education for the patients and assistance to clinicians to delivery of interventions. Mobile phone apps have also been established to benefit patients in a scope of interventions across numerous medical specialties and treatment modalities. Medical apps have their advantages and disadvantages. It is important that clinicians have access to knowledge to make decisions regarding the use of medical apps on the basis of risk-benefit ratio. Mobile apps that deliver psycho social interventions offer unique challenges and opportunities. A number of reviews have highlighted the potential use of such apps. There is a need to describe, report and study their side effects too. The adverse effects associated with these apps can broadly be divided into: (1) those resulting from the security and safety concerns; (2) those arising from the use of a particular psycho social intervention; and (3) those due to the interaction with digital technology. There is a need to refine and reconsider the safety and adverse effects in this area. The safety profile of a mobile PSI app should describe its safety profile in: (1) privacy and security; (2) adverse effects of psychotherapy; and (3) adverse effects unique to the use of apps and the internet. This is, however, a very new area and further research and reporting is required to inform clinical decision making. PMID:27354959

  15. Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update.

    PubMed

    Naeem, Farooq; Gire, Nadeem; Xiang, Shuo; Yang, Megan; Syed, Yumeen; Shokraneh, Farhad; Adams, Clive; Farooq, Saeed

    2016-06-22

    Recent years have seen a rapidly increasing trend towards the delivery of health technology through mobile devices. Smartphones and tablet devices are thus becoming increasingly popular for accessing information and a wide range of services, including health care services. Modern mobile apps can be used for a variety of reasons, ranging from education for the patients and assistance to clinicians to delivery of interventions. Mobile phone apps have also been established to benefit patients in a scope of interventions across numerous medical specialties and treatment modalities. Medical apps have their advantages and disadvantages. It is important that clinicians have access to knowledge to make decisions regarding the use of medical apps on the basis of risk-benefit ratio. Mobile apps that deliver psycho social interventions offer unique challenges and opportunities. A number of reviews have highlighted the potential use of such apps. There is a need to describe, report and study their side effects too. The adverse effects associated with these apps can broadly be divided into: (1) those resulting from the security and safety concerns; (2) those arising from the use of a particular psycho social intervention; and (3) those due to the interaction with digital technology. There is a need to refine and reconsider the safety and adverse effects in this area. The safety profile of a mobile PSI app should describe its safety profile in: (1) privacy and security; (2) adverse effects of psychotherapy; and (3) adverse effects unique to the use of apps and the internet. This is, however, a very new area and further research and reporting is required to inform clinical decision making. PMID:27354959

  16. 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

  17. 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…

  18. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... event report? (a) What form must I complete and submit? There are two versions of the MEDWATCH form for... report form. If you are a manufacturer and the information from another reporter's Form 3500A is...

  19. 77 FR 53779 - Reports by Air Carriers on Incidents Involving Animals During Air Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-04

    ...This action extends the comment period of an NPRM on the reporting of incidents involving animals during air transport that was published in the Federal Register on June 29, 2012. See 77 FR 38747. The Department of Transportation is extending the period for interested persons to submit comments on this rulemaking from August 28, 2012, to September 27, 2012. This extension is a result of a......

  20. Adverse events associated with incretin-based drugs in Japanese spontaneous reports: a mixed effects logistic regression model

    PubMed Central

    Narushima, Daichi; Kawasaki, Yohei; Takamatsu, Shoji

    2016-01-01

    Background: Spontaneous Reporting Systems (SRSs) are passive systems composed of reports of suspected Adverse Drug Events (ADEs), and are used for Pharmacovigilance (PhV), namely, drug safety surveillance. Exploration of analytical methodologies to enhance SRS-based discovery will contribute to more effective PhV. In this study, we proposed a statistical modeling approach for SRS data to address heterogeneity by a reporting time point. Furthermore, we applied this approach to analyze ADEs of incretin-based drugs such as DPP-4 inhibitors and GLP-1 receptor agonists, which are widely used to treat type 2 diabetes. Methods: SRS data were obtained from the Japanese Adverse Drug Event Report (JADER) database. Reported adverse events were classified according to the MedDRA High Level Terms (HLTs). A mixed effects logistic regression model was used to analyze the occurrence of each HLT. The model treated DPP-4 inhibitors, GLP-1 receptor agonists, hypoglycemic drugs, concomitant suspected drugs, age, and sex as fixed effects, while the quarterly period of reporting was treated as a random effect. Before application of the model, Fisher’s exact tests were performed for all drug-HLT combinations. Mixed effects logistic regressions were performed for the HLTs that were found to be associated with incretin-based drugs. Statistical significance was determined by a two-sided p-value <0.01 or a 99% two-sided confidence interval. Finally, the models with and without the random effect were compared based on Akaike’s Information Criteria (AIC), in which a model with a smaller AIC was considered satisfactory. Results: The analysis included 187,181 cases reported from January 2010 to March 2015. It showed that 33 HLTs, including pancreatic, gastrointestinal, and cholecystic events, were significantly associated with DPP-4 inhibitors or GLP-1 receptor agonists. In the AIC comparison, half of the HLTs reported with incretin-based drugs favored the random effect, whereas HLTs

  1. Acidosis: A potential explanation for adverse fetal outcome in intrahepatic cholestasis of pregnancy. A case report

    PubMed Central

    Visser, W; Smit, LS; Cornette, J

    2014-01-01

    Background Intrahepatic cholestasis of pregnancy is a cholestatic disorder with an increased risk for adverse perinatal outcome. The mechanism underlying intrauterine demise is poorly understood. Case A nulliparous woman with gestational age of 36 plus 6 weeks presented with suspected intrahepatic cholestasis. Continuous CTG monitoring evolved from a normal pattern towards a non-reassuring pattern. A male neonate was delivered by caesarean section. Apgar scores 0, 1 and 4 at 1, 5 and 10 min. Fetal cord gas analysis showed pH 6.98, base deficit –15 mmol/L. Blood results showed maternal serum bile acid concentration of 220 µmol/L. Conclusion Our case suggests gradual evolution towards hypoxia and acidosis. It is unknown whether certain components in the bile acid concentrations might contribute to a fetal metabolic component of the acidosis.

  2. Life threatening biphasic adverse reactions to desmopressin: case report and review of the literature.

    PubMed

    Wang, Lijun; Chen, Ruijun; Tian, Fang; Wang, Wei; Wang, Li; Yu, Baojun; Huang, Xianwen; Zhang, Yuehui; Su, Shengyuan; Ma, Guangnian; Wang, Kaichen

    2016-08-01

    Treatment with desmopressin diacetate arginine vasopressin (DDAVP) and its withdrawal are associated with side effects. We present a rare case of severe biphasic adverse reactions induced by DDAVP and its withdrawal in a 63-year-old female patient. A lump in the left axillary region was biopsied, and she received DDAVP after surgery. The following day, she lost consciousness, with foaming at the mouth and seizures. Hypotonic encephalopathy was considered. DDAVP was ceased, and she received electrolytes. On day 1, she displayed low blood pressure and increased urine output. She received DDAVP and dopamine as well as electrolytes. The patient was ambulatory on day 7 and was discharged without brain abnormalities on MRI. In conclusion, severe hyponatremia induced by DDAVP and massive polyuria and hypovolemic shock induced by DDAVP withdrawal are life-threatening conditions. This case underlines the need to be vigilant when administering DDAVP and to monitor for any side effects. PMID:27142268

  3. Improving patient safety incident reporting systems by focusing upon feedback - lessons from English and Welsh trusts.

    PubMed

    Wallace, Louise M; Spurgeon, Peter; Benn, Jonathan; Koutantji, Maria; Vincent, Charles

    2009-08-01

    This paper describes practical implications and learning from a multi-method study of feedback from patient safety incident reporting systems. The study was performed using the Safety Action and Information Feedback from Incident Reporting model, a model of the requirements of the feedback element of a patient safety incident reporting and learning system, derived from a scoping review of research and expert advice from world leaders in safety in high-risk industries. We present the key findings of the studies conducted in the National Health Services (NHS) trusts in England and Wales in 2006. These were a survey completed by risk managers for 351 trusts in England and Wales, three case studies including interviews with staff concerning an example of good practice feedback and an audit of 90 trusts clinical risk staff newsletters. We draw on an Expert Workshop that included 71 experts from the NHS, from regulatory bodies in health care, Royal Colleges, Health and Safety Executive and safety agencies in health care and high-risk industries (commercial aviation, rail and maritime industries). We draw recommendations of enduring relevance to the UK NHS that can be used by trust staff to improve their systems. The recommendations will be of relevance in general terms to health services worldwide. PMID:19633181

  4. 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

  5. Desensitization and immune tolerance induction in children with severe factor IX deficiency; inhibitors and adverse reactions to replacement therapy: a case-report and literature review.

    PubMed

    Bon, Andrea; Morfini, Massimo; Dini, Alessandro; Mori, Francesca; Barni, Simona; Gianluca, Sottilotta; de Martino, Maurizio; Novembre, Elio

    2015-01-01

    Hemophilia B is a rare X-linked recessive disorder with plasma factor IX (FIX) deficiency. 1-3% of patients treated with exogenous FIX-containing products develop inhibitors (i.e. polyclonal high affinity immunoglobulins) that neutralize the procoagulant activity of a specific coagulation factor. Although the incidence of inhibitors in hemophilia B patients is low, most are "high titer" and frequently associated with the development of severe allergic or anaphylactic reactions. Immune tolerance induction as a strategy for inhibitor eradication was first described in 1984. Unfortunately, the overall reported success of immune tolerance induction in FIX deficiency with inhibitors is approximately 25-40%.We report the case of a 2-year-old boy with hemophilia B severe FIX deficiency (<1%), inhibitor antibodies to FIX development, and a history of adverse reactions to FIX infusions, who underwent a successful desensitization and immune tolerance induction with a daily FIX infusion. With this regimen the inhibitor titer decreased with effective bleeding prevention. PMID:25887512

  6. 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. PMID:26400974

  7. 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

  8. 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

  9. Rising incidence of early-onset colorectal cancer in Australia over two decades: report and review.

    PubMed

    Young, Joanne P; Win, Aung Ko; Rosty, Christophe; Flight, Ingrid; Roder, David; Young, Graeme P; Frank, Oliver; Suthers, Graeme K; Hewett, Peter J; Ruszkiewicz, Andrew; Hauben, Ehud; Adelstein, Barbara-Ann; Parry, Susan; Townsend, Amanda; Hardingham, Jennifer E; Price, Timothy J

    2015-01-01

    The average age at diagnosis for colorectal cancer (CRC) in Australia is 69, and the age-specific incidence rises rapidly after age 50 years. The incidence has stabilized or is declining in older age groups in Australia during recent decades, possibly related to the increased uptake of screening and high-risk surveillance. In the same time frame, a rising incidence of CRC in younger adults has been well-documented in the United States. This rise in incidence in the young has not been reported from other countries that share long-term exposure to westernised urban lifestyles. Using data from the Australian Institute of Health and Welfare, we examined trends in national incidence rates for CRC under age 50 years and observed that rates in people under age 40 years have been rising for the last two decades. We further performed a review of the literature regarding CRC in young adults to outline the extent of current understanding, explore potential risk factors such as obesity, alcohol, and sedentary lifestyles, and to identify the questions remaining to be addressed. Although absolute numbers might not justify a population screening approach, the dispersal of young adults with CRC across the primary health-care system decreases probability of their recognition. Patient and physician awareness, aided by stool and emerging blood-screening tests and risk profiling tools, have the potential to aid in identification of those young adults who would most benefit from a colonoscopy through early detection of CRCs or by removal of advanced polyps. PMID:25251195

  10. 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

  11. 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

  12. Unemployment and lung cancer incidence in the Province of Opole. Brief report.

    PubMed

    Chawińska, Ewa; Tukiendorf, Andrzej; Miszczyk, Leszek

    2013-06-01

    In this geostatistical analysis we present the results of interrelation between unemployment rate and lung cancer incidence ratios in the Province of Opole, Poland. In the study, unemployment statistics and population data were analyzed together with the registered (histopathologically confirmed) lung cancer cases (C34, ICD10) in sex-stratified working age population (18-65 years). The data were collected in the years 2006-2008 in the Statistical Office in Opole and Opole Cancer Registry, Poland. The statistically significant positive correlation/interrelation between unemployment rate and lung cancer incidence ratios in male population was established; in females, this effect was statistically insignificant. The obtained results are consistent with the most up-to-date reports supporting the thesis that a higher burden of disease is observed in more deprived areas. The statistics may have practical relevance in terms of improving health status of the local population following economic reforms. PMID:24053069

  13. 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

  14. 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

  15. 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

  16. Abuse liability of flupirtine revisited: implications of spontaneous reports of adverse drug reactions.

    PubMed

    Gahr, Maximilian; Freudenmann, Roland W; Connemann, Bernhard J; Hiemke, Christoph; Schönfeldt-Lecuona, Carlos

    2013-12-01

    Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP's agonistic effects at the GABAA receptor might prime addictive behaviors, and literature provides some anecdotal reports on FLP abuse/dependence. To shed more light on this topic we acquired and evaluated data obtained from a national German pharmacovigilance database. We analyzed all reports of FLP abuse/dependence that were recorded in the database of the German Federal Institute for Drugs and Medical Devices (BfArM). A total of n = 48 reports of FLP abuse/dependence could be identified (mean age 45 years, 62.5% female). First reports were submitted to BfArM in 1991 with increasing numbers of annual reports from the year 2006 on. Mean daily FLP dosage was 805 mg (range 200-3,000 mg). Current or previous substance abuse/dependence was reported in 21% and 17%, respectively. Mean duration of FLP abuse/dependence until report to BfArM was 23 months (range 1-84 months). Withdrawal syndromes after discontinuation of FLP were reported in n = 9 (19%). Our findings strengthen the hypothesis that FLP features a potential to cause addictive behaviors. Female sex, age >40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence. PMID:24037995

  17. Patient-Safety-Related Hospital Deaths in England: Thematic Analysis of Incidents Reported to a National Database, 2010–2012

    PubMed Central

    Donaldson, Liam J.; Panesar, Sukhmeet S.; Darzi, Ara

    2014-01-01

    Background Hospital mortality is increasingly being regarded as a key indicator of patient safety, yet methodologies for assessing mortality are frequently contested and seldom point directly to areas of risk and solutions. The aim of our study was to classify reports of deaths due to unsafe care into broad areas of systemic failure capable of being addressed by stronger policies, procedures, and practices. The deaths were reported to a patient safety incident reporting system after mandatory reporting of such incidents was introduced. Methods and Findings The UK National Health Service database was searched for incidents resulting in a reported death of an adult over the period of the study. The study population comprised 2,010 incidents involving patients aged 16 y and over in acute hospital settings. Each incident report was reviewed by two of the authors, and, by scrutinising the structured information together with the free text, a main reason for the harm was identified and recorded as one of 18 incident types. These incident types were then aggregated into six areas of apparent systemic failure: mismanagement of deterioration (35%), failure of prevention (26%), deficient checking and oversight (11%), dysfunctional patient flow (10%), equipment-related errors (6%), and other (12%). The most common incident types were failure to act on or recognise deterioration (23%), inpatient falls (10%), healthcare-associated infections (10%), unexpected per-operative death (6%), and poor or inadequate handover (5%). Analysis of these 2,010 fatal incidents reveals patterns of issues that point to actionable areas for improvement. Conclusions Our approach demonstrates the potential utility of patient safety incident reports in identifying areas of service failure and highlights opportunities for corrective action to save lives. Please see later in the article for the Editors' Summary PMID:24959751

  18. Adverse events, toxicity and post-mortem data on duloxetine: case reports and literature survey.

    PubMed

    Vey, Eric L; Kovelman, Inna

    2010-05-01

    Duloxetine, a dual acting norepinephrine serotonin reuptake inhibitor, is a relatively new pharmacologic agent utilized in the treatment of depression, as well as diabetic neuropathic pain, fibromyalgia, and female stress urinary incontinence. This expanding scope of usage will inevitably lead to its eventual appearance during routine post-mortem toxicologic assays. Currently there is a paucity of post-mortem toxicologic data concerning duloxetine. The current report provides six additional case reports of post-mortem duloxetine levels, along with a review of duloxetine's pharmacokinetics, and the toxicologic manifestations which have been reported in the literature. The post-mortem levels reported, including the highest level recorded to date, are integrated with previously published reports to generate a foundation for a nascent guide to the interpretation of post-mortem duloxetine levels that could be encountered during routine post-mortem toxicologic analyses, and establish a basis upon which the establishment of toxic and lethal thresholds for this compound can be further elucidated with greater clarity. PMID:20382351

  19. 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

  20. Prevalence and Perceived Preventability of Self-Reported Adverse Drug Events – A Population-Based Survey of 7099 Adults

    PubMed Central

    Hakkarainen, Katja Marja; Andersson Sundell, Karolina; Petzold, Max; Hägg, Staffan

    2013-01-01

    Purpose Adverse drug events (ADEs) are common and often preventable among inpatients, but self-reported ADEs have not been investigated in a representative sample of the general public. The objectives of this study were to estimate the 1-month prevalence of self-reported ADEs among the adult general public, and the perceived preventability of 2 ADE categories: adverse drug reactions (ADRs) and sub-therapeutic effects (STEs). Methods In this cross-sectional study, a postal survey was sent in October 2010 to a random sample of 13 931 Swedish residents aged ≥18 years. Self-reported ADEs experienced during the past month included ADRs, STEs, drug dependence, drug intoxications and morbidity due to drug-related untreated indication. ADEs could be associated with prescription, non-prescription or herbal drugs. The respondents estimated whether ADRs and STEs could have been prevented. ADE prevalences in age groups (18–44, 45–64, or ≥65 years) were compared. Results Of 7099 respondents (response rate 51.0%), ADEs were reported by 19.4% (95% confidence interval, 18.5–20.3%), and the prevalence did not differ by age group (p>0.05). The prevalences of self-reported ADRs, STEs, and morbidities due to drug-related untreated indications were 7.8% (7.2–8.4%), 7.6% (7.0–8.2%) and 8.1% (7.5–8.7%), respectively. The prevalence of self-reported drug dependence was 2.2% (1.9–2.6%), and drug intoxications 0.2% (0.1–0.3%). The respondents considered 19.2% (14.8–23.6%) of ADRs and STEs preventable. Although reported drugs varied between ADE categories, most ADEs were attributable to commonly dispensed drugs. Drugs reported for all and preventable events were similar. Conclusions One-fifth of the adult general public across age groups reported ADEs during the past month, indicating a need for prevention strategies beyond hospitalised patients. For this, the underlying causes of ADEs should increasingly be investigated. The high burden of ADEs and preventable ADEs

  1. 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

  2. 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. PMID:26605558

  3. 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

  4. Patient safety incident reporting: a qualitative study of thoughts and perceptions of experts 15 years after 'To Err is Human'.

    PubMed

    Mitchell, Imogen; Schuster, Anne; Smith, Katherine; Pronovost, Peter; Wu, Albert

    2016-02-01

    One of the key recommendations of the Institute of Medicine's (IOM) report, To Err is Human, 15 years ago was for greater attention to incident reporting in healthcare, analogous to the role it has played in aviation and other high-risk industries. With the passage of time and maturation of the patient safety field, we conducted semistructured interviews with 11 international patient safety experts with knowledge of the US healthcare and meeting at least one of the following criteria: (1) involved in the development of the IOM's recommendations, (2) responsible for the design and/or implementation of national or regional incident reporting systems, (3) conducted research on patient safety/incident reporting at a national level. Five key challenges emerged to explain why incident reporting has not reached its potential: poor processing of incident reports (triaging, analysis, recommendations), inadequate engagement of doctors, insufficient subsequent visible action, inadequate funding and institutional support of incident reporting systems and inadequate usage of evolving health information technology. Leading patient safety experts acknowledge the current challenges of incident reports. The future of incident reporting lies in targeted incident reporting, effective triaging and robust analysis of the incident reports and meaningful engagement of doctors. Incident reporting must be coupled with visible, sustainable action and linkage of incident reports to the electronic health record. If the healthcare industry wants to learn from its mistakes, miss or near miss events, it will need to take incident reporting as seriously as the health budget. PMID:26217037

  5. [Adverse events of psychotropic drugs].

    PubMed

    Watanabe, Koichiro; Kikuchi, Toshiaki

    2014-01-01

    The authors discuss adverse events which are often missed but clinicians should pay attention to in order to preserve patients'quality of life(QOL). Among mood stabilizers, lithium may cause a urinary volume increase, hyperparathyroidism, and serum calcium elevation; sodium valproate possibly increases androgenic hormone levels and the risk of polycystic ovary syndrome (PCOS) as well as hypothyroidism. Moreover, in addition to teratogenesis, it has been reported that fetal exposure to a higher dose of valproate is associated with a lower intelligence quotient and higher incidence of autism spectrum disorders in children. Antidepressants with a higher affinity for serotonin transporters might induce gastrointestinal bleeding, and some antidepressants cause sexual dysfunction more frequently than others. Activation syndrome is still a key side effect which should be noted. Regarding the adverse events of antipsychotics, subjective side effects unpleasant to patients such as dysphoria and a lower subjective well-being should not be overlooked. We clinicians have to cope with adverse events worsening the QOL of patients with psychiatric disorders and, therefore, we need to adopt appropriate counter-measures. PMID:24864567

  6. 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

  7. A critical evaluation of reports associating ayahuasca with life-threatening adverse reactions.

    PubMed

    dos Santos, Rafael Guimarāes

    2013-01-01

    Ayahuasca is a botanical hallucinogenic preparation traditionally consumed by Northwestern Amazonian indigenous groups. Scientific evidence suggests good tolerability after acute administration of ayahuasca and also after years or even decades of its ritual consumption. Nevertheless, some scientific and media reports associate ayahuasca or some of its alkaloids with severe intoxications. The purpose of the present text is to do a critical evaluation of these reports. The evaluation of the cases highlights the fact that some lack accurate forensic/toxicological information, while others are not directly relevant to traditional ayahuasca preparations. These limitations reduce the possibility of an accurate risk assessment, which could indicate potential contraindications and susceptibilities for ayahuasca consumption. Nevertheless, even with these limitations, the cases suggest that previous cardiac and hepatic pathologies and current use of serotonergic drugs/medications are contraindications to ayahuasca use, and that caution should be taken when using different botanical species and extracted/synthetic alkaloids to prepare ayahuasca analogues. PMID:23909005

  8. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting in a tertiary care teaching hospital of Sikkim

    PubMed Central

    Datta, Supratim; Sengupta, Shramana

    2015-01-01

    Aim: Spontaneous voluntary adverse drug reaction (ADR) reporting is paramount to the success of the Pharmacovigilance Programme of India. There has however been minimal and sporadic voluntary reporting of ADR's at the ADR Monitoring Centre (AMC) Gangtok, Sikkim. Knowledge, perception, attitude, and awareness of health professionals are determinants of reporting practices. This questionnaire study aims at evaluating these indicators in the teaching hospital attached to the Medical Institute and find out methods to improve existing reporting practices. Materials and Methods: This is a cross-sectional questionnaire-based observational study carried out in the Medical, Surgical and Pathology Departments of the Teaching Hospital, Gangtok, Sikkim over a period of 2 months. The questionnaires were filled by the respondents and returned back to us within the next 24 h. Data obtained from filled questionnaires were thereby analyzed. Results: The overall correct response rate to the knowledge-based questions was 56.3%. While 97% of respondents were of the view that ADR reporting was necessary, 35% of the respondents felt that the difficulty in deciding the causality of an ADR discouraged them from reporting. 79% of the respondents were not aware of the presence of an AMC affiliated to the hospital, and 87% of the respondents admitted that they were not sending filled ADR forms to the AMC. Conclusions: The study indicates that the respondents have an average knowledge and positive attitude toward ADR reporting and pharmacovigilance. There is however a lack of awareness and poor ADR reporting practices. Efforts are required to enhance awareness and attitude toward pharmacovigilance and ADR reporting. PMID:26623391

  9. Understanding patient-to-worker violence in hospitals: a qualitative analysis of documented incident reports

    PubMed Central

    Arnetz, Judith E.; Hamblin, Lydia; Essenmacher, Lynnette; Upfal, Mark J.; Ager, Joel; Luborsky, Mark

    2016-01-01

    Aim To explore catalysts to, and circumstances surrounding, patient-to-worker violent incidents recorded by employees in a hospital system database. Background Violence by patients towards healthcare workers (Type II workplace violence) is a significant occupational hazard in hospitals worldwide. Studies to date have failed to investigate its root causes due to a lack of empirical research based on documented episodes of patient violence. Design Qualitative content analysis. Methods Content analysis was conducted on the total sample of 214 Type II incidents documented in 2011 by employees of an American hospital system with a centralized reporting system. Findings The majority of incidents were reported by nurses (39·8%), security staff (15·9%) and nurse assistants (14·4%). Three distinct themes were identified from the analysis: Patient Behaviour, Patient Care and Situational Events. Specific causes of violence related to Patient Behaviour were cognitive impairment and demanding to leave. Catalysts related to patient care were the use of needles, patient pain/discomfort and physical transfers of patients. Situational factors included the use/presence of restraints; transitions in the care process; intervening to protect patients and/or staff; and redirecting patients. Conclusions Identifying catalysts and situations involved in patient violence in hospitals informs administrators about potential targets for intervention. Hospital staff can be trained to recognize these specific risk factors for patient violence and can be educated in how to best mitigate or prevent the most common forms of violent behaviour. A social–ecological model can be adapted to the hospital setting as a framework for prevention of patient violence towards staff. PMID:25091833

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

    PubMed Central

    2015-01-01

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

  11. Adverse effects of spinal manipulation: a systematic review

    PubMed Central

    Ernst, E

    2007-01-01

    Objective To identify adverse effects of spinal manipulation. Design Systematic review of papers published since 2001. Setting Six electronic databases. Main outcome measures Reports of adverse effects published between January 2001 and June 2006. There were no restrictions according to language of publication or research design of the reports. Results The searches identified 32 case reports, four case series, two prospective series, three case-control studies and three surveys. In case reports or case series, more than 200 patients were suspected to have been seriously harmed. The most common serious adverse effects were due to vertebral artery dissections. The two prospective reports suggested that relatively mild adverse effects occur in 30% to 61% of all patients. The case-control studies suggested a causal relationship between spinal manipulation and the adverse effect. The survey data indicated that even serious adverse effects are rarely reported in the medical literature. Conclusions Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation. PMID:17606755

  12. 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

  13. The United States Department of Energy (DOE) Computerized Accident/Incident Reporting System (CAIRS)

    SciTech Connect

    Briscoe, G.J.

    1993-06-07

    The Department of Energy`s (DOE) Computerized Accident/Incident Reporting System (CAIRS) is a comprehensive data base containing more than 50,000 investigation reports of injury/illness, property damage and vehicle accident cases representing safety data from 1975 to the present for more than 150 DOE contractor organizations. A special feature is that the text of each accident report is translated using a controlled dictionary and rigid sentence structure called Factor Relationship and Sequence of Events (FRASE) that enhances the ability to retrieve specific types of information and to perform detailed analyses. DOE summary and individual contractor reports are prepared quarterly and annually. In addition, ``Safety Performance Profile`` reports for individual organizations are prepared to provide advance information to appraisal teams, and special topical reports are prepared for areas of concern such as an increase in the number of security injuries or environmental releases. The data base is open to all DOE and Contractor registered users with no access restrictions other than that required by the Privacy Act.

  14. A review of medication incidents reported to the National Reporting and Learning System in England and Wales over 6 years (2005–2010)

    PubMed Central

    Cousins, David H; Gerrett, David; Warner, Bruce

    2012-01-01

    A review of all medication incidents reported to the National Reporting and Learning System (NRLS) in England in Wales between 1 January 2005 and 31 December 2010 was undertaken. The 526 186 medication incident reports represented 9.68% of all patient safety incidents. Medication incidents from acute general hospitals (394 951) represented 75% of reports. There were relatively smaller numbers of medication incident reports (44 952) from primary care, representing 8.5% of the total. Of 86 821 (16%) medication incidents reporting actual patient harm, 822 (0.9%) resulted in death or severe harm. The incidents involving medicine administration (263 228; 50%) and prescribing (97 097; 18%) were the process steps with the largest number of reports. Omitted and delayed medicine (82 028; 16%) and wrong dose (80 170; 15%) represented the largest error categories. Thirteen medicines or therapeutic groups accounted for 377 (46%) of the incidents with outcomes of death or severe harm. The National Patient Safety Agency (NPSA) has issued guidance to help minimize incidents with many of these medicines. Many recent incidents could have been prevented if the NPSA guidance had been better implemented. It is recommended that healthcare organizations in all sectors establish an effective infrastructure to oversee and promote safe medication practice, including an annual medication safety report. In the future, preventable harms from medication incidents can be further minimized by; the continued use of the NRLS to identify and prioritize important actions to improve medication safety, a central organization continuing to issue medication safety guidance to the service and better methods to ensure that the National Health Service has implemented this guidance. PMID:22188210

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

    PubMed Central

    2011-01-01

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

  16. Adverse reaction to sulphonamides in a burned patient--a case report.

    PubMed

    Sawada, Y

    1985-12-01

    This is a case report of a patient who developed severe drug eruptions suspected to have been caused by sulphamethoxazole-trimethoprim (ST) administered orally for the treatment of urinary infection after burn injury. He had been treated topically with silver sulphadiazine (AgSD) after injury. The immunological examinations revealed positive reactions to both drugs, so that it is surmised that AgSD created the sensitivity and might be concerned in these drug eruptions. For such reasons, it is advisable, especially in patients who have been previously treated with topical or oral sulphonamides or have had episodes of hypersensitivity to such drugs, to administer sulphonamides carefully, or if possible to avoid administration. PMID:2936433

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

    PubMed Central

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

    2013-01-01

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

  18. 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.

  19. 12 CFR 250.181 - Reports of change in control of bank management incident to a merger.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Reports of change in control of bank management... Reports of 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...

  20. 12 CFR 250.181 - Reports of change in control of bank management incident to a merger.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Reports of change in control of bank management... Reports of 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...

  1. 12 CFR 250.181 - Reports of change in control of bank management incident to a merger.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Reports of change in control of bank management... Reports of 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...

  2. 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

  3. Interactions between life stress factors and carrying the APOE4 allele adversely impact self-reported health in old adults.

    PubMed

    Zeng, Yi; Hughes, Claude L; Lewis, Megan A; Li, Jianxin; Zhang, Fengyu

    2011-10-01

    Based on the multiple logistic regression analysis of data from a random sample of 1,023 old adults collected in Taiwan in 2000, we found that interactions between carrying the APOE4 allele and one of four life stress factors (relocated mainlander, living in a crowded household with six or more persons, living in an earthquake-damaged house, and monthly financial difficulty) significantly increased the odds ratio of poor self-reported health. Correlations between carrying the APOE4 allele and the life stress factors were ruled out by statistical tests. These life stress factors had a substantially larger adverse impact on self-reported health in APOE4 allele carriers than in noncarriers. This study provides evidence that interaction between carrying APOE4 allele and chronic life stressors has significant impacts on self-reported health while controlling for various sociodemographic and health behavior factors. Further studies with richer biomarkers are warranted for deeper understanding of the biological mechanisms. PMID:21768502

  4. 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

  5. Isolated Single Umbilical Artery in Twin Pregnancies and its Adverse Pregnancy Outcomes - A Case Report and Review of Literature

    PubMed Central

    Raiz, Iqbal

    2015-01-01

    Single umbilical artery is the most common congenital abnormality of the umbilical cord and is seen in 4-11% of twin pregnancies. It is usually associated with intrauterine growth retardation, preterm labour, small-for-dates and other structural anomalies. There is no significant difference in the incidence between monochorionic and dichorionic twins. The left artery is usually absent more commonly than the right. The female co-twin was predominantly more affected than their male counterparts. Single umbilical artery is found twice more common in white women than in Afro-Asians and Americans. The hemodynamic disturbances occur early in the embryonic development, influence greatly in the development of single umbilical artery. Genetic and environmental factors also play a major role in the development of this anomaly. The pregnancies with single umbilical artery were classified as high risk group, because the overall perinatal mortality rate was estimated to be as high as 20%. There is a significant increase in the occurrence of single umbilical artery in pregnancies due to artificial reproductive technologies, as well as in spontaneous miscarriages. Prenatal ultrasonography is the principal diagnostic technique employed to identify single umbilical artery during 3rd trimester of pregnancy. The present case, reports the presence of a single umbilical artery in a monozygotic, monochorionic twin pregnancy, which is acardiac-acephalic fetus, small for dates, female sex, associated with other major structural anomalies, and was still born. Authors analyse its incidence, clinical presentations and pregnancy outcome and also review the pertinent literature. PMID:25737967

  6. 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

  7. 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. PMID:17854989

  8. 30 CFR 250.189 - Reporting requirements for incidents requiring immediate notification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... immediate notification. 250.189 Section 250.189 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT... for incidents requiring immediate notification. For an incident requiring immediate notification under... incident or injury/fatality); (d) Lease number, OCS area, and block; (e) Platform/facility name and...

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

    PubMed Central

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

    2015-01-01

    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

  10. 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

  11. 21 CFR 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false If I am a manufacturer, what information must I submit in my individual adverse event reports? 803.52 Section 803.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING; (Eff. Until 8-14-15) Manufacturer...

  12. Adverse reaction to metal bearing leading to femoral stem fractures: a literature review and report of two cases

    PubMed Central

    Al-Azzani, Waheeb A.K.; Iqbal, Hafiz J.; John, Alun

    2016-01-01

    Metal-on-metal (MoM) bearing in total hip replacement (THR) has a high failure rate due to adverse reaction to metal debris (ARMD). There is a spectrum of soft tissue and bony changes in ARMD including muscle necrosis and osteolysis. In our institution, more than 1500 MoM THRs were implanted since 2003. Recently, we have revised significant numbers of these. We report our experience and management of a mode of failure of MoM THR that has been infrequently reported—the distal femoral stem fracture. We report on two patients who presented with worsening pain attributable to fracture of the femoral stem. Severe femoral osteolysis led to loss of proximal stem support and eventual fatigue fracture of the component. Both patients were revised employing a posterior approach. Bone trephine was used to extract a well-fixed distal stem fragment without any windows. Both patients had successful outcome after revision with excellent pain relief and no complications. PMID:26846269

  13. 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.

  14. Multi-media authoring - Instruction and training of air traffic controllers based on ASRS incident reports

    NASA Technical Reports Server (NTRS)

    Armstrong, Herbert B.; Roske-Hofstrand, Renate J.

    1989-01-01

    This paper discusses the use of computer-assisted instructions and flight simulations to enhance procedural and perceptual motor task training. Attention is called to the fact that incorporating the accident and incident data contained in reports filed with the Aviation Safety Reporting System (ASRS) would be a valuable training tool which the learner could apply for other situations. The need to segment the events is emphasized; this would make it possible to modify events in order to suit the needs of the training environment. Methods were developed for designing meaningful scenario development on runway incursions on the basis of analysis of ASRS reports. It is noted that, while the development of interactive training tools using the ASRS and other data bases holds much promise, the design and production of interactive video programs and laser disks are very expensive. It is suggested that this problem may be overcome by sharing the costs of production to develop a library of materials available to a broad range of users.

  15. 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

  16. 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.

  17. A review of patient safety incidents reported as 'severe' or 'death' from critical care units in England and Wales between 2004 and 2014.

    PubMed

    Thomas, A N; MacDonald, J J

    2016-09-01

    We analysed 1743 patient safety incidents reported between 2004 and 2014 from critical care units in England and Wales where the harm had been classified as 'severe' (1346, 77%) or 'death' (397, 23%). We classified 593 (34%) of these incidents as resulting in temporary harm, and 782 (45%) as more than temporary harm, of which 389 (22%) may have contributed to the patient's death. We found no described harm in 368 (21%) incidents. We classified 1555 (89%) of the incidents as being avoidable or potentially avoidable. There were changes over time for some incident types (pressure sores: 10 incidents in 2007, 64 in 2012; infections: 60 incidents in 2007, 10 in 2012) and some changes in response to national guidance. We made a comparison with a dataset of all incidents reported from units in North-West England, and this confirmed that the search strategy identified more severe incidents, but did not identify all incidents that contributed to mortality. PMID:27456207

  18. Akt activation is a common event in pediatric malignant gliomas and a potential adverse prognostic marker: a report from the children’s oncology group

    PubMed Central

    Hamilton, Ronald L.; Murdoch, Geoffrey H.; Burger, Peter C.; Brat, Daniel J.; Rosenblum, Marc K.; Nikiforova, Marina N.; Holmes, Emiko J.; Zhou, Tianni; Cohen, Kenneth J.; Jakacki, Regina I.

    2010-01-01

    Aberrant activation of Akt is a common finding in adult malignant gliomas, resulting in most cases from mutations or deletions involving PTEN, which allows constitutive Akt phosphorylation. In contrast, we have previously reported that pediatric malignant gliomas, which are morphologically similar to lesions arising in adults, have a substantially lower incidence of genomic alterations of PTEN. The objective of this study was to determine whether Akt activation was also an uncommon finding in childhood malignant gliomas and whether this feature was associated with survival. To address this issue, we examined the frequency of Akt activation, determined by overexpression of the activated phosphorylated form of Akt (Se473) on immunohistochemical analysis, in a series of 53 childhood malignant gliomas obtained from newly diagnosed patients treated on the Children’s Oncology Group ACNS0126 and 0423 studies. The relationship between Akt activation and p53 over-expression, MIB1 labeling, and tumor histology was evaluated. The association between Akt activation and survival was also assessed. Overexpression of activated Akt was observed in 42 of 53 tumors, far in excess of the frequency of PTEN mutations we have previously observed. There was no association between Akt activation and either histology, p53 overexpression, or MIB1 proliferation indices. Although tumors that lacked Akt overexpression had a trend toward more favorable event-free survival and overall survival (p = 0.06), this association reflected that non-overexpressing tumors were significantly more likely to have undergone extensive tumor removal, which was independently associated with outcome. Activation of Akt is a common finding in pediatric malignant gliomas, although it remains uncertain whether this is an independent adverse prognostic factor. In view of the frequency of Akt activation, the evaluation of molecularly targeted therapies that inhibit this pathway warrants consideration for these tumors

  19. 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...

  20. 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 incident to a merger. 250.181 Section 250.181 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM MISCELLANEOUS INTERPRETATIONS Interpretations § 250.181 Reports of change in control of...

  1. 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

  2. Analysis of the Interaction between Clopidogrel, Aspirin, and Proton Pump Inhibitors Using the FDA Adverse Event Reporting System Database.

    PubMed

    Suzuki, Yukiya; Suzuki, Honami; Umetsu, Ryogo; Uranishi, Hiroaki; Abe, Junko; Nishibata, Yuri; Sekiya, Yasuaki; Miyamura, Nobuteru; Hara, Hideaki; Tsuchiya, Teruo; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Clopidogrel is an antiplatelet agent widely used in combination with aspirin to limit the occurrence of cardiovascular (embolic/thrombotic) events. Consensus guidelines recommend proton pump inhibitors (PPIs) as a gastrointestinal (GI) prophylactic measure for all patients receiving dual antiplatelet therapy with clopidogrel and aspirin. The objective of this study was to analyze the effect of the simultaneous use of clopidogrel, aspirin, and PPIs on hemorrhagic and embolic/thrombotic events using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Reports of hemorrhagic and embolic/thrombotic events between 2004 and 2013 were analyzed with a reporting odds ratio (ROR) algorithm and logistic regression methods. The Medical Dictionary for Regulatory Activities Preferred Terms was used to identify such events. Regarding hemorrhagic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 4.40 (95% confidence interval [CI], 4.02-4.81) and 3.40 (95% CI, 2.84-4.06), respectively. For embolic/thrombotic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 2.37 (95% CI, 2.16-2.59) and 2.38 (95% CI, 2.00-2.84), respectively. Among patients included in the FAERS database, the concurrent use of aspirin and clopidogrel with PPIs reduced the adjusted ROR of GI hemorrhagic events. PPIs had little influence on the adjusted ROR of embolic/thrombotic events. These results support the use of PPIs as a preventive measure against GI hemorrhagic events for patients receiving clopidogrel and aspirin. PMID:25947914

  3. Patient-reported adverse drug reactions and their influence on adherence and quality of life of chronic myeloid leukemia patients on per oral tyrosine kinase inhibitor treatment

    PubMed Central

    Kekäle, Meri; Peltoniemi, Marikki; Airaksinen, Marja

    2015-01-01

    Purpose To evaluate adverse drug reactions (ADRs) experienced by chronic myeloid leukemia (CML) patients during per oral tyrosine kinase inhibitor (TKI) treatment and correlation of ADR symptoms with medication adherence and perceived quality of life (QoL). Patients and methods Eighty-six adult, chronic-phase CML patients who had been on TKI treatment (79% on imatinib, 10.5% dasatinib, and 10.5% nilotinib) for at least 6 months participated in the study (mean age: 57.8 years, 52% males). The mean time from diagnosis was 5.1 years. All patients were interviewed, and patient-reported ADRs were obtained using a structured list. Adherence was assessed using Morisky’s 8-item Medication Adherence Scale (MMAS). The symptoms’ interference with patient’s daily QoL was measured by asking patients about the influence of symptom(s) on their mood, general condition, enjoyment of life, walking, relationships, and work. Results Ninety-seven percent of the patients were suffering from at least one ADR. The mean number of different symptoms was seven (range: 0–15, median 6). The most commonly perceived ADRs were muscle soreness or cramp (69/86, 80%); swelling of hands, legs, feet, or around the eyes (59/86, 69%); and fatigue (43/86, 50%). No correlation was found between adherence and ADRs, because symptoms were equally common in each MMAS adherence class. Half of the patients felt that the ADRs had a negative influence on their daily QoL. A quarter of the patients reported that ADRs affected either their mood, general condition, or enjoyment of life. The incidence of almost all ADRs was much higher among patients reporting negative influence of ADRs on their daily life compared to total study population (P=0.016). Conclusion TKI-related ADRs were common among CML patients irrespective of patient’s adherence level. Patients who reported that ADRs had a negative influence on their daily QoL perceived more ADRs than those who did not experience a negative influence. PMID

  4. Delayed Immune Mediated Adverse Effects to Hyaluronic Acid Fillers: Report of Five Cases and Review of the Literature

    PubMed Central

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

    2015-01-01

    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

  5. Mix of methods is needed to identify adverse events in general practice: A prospective observational study

    PubMed Central

    Wetzels, Raymond; Wolters, René; van Weel, Chris; Wensing, Michel

    2008-01-01

    Background The validity and usefulness of incident reporting and other methods for identifying adverse events remains unclear. This study aimed to compare five methods in general practice. Methods In a prospective observational study, with five general practitioners, five methods were applied and compared. The five methods were physician reported adverse events, pharmacist reported adverse events, patients' experiences of adverse events, assessment of a random sample of medical records, and assessment of all deceased patients. Results A total of 68 events were identified using these methods. The patient survey accounted for the highest number of events and the pharmacist reports for the lowest number. No overlap between the methods was detected. The patient survey accounted for the highest number of events and the pharmacist reports for the lowest number. Conclusion A mix of methods is needed to identify adverse events in general practice. PMID:18554418

  6. 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

  7. 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

  8. [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

  9. 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

  10. An updated evaluation of reported no-observed adverse effect levels for chrysotile asbestos for lung cancer and mesothelioma.

    PubMed

    Pierce, Jennifer S; Ruestow, Peter S; Finley, Brent L

    2016-08-01

    Although consumption of chrysotile asbestos has decreased since the 1970s, the latency period of asbestos-related cancers is thought to be at least 20-30 years, and therefore the potential health risks associated with historical exposures is still actively researched. This analysis represents an update to a previous paper in which we evaluated the exposure-response relationships for lung cancer and mesothelioma in chrysotile-exposed cohorts. Here, we review several recently published studies as well as updated information from previous studies. For each of the 14 studies considered, we identified the "no-observed adverse effect level" (NOAEL) for lung cancer and/or mesothelioma. NOAEL values for lung cancer ranged from 1.1 to <20 f/cc-years to 1600-3200 f/cc-years, and for mesothelioma ranged from 100-400 f/cc-years to 800-1599 f/cc-years. The range of "best estimate" NOAELs was estimated to be 89-168 f/cc-years for lung cancer and 208-415 f/cc-years for mesothelioma. None of the six cohorts of cement or friction product manufacturing workers exhibited an increased lung cancer risk at any exposure level, while all of the five studies of textile workers reported an increased risk at one or more exposure levels. This is likely because friction and cement workers were exposed to much shorter chrysotile fibers. Of the seven cases of peritoneal mesothelioma reported in the included studies, none were observed in the analyses of cement or friction product manufacturing workers in the absence of crocidolite exposure. These findings will help characterize potential worker and consumer health risks associated with historical and current chrysotile exposures. PMID:27031024

  11. Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    PubMed

    Bruner, Deborah Watkins; Hanisch, Laura J; Reeve, Bryce B; Trotti, Andy M; Schrag, Deborah; Sit, Laura; Mendoza, Tito R; Minasian, Lori; O'Mara, Ann; Denicoff, Andrea M; Rowland, Julia H; Montello, Michael; Geoghegan, Cindy; Abernethy, Amy P; Clauser, Steven B; Castro, Kathleen; Mitchell, Sandra A; Burke, Laurie; Trentacosti, Ann Marie; Basch, Ethan M

    2011-03-01

    The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty

  12. Childhood adversities and adult-onset asthma: a cohort study

    PubMed Central

    Korkeila, Jyrki; Lietzen, Raija; Sillanmäki, Lauri H; Rautava, Päivi; Korkeila, Katariina; Kivimäki, Mika; Koskenvuo, Markku; Vahtera, Jussi

    2012-01-01

    Objectives Childhood adversities may be important determinants of later illnesses and poor health behaviour. However, large-scale prospective studies on the associations between childhood adversities and the onset of asthma in adulthood are lacking. Design Prospective cohort study with 7-year follow-up. Setting Nationally representative study. Data were collected from the Health and Social Support (HeSSup) survey and national registers. Participants The participants represent the Finnish population from the following age groups: 20–24, 30–34, 40–44, and 50–54 years at baseline in 1998 (24 057 survey participants formed the final cohort of this study). The occurrence of childhood adversities was assessed at baseline with a six-item survey scale. The analyses were adjusted for sociodemographic characteristics, behavioural health risks and common mental disorders. Primary and secondary outcomes The survey data were linked to data from national health registers on incident asthma during a 7-year follow-up to define new-onset asthma cases with verified diagnoses. Results A total of 12 126 (59%) participants reported that they encountered a childhood adversity. Of them 3677 (18% of all) endured three to six adversities. During a follow-up of 7 years, 593 (2.9%) participants were diagnosed with incident asthma. Those who reported three or more childhood adversities had a 1.6-fold (95% CI 1.31 to 2.01) greater risk of asthma compared to those without childhood adversities. This hazard attenuated but remained statistically significant after adjustment for conventional risk factors (HR 1.33; 95% CI 1.06 to 1.67). Conclusions Adults who report having encountered adversities in childhood may have an increased risk of developing asthma. PMID:23069774

  13. Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study

    PubMed Central

    2011-01-01

    Background Spontaneous reporting of adverse drug reactions (ADRs) is an important method for pharmacovigilance, but under-reporting and poor quality of reports are major limitations. The aim of this study was to evaluate if repeated one-page ADR information letters affect (i) the reporting rate of ADRs and (ii) the quality of the ADR reports. Methods All 151 primary healthcare units in the Region Västra Götaland, Sweden, were randomly allocated (1:1) to an intervention (n = 77) or a control group (n = 74). The intervention consisted of one-page ADR information letters administered at three occasions during 2008 to all physicians and nurses in the intervention units. The number of ADR reports received from the 151 units was registered, as was the quality of the reports, which was defined as high if the ADR was to be reported according to Swedish regulations, that is, if the ADR was (i) serious, (ii) unexpected, and/or (iii) related to the use of new drugs and not labelled as common in the Summary of Product Characteristics. A questionnaire was administered to evaluate if the ADR information letter had reached the intended recipient. Results Before the intervention, no significant differences in reporting rate or number of high quality reports could be detected between the randomization groups. In 2008, 79 reports were sent from 37 intervention units and 52 reports from 30 control units (mean number of reports per unit ± standard deviation: 1.0 ± 2.5 vs. 0.7 ± 1.2, P = 0.34). The number of high quality reports was higher in intervention units than in control units (37 vs. 15 reports, 0.5 ± 0.9 vs. 0.2 ± 0.6, P = 0.048). According to the returned questionnaires (n = 1,292, response rate 57%), more persons in the intervention than in the control group had received (29% vs. 19%, P < 0.0001) and read (31% vs. 26%, P < 0.0001) an ADR information letter. Conclusions This study suggests that repeated ADR information letters to physicians and nurses do not increase

  14. 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...

  15. 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...

  16. 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...

  17. 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 =…

  18. 30 CFR 250.189 - Reporting requirements for incidents requiring immediate notification.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... immediate notification. 250.189 Section 250.189 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF... notification. For an incident requiring immediate notification under § 250.188(a), you must notify the District... representative's name and telephone number (if a contractor is involved in the incident or injury/fatality);...

  19. Incidence of Deep Vein Thrombosis in Patients Undergoing Degenerative Spine Surgery onProphylactic Dalteparin; A Single Center Report

    PubMed Central

    Moayer, AlirezaFarid; Mohebali, Navideh; Razmkon, Ali

    2016-01-01

    Objective: To determine the incidence of deep vein thrombosis (DVT)in patients undergoing spinal surgeries receiving prophylactic doses of Deltaparin in a single center in central Iran. Method: This cross-sectional study was conducted in Shariatee hospital of Isfahan during a 12-month period. We included all the patients undergoing elective spinal surgeries in our center during the study period who received prophylactic dosages of subcutaneous Dalteparin (5000unit daily) thefirst postoperative day. Those with absolute contraindications of anticoagulation therapy were not included in the study. Patients were followed for 3 months clinically and the incidence of DVT was recorded. DVT was suspected clinically and was confirmed by color Doppler sonography. Results: Overall we included 120 patients with mean age of 44.8 ± 12.6years among whom there were 54 (45%) men and 66 (55%) women. Lumbar discectomy (32.9%)and laminectomy (20.2%)were the most common performed procedures. DVT was detected in 1 (0.83%) patient in postoperative period. None of the patients developed pulmonary embolism and none hemorrhagic adverse event was recorded. The patient was treated with therapeutic unfractionated heparin and was discharged with warfarin.  Conclusion: Our results shows the efficacy of LMWH (Dalteparin) in reducing the incidence of DVT to 0.83%. These results also show the safety of Dalteparin in spine surgery because of lack of bleeding complication. PMID:27162925

  20. Adverse reactions to sulfites

    PubMed Central

    Yang, William H.; Purchase, Emerson C.R.

    1985-01-01

    Sulfites are widely used as preservatives in the food and pharmaceutical industries. In the United States more than 250 cases of sulfite-related adverse reactions, including anaphylactic shock, asthmatic attacks, urticaria and angioedema, nausea, abdominal pain and diarrhea, seizures and death, have been reported, including 6 deaths allegedly associated with restaurant food containing sulfites. In Canada 10 sulfite-related adverse reactions have been documented, and 1 death suspected to be sulfite-related has occurred. The exact mechanism of sulfite-induced reactions is unknown. Practising physicians should be aware of the clinical manifestations of sulfite-related adverse reactions as well as which foods and pharmaceuticals contain sulfites. Cases should be reported to health officials and proper advice given to the victims to prevent further exposure to sulfites. The food industry, including beer and wine manufacturers, and the pharmaceutical industry should consider using alternative preservatives. In the interim, they should list any sulfites in their products. PMID:4052897

  1. A safety incident reporting system for primary care. A systematic literature review and consensus procedure by the LINNEAUS collaboration on patient safety in primary care

    PubMed Central

    Klemp, Kerstin; Zwart, Dorien; Hansen, Jørgen; Hellebek, Torben; Luettel, Dagmar; Verstappen, Wim; Beyer, Martin; Gerlach, Ferdin M.; Hoffmann, Barbara; Esmail, Aneez

    2015-01-01

    Background: Incident reporting is widely used in both patient safety improvement programmes, and in research on patient safety. Objective: To identify the key requirements for incident reporting systems in primary care; to develop an Internet-based incident reporting and learning system for primary care. Methods: A literature review looking at the purpose, design and requirements of an incident reporting system (IRS) was used to update an existing incident reporting system, widely used in Germany. Then, an international expert panel with knowledge on IRS developed the criteria for the design of a new web-based incident reporting system for European primary care. A small demonstration project was used to create a web-based reporting system, to be made freely available for practitioners and researchers. The expert group compiled recommendations regarding the desirable features of an incident reporting system for European primary care. These features covered the purpose of reporting, who should be involved in reporting, the mode of reporting, design considerations, feedback mechanisms and preconditions necessary for the implementation of an IRS. Results: A freely available web-based reporting form was developed, based on these criteria. It can be modified for local contexts. Practitioners and researchers can use this system as a means of recording patient safety incidents in their locality and use it as a basis for learning from errors. Conclusion: The LINNEAUS collaboration has provided a freely available incident reporting system that can be modified for a local context and used throughout Europe. PMID:26339835

  2. 21 CFR 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false If I am a user facility, what information must I submit in my individual adverse event reports? 803.32 Section 803.32 Food and Drugs FOOD AND DRUG... laboratory data; and (7) Description of other relevant history, including preexisting medical conditions....

  3. 21 CFR 803.42 - If I am an importer, what information must I submit in my individual adverse event reports?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false If I am an importer, what information must I submit in my individual adverse event reports? 803.42 Section 803.42 Food and Drugs FOOD AND DRUG..., including dates and laboratory data; and (7) Description of other relevant patient history,...

  4. 21 CFR 803.11 - What form should I use to submit reports of individual adverse events and where do I obtain these...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What form should I use to submit reports of individual adverse events and where do I obtain these forms? 803.11 Section 803.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL...

  5. Association between Selective Beta-adrenergic Drugs and Blood Pressure Elevation: Data Mining of the Japanese Adverse Drug Event Report (JADER) Database.

    PubMed

    Ohyama, Katsuhiro; Inoue, Michiko

    2016-01-01

    Selective beta-adrenergic drugs are used clinically to treat various diseases. Because of imperfect receptor selectivity, beta-adrenergic drugs cause some adverse drug events by stimulating other adrenergic receptors. To examine the association between selective beta-adrenergic drugs and blood pressure elevation, we reviewed the Japanese Adverse Drug Event Reports (JADERs) submitted to the Japan Pharmaceuticals and Medical Devices Agency. We used the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms extracted from Standardized MedDRA queries for hypertension to identify events related to blood pressure elevation. Spontaneous adverse event reports from April 2004 through May 2015 in JADERs, a data mining algorithm, and the reporting odds ratio (ROR) were used for quantitative signal detection, and assessed by the case/non-case method. Safety signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. A total of 2021 reports were included in this study. Among the nine drugs examined, significant signals were found, based on the 95%CI for salbutamol (ROR: 9.94, 95%CI: 3.09-31.93) and mirabegron (ROR: 7.52, 95%CI: 4.89-11.55). The results of this study indicate that some selective beta-adrenergic drugs are associated with blood pressure elevation. Considering the frequency of their indications, attention should be paid to their use in elderly patients to avoid adverse events. PMID:27374969

  6. 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. PMID:24618875

  7. My brother's reaper: examining officially reported siblicide incidents in the United States, 2000-2007.

    PubMed

    Walsh, Jeffrey A; Krienert, Jessie L

    2014-01-01

    With higher rates than any other form of intrafamilial violence, Hoffman and Edwards (2004) note, sibling violence "constitutes a pandemic form of victimization of children, with the symptoms often going unrecognized and the effect ignored" (p. 187). Approximately 80% of children reside with at least one sibling (Kreider, 2008), and in its most extreme form sibling violence manifests as siblicide. Siblicide is poorly understood with fewer than 20 empirical studies identified in the extant literature since 1980 (see Eriksen & Jensen, 2006). The present work employs 8 years of Supplemental Homicide Report (SHR) data, 2000-2007, with siblicide victims and offenders age 21 years and younger, to construct contemporary victim and offender profiles examining incident characteristics. Findings highlight the sex-based nature of the offense with unique victimization patterns across victims and offenders. Older brothers using a firearm are the most frequent offenders against both male and female siblings. Strain as a theoretical foundation of siblicide is offered as an avenue for future inquiry. PMID:25069154

  8. 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.

  9. 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

  10. "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

  11. Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

    PubMed Central

    Perrone, Valentina; Conti, Valentino; Venegoni, Mauro; Scotto, Stefania; Degli Esposti, Luca; Sangiorgi, Diego; Prestini, Lucia; Radice, Sonia; Clementi, Emilio; Vighi, Giuseppe

    2014-01-01

    Objective The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal, respiratory thoracic and mediastinal, and nervous system disorders. The most common Anatomical Therapeutic Chemical classes involved in admissions were J (anti-infectives and immunomodulating agents), B (blood and blood-forming organs), and N (nervous system). Older age, yellow and red triage, higher number of concomitantly taken drugs, and previous attendance in ED for the same ADR were significantly associated with an increased risk of hospitalization. The total cost associated with ADR management was €5,184,270, with a mean cost per patient of €585. Fifty-eight percent of the economic burden was defined as probably/definitely preventable. Conclusion ADRs are a serious health/economic issue in EDs. This assessment provides a thorough estimation of their seriousness, preventability, and burden impact in a large population from a representative European region. PMID

  12. A systematic review of patient-reported outcome instruments of dermatologic adverse events associated with targeted cancer therapies

    PubMed Central

    Chan, Alexandre; Cameron, Michael C.; Garden, Benjamin; Boers-Doets, Christine B.; Schindler, Katja; Epstein, Joel B.; Choi, Jennifer; Beamer, Laura; Roeland, Eric; Russi, Elvio G.; Bensadoun, René-Jean; Teo, Yi Ling; Chan, Raymond J.; Shih, Vivianne; Bryce, Jane; Raber-Durlacher, Judith; Gerber, Peter Arne; Freytes, César O.; Rapoport, Bernardo; LeBoeuf, Nicole; Sibaud, Vincent; Lacouture, Mario E.

    2016-01-01

    Purpose Dermatologic adverse events (dAE) in cancer treatment are frequent with use of targeted therapies. These dAEs have been shown to have significant impact on health-related quality of life (HRQoL). While standardized assessment tools have been developed for physicians to assess severity of dAEs, there is a discord between objective and subjective measures. The identification of patient-reported outcome (PRO) instruments useful in the context of targeted cancer therapies is therefore important in both the clinical and research settings for the overall evaluation of dAEs and their impact on HRQoL. Methods A comprehensive, systematic literature search of published articles was conducted by two independent reviewers in order to identify PRO instruments previously utilized in patient populations with dAEs from targeted cancer therapies. The identified PRO instruments were studied to determine which HRQoL issues relevant to dAEs were addressed, as well as the process of development and validation of these instruments. Results Thirteen articles identifying six PRO instruments met the inclusion criteria. Four instruments were general dermatology (Skindex-16©, Skindex-29©, Dermatology Life Quality Index [DLQI], and DIELH-24), and two were symptom-specific (Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitors-18 [FACT-EGFRI-18] and Hand-Foot Syndrome 14 [HFS-14]). Conclusions While there are several PRO instruments that have been tested in the context of targeted cancer therapy, additional work is needed to develop new instruments and to further validate the instruments identified in this study in patients receiving targeted therapies. PMID:25564221

  13. The adverse prognostic hallmarks in identical twins with Langerhans cell histiocytosis: a clinical report and literature review.

    PubMed

    Chai, Damin; Tao, Yisheng; Bao, Zhengqi; Yang, Li; Feng, Zhenzhong; Ma, Li; Liang, Limei; Zhou, Xinwen

    2013-01-01

    Langerhans cell histiocytosis (LCH) is characterized by uncontrolled proliferation of Langerhans cells accompanying eosinophils. It often attacks children under 10 years of age. LCH in identical twins is very rare and its prognosis is different. Here we report identical-twin sisters with LCH. Computed tomography (CT) revealed osteolytic change in each twin's skull, and the elder exhibited poor eyesight. There were massive histiocyte-like cells surrounded by eosinophils in pathologic specimen of the abnormal lesions, which is typical pathologic finding in LCH. These pathologic cells were positive for S-100 and the cell surface protein CD1 antigen (CD1α), the known markers of LCH. After treating them with surgery, no symptoms were seen in the younger until now. While the older was found another soft mass (about 2.0 cm in diameter) in the left temporal area 18 months later. The same treatment was given to the older after admission, and she is healthy to date. To explore the relationship between hallmarks and the prognosis of identical-twin patients with LCH, we retrieved the 16 literatures (16 identical-twin pairs, 31 patients) listed in PubMed during the past 60 years. The data revealed all those patients who have disseminated to the bone marrow, spleen and liver with symptoms of fever and hepatosplenomegaly exhibited worse prognosis (9 out of the 31 patients). The other identical-twin subjects without infiltration of those organs recovered well. In conclusion, this study reveals the adverse hallmarks of prognosis in identical-twin patients with LCH by reviewing relevant literatures. PMID:23924960

  14. 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

  15. 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

  16. 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…

  17. 49 CFR 225.12 - Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 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...

  18. 49 CFR 225.12 - Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... employee human factor as cause; Employee Human Factor Attachment; notice to employee; employee supplement..., AND INVESTIGATIONS § 225.12 Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human Factor Attachment; notice to employee; employee supplement. (a) Rail...

  19. 49 CFR 225.12 - Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human...

    Code of Federal Regulations, 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...

  20. 49 CFR 225.12 - Rail Equipment Accident/Incident Reports alleging employee human factor as cause; Employee Human...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 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...

  1. 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...

  2. 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…

  3. 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

  4. 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

  5. 30 CFR 285.833 - What are the reporting requirements for incidents requiring written notification?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MANAGEMENT, REGULATION, AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Environmental and Safety Management, Inspections, and Facility Assessments for Activities Conducted Under SAPs, COPs and GAPs Incident...

  6. 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

  7. Acute adverse reactions to magnetic resonance contrast media--gadolinium chelates.

    PubMed

    Li, A; Wong, C S; Wong, M K; Lee, C M; Au Yeung, M C

    2006-05-01

    The objective of this study was to evaluate the clinical safety of intravenous gadolinium-based contrast media used in patients who underwent MRI at a single institution. Acute adverse reactions to intravenous gadolinium-based contrast media used for MRI at the Princess Margaret Hospital, Hong Kong, SAR, from January 1999 to November 2004 were recorded in an incidence log book. The medical records of patients' demographics were retrospectively reviewed and the nature, frequency and severity of the adverse reactions were investigated and documented. The incidence of acute adverse reactions to intravenous gadolinium-based contrast media was 0.48% (45 patients with 46 adverse reactions). The severity of these adverse reactions were 96% mild, 2% moderate (one patient developed shortness of breath that required oxygen supplementation and intravenous steroidal management) and 2% severe (one patient developed an anaphylactoid reaction, but successfully recovered through timely resuscitation). No patients were recorded as having contrast extravasation and none died as a result of any adverse reaction. Among the 45 patients who developed adverse reactions, three patients (6.7%) had prior adverse reactions to iodinated contrast media, three (6.7%) had prior reactions to a different gadolinium-based contrast agent, one (2%) had asthma and nine (20%) had a history of drug/food allergy. Overall, 41% of the adverse reactions were not documented in the final MRI report or the clinical medical records. Gadolinium-based contrast media are safe and well tolerated by the vast majority of patients. In our study, the adverse reaction rate (0.48%) and the incidence of severe anaphylactoid reaction (0.01%) concur with those reported in the literature. Although most of the symptoms are mild and transient, these adverse reactions must be accurately documented and managed. PMID:16632615

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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…

  13. 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, Product... either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written...

  14. 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.

  15. Grazing incidence metal optics for the Berkeley Extreme Ultraviolet Explorer satellite - A progress report

    NASA Technical Reports Server (NTRS)

    Finley, D.; Malina, R. F.; Bowyer, S.

    1985-01-01

    The four flight Wolter-Schwarzschild mirrors currently under fabrication for the Extreme Ultraviolet Explorer (EUVE) satellite are described. The principal figuring operation of these grazing incidence metal mirrors (gold over nickel on an aluminum substrate) is carried out by diamond turning at the Lawrence Livermore National Laboratories. Turning has been accomplished and optical testing results analyzed for three of the mirrors. As-turned values of 1.7 arc sec full width at half maximum (FWHM) and half energy width (HEW) of 5 arc seconds in the visible have been achieved. These results illustrate the great potential of precision fabrication technology for the production of large grazing incidence optics.

  16. 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.

  17. Prostate cancer incidence in men with self-reported prostatitis after 15 years of follow-up

    PubMed Central

    Vaarala, Markku H.; Mehik, Aare; Ohtonen, Pasi; Hellström, Pekka A.

    2016-01-01

    Controversy exists regarding a possible association between prostatitis and prostate cancer. To further evaluate the incidence of prostate cancer following prostatitis, a study of prostate cancer incidence in a cohort of Finnish men was performed. The original survey evaluating self-reported prostatitis was conducted in 1996–1997. A database review was conducted focusing on prostate cancer diagnoses in the cohort. In 2012, there were 13 (5.2%) and 27 (1.8%) prostate cancer cases among men with (n=251) and without (n=1,521) prostatitis symptoms, respectively. There were no significant differences in age, primary therapy distribution, prostate-specific antigen levels, Gleason score, clinical T-class at the time of prostate cancer diagnosis, or time lag between the original survey and prostate cancer diagnosis. The standardized incidence ratio (SIR) of prostate cancer was 1.16 [95% confidence interval (CI), 0.62–1.99] and 0.44 (95% CI, 0.29–0.64) among men with and without prostatitis symptoms, respectively. After 15 years of follow-up subsequent to self-reported prostatitis, no evident increase in incidence of prostate cancer was detected among Finnish men with prostatitis symptoms. The higher percentage of prostate cancer among men with prostatitis symptoms appears to be due to coincidentally low SIR of prostate cancer among men without prostatitis symptoms, and may additionally be due to increased diagnostic examinations. Further research is required to confirm this speculation.

  18. 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…

  19. 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 de