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Sample records for adverse events study

  1. An adverse event capture and management system for cancer studies

    PubMed Central

    2015-01-01

    Background Comprehensive capture of Adverse Events (AEs) is crucial for monitoring for side effects of a therapy while assessing efficacy. For cancer studies, the National Cancer Institute has developed the Common Terminology Criteria for Adverse Events (CTCAE) as a required standard for recording attributes and grading AEs. The AE assessments should be part of the Electronic Health Record (EHR) system; yet, due to patient-centric EHR design and implementation, many EHR's don't provide straightforward functions to assess ongoing AEs to indicate a resolution or a grade change for clinical trials. Methods At UAMS, we have implemented a standards-based Adverse Event Reporting System (AERS) that is integrated with the Epic EHR and other research systems to track new and existing AEs, including automated lab result grading in a regulatory compliant manner. Within a patient's chart, providers can launch AERS, which opens the patient's ongoing AEs as default and allows providers to assess (resolution/ongoing) existing AEs. In another tab, it allows providers to create a new AE. Also, we have separated symptoms from diagnoses in the CTCAE to minimize inaccurate designation of the clinical observations. Upon completion of assessments, a physician would submit the AEs to the EHR via a Health Level 7 (HL7) message and then to other systems utilizing a Representational State Transfer Web Service. Conclusions AERS currently supports CTCAE version 3 and 4 with more than 65 cancer studies and 350 patients on those studies. This type of standard integrated into the EHR aids in research and data sharing in a compliant, efficient, and safe manner. PMID:26424052

  2. Adverse drug events in hospital: pilot study with trigger tool

    PubMed Central

    Rozenfeld, Suely; Giordani, Fabiola; Coelho, Sonia

    2013-01-01

    OBJECTIVE To estimate the frequency of and to characterize the adverse drug events at a terciary care hospital. METHODS A retrospective review was carried out of 128 medical records from a hospital in Rio de Janeiro in 2007, representing 2,092 patients. The instrument used was a list of triggers, such as antidotes, abnormal laboratory analysis results and sudden suspension of treatment, among others. A simple random sample of patients aged 15 and over was extracted. Oncologic and obstetric patients were excluded as were those hospitalized for less than 48 hours or in the emergency room. Social and demographic characteristics and those of the disease of patients who underwent adverse events were compared with those of patients who did not in order to test for differences between the groups. RESULTS Around 70.0% of the medical records assessed showed at least one trigger. Adverse drug events triggers had an overall positive predictive value of 14.4%. The incidence of adverse drug events was 26.6 per 100 patients and 15.6% patients suffered one or more event. The median length of stay for patients suffering an adverse drug event was 35.2 days as against 10.7 days for those who did not (p < 0.01). The pharmacological classes most commonly associated with an adverse drug event were related to the cardiovascular system, nervous system and alimentary tract and metabolism. The most common active substances associated with an adverse drug event were tramadol, dypirone, glibenclamide and furosemide. Over 80.0% of events provoked or contributed to temporary harm to the patient and required intervention and 6.0% may have contributed to the death of the patient. It was estimated that in the hospital, 131 events involving drowsiness or fainting 33 involving falls, and 33 episodes of hemorrhage related to adverse drug effects occur annually. CONCLUSIONS Almost one-sixth of in-patients (16,0%) suffered an adverse drug event. The instrument used may prove useful as a technique for

  3. Vaccine Adverse Events

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Vaccines, Blood & Biologics Home Vaccines, Blood & Biologics Safety & Availability ( ... Center for Biologics Evaluation & Research Vaccine Adverse Events Vaccine Adverse Events Share Tweet Linkedin Pin it More ...

  4. Severe Autoimmune Adverse Events Post Herpes Zoster Vaccine: A Case-Control Study of Adverse Events in a National Database.

    PubMed

    Lai, Yi Chun; Yew, Yik Weng

    2015-07-01

    Zoster vaccine is recommended to reduce the incidence of herpes zoster and its complication of postherpetic neuralgia in older adults. However, there have been reports of autoimmune side effects post vaccination. We therefore aim to investigate the possible relationship of severe autoimmune adverse events (arthritis, vasculitis, systemic lupus erythematosus, thrombocytopenia, alopecia, Guillain-Barre syndrome, optic neuritis and multiple sclerosis) post zoster vaccination with a matched case-control study of reported events in the Vaccine Adverse Event Reporting System (VAERS). Our study showed no significantly increased risks of severe autoimmune adverse events, except arthritis and alopecia, after vaccination. Compared to the unexposed, patients with zoster vaccination had 2.2 and 2.7 times the odds of developing arthritis and alopecia, respectively (P<0.001 and P=0.015, respectively). However, almost none of these events was life threatening. Zoster vaccine is, therefore, relatively safe and unlikely to exacerbate or induce autoimmune diseases. Given its benefits and safety but low coverage, dermatologists and primary care physicians should encourage zoster vaccine use in elderly patients, including selected patients with autoimmune diseases.

  5. Analysing adverse events by time-to-event models: the CLEOPATRA study.

    PubMed

    Proctor, Tanja; Schumacher, Martin

    2016-07-01

    When analysing primary and secondary endpoints in a clinical trial with patients suffering from a chronic disease, statistical models for time-to-event data are commonly used and accepted. This is in contrast to the analysis of data on adverse events where often only a table with observed frequencies and corresponding test statistics is reported. An example is the recently published CLEOPATRA study where a three-drug regimen is compared with a two-drug regimen in patients with HER2-positive first-line metastatic breast cancer. Here, as described earlier, primary and secondary endpoints (progression-free and overall survival) are analysed using time-to-event models, whereas adverse events are summarized in a simple frequency table, although the duration of study treatment differs substantially. In this paper, we demonstrate the application of time-to-event models to first serious adverse events using the data of the CLEOPATRA study. This will cover the broad range between a simple incidence rate approach over survival and competing risks models (with death as a competing event) to multi-state models. We illustrate all approaches by means of graphical displays highlighting the temporal dynamics and compare the obtained results. For the CLEOPATRA study, the resulting hazard ratios are all in the same order of magnitude. But the use of time-to-event models provides valuable and additional information that would potentially be overlooked by only presenting incidence proportions. These models adequately address the temporal dynamics of serious adverse events as well as death of patients. Copyright © 2016 John Wiley & Sons, Ltd.

  6. Transfusion related adverse events in the Platelet Dose study

    PubMed Central

    Kaufman, Richard M.; Assmann, Susan F.; Triulzi, Darrell J.; Strauss, Ronald G.; Ness, Paul; Granger, Suzanne; Slichter, Sherrill J.

    2014-01-01

    BACKGROUND How platelet (PLT) product characteristics such as dose, source (whole blood-derived (WBD) vs. apheresis), storage duration, and ABO matching status affect the risks of transfusion-related adverse events (TRAEs) is unclear. Similarly, more information is needed to define how recipient characteristics affect the frequency of TRAEs following PLT transfusion. STUDY DESIGN AND METHODS In the multicenter Platelet Dose (“PLADO”) study, pediatric and adult hematology-oncology patients with hypoproliferative thrombocytopenia were randomized to receive low-dose (LD), medium-dose (MD), or high-dose (HD) PLT prophylaxis for a pre-transfusion PLT count ≤10,000/μL. All PLT units (apheresis or WBD) were leukoreduced. Post hoc analyses of PLADO data were performed using multi-predictor models. RESULTS 5034 PLT transfusions to 1102 patients were analyzed. A TRAE occurred with 501 PLT transfusions (10.0%). The most common TRAEs were fever (6.6% of transfusions), allergic/hypersensitivity reactions (1.9%), and sinus tachycardia (1.8%). Patients assigned HD PLTs were more likely than LD or MD patients to experience any TRAE (OR for HD vs. MD 1.50, 95% CI (1.10, 2.05), three-group comparison p=0.02). PLT source and ABO matching status were not significantly related to overall TRAE risk. Compared to a patient’s first PLT transfusion, subsequent PLT transfusions were less likely to have a TRAE reported, primarily due to a lower risk of allergic/hypersensitivity reactions. CONCLUSION The most important PLT unit characteristic associated with TRAEs was PLT dose per transfusion. HD PLTs may increase the risk of TRAEs, and LD PLTs may reduce the risk. PMID:25065959

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

    PubMed Central

    Golder, Su; Wright, Kath

    2016-01-01

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

  8. Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study

    PubMed Central

    Kwong, Shirley L.; Padua, Florecita R.

    2013-01-01

    Background Intravenous immunoglobulin (IVIG) is a biological product with adverse effects that appears to vary considerably among different IVIG preparations. Objectives To describe the adverse events of patients given intravenous immunoglobulin infusions. Method Data was collected on all patients receiving IVIG infusion at a tertiary hospital from January 2001 to December 2010. Descriptive statistics was used. Results 77 patients (45 males, 32 females) received IVIG infusions. Thirty two percent (n = 25) experienced adverse reactions. The most common indication was Kawasaki disease (85.7%) followed by immunodeficiency disorders (7.8%). Majority of the patients were children, with the highest frequency of infusions among those aged 2 to 8 years old (52%). 36 infusions were associated with occurrence of adverse effects. Fever was the most common adverse event (n = 11, 30.6%), followed by rash (n = 8, 22.2%) and chills (n = 7, 19.4%). Other adverse events were cyanosis (n = 3, 8.3%), hypotension (n = 2, 5.6%), hypothermia (n = 2, 5.6%), irritability (n = 1, 2.8%), vomiting (n = 1, 2.8%), and chest pain (n = 1, 2.8%). Adverse events were observed to occur most frequently within 1 to 6 h from onset of IVIG infusion. Among the various IVIG preparations available locally (Gammagard, Kiovig, Gamimune, Veno-S & IV Globulin S), Gammagard was the brand frequently used (50.7%). It also has the most number of adverse events, with 17 out of 41 (41.5%) infusions resulting in adverse reactions. Most of the reactions occurred with fast infusion rates, and clinical manifestations subsided when the rate of infusion was reduced. Conclusion In this study, thirty two percent of patients given IVIG infusions experienced adverse events. Fever was the most common manifestation. Symptoms occurred within 1 to 6 h from onset of infusion, were affected by fast infusion rates, and managed by reducing the rate of infusion. PMID:24260730

  9. Serious Adverse Events in Randomized Psychosocial Treatment Studies: Safety or Arbitrary Edicts?

    ERIC Educational Resources Information Center

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

    2008-01-01

    Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance-abusing participants (N =…

  10. Adverse events associated with chloramphenicol use in dogs: a retrospective study (2007-2013).

    PubMed

    Short, J; Zabel, S; Cook, C; Schmeitzel, L

    2014-11-29

    Chloramphenicol is a broad spectrum antibiotic that has been increasingly utilised since the emergence of methicillin-resistant staphylococcal infections. Due to toxicities in humans, use of the drug has been limited. In dogs, gastrointestinal signs are common adverse events described, and bone marrow suppression is possible. The aim of this study was to evaluate the adverse events associated with chloramphenicol in dogs seen by one specialty practice from January 2007 through June 2013. The database was searched for all dogs prescribed chloramphenicol during the time period. Dosage, length of treatment, age and body weight of the dogs were recorded as well as any adverse events that occurred during treatment. A total of 105 cases were evaluated. Thirty-nine dogs experienced at least one adverse event while on the medication. The most commonly noted were gastrointestinal signs and hindlimb weakness. The mean body weight for dogs with hindlimb weakness was 35.3 kg, which was significant. Resolution was documented in 54 per cent of cases when the drug was discontinued. Methicillin-resistant Staphylococcus pseudintermedius on bacterial culture was listed as the reason for chloramphenicol use in 76 per cent of the cases. Based on this information, further prospective studies are recommended to evaluate the reproducibility of this report.

  11. OAE: The Ontology of Adverse Events

    PubMed Central

    2014-01-01

    Background A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. For example, using the data extracted from the Vaccine Adverse Event Reporting System (VAERS), OAE was used to analyse vaccine adverse events associated with the administrations of different types of influenza vaccines. OAE has also been used to represent and classify the vaccine adverse events cited in package inserts of FDA-licensed human vaccines in the USA. Conclusion OAE is a biomedical ontology that logically defines and classifies various adverse events occurring after medical interventions. OAE has successfully been applied in several adverse event studies. The OAE ontological framework provides a platform for systematic representation and analysis of

  12. [Frailty as a predictor of adverse events in epidemiological studies: literature review].

    PubMed

    Romero Rizos, Luis; Abizanda Soler, Pedro

    2013-01-01

    Several epidemiological studies have analyzed the association between frailty status and adverse geriatric health outcomes, with there being a clear relationship being demonstrated in mortality, disability, mobility loss, institutionalization and falls. However, different studies have evaluated different number of these adverse events, with different criteria, and with different follow-up periods. As a result of this relationship, the objective of geriatric medicine must not only be the prevention, diagnosis and treatment of diseases based on multidisciplinary team work and use of geriatric units according to functional status of patients, but the detection, prevention and treatment of frailty. Frailty must be considered as a pre-disability state that can be prevented and treated to delay its progression towards disability, institutionalization, and death. The characterization of frailty status can also help other medical specialties to stratify the risk of adverse health outcomes in oncology treatments, surgical interventions, or diagnostic procedures.

  13. Hospital deaths and adverse events in Brazil

    PubMed Central

    2011-01-01

    Background Adverse events are considered a major international problem related to the performance of health systems. Evaluating the occurrence of adverse events involves, as any other outcome measure, determining the extent to which the observed differences can be attributed to the patient's risk factors or to variations in the treatment process, and this in turn highlights the importance of measuring differences in the severity of the cases. The current study aims to evaluate the association between deaths and adverse events, adjusted according to patient risk factors. Methods The study is based on a random sample of 1103 patient charts from hospitalizations in the year 2003 in 3 teaching hospitals in the state of Rio de Janeiro, Brazil. The methodology involved a retrospective review of patient charts in two stages - screening phase and evaluation phase. Logistic regression was used to evaluate the relationship between hospital deaths and adverse events. Results The overall mortality rate was 8.5%, while the rate related to the occurrence of an adverse event was 2.9% (32/1103) and that related to preventable adverse events was 2.3% (25/1103). Among the 94 deaths analyzed, 34% were related to cases involving adverse events, and 26.6% of deaths occurred in cases whose adverse events were considered preventable. The models tested showed good discriminatory capacity. The unadjusted odds ratio (OR 11.43) and the odds ratio adjusted for patient risk factors (OR 8.23) between death and preventable adverse event were high. Conclusions Despite discussions in the literature regarding the limitations of evaluating preventable adverse events based on peer review, the results presented here emphasize that adverse events are not only prevalent, but are associated with serious harm and even death. These results also highlight the importance of risk adjustment and multivariate models in the study of adverse events. PMID:21929810

  14. 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

  15. Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data

    PubMed Central

    Alemzadeh, Homa; Raman, Jaishankar; Leveson, Nancy; Kalbarczyk, Zbigniew; Iyer, Ravishankar K.

    2016-01-01

    Background Use of robotic systems for minimally invasive surgery has rapidly increased during the last decade. Understanding the causes of adverse events and their impact on patients in robot-assisted surgery will help improve systems and operational practices to avoid incidents in the future. Methods By developing an automated natural language processing tool, we performed a comprehensive analysis of the adverse events reported to the publicly available MAUDE database (maintained by the U.S. Food and Drug Administration) from 2000 to 2013. We determined the number of events reported per procedure and per surgical specialty, the most common types of device malfunctions and their impact on patients, and the potential causes for catastrophic events such as patient injuries and deaths. Results During the study period, 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant (mean = 83.4, 95% confidence interval (CI), 74.2–92.7 per 100,000 procedures) over the years. Surgical specialties for which robots are extensively used, such as gynecology and urology, had lower numbers of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9 per 100,000 procedures, Risk Ratio = 2.2, 95% CI, 1.9–2.6). Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. Device malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of all the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to

  16. 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

  17. Hospitalizations Due to Adverse Drug Events in the Elderly—A Retrospective Register Study

    PubMed Central

    Laatikainen, Outi; Sneck, Sami; Bloigu, Risto; Lahtinen, Minna; Lauri, Timo; Turpeinen, Miia

    2016-01-01

    Adverse drug events (ADEs) are more likely to affect geriatric patients due to physiological changes occurring with aging. Even though this is an internationally recognized problem, similar research data in Finland is still lacking. The aim of this study was to determine the number of geriatric medication-related hospitalizations in the Finnish patient population and to discover the potential means of recognizing patients particularly at risk of ADEs. The study was conducted retrospectively from the 2014 emergency department patient records in Oulu University Hospital. A total number of 290 admissions were screened for ADEs, adverse drug reactions (ADRs) and drug-drug interactions (DDIs) by a multi-disciplinary research team. Customized Naranjo scale was used as a control method. All admissions were categorized into “probable,” “possible,” or “doubtful” by both assessment methods. In total, 23.1% of admissions were categorized as “probably” or “possibly” medication-related. Vertigo, falling, and fractures formed the largest group of ADEs. The most common ADEs were related to medicines from N class of the ATC-code system. Age, sex, residence, or specialty did not increase the risk for medication-related admission significantly (min p = 0.077). Polypharmacy was, however, found to increase the risk (OR 3.3; 95% CI, 1.5–6.9; p = 0.01). In conclusion, screening patients for specific demographics or symptoms would not significantly improve the recognition of ADEs. In addition, as ADE detection today is largely based on voluntary reporting systems and retrospective manual tracking of errors, it is evident that more effective methods for ADE detection are needed in the future. PMID:27761112

  18. Predictors of Spontaneous and Systematically Assessed Suicidal Adverse Events in the Treatment of SSRI Resistant Depression in Adolescents (TORDIA) Study

    PubMed Central

    Brent, David; Emslie, Graham; Clarke, Greg; Asarnow, Joan Rosenbaum; Spirito, Anthony; Ritz, Louise; Vitiello, Benedetto; Iyengar, Satish; Birmaher, Boris; Ryan, Neal; Zelazny, Jamie; Onorato, Matthew; Kennard, Betsy; Mayes, Taryn; DeBar, Lynn; McCracken, James; Strober, Michael; Suddath, Robert; Leonard, Henrietta; Porta, Giovanna; Keller, Marty

    2013-01-01

    Objective The authors sought to identify predictors of self-harm adverse events in treatment-resistant, depressed adolescents during the first 12 weeks of treatment. Method Depressed adolescents (N=334) who had not responded to a previous trial with an SSRI antidepressant were randomized to a switch to either another SSRI or venlafaxine, with or without cognitive behavior therapy. Self-harm events, i.e., suicidal and non-suicidal self-injury adverse events were assessed by spontaneous report for the first 181 participants, and by systematic weekly assessment for the last 153 participants. Results Higher rates of suicidal (20.8% vs. 8.8%) and nonsuicidal self-injury (17.6% vs. 2.2%), but not serious adverse events (8.4% vs. 7.3%) were detected with systematic monitoring. Median time to a suicidal event was 3 weeks, predicted by high baseline suicidal ideation, family conflict, and drug and alcohol use. Median time to nonsuicidal self-injury was 2 weeks, predicted by previous history of nonsuicidal self-injury. While there were no main effects of treatment, venlafaxine treatment was associated with a higher rate of self-harm adverse events in those with higher suicidal ideation. Adjunctive use of benzodiazepines, while in a small number of participants (N=10) was associated with higher rate of both suicidal and nonsuicidal self-injury adverse events. Conclusions Since predictors of suicidal adverse events also predict poor response to treatment, and many of these events occurred early in treatment, improving the speed of response to depression, by targeting of family conflict, suicidal ideation, and drug use may help to reduce their incidence. The relationship of venlafaxine and of benzodiazepines to selfharm events requires further study and clinical caution. PMID:19223438

  19. The international serious adverse events consortium.

    PubMed

    Holden, Arthur L; Contreras, Jorge L; John, Sally; Nelson, Matthew R

    2014-11-01

    The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.

  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.

  1. Studying critical values: adverse event identification following a critical laboratory values study at the ohio state university medical center.

    PubMed

    Jenkins, James J; Mac Crawford, J; Bissell, Michael G

    2007-10-01

    No study to date has used laboratory critical values to evaluate variations in patient adverse events. We retrospectively analyzed a database of critical values to determine their distribution by hospital unit over time. The data were drawn from the Ohio State University Medical Center Information Warehouse (Columbus) for a 58-month period. Critical values were plotted over time on statistical control charts and analyzed for unusual peaks in monthly occurrence rates. Chart review of individual patient results yielded several predictor variables for the unusual peaks. Of these, occurrence of patient adverse events was the most relevant independent predictor variable for a month with an unusual number of critical values vs a normal month. This result epidemiologically confirms the basic premise of critical value reporting and suggests that the control-chart method of this type could be a new statistical tool to compare clinical activity of different hospital locations at different times.

  2. 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

  3. Neurological adverse events in patients receiving anti-TNF therapy: a prospective imaging and electrophysiological study

    PubMed Central

    2014-01-01

    Introduction The aim was to investigate the frequency of neurological adverse events in patients with rheumatoid arthritis (RA) and spondylarthropathies (SpA) treated with tumor necrosis factor (TNF) α antagonists. Methods Seventy-seven patients eligible for anti-TNFα therapy were evaluated. There were 36 patients with RA, 41 with SpA [24 psoriatic arthritis (PsA) and 17 with ankylosing spondylitis (AS)]. All patients had a complete physical and neurological examination. Brain and cervical spine magnetic resonance imaging (MRI) and neurophysiological tests were performed in all patients before the initiation of anti-TNFα therapy and after a mean of 18 months or when clinical symptoms and signs indicated a neurological disease. Exclusion criteria included hypertension, diabetes mellitus, dyslipidemia, heart arrhythmias, atherothrombotic events, vitamin B12 and iron deficiency, head and neck trauma and neurological surgeries. Results Two patients did not receive anti-TNFα therapy because brain MRIs at baseline revealed lesions compatible with demyelinating diseases. Thus, 75 patients received anti-TNFα (38 infliximab, 19 adalimumab and 18 etanercept). Three patients developed neurological adverse events. A 35-year-old man with PsA after 8 months of infliximab therapy presented with paresis of the left facial nerve and brain MRI showed demyelinating lesions. Infliximab was discontinued and he was treated with pulses of corticosteroids recovering completely after two months. The second patient was a 45-year-old woman with RA who after 6 months of adalimumab therapy presented with optic neuritis. The third patient was a 50-year-old woman with AS, whom after 25 months of infliximab therapy, presented with tingling and numbness of the lower extremities and neurophysiological tests revealed peripheral neuropathy. In both patients anti-TNF were discontinued and they improved without treatment after 2 months. The rest of our patients showed no symptoms and MRIs

  4. 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.

  5. Adverse events in the intensive care unit: impact on mortality and length of stay in a prospective study.

    PubMed

    Roque, Keroulay Estebanez; Tonini, Teresa; Melo, Enirtes Caetano Prates

    2016-10-20

    This study sought to evaluate the occurrence of adverse events and their impacts on length of stay and mortality in an intensive care unit (ICU). This is a prospective study carried out in a teaching hospital in Rio de Janeiro, Brazil. The cohort included 355 patients over 18 years of age admitted to the ICU between August 1, 2011 and July 31, 2012. The process we used to identify adverse events was adapted from the method proposed by the Institute for Healthcare Improvement. We used a logistical regression to analyze the association between adverse event occurrence and death, adjusted by case severity. We confirmed 324 adverse events in 115 patients admitted over the year we followed. The incidence rate was 9.3 adverse events per 100 patients-day and adverse event occurrence impacted on an increase in length of stay (19 days) and in mortality (OR = 2.047; 95%CI: 1.172-3.570). This study highlights the serious problem of adverse events in intensive care and the risk factors associated with adverse event incidence. Resumo: Este estudo teve como objetivo avaliar a ocorrência de eventos adversos e o impacto deles sobre o tempo de permanência e a mortalidade na unidade de terapia intensiva (UTI). Trata-se de um estudo prospectivo desenvolvido em um hospital de ensino do Rio de Janeiro, Brasil. A coorte foi formada por 355 pacientes maiores de 18 anos, admitidos na UTI, no período de 1º de agosto de 2011 a 31 de julho de 2012. O processo de identificação de eventos adversos baseou-se em uma adaptação do método proposto pelo Institute for Healthcare Improvement. A regressão logística foi utilizada para analisar a associação entre a ocorrência de evento adverso e o óbito, ajustado pela gravidade do paciente. Confirmados 324 eventos adversos em 115 pacientes internados ao longo de um ano de seguimento. A taxa de incidência foi de 9,3 eventos adversos por 100 pacientes-dia, e a ocorrência de evento adverso impactou no aumento do tempo de internação (19

  6. Organisational sources of safety and danger: sociological contributions to the study of adverse events

    PubMed Central

    West, E.

    2000-01-01

    Organisational sociology has long accepted that mistakes of all kinds are a common, even normal, part of work. Medical work may be particularly prone to error because of its complexity and technological sophistication. The results can be tragic for individuals and families. This paper describes four intrinsic characteristics of organisations that are relevant to the level of risk and danger in healthcare settings—namely, the division of labour and "structural secrecy" in complex organisations; the homophily principle and social structural barriers to communication; diffusion of responsibility and the "problem of many hands"; and environmental or other pressures leading to goal displacement when organisations take their "eyes off the ball". The paper argues that each of these four intrinsic characteristics invokes specific mechanisms that increase danger in healthcare organisations but also offer the possibility of devising strategies and behaviours to increase patient safety. Stated as hypotheses, these ideas could be tested empirically, thus adding to the evidence on which the avoidance of adverse events in healthcare settings is based and contributing to the development of theory in this important area. (Quality in Health Care 2000;9:120–126) Key Words: organisation; safety; errors; adverse events PMID:11067250

  7. Early Adverse Events and Attrition in SSRI Treatment: A Suicide Assessment Methodology Study (SAMS) Report

    PubMed Central

    Warden, Diane; Trivedi, Madhukar H.; Wisniewski, Stephen R.; Kurian, Benji; Zisook, Sidney; Kornstein, Susan G.; Friedman, Edward S.; Miyahara, Sachiko; Leuchter, Andrew F.; Fava, Maurizio; Rush, John

    2011-01-01

    Adverse events during selective serotonin reuptake inhibitor (SSRI) treatment are frequent and may lead to premature treatment discontinuation. If attrition is associated with early worsening of side effects or the frequency, intensity, or burden of side effects, interventions to maximize retention could be focused on patients with these events. Outpatient participants (n=265) with nonpsychotic major depressive disorder entered an 8-week trial with an SSRI. At baseline and week 2, specific side effects were evaluated with the Systematic Assessment for Treatment Emergent Events – Systematic Inquiry, and at week 2 the Frequency, Intensity, and Burden of Side Effects Rating globally assessed side effects. Attrition was defined by those participants who left treatment after week 2 but before week 8. No specific week 2 side effect, either treatment emergent or with worsening intensity, was independently associated with attrition. Global ratings of side effect frequency, intensity, or burden at week 2 were also not associated with subsequent attrition. Neither global ratings nor specific side effects at week 2 were related to patient attrition during SSRI treatment. Other factors appear to contribute to patient decisions about continuing with treatment. PMID:20473060

  8. Absence of adverse events in healthy individuals using probiotics--analysis of six randomised studies by one study group.

    PubMed

    Tapiovaara, L; Lehtoranta, L; Poussa, T; Mäkivuokko, H; Korpela, R; Pitkäranta, A

    2016-01-01

    Consumption of live bacteria as probiotic supplements is increasing. There is, however, a lack of information on the safety of ingested probiotics. The main objective of this study was to investigate the adverse events (AEs) of specific probiotics (Lactobacillus rhamnosus GG (LGG) alone or LGG in combination with L. rhamnosus Lc705, Propionibacterium freudenreichii JS, Bifidobacterium lactis BB12, or Bifidobacterium breve 99) studied in six of our study groups' clinical trials, by analysing individual participant data. A secondary objective was to study AEs associated with the consumed probiotic species and mixtures in three specific categories; 'gastrointestinal disorders', 'respiratory, thoracic and mediastinal disorders' and 'infections and infestations'. Six randomised, double-blind, placebo-controlled clinical studies by our study group were included in this AE analysis (study population n=1,909). All AE data were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0. From the 26 CTCAE System Organ Classes, we identified AEs in 20 classes among 1,909 subjects. Probiotic ingestion did not result in statistically significant differences in AEs in different groups, when compared to placebo. A subgroup analysis of gastrointestinal, respiratory, thoracic and mediastinal disorders, infections and infestations, found no differences between the intervention groups or for different probiotic combinations (risk ratio (RR) = 0.97, 95% confidence interval (CI): 0.93-1.02, P=0.30; RR=0.99, 95% CI: 0.97-1.01, P=0.35; RR=0.99, 95% CI: 0.93-1.06, P=0.62, respectively). As a conclusion, ingestion of probiotic supplementations containing LGG alone, or LGG in combination with L. rhamnosus Lc705, P. freudenreichii JS, B. breve 99, or B. lactis BB12 did not seem to cause AEs in young and elderly subjects in this analysis.

  9. Serious Adverse Events After Cataract Surgery

    PubMed Central

    Stein, Joshua D.

    2013-01-01

    Purpose Over the past several decades there have been many advances in the equipment, instrumentation and techniques of performing cataract surgery. This review will address the impact of these advances on the safety profile of cataract surgery. Recent Findings Recent studies have demonstrated a decline in the risk of serious postoperative adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) following cataract surgery. Factors that increase the risk of serious complications from cataract surgery include patient-related factors (male sex, concomitant diabetic retinopathy, same day cataract surgery combined with another intraocular surgery, tamsulosin use) and surgeon-related factors (low surgical volume, limited experience, operating on patients who are most prone to adverse events). Summary Cataract surgery continues to be a very safe surgical procedure with few patients experiencing serious sight-threatening adverse events. Studies in the literature have helped surgeons identify patients who are at high risk for surgical complications and to develop strategies to limit surgical complications when operating on these patients. As multifocal intraocular lenses, femtosecond laser technology, and other surgical innovations continue to gain popularity, it will be interesting in the coming years to determine whether there will be a continued reduction in complications of cataract surgery. PMID:22450221

  10. [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.

  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. 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

  13. Determinants of Adverse Events in Vascular Surgery

    PubMed Central

    Hernandez-Boussard, Tina; McDonald, Kathryn; Morton, John; Dalman, Ron L; Bech, Fritz R

    2016-01-01

    Background Patient safety is a national priority. Patient Safety Indicators (PSIs) monitor potential adverse events during hospital stays. Surgical specialty PSI benchmarks do not exist, which are needed to account for differences in the range of procedures performed, reasons for the procedure, and differences in patient characteristics. A comprehensive profile of adverse events in vascular surgery was created. Study Design The Nationwide Inpatient Sample was queried for 8 vascular procedures using ICD-9-CM codes from 2005–2009. Factors associated with PSI development were evaluated in univariate and multivariate analyses. Results A total of 1,412,703 patients underwent a vascular procedure and 5.2% developed a PSI. PSIs were more frequent in female, non-white patients with public payers (p<.01). Patients at mid and low volume hospitals had greater odds of developing a PSI (Odds Ratio [OR], 1.17; 95% Confidence Interval [CI], 1.10–1.23 and OR, 1.69; CI, 1.53–1.87). Amputations had highest PSI risk-adjusted rate (RAR) and carotid endarterectomy and endovascular abdominal aortic aneurysm (AAA) repair had lower RAR (p<.0001). PSI RAR increased linearly by severity of patient indication: claudicants (OR, 0.40, CI, 0.35–0.46), rest pain patients (OR, 0.78, CI 0.69–0.90), ulcer (OR: 1.20, CI: 1.07–1.34) and gangrene patients (OR:1.85, CI: 1.66–2.06). Conclusions Patient safety events in vascular surgery were high and varied by procedure, with amputations and open AAA having substantially more potential adverse events. PSIs were associated with black race, public payer, and procedure indication. It is important to note the overall higher rates of PSIs occurring in vascular patients and appropriately adjust benchmarks for this surgical specialty. PMID:22425449

  14. Design of Adverse Drug Events-Scorecards.

    PubMed

    Marcilly, Romaric; Chazard, Emmanuel; Beuscart-Zéphir, Marie-Catherine; Hackl, Werner; Băceanu, Adrian; Kushniruk, Andre; Borycki, Elizabeth M

    2011-01-01

    This paper presents the design of Adverse Drug Event-Scorecards. The scorecards described are innovative and novel, not having previously been reported in the literature. The Scorecards provide organizations (e.g. hospitals) with summary information about Adverse Drug Events (ADEs) using a Web-based platform. The data used in the Scorecards are routinely updated and report on ADEs detected through data mining processes. The development of the ADE Scorecards is ongoing and they are currently undergoing clinical testing.

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

    PubMed

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

    2015-04-08

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

  16. The Role of Personal Goals in Depressive Reaction to Adverse Life Events: A Cross-Sectional Study

    PubMed Central

    Couyoumdjian, Alessandro; Ottaviani, Cristina; Trincas, Roberta; Spitoni, Grazia; Tenore, Katia; Mancini, Francesco

    2012-01-01

    Consistent with cognitive views of depression, we aimed to investigate the mediating role of personal goals in the relationship between stressful events and distinct patterns of depressive symptoms in a nonclinical sample. Participants identified a dysphoric episode that occurred in the previous year by reporting the severity of 12 depressive symptoms and their plausible cause. A goal taxonomy was used to determine how much the event interfered with the achievement of a series of personal goals. After controlling for age and current level of depression, the patterns of symptoms differed based on the triggering events. The relationship between sadness and affective losses was partially mediated by the personal goal of lovableness, and success was a partial mediator in the association between an event of failure and symptoms of worthlessness and anhedonia. Although the cross-sectional design of the study does not allow for conclusions on the direction of effects, findings suggest the importance of motivational factors in the development of specific patterns of depressive symptoms to adverse events. Assuming a continuum from low mood to clinical depression, treatment models could benefit from a precise identification of the specific stressors that initiate depressive behaviour and the personal meaning assigned to those events. PMID:23304090

  17. Understanding adverse events: human factors.

    PubMed Central

    Reason, J

    1995-01-01

    (1) Human rather than technical failures now represent the greatest threat to complex and potentially hazardous systems. This includes healthcare systems. (2) Managing the human risks will never be 100% effective. Human fallibility can be moderated, but it cannot be eliminated. (3) Different error types have different underlying mechanisms, occur in different parts of the organisation, and require different methods of risk management. The basic distinctions are between: Slips, lapses, trips, and fumbles (execution failures) and mistakes (planning or problem solving failures). Mistakes are divided into rule based mistakes and knowledge based mistakes. Errors (information-handling problems) and violations (motivational problems) Active versus latent failures. Active failures are committed by those in direct contact with the patient, latent failures arise in organisational and managerial spheres and their adverse effects may take a long time to become evident. (4) Safety significant errors occur at all levels of the system, not just at the sharp end. Decisions made in the upper echelons of the organisation create the conditions in the workplace that subsequently promote individual errors and violations. Latent failures are present long before an accident and are hence prime candidates for principled risk management. (5) Measures that involve sanctions and exhortations (that is, moralistic measures directed to those at the sharp end) have only very limited effectiveness, especially so in the case of highly trained professionals. (6) Human factors problems are a product of a chain of causes in which the individual psychological factors (that is, momentary inattention, forgetting, etc) are the last and least manageable links. Attentional "capture" (preoccupation or distraction) is a necessary condition for the commission of slips and lapses. Yet, its occurrence is almost impossible to predict or control effectively. The same is true of the factors associated with

  18. Adverse Drug Event-based Stratification of Tumor Mutations: A Case Study of Breast Cancer Patients Receiving Aromatase Inhibitors.

    PubMed

    Wang, Chen; Zimmermann, Michael T; Prodduturi, Naresh; Chute, Christopher G; Jiang, Guoqian

    2014-01-01

    Adverse drug events (ADEs) are a critical factor for selecting cancer therapy options. The underlying molecular mechanisms of ADEs associated with cancer therapy drugs may overlap with their antineoplastic mechanisms; an aspect of toxicity. In the present study, we develop a novel knowledge-driven approach that provides an ADE-based stratification (ADEStrata) of tumor mutations. We demonstrate clinical utility of the ADEStrata approach through performing a case study of breast invasive carcinoma (BRCA) patients receiving aromatase inhibitors (AI) from The Cancer Genome Atlas (TCGA) (n=212), focusing on the musculoskeletal adverse events (MS-AEs). We prioritized somatic variants in a manner that is guided by MS-AEs codified as 6 Human Phenotype Ontology (HPO) terms. Pathway enrichment and hierarchical clustering of prioritized variants reveals clusters associated with overall survival. We demonstrated that the prediction of per-patient ADE propensity simultaneously identifies high-risk patients experiencing poor outcomes. In conclusion, the ADEStrata approach could produce clinically and biologically meaningful tumor subtypes that are potentially predictive of the drug response to the cancer therapy drugs.

  19. Combined adverse effects of cascading events on systems' functionality: an insular case study, French West Indies

    NASA Astrophysics Data System (ADS)

    Desramaut, Nicolas; Wang, Justin; Gehl, Pierre; Marti, Jose; Baills, Audrey; Reveillere, Arnaud

    2013-04-01

    In our modern societies, lifelines play a vital role, even in normal conditions. Therefore, during crises, the dependency to critical infrastructures is likely to be exacerbated. Indeed, in order to provide quick emergency services to the population, systems have to be functional. However, even if not directly damaged, in order to be functional, elements of the different systems have to receive enough resources but also to be able to supply their own services. In a multi-risk approach, this necessity to take into account systemic vulnerability to assess the real impact of natural hazards on society is even made more obvious. For example, impacts of one hazard, taken separately, might not significantly affect societies, but might reduce redundancy, and therefore could increase functional vulnerability to other hazards. The present study aims at analyzing the effects of cascading events on the behaviour of interdependent systems and on the capacities of the health care system to treat the victims. In order to work on a close system, an insular context (Guadeloupe, French West Indies) has been selected. The hazard cascading scenario consists of a M6.3 earthquake striking Basse-Terre, and triggering landslides in the mountainous areas where antecedent precipitations have made the area prone to slide. Damages due to earthquakes have been estimated for the 5 considered systems (buildings, healthcare system, electrical network, water supply network and transportation). Due to their localization in mountainous areas, landslides would affect only transportation networks, with closure of roads. The inter- and intra-dependencies of systems have been modeled thanks to the I2Sim platform developed at UBC. The functionality of each element is therefore the consequence of the physical (direct damage) but also functional (indirect) damage. Analyses are performed for different strategies of resources allocations, and one of the final results is the impact of the induced landslides

  20. Association Patterns in Open Data to Explore Ciprofloxacin Adverse Events

    PubMed Central

    2015-01-01

    Summary Background Ciprofloxacin is one of the main drugs to treat bacterial infections. Bacterial infections can lead to high morbidity, mortality, and costs of treatment in the world. In this study, an analysis was conducted using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database on the adverse events of ciprofloxacin. Objectives The aim of this study was to explore unknown associations among the adverse events of ciprofloxacin, patient demographics and adverse event outcomes. Methods A search of FDA AERS reports was performed and some statistics was highlighted. The most frequent adverse events and event outcomes of ciprofloxacin were listed, age and gender specific distribution of adverse events are reported, then the apriori algorithm was applied to the dataset to obtain some association rules and objective measures were used to select interesting ones. Furthermore, the results were compared against classical data mining algorithms and discussed. Results The search resulted in 6 531 reports. The reports included within the dataset consist of 3 585 (55.8%) female and 2 884 (44.1%) male patients. The mean age of patients is 54.59 years. Preschool child, middle aged and aged groups have most adverse events reports in all groups. Pyrexia has the highest frequency with ciprofloxacin, followed by pain, diarrhoea, and anxiety in this order and the most frequent adverse event outcome is hospitalization. Age and gender based differences in the events in patients were found. In addition, some of the interesting associations obtained from the Apriori algorithm include not only psychiatric disorders but specifically their manifestation in specific gender groups. Conclusions The FDA AERS offers an important data resource to identify new or unknown adverse events of drugs in the biomedical domain. The results that were obtained in this study can provide valuable information for medical researchers and decision makers at the

  1. Peripheral Venous Catheter-Related Adverse Events: Evaluation from a Multicentre Epidemiological Study in France (the CATHEVAL Project)

    PubMed Central

    Miliani, Katiuska; Taravella, Raphaël; Thillard, Denis; Chauvin, Valérie; Martin, Emmanuelle; Edouard, Stéphanie; Astagneau, Pascal

    2017-01-01

    Introduction Peripheral venous catheters (PVC) are medical devices most frequently used during hospital care. Although the frequency of specific PVC-related adverse events (PVCAEs) has been reported, the global risk related to the insertion of this device is poorly estimated. The aim of this study is to determine the incidence of PVCAEs during the indwell time, after catheter removal, and to identify practice-mirroring risk factors. Methods A prospective observational study was conducted as a part of a research project, called CATHEVAL, in one surgery ward and four medicine wards from three public general tertiary care hospitals in Northern France that were invited to participate between June-2013 and June-2014. Each participating ward included during a two-month study period all patients older than 15 years carrying a PVC. All inserted PVCs were monitored from insertion of PVC to up to 48 hours after removal. Monitored data included several practice-mirroring items, as well as the occurrence of at least one PVCAE. A multivariate Cox proportional hazard model, based on a marginal risk approach, was used to identify factors associated with the occurrence of at least one PVCAE. Results Data were analysed for 815 PVCs (1964 PVC-days) in 573 patients. The incidence of PVCAE was 52.3/100 PVCs (21.9/100 PVC-days). PVCAEs were mainly clinical: phlebitis (20.1/100 PVCs), haematoma (17.7/100 PVCs) and liquid/blood escape (13.1/100 PVCs). Infections accounted for only 0.4/100 PVCs. The most frequent mechanical PVCAEs, was obstruction/occlusion of PVC (12.4/100 PVCs). The incidence of post-removal PVCAEs was 21.7/100 PVCs. Unstable PVC and unclean dressing were the two main risk factors. Conclusion Limitation of breaches in healthcare quality including post-removal monitoring should be reinforced to prevent PVC-related adverse events in hospital settings. PMID:28045921

  2. Glaucoma-related adverse events in the first five years after unilateral cataract removal in the Infant Aphakia Treatment Study

    PubMed Central

    Freedman, Sharon F.; Lynn, Michael J.; Beck, Allen D.; Bothun, Erick D.; Orge, Faruk H.; Lambert, Scott R.

    2015-01-01

    Importance Glaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy, yet their relationship to aphakia versus primary intraocular lens (IOL) implantation remains unsettled. Objective To identify and characterize cases of glaucoma and glaucoma-related adverse events (glaucoma+glaucoma suspect) among children in the Infant Aphakia Treatment Study (IATS) by the age of five years. Design, Setting, and Participants A multicenter randomized controlled trial of 114 infants with unilateral congenital cataract who were between age 1–6 months at surgery. Interventions Participants were randomized at cataract surgery to either primary IOL, or no IOL implantation (contact lens [CL]). Standardized definitions of glaucoma and glaucoma suspect were created for IATS and applied for surveillance and diagnosis. Main Outcome Measures Development of glaucoma and glaucoma+glaucoma suspect in operated eyes up to age five years, plus intraocular pressure, visual acuity, and axial length at age five years. Results Product limit estimates of the risk of glaucoma and glaucoma+glaucoma suspect at 4.8 years after surgery were 17% (95%CI=11%–25%) and 31% (95%CI=24%–41%), respectively. The CL and IOL groups were not significantly different for either outcome: glaucoma (hazard ratio(HR)=0.8[95%CI=0.3–2.0],p=0.62); glaucoma+glaucoma suspect: (HR=1.3[95%CI=0.6–2.5],p=0.58). Younger (versus older) age at surgery conferred increased risk of glaucoma (26% versus 9%, respectively at 4.8 years after surgery (HR=3.2[95%CI=1.2–8.3]), and smaller (versus larger) corneal diameter showed increased risk for glaucoma+glaucoma suspect (HR=2.5[95%CI=1.3–5.0]). Age and corneal diameter were significantly positively correlated. Glaucoma was predominantly open angle (19/20 cases, 95%), most eyes received medication (19/20, 95%), and 8/20 (40%) eyes had surgery. Conclusions and Relevance These results suggest that glaucoma-related adverse events

  3. Adverse events in 50 cats with allergic dermatitis receiving ciclosporin.

    PubMed

    Heinrich, Nicole A; McKeever, Patrick J; Eisenschenk, Melissa C

    2011-12-01

    Ciclosporin is an immunosuppressive drug that has been used to treat allergies and other immune-mediated diseases in cats, dogs and humans. Information about the adverse effects of ciclosporin in cats has been limited to smaller studies and case reports. Adverse effects in dogs are mainly gastrointestinal in nature, but humans can also experience hypertension and altered renal function. The aim of this retrospective case series study was to document the occurrence and clinical appearance of adverse events in cats receiving ciclosporin to treat allergic skin disease. The medical records of 50 cats with allergic dermatitis treated with oral ciclosporin (1.9-7.3 mg/kg/day) were reviewed. Adverse events occurred in 66% (33 cats). Adverse events likely to be associated with ciclosporin included the following: vomiting or diarrhoea within 1-8 weeks of receiving ciclosporin (24%), weight loss (16%), anorexia and subsequent hepatic lipidosis (2%) and gingival hyperplasia (2%). Other adverse events less likely to be associated with ciclosporin therapy included the following: weight gain (14%), dental tartar and gingivitis (10%), otitis (4%), chronic diarrhoea (4%), inflammatory bowel disease with indolent gastrointestinal lymphoma (2%), urinary tract infection (2%), cataract (2%), elevated liver enzymes (2%), hyperthyroidism and renal failure (2%) and transient inappropriate urination (2%). Some cats experienced multiple adverse events. Case-control studies are needed to prove cause and effect of ciclosporin with regard to these adverse events.

  4. Adverse events related to blood transfusion.

    PubMed

    Sahu, Sandeep; Hemlata; Verma, Anupam

    2014-09-01

    The acute blood transfusion reactions are responsible for causing most serious adverse events. Awareness about various clinical features of acute and delayed transfusion reactions with an ability to assess the serious reactions on time can lead to a better prognosis. Evidence-based medicine has changed today's scenario of clinical practice to decrease adverse transfusion reactions. New evidence-based algorithms of transfusion and improved haemovigilance lead to avoidance of unnecessary transfusions perioperatively. The recognition of adverse events under anaesthesia is always challenging. The unnecessary blood transfusions can be avoided with better blood conservation techniques during surgery and with anaesthesia techniques that reduce blood loss. Better and newer blood screening methods have decreased the infectious complications to almost negligible levels. With universal leukoreduction of red blood cells (RBCs), selection of potential donors such as use of male donors only plasma and restriction of RBC storage, most of the non-infectious complications can be avoided.

  5. Adverse Events of Auricular Therapy: A Systematic Review

    PubMed Central

    Molassiotis, Alexander; Wang, Tao; Suen, Lorna K. P.

    2014-01-01

    The aim of this study was to systematically evaluate the literature on adverse events associated with auricular therapy (AT). Case reports, case series, surveys, and all types of clinical trials reporting adverse events of AT were included. Relevant articles were mainly retrieved from 13 electronic databases and seven Chinese journals on complementary medicine. AT-related adverse events were reported in 32 randomized controlled trials, five uncontrolled clinical trials, four case reports, and two controlled clinical trials. For auricular acupuncture, the most frequently reported adverse events were tenderness or pain at insertion, dizziness, local discomfort, minor bleeding and nausea, and so forth. For auricular acupressure, local skin irritation and discomfort, mild tenderness or pain, and dizziness were commonly reported. Skin irritation, local discomfort, and pain were detected in auricular electroacupuncture, and minor infection was identified in auricular bloodletting therapy. Most of these events were transient, mild, and tolerable, and no serious adverse events were identified. Our findings provide preliminary evidence that AT is a relatively safe approach. Considering the patient's safety, prospective or retrospective surveys are needed in future research to gather practitioner-reported and patient-reported adverse events on AT, and the quality of adverse events reporting in future AT trials should be improved. PMID:25435890

  6. Admissions and Readmissions Related to Adverse Events, 2007-2014

    DTIC Science & Technology

    2015-12-01

    1.0 Pregnancy, childbirth and puerperium 1,071 2.3 107 0.5 4,172 7.5 5 0.4 816 1.9 5,525 4.3 Respiratory system 3,609 7.8 638 2.8 3,110 5.6 200 14.3...This study assessed adverse events as they relate to readmissions in the Military Health System (MHS). Among 142,579 admissions with an adverse event...The following study retrospectively assessed admissions and readmissions for adverse events in the Military Health System (MHS) by quantifying

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

    PubMed

    Nakayama, Tetsuo; Onoda, Kazumasa

    2007-01-05

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

  8. Data mining for signal detection of adverse event safety data.

    PubMed

    Chen, Hung-Chia; Tsong, Yi; Chen, James J

    2013-01-01

    The Adverse Event Reporting System (AERS) is the primary database designed to support the Food and Drug Administration (FDA) postmarketing safety surveillance program for all approved drugs and therapeutic biologic products. Most current disproportionality analysis focuses on the detection of potential adverse events (AE) involving a single drug and a single AE only. In this paper, we present a data mining biclustering technique based on the singular value decomposition to extract local regions of association for a safety study. The analysis consists of collection of biclusters, each representing an association between a set of drugs with the corresponding set of adverse events. Significance of each bicluster can be tested using disproportionality analysis. Individual drug-event combination can be further tested. A safety data set consisting of 193 drugs with 8453 adverse events is analyzed as an illustration.

  9. [Adverse events in patients from a pediatric hospital.

    PubMed

    Ornelas-Aguirre, José Manuel; Arriaga-Dávila, José de Jesús; Domínguez-Serrano, María Isabel; Guzmán-Bihouet, Beatriz Filomena; Navarrete-Navarro, Susana

    2013-01-01

    Background: detection of adverse events is part of the safety management in hospitalized patients. The objective of this study was to describe the incidence of adverse events that occurred in a pediatric hospital. Methods: cross-sectional study of the adverse events occurred in a pediatric hospital from 2007 to 2009. Factors associated with their developmental causes were identified. The statistical analysis was descriptive and bivariate, with contingency tables to estimate the relationship between those factors. A p value = 0.05 was considered significant. Results: a total of 177 adverse events were registered. When they began, human factor occurred in 23 cases (13 %, OR = 1.41, p = 0.001), organizational factor was present in 71 cases (40 %, OR = 1.91, p = 0.236) and technical factor in 46 cases (26 %, OR = 0.87, p = 0.01). Blows or bruises from falls as a result of adverse events occurred in 71 cases (40 %, 95 % CI = 64-78). Conclusions: we found 1.84 events per 100 hospital discharges during the study period. The fall of patients ranked first of the adverse events identified.

  10. Adverse life events and delinquent behavior among Kenyan adolescents: a cross-sectional study on the protective role of parental monitoring, religiosity, and self-esteem

    PubMed Central

    2014-01-01

    Background Past research provides strong evidence that adverse life events heighten the risk of delinquent behavior among adolescents. Urban informal (slum) settlements in sub-Saharan Africa are marked by extreme adversity. However, the prevalence and consequences of adverse life events as well as protective factors that can mitigate the effects of exposure to these events in slum settlements is largely understudied. We examine two research questions. First, are adverse life events experienced at the individual and household level associated with a higher likelihood of delinquent behavior among adolescents living in two slums in Nairobi, Kenya? Second, are parental monitoring, religiosity, and self-esteem protective against delinquency in a context of high adversity? Methods We used cross-sectional data from 3,064 males and females aged 12–19 years who participated in the Transitions to Adulthood Study. We examined the extent to which a composite index of adverse life events was associated with delinquent behavior (measured using a composite index derived from nine items). We also examined the direct and moderating effects of three protective factors: parental monitoring, religiosity, and self-esteem. Results Fifty-four percent of adolescents reported at least one adverse life event, while 18% reported three or more adverse events. For both males and females, adversity was positively and significantly associated with delinquency in bivariate and multivariate models. Negative associations were observed between the protective factors and delinquency. Significant adverse events × protective factor interaction terms were observed for parental monitoring (females and males), religiosity (males), and self-esteem (females). Conclusions Similar to research in high income countries, adverse life events are associated with an increased likelihood of delinquent behavior among adolescents living in urban slums in Kenya, a low-income country. However, parental monitoring

  11. Response to treatment and adverse events associated with use of recombinant activated factor VII in children: a retrospective cohort study

    PubMed Central

    Cooper, James D.; Ritchey, Arthur K.

    2016-01-01

    Background: Recombinant activated factor VII (rFVIIa) is United States (US) Food and Drug Administration (FDA)-approved for patients with hemophilia with inhibitors or congenital factor VII deficiency. Initial reports of off-label use highlighted its efficacy, though newer reports have not repeated these findings. In both types of publication, though, secondary thromboses have been seen in adult patients. The data in children are less clear. Methods: This study analyzed all rFVIIa use at a large children’s hospital for characteristics and outcomes. Recipients of rFVIIa were identified retrospectively via the electronic medical record. Data on patient diagnosis, lab data, other treatments, adverse events, and outcomes were collected. Results: Over 33 months, 66 patient episodes were treated with a total of 606 doses (median = 2). The most common indication (36.4%) was gastrointestinal bleeding (24/66 patients). Only one patient received a dose for an approved labeled indication. For control of bleeding, 33.3% of courses were unsuccessful (19/57). Bleeding from multiple sites was associated with treatment failure. In 16.7% of patients (11/66), unexpected adverse thromboses developed within 1 week of completing a course of rFVIIa. Thromboses in both intra- and extra-corporeal sites were included if they compromised patient care. Conclusions: In the majority of cases reviewed, rFVIIa was successful in stopping or slowing serious bleeding episodes. It was least effective when a patient had diffuse bleeding at the time of administration. The thrombosis rate of 16.7% was higher than expected, though causality cannot be declared. Further investigation is needed to determine the risk–benefit ratio in children. PMID:28255432

  12. Prevalence of negative life events and chronic adversities in European pre- and primary-school children: results from the IDEFICS study

    PubMed Central

    2012-01-01

    Background Children are not always recognized as being susceptible to stress, although childhood stressors may originate from multiple events in their everyday surroundings with negative effects on children’s health. Methods As there is a lack of large-scale, European prevalence data on childhood adversities, this study presents the prevalence of (1) negative life events and (2) familial and social adversities in 4637 European pre- and primary-school children (4–11 years old), using a parentally-reported questionnaire embedded in the IDEFICS project (‘Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS’). Results The following findings were observed: (1) Certain adversities occur only rarely, while others are very regular (i.e. parental divorce); (2) A large percentage of children is shielded from stressors, while a small group of children is exposed to multiple, accumulating adversities; (3) The prevalence of childhood adversity is influenced by geographical location (e.g. north versus south), age group and sex; (4) Childhood adversities are associated and co-occur, resulting in potential cumulative childhood stress. Conclusions This study demonstrated the importance of not only studying traumatic events but also of focusing on the early familial and social environment in childhood stress research and indicated the importance of recording or monitoring childhood adversities. PMID:23173879

  13. Statin-Associated Muscle Adverse Events

    PubMed Central

    Al-Mohaissen, Maha A.; Ignaszewski, Martha J.; Frohlich, Jiri; Ignaszewski, Andrew P.

    2016-01-01

    Statins are potent medications which reduce low-density lipoprotein cholesterol (LDL-C) levels. Their efficacy in cardiovascular risk reduction is well established and indications for their use are expanding. While statins are generally well tolerated and safe, adverse events are relatively common, particularly statin-associated muscle adverse events (SaMAEs), which are the most frequently encountered type of adverse event. Recent guidelines and guideline updates on SaMAEs and statin intolerance have included revised definitions of SaMAEs, incorporating new evidence on their pathogenesis and management. As SaMAEs emerge as a therapeutic challenge, it is important for physicians to be aware of updates on management strategies to ensure better patient outcomes. The majority of patients who are considered statin-intolerant can nevertheless tolerate some forms of statin therapy and successfully achieve optimal LDL-C levels. This review article discusses the recent classification of SaMAEs with emphasis on pathogenesis and management strategies. PMID:28003885

  14. Adverse cardiac events to monoclonal antibodies used for cancer therapy

    PubMed Central

    Kounis, Nicholas G; Soufras, George D; Tsigkas, Grigorios; Hahalis, George

    2014-01-01

    Monoclonal antibodies are currently used in the treatment of neoplastic, hematological, or inflammatory diseases, a practice that is occasionally associated with a variety of systemic and cutaneous adverse events. Cardiac adverse events include cardiomyopathy, ventricular dysfunction, arrhythmias, arrests, and acute coronary syndromes, such as acute myocardial infarction and vasospastic angina pectoris. These events generally follow hypersensitivity reactions including cutaneous erythema, pruritus chills, and precordial pain. Recently, IgE specific for therapeutic monoclonal antibodies have been detected, pointing to the existence of hypersensitivity and Kounis hypersensitivity-associated syndrome. Therefore, the careful monitoring of cardiovascular events is of paramount importance in the course of monoclonal antibody-based therapies. Moreover, further studies are needed to elucidate the pathophysiology of cardiovascular adverse events elicited by monoclonal antibodies and to identify preventive, protective, and therapeutic measures. PMID:25340003

  15. Impact of age, sex and route of administration on adverse events after opioid treatment in the emergency department: A retrospective study

    PubMed Central

    Daoust, Raoul; Paquet, Jean; Lavigne, Gilles; Piette, Éric; Chauny, Jean-Marc

    2015-01-01

    BACKGROUND: The efficacy of opioids for acute pain relief in the emergency department (ED) is well recognized, but treatment with opioids is associated with adverse events ranging from minor discomforts to life-threatening events. OBJECTIVE: To assess the impact of age, sex and route of administration on the incidence of adverse events due to opioid administration in the ED. METHODS: Real-time archived data were analyzed retrospectively in a tertiary care urban hospital. All consecutive patients (≥16 years of age) who were assigned to an ED bed and received an opioid between March 2008 and December 2012 were included. Adverse events were defined as: nausea/vomiting (minor); systolic blood pressure (SBP) <90 mmHg, oxygen saturation (Sat) <92% and respiration rate <10 breaths/min (major) within 2 h of the first opioid doses. RESULTS: In the study period, 31,742 patients were treated with opioids. The mean (± SD) age was 55.8±20.5 years, and 53% were female. The overall incidence of adverse events was 12.0% (95% CI 11.6% to 12.4%): 5.9% (95% CI 5.6% to 6.2%) experienced nausea/vomiting, 2.4% (95% CI 2.2% to 2.6%) SBP <90 mmHg, 4.7% (95% CI 4.5% to 4.9%) Sat that dropped to <92% and 0.09% respiration rate <10 breaths/min. After controlling for confounding factors, these adverse events were associated with: female sex (more nausea/vomiting, more SBP <90 mmHg, less Sat <92%); age ≥65 years (less nausea/vomiting, more SBP <90 mmHg, more Sat <92%); and route of administration (intravenous > subcutaneous > oral). CONCLUSIONS: The incidence of adverse events associated with opioid administration in the ED is generally low and is associated with age, sex and route of administration. PMID:25664538

  16. Lower mortality following pulmonary adverse events and sepsis with ticagrelor compared to clopidogrel in the PLATO study.

    PubMed

    Storey, Robert F; James, Stefan K; Siegbahn, Agneta; Varenhorst, Christoph; Held, Claes; Ycas, Joseph; Husted, Steen E; Cannon, Christopher P; Becker, Richard C; Steg, Ph Gabriel; Åsenblad, Nils; Wallentin, Lars

    2014-01-01

    In the PLATelet inhibition and patient Outcomes (PLATO) study of patients with acute coronary syndromes, ticagrelor reduced mortality compared to clopidogrel but the mechanisms for this mortality reduction remain uncertain. We analysed adverse events (AEs) consistent with either pulmonary infection or sepsis, and subsequent mortality, in 18,421 PLATO patients treated with ticagrelor or clopidogrel. AEs occurring within 7 days of last dose of study medication were defined as "on-treatment". Serial measurements of blood leukocyte counts, C-reactive protein and interleukin-6 were performed. Fewer on-treatment pulmonary AEs occurred in the ticagrelor compared to the clopidogrel group (275 vs. 331 respectively; p = 0.019), with fewer deaths following these AEs (33 vs. 71; p < 0.001), particularly in those who remained on study medication three days after AE onset (10 vs. 43; p < 0.001). There were fewer deaths attributed to sepsis in the ticagrelor group (7 vs. 23; p = 0.003). Leukocyte counts were lower in the clopidogrel group during treatment (p < 0.0001 at 1, 3 and 6 months) but not at 1 month post-discontinuation. C-reactive protein increased more at discharge in the ticagrelor group (28.0 ± 38.0 vs. 26.1 ± 36.6 mg/l; p < 0.001) and interleukin-6 remained higher during the first month of treatment with ticagrelor. We conclude that the mortality risk following pulmonary AEs and sepsis in acute coronary syndrome patients appears to be lower during ticagrelor compared to clopidogrel therapy. Further work should assess whether ticagrelor and clopidogrel have differential effects on immune signalling.

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

    PubMed

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

    2015-01-01

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

  18. [Adverse events of immune checkpoint inhibitors].

    PubMed

    Foller, S; Oppel-Heuchel, H; Fetter, I; Winkler, Y; Grimm, M-O

    2017-04-01

    After immune checkpoint inhibitor therapy was approved for renal cell carcinoma last year, this new immune therapy has spread to urology. Further approvals (atezolizumab, nivolumab, pembrolizumab) are expected in 2017 for metastatic urothelial carcinoma that has progressed following treatment with platinum-based chemotherapy. With expanding use of immune checkpoint inhibitors, experience in diagnosing and managing immune-mediated adverse events increases. Although of low incidence, grade 3/4 toxicities play a central role. Organs most common for immune-mediated adverse events are skin, liver (hepatitis), kidneys (nephritis), gastrointestinal tract (diarrhea and colitis), lungs (pneumonitis), and endocrine organs (hyper-, hypothyroidism and hypophysitis). Diagnostic workup includes routine laboratory tests (including liver function tests) and may be supplemented with hormone values. In cases of pneumonitis or hypophysitis, imaging (high-resolution CT, MRI) can confirm diagnoses. Immune-mediated toxicities are treated with therapy interruption and administration of corticosteroids (and in individual cases additional immunosuppression). Dose modification is not intended!

  19. Development of a Pediatric Adverse Events Terminology

    PubMed Central

    Gipson, Debbie S.; Kirkendall, Eric S.; Gumbs-Petty, Brenda; Quinn, Theresa; Steen, A.; Hicks, Amanda; McMahon, Ann; Nicholas, Savian; Zhao-Wong, Anna; Taylor-Zapata, Perdita; Turner, Mark; Herreshoff, Emily; Jones, Charlotte; Davis, Jonathan M.; Haber, Margaret; Hirschfeld, Steven

    2017-01-01

    In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute’s Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute’s Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization. PMID:28028203

  20. Development of a Pediatric Adverse Events Terminology.

    PubMed

    Gipson, Debbie S; Kirkendall, Eric S; Gumbs-Petty, Brenda; Quinn, Theresa; Steen, A; Hicks, Amanda; McMahon, Ann; Nicholas, Savian; Zhao-Wong, Anna; Taylor-Zapata, Perdita; Turner, Mark; Herreshoff, Emily; Jones, Charlotte; Davis, Jonathan M; Haber, Margaret; Hirschfeld, Steven

    2017-01-01

    In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute's Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute's Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization.

  1. 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

  2. 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

  3. Patient stratification and identification of adverse event correlations in the space of 1190 drug related adverse events

    PubMed Central

    Roitmann, Eva; Eriksson, Robert; Brunak, Søren

    2014-01-01

    Purpose: New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse event co-occurrences. Methods: We analyzed the similarity of adverse event profiles of 2347 patients extracted from EMRs from a mental health center in Denmark. The patients were clustered based on their adverse event profiles and the similarities were presented as a network. The set of adverse events in each main patient cluster was evaluated. Co-occurrences of adverse events in patients (p-value < 0.01) were identified and presented as well. Results: We found that each cluster of patients typically had a most distinguishing adverse event. Examination of the co-occurrences of adverse events in patients led to the identification of potentially interesting adverse event correlations that may be further investigated as well as provide further patient stratification opportunities. Conclusions: We have demonstrated the feasibility of a novel approach in pharmacovigilance to stratify patients based on fine-grained adverse event profiles, which also makes it possible to identify adverse event correlations. Used on larger data sets, this data-driven method has the potential to reveal unknown patterns concerning adverse event occurrences. PMID:25249979

  4. Cadec: A corpus of adverse drug event annotations.

    PubMed

    Karimi, Sarvnaz; Metke-Jimenez, Alejandro; Kemp, Madonna; Wang, Chen

    2015-06-01

    CSIRO Adverse Drug Event Corpus (Cadec) is a new rich annotated corpus of medical forum posts on patient-reported Adverse Drug Events (ADEs). The corpus is sourced from posts on social media, and contains text that is largely written in colloquial language and often deviates from formal English grammar and punctuation rules. Annotations contain mentions of concepts such as drugs, adverse effects, symptoms, and diseases linked to their corresponding concepts in controlled vocabularies, i.e., SNOMED Clinical Terms and MedDRA. The quality of the annotations is ensured by annotation guidelines, multi-stage annotations, measuring inter-annotator agreement, and final review of the annotations by a clinical terminologist. This corpus is useful for studies in the area of information extraction, or more generally text mining, from social media to detect possible adverse drug reactions from direct patient reports. The corpus is publicly available at https://data.csiro.au.(1).

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

    PubMed

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

    2009-01-01

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

  6. Adverse Respiratory Events Associated With Hypnotics Use in Patients of Chronic Obstructive Pulmonary Disease: A Population-Based Case-Control Study.

    PubMed

    Chung, Wei-Sheng; Lai, Ching-Yuan; Lin, Cheng-Li; Kao, Chia-Hung

    2015-07-01

    Insomnia is prevalent in patients with chronic obstructive pulmonary disease (COPD).We conducted a population-based case-control study to evaluate the effects of hypnotics on the risk of adverse respiratory events in patients with COPD.The case-control study was investigated using data retrieved from the Taiwan National Health Insurance Research Database. Patients with newly diagnosed adverse respiratory events (pneumonia, COPD with acute exacerbation, acute respiratory failure, and cardiopulmonary arrest) were included in the case group. Patients with COPD and no history of adverse respiratory events were randomly selected for the control group, which was frequency-matched with the case group according to index date, age (per 10 years), and sex. Patients who had used hypnotics within 1 month meant active users. The odds ratios (ORs) and 95% confidence intervals (CIs) of were calculated using univariable and multivariable logistic regression models.Most of the study participants were male (71.6%), and the mean ages of the participants in the case and control groups were 69.2 (±12.4) and 67.5 (±12.3) years, respectively. After potential confounding factors were adjusting for, the adjusted ORs of adverse respiratory events were 12.0 for active users of benzodiazepines (95% CI, 8.11-17.6) and 10.5 for active users of nonbenzodiazepines (95% CI, 7.68-14.2) compared with the adjusted ORs of those who never used hypnotics.The results of this epidemiological study suggested that hypnotics increased the risk of adverse respiratory events in patients with COPD.

  7. 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

  8. Regular treatment with formoterol for chronic asthma: serious adverse events

    PubMed Central

    Cates, Christopher J; Cates, Matthew J

    2014-01-01

    Background Epidemiological evidence has suggested a link between beta2-agonists and increases in asthma mortality. There has been much debate about possible causal links for this association, and whether regular (daily) long-acting beta2-agonists are safe. Objectives The aim of this review is to assess the risk of fatal and non-fatal serious adverse events in trials that randomised patients with chronic asthma to regular formoterol versus placebo or regular short-acting beta2-agonists. Search methods We identified trials using the Cochrane Airways Group Specialised Register of trials. We checked websites of clinical trial registers for unpublished trial data and Food and Drug Administration (FDA) submissions in relation to formoterol. The date of the most recent search was January 2012. Selection criteria We included controlled, parallel design clinical trials on patients of any age and severity of asthma if they randomised patients to treatment with regular formoterol and were of at least 12 weeks’ duration. Concomitant use of inhaled corticosteroids was allowed, as long as this was not part of the randomised treatment regimen. Data collection and analysis Two authors independently selected trials for inclusion in the review. One author extracted outcome data and the second author checked them. We sought unpublished data on mortality and serious adverse events. Main results The review includes 22 studies (8032 participants) comparing regular formoterol to placebo and salbutamol. Non-fatal serious adverse event data could be obtained for all participants from published studies comparing formoterol and placebo but only 80% of those comparing formoterol with salbutamol or terbutaline. Three deaths occurred on regular formoterol and none on placebo; this difference was not statistically significant. It was not possible to assess disease-specific mortality in view of the small number of deaths. Non-fatal serious adverse events were significantly increased when

  9. Severe Adverse Events Following Cataract Surgery Among Medicare Beneficiaries

    PubMed Central

    Stein, Joshua D.; Grossman, Daniel S.; Mundy, Kevin M.; Sugar, Alan; Sloan, Frank A.

    2012-01-01

    Purpose To determine rates and risk factors associated with severe post-operative complications following cataract surgery and whether they have been changing over the past decade. Design Retrospective longitudinal cohort study Participants 221,594 Medicare beneficiaries who underwent cataract surgery during 1994–2006. Methods Beneficiaries were stratified into 3 cohorts, those who underwent initial cataract surgery during 1994-5, 1999–2000, or 2005-6. One year rates of post-operative severe adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) were determined for each cohort. Cox regression analyses determined the hazard of developing severe adverse events for each cohort with adjustment for demographic factors, ocular and medical conditions, and surgeon case-mix. Main Outcome Measures Time period rates of development of severe post-operative adverse events. Results Among the 221,594 individuals who underwent cataract surgery, 0.5% (1,086) had at least one severe post-operative complication. After adjustment for confounders, individuals who underwent cataract surgery during 1994-5 had a 21% increased hazard of being diagnosed with a severe post-operative complication (Hazard Ratio (HR): 1.21; [95% Confidence Interval (CI): 1.05–1.41]) relative to individuals who underwent cataract surgery during 2005-6. Those who underwent cataract surgery during 1999–2000 had a 20% increased hazard of experiencing a severe complication (HR: 1.20 [95% CI: 1.04–1.39]) relative to the 2005-6 cohort. Risk factors associated with severe adverse events include a prior diagnosis of proliferative diabetic retinopathy (HR: 1.62 [95% CI: 1.07–2.45]) and cataract surgery combined with another intraocular surgical procedure on the same day (HR: 2.51 [95% CI: 2.07–3.04]). Individuals receiving surgery by surgeons with the case-mix least prone to developing a severe adverse event (HR: 0.52 [95% CI: 0.44–0.62]) had a 48% reduced hazard of a severe

  10. VA Health Care: Actions Needed to Assess Decrease in Root Cause Analyses of Adverse Events

    DTIC Science & Technology

    2015-07-01

    VA HEALTH CARE Actions Needed to Assess Decrease in Root Cause Analyses of Adverse Events Report to Congressional...2015 4. TITLE AND SUBTITLE VA Health Care: Actions Needed to Assess Decrease in Root Cause Analyses of Adverse Events 5a. CONTRACT NUMBER 5b...Analyses of Adverse Events Why GAO Did This Study Adverse events are incidents that pose a risk of injury to a patient as the result of a medical

  11. Adverse-event profile of Crataegus spp.: a systematic review.

    PubMed

    Daniele, Claudia; Mazzanti, Gabriela; Pittler, Max H; Ernst, Edzard

    2006-01-01

    Crataegus spp. (hawthorn) monopreparations are predominantly used for treating congestive heart failure. The effectiveness of hawthorn preparations (flowers with leaves; berries) is documented in a number of clinical studies, reviews and meta-analyses. The aim of this article is to assess the safety data of all available human studies on hawthorn monopreparations. Systematic searches were conducted on MEDLINE, EMBASE, AMED, The Cochrane Library, the UK National Research Register and the US ClinicalTrials.gov (up to January 2005). Data were requested from the spontaneous reporting scheme of the WHO. Hand searches were also conducted in a sample of relevant medical journals, conference proceedings, reference lists of identified articles and our own files. Eight manufacturers of hawthorn-containing preparations were contacted and asked to supply any information on adverse events or drug interactions. Data from all clinical studies and reports were assessed. Only human studies on monopreparations were included. Data from hawthorn-containing combination preparations and homeopathic preparations were excluded. All studies were read and evaluated by one reviewer and independently verified by at least one additional reviewer.Twenty-nine clinical studies were identified, of which 24 met our inclusion criteria. A total of 7311 patients were enrolled, and data from 5,577 patients were available for analysis. The daily dose and duration of treatment with hawthorn monopreparations ranged from 160 to 1,800 mg and from 3 to 24 weeks, respectively. The extracts most used in the clinical trials were WS 1,442 (extract of hawthorn standardised to 18.75% oligomeric procyanidins) and LI 132 (extract of hawthorn standardised to 2.25% flavonoids). Overall, 166 adverse events were reported. Most of these adverse events were, in general, mild to moderate; eight severe adverse events have been reported with the LI 132 extract. The most frequent adverse events were dizziness/vertigo (n = 15

  12. The Relationship Between the Adverse Events and Efficacy of Sorafenib in Patients With Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Study from Northwest China.

    PubMed

    Zheng, Yu; Wang, Fuli; Wu, Guojun; Zhang, Longlong; Wang, Yangmin; Wang, Zhiping; Chen, Peng; Wang, Qing; Lu, Jingyi; Wang, Yujie; Li, Peijun; Wang, Jian; Lu, Xitao; Yuan, Jianlin

    2015-12-01

    The aim of the study is to evaluate the relationship between the adverse events and efficacy of sorafenib in patients with metastatic renal cell carcinoma (mRCC), with a purpose to guide the judgment of efficacy in sorafenib treatment.Eighty-three mRCC patients who received sorafenib therapy at northwest China were studied retrospectively. Univariate and multivariate analyses were performed to correlate tumor response, progression-free survival (PFS), and overall survival (OS) with adverse event types and grades.Among 83 patients who underwent sorafenib therapy, 2 cases (2.4%) had completed response (CR), 14 cases (16.9%) had partial response (PR), 57 cases (68.7%) had stable disease (SD), and 10 cases (12.0%) developed progressive disease (PD). The median PFS and OS were 15.0 and 29.0 months, respectively. The most frequent grade 1 or 2 adverse events included hand-foot syndrome (68.7%), diarrhea (54.2%), and alopecia (51.8%). The most common grade 3 or 4 adverse events were hand-foot syndrome (6.0%), hypertension (4.8%), and diarrhea (3.6%). The frequency and severity of adverse events correlated with tumor response rate (both with P < 0.05). Multivariate analysis showed the independent predictors of better PFS included rash (OR 0.307, 95%CI 0.148-0.636, P = 0.001) and diarrhea (OR 0.391, 95%CI 0.169-0.783, P = 0.008). Elevated transaminase was the independent predictor of poor PFS (OR 2.606, 95%CI 1.299-5.532, P = 0.012). For OS, rash (OR 0.473, 95%CI 0.253-0.886, P = 0.019) and diarrhea (OR 0.321, 95%CI 0.171-0.605, P = 0.000) correlated with better OS.Sorafenib-related adverse events are associated with efficacy in patients with mRCC from northwest China. Rash and diarrhea are independent protective factors of both PFS and OS, and elevated transaminase is an independent risk factor of PFS. A large prospective study is warranted.

  13. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    PubMed

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

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

    PubMed

    Carroll, Rhonda; McLean, Jenny; Walsh, Michael

    2003-01-01

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

  15. Bias correction of risk estimates in vaccine safety studies with rare adverse events using a self-controlled case series design.

    PubMed

    Zeng, Chan; Newcomer, Sophia R; Glanz, Jason M; Shoup, Jo Ann; Daley, Matthew F; Hambidge, Simon J; Xu, Stanley

    2013-12-15

    The self-controlled case series (SCCS) method is often used to examine the temporal association between vaccination and adverse events using only data from patients who experienced such events. Conditional Poisson regression models are used to estimate incidence rate ratios, and these models perform well with large or medium-sized case samples. However, in some vaccine safety studies, the adverse events studied are rare and the maximum likelihood estimates may be biased. Several bias correction methods have been examined in case-control studies using conditional logistic regression, but none of these methods have been evaluated in studies using the SCCS design. In this study, we used simulations to evaluate 2 bias correction approaches-the Firth penalized maximum likelihood method and Cordeiro and McCullagh's bias reduction after maximum likelihood estimation-with small sample sizes in studies using the SCCS design. The simulations showed that the bias under the SCCS design with a small number of cases can be large and is also sensitive to a short risk period. The Firth correction method provides finite and less biased estimates than the maximum likelihood method and Cordeiro and McCullagh's method. However, limitations still exist when the risk period in the SCCS design is short relative to the entire observation period.

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

    PubMed Central

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

    2017-01-01

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

  17. Adverse perinatal events associated with ART.

    PubMed

    Skora, Daniel; Frankfurter, David

    2012-04-01

    Since the advent of ART, much research has focused on the potential adverse for resultant harm. Prematurity, low birth-weight, PIH, congenital malformations, and CP are closely tied to multiple gestation. With the increase in elective single embryo transfer, there will be a reduction in adversity related to multiple birth. It is understood that underlying causes of infertility, including advanced maternal age, PCOS, thyroid disease, and uterine fibroids, predispose to adverse outcomes. However, imprinting abnormalities do not appear to stem from multiple births, and thus the need to consider the association between fertility treatment and methylation disorders remains essential. These, as well as risks of multi-fetal gestation, must be discussed with patients when considering using assisted reproduction.

  18. Text mining electronic health records to identify hospital adverse events.

    PubMed

    Gerdes, Lars Ulrik; Hardahl, Christian

    2013-01-01

    Manual reviews of health records to identify possible adverse events are time consuming. We are developing a method based on natural language processing to quickly search electronic health records for common triggers and adverse events. Our results agree fairly well with those obtained using manual reviews, and we therefore believe that it is possible to develop automatic tools for monitoring aspects of patient safety.

  19. Gambling and Adverse Life Events Among Urban Adolescents

    PubMed Central

    Lee, Grace P.; Derevensky, Jeffrey L.; Ialongo, Nicholas S.; Martins, Silvia S.

    2011-01-01

    This study explored the cross sectional association between adverse life events and gambling in a sample of 515 urban adolescents (average age 17, 55% male, 88% African American). Approximately half of the sample had gambled in the past year (51%); 78% of the gamblers gambled monthly and 39% had a gambling-related problem. On the other hand, 88% of the sample had experienced at least one life event in the past year, and those experiencing events tended to live in more disadvantaged neighborhoods. The mere acknowledgement of experiencing a stressful life event in the past year (yes/no) was not associated with an increase in odds of being a gambler, with gambling more frequently, or with having a gambling problem. However, when the context of the event was considered, an association was found between directly experiencing threatening and deviant/violent types of events and frequent gambling (OR > 2). Additionally, the probability of being a gambler increased as the number of events experienced increased (aOR = 1.07, 95% CI = 1.01, 1.13, P = 0.013), but problems among gamblers were not associated with the number of events experienced (aOR = 1.01, 95% CI = 0.92, 1.11, P = 0.876). During adolescence, life events appear to be connected more with the frequency of gambling rather than with problems related to gambling. PMID:21614529

  20. [The association between adverse events and nursing care: measurement problems].

    PubMed

    Palese, Alvisa

    2011-01-01

    The association between adverse events and nursing care: measurement problems. Staffing of RNs below target levels has been associated with increased adverse events, included mortality. Some events may be directly associated to lack of surveillance or care, others occur as a result of neglected care and cannot be associated to the shift with levels of nurses below the target. However, a close look to negative events, neglecting positive events provides an incomplete view. Such studies have been criticized because they have not shown a direct link between the level of staffing and individual patient experiences, often did not control for sill mix and did not explore in depth what nurses do and what are their priorities when there is an higher workload. Often these studies present data with mean values ignoring that nurse staffing is not the same across an entire hospital and nursing care is delivered in geographically-based units, with wide variation in staffing levels. A future challenge of research is to combine a descriptive-quantitative approach with the collection of more qualitative data and prospective designs.

  1. Study of adverse events following immunisation with universal and newer vaccines in the Serampore IMA Child Clinic over a period of 7 years.

    PubMed

    Das, Pradip Kumar

    2013-04-01

    Immunisation is an important part of childcare practice. It is one of the most beneficial and cost effective measures for the prevention of diseases. From the previous retrospective studies, it was evident that smallpox has been completely eradicated throughout now-a-days with the wholehearted and sincere efforts of healthcare providers by applying efficient and safe vaccine against smallpox, same is true also to polio which is now close to worldwide eradication and measles and rubella are no longer endemic in certain parts of the world. Not only has that with the introduction of safer and more efficient newer vaccines, the incidence of most other vaccine preventable disease of childhood also reduced considerably. The aim of the present study is to estimate the incidence and clinical presentation of adverse events following immunisation with universal and newer vaccines for a period of seven years using prospective active surveillance. Children under the age of 7 years were taken for universal and newer scheduled vaccinations given in the Serampore IMA Child Clinic under the supervision of the clinicians maintaining strictly the guidelines of Expanded Programme of Immunisation (Government of India). This study of adverse events following immunisation in the Serampore IMA Child Clinic confirms that the adverse events such as fever (0.37%), pain and swelling at the site of injection (0.32%0, urticarial rash (0.02%), anaphylactic shock (0.003%) are negligible. There were only two reports of anaphylaxis following preschool and infant schedule vaccines, including measles, mumps and rubella (MMR), Haemophilus influenzae type B vaccines and typhoid vaccines in approximately 52,000 infants received over a period of 7 years starting from 1st April, 2005 to 31st March, 2012 and there were no deaths or longterm effects reported during the post follow-up period in the Serampore IMA Child Clinic.

  2. Regular treatment with salmeterol for chronic asthma: serious adverse events

    PubMed Central

    Cates, Christopher J; Cates, Matthew J

    2014-01-01

    treated with regular salmeterol (95% CI 95 to 2606). There is insufficient evidence to assess whether the risk in children is higher or lower than in adults. We found no significant increase in fatal or non-fatal serious adverse events when regular salmeterol was compared with regular salbutamol. We combined individual patient data from the two largest studies (SNS: n=25,180 and SMART: n=26,355), as all the asthma-related deaths in adults occurred in these studies. In patients who were not taking inhaled corticosteroids, compared to regular salbutamol or placebo, there was a significant increase in risk of asthma-related death with regular salmeterol (Peto OR 6.15 95% CI 1.73 to 21.84). The confidence interval for patients who were taking inhaled corticosteroids is wide and cannot rule in or out an increase in asthma mortality in the presence of an inhaled corticosteroid (Peto OR 2.03 95% CI 0.82 to 5.00). Authors’ conclusions In comparison with placebo, we have found an increased risk of serious adverse events with regular salmeterol. There is also a clear increase in risk of asthma-related mortality in patients not using inhaled corticosteroids in the two large surveillance studies. Although the increase in asthma-related mortality was smaller in patients taking inhaled corticosteroids at baseline, the confidence interval is wide, so we cannot conclude that the inhaled corticosteroids abolish the risks of regular salmeterol. The adverse effects of regular salmeterol in children remain uncertain due to the small number of children studied. PMID:18646149

  3. CareTrack Kids—part 3. Adverse events in children's healthcare in Australia: study protocol for a retrospective medical record review

    PubMed Central

    Hibbert, Peter D; Hallahan, Andrew R; Muething, Stephen E; Lachman, Peter; Hooper, Tamara D; Wiles, Louise K; Jaffe, Adam; White, Les; Wheaton, Gavin R; Runciman, William B; Dalton, Sarah; Williams, Helena M; Braithwaite, Jeffrey

    2015-01-01

    Introduction A high-quality health system should deliver care that is free from harm. Few large-scale studies of adverse events have been undertaken in children's healthcare internationally, and none in Australia. The aim of this study is to measure the frequency and types of adverse events encountered in Australian paediatric care in a range of healthcare settings. Methods and analysis A form of retrospective medical record review, the Institute of Healthcare Improvement's Global Trigger Tool, will be modified to collect data. Records of children aged <16 years managed during 2012 and 2013 will be reviewed. We aim to review 6000–8000 records from a sample of healthcare practices (hospitals, general practices and specialists). Ethics and dissemination Human Research Ethics Committee approvals have been received from the Sydney Children's Hospital Network, Children's Health Queensland Hospital and Health Service, and the Women's and Children's Hospital Network in South Australia. An application is under review with the Royal Australian College of General Practitioners. 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:25854978

  4. Declining Long-Term Risk of Adverse Events after First-time Community-presenting Venous Thromboembolism: The Population-based Worcester VTE Study (1999 to 2009)

    PubMed Central

    Huang, W.; Goldberg, R.J.; Cohen, A.T.; Anderson, F.A.; Kiefe, C.I.; Gore, J.M.; Spencer, F.A.

    2015-01-01

    Introduction Contemporary trends in health-care delivery are shifting the management of venous thromboembolism (VTE) events (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) from the hospital to the community, which may have implications for its prevention, treatment, and outcomes. Materials and Methods Population-based surveillance study monitoring trends in clinical epidemiology among residents of the Worcester, Massachusetts, metropolitan statistical area (WMSA) diagnosed with an acute VTE in all 12 WMSA hospitals. Patients were followed for up to 3 years after their index event. Total of 2334 WMSA residents diagnosed with first-time community-presenting VTE (occurring in an ambulatory setting or diagnosed within 24 hours of hospitalization) from 1999 through 2009. Results While PE patients were consistently admitted to the hospital for treatment over time, the proportion diagnosed with DVT-alone admitted to the hospital decreased from 67% in 1999 to 37% in 2009 (p value for trend <0.001). Among hospitalized patients, the mean length of stay decreased from 5.6 to 4.8 days (p value for trend <0.001). Between 1999 and 2009, treatment of VTE shifted from warfarin and unfractionated heparin towards use of low-molecular-weight heparins and newer anticoagulants; also, 3-year cumulative event rates decreased for all-cause mortality (41–26%), major bleeding (12–6%), and recurrent VTE (17–9%). Conclusions A decade of change in VTE management was accompanied by improved long-term outcomes. However, rates of adverse events remained fairly high in our population-based surveillance study, implying that new risk-assessment tools to identify individuals at increased risk for developing major adverse outcomes over the long-term are needed. PMID:25921936

  5. Periodontal Treatment Reduces Risk of Adverse Respiratory Events in Patients With Chronic Obstructive Pulmonary Disease: A Propensity-Matched Cohort Study.

    PubMed

    Shen, Te-Chun; Chang, Pei-Ying; Lin, Cheng-Li; Chen, Chia-Hung; Tu, Chih-Yen; Hsia, Te-Chun; Shih, Chuen-Ming; Hsu, Wu-Huei; Sung, Fung-Chang; Kao, Chia-Hung

    2016-05-01

    Treatment of periodontal diseases has been associated with benefit outcomes for patients with chronic obstructive pulmonary disease (COPD). However, no population-based cohort study has been conducted. We evaluated this relationship by retrospective cohort study using a large population data.Using the National Health Insurance claims data of Taiwan, we identified 5562 COPD patients with periodontal diseases who had received periodontal treatment as the treatment group. The comparison group was selected at a 1:1 ratio matched by the propensity score estimated with age, sex, date of COPD diagnosis and periodontal treatment, and comorbidities. Both groups were followed up for 5 years to compare risks of acute exacerbation, pneumonia, and acute respiratory failure.The incidence rates of adverse respiratory events were significantly lower in the treatment group than in the comparison group: 3.79 versus 4.21 per 100 person-years for emergency room visits, 2.75 versus 3.65 per 100 person-years for hospitalizations, and 0.66 versus 0.75 per 100 person-years for intensive care unit admissions. The treatment group also had a 37% reduced risk of deaths (1.81 vs 2.87 per 100 person-years), with an adjusted hazard ratio of 0.57 (95% confidence interval 0.52-0.62).Periodontal treatment for COPD patients could reduce the risk of adverse respiratory events and mortality. The adequate periodontal health care is important for COPD patients with periodontal diseases.

  6. Vaccine adverse events: separating myth from reality.

    PubMed

    Kimmel, Sanford R

    2002-12-01

    Vaccines have turned many childhood diseases into distant memories in industrialized countries. However, questions have been raised about the safety of some vaccines because of rare but serious adverse effects that have been attributed to them. Pain, swelling, and redness at the injection site are common local reactions to vaccines. Fever and irritability may occur after some immunizations. Currently, no substantial evidence links measles-mumps-rubella vaccine to autism, or hepatitis B vaccine to multiple sclerosis. Thimerosal is being eliminated from routine childhood vaccines because of concerns that multiple immunizations with vaccines containing this preservative could exceed recommended mercury exposures. Family physicians should be knowledgeable about vaccines so that they can inform their patients of the benefits of immunization and any proven risks. If immunization rates fall, the incidence of vaccine-preventable illnesses may rise.

  7. Adverse events after hepatitis A B combination vaccine.

    PubMed

    Woo, Emily Jane; Miller, Nancy B; Ball, Robert

    2006-03-24

    In May 2001, the U.S. Food and Drug Administration (FDA) approved Hepatitis A Inactivated and Hepatitis B Recombinant Vaccine (HEPAB) for immunization of adults. From May 2001 to September 2003, the Vaccine Adverse Event Reporting System (VAERS) received 305 reports of adverse events after HEPAB. Many events were similar to those reported after the monovalent hepatitis A and B vaccines. Non-serious events included constitutional symptoms and local reactions. Serious events included neurologic, hepatobiliary, and dermatologic conditions, and detailed medical and epidemiological review did not suggest a clear pattern of evidence supporting a causal relationship with the vaccine, except for injection site reactions and some allergic reactions.

  8. Measuring errors and adverse events in health care.

    PubMed

    Thomas, Eric J; Petersen, Laura A

    2003-01-01

    In this paper, we identify 8 methods used to measure errors and adverse events in health care and discuss their strengths and weaknesses. We focus on the reliability and validity of each, as well as the ability to detect latent errors (or system errors) versus active errors and adverse events. We propose a general framework to help health care providers, researchers, and administrators choose the most appropriate methods to meet their patient safety measurement goals.

  9. A Framework of Knowledge Integration and Discovery for Supporting Pharmacogenomics Target Predication of Adverse Drug Events: A Case Study of Drug-Induced Long QT Syndrome

    PubMed Central

    Jiang, Guoqian; Wang, Chen; Zhu, Qian; Chute, Christopher G.

    2013-01-01

    Knowledge-driven text mining is becoming an important research area for identifying pharmacogenomics target genes. However, few of such studies have been focused on the pharmacogenomics targets of adverse drug events (ADEs). The objective of the present study is to build a framework of knowledge integration and discovery that aims to support pharmacogenomics target predication of ADEs. We integrate a semantically annotated literature corpus Semantic MEDLINE with a semantically coded ADE knowledgebase known as ADEpedia using a semantic web based framework. We developed a knowledge discovery approach combining a network analysis of a protein-protein interaction (PPI) network and a gene functional classification approach. We performed a case study of drug-induced long QT syndrome for demonstrating the usefulness of the framework in predicting potential pharmacogenomics targets of ADEs. PMID:24303306

  10. Accelerated Infliximab Infusion: Safety, Factors Predicting Adverse Events, Patients’ Satisfaction and Cost Analysis. A Cohort Study in IBD Patients

    PubMed Central

    Mazzuoli, S.; Tricarico, D.; Demma, F.; Furneri, G.; Guglielmi, F. W.

    2016-01-01

    Background Standard Infliximab infusion consists of a 2-hour intravenous administration. Recently, Infliximab shortened infusion has been included in the Infliximab label as possible maintenance regimen for patients tolerating Infliximab induction therapy. Aim To verify if accelerated 1-hour Infliximab infusions are as safe as standard administrations, in patients with Inflammatory Bowel Disease. Methods Seventy-four patients treated between September 2008 and November 2014 were evaluated. Patients were eligible for 1-hour infusion if they had no history of infusion reactions during the previous 2-hour infusions. Results Twenty-three patients received 2-hour infusions, 16 patients received 1-hour infusions, 35 patients received 2-hour infusions followed by 1-hour infusions. A total of 1,123 Infliximab infusions were administered. The proportion of patients experiencing infusion reaction was: 4% over the 1-hour infusions and 9% over the 2-hour (P = 0.318). Adverse reaction/infusion rate was 0.55% over the 1-hour infusions and 0.66% over the 2-hour (P = 0.835). In the logistic model, accelerated infusion was the only statistically significant predictor of infusion reaction risk reduction (-90%; P = 0.024). Mean satisfaction was 8/10 (±0.84) with 1-hour regimen and 6/10 (±0.56) with 2-hour infusions (P = 0.000). The mean total cost was reduced by 47% with the 1-hour regimen (133.54€ and 250.86€ for 1-hour and 2-hour infusions, respectively). Conclusions Accelerated Infliximab infusion does not increase the acute infusion reaction incidence. In patients with inflammatory bowel disease, the 1-hour regimen should be preferred to 2-hour protocol also due to positive effects on indirect costs and patient’s satisfaction. PMID:27851772

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

    NASA Technical Reports Server (NTRS)

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

    2004-01-01

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

  12. Managing adverse events in the use of bevacizumab and chemotherapy.

    PubMed

    Blowers, Elaine; Hall, Kate

    The anti-angiogenic agent bevacizumab (Avastin) has received regulatory approval for the treatment of metastatic breast cancer (MBC) in combination with the taxane chemotherapy agent paclitaxel. A range of side-effects associated with this agent have been identified across different tumour types; these are known to differ from those frequently reported with chemotherapy agents. This article is part one of a two-part literature review that was conducted to provide insight into the range, frequency and severity of adverse events that arise specifically in breast cancer when bevacizumab is combined with cytotoxic chemotherapy. PubMed and the websites of oncology conferences were searched to identify studies of bevacizumab plus chemotherapy in patients with MBC. Seventeen studies met the search criteria, including 3,836 bevacizumab-treated patients. Side-effects associated with bevacizumab included hypertension, proteinuria, thromboembolic events, bleeding and cardiac toxicity. Part two of the series will appear in the next issue of BJN.

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

    PubMed

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

    2012-01-01

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

  14. Frequency of Adverse Events after Vaccination with Different Vaccinia Strains

    PubMed Central

    Kretzschmar, Mirjam; Wallinga, Jacco; Teunis, Peter; Xing, Shuqin; Mikolajczyk, Rafael

    2006-01-01

    Background Large quantities of smallpox vaccine have been stockpiled to protect entire nations against a possible reintroduction of smallpox. Planning for an appropriate use of these stockpiled vaccines in response to a smallpox outbreak requires a rational assessment of the risks of vaccination-related adverse events, compared to the risk of contracting an infection. Although considerable effort has been made to understand the dynamics of smallpox transmission in modern societies, little attention has been paid to estimating the frequency of adverse events due to smallpox vaccination. Studies exploring the consequences of smallpox vaccination strategies have commonly used a frequency of approximately one death per million vaccinations, which is based on a study of vaccination with the New York City Board of Health (NYCBH) strain of vaccinia virus. However, a multitude of historical studies of smallpox vaccination with other vaccinia strains suggest that there are strain-related differences in the frequency of adverse events after vaccination. Because many countries have stockpiled vaccine based on the Lister strain of vaccinia virus, a quantitative evaluation of the adverse effects of such vaccines is essential for emergency response planning. We conducted a systematic review and statistical analysis of historical data concerning vaccination against smallpox with different strains of vaccinia virus. Methods and Findings We analyzed historical vaccination data extracted from the literature. We extracted data on the frequency of postvaccinal encephalitis and death with respect to vaccinia strain and age of vaccinees. Using a hierarchical Bayesian approach for meta-analysis, we estimated the expected frequencies of postvaccinal encephalitis and death with respect to age at vaccination for smallpox vaccines based on the NYCBH and Lister vaccinia strains. We found large heterogeneity between findings from different studies and a time-period effect that showed

  15. Effect of Two Different Methods of Initiating Atomoxetine on the Adverse Event Profile of Atomoxetine

    ERIC Educational Resources Information Center

    Greenhill, Laurence L.; Newcorn, Jeffrey H.; Gao, Haitao; Feldman, Peter D.

    2007-01-01

    Objective: To compare the effects of two different methods for initiating atomoxetine in terms of the incidence of early adverse events. Method: Data on atomoxetine treatment-emergent adverse events in youths, ages 6 to 18 years, were analyzed from five randomized, double-blind, placebo-controlled, acute-phase studies. Two studies involve…

  16. [The extra cost of care-related adverse events in hospitals].

    PubMed

    Nestrigue, Clément; Or, Zeynep

    2016-04-01

    Adverse events bring into question the safety and quality of care for patients, but also represent a significant cost for society. For example, the annual cost of nine adverse events assessed in a study by the French Institute for Research and Documentation in Health Economics (IRDES) was estimated at €682 million in 2007.

  17. Low socioeconomic status is associated with adverse events in children and teens on insulin pumps under a universal access program: a population-based cohort study

    PubMed Central

    Shulman, Rayzel; Stukel, Therese A; Miller, Fiona A; Newman, Alice; Daneman, Denis; Wasserman, Jonathan D; Guttmann, Astrid

    2016-01-01

    Objective To describe adverse events in pediatric insulin pump users since universal funding in Ontario and to explore the role of socioeconomic status and 24-hour support. Research design and methods Population-based cohort study of youth (<19 years) with type 1 diabetes (n=3193) under a universal access program in Ontario, Canada, from 2006 to 2013. We linked 2012 survey data from 33 pediatric diabetes centers to health administrative databases. The relationship between patient and center-level characteristics and time to first diabetic ketoacidosis (DKA) admission or death was tested using a Cox proportional hazards model and the rate of diabetes-related emergency department visits and hospitalizations with a Poisson model, both using generalized estimating equations. Results The rate of DKA was 5.28/100 person-years and mortality 0.033/100 person-years. Compared with the least deprived quintile, the risk of DKA or death for those in the most deprived quintile was significantly higher (HR 1.58, 95% CI 1.05 to 2.38) as was the rate of diabetes-related acute care use (RR 1.60, 95% CI 1.27 to 2.00). 24-hour support was not associated with these outcomes. Higher glycated hemoglobin, prior DKA, older age, and higher nursing patient load were associated with a higher risk of DKA or death. Conclusions The safety profile of pump therapy in the context of universal funding is similar to other jurisdictions and unrelated to 24-hour support. Several factors including higher deprivation were associated with an increased risk of adverse events and could be used to inform the design of interventions aimed at preventing poor outcomes in high-risk individuals. PMID:27547416

  18. Serious adverse events associated with yellow fever vaccine.

    PubMed

    de Menezes Martins, Reinaldo; Fernandes Leal, Maria da Luz; Homma, Akira

    2015-01-01

    Yellow fever vaccine was considered one of the safest vaccines, but in recent years it was found that it could rarely cause invasive and disseminated disease in some otherwise healthy individuals, with high lethality. After extensive studies, although some risk factors have been identified, the real cause of causes of this serious adverse event are largely unknown, but findings point to individual host factors. Meningoencephalitis, once considered to happen only in children less than 6 months of age, has also been identified in older children and adults, but with good prognosis. Efforts are being made to develop a safer yellow fever vaccine, and an inactivated vaccine or a vaccine prepared with the vaccine virus envelope produced in plants are being tested. Even with serious and rare adverse events, yellow fever vaccine is the best way to avoid yellow fever, a disease of high lethality and should be used routinely in endemic areas, and on people from non-endemic areas that could be exposed, according to a careful risk-benefit analysis.

  19. Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes

    PubMed Central

    Mackenzie, Isla S; MacDonald, Thomas M; Shakir, Saad; Dryburgh, Moira; Mantay, Brian J; McDonnell, Patrick; Layton, Deborah

    2012-01-01

    AIMS During the global H1N1 influenza A (swine flu) pandemic 2009–2010, swine flu vaccines were expeditiously licensed and a mass vaccination programme for high risk groups, including pregnant women, was introduced in the UK. This pilot active safety surveillance study was performed to establish the feasibility of rapidly monitoring the new swine flu vaccines in large patient numbers receiving or offered the vaccination under normal conditions of use within a short time frame. METHODS A cohort design with safety data capture through modern technologies was carried out in Scotland, UK during the winter swine flu vaccination programme 2009–2010 in individuals receiving or offered the swine flu vaccination. The main outcome measures were self-reported serious adverse events (SAEs) and pregnancy outcomes. RESULTS The cohort comprised 4066 people; 3754 vaccinated and 312 offered the vaccination but not vaccinated. There were 939 self-reported events (838 different events), 53 judged to fit SAE criteria by the investigators, with nine judged as possibly, probably or definitely vaccine related. None of the seven deaths (six in vaccinees) were judged as vaccine related. One hundred and twenty-eight women reported 130 pregnancies during the study with 117 pregnant at study start. There were reports of four miscarriages in three women and six possible congenital abnormalities in live births. CONCLUSIONS Overall, no significant safety issues were identified. The methodology and use of modern technologies to collect safety data from large numbers of patients was successful and could be used again in similar safety studies. PMID:22082196

  20. A comparison of active adverse event surveillance systems worldwide.

    PubMed

    Huang, Yu-Lin; Moon, Jinhee; Segal, Jodi B

    2014-08-01

    Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems' structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based-the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian-the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European-the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK-the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances.

  1. Evaluating imbalances of adverse events during biosimilar development

    PubMed Central

    Vana, Alicia M.; Freyman, Amy W.; Reich, Steven D.; Yin, Donghua; Li, Ruifeng; Anderson, Scott; Jacobs, Ira A.; Zacharchuk, Charles M.; Ewesuedo, Reginald

    2016-01-01

    ABSTRACT Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials. PMID:27050730

  2. Adverse Drug Events caused by Serious Medication Administration Errors

    PubMed Central

    Sawarkar, Abhivyakti; Keohane, Carol A.; Maviglia, Saverio; Gandhi, Tejal K; Poon, Eric G

    2013-01-01

    OBJECTIVE To determine how often serious or life-threatening medication administration errors with the potential to cause patient harm (or potential adverse drug events) result in actual patient harm (or adverse drug events (ADEs)) in the hospital setting. DESIGN Retrospective chart review of clinical events that transpired following observed medication administration errors. BACKGROUND Medication errors are common at the medication administration stage for hospitalized patients. While many of these errors are considered capable of causing patient harm, it is not clear how often patients are actually harmed by these errors. METHODS In a previous study where 14,041 medication administrations in an acute-care hospital were directly observed, investigators discovered 1271 medication administration errors, of which 133 had the potential to cause serious or life-threatening harm to patients and were considered serious or life-threatening potential ADEs. In the current study, clinical reviewers conducted detailed chart reviews of cases where a serious or life-threatening potential ADE occurred to determine if an actual ADE developed following the potential ADE. Reviewers further assessed the severity of the ADE and attribution to the administration error. RESULTS Ten (7.5% [95% C.I. 6.98, 8.01]) actual adverse drug events or ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% [95% C.I. 2.12, 3.6]) serious and life threatening potential ADEs led to serious or life threatening ADEs. Half of the ten actual ADEs were caused by dosage or monitoring errors for anti-hypertensives. The life threatening ADE was caused by an error that was both a transcription and a timing error. CONCLUSION Potential ADEs at the medication administration stage can cause serious patient harm. Given previous estimates of serious or life-threatening potential ADE of 1.33 per 100

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

    PubMed

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

    2015-01-01

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

  4. 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

  5. In-hospital percentage BNP reduction is highly predictive for adverse events in patients admitted for acute heart failure: the Italian RED Study

    PubMed Central

    2010-01-01

    Introduction Our aim was to evaluate the role of B-type natriuretic peptide (BNP) percentage variations at 24 hours and at discharge compared to its value at admission in order to demonstrate its predictive value for outcomes in patients with acute decompensated heart failure (ADHF). Methods This was a multicenter Italian (8 centers) observational study (Italian Research Emergency Department: RED). 287 patients with ADHF were studied through physical exams, lab tests, chest X Ray, electrocardiograms (ECGs) and BNP measurements, performed at admission, at 24 hours, and at discharge. Follow up was performed 180 days after hospital discharge. Logistic regression analysis was used to estimate odds ratios (OR) for the various subgroups created. For all comparisons, a P value < 0.05 was considered statistically significant. Results BNP median (interquartile range (IQR)) value at admission was 822 (412 - 1390) pg\\mL; at 24 hours was 593 (270 - 1953) and at discharge was 325 (160 - 725). A BNP reduction of >46% at discharge had an area under curve (AUC) of 0.70 (P < 0.001) for predicting future adverse events. There were 78 events through follow up and in 58 of these patients the BNP level at discharge was >300 pg/mL. A BNP reduction of 25.9% after 24 hours had an AUC at ROC curve of 0.64 for predicting adverse events (P < 0.001). The odds ratio of the patients whose BNP level at discharge was <300 pg/mL and whose percentage decrease at discharge was <46% compared to the group whose BNP level at discharge was <300 pg/mL and whose percentage decrease at discharge was >46% was 4.775 (95% confidence interval (CI) 1.76 - 12.83, P < 0.002). The odds ratio of the patients whose BNP level at discharge was >300 pg/mL and whose percentage decrease at discharge was <46% compared to the group whose BNP level at discharge was <300 pg/mL and whose percentage decrease at discharge was >46% was 9.614 (CI 4.51 - 20.47, P < 0.001). Conclusions A reduction of BNP >46% at hospital discharge

  6. Adverse event detection in drug development: recommendations and obligations beyond phase 3.

    PubMed

    Berlin, Jesse A; Glasser, Susan C; Ellenberg, Susan S

    2008-08-01

    Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detect an increased incidence of rare adverse events or events with significant latency. For most drugs, only about 500 to 3000 participants are studied, for relatively short durations, before a drug is marketed. Systems for assessment of postmarketing adverse events include spontaneous reports, computerized claims or medical record databases, and formal postmarketing studies. We briefly review the strengths and limitations of each. Postmarketing surveillance is essential for developing a full understanding of the balance between benefits and adverse effects. More work is needed in analysis of data from spontaneous reports of adverse effects and automated databases, design of ad hoc studies, and design of economically feasible large randomized studies.

  7. Predicting adverse drug events from personal health messages.

    PubMed

    Chee, Brant W; Berlin, Richard; Schatz, Bruce

    2011-01-01

    Adverse drug events (ADEs) remain a large problem in the United States, being the fourth leading cause of death, despite post market drug surveillance. Much post consumer drug surveillance relies on self-reported "spontaneous" patient data. Previous work has performed datamining over the FDA's Adverse Event Reporting System (AERS) and other spontaneous reporting systems to identify drug interactions and drugs correlated with high rates of serious adverse events. However, safety problems have resulted from the lack of post marketing surveillance information about drugs, with underreporting rates of up to 98% within such systems. We explore the use of online health forums as a source of data to identify drugs for further FDA scrutiny. In this work we aggregate individuals' opinions and review of drugs similar to crowd intelligence3. We use natural language processing to group drugs discussed in similar ways and are able to successfully identify drugs withdrawn from the market based on messages discussing them before their removal.

  8. Antimicrobial postexposure prophylaxis for anthrax: adverse events and adherence.

    PubMed

    Shepard, Colin W; Soriano-Gabarro, Montse; Zell, Elizabeth R; Hayslett, James; Lukacs, Susan; Goldstein, Susan; Factor, Stephanie; Jones, Joshua; Ridzon, Renee; Williams, Ian; Rosenstein, Nancy

    2002-10-01

    We collected data during postexposure antimicrobial prophylaxis campaigns and from a prophylaxis program evaluation 60 days after start of antimicrobial prophylaxis involving persons from six U.S. sites where Bacillus anthracis exposures occurred. Adverse events associated with antimicrobial prophylaxis to prevent anthrax were commonly reported, but hospitalizations and serious adverse events as defined by Food and Drug Administration criteria were rare. Overall adherence during 60 days of antimicrobial prophylaxis was poor (44%), ranging from 21% of persons exposed in the Morgan postal facility in New York City to 64% of persons exposed at the Brentwood postal facility in Washington, D.C. Adherence was highest among participants in an investigational new drug protocol to receive additional antibiotics with or without anthrax vaccine--a likely surrogate for anthrax risk perception. Adherence of <60 days was not consistently associated with adverse events.

  9. Adverse Renal, Endocrine, Hepatic, and Metabolic Events during Maintenance Mood Stabilizer Treatment for Bipolar Disorder: A Population-Based Cohort Study

    PubMed Central

    Marston, Louise; Walters, Kate; Geddes, John R.; King, Michael; Osborn, David P. J.

    2016-01-01

    Background There is limited, poorly characterized information about adverse events occurring during maintenance treatment of bipolar disorder. We aimed to determine adverse event rates during treatment with lithium, valproate, olanzapine, and quetiapine. Methods and Findings We conducted a propensity score adjusted cohort study using nationally representative United Kingdom electronic health records from January 1, 1995, until December 31, 2013. We included patients who had a diagnosis of bipolar disorder and were prescribed lithium (n = 2148), valproate (n = 1670), olanzapine (n = 1477), or quetiapine (n = 1376) as maintenance mood stabilizer treatment. Adverse outcomes were chronic kidney disease, thyroid disease, hypercalcemia, weight gain, hypertension, type 2 diabetes mellitus, cardiovascular disease, and hepatotoxicity. The propensity score included important demographic, physical health, and mental health predictors of drug treatment allocation. The median duration of drug treatment was 1.48 y (interquartile range 0.64–3.43). Compared to patients prescribed lithium, those taking valproate, olanzapine, and quetiapine had reduced rates of chronic kidney disease stage 3 or more severe, following adjustment for propensity score, age, and calendar year, and accounting for clustering by primary care practice (valproate hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.45–0.69; p < 0.001, olanzapine HR 0.57; 95% CI 0.45–0.71; p < 0.001, quetiapine HR 0.62; 95% CI 0.47–0.80; p < 0.001). Hypothyroidism was reduced in those taking valproate (HR 0.60; 95% CI 0.40–0.89; p = 0.012) and olanzapine (HR 0.48; 95% CI 0.29–0.77; p = 0.003), compared to those taking lithium. Rates of new onset hyperthyroidism (valproate HR 0.24; 95% CI 0.09–0.61; p = 0.003, olanzapine HR 0.31; 95% CI 0.13–0.73; p = 0.007) and hypercalcemia (valproate HR 0.25; 95% CI 0.10–0.60; p = 0.002, olanzapine HR 0.32; 95% CI 0.14–0.76; p = 0.008, quetiapine HR 0.23; 95% CI 0.07

  10. Vaccine-related adverse events in Cuban children, 1999-2008.

    PubMed

    Galindo, Belkys M; Concepción, Damarys; Galindo, Miguel A; Pérez, Antonio; Saiz, Jesús

    2012-01-01

    INTRODUCTION Cuba has implemented an effective National Immunization Program since 1962. The schedule, administered primarily to children, comprises 11 vaccines (8 domestically produced) protecting against 13 diseases. In 1999 Cuba launched a national vaccine adverse event surveillance system to monitor and assess the safety of the immunization program, its vaccination procedures and the products administered. OBJECTIVES Describe adverse events following vaccination reported in children aged <16 years in Cuba from 1999 through 2008. METHODS A retrospective descriptive study was conducted of adverse events following vaccination reported from January 1999 through December 2008. Variables used: year, number of adverse events, province, type of vaccine, type and severity of adverse events (common minor, rare, severe), vaccination program errors, number of deaths, and final results of investigations of severe events. Percentages and rates per dose administered were calculated. Adverse event rates were calculated per 100,000 doses administered and by percentages of individual effects among events reported. RESULTS A total of 45,237,532 vaccine doses were administered, and 26,159 vaccine-associated adverse events were reported (overall rate: 57.8 per 100,000 doses). The group aged 0-5 years reported the highest rate of vaccine-associated adverse events (82/100,000 doses). The DTwP vaccine exhibited the highest rate of adverse events. Common minor events were: fever (17,538), reactions at injection site (4470) and systemic side effects (2422). Rare events (by WHO definition) reported were: persistent crying (2666), hypotonic-hyporesponsive episodes (3), encephalopathy (2) and febrile seizures (112). Severe events included: anaphylaxis (2), respiratory distress (1), multiple organ failure (1), sudden death (1), vaccine-associated paralytic poliomyelitis (2), toxic shock syndrome (3), and sepsis (1). The 10 deaths and 3 cases of disability were investigated by an expert

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

    PubMed Central

    Sakaeda, Toshiyuki; Kadoyama, Kaori; Okuno, Yasushi

    2011-01-01

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

  12. Negative affect predicts adults' ratings of the current, but not childhood, impact of adverse childhood events.

    PubMed

    LaNoue, Marianna; Graeber, David A; Helitzer, Deborah L; Fawcett, Jan

    2013-10-01

    Adverse childhood events (ACE's) have been empirically related to a wide range of negative health and mental health outcomes. However, not all individuals who experience ACE's follow a trajectory of poor outcomes, and not all individuals perceive the impact of ACE's as necessarily negative. The purpose of this study was to investigate positive and negative affect as predictors of adults' ratings of both the childhood and adult impact of their childhood adversity. Self-report data on ACE experiences, including number, severity, and 'impact' were collected from 158 community members recruited on the basis of having adverse childhood experiences. Results indicated that, regardless of event severity and number of different types of adverse events experienced, high levels of negative affect were the strongest predictor of whether the adult impact of the adverse childhood events was rated as negative. All individuals rated the childhood impact of events the same. Implications are discussed.

  13. Genomic architecture of pharmacological efficacy and adverse events

    PubMed Central

    Chhibber, Aparna; Kroetz, Deanna L; Tantisira, Kelan G; McGeachie, Michael; Cheng, Cheng; Plenge, Robert; Stahl, Eli; Sadee, Wolfgang; Ritchie, Marylyn D; Pendergrass, Sarah A

    2015-01-01

    The pharmacokinetic and pharmacodynamic disciplines address pharmacological traits, including efficacy and adverse events. Pharmacogenomics studies have identified pervasive genetic effects on treatment outcomes, resulting in the development of genetic biomarkers for optimization of drug therapy. Pharmacogenomics-based tests are already being applied in clinical decision making. However, despite substantial progress in identifying the genetic etiology of pharmacological response, current biomarker panels still largely rely on single gene tests with a large portion of the genetic effects remaining to be discovered. Future research must account for the combined effects of multiple genetic variants, incorporate pathway-based approaches, explore gene-gene interactions and nonprotein coding functional genetic variants, extend studies across ancestral populations, and prioritize laboratory characterization of molecular mechanisms. Because genetic factors can play a key role in drug response, accurate biomarker tests capturing the main genetic factors determining treatment outcomes have substantial potential for improving individual clinical care. PMID:25521360

  14. Identification and prevalence of adverse drug events caused by potentially inappropriate medication in homebound elderly patients: a retrospective study using a nationwide survey in Japan

    PubMed Central

    Onda, Mitsuko; Imai, Hirohisa; Takada, Yurina; Fujii, Shingo; Shono, Takako; Nanaumi, Yoko

    2015-01-01

    Objectives A nationwide large-scale survey was conducted to identify the prevalence and causal medications of adverse drug events (ADEs) that are caused by potentially inappropriate medications (PIMs) given to homebound elderly patients, factors associated with ADEs, and measures taken by pharmacists to manage ADEs and their effects on ADEs. Settings A questionnaire was mailed to 3321 pharmacies nationwide. It asked about the details of PIMs and ADEs of up to 5 patients for whom home visits were provided by a pharmacist. Questionnaire forms were filled in by pharmacists who visited the patients. Design and participants Between 23 January and 13 February 2013, comprehensive assessment forms were sent to 3321 pharmacies. Data collected from 1890 pharmacies including data of 4815 patients were analysed and 28 patients of unknown sex were excluded. Their average age was 82.7 years. PIMs were identified based on the 2003 Beers Criteria Japan. Results There were 600 patients who did not provide valid answers regarding the medications. In the remaining 4243 patients, one or more medications that were considered to be PIMs had been prescribed to 48.4% of patients. PIM-induced ADEs were found in 8% of these patients by pharmacists during home visits. The top ADE-inducing medications were strong anticholinergic antihistamines, benzodiazepines, sulpiride and digoxin. The most common ADEs associated with benzodiazepines were frequent lightheadedness, somnolence and sleepiness, which increase the risk of falls and subsequent fractures in elderly patients. The following factors associated with ADEs were identified: sex, pharmacist awareness of prescription issues, frequency of visits and time spent at patients’ homes, and the frequency of detailed checks for patient adverse reactions by pharmacists. Conclusions The PIM prevalence associated with home healthcare in Japan was relatively high, as reported in previous studies. The present study suggests that pharmacists could

  15. Guidelines for submitting adverse event reports for publication.

    PubMed

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

    2009-01-01

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

  16. Guidelines for submitting adverse event reports for publication.

    PubMed

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

    2007-05-01

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

  17. Guidelines for submitting adverse event reports for publication.

    PubMed

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

    2007-01-01

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

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

    PubMed Central

    Thomas, Eric J; Brennan, Troyen A

    2000-01-01

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

  19. Imaging atlas for eligibility and on-study safety of potential shoulder adverse events in anti-NGF studies (Part 3).

    PubMed

    Roemer, F W; Hayes, C W; Miller, C G; Hoover, K; Guermazi, A

    2015-01-01

    Despite promising results, the U.S. Food and Drug Administration (FDA) put on hold trials assessing anti-nerve growth factor (a-NGF) compounds due to concerns over accelerated rates of OA progression. The mechanism of these events is unclear but joint adverse events were observed particularly in patients using a-NGFs in combination with non-steroidal anti-inflammatory drugs (NSAIDs), suggesting that the significantly greater analgesic effect of these separate classes of drugs prompted patients to permit increased joint load without experiencing the usual pain that would limit joint stress. Development of a-NGF drugs is continuing with stringent safety criteria included in future trials as a-NGF therapies offer potential as the first new class of analgesics in many years. Potential imaging joint safety findings and exclusionary criteria for eligibility for the large weight bearing joints were presented in parts I and II of this atlas. The shoulder as a non-weight bearing joint is likely to be less affected by increased loading due to efficacious pain reduction. However, it remains prone to degeneration especially due to concomitant rotator cuff pathology and previous trauma and inflammatory disorders. This third part of the atlas illustrates imaging findings relevant for eligibility and potential joint safety findings such as osteonecrosis, incidental findings such as large cystic lesions, inflammatory disorders, bone marrow disorders and metastases.

  20. Evaluation of Perioperative Medication Errors and Adverse Drug Events

    PubMed Central

    Nanji, Karen C.; Patel, Amit; Shaikh, Sofia; Seger, Diane L.; Bates, David W.

    2015-01-01

    Background The purpose of this study is to assess the rates of perioperative medication errors (MEs) and adverse drug events (ADEs) as percentages of medication administrations, evaluate their root causes, and formulate targeted solutions to prevent them. Methods In this prospective observational study, anesthesia-trained study staff (anesthesiologists/nurse anesthetists) observed randomly selected operations at a 1,046 bed tertiary care academic medical center to identify MEs and ADEs over eight months. Retrospective chart abstraction was performed to flag events that were missed by observation. All events subsequently underwent review by two independent reviewers. Primary outcomes were the incidence of MEs and ADEs. Results A total of 277 operations were observed with 3,671 medication administrations of which 193 (5.3%, 95% CI 4.5 to 6.0) involved a ME and/or ADE. Of these, 153 (79.3%) were preventable and 40 (20.7%) were non-preventable. The events included 153 (79.3%) errors and 91 (47.2%) ADEs. While 32 (20.9%) of the errors had little potential for harm, 51 (33.3%) led to an observed ADE and an additional 70 (45.8%) had the potential for patient harm. Of the 153 errors, 99 (64.7%) were serious, 51 (33.3%) were significant and 3 (2.0%) were life-threatening. Conclusions One in twenty perioperative medication administrations included an ME and/or ADE. More than one third of the MEs led to observed ADEs, and the remaining two thirds had the potential for harm. These rates are markedly higher than those reported by retrospective surveys. Specific solutions exist which have the potential to decrease the incidence of perioperative MEs. PMID:26501385

  1. Adverse-drug-event surveillance using narrative nursing records in electronic nursing records.

    PubMed

    Ahn, Hee-Jung; Park, Hyeoun-Ae

    2013-01-01

    The purpose of this study was to determine whether the frequency of adverse drug events can be extracted by analyzing narrative nursing statements documented in standardized terminology-based electronic nursing records. For this study, we reviewed the narrative nursing documentations of 487 admissions of 355 cancer patients who were treated with cisplatin at a tertiary-care hospital in Korea. Narrative nursing statements with the terms "adverse drug reaction," "allergy," "hypersensitivity," and other adverse drug events listed in the safety information were analyzed. In addition, nausea, one of the most frequent adverse drug events, was further examined. Narrative statements documenting the presence or absence of an "adverse drug reaction," "allergy," and "hypersensitivity" were found in 162 admissions (33.3%). The presence or absence of adverse drug events due to cisplatin was documented in 476 admissions (97.7%). At least one adverse drug event was noted in 258 admissions (53.0%). The presence of nausea was documented in 214 admissions (43.9%), and the mean duration of nausea was 5.2 days. The results of this study suggest that adverse drug events can be monitored using narrative nursing statements documented in standardized terminology-based electronic nursing records.

  2. Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors

    PubMed Central

    Schmitz, Astrid; Albers, Bernhard; Schrappe, Matthias

    2010-01-01

    Objectives To perform a systematic review of the frequency of (preventable) adverse events (AE/PAE) and to analyse contributing factors, such as sample size, settings, type of events, terminology, methods of collecting data and characteristics of study populations. Review methods Search of Medline and Embase from 1995 to 2007. Included were original papers with data on the frequency of AE or PAE, explicit definition of study population and information about methods of assessment. Results were included with percentages of patients having one or more AE/PAE. Extracted data enclosed contributing factors. Data were abstracted and analysed by two researchers independently. Results 156 studies in 152 publications met our inclusion criteria. 144/156 studies reported AE, 55 PAE (43 both). Sample sizes ranged from 60 to 8 493 876 patients (median: 1361 patients). The reported results for AE varied from 0.1% to 65.4%, and for PAE from 0.1% to 33.9%. Variation clearly decreased with increasing sample size. Estimates did not differ according to setting, type of event or terminology. In studies with fewer than 1000 patients, chart review prevailed, whereas surveys with more than 100 000 patients were based mainly on administrative data. No effect of patient characteristics was found. Conclusions The funnel-shaped distribution of AE and PAE rates with sample size is a probable consequence of variation and can be taken as an indirect indicator of study validity. A contributing factor may be the method of data assessment. Further research is needed to explain the results when analysing data by types of event or terminology. PMID:20679137

  3. [Photodegradation of chlorpromazine, a drug-related adverse event].

    PubMed

    Chabi, Yossounon; Brahim, Kheira; Da Costa, Maryline; Caffin, Anne-Gaëlle; Camus, Gisèle; Paillet, Michel; Bohand, Xavier

    2016-04-01

    The photodegradation of an active substance during treatment is a rare drug-related adverse event which can sometimes have serious consequences. Health professionals must be aware of the specific storage and administration instructions with regard to chlorpromazine and ensure that they are respected.

  4. [Learning from errors after a care-related adverse event].

    PubMed

    Richard, Christian; Pibarot, Marie-Laure; Zantman, Françoise

    2016-04-01

    The mobilisation of all health professionals with regard to the detection and analysis of care-related adverse events is an essential element in the improvement of the safety of care. This approach is required by the authorities and justifiably expected by users.

  5. Hematological Adverse Events in Clozapine-Treated Children and Adolescents

    ERIC Educational Resources Information Center

    Gerbino-Rosen, Ginny; Roofeh, David; Tompkins, D. Andrew; Feryo, Doug; Nusser, Laurie; Kranzler, Harvey; Napolitano, Barbara; Frederickson, Anne; Henderson, Inika; Rhinewine, Joe; Kumra, Sanjiv

    2005-01-01

    Objective: To retrospectively examine rates of hematological adverse events (HAEs) in psychiatrically ill, hospitalized children treated with clozapine. Method: Clozapine treatment was administered in an open-label fashion using a flexible titration schedule, and data from weekly complete blood counts was obtained. The rate of neutropenia and…

  6. Systematic review on the prevalence, frequency and comparative value of adverse events data in social media

    PubMed Central

    Golder, Su; Norman, Gill; Loke, Yoon K

    2015-01-01

    Aim The aim of this review was to summarize the prevalence, frequency and comparative value of information on the adverse events of healthcare interventions from user comments and videos in social media. Methods A systematic review of assessments of the prevalence or type of information on adverse events in social media was undertaken. Sixteen databases and two internet search engines were searched in addition to handsearching, reference checking and contacting experts. The results were sifted independently by two researchers. Data extraction and quality assessment were carried out by one researcher and checked by a second. The quality assessment tool was devised in-house and a narrative synthesis of the results followed. Results From 3064 records, 51 studies met the inclusion criteria. The studies assessed over 174 social media sites with discussion forums (71%) being the most popular. The overall prevalence of adverse events reports in social media varied from 0.2% to 8% of posts. Twenty-nine studies compared the results from searching social media with using other data sources to identify adverse events. There was general agreement that a higher frequency of adverse events was found in social media and that this was particularly true for ‘symptom’ related and ‘mild’ adverse events. Those adverse events that were under-represented in social media were laboratory-based and serious adverse events. Conclusions Reports of adverse events are identifiable within social media. However, there is considerable heterogeneity in the frequency and type of events reported, and the reliability or validity of the data has not been thoroughly evaluated. PMID:26271492

  7. Real-life versus package insert: a post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers.

    PubMed

    Hatz, Christoph; Beck, Bernhard; Steffen, Robert; Genton, Blaise; d'Acremont, Valérie; Loutan, Louis; Hartmann, Katharina; Herzog, Christian

    2011-07-12

    There are various methods to collect adverse events (AEs) in clinical trials. The methods how AEs are collected in vaccine trials is of special interest: solicited reporting can lead to over-reporting events that have little or no biological relationship to the vaccine. We assessed the rate of AEs listed in the package insert for the virosomal hepatitis A vaccine Epaxal(®), comparing data collected by solicited or unsolicited self-reporting. In an open, multi-centre post-marketing study, 2675 healthy travellers received single doses of vaccine administered intramuscularly. AEs were recorded based on solicited and unsolicited questioning during a four-day period after vaccination. A total of 2541 questionnaires could be evaluated (95.0% return rate). Solicited self-reporting resulted in significantly higher (p<0.0001) rates of subjects with AEs than unsolicited reporting, both at baseline (18.9% solicited versus 2.1% unsolicited systemic AEs) and following immunization (29.6% versus 19.3% local AEs; 33.8% versus 18.2% systemic AEs). This could indicate that actual reporting rates of AEs with Epaxal(®) may be substantially lower than described in the package insert. The distribution of AEs differed significantly between the applied methods of collecting AEs. The most common AEs listed in the package insert were reported almost exclusively with solicited questioning. The reporting of local AEs was more likely than that of systemic AEs to be influenced by subjects' sex, age and study centre. Women reported higher rates of AEs than men. The results highlight the need for detailing the methods how vaccine tolerability was reported and assessed.

  8. Systematic Review: Adverse Events of Fecal Microbiota Transplantation

    PubMed Central

    Wang, Weiqiang; Cao, Xiaocang; Piao, Meiyu; Khan, Samiullah; Yan, Fang; Cao, Hailong; Wang, Bangmao

    2016-01-01

    Background Fecal microbiota transplantation (FMT) is a microbiota-based therapy that shows therapeutic potential in recurrent or refractory Clostridium difficile infections and other intestinal or extra-intestinal disorders. Nonetheless, adverse events (AEs) remain a major challenge in the application of FMT. Aim To review the AEs of FMT and to address the concerns of safety during the procedure. Methods Publications were retrieved in the databases of Medline, Embase and Cochrane Library. AEs were classified according to their causality with FMT or their severity. Results A total of 7562 original articles about FMT were identified in this study, 50 of them fulfilled the inclusion criteria. Totally 78 kinds of AEs were revealed enrolled in these 50 selected publications. The total incidence rate of AEs was 28.5%. Among the 42 publications, 5 kinds were definitely and 38 kinds were probably related to FMT. The commonest FMT-attributable AE was abdominal discomfort, which was reported in 19 publications. For upper gastrointestinal routes of FMT, 43.6% (89/204) patients were compromised by FMT-attributable AE, while the incidence dropped to 17.7% (76/430) for lower gastrointestinal routes. In contrast, the incidences of serious adverse events (SAEs) were 2.0% (4/196) and 6.1% (40/659) for upper and lower gastrointestinal routes, respectively. A total of 44 kinds of SAEs occurred in 9.2% patients, including death (3.5%, 38/1089), infection (2.5%, 27/1089), relapse of inflammatory bowel diseases (0.6%, 7/1089) and Clostridium difficile infection (0.9%, 10/1089). Conclusion Consequently, both AEs and SAEs are not rare and should be carefully monitored throughout FMT. However, high quality randomized controlled trials are still needed for the more definite incidence of AEs of FMT. PMID:27529553

  9. 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.

  10. 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

  11. 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

  12. Possible adverse events in children treated by manual therapy: a review

    PubMed Central

    2010-01-01

    Background Pediatric manual therapy is controversial within the medical community particularly with respect to adverse events. Pediatric manual therapy (Ped MT) is commonly used by a number of professions such as chiropractors, osteopaths and naturopaths for a variety of treatments in children. Ped MT interventions range from advice, light touch, massage, through to mobilisation and high velocity spinal manipulation. However, current evidence related to adverse events associated with Ped MT is not well understood. Objective To update the clinical research literature from the 2007 report by Vohra, Johnston, Cramer and Humphreys on possible adverse events in children treated by spinal manipulation. Methods A review of the clinical research literature from June 2004 until January 2010 as reported in MEDLINE, PubMed and PubMed Central for adverse events specifically related to the treatment of pediatric cases by manual therapy. Results Only three new clinical studies, one systematic review with meta-analysis and one evidence report were identified. Two clinical studies reported on chiropractic care and one on osteopathic spinal manipulation in children. The systematic review investigated all studies of adverse events and manual therapy and was not specific for pediatric patients. The evidence review focused on effectiveness of spinal manipulation in a variety of musculoskeletal conditions. No serious or catastrophic adverse events were reported in the clinical studies or systematic review. However for adults, it has been estimated that between 0.003% and 0.13% of manual therapy treatments may result in a serious adverse event. Although mild to moderate adverse events are common in adults, an accurate estimate from high quality pediatric studies is currently not available. Conclusions There is currently insufficient research evidence related to adverse events and manual therapy. However, clinical studies and systematic reviews from adult patients undergoing manual

  13. Signal detection to identify serious adverse events (neuropsychiatric events) in travelers taking mefloquine for chemoprophylaxis of malaria

    PubMed Central

    Naing, Cho; Aung, Kyan; Ahmed, Syed Imran; Mak, Joon Wah

    2012-01-01

    Background For all medications, there is a trade-off between benefits and potential for harm. It is important for patient safety to detect drug-event combinations and analyze by appropriate statistical methods. Mefloquine is used as chemoprophylaxis for travelers going to regions with known chloroquine-resistant Plasmodium falciparum malaria. As such, there is a concern about serious adverse events associated with mefloquine chemoprophylaxis. The objective of the present study was to assess whether any signal would be detected for the serious adverse events of mefloquine, based on data in clinicoepidemiological studies. Materials and methods We extracted data on adverse events related to mefloquine chemoprophylaxis from the two published datasets. Disproportionality reporting of adverse events such as neuropsychiatric events and other adverse events was presented in the 2 × 2 contingency table. Reporting odds ratio and corresponding 95% confidence interval [CI] data-mining algorithm was applied for the signal detection. The safety signals are considered significant when the ROR estimates and the lower limits of the corresponding 95% CI are ≥2. Results Two datasets addressing adverse events of mefloquine chemoprophylaxis (one from a published article and one from a Cochrane systematic review) were included for analyses. Reporting odds ratio 1.58, 95% CI: 1.49–1.68 based on published data in the selected article, and 1.195, 95% CI: 0.94–1.44 based on data in the selected Cochrane review. Overall, in both datasets, the reporting odds ratio values of lower 95% CI were less than 2. Conclusion Based on available data, findings suggested that signals for serious adverse events pertinent to neuropsychiatric event were not detected for mefloquine. Further studies are needed to substantiate this. PMID:22936859

  14. Failure of fertility therapy and subsequent adverse cardiovascular events

    PubMed Central

    Udell, Jacob A.; Lu, Hong; Redelmeier, Donald A.

    2017-01-01

    BACKGROUND: Infertility may indicate an underlying predisposition toward premature cardiovascular disease, yet little is known about potential long-term cardiovascular events following fertility therapy. We investigated whether failure of fertility therapy is associated with subsequent adverse cardiovascular events. METHODS: We performed a population-based cohort analysis of women who received gonadotropin-based fertility therapy between Apr. 1, 1993, and Mar. 31, 2011, distinguishing those who subsequently gave birth and those who did not. Using multivariable Poisson regression models, we estimated the relative rate ratio of adverse cardiovascular events associated with fertility therapy failure, accounting for age, year, baseline risk factors, health care history and number of fertility cycles. The primary outcome was subsequent treatment for nonfatal coronary ischemia, stroke, transient ischemic attack, heart failure or thromboembolism. RESULTS: Of 28 442 women who received fertility therapy, 9349 (32.9%) subsequently gave birth and 19 093 (67.1%) did not. The median number of fertility treatments was 3 (interquartile range 1–5). We identified 2686 cardiovascular events over a median 8.4 years of follow-up. The annual rate of cardiovascular events was 19% higher among women who did not give birth after fertility therapy than among those who did (1.08 v. 0.91 per 100 patient-years, p < 0.001), equivalent to a 21% relative increase in the annual rate (95% confidence interval 13%–30%). We observed no association between event rates and number of treatment cycles. INTERPRETATION: Fertility therapy failure was associated with an increased risk of long-term adverse cardiovascular events. These women merit surveillance for subsequent cardiovascular events. PMID:28385819

  15. 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

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

    PubMed Central

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2015-01-01

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

  17. A pipeline to extract drug-adverse event pairs from multiple data sources

    PubMed Central

    2014-01-01

    Background Pharmacovigilance aims to uncover and understand harmful side-effects of drugs, termed adverse events (AEs). Although the current process of pharmacovigilance is very systematic, the increasing amount of information available in specialized health-related websites as well as the exponential growth in medical literature presents a unique opportunity to supplement traditional adverse event gathering mechanisms with new-age ones. Method We present a semi-automated pipeline to extract associations between drugs and side effects from traditional structured adverse event databases, enhanced by potential drug-adverse event pairs mined from user-comments from health-related websites and MEDLINE abstracts. The pipeline was tested using a set of 12 drugs representative of two previous studies of adverse event extraction from health-related websites and MEDLINE abstracts. Results Testing the pipeline shows that mining non-traditional sources helps substantiate the adverse event databases. The non-traditional sources not only contain the known AEs, but also suggest some unreported AEs for drugs which can then be analyzed further. Conclusion A semi-automated pipeline to extract the AE pairs from adverse event databases as well as potential AE pairs from non-traditional sources such as text from MEDLINE abstracts and user-comments from health-related websites is presented. PMID:24559132

  18. Lost in translation: preclinical studies on 3,4-methylenedioxymethamphetamine provide information on mechanisms of action, but do not allow accurate prediction of adverse events in humans

    PubMed Central

    Green, AR; King, MV; Shortall, SE; Fone, KCF

    2012-01-01

    3,4-Methylenedioxymethamphetamine (MDMA) induces both acute adverse effects and long-term neurotoxic loss of brain 5-HT neurones in laboratory animals. However, when choosing doses, most preclinical studies have paid little attention to the pharmacokinetics of the drug in humans or animals. The recreational use of MDMA and current clinical investigations of the drug for therapeutic purposes demand better translational pharmacology to allow accurate risk assessment of its ability to induce adverse events. Recent pharmacokinetic studies on MDMA in animals and humans are reviewed and indicate that the risks following MDMA ingestion should be re-evaluated. Acute behavioural and body temperature changes result from rapid MDMA-induced monoamine release, whereas long-term neurotoxicity is primarily caused by metabolites of the drug. Therefore acute physiological changes in humans are fairly accurately mimicked in animals by appropriate dosing, although allometric dosing calculations have little value. Long-term changes require MDMA to be metabolized in a similar manner in experimental animals and humans. However, the rate of metabolism of MDMA and its major metabolites is slower in humans than rats or monkeys, potentially allowing endogenous neuroprotective mechanisms to function in a species specific manner. Furthermore acute hyperthermia in humans probably limits the chance of recreational users ingesting sufficient MDMA to produce neurotoxicity, unlike in the rat. MDMA also inhibits the major enzyme responsible for its metabolism in humans thereby also assisting in preventing neurotoxicity. These observations question whether MDMA alone produces long-term 5-HT neurotoxicity in human brain, although when taken in combination with other recreational drugs it may induce neurotoxicity. LINKED ARTICLES This article is commented on by Parrott, pp. 1518–1520 of this issue. To view this commentary visit http://dx.doi.org/10.1111/j.1476-5381.2012.01941.x and to view the the

  19. Adverse events to monoclonal antibodies used for cancer therapy

    PubMed Central

    Baldo, Brian A

    2013-01-01

    Fifteen monoclonal antibodies (mAbs) are currently registered and approved for the treatment of a range of different cancers. These mAbs are specific for a limited number of targets (9 in all). Four of these molecules are indeed directed against the B-lymphocyte antigen CD20; 3 against human epidermal growth factor receptor 2 (HER2 or ErbB2), 2 against the epidermal growth factor receptor (EGFR), and 1 each against epithelial cell adhesion molecule (EpCAM), CD30, CD52, vascular endothelial growth factor (VEGF), tumor necrosis factor (ligand) superfamily, member 11 (TNFSF11, best known as RANKL), and cytotoxic T lymphocyte-associated protein 4 (CTLA4). Collectively, the mAbs provoke a wide variety of systemic and cutaneous adverse events including the full range of true hypersensitivities: Type I immediate reactions (anaphylaxis, urticaria); Type II reactions (immune thrombocytopenia, neutopenia, hemolytic anemia); Type III responses (vasculitis, serum sickness; some pulmonary adverse events); and Type IV delayed mucocutaneous reactions as well as infusion reactions/cytokine release syndrome (IRs/CRS), tumor lysis syndrome (TLS), progressive multifocal leukoencephalopathy (PML) and cardiac events. Although the term “hypersensitivity” is widely used, no common definition has been adopted within and between disciplines and the requirement of an immunological basis for a true hypersensitivity reaction is sometimes overlooked. Consequently, some drug-induced adverse events are sometimes incorrectly described as “hypersensitivities” while others that should be described are not. PMID:24251081

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

    PubMed Central

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

    2007-01-01

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

  1. The Effect of Work Hours on Adverse Events and Errors in Health Care

    PubMed Central

    Olds, Danielle M.; Clarke, Sean P.

    2010-01-01

    Introduction We studied the relationship between registered nurses' extended work duration with adverse events and errors, including needlestick injuries, work-related injuries, patient falls with injury, nosocomial infections, and medication errors. Method Using bivariate and multivariate logistic regression, this secondary analysis of 11,516 registered nurses examined nurse characteristics, work hours, and adverse events and errors. Results All of the adverse event and error variables were significantly related to working more than 40 hours in the average week. Medication errors and needlestick injuries had the strongest and most consistent relationships with the work hour and voluntary overtime variables. Discussion This study confirms prior findings that increased work hours raise the likelihood of adverse events and errors in healthcare, and further found the same relationship with voluntary overtime. Impact on Industry Legislation has focused on mandatory overtime; however, this study demonstrated that voluntary overtime could also negatively impact nurse and patient safety. PMID:20497801

  2. Soy Isoflavones for Reducing Bone Loss (SIRBL) Study: Effect of a three-year trial on hormones, adverse events, and endometrial thickness in postmenopausal women

    PubMed Central

    Alekel, D. Lee; Genschel, Ulrike; Koehler, Kenneth J; Hofmann, Heike; Van Loan, Marta D; Beer, Bonnie S.; Hanson, Laura N; Peterson, Charles T; Kurzer, Mindy S

    2014-01-01

    Objectives To assess the overall safety and potential endometrial stimulation of soy isoflavone tablets consumed (3-year) by postmenopausal women. To determine the endometrial thickness response-to-treatment among compliant women, taking into account hormone concentrations and other hypothesized modifying factors. Methods We randomized healthy postmenopausal women (45.8–65.0 years) to placebo control or two doses (80 or 120 mg/day) of soy isoflavones at two sites. We used intent-to-treat (N=224) and compliant (>95%; N=208) analyses to assess circulating hormone concentrations, adverse events, and endometrial thickness (via transvaginal ultrasound). Results Median values for endometrial thickness (mm) declined from baseline through 36 mo. Nonparametric ANOVA for treatment differences among groups showed no differences in absolute (or percentage change) endometrial thickness at any time point (Chi-Square p-values ranged from 0.12–0.69), nor in circulating hormones at any time point. A greater number of adverse events for the genitourinary system (p=0.005) was noted in the 80 compared to 120 mg/day group, whereas other systems showed no treatment effects. The model predicting the endometrial thickness response-(using natural logarithm)-to-treatment with compliant women across time points was significant (p<0.0001), indicating that estrogen exposure (p=0.0013), plasma 17 β-estradiol (p=0.0086), and alcohol intake (p=0.023) contributed significantly to the response. Neither the 80 (p=0.57) nor 120 (p=0.43) mg/day dose exerted an effect on endometrial thickness across time. Conclusions Our RCT verified the long-term overall safety of consuming soy isoflavone tablets by postmenopausal women who displayed excellent compliance. We found no evidence of a treatment effect on endometrial thickness, adverse events, or circulating hormone concentrations, most notably thyroid function, during a three year period. PMID:25003624

  3. Association of common genetic variants with risperidone adverse events in a Spanish schizophrenic population.

    PubMed

    Almoguera, B; Riveiro-Alvarez, R; Lopez-Castroman, J; Dorado, P; Vaquero-Lorenzo, C; Fernandez-Piqueras, J; Llerena, A; Abad-Santos, F; Baca-García, E; Dal-Ré, R; Ayuso, C

    2013-04-01

    Risperidone non-compliance is often high due to undesirable side effects, whose development is in part genetically determined. Studies with genetic variants involved in the pharmacokinetics and pharmacodynamics of risperidone have yielded inconsistent results. Thus, the aim of this study was to investigate the putative association of genetic markers with the occurrence of four frequently observed adverse events secondary to risperidone treatment: sleepiness, weight gain, extrapyramidal symptoms and sexual adverse events. A series of 111 schizophrenia inpatients were genotyped for genetic variants previously associated with or potentially involved in risperidone response. Presence of adverse events was the main variable and potential confounding factors were considered. Allele 16Gly of ADRB2 was significantly associated with a higher risk of sexual adverse events. There were other non-significant trends for DRD3 9Gly and SLC6A4 S alleles. Our results, although preliminary, provide new candidate variants of potential use in risperidone safety prediction.

  4. Childhood adverse life events and parental psychopathology as risk factors for bipolar disorder.

    PubMed

    Bergink, V; Larsen, J T; Hillegers, M H J; Dahl, S K; Stevens, H; Mortensen, P B; Petersen, L; Munk-Olsen, T

    2016-10-25

    Childhood adverse events are risk factors for later bipolar disorder. We quantified the risks for a later diagnosis of bipolar disorder after exposure to adverse life events in children with and without parental psychopathology. This register-based population cohort study included all persons born in Denmark from 1980 to 1998 (980 554 persons). Adversities before age 15 years were: familial disruption; parental somatic illness; any parental psychopathology; parental labour market exclusion; parental imprisonment; placement in out-of-home care; and parental natural and unnatural death. We calculated risk estimates of each of these eight life events as single exposure and risk estimates for exposure to multiple life events. Main outcome variable was a diagnosis of bipolar disorder after the age of 15 years, analysed with Cox proportional hazard regression. Single exposure to most of the investigated adversities were associated with increased risk for bipolar disorder, exceptions were parental somatic illness and parental natural death. By far the strongest risk factor for bipolar disorder in our study was any mental disorder in the parent (hazard ratio 3.53; 95% confidence interval 2.73-4.53) and the additional effects of life events on bipolar risk were limited. An effect of early adverse life events on bipolar risk later in life was mainly observed in children without parental psychopathology. Our findings do not exclude early-life events as possible risk factors, but challenge the concept of adversities as important independent determinants of bipolar disorder in genetically vulnerable individuals.

  5. Childhood adverse life events and parental psychopathology as risk factors for bipolar disorder

    PubMed Central

    Bergink, V; Larsen, J T; Hillegers, M H J; Dahl, S K; Stevens, H; Mortensen, P B; Petersen, L; Munk-Olsen, T

    2016-01-01

    Childhood adverse events are risk factors for later bipolar disorder. We quantified the risks for a later diagnosis of bipolar disorder after exposure to adverse life events in children with and without parental psychopathology. This register-based population cohort study included all persons born in Denmark from 1980 to 1998 (980 554 persons). Adversities before age 15 years were: familial disruption; parental somatic illness; any parental psychopathology; parental labour market exclusion; parental imprisonment; placement in out-of-home care; and parental natural and unnatural death. We calculated risk estimates of each of these eight life events as single exposure and risk estimates for exposure to multiple life events. Main outcome variable was a diagnosis of bipolar disorder after the age of 15 years, analysed with Cox proportional hazard regression. Single exposure to most of the investigated adversities were associated with increased risk for bipolar disorder, exceptions were parental somatic illness and parental natural death. By far the strongest risk factor for bipolar disorder in our study was any mental disorder in the parent (hazard ratio 3.53; 95% confidence interval 2.73–4.53) and the additional effects of life events on bipolar risk were limited. An effect of early adverse life events on bipolar risk later in life was mainly observed in children without parental psychopathology. Our findings do not exclude early-life events as possible risk factors, but challenge the concept of adversities as important independent determinants of bipolar disorder in genetically vulnerable individuals. PMID:27779625

  6. Risk Factors for GI Adverse Events in a Phase III Randomized Trial of Bevacizumab in First-Line Therapy of Advanced Ovarian Cancer: A Gynecologic Oncology Group Study

    PubMed Central

    Burger, Robert A.; Brady, Mark F.; Bookman, Michael A.; Monk, Bradley J.; Walker, Joan L.; Homesley, Howard D.; Fowler, Jeffrey; Greer, Benjamin E.; Boente, Matthew; Fleming, Gini F.; Lim, Peter C.; Rubin, Stephen C.; Katsumata, Noriyuki; Liang, Sharon X.

    2014-01-01

    Purpose To evaluate risk factors for GI adverse events (AEs) within a phase III trial of bevacizumab in first-line ovarian cancer therapy. Patients and Methods Women with previously untreated advanced disease after surgery were randomly allocated to six cycles of platinum-taxane chemotherapy plus placebo cycles (C)2 to C22 (R1); chemotherapy plus bevacizumab C2 to C6 plus placebo C7 to C22 (R2); or chemotherapy plus bevacizumab C2 to C22 (R3). Patients were evaluated for history or on-study development of potential risk factors for GI AEs defined as grade ≥ 2 perforation, fistula, necrosis, or hemorrhage. Results Of 1,873 patients enrolled, 1,759 (94%) were evaluable, and 2.8% (50 of 1,759) experienced a GI AE: 10 of 587 (1.7%, R1), 20 of 587 (3.4%, R2), and 20 of 585 (3.4%, R3). Univariable analyses indicated that previous treatment of inflammatory bowel disease (IBD; P = .005) and small bowel resection (SBR; P = .032) or large bowel resection (LBR; P = .012) at primary surgery were significantly associated with a GI AE. The multivariable estimated relative odds of a GI AE were 13.4 (95% CI, 3.44 to 52.3; P < .001) for IBD; 2.05 (95% CI, 1.09 to 3.88; P = .026) for LBR; 1.95 (95% CI, 0.894 to 4.25; P = .093) for SBR; and 2.15 for bevacizumab exposure (aggregated 95% CI, 1.05 to 4.40; P = .036). Conclusion History of treatment for IBD, and bowel resection at primary surgery, increase the odds of GI AEs in patients receiving first-line platinum-taxane chemotherapy for advanced ovarian cancer. After accounting for these risk factors, concurrent bevacizumab doubles the odds of a GI AE, but is not appreciably increased by continuation beyond chemotherapy. PMID:24637999

  7. Geriatric Assessment to Predict Survival and Risk of Serious Adverse Events in Elderly Newly Diagnosed Multiple Myeloma Patients: A Multicenter Study in China

    PubMed Central

    Zhong, Yu-Ping; Zhang, Yi-Zhuo; Liao, Ai-Jun; Li, Su-Xia; Tian, Chen; Lu, Jin

    2017-01-01

    Background: Elderly multiple myeloma (MM) patients often tend to suffer a variety of diseases, so the treatment of choice is very difficult for the elderly myeloma patients. The overall survival (OS) time and side effects with elderly patients are unclear in China. The study tried to find out the role of geriatric assessment in the Chinese elderly MM. Methods: We retrospectively analyzed the data of 628 newly diagnosed patients from six hospitals from June 2011 to June 2013. A geriatric assessment had been performed to assess comorbidities, cognitive, and physical status for these patients. The primary endpoint was to evaluate different physical states of elderly patients with OS time and treatment-related side effects. Results: An additive scoring system (range: 0–5), based on age, Katz's Activity of Daily Living (ADL) and Lawton's Instrumental Activity of Daily Living (IADL) ≤5 and Charlson Comorbidity Index (CCI) was developed to identify three groups: fit (score = 0); intermediate-fitness (score = 1); and frail (score ≥2). The 3-year OS was 63% in fit patients, 63% in intermediate-fitness patients, and 49% in frail patients ≥3 hematologic adverse events (AEs) were documented in 45 (35.4%) fit, 34 (34%) intermediate-fitness, and 121 (30.2%) frail patients. The risk of a grade ≥3 hematologic AEs was not significantly increase in intermediate-fitness (hazard ratios [HR]: 0.99, 95% confidence interval [CI]: 0.54–1.47, P = 1.000) and in frail patients (HR: 1.16, 95% CI: 0.70–1.93, P = 0.558) compared with fit ones. Conclusions: MM occurs earlier in life and being advanced when the diagnosis is made in the mainland of China. The overall survival in frailty with International Staging System (ISS) II/III was the worst in all patients. PMID:28091402

  8. [Methodical reflections on epidemiological methods to measure adverse medical device events].

    PubMed

    Lessing, C

    2009-06-01

    Drugs and medical devices are common remedies in patient care. Concerning patient safety, much research has been undertaken to study medication-related events, such as adverse drug events or medication errors; however, only little is known about device-related events and patient safety. Until now, only one survey on the epidemiology of adverse medical device events has been published. Estimates amount to 8.4 adverse medical device events/100 hospitalizations. As this indicates, further research is needed on epidemiological methodology to investigate the frequency, distribution, causes and results of medical device-related events. Only profound knowledge will constitute a resilient base for the development of safety strategies which can be then implemented and evaluated. Also in the German health care system, the special challenges described for data collection have to be mastered.

  9. Associations between childhood adversity, adult stressful life events, and past-year drug use disorders in the National Epidemiological Study of Alcohol and Related Conditions (NESARC).

    PubMed

    Myers, Bronwyn; McLaughlin, Katie A; Wang, Shuai; Blanco, Carlos; Stein, Dan J

    2014-12-01

    Stress sensitization, whereby CA lowers tolerance to later stressors, has been proposed as a potential mechanism explaining the association between exposure to childhood adversities (CA) and drug use disorders in adulthood. However, this mechanism remains untested. This paper begins to address this gap through exploring associations between CA exposure and stressful events in adulthood for predicting drug use disorders. We used data drawn from Wave 2 of the U.S. National Epidemiological Survey of Alcohol and Related Conditions (n = 34,653) to explore whether the association between past-year stressful life events and the 12-month prevalence of disordered cannabis, stimulant, and opiate use varied by the number of types of CA that an individual was exposed to. Past-year stressful life events were associated with an increased risk of cannabis, stimulant, and opiate use disorders among men and women. Exposure to CA was associated with increased risk for disordered cannabis use among men and women and opiate use among men only. Finally, we found significant associations between exposure to CA and past-year stressful life events in predicting disordered drug use, but only for women in relation to disordered stimulant and opiate use. Findings are suggestive of possible stress sensitization effects in predicting disordered stimulant and opiate use among women. Implications of these findings for the prevention and treatment of drug use disorders and for future research are discussed.

  10. Associations between childhood adversity, adult stressful life events, and past-year drug use disorders in the National Epidemiological Study of Alcohol and Related Conditions (NESARC)

    PubMed Central

    Myers, Bronwyn; McLaughlin, Katie A.; Wang, Shuai; Blanco, Carlos; Stein, Dan J.

    2014-01-01

    Stress sensitization, whereby CA lowers tolerance to later stressors, has been proposed as a potential mechanism explaining the association between exposure to childhood adversities (CA) and drug use disorders in adulthood. However this mechanism remains untested. This paper begins to address this gap through exploring associations between CA exposure and stressful events in adulthood for predicting drug use disorders. We used data drawn from Wave 2 of the U.S. National Epidemiological Survey of Alcohol and Related Conditions (n=34,653) to explore whether the association between past-year stressful life events and the 12-month prevalence of disordered cannabis, stimulant and opiate use varied by the number of types of CA that an individual was exposed to. Past-year stressful life events were associated with an increased risk of cannabis, stimulant and opiate use disorders among men and women. Exposure to CA was associated with increased risk for disordered cannabis use among men and women and opiate use among men only. Finally, we found significant associations between exposure to CA and past year stressful life events in predicting disordered drug use, but only for women in relation to disordered stimulant and opiate use. Findings are suggestive of possible stress sensitization effects in predicting disordered stimulant and opiate use among women. Implications of these findings for the prevention and treatment of drug use disorders and for future research are discussed. PMID:25134042

  11. Evidence-based interventions to reduce adverse events in hospitals: a systematic review of systematic reviews

    PubMed Central

    Zegers, Marieke; Hesselink, Gijs; Geense, Wytske; Vincent, Charles; Wollersheim, Hub

    2016-01-01

    Objective To provide an overview of effective interventions aimed at reducing rates of adverse events in hospitals. Design Systematic review of systematic reviews. Data sources PubMed, CINAHL, PsycINFO, the Cochrane Library and EMBASE were searched for systematic reviews published until October 2015. Study selection English-language systematic reviews of interventions aimed at reducing adverse events in hospitals, including studies with an experimental design and reporting adverse event rates, were included. Two reviewers independently assessed each study's quality and extracted data on the study population, study design, intervention characteristics and adverse patient outcomes. Results Sixty systematic reviews with moderate to high quality were included. Statistically significant pooled effect sizes were found for 14 types of interventions, including: (1) multicomponent interventions to prevent delirium; (2) rapid response teams to reduce cardiopulmonary arrest and mortality rates; (3) pharmacist interventions to reduce adverse drug events; (4) exercises and multicomponent interventions to prevent falls; and (5) care bundle interventions, checklists and reminders to reduce infections. Most (82%) of the significant effect sizes were based on 5 or fewer primary studies with an experimental study design. Conclusions The evidence for patient-safety interventions implemented in hospitals worldwide is weak. The findings address the need to invest in high-quality research standards in order to identify interventions that have a real impact on patient safety. Interventions to prevent delirium, cardiopulmonary arrest and mortality, adverse drug events, infections and falls are most effective and should therefore be prioritised by clinicians. PMID:27687901

  12. A prospective observational study to examine the relationship between quality of life and adverse events of first-line chemotherapy plus cetuximab in patients with KRAS wild-type unresectable metastatic colorectal cancer: QUACK Trial.

    PubMed

    Ooki, Akira; Ando, Masahiko; Sakamoto, Junichi; Sato, Atushi; Fujii, Hirofumi; Yamaguchi, Kensei

    2014-04-01

    We have planned a multicentre prospective study to examine the relative impact of the efficacy and adverse events of cetuximab plus first-line chemotherapy on the quality of life in Japanese patients with KRAS wild-type unresectable colorectal cancer. The Dermatology Life Quality Index and the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core 30 will be used to assess dermatology-specific and health-related quality of life. The severity of adverse events will be assessed by using the National Cancer Institute Common Terminology Criteria for adverse Events ver. 4.0. The endpoints will be the following associations: adverse events, including skin toxicity and quality of life; efficacy and skin toxicity; efficacy and quality of life; and skin-related quality of life and health-related quality of life. A total of 140 patients are considered to be appropriate for inclusion in this study. The results of this study will provide more information to both patients and physicians regarding the practical use of cetuximab and its impact on quality of life in patients with unresectable colorectal cancer in Japan. This study was registered at the University Hospital Medical Information Network Clinical Trial Registry as UMIN000010985.

  13. Adverse drug events: database construction and in silico prediction.

    PubMed

    Cheng, Feixiong; Li, Weihua; Wang, Xichuan; Zhou, Yadi; Wu, Zengrui; Shen, Jie; Tang, Yun

    2013-04-22

    Adverse drug events (ADEs) are the harms associated with uses of given medications at normal dosages, which are crucial for a drug to be approved in clinical use or continue to stay on the market. Many ADEs are not identified in trials until the drug is approved for clinical use, which results in adverse morbidity and mortality. To date, millions of ADEs have been reported around the world. Methods to avoid or reduce ADEs are an important issue for drug discovery and development. Here, we reported a comprehensive database of adverse drug events (namely MetaADEDB), which included more than 520,000 drug-ADE associations among 3059 unique compounds (including 1330 drugs) and 13,200 ADE items by data integration and text mining. All compounds and ADEs were annotated with the most commonly used concepts defined in Medical Subject Headings (MeSH). Meanwhile, a computational method, namely the phenotypic network inference model (PNIM), was developed for prediction of potential ADEs based on the database. The area under the receive operating characteristic curve (AUC) is more than 0.9 by 10-fold cross validation, while the AUC value was 0.912 for an external validation set extracted from the US-FDA Adverse Events Reporting System, which indicated that the prediction capability of the method was reliable. MetaADEDB is accessible free of charge at http://www.lmmd.org/online_services/metaadedb/. The database and the method provide us a useful tool to search for known side effects or predict potential side effects for a given drug or compound.

  14. [Procedure adverse events: nursing care in central venous catheter fracture].

    PubMed

    Pérez-Juan, Eva; Maqueda-Palau, Mònica; Romero-Grilo, Cristina; Muñoz-Moles, Yolanda

    2014-01-01

    In a intensive care unit (ICU) there are many factors that can lead to the occurrence of adverse events. A high percentage of these events are associated with the administration of drugs. Diagnostic tests, such as computed tomography, is common in critically ill patients and technique can be performed with injection of contrast agent to enhance the visualization of soft tissue. The contrast is a medication and the nurse is responsible for its proper administration. The management of the critically ill patient is complex. ICU team and radiology shares responsibility for the care and safety of the patient safety during the transfer and performing tests with contrast. The World Health Organisation patient safety strategies, recommends analysing errors and learning from them. Therefore, it was decided to investigate the causes of the category E severity adverse events that occurred in a patient who was admitted to the ICU for septic shock of abdominal origin. An abdominal computed tomography was performed with contrast which was injected through a central venous catheter. The contrast did not appear in the image. What happened? Causal analysis helped to understand what triggered the event. A care plan and an algorithm were drafted to prevent it from happening again, with the following objectives: improving knowledge, skills and promoting positive attitudes towards patient safety, working at primary, secondary and tertiary care levels.

  15. CLINICAL MANAGEMENT OF LOCALIZED BCG ADVERSE EVENTS IN CHILDREN.

    PubMed

    Moreira, Thais das Neves Fraga; Moraes-Pinto, Maria Isabel de; Costa-Carvalho, Beatriz Tavares; Grumach, Anete Sevciovic; Weckx, Lily Yin

    2016-11-03

    BCG adverse events (BCG-AE) are rare conditions with no well-established treatment. This study aims to describe clinical characteristics and outcome of localized BCG-AE. Children with BCG-AEs who were treated at the Reference Center for Special Immunobiologicals of the Federal University of São Paulo from 2009 to 2011 were included. Patients were followed monthly until 3 months after healing. One hundred and twenty-seven patients with localized BCG-AE were followed: 67 (52.7%) had suppurative lymphadenitis; 30 (23.6%) injection-site abscess; five (3.9%) had enlarged lymph node > 3 cm; four (3.1%) had ulcer > 1 cm; and one (0.8%) had a local bacterial infection. Five patients (3.9%) had more than one BCG-AE simultaneously. Fifteen patients (11.8%) had atypical manifestations: seven wart-like lesions; five BCG reactivations; two other dermatologic lesions and one with vasomotor phenomenon. Isoniazid was used in 96 patients with typical BCG-AE (85.7%) until lesion resolution which took place 3.1 months later (in median); the healing rate was 90.6%. Patients with atypical manifestations had an individual approach. Regarding the outcome, 105/112 patients with typical AE and 13/15 patients with atypical AE had resolution of BCG-AE. Localized BCG-AE caused by BCG Moreau RJ had positive outcome when treated with a short course of isoniazid. Atypical BCG-AE are not infrequent.

  16. Closure of Interatrial Septal Communications: Adverse Events and Lessons Learned

    PubMed Central

    Wagdi, Philipp

    2011-01-01

    Background Percutaneous closure of interatrial septal communications (IASC) is generally being regarded as a safe and straightforward intervention. Reporting and classification of adverse events (AE) as is the case for percutaneous coronary intervention (PCI) is not standardized. Also, the focus of reported larger studies has not been primarily on AE and strategies to avoid them. Methods The data of all 112 consecutive patients undergoing IASC by a single operator were reviewed. In analogy to classification for PCI, an AE was considered to be major if any of the following occurred: death, major or minor stroke, myocardial infarction, the need for an originally unplanned additional surgery or intervention or blood transfusion. Every AE and how it may have been avoided is reviewed in detail. Results Major AE according to the suggested classification occurred in 2.7% of patients, including tamponade in 1 patient necessitating thoracotomy 7 months after IASC, percutaneous retrieval of an embolized device in 1 patient, and ambulatory same day surgical treatment of an arteriovenous fistula in 1 patient. Conclusions The proposed new classification of AE provides a unified and comparable approach for IASC procedures. Retrospectively, two of the 3 major AE could have probably been avoided by more thoughtful patient and material selection.

  17. Pharmacogenetic Foundations of Therapeutic Efficacy and Adverse Events of Statins

    PubMed Central

    Arrigoni, Elena; Del Re, Marzia; Fidilio, Leonardo; Fogli, Stefano; Danesi, Romano; Di Paolo, Antonello

    2017-01-01

    Background: In the era of precision medicine, more attention is paid to the search for predictive markers of treatment efficacy and tolerability. Statins are one of the classes of drugs that could benefit from this approach because of their wide use and their incidence of adverse events. Methods: Literature from PubMed databases and bibliography from retrieved publications have been analyzed according to terms such as statins, pharmacogenetics, epigenetics, toxicity and drug–drug interaction, among others. The search was performed until 1 October 2016 for articles published in English language. Results: Several technical and methodological approaches have been adopted, including candidate gene and next generation sequencing (NGS) analyses, the latter being more robust and reliable. Among genes identified as possible predictive factors associated with statins toxicity, cytochrome P450 isoforms, transmembrane transporters and mitochondrial enzymes are the best characterized. Finally, the solute carrier organic anion transporter family member 1B1 (SLCO1B1) transporter seems to be the best target for future studies. Moreover, drug–drug interactions need to be considered for the best approach to personalized treatment. Conclusions: Pharmacogenetics of statins includes several possible genes and their polymorphisms, but muscular toxicities seem better related to SLCO1B1 variant alleles. Their analysis in the general population of patients taking statins could improve treatment adherence and efficacy; however, the cost–efficacy ratio should be carefully evaluated. PMID:28067828

  18. Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data

    PubMed Central

    Eldredge, Christina; Cho, Chi C; Cisler, Ron A

    2016-01-01

    Background Understanding adverse event patterns in clinical studies across populations is important for patient safety and protection in clinical trials as well as for developing appropriate drug therapies, procedures, and treatment plans. Objectives The objective of our study was to conduct a data-driven population-based analysis to estimate the incidence, diversity, and association patterns of adverse events by age of the clinical trials patients and participants. Methods Two aspects of adverse event patterns were measured: (1) the adverse event incidence rate in each of the patient age groups and (2) the diversity of adverse events defined as distinct types of adverse events categorized by organ system. Statistical analysis was done on the summarized clinical trial data. The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained from ClinicalTrials.gov, and 186,339 clinical studies were analyzed; data were extracted from the 17,853 clinical trials that reported clinical outcomes. The total number of clinical trial participants was 6,808,619, and total number of participants affected by adverse events in these trials was 1,840,432. The trial participants were divided into eight different age groups to support cross-age group comparison. Results In general, children and older patients are more susceptible to adverse events in clinical trial studies. Using the lowest incidence age group as the reference group (20-29 years), the incidence rate of the 0-9 years-old group was 31.41%, approximately 1.51 times higher (P=.04) than the young adult group (20-29 years) at 20.76%. The second-highest group is the 50-59 years-old group with an incidence rate of 30.09%, significantly higher (P<.001) when compared with the lowest incidence in the 20-29 years-old group. The adverse event diversity also increased with increase in patient age. Clinical studies that recruited older

  19. Emotional Suppression Mediates the Relation Between Adverse Life Events and Adolescent Suicide: Implications for Prevention

    PubMed Central

    Kaplow, Julie B.; Gipson, Polly Y.; Horwitz, Adam G.; Burch, Bianca N.; King, Cheryl A.

    2016-01-01

    Suicidal ideation substantially increases the odds of future suicide attempts, and suicide is the second leading cause of death among adolescents. A history of adverse life events has been linked with future suicidal ideation and attempts, although studies examining potential mediating variables have been scarce. One probable mediating mechanism is how the individual copes with adverse life events. For example, certain coping strategies appear to be more problematic than others in increasing future psychopathology, and emotional suppression in particular has been associated with poor mental health outcomes in adults and children. However, no studies to date have examined the potential mediating role of emotional suppression in the relation between adverse life events and suicidal thoughts/behavior in adolescence. The goal of the current study was to examine emotional suppression as a mediator in the relation between childhood adversity and future suicidal thoughts/behaviors in youth. A total of 625 participants, aged 14–19 years, seeking ER services were administered measures assessing adverse life events, coping strategies, suicidal ideation in the last 2 weeks, and suicide attempts in the last month. The results suggest that emotional suppression mediates the relation between adversity and both (1) suicidal thoughts and (2) suicide attempts above and beyond demographic variables and depressive symptoms. This study has important implications for interventions aimed at preventing suicidal thoughts and behavior in adolescents with histories of adversity. PMID:23412949

  20. Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study

    PubMed Central

    2010-01-01

    Background A rise in gastrointestinal (GI) adverse events (AEs) and a decline in bone mineral density (BMD) was observed in patients previously tolerant to brand alendronate shortly after generic versions were introduced in July 2005 to the Canadian market. The objective of our study was to quantify changes in AE rates and BMD scores, as well as associated alendronate discontinuation among patients before and after switch from brand to generic alendronate. Methods A chart review of postmenopausal women 50 years of age and older between 2003 and 2007 was conducted in two specialized tertiary care referral centers. Patients on alendronate both before and after July 2005 were included. The change in the number of AEs, changes in BMD and associated alendronate discontinuation was compared before and after the switch from brand to generic alendronate. Results 301 women with an average age of 67.6 years (standard deviation (SD) = 9.5) had a total of 47 AEs between July 2003 and December 2007 that resulted in discontinuation of the medication. There was a significant increase in the rate of AEs per patient-months-at-risk from 0.0001 before to 0.0044 after October 2005 (p < 0.001). The most common AEs were GI in nature (stomach pain, GI upset, nausea, and reflux). In addition, 23 patients discontinued alendronate due to BMD reduction after January 2006. In these patients, BMD scores were significantly reduced from their prior BMD measures (change of -0.0534, p < 0.001 for spine BMD and change of -0.0338, p = 0.01 for femur BMD). Among patients who discontinued due to BMD reduction, BMD was stable in the period prior to January 2006 (change of -0.0066, p = 0.5 for spine BMD and change of 0.0011, p = 0.9 for femur BMD); however, testing for reduction after January 2006 in BMD measures (one-sided T-test) revealed there was a significant reduction in BMD scores for both anatomic sites (change of -0.0321, p = .005 for spine, change of -0.0205, p = 0.05 for femur). Conclusions

  1. Postoperative pharyngolaryngeal adverse events with laryngeal mask airway (LMA Supreme) in laparoscopic surgical procedures with cuff pressure limiting 25 cmH₂O: prospective, blind, and randomised study.

    PubMed

    Kang, Joo-Eun; Oh, Chung-Sik; Choi, Jae Won; Son, Il Soon; Kim, Seong-Hyop

    2014-01-01

    To reduce the incidence of postoperative pharyngolaryngeal adverse events, laryngeal mask airway (LMA) manufacturers recommend maximum cuff pressures not exceeding 60 cmH₂O. We performed a prospective randomised study, comparing efficacy and adverse events among patients undergoing laparoscopic surgical procedures who were allocated randomly into low (limiting 25 cmH₂O, L group) and high (at 60 cmH₂O, H group) LMA cuff pressure groups with LMA Supreme. Postoperative pharyngolaryngeal adverse events were evaluated at discharge from postanaesthetic care unit (PACU) (postoperative day 1, POD 1) and 24 hours after discharge from PACU (postoperative day 2, POD 2). All patients were well tolerated with LMA without ventilation failure. Before pneumoperitoneum, cuff volume and pressure and oropharyngeal leak pressure (OLP) showed significant differences. Postoperative sore throat at POD 2 (3 versus 12 patients) and postoperative dysphagia at POD 1 and POD 2 (0 versus 4 patients at POD 1; 0 versus 4 patients at POD 2) were significantly lower in L group, compared with H group. In conclusion, LMA with cuff pressure limiting 25 cmH₂O allowed both efficacy of airway management and lower incidence of postoperative adverse events in laparoscopic surgical procedures. This clinical trial is registered with KCT0000334.

  2. Drug-Related Adverse Events of Osteoporosis Therapy.

    PubMed

    Khan, Moin; Cheung, Angela M; Khan, Aliya A

    2017-03-01

    Postmenopausal osteoporosis is associated with microarchitectural deterioration and increased risk of fracture. Osteoporosis therapy effectively reduces the risk of vertebral, nonvertebral, and hip fracture and has been associated with increased survival. Currently approved treatments for osteoporosis include bisphosphonates, denosumab, selective estrogen receptor modulators, and teriparatide. This article reviews the adverse events of therapy associated with these medical interventions. Hormone replacement therapy is not included, because it is no longer indicated for the treatment of osteoporosis in all countries. Calcitonin and strontium ranelate are also not included, because their indication for osteoporosis has recently been limited or withdrawn.

  3. Data-mining-based detection of adverse drug events.

    PubMed

    Chazard, Emmanuel; Preda, Cristian; Merlin, Béatrice; Ficheur, Grégoire; Beuscart, Régis

    2009-01-01

    Every year adverse drug events (ADEs) are known to be responsible for 98,000 deaths in the USA. Classical methods rely on report statements, expert knowledge, and staff operated record review. One of our objectives, in the PSIP project framework, is to use data mining (e.g., decision trees) to electronically identify situations leading to risk of ADEs. 10,500 hospitalization records from Denmark and France were used. 500 rules were automatically obtained, which are currently being validated by experts. A decision support system to prevent ADEs is then to be developed. The article examines a decision tree and the rules in the field of vitamin K antagonists.

  4. Adverse Event and Complication Management in Gastrointestinal Endoscopy.

    PubMed

    Richter, James M; Kelsey, Peter B; Campbell, Emily J

    2016-03-01

    Gastrointestinal endoscopy is a remarkably safe set of diagnostic and therapeutic techniques, and yet a small number of significant complications and adverse events are expected. Serious complications may have a material effect on the patient's health and well-being. They need to be anticipated and prevented if possible and managed effectively when identified. When complications occur they need to be discussed frankly with patients and their families. Informed consent, prevention, early detection, reporting, and systems improvement are critical aspects of effective complication management. Optimal complication management may improve patient satisfaction and outcome, as well as preserving the reputation and confidence of the endoscopist, and may minimize litigation.

  5. Immune-Related Adverse Events Associated with Immune Checkpoint Inhibitors.

    PubMed

    Day, Daphne; Hansen, Aaron R

    2016-12-01

    Immune checkpoint inhibitors (ICIs), including antibodies targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed cell death protein-1 (PD-1), have shown durable treatment responses in multiple tumor types by enhancing antitumor immunity. However, removal of self-tolerance can induce autoimmunity and produce a unique immune-driven toxicity profile, termed immune-related adverse events (irAEs). As ICIs gain approval for a growing number of indications, it is imperative clinicians increase their knowledge of and ability to manage irAEs. This review examines the etiology, presentation, kinetics, and treatment of irAEs and aims to provide practical guidance for clinicians.

  6. CLINICAL MANAGEMENT OF LOCALIZED BCG ADVERSE EVENTS IN CHILDREN

    PubMed Central

    MOREIRA, Thais das Neves Fraga; de MORAES-PINTO, Maria Isabel; COSTA-CARVALHO, Beatriz Tavares; GRUMACH, Anete Sevciovic; WECKX, Lily Yin

    2016-01-01

    SUMMARY BCG adverse events (BCG-AE) are rare conditions with no well-established treatment. This study aims to describe clinical characteristics and outcome of localized BCG-AE. Children with BCG-AEs who were treated at the Reference Center for Special Immunobiologicals of the Federal University of São Paulo from 2009 to 2011 were included. Patients were followed monthly until 3 months after healing. One hundred and twenty-seven patients with localized BCG-AE were followed: 67 (52.7%) had suppurative lymphadenitis; 30 (23.6%) injection-site abscess; five (3.9%) had enlarged lymph node > 3 cm; four (3.1%) had ulcer > 1 cm; and one (0.8%) had a local bacterial infection. Five patients (3.9%) had more than one BCG-AE simultaneously. Fifteen patients (11.8%) had atypical manifestations: seven wart-like lesions; five BCG reactivations; two other dermatologic lesions and one with vasomotor phenomenon. Isoniazid was used in 96 patients with typical BCG-AE (85.7%) until lesion resolution which took place 3.1 months later (in median); the healing rate was 90.6%. Patients with atypical manifestations had an individual approach. Regarding the outcome, 105/112 patients with typical AE and 13/15 patients with atypical AE had resolution of BCG-AE. Localized BCG-AE caused by BCG Moreau RJ had positive outcome when treated with a short course of isoniazid. Atypical BCG-AE are not infrequent. PMID:27828625

  7. Cutaneous adverse events in multiple sclerosis patients treated with daclizumab

    PubMed Central

    Cortese, Irene; Ohayon, Joan; Fenton, Kaylan; Lee, Chyi-Chia; Raffeld, Mark; Cowen, Edward W.; DiGiovanna, John J.

    2016-01-01

    Objective: To analyze the spectrum and mechanisms of cutaneous adverse events (AEs) in patients with multiple sclerosis treated with daclizumab high-yield process (DAC-HYP). Methods: A total of 31 participants in an institutional review board–approved open-label phase I study of DAC-HYP (NCT01143441) were prospectively evaluated over 42 months for development of cutaneous AEs. Participants provided written informed consent. Fifteen participants were naive to anti-CD25 therapy (cohort B), while 16 had received daclizumab (Zenapax; Hoffmann-La Roche) IV for 4–9 years (mean 5.8 years) prior to enrollment (cohort A). Immunohistochemistry was performed on pretreatment and posttreatment skin biopsies of normal-appearing skin (cohort B only) and on lesional biopsies in participants presenting with rash (both cohorts). Results: Cutaneous AEs occurred in 77% of patients, the majority presenting with patches of eczema requiring no treatment. Moderate to severe rash developed in 6 participants (19%) and required discontinuation of DAC-HYP in 4 (13%). More severe rashes presented psoriasiform phenotype, but lesional biopsies lacked features of either psoriasis or drug hypersensitivity eruptions. Instead, irrespective of clinical severity, lesional biopsies showed nonspecific features of eczematous dermatitis, but with prominent CD56+ lymphocytic infiltrates. Pretreatment and posttreatment biopsies of normal-appearing skin demonstrated no histopathologic changes. Conclusions: Observed cutaneous AEs are likely related to the immunomodulatory effects DAC-HYP exerts on innate lymphoid cells, including natural killer cells. Vigilance and timely management of skin reactions may prevent treatment discontinuation in participants with severe rash. PMID:26843560

  8. Association Between Vascular Access Dysfunction and Subsequent Major Adverse Cardiovascular Events in Patients on Hemodialysis: A Population-Based Nested Case-Control Study.

    PubMed

    Kuo, Te-Hui; Tseng, Chien-Tzu; Lin, Wei-Hung; Chao, Jo-Yen; Wang, Wei-Ming; Li, Chung-Yi; Wang, Ming-Cheng

    2015-07-01

    The association between dialysis vascular access dysfunction and the risk of developing major adverse cardiovascular events (MACE) in hemodialysis patients is unclear and has not yet been investigated. We analyzed data from the National Health Insurance Research Database of Taiwan to quantify this association. Adopting a case-control design nested within a cohort of patients who received hemodialysis from 2001 to 2010, we identified 9711 incident cases of MACE during the stage of stable maintenance dialysis and 19,422 randomly selected controls matched to cases on age, gender, and duration of dialysis. Events of vascular access dysfunction in the 6-month period before the date of MACE onset (ie, index date) for cases and before index dates for controls were evaluated retrospectively. The presence of vascular access dysfunction was associated with a 1.385-fold higher odds of developing MACE as estimated from the logistic regression analysis. This represents a significantly increased adjusted odds ratio (OR) at 1.268 (95% confidence interval [CI] = 1.186-1.355) after adjustment for comorbidities and calendar years of initiating dialysis. We also noted a significant exposure-response trend (P < 0.001) between the frequency of vascular access dysfunction and MACE, with the greatest risk (adjusted OR = 1.840, 95% CI = 1.549-2.186) noted in patients with ≥3 vascular access events. We concluded that dialysis vascular access dysfunction was significantly associated with an increased risk of MACE. Hence, vascular access failure can be an early sign for MACE in patients receiving maintenance hemodialysis. Active monitoring and treatment of cardiovascular risk factors and related diseases, not merely managing vascular access dysfunction, would be required to reduce the risk of MACE.

  9. Management of sorafenib-related adverse events: a clinician's perspective.

    PubMed

    Brose, Marcia S; Frenette, Catherine T; Keefe, Stephen M; Stein, Stacey M

    2014-02-01

    Sorafenib, a tyrosine kinase inhibitor, is approved for the treatment of patients with unresectable hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC). It is being evaluated in phase II and III clinical trials, which include treatment as a single agent (locally advanced/metastatic radioactive iodine-refractory differentiated thyroid cancer [DTC]), as part of multimodality care (HCC), and in combination with chemotherapeutic agents (metastatic breast cancer). Sorafenib-related adverse events (AEs) that commonly occur across these tumor types include hand-foot skin reaction (HSFR), rash, upper and lower gastrointestinal (GI) distress (ie, diarrhea), fatigue, and hypertension. These commonly range from grade 1 to 3, per the Common Terminology Criteria for Adverse Events (CTCAE), and often occur early in treatment. The goal for the management of these AEs is to prevent, treat, and/or minimize their effects, thereby enabling patients to remain on treatment and improve their quality of life. Proactive management, along with ongoing patient education (before and during sorafenib treatment), can help to effectively manage symptoms, often without the need for sorafenib dose modification or drug holidays. Effective management techniques for common sorafenib-related AEs, as well other important disease sequelae not directly related to treatment, are presented. Recommendations and observations are based on physician/author experience and recommendations from published literature.

  10. Prior adversities predict posttraumatic stress reactions in adolescents following the Oslo Terror events 2011

    PubMed Central

    Nordanger, Dag Ø.; Breivik, Kyrre; Haugland, Bente Storm; Lehmann, Stine; Mæhle, Magne; Braarud, Hanne Cecilie; Hysing, Mari

    2014-01-01

    Background Former studies suggest that prior exposure to adverse experiences such as violence or sexual abuse increases vulnerability to posttraumatic stress reactions in victims of subsequent trauma. However, little is known about how such a history affects responses to terror in the general adolescent population. Objective To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. Method We used data from 10,220 high school students in a large cross-sectional survey of adolescents in Norway that took place seven months after the Oslo Terror events. Prior exposure assessed was: direct exposure to violence, witnessing of violence, and unwanted sexual acts. We explored how these prior adversities interact with well-established risk factors such as proximity to the events, perceived life threat during the terror events, and gender. Results All types of prior exposure as well as the other risk factors were associated with terror-related posttraumatic stress reactions. The effects of prior adversities were, although small, independent of adolescents’ proximity to the terror events. Among prior adversities, only the effect of direct exposure to violence was moderated by perceived life threat. Exposure to prior adversities increased the risk of posttraumatic stress reactions equally for both genders, but proximity to the terror events and perceived life threat increased the risk more in females. Conclusions Terror events can have a more destabilizing impact on victims of prior adversities, independent of their level of exposure. The findings may be relevant to mental health workers and others providing post-trauma health care. PMID:24872862

  11. Analysis of 415 adverse events in dental practice in Spain from 2000 to 2010

    PubMed Central

    Perea-Pérez, Bernardo; Labajo-González, Elena; Santiago-Sáez, Andrés; Albarrán-Juan, Elena; Villa-Vigil, Alfonso

    2014-01-01

    Introduction: The effort to increase patient safety has become one of the main focal points of all health care professions, despite the fact that, in the field of dentistry, initiatives have come late and been less ambitious. The main objective of patient safety is to avoid preventable adverse events to the greatest extent possible and to limit the negative consequences of those which are unpreventable. Therefore, it is essential to ascertain what adverse events occur in each dental care activity in order to study them in-depth and propose measures for prevention. Objectives: To ascertain the characteristics of the adverse events which originate from dental care, to classify them in accordance with type and origin, to determine their causes and consequences, and to detect the factors which facilitated their occurrence. Material and Methods: This study includes the general data from the series of adverse dental vents of the Spanish Observatory for Dental Patient Safety (OESPO) after the study and analysis of 4,149 legal claims (both in and out of court) based on dental malpractice from the years of 2000 to 2010 in Spain. Results: Implant treatments, endodontics and oral surgery display the highest frequencies of adverse events in this series (25.5%, 20.7% and 20.4% respectively). Likewise, according to the results, up to 44.3% of the adverse events which took place were due to predictable and preventable errors and complications. Conclusions: A very significant percentage were due to foreseeable and preventable errors and complications that should not have occurred. Key words:Patient safety, adverse event, medical care risk, dentistry. PMID:24880444

  12. 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

  13. Adverse Events of Extracorporeal Ultrasound-Guided High Intensity Focused Ultrasound Therapy

    PubMed Central

    Yu, Tinghe; Luo, Jun

    2011-01-01

    Background High-intensity focused ultrasound (HIFU) is considered to be an alternative to surgery. Extracorporeal ultrasound-guided HIFU (USgFU) has been clinically used to treat solid tumors. Preliminary trials in a small sample of a Western population suggested that this modality was safe. Most trials are performed in China thereby providing comprehensive data for understanding the safety profile. The aim of this study was to evaluate adverse events of USgFU therapy. Methods and Findings Clinical data were searched in 2 Chinese databases. Adverse events of USgFU were summarized and compared with those of magnetic resonance-guided HIFU (MRgFU; for uterine, bone or breast tumor) and transrectal ultrasound-guided HIFU (for prostate cancer or benign prostate hyperplasia). USgFU treatment was performed using 7 types of device. Side effects were evaluated in 13262 cases. There were fewer adverse events in benign lesions than in malignant lesions (11.81% vs. 21.65%, p<0.0001). Rates of adverse events greatly varied between the disease types (0–280%, p<0.0001) and between the applied HIFU devices in both malignant (10.58–44.38%, p<0.0001) and benign lesions (1.67–17.57%, p<0.0001). Chronological analysis did not demonstrate a decrease in the rate of adverse events. Based upon evaluable adverse events, incidences in USgFU were consistent with those in MRgFU or transrectal HIFU. Some side effects frequently occurred following transrectal HIFU were not reported in USgFU. Several events including intrahepatic metastasis, intraoperative high fever, and occlusions of the superior mesenteric artery should be of particular concern because they have not been previously noted. The types of adverse events suggested that they were ultrasonic lesions. Conclusion The frequency of adverse events depended on the location of the lesion and the type of HIFU device; however, side effects of USgFU were not yet understood. USgFU did not decrease the incidence of adverse events compared

  14. Syntax Score and Major Adverse Cardiac Events in Patients with Suspected Coronary Artery Disease: Results from a Cohort Study in a University-Affiliated Hospital in Southern Brazil

    PubMed Central

    Fuchs, Felipe C.; Ribeiro, Jorge P.; Fuchs, Flávio D.; Wainstein, Marco V.; Bergoli, Luis C.; Wainstein, Rodrigo V.; Zen, Vanessa; Kerkhoff, Alessandra C.; Moreira, Leila B.; Fuchs, Sandra C.

    2016-01-01

    Background: The importance of coronary anatomy in predicting cardiovascular events is well known. The use of traditional anatomical scores in routine angiography, however, has not been incorporated to clinical practice. SYNTAX score (SXscore) is a scoring system that estimates the anatomical extent of coronary artery disease (CAD). Its ability to predict outcomes based on a baseline diagnostic angiography has not been tested to date. Objective: To evaluate the performance of the SXscore in predicting major adverse cardiac events (MACE) in patients referred for diagnostic angiography. Methods: Prospective cohort of 895 patients with suspected CAD referred for elective diagnostic coronary angiography from 2008 to 2011, at a university-affiliated hospital in Brazil. They had their SXscores calculated and were stratified in three categories: no significant CAD (n = 495), SXscoreLOW-INTERMEDIATE: < 23 (n = 346), and SXscoreHIGH: ≥ 23 (n = 54). Primary outcome was a composite of cardiac death, myocardial infarction, and late revascularization. Secondary endpoints were the components of MACE and death from any cause. Results: On average, patients were followed up for 1.8 ± 1.4 years. The primary outcome occurred in 2.2%, 15.3%, and 20.4% in groups with no significant CAD, SXscoreLOW-INTERMEDIATE, and SXscoreHIGH, respectively (p < 0.001). All-cause death was significantly higher in the SXscoreHIGH compared with the 'no significant CAD' group, 16.7% and 3.8% (p < 0.001), respectively. After adjustment for confounding factors, all outcomes remained associated with the SXscore. Conclusions: SXscore independently predicts MACE in patients submitted to diagnostic coronary angiography. Its routine use in this setting could identify patients with worse prognosis. PMID:27509092

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

    MedlinePlus

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

  16. 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.

  17. Acupuncture-related adverse events: a systematic review of the Chinese literature

    PubMed Central

    Shang, Hongcai; Gao, Xiumei; Ernst, Edzard

    2010-01-01

    Abstract Objective To systematically review the Chinese-language literature on acupuncture-related adverse events. Methods We searched three Chinese databases (the Chinese Biomedical Literature Database, 1980–2009; the Chinese Journal Full-Text Database, 1980–2009; and the Weipu Journal Database, 1989–2009) to identify Chinese-language articles about the safety of traditional needle acupuncture. Case reports, case series, surveys and other observational studies were included if they reported factual data, but review articles, translations and clinical trials were excluded. Findings The inclusion criteria were met by 115 articles (98 case reports and 17 case series) that in total reported on 479 cases of adverse events after acupuncture. Fourteen patients died. Acupuncture-related adverse events were classified into three categories: traumatic, infectious and “other”. The most frequent adverse events were pneumothorax, fainting, subarachnoid haemorrhage and infection, while the most serious ones were cardiovascular injuries, subarachnoid haemorrhage, pneumothorax and recurrent cerebral haemorrhage. Conclusion Many acupuncture-related adverse events, most of them owing to improper technique, have been described in the published Chinese literature. Efforts should be made to find effective ways of monitoring and minimizing the risks related to acupuncture. PMID:21124716

  18. Management of egfr tki–induced dermatologic adverse events

    PubMed Central

    Melosky, B.; Leighl, N.B.; Rothenstein, J.; Sangha, R.; Stewart, D.; Papp, K.

    2015-01-01

    Targeting the epidermal growth factor receptor (egfr) pathway has become standard practice for the treatment of advanced non-small-cell lung cancer. Compared with chemotherapy, egfr tyrosine kinase inhibitors (tkis) have been associated with improved efficacy in patients with an EGFR mutation. Together with the increase in efficacy comes an adverse event (ae) profile different from that of chemotherapy. That profile includes three of the most commonly occurring dermatologic aes: acneiform rash, stomatitis, and paronychia. Currently, no randomized clinical trials have evaluated the treatments for the dermatologic aes that patients experience when taking egfr tkis. Based on the expert opinion of the authors, some basic strategies have been developed to manage those key dermatologic aes. Those strategies have the potential to improve patient quality of life and compliance and to prevent inappropriate dose reductions. PMID:25908911

  19. Automatic adverse drug events detection using letters to the editor.

    PubMed

    Yang, Chao; Srinivasan, Padmini; Polgreen, Philip M

    2012-01-01

    We present and test the intuition that letters to the editor in journals carry early signals of adverse drug events (ADEs). Surprisingly these letters have not yet been exploited for automatic ADE detection unlike for example, clinical records and PubMed. Part of the challenge is that it is not easy to access the full-text of letters (for the most part these do not appear in PubMed). Also letters are likely underrated in comparison with full articles. Besides demonstrating that this intuition holds we contribute techniques for post market drug surveillance. Specifically, we test an automatic approach for ADE detection from letters using off-the-shelf machine learning tools. We also involve natural language processing for feature definitions. Overall we achieve high accuracy in our experiments and our method also works well on a second new test set. Our results encourage us to further pursue this line of research.

  20. Adverse event prediction in patients with left ventricular assist devices.

    PubMed

    Tsipouras, Markos G; Karvounis, Evaggelos C; Tzallas, Alexandros T; Katertsidis, Nikolaos S; Goletsis, Yorgos; Frigerio, Maria; Verde, Alessandro; Trivella, Maria G; Fotiadis, Dimitrios I

    2013-01-01

    This work presents the Treatment Tool, which is a component of the Specialist's Decision Support Framework (SDSS) of the SensorART platform. The SensorART platform focuses on the management of heart failure (HF) patients, which are treated with implantable, left ventricular assist devices (LVADs). SDSS supports the specialists on various decisions regarding patients with LVADs including decisions on the best treatment strategy, suggestion of the most appropriate candidates for LVAD weaning, configuration of the pump speed settings, while also provides data analysis tools for new knowledge extraction. The Treatment Tool is a web-based component and its functionality includes the calculation of several acknowledged risk scores along with the adverse events appearance prediction for treatment assessment.

  1. A review of adverse events caused by immune checkpoint inhibitors.

    PubMed

    Fukushima, Satoshi

    2016-01-01

      There has been no effective therapy in the unresectable melanoma for more than 40 years. Anti-PD-1 antibody and anti-CTLA-4 antibody have totally changed the situation. They have clearly shown the survival benefits of the patients with metastatic melanoma. However, immune checkpoint inhibitors sometimes induce various kinds of immune-related adverse events (irAEs). It is very important for the clinicians to know the reported cases of irAEs and to keep in mind the symptoms of irAEs for the early detection. This review describes the previously reported irAEs and adequate managements for irAEs induced by immune checkpoint inhibitors.

  2. Corneal transplantation: study of the data of a regional eye bank for the year 2013 and analysis of the evolution of the adverse events reported in France since 2010.

    PubMed

    Gauthier, Anne-Sophie; Castelbou, Marie; Garnier, Mélanie Bidaut; Pizzuto, Joëlle; Roux, Stephan; Gain, Philippe; Pouthier, Fabienne; Delbosc, Bernard

    2017-01-23

    To analyze the data of the adverse events collected in a single major eye bank (EFS Bourgogne Franche Comté, Besançon, France) for the year 2013 and to report the French data of biovigilance provided by the French National Agency for Medicines and Health Products Safety (ANSM) between 2010 and 2013. we have set up a study of adverse events in 2013, in collaboration with a single eye bank (EFS Bourgogne Franche Comté, Besançon, France). A survey was sent to the surgeon for each delivered corneal button by the eye bank in 2013. They were asked for each grafted patient performed in their center, the type of graft (penetrating keratoplasty, anterior keratoplasty or endothelial keratoplasty), the occurrence of adverse events (primary failure, infectious keratis, endophthalmitis, immune rejection, and other events) and the time interval between surgery and events (Less than 1 postoperative month, between 1 month and 1 year postoperatively, >1 year postoperatively). In 2013, 407 corneal buttons were delivered by the eye bank of Besançon in 21 medical centers which performed corneal grafts and we sent 407 surveys. We received 243 completed questionnaires (59.75%) from 11 centers (52.38%). The global reported rate of adverse events was 27.54% of the graft (n = 65/236 corneal grafts performed in 11 centers in 2013; 20% of Primary graft failure, 11% of infectious keratitis, 1% of endophthalmitis, 34% of rejection, 34% of other incidents). 30.16% of complications were noticed before the first month after surgery versus 52.38% of complications noticed between the first month and the first year after surgery and 17.46% of complications noticed after the post-operative first year The most common causes of adverse events after PK were Immune rejection (13.17%), surgical causes (5.98%) and infection (4.79%) and after EK were Primary graft failure (8.2%) and surgical causes (19.67%). In 2013, in France 0.83% of adverse events were notified in ANSM. For the 236 performed

  3. 78 FR 71620 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-29

    ... Collection; Comment Request; Adverse Event Program for Medical Products AGENCY: Food and Drug Administration... solicits comments on the collection of information regarding the Adverse Event Program for medical devices... techniques, when appropriate, and other forms of information technology. Adverse Event Program for...

  4. 77 FR 17076 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ... Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by... notice solicits comments on the collection of information associated with adverse event reporting and... appropriate, and other forms of information technology. Adverse Event Reporting and Recordkeeping for...

  5. Shattering world assumptions: A prospective view of the impact of adverse events on world assumptions.

    PubMed

    Schuler, Eric R; Boals, Adriel

    2016-05-01

    Shattered Assumptions theory (Janoff-Bulman, 1992) posits that experiencing a traumatic event has the potential to diminish the degree of optimism in the assumptions of the world (assumptive world), which could lead to the development of posttraumatic stress disorder. Prior research assessed the assumptive world with a measure that was recently reported to have poor psychometric properties (Kaler et al., 2008). The current study had 3 aims: (a) to assess the psychometric properties of a recently developed measure of the assumptive world, (b) to retrospectively examine how prior adverse events affected the optimism of the assumptive world, and (c) to measure the impact of an intervening adverse event. An 8-week prospective design with a college sample (N = 882 at Time 1 and N = 511 at Time 2) was used to assess the study objectives. We split adverse events into those that were objectively or subjectively traumatic in nature. The new measure exhibited adequate psychometric properties. The report of a prior objective or subjective trauma at Time 1 was related to a less optimistic assumptive world. Furthermore, participants who experienced an intervening objectively traumatic event evidenced a decrease in optimistic views of the world compared with those who did not experience an intervening adverse event. We found support for Shattered Assumptions theory retrospectively and prospectively using a reliable measure of the assumptive world. We discuss future assessments of the measure of the assumptive world and clinical implications to help rebuild the assumptive world with current therapies. (PsycINFO Database Record

  6. Single dose oral analgesics for postoperative pain have few adverse events.

    PubMed

    Wong, Yin J

    2016-09-01

    Data sourcesThe Cochrane Database of Systematic Reviews on the Cochrane Library.Study selectionAll Cochrane reviews of RCTs between 1999 to 2015, conducted in adults examining the adverse events associated with single dose oral analgesics used for acute post-operative pain were considered.Data extraction and synthesisStudies were searched, reviewed and assessed independently by two reviewers and standard data items extracted. Methodological quality was assessed using criteria adapted from AMSTAR (Assessing the Methodological Quality of Systematic Reviews).ResultsData from 39 Cochrane reviews of 41 different analgesics or analgesic combinations involving a total of 350 studies involving 35,000 adults were included. Most analgesics were tested in a narrow dose range. For most NSAIDs, paracetamol (acetaminophen), and combinations not containing opioids, the rates of adverse events were similar to that of placebos (NSAID 3% - 44% vs 4 - 46%; paracetamol 7-18% vs 6-16%; combination 11-30% vs 6-48%). However, for higher dosages, like 1000 mg aspirin, 1000 mg diflunisal, and opioids or drug combinations containing opioids, there was a statistically significant difference in the incidence of adverse events reported (NNH 7.7(95%CI; 4.8 - 20) for 1000 mg aspirin; 7.5(95%CI; 4.8-17) for 1000 mg diflunisal; 3.5-8.6 for opioids and combinations). Serious adverse events were rare, occurring at about 1 in 3,200.ConclusionsDespite ongoing problems with the measurement, recording and reporting of adverse events in clinical trials and in systematic reviews, the large amount of information available for single oral doses of analgesics provides evidence that adverse events rates are generally similar with active drug and placebo in these circumstances, except at higher doses of some drugs, and in combinations including opioids.

  7. Novel algorithms for improved pattern recognition using the US FDA Adverse Event Network Analyzer.

    PubMed

    Botsis, Taxiarchis; Scott, John; Goud, Ravi; Toman, Pamela; Sutherland, Andrea; Ball, Robert

    2014-01-01

    The medical review of adverse event reports for medical products requires the processing of "big data" stored in spontaneous reporting systems, such as the US Vaccine Adverse Event Reporting System (VAERS). VAERS data are not well suited to traditional statistical analyses so we developed the FDA Adverse Event Network Analyzer (AENA) and three novel network analysis approaches to extract information from these data. Our new approaches include a weighting scheme based on co-occurring triplets in reports, a visualization layout inspired by the islands algorithm, and a network growth methodology for the detection of outliers. We explored and verified these approaches by analysing the historical signal of Intussusception (IS) after the administration of RotaShield vaccine (RV) in 1999. We believe that our study supports the use of AENA for pattern recognition in medical product safety and other clinical data.

  8. Dietary patterns and the risk of major adverse cardiovascular events in a global study of high-risk patients with stable coronary heart disease

    PubMed Central

    Stewart, Ralph A. H.; Wallentin, Lars; Benatar, Jocelyne; Danchin, Nicolas; Hagström, Emil; Held, Claes; Husted, Steen; Lonn, Eva; Stebbins, Amanda; Chiswell, Karen; Vedin, Ola; Watson, David; White, Harvey D.

    2016-01-01

    Objectives To determine whether dietary pattern assessed by a simple self-administered food frequency questionnaire is associated with major adverse cardiovascular events (MACE) in high-risk patients with stable coronary artery disease. Background A Mediterranean dietary pattern has been associated with lower cardiovascular (CV) mortality. It is less certain whether foods common in western diets are associated with CV risk. Methods At baseline, 15 482 (97.8%) patients (mean age 67 ± 9 years) with stable coronary heart disease from 39 countries who participated in the Stabilisation of atherosclerotic plaque by initiation of darapladib therapy (STABILITY) trial completed a life style questionnaire which included questions on common foods. A Mediterranean diet score (MDS) was calculated for increasing consumption of whole grains, fruits, vegetables, legumes, fish, and alcohol, and for less meat, and a ‘Western diet score’ (WDS) for increasing consumption of refined grains, sweets and deserts, sugared drinks, and deep fried foods. A multi-variable Cox proportional hazards models assessed associations between MDS or WDS and MACE, defined as CV death, non-fatal myocardial infarction, or non-fatal stroke. Results After a median follow-up of 3.7 years MACE occurred in 7.3% of 2885 subjects with an MDS ≥15, 10.5% of 4018 subjects with an MDS of 13–14, and 10.8% of 8579 subjects with an MDS ≤12. A one unit increase in MDS >12 was associated with lower MACE after adjusting for all covariates (+1 category HR 0.95, 95% CI 0.91, 0.98, P = 0.002). There was no association between WDS (adjusted model +1 category HR 0.99, 95% CI 0.97, 1.01) and MACE. Conclusion Greater consumption of healthy foods may be more important for secondary prevention of coronary artery disease than avoidance of less healthy foods typical of Western diets. PMID:27109584

  9. Designing an Adverse Drug Event Reporting System to Prevent Unintentional Reexposures to Harmful Drugs: Study Protocol for a Multiple Methods Design

    PubMed Central

    Small, Serena S; Badke, Katherin; Wickham, Maeve E; Bailey, Chantelle; Chruscicki, Adam; Ackerley, Christine; Balka, Ellen; Hohl, Corinne M

    2016-01-01

    Background Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs. Objective We aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada. Methods To develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting. Results This is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable

  10. Depicting adverse events in cardiac theatre: the preliminary conception of the RECORD model

    PubMed Central

    2013-01-01

    Human error is a byproduct of the human activity and may results in random unintended events; they may have major consequences when it comes to delivery of medicine. Furthermore the causes of error in surgical practice are multifaceted and complex. This article aims to raise awareness for safety measures in the cardiac surgical room and briefly “touch upon” the human factors that could lead to adverse outcomes. Finally, we describe a model that would enable us to depict and study adverse events in the operating theatre. PMID:23510398

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

    PubMed

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

    2014-01-01

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

  12. High STOP-BANG questionnaire scores predict intraoperative and early postoperative adverse events

    PubMed Central

    Seet, Edwin; Chua, Maureen; Liaw, Chen Mei

    2015-01-01

    INTRODUCTION Obstructive sleep apnoea (OSA) is the most common sleep-related breathing disorder associated with multisystemic organ involvement. The STOP-BANG questionnaire is a concise, validated questionnaire that is used to screen for OSA. This study aimed to establish the use of the STOP-BANG questionnaire for perioperative patient risk stratification. METHODS In this retrospective cohort study, we extracted the demographic, medical and perioperative outcome data of all patients who underwent elective surgery, excluding ophthalmic surgeries, from January to December 2011. Multivariate regression analysis was used to predict independent risk factors for intraoperative and early postoperative adverse events. RESULTS Of the 5,432 patients analysed, 7.4% had unexpected intraoperative and early postoperative adverse events. We found that the risk of unexpected intraoperative and early postoperative adverse events was greater in patients with STOP-BANG scores ≥ 3 compared to those with a STOP-BANG score of 0 (score 3: odds ratio [OR] 3.6, 95% confidence interval [CI] 2.1–6.3, p < 0.001; score 4: OR 3.4, 95% CI 1.8–6.5, p < 0.001; score 5: OR 6.4, 95% CI 2.7–15.0, p < 0.001; score ≥ 6: OR 5.6, 95% CI 2.1–15.4, p < 0.001). Patients with STOP-BANG scores ≥ 5 had a fivefold increased risk of unexpected intraoperative and early postoperative adverse events, while patients with STOP-BANG scores ≥ 3 had a ‘one in four’ chance of having an adverse event. Other independent predictors included older age (p < 0.001), American Society of Anesthesiologists class ≥ 2 (p < 0.003) and uncontrolled hypertension (p = 0.028). CONCLUSION STOP-BANG score may be used as a preoperative risk stratification tool to predict the risk of intraoperative and early postoperative adverse events. PMID:25917473

  13. Antipsychotics-Associated Serious Adverse Events in Children: An Analysis of the FAERS Database

    PubMed Central

    Kimura, Goji; Kadoyama, Kaori; Brown, J.B.; Nakamura, Tsutomu; Miki, Ikuya; Nisiguchi, Kohshi; Sakaeda, Toshiyuki; Okuno, Yasushi

    2015-01-01

    Objective: The reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 1997 to 2011 were reviewed to assess serious adverse events induced by the administration of antipsychotics to children. Methods: Following pre-processing of FAERS data by elimination of duplicated records as well as adjustments to standardize drug names, reports involving haloperidol, olanzapine, quetiapine, clozapine, ziprasidone, risperidone, and aripiprazole were analyzed in children (age 0-12). Signals in the data that signified a drug-associated adverse event were detected via quantitative data mining algorithms. The algorithms applied to this study include the empirical Bayes geometric mean, the reporting odds ratio, the proportional reporting ratio, and the information component of a Bayesian confidence propagation neural network. Neuroleptic malignant syndrome (NMS), QT prolongation, leukopenia, and suicide attempt were focused on as serious adverse events. Results: In regard to NMS, the signal scores for haloperidol and aripiprazole were greater than for other antipsychotics. Significant signals of the QT prolongation adverse event were detected only for ziprasidone and risperidone. With respect to leukopenia, the association with clozapine was noteworthy. In the case of suicide attempt, signals for haloperidol, olanzapine, quetiapine, risperidone, and aripiprazole were detected. Conclusions: It was suggested that there is a level of diversity in the strength of the association between various first- and second-generation antipsychotics with associated serious adverse events, which possibly lead to fatal outcomes. We recommend that research be continued in order to gather a large variety and quantity of related information, and that both available and newly reported data be placed in the context of multiple medical viewpoints in order to lead to improved levels of care. PMID:25589889

  14. Assessing Adverse Events of Postprostatectomy Radiation Therapy for Prostate Cancer: Evaluation of Outcomes in the Regione Emilia-Romagna, Italy

    SciTech Connect

    Showalter, Timothy N.; Hegarty, Sarah E.; Rabinowitz, Carol; Maio, Vittorio; Hyslop, Terry; Dicker, Adam P.; Louis, Daniel Z.

    2015-03-15

    Purpose: Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events. Methods: The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapy were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate. Results: A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes). Conclusion: Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However

  15. Prevention of adverse events in hospitalized patients using an antimicrobial review program.

    PubMed Central

    Guglielmo, B J; Luber, A D; Corelli, R L; Flaherty, J F; Jacobs, R A

    1999-01-01

    OBJECTIVE: To evaluate whether an antimicrobial review system is associated with a reduction in antimicrobial-associated adverse events. DESIGN: All antimicrobial medication orders for patients hospitalized over a two-year period were evaluated. High-level interventions intended to prevent adverse antimicrobial events were collated. Based on literature estimates of adverse antimicrobial events, potential reduction of high-level adverse antimicrobial events was estimated. SETTING: Department of Clinical Pharmacy and Division of Infectious Diseases at a tertiary care teaching hospital. RESULTS: A total of 452 interventions were classified as "high-level." The incidence of preventable adverse antimicrobial events requiring intervention was 16 per 1000 antimicrobial orders. The incidence of high-level errors necessitating intervention was 4.4 per 1000 antimicrobial orders. An estimated 125 to 198 high-level adverse events were avoided. CONCLUSION: An antimicrobial review program has the potential to reduce significant adverse events in hospitalized patients. PMID:10560287

  16. The Adverse Events of Oxycodone in Cancer-Related Pain

    PubMed Central

    Ma, Hu; Liu, Yuan; Huang, Lang; Zeng, Xian-Tao; Jin, Su-Han; Yue, Guo-Jun; Tian, Xu; Zhou, Jian-Guo

    2016-01-01

    Abstract The adverse events (AEs) of oxycodone in cancer-related pain were controversial, so we conducted a meta-analysis to determine it. PubMed, Embase, CBM, CNKI, WanFang database, The Cochrane library, Web of Science, and the reference of included studies were searched to recognize pertinent studies. Relative risk (RR) with 95% confidence intervals (CIs) for all AEs were all extracted. The fixed-effects model was used to calculate pooled RRs and 95% CIs. Power calculation was performed using macro embedded in SAS software after all syntheses were completed. We identified 11 eligible trials involving 1211 patients: 604 patients included in oxycodone group and 607 patients involved in control group. Our quantitative analysis included 8 AEs, and the pooled analyses indicated that oxycodone compared with other opioids in cancer-related pain were not significantly decreased RRs of all AEs (dizziness RR = 0.94, 95% CI: 0.69–1.30, Z = 0.35, P = 0.72; nausea RR = 0.88, 95% CI: 0.72–1.07, Z = 1.26, P = 0.21; vomiting RR = 0.89, 95% CI: 0.70–1.15, Z = 0.9, P = 0.37; sleepiness RR = 0.86, 95% CI: 0.38–1.36, Z = 0.36, P = 0.72; constipation RR = 0.98, 95% CI: 0.81–1.19, Z = 0.21, P = 0.83; anorexia RR = 0.97, 95% CI = 0.58–1.62, Z = 0.11, P = 0.91; pruritus RR = 0.76, 95% CI: 0.44–1.30, Z = 1.01, P = 0.31; dysuria RR = 0.33, 95% CI: 0.07–1.62, Z = 1.36, P = 0.1)]. The subgroup analysis shown that Ox controlled-release (CR) had less sleepiness compared with MS-contin (Mc) CR (RR = 0.47, 95% CI: 0.25–0.90, P = 0.02). The power analysis suggests that all AEs have low statistical power. The present meta-analysis detected that no statistically significant difference were found among oxycodone and other opioids in all AEs, but Ox CR may had less sleepiness compared with Mc CR when subgroup analysis were conducted. PMID:27082588

  17. Adverse events of gastric electrical stimulators recorded in the Manufacturer and User Device Experience (MAUDE) Registry.

    PubMed

    Bielefeldt, Klaus

    2017-01-01

    The role of gastric electrical stimulation for patients with refractory symptoms of gastroparesis remains controversial. Open label studies suggest benefit while randomized controlled trials did not demonstrate differences between active and sham intervention. Using a voluntary reporting system of the Federal Drug Administration, we examined the type and frequency of adverse events.

  18. TIMI Frame Count and Adverse Events in Women with No Obstructive Coronary Disease: A Pilot Study from the NHLBI-Sponsored Women's Ischemia Syndrome Evaluation (WISE)

    PubMed Central

    Petersen, John W.; Johnson, B. Delia; Kip, Kevin E.; Anderson, R. David; Handberg, Eileen M.; Sharaf, Barry; Mehta, Puja K.; Kelsey, Sheryl F.; Merz, C. Noel Bairey; Pepine, Carl J.

    2014-01-01

    Background TIMI frame count (TFC) predicts outcomes in patients with obstructive coronary artery disease (CAD); it remains unclear whether TFC predicts outcomes in patients without obstructive CAD. Methods TFC was determined in a sample of women with no obstructive CAD enrolled in the Women's Ischemia Syndrome Evaluation (WISE) study. Because TFC is known to be higher in the left anterior descending artery (LAD), TFC determined in the LAD was divided by 1.7 to provide a corrected TFC (cTFC). Results A total of 298 women, with angiograms suitable for TFC analysis and long-term (6–10 year) follow up data, were included in this sub-study. Their age was 55±11 years, most were white (86%), half had a history of smoking, and half had a history of hypertension. Higher resting cTFC was associated with a higher rate of hospitalization for angina (34% in women with a cTFC >35, 15% in women with a cTFC ≤35, P<0.001). cTFC provided independent prediction of hospitalization for angina after adjusting for many baseline characteristics. In this cohort, resting cTFC was not predictive of major events (myocardial infarction, heart failure, stroke, or all-cause death), cardiovascular events, all-cause mortality, or cardiovascular mortality. Conclusions In women with signs and symptoms of ischemia but no obstructive CAD, resting cTFC provides independent prediction of hospitalization for angina. Larger studies are required to determine if resting TFC is predictive of major events in patients without obstructive coronary artery disease. PMID:24800739

  19. Prevention and management of adverse events related to regorafenib.

    PubMed

    De Wit, Mieke; Boers-Doets, Christine B; Saettini, Alessandra; Vermeersch, Kristina; de Juan, Carmen Roncero; Ouwerkerk, Jan; Raynard, See-See; Bazin, Ashley; Cremolini, Chiara

    2014-03-01

    Regorafenib is an oral multikinase inhibitor that has shown antitumor activity in a range of solid tumors. Based on data from phase III clinical trials, regorafenib is indicated for the treatment of adult patients with metastatic colorectal cancer who have previously been treated with, or are not considered candidates for, other available therapies, and in patients with advanced gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other appropriate treatments. A panel of oncology nurses, research coordinators, and other medical oncology experts, experienced in the care of patients treated with regorafenib, met to discuss the best practice for the management of regorafenib-associated adverse events (AEs). The panel agreed that, in clinical trials and daily practice with regorafenib, AEs are common but mostly manageable. The most common and/or important AEs associated with regorafenib were considered to be hand-foot skin reaction, rash or desquamation, stomatitis, diarrhea, hypertension, liver abnormalities, and fatigue. This manuscript describes the experience and recommendations of the panel for managing these AEs in everyday clinical practice. Appropriate education, monitoring, and management are considered essential for reducing the incidence, duration, and severity of regorafenib-associated AEs.

  20. Adverse drug events and medication errors: detection and classification methods.

    PubMed

    Morimoto, T; Gandhi, T K; Seger, A C; Hsieh, T C; Bates, D W

    2004-08-01

    Investigating the incidence, type, and preventability of adverse drug events (ADEs) and medication errors is crucial to improving the quality of health care delivery. ADEs, potential ADEs, and medication errors can be collected by extraction from practice data, solicitation of incidents from health professionals, and patient surveys. Practice data include charts, laboratory, prescription data, and administrative databases, and can be reviewed manually or screened by computer systems to identify signals. Research nurses, pharmacists, or research assistants review these signals, and those that are likely to represent an ADE or medication error are presented to reviewers who independently categorize them into ADEs, potential ADEs, medication errors, or exclusions. These incidents are also classified according to preventability, ameliorability, disability, severity, stage, and responsible person. These classifications, as well as the initial selection of incidents, have been evaluated for agreement between reviewers and the level of agreement found ranged from satisfactory to excellent (kappa = 0.32-0.98). The method of ADE and medication error detection and classification described is feasible and has good reliability. It can be used in various clinical settings to measure and improve medication safety.

  1. Data mining to generate adverse drug events detection rules.

    PubMed

    Chazard, Emmanuel; Ficheur, Grégoire; Bernonville, Stéphanie; Luyckx, Michel; Beuscart, Régis

    2011-11-01

    Adverse drug events (ADEs) are a public health issue. Their detection usually relies on voluntary reporting or medical chart reviews. The objective of this paper is to automatically detect cases of ADEs by data mining. 115,447 complete past hospital stays are extracted from six French, Danish, and Bulgarian hospitals using a common data model including diagnoses, drug administrations, laboratory results, and free-text records. Different kinds of outcomes are traced, and supervised rule induction methods (decision trees and association rules) are used to discover ADE detection rules, with respect to time constraints. The rules are then filtered, validated, and reorganized by a committee of experts. The rules are described in a rule repository, and several statistics are automatically computed in every medical department, such as the confidence, relative risk, and median delay of outcome appearance. 236 validated ADE-detection rules are discovered; they enable to detect 27 different kinds of outcomes. The rules use a various number of conditions related to laboratory results, diseases, drug administration, and demographics. Some rules involve innovative conditions, such as drug discontinuations.

  2. 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.

  3. Control charts for monitoring accumulating adverse event count frequencies from single and multiple blinded trials.

    PubMed

    Gould, A Lawrence

    2016-12-30

    Conventional practice monitors accumulating information about drug safety in terms of the numbers of adverse events reported from trials in a drug development program. Estimates of between-treatment adverse event risk differences can be obtained readily from unblinded trials with adjustment for differences among trials using conventional statistical methods. Recent regulatory guidelines require monitoring the cumulative frequency of adverse event reports to identify possible between-treatment adverse event risk differences without unblinding ongoing trials. Conventional statistical methods for assessing between-treatment adverse event risks cannot be applied when the trials are blinded. However, CUSUM charts can be used to monitor the accumulation of adverse event occurrences. CUSUM charts for monitoring adverse event occurrence in a Bayesian paradigm are based on assumptions about the process generating the adverse event counts in a trial as expressed by informative prior distributions. This article describes the construction of control charts for monitoring adverse event occurrence based on statistical models for the processes, characterizes their statistical properties, and describes how to construct useful prior distributions. Application of the approach to two adverse events of interest in a real trial gave nearly identical results for binomial and Poisson observed event count likelihoods. Copyright © 2016 John Wiley & Sons, Ltd.

  4. 'Skating on thin ice?' Consultant surgeon's contemporary experience of adverse surgical events.

    PubMed

    Skevington, Suzanne M; Langdon, Joanne E; Giddins, Grey

    2012-01-01

    Concerns about patient safety have prompted studies of adverse surgical events (ASEs), but descriptive classification of errors and malpractice claims have overshadowed qualitative investigations into the processes that lead to expert errors and their solutions. We studied consultant surgeon's perspectives on how and why events occurred through semi-structured interviews about general and specific events. The sample contained heterogeneous cross-section of ages, gender and specialists, with >2 years consultant status and working within a 25-mile radius. Overarching findings included (1) pressures to work harder, faster and beyond capability within a blaming culture; (2) optimism bias from over-confidence and complacency; and (3) multiple pressures to 'finish' an operation or list, resulting in completion bias. Seven high order themes were identified on the healthcare system, adverse event types, contributing factors, emotions, cognitive processes, error detection, and strategies, solutions and barriers. The process of classifying event types guided solution selection, and the decision about whether to formally report it. How serious consequences were for patients and their temporal effects, defined an adversity continuum. Minor events arose routinely i.e. technical discrepancies, side-effects. More problematic were sub-optimal outcomes and avoidable events. Despite their expertise, consultants were vulnerable to unavoidable, uncontrollable events which were major concerns. Most serious were near-misses, errors and mistakes. However, major errors did not inevitably lead to a catastrophe and minor errors could be extremely serious. A 'cascade' of minor events exacerbated by negative emotions can precipitate major events, and interception methods need investigation. Consultants felt powerless and helpless to change environmental, organisational and systemic problems; new communication and action channels are desirable. Confidence building in team leadership would

  5. Adverse Respiratory Events Associated With Hypnotics Use in Patients of Chronic Obstructive Pulmonary Disease

    PubMed Central

    Chung, Wei-Sheng; Lai, Ching-Yuan; Lin, Cheng-Li; Kao, Chia-Hung

    2015-01-01

    Abstract Insomnia is prevalent in patients with chronic obstructive pulmonary disease (COPD). We conducted a population-based case-control study to evaluate the effects of hypnotics on the risk of adverse respiratory events in patients with COPD. The case-control study was investigated using data retrieved from the Taiwan National Health Insurance Research Database. Patients with newly diagnosed adverse respiratory events (pneumonia, COPD with acute exacerbation, acute respiratory failure, and cardiopulmonary arrest) were included in the case group. Patients with COPD and no history of adverse respiratory events were randomly selected for the control group, which was frequency-matched with the case group according to index date, age (per 10 years), and sex. Patients who had used hypnotics within 1 month meant active users. The odds ratios (ORs) and 95% confidence intervals (CIs) of were calculated using univariable and multivariable logistic regression models. Most of the study participants were male (71.6%), and the mean ages of the participants in the case and control groups were 69.2 (±12.4) and 67.5 (±12.3) years, respectively. After potential confounding factors were adjusting for, the adjusted ORs of adverse respiratory events were 12.0 for active users of benzodiazepines (95% CI, 8.11–17.6) and 10.5 for active users of nonbenzodiazepines (95% CI, 7.68–14.2) compared with the adjusted ORs of those who never used hypnotics. The results of this epidemiological study suggested that hypnotics increased the risk of adverse respiratory events in patients with COPD. PMID:26166105

  6. Prognostic significance of adverse events in patients with hepatocellular carcinoma treated with sorafenib

    PubMed Central

    Granito, Alessandro; Marinelli, Sara; Negrini, Giulia; Menetti, Saverio; Benevento, Francesca; Bolondi, Luigi

    2016-01-01

    Sorafenib is the standard treatment for patients with hepatocellular carcinoma (HCC) with advanced stage disease. Although its effectiveness has been demonstrated by randomized clinical trials and confirmed by field practice studies, reliable markers predicting therapeutic response have not yet been identified. Like other tyrosine kinase inhibitors, treatment with sorafenib is burdened by the development of adverse effects, the most frequent being cutaneous toxicity, diarrhoea, arterial hypertension and fatigue. In recent years, several studies have analysed the correlation between off-target effects and sorafenib efficacy in patients with HCC. In this review, an overview of the studies assessing the prognostic significance of sorafenib-related adverse events is provided. PMID:26929785

  7. Risk of cardiovascular adverse events from trastuzumab (Herceptin(®)) in elderly persons with breast cancer: a population-based study.

    PubMed

    Tsai, H-T; Isaacs, C; Fu, A Z; Warren, J L; Freedman, A N; Barac, A; Huang, C-Y; Potosky, A L

    2014-02-01

    Randomized controlled trials have reported a 4-5 times increased risk of heart failure (HF) in breast cancer patients receiving trastuzumab (Herceptin (®) ) compared to patients who do not receive trastuzumab. However, data regarding the cardiac effects of trastuzumab on elderly patients treated in general practice remain very limited. Using the US surveillance, epidemiology, and end results (SEER)-Medicare database, we conducted a retrospective cohort study on the cardiac effects of trastuzumab use in all incident breast cancer patients diagnosed from 1998 to 2007 who were 66 years and older, had no prior recent claims for cardiomyopathy (CM) or HF, and were followed through 2009. We defined our outcome as the first CM/HF event after diagnosis. We performed Cox-proportional hazard models with propensity score adjustment to estimate CM/HF risk associated with trastuzumab use. A total of 6,829 out of 68,536 breast cancer patients (median age: 75) had an incident CM/HF event. Patients who received trastuzumab tended to be younger, non-white, diagnosed more recently, and had a stage IV diagnosis. Trastuzumab use was associated with an increased risk of CM/HF (HR = 2.08, 95 % CI 1.77-2.44, p < 0.001). The trastuzumab-associated CM/HF risk was stronger in patients who were younger (HR = 2.52 for 66-75 years and HR = 1.44 for 76 years and older, p < 0.001) and diagnosed in recent years (HR = 2.58 for 2006-2007 vs. 1.86 for 1998-2005, p = 0.01). The twofold risk of CM/HF associated with trastuzumab remained regardless of patients' diagnosis stage, presence of hypertension, cardiovascular comorbidities, or receipt of anthracyclines, taxanes, or radiation. Trastuzumab may double CM/HF risk among elderly breast cancer patients. Our findings reinforce the need to prevent and manage cardiac risk among elderly breast cancer patients receiving trastuzumab.

  8. Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole.

    PubMed

    Jakobsen, Klaus Damgaard; Bruhn, Christina Hedegaard; Pagsberg, Anne-Katrine; Fink-Jensen, Anders; Nielsen, Jimmi

    2016-10-01

    Aripiprazole is a partial dopamine agonist with only minor neurological and psychiatric adverse effects, making it a potential first-line drug for the treatment of psychiatric disorders. However, the evidence of its use in children and adolescents is rather sparse. The aim of this case study is to discuss adverse drug reaction (ADR) reports concerning aripiprazole-associated neurological and psychiatric events in children and adolescents. The ADR report database at Danish Medicines Agency was searched for all ADRs involving children and adolescents (<18 years) reported by the search term [aripiprazole] AND all spontaneous reports since the introduction of aripiprazole in 2003 until December 31, 2015. Nineteen case reports were included in the study and included both patients with psychotic disorders (PS group) and nonpsychotic disorders (non-PS group). The PS group consisted of 5 patients with schizophrenia and psychoses, not otherwise specified; and the non-PS group consisted of fourteen cases including autism spectrum disorders, attention deficit and hyperactivity disorder, obsessive-compulsive disorder, and Tourette syndrome. The main reported adverse effects in the non-PS group were chronic insomnia, Parkinsonism, behavioral changes psychoses, and weight gain, whereas the adverse effects in the PS group was predominantly anxiety, convulsions, and neuroleptic malignant syndrome. Although aripiprazole is considered safe and well tolerated in children and adolescents, severe adverse events as neuroleptic malignant syndrome, extreme insomnia, and suicidal behavior has been reported to health authorities. Clinicians should pay attention to these possible hazards when prescribing aripiprazole to this vulnerable group of patients.

  9. Systemic glucocorticoid therapy: a review of its metabolic and cardiovascular adverse events.

    PubMed

    Fardet, Laurence; Fève, Bruno

    2014-10-01

    The prevalence of use of long-term systemic glucocorticoid therapy in the general adult population is 1 %. This figure increases to up to 3 % in elderly women. Metabolic (i.e. diabetes mellitus, dyslipidemia, weight gain, lipodystrophy) and cardiovascular (i.e. hypertension, cardiovascular events) adverse events are commonly observed in these patients and can be life threatening. Paradoxically, there is very few data on some of these adverse events and many of the available studies remain inconclusive. Incidence of and risk factors for dyslipidemia, weight gain and lipodystrophy are poorly defined. The optimal treatment plan for patients diagnosed with glucocorticoid-induced diabetes or hypertension is undetermined. Finally, there is no medical consensus on the best strategies for the prevention and detection of these complications. However, certain of these questions can be answered by looking at available data on patients with endogenous hypercortisolism (i.e. Cushing's syndrome). This article reviews the pathophysiology, incidence, risk factors, screening, and treatment of glucocorticoid-induced weight gain, lipodystrophy, diabetes, dyslipidemia, hypertension, and cardiovascular events. It also focuses on the possible prevention of these adverse events by targeting the glucocorticoid receptor using selective glucocorticoid receptor modulators.

  10. Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation

    PubMed Central

    Mirza, Sohail K; Deyo, Richard A; Heagerty, Patrick J; Turner, Judith A; Lee, Lorri A; Goodkin, Robert

    2006-01-01

    Background Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1) specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2) quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery. Methods We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases. Results During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%). Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35), but agreement was substantial (kappa ≥ 0.61) for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted kappa = 0.44). Adverse

  11. [Efforts to prevent adverse events in the United States--health care risk management and a fresh perspective on adverse events prevention].

    PubMed

    Ayuzawa, J

    2001-03-01

    Not causing adverse events is never-ceasing issue in the health care field. However, the advances and greater specialization of medical technologies and the increasing number of elderly people, are all factors in the occurrence of adverse events. At the same time, greater efficiency is now demanded in the health care field, and the problem of preventing adverse events has become tougher than ever before. Given the situation, a fresh perspective on attempts to prevent adverse events may be important. One hint for such a new perspective is the health care risk management that is widely practiced in the health care field in the United States. This was introduced in the mid-1970s to counter the disputes and lawsuits at the time, but over the years the focus has shifted to the importance of prevention, and is now recognized as a means to work toward the assurance of quality of health care. Hints are also found in the suggestions related to adverse events prevention. In "To Err Is Human," published in November 1999 in the United States, includes proposals to "respect human limits in process design" and "promote effective team functioning," which are just the approaches we should adopt for a new perspective. I would also like to draw attention to the idea that there should be investigations into "developing effective mechanisms for identifying and dealing with unsafe practitioners" and the importance of "protecting voluntary reporting systems" that is mentioned. Adopting American methods unchanged to the health care system in Japan may not be appropriate, but the way of thinking and know-how from health care risk management, as well as the suggestions for adverse events prevention will provide us new perspectives on adverse events prevention, from which we should work toward a system of more efficient, and high-quality adverse events prevention.

  12. 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

  13. Recent Literature on Medication Errors and Adverse Drug Events in Older Adults

    PubMed Central

    Naples, Jennifer G.; Hanlon, Joseph T.; Schmader, Kenneth E.; Semla, Todd P.

    2015-01-01

    Medication errors and adverse drug events are common in older adults, but locating literature addressing these issues is often challenging. The objective of this article was to summarize recent studies addressing medication errors and adverse drug events in a single location to improve accessibility for individuals working with older adults. The authors conducted a comprehensive literature search for studies published in 2014 and identified 51 potential articles. After critical review, 17 studies were selected for inclusion based on innovation, rigorous observational or experimental study designs, and use of reliable, valid measures. Four articles characterizing potentially inappropriate prescribing and interventions to optimize medication regimens were annotated and critiqued in detail. We hope that health policy makers and clinicians find this information helpful in improving the quality of care for older adults. PMID:26804210

  14. Plasma Asymmetric Dimethylarginine and Adverse Events in Patients with Atrial Fibrillation Referred for Coronary Angiogram

    PubMed Central

    Chao, Tze-Fan; Lu, Tse-Min; Lin, Yenn-Jiang; Tsao, Hsuan-Ming; Chang, Shih-Lin; Lo, Li-Wei; Hu, Yu-Feng; Tuan, Ta-Chuan; Hsieh, Ming-Hsiung; Chen, Shih-Ann

    2013-01-01

    Objectives Elevated plasma levels of asymmetric dimethylarginine (ADMA) have been reported to be associated with endothelial dysfunction, inflammation, and oxidative stress in multiple cardiovascular diseases. This study aimed to investigate whether ADMA was a predictor of clinical outcomes in atrial fibrillation (AF). Methods and Results From 2006-2009, 990 individuals were referred to our institution for coronary angiography. Among these patients, 141 subjects with a diagnosis of AF, including 52 paroxysmal AF (PAF) and 89 non-paroxysmal AF (non-PAF) patients, were identified as the study population. Plasma ADMA levels were measured. An adverse event was defined as the occurrence of ischemic stroke or cardiovascular death. The ADMA levels were higher in AF than non-AF patients (0.50±0.13 versus 0.45±0.07 µmol/L; p<0.001). Besides, non-PAF patients had higher ADMA levels than PAF patients (0.52±0.15 versus 0.48±0.08 µmol/L; p<0.001). During the follow-up of 30.7±14.4 months, 21 patients (14.9%) experienced adverse events, including cardiovascular death in 7 patients and ischemic stroke in 14. ADMA level, CHA2DS2-VASc score, and left atrial diameter were independent predictors of adverse events in the multivariate analysis. At a cutoff-value of 0.55 µmol/L, the Kaplan-Meier survival analysis showed that patients with a high ADMA level had a higher event rate during the follow-up period. Conclusions A higher level of ADMA was a risk factor of adverse events in AF patients, which was independent from the CHA2DS2-VASc score. It deserves to further study whether ADMA could potentially refine the clinical risk stratification in AF. PMID:23951217

  15. Impact of Extended-Duration Shifts on Medical Errors, Adverse Events, and Attentional Failures

    PubMed Central

    Barger, Laura K; Ayas, Najib T; Cade, Brian E; Cronin, John W; Rosner, Bernard; Speizer, Frank E; Czeisler, Charles A

    2006-01-01

    Background A recent randomized controlled trial in critical-care units revealed that the elimination of extended-duration work shifts (≥24 h) reduces the rates of significant medical errors and polysomnographically recorded attentional failures. This raised the concern that the extended-duration shifts commonly worked by interns may contribute to the risk of medical errors being made, and perhaps to the risk of adverse events more generally. Our current study assessed whether extended-duration shifts worked by interns are associated with significant medical errors, adverse events, and attentional failures in a diverse population of interns across the United States. Methods and Findings We conducted a Web-based survey, across the United States, in which 2,737 residents in their first postgraduate year (interns) completed 17,003 monthly reports. The association between the number of extended-duration shifts worked in the month and the reporting of significant medical errors, preventable adverse events, and attentional failures was assessed using a case-crossover analysis in which each intern acted as his/her own control. Compared to months in which no extended-duration shifts were worked, during months in which between one and four extended-duration shifts and five or more extended-duration shifts were worked, the odds ratios of reporting at least one fatigue-related significant medical error were 3.5 (95% confidence interval [CI], 3.3–3.7) and 7.5 (95% CI, 7.2–7.8), respectively. The respective odds ratios for fatigue-related preventable adverse events, 8.7 (95% CI, 3.4–22) and 7.0 (95% CI, 4.3–11), were also increased. Interns working five or more extended-duration shifts per month reported more attentional failures during lectures, rounds, and clinical activities, including surgery and reported 300% more fatigue-related preventable adverse events resulting in a fatality. Conclusions In our survey, extended-duration work shifts were associated with an

  16. Adverse events attributed to traditional Korean medical practices: 1999–2010

    PubMed Central

    Shin, Hyeun-Kyoo; Jeong, Soo-Jin; Ernst, Edzard

    2013-01-01

    Abstract Objective To investigate adverse events attributed to traditional medical treatments in the Republic of Korea. Methods Adverse events recorded in the Republic of Korea between 1999 and 2010 – by the Food and Drug Administration, the Consumer Agency or the Association of Traditional Korean Medicine – were reviewed. Records of adverse events attributed to the use of traditional medical practices, including reports of medicinal accidents and consumers’ complaints, were investigated. Findings Overall, 9624 records of adverse events attributed to traditional medical practices – including 522 linked to herbal treatments – were identified. Liver problems were the most frequently reported adverse events. Only eight of the adverse events were recorded by the pharmacovigilance system run by the Food and Drug Administration. Of the 9624 events, 1389 – mostly infections, cases of pneumothorax and burns – were linked to physical therapy (n = 285) or acupuncture/moxibustion (n = 1104). Conclusion In the Republic of Korea, traditional medical practices often appear to have adverse effects, yet almost all of the adverse events attributed to such practices between 1999 and 2010 were missed by the national pharmacovigilance system. The Consumer Agency and the Association of Traditional Korean Medicine should be included in the national pharmacovigilance system. PMID:23940404

  17. 5 CFR 1631.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1631.33 Section 1631.33 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  18. 29 CFR 2.24 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 1 2012-07-01 2012-07-01 false Procedure in the event of an adverse ruling. 2.24 Section 2.24 Labor Office of the Secretary of Labor GENERAL REGULATIONS Employees Served With Subpoenas § 2.24 Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  19. 22 CFR 172.7 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Procedure in the event of an adverse ruling. 172.7 Section 172.7 Foreign Relations DEPARTMENT OF STATE ACCESS TO INFORMATION SERVICE OF PROCESS... FEDERAL OR STATE LITIGATION; EXPERT TESTIMONY § 172.7 Procedure in the event of an adverse ruling. If...

  20. 29 CFR 1610.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 4 2011-07-01 2011-07-01 false Procedure in the event of an adverse ruling. 1610.36 Section 1610.36 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  1. 10 CFR 1707.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 1707.210 Section 1707.210 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD TESTIMONY BY DNFSB EMPLOYEES AND....210 Procedure in the event of an adverse ruling. If the court or other competent authority fails...

  2. 5 CFR 1305.4 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1305.4 Section 1305.4 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET ADMINISTRATIVE....4 Procedure in the event of an adverse ruling. If the court or other authority declines to stay...

  3. 5 CFR 2502.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 2502.33 Section 2502.33 Administrative Personnel OFFICE OF ADMINISTRATION, EXECUTIVE OFFICE OF... Other Authorities § 2502.33 Procedure in the event of an adverse ruling. If the court or other...

  4. 12 CFR 404.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 404.33 Section 404.33 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES INFORMATION DISCLOSURE... § 404.33 Procedure in the event of an adverse ruling. If the court or other authority declines to...

  5. 45 CFR 1201.8 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 4 2011-10-01 2011-10-01 false Procedure in the event of an adverse ruling. 1201.8 Section 1201.8 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR... OR STATE LITIGATION § 1201.8 Procedure in the event of an adverse ruling. If the court or...

  6. 28 CFR 16.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Procedure in the event of an adverse ruling. 16.28 Section 16.28 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION OR DISCLOSURE OF... event of an adverse ruling. If the court or other authority declines to stay the effect of the demand...

  7. 29 CFR 1610.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 4 2012-07-01 2012-07-01 false Procedure in the event of an adverse ruling. 1610.36 Section 1610.36 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  8. 45 CFR 1201.8 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Procedure in the event of an adverse ruling. 1201.8 Section 1201.8 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR... OR STATE LITIGATION § 1201.8 Procedure in the event of an adverse ruling. If the court or...

  9. 19 CFR 103.25 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Procedure in the event of an adverse ruling. 103.25 Section 103.25 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY... Foreign Proceedings § 103.25 Procedure in the event of an adverse ruling. If the court or other...

  10. 12 CFR 404.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 404.33 Section 404.33 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES INFORMATION DISCLOSURE... § 404.33 Procedure in the event of an adverse ruling. If the court or other authority declines to...

  11. 10 CFR 9.204 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 9.204 Section 9.204 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Production or Disclosure in Response to Subpoenas or Demands of Courts or Other Authorities § 9.204 Procedure in the event of an adverse ruling....

  12. 12 CFR 1070.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 9 2014-01-01 2014-01-01 false Procedure in the event of an adverse ruling. 1070.36 Section 1070.36 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION DISCLOSURE OF RECORDS... Procedure in the event of an adverse ruling. If a stay or, or other relief from, the effect of a demand...

  13. 28 CFR 16.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Procedure in the event of an adverse ruling. 16.28 Section 16.28 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION OR DISCLOSURE OF... event of an adverse ruling. If the court or other authority declines to stay the effect of the demand...

  14. 29 CFR 1610.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 4 2010-07-01 2010-07-01 false Procedure in the event of an adverse ruling. 1610.36 Section 1610.36 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  15. 45 CFR 1201.8 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 4 2013-10-01 2013-10-01 false Procedure in the event of an adverse ruling. 1201.8 Section 1201.8 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR... OR STATE LITIGATION § 1201.8 Procedure in the event of an adverse ruling. If the court or...

  16. 5 CFR 1216.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1216.210 Section 1216.210 Administrative Personnel MERIT SYSTEMS PROTECTION BOARD ORGANIZATION... Procedure in the event of an adverse ruling. If the court or other competent authority fails to stay...

  17. 10 CFR 202.26 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 202.26 Section 202.26 Energy DEPARTMENT OF ENERGY OIL PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  18. 29 CFR 2.24 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 1 2011-07-01 2011-07-01 false Procedure in the event of an adverse ruling. 2.24 Section 2.24 Labor Office of the Secretary of Labor GENERAL REGULATIONS Employees Served With Subpoenas § 2.24 Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  19. 10 CFR 9.204 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 9.204 Section 9.204 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Production or Disclosure in Response to Subpoenas or Demands of Courts or Other Authorities § 9.204 Procedure in the event of an adverse ruling....

  20. 45 CFR 1201.8 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 4 2014-10-01 2014-10-01 false Procedure in the event of an adverse ruling. 1201.8 Section 1201.8 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR... OR STATE LITIGATION § 1201.8 Procedure in the event of an adverse ruling. If the court or...

  1. 19 CFR 103.25 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 19 Customs Duties 1 2012-04-01 2012-04-01 false Procedure in the event of an adverse ruling. 103.25 Section 103.25 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY... Foreign Proceedings § 103.25 Procedure in the event of an adverse ruling. If the court or other...

  2. 29 CFR 1610.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 4 2013-07-01 2013-07-01 false Procedure in the event of an adverse ruling. 1610.36 Section 1610.36 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  3. 22 CFR 504.13 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Procedure in the event of an adverse ruling. 504.13 Section 504.13 Foreign Relations BROADCASTING BOARD OF GOVERNORS TESTIMONY BY BBG EMPLOYEES... Requests for Testimony and Production of Documents § 504.13 Procedure in the event of an adverse ruling....

  4. 10 CFR 202.26 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 3 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 202.26 Section 202.26 Energy DEPARTMENT OF ENERGY OIL PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  5. 29 CFR 2.24 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 1 2014-07-01 2013-07-01 true Procedure in the event of an adverse ruling. 2.24 Section 2.24 Labor Office of the Secretary of Labor GENERAL REGULATIONS Employees Served With Subpoenas § 2.24 Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  6. 12 CFR 404.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Procedure in the event of an adverse ruling. 404.33 Section 404.33 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES INFORMATION DISCLOSURE... § 404.33 Procedure in the event of an adverse ruling. If the court or other authority declines to...

  7. 22 CFR 504.13 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Procedure in the event of an adverse ruling. 504.13 Section 504.13 Foreign Relations BROADCASTING BOARD OF GOVERNORS TESTIMONY BY BBG EMPLOYEES... Requests for Testimony and Production of Documents § 504.13 Procedure in the event of an adverse ruling....

  8. 19 CFR 103.25 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 1 2011-04-01 2011-04-01 false Procedure in the event of an adverse ruling. 103.25 Section 103.25 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY... Foreign Proceedings § 103.25 Procedure in the event of an adverse ruling. If the court or other...

  9. 10 CFR 1707.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 1707.210 Section 1707.210 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD TESTIMONY BY DNFSB EMPLOYEES AND....210 Procedure in the event of an adverse ruling. If the court or other competent authority fails...

  10. 10 CFR 1707.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1707.210 Section 1707.210 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD TESTIMONY BY DNFSB EMPLOYEES AND....210 Procedure in the event of an adverse ruling. If the court or other competent authority fails...

  11. 22 CFR 172.7 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Procedure in the event of an adverse ruling. 172.7 Section 172.7 Foreign Relations DEPARTMENT OF STATE ACCESS TO INFORMATION SERVICE OF PROCESS... FEDERAL OR STATE LITIGATION; EXPERT TESTIMONY § 172.7 Procedure in the event of an adverse ruling. If...

  12. 28 CFR 16.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Procedure in the event of an adverse ruling. 16.28 Section 16.28 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION OR DISCLOSURE OF... event of an adverse ruling. If the court or other authority declines to stay the effect of the demand...

  13. 19 CFR 103.25 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 19 Customs Duties 1 2013-04-01 2013-04-01 false Procedure in the event of an adverse ruling. 103.25 Section 103.25 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY... Foreign Proceedings § 103.25 Procedure in the event of an adverse ruling. If the court or other...

  14. 5 CFR 1305.4 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 1305.4 Section 1305.4 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET ADMINISTRATIVE....4 Procedure in the event of an adverse ruling. If the court or other authority declines to stay...

  15. Data and Safety Monitoring Board evaluation and management of a renal adverse event signal in TOPCAT.

    PubMed

    Bristow, Michael R; Sharma, Kavita; Assmann, Susan F; Linas, Stuart; Gersh, Bernard J; Grady, Christine; Rice, Madeline Murguia; Singh, Steven; Boineau, Robin; McKinlay, Sonja M; Greenberg, Barry H

    2017-04-01

    Clinical trial Data and Safety Monitoring Boards (DSMBs) have a primary obligation of ensuring study participant safety, while maintaining trial integrity. The role of DSMBs is expanding, and ideally should include post-hoc reporting of deliberative processes related to clinically important safety issues or factors that could impact on future trial designs. We describe how the TOPCAT DSMB detected, investigated, and adjudicated an unexpectedly large renal adverse event signal midway through the trial, and offer general guidelines for dealing with similar unanticipated occurrences in future trials. The detection of a greater than expected incidence of deterioration in renal function, occurring in 6.1% of patients in the spironolactone arm compared with 3.9% in the placebo arm (P = 0.009), led to an in-depth DSMB review of associated study medication withdrawals and adverse events. The trial continued uninterrupted throughout the review, which reached the conclusions that spironolactone-associated renal dysfunction did not compromise overall patient safety or interfere with a perceived efficacy signal. Although no discrete mechanism for the spironolactone-associated renal adverse event signal was identified, likely possibilities are discussed. In clinical trials, DSMBs and co-ordinating centres should have the resources to detect, investigate, and adjudicate unexpected safety issues, with goals of ensuring patient safety and preserving the potential for detection of therapeutic effectiveness. In TOPCAT, spironolactone-associated renal dysfunction emerged as a potentially trial-threatening adverse event and, although clinically important, did not lead to compromise of patient safety, trial interruption, termination, or apparent loss of treatment effectiveness.

  16. Hospital volume and adverse events following esophageal endoscopic submucosal dissection in Japan.

    PubMed

    Odagiri, Hiroyuki; Yasunaga, Hideo; Matsui, Hiroki; Matsui, Shigeru; Fushimi, Kiyohide; Kaise, Mitsuru

    2017-04-01

    Background and study aims Esophageal endoscopic submucosal dissection (ESD) has gradually acquired popularity as a minimally invasive surgery for early cancers not only in Japan, but also in other countries. However, most reported outcomes have been based on relatively small samples of patients from specialized centers. Therefore, the association between hospital volume and the rate of adverse events following esophageal ESD has been poorly understood. Patients and methods Using a nationwide administrative database in Japan, we identified patients who underwent esophageal ESD between 1 July 2007 and 31 March 2013. Hospital volume was defined as the number of esophageal ESD procedures performed per year at each hospital and was categorized into quartiles. Results In total, 12 899 esophageal ESD procedures at 699 institutions were identified during the study period. Perforation and perforation-related disorders were observed in 422 patients (3.3 %), and one patient died after perforation. There was a significant association between a lower hospital volume and a higher proportion of adverse events following esophageal ESD. Although not statistically significant, a similar tendency was observed in the occurrence of blood transfusion within 1 week after ESD and all-cause in-hospital death. Multivariable logistic regression analysis showed that hospitals with very high case volumes were less likely to experience adverse events following esophageal ESD than hospitals with very low volumes. Conclusions The proportion of perforation and perforation-related disorders following esophageal ESD was permissibly low, and there was a linear association between higher hospital volume and lower rates of adverse events following esophageal ESD.

  17. Teaching dental students about patient communication following an adverse event: a pilot educational module.

    PubMed

    Raja, Sheela; Rajagopalan, Chelsea F; Patel, Janki; Van Kanegan, Kevin

    2014-05-01

    Adverse events are an important but understudied area in dentistry. Most dentists will face the issue of an adverse event several times in their clinical careers. The authors implemented a six-hour pilot educational module at one dental school to improve fourth-year dental students' knowledge and confidence in communicating with patients about adverse events. Based on results from the twenty-nine students who completed both the pre- and posttests, the module significantly increased the students' knowledge of the key concepts involved in adverse events. However, the module did not improve the students' confidence that they would be able to implement these communication skills in clinical situations. Based on these results, this article discusses how future educational efforts can be modified to better prepare students for the communication challenges associated with adverse events.

  18. The reasons of the nursing staff to notify adverse events 1

    PubMed Central

    de Paiva, Miriam Cristina Marques da Silva; Popim, Regina Célia; Melleiro, Marta Maria; Tronchim, Daisy Maria Rizatto; Lima, Silvana Andréa Molina; Juliani, Carmen Maria Casquel Monti

    2014-01-01

    OBJECTIVE: this research aimed to understand the motivation for reporting adverse events from the perspective of nursing staff in the work environment. METHOD: qualitative study that used the phenomenology of Alfred Schutz for reference, which offers a systematic approach to understand the social aspects of human action. Data were collected by open interviews with 17 nurses and 14 technicians/assistant nurses in a university hospital. RESULTS: motivation was revealed through six categories: all types of occurrences must be reported; the incident report is an auxiliary instrument to health care provision management; the culture of punishment in transition; nurses as the agents responsible for voluntary reporting; sharing problems with higher management and achieving quality in the work process. DISCUSSION: it was unveiled that, when reporting adverse events, team members perceived themselves to be in a collaborative relationship with the institution and trusted that they would receive administrative support and professional security, which encouraged them to continue reporting. Reporting allows health care professionals to share responsibilities with managers and encourages corrective actions. FINAL CONSIDERATIONS: the study revealed the nursing staff's motivation for adverse event reporting, contributing to reflections on institutional policies aimed at patient safety in health care. PMID:25493669

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

    PubMed

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

    2014-11-20

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

  20. In-hospital versus post discharge adverse events following carotid endarterectomy

    PubMed Central

    Fokkema, M; Bensley, RP; Lo, RC; Hamdan, AD; Wyers, MC; Moll, FL; de Borst, GJ; Schermerhorn, ML

    2013-01-01

    Introduction and objectives Most studies based on state and nation-wide registries evaluating perioperative outcome after carotid endarterectomy (CEA) rely on hospital discharge data only. Therefore, the true 30-day complication risk after carotid revascularization may be underestimated. Methods We used the National Surgical Quality Improvement Program (NSQIP) database 2005–2010 to assess the in-hospital and post discharge rate of any stroke, death, cardiac event (new Q-wave MI or cardiac arrest), combined stroke/death and combined adverse outcome (S/D/CE) at 30 days following CEA. Multivariable analyses were used to identify predictors for in-hospital and post discharge events separately, and in particular, those that predict post discharge events distinctly. Results A total of 35,916 patients who underwent CEA during 2005–2010 were identified in the NSQIP database. 59% were male (median age 72 years) and 44% had a previous neurologic event. Thirty-day stroke rate was 1.6% (n=591), death rate was 0.8% (n=272), cardiac event rate was 1.0% (n=350), stroke or death rate was 2.2% (n=794) and combined S/D/CE rate was 2.9% (n=1043). 33% of strokes, 53% of deaths, 32% of cardiac events, 40% of combined stroke/death and 38% of combined S/D/CE took place after hospital discharge. Patients with a prior stroke or TIA had similar proportions of post discharge events as compared to patients without prior symptoms. Independent predictors for post discharge events, but not for in-hospital events were female gender (stroke [OR 1.6, 95% CI 1.2–2.1] and stroke/death [OR 1.4, 95% CI 1.1–1.7]), renal failure (stroke [OR 3.0, 95% CI 1.4–6.2]) and COPD (stroke/death [OR 1.8, 95% CI 1.4–2.4] and S/D/CE [OR 1.8, 95% CI 1.4–2.3]). Conclusions With 38% of perioperative adverse events after CEA happening post hospitalization, regardless of symptoms status, we need to be alert to the ongoing risks after discharge particularly in women, patients with renal failure, or a history

  1. Adverse events and technical complaints related to central venous catheters marketed in Brazil

    PubMed Central

    Morais, Luciene de Oliveira; Friedrich, Karen; Melchior, Stela Candioto; Silva, Michele Feitoza; Gemal, Andre Luis; Delgado, Isabella Fernandes

    2013-01-01

    Aim The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. Methods Notifications were categorized and evaluated to: (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel(r) 2010 was used to categorize and systematize the data. Results Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. Conclusion These data support a necessity for cooperation between all entities of the National Health Surveillance System to check compliance of this type of product and to properly report adverse events and technical complaints. It is also important to incorporate minimum standards for the management of technologies in health services, including in the acquisition of products and training of staff. PMID:23904810

  2. Identifying adverse drug event information in clinical notes with distributional semantic representations of context.

    PubMed

    Henriksson, Aron; Kvist, Maria; Dalianis, Hercules; Duneld, Martin

    2015-10-01

    For the purpose of post-marketing drug safety surveillance, which has traditionally relied on the voluntary reporting of individual cases of adverse drug events (ADEs), other sources of information are now being explored, including electronic health records (EHRs), which give us access to enormous amounts of longitudinal observations of the treatment of patients and their drug use. Adverse drug events, which can be encoded in EHRs with certain diagnosis codes, are, however, heavily underreported. It is therefore important to develop capabilities to process, by means of computational methods, the more unstructured EHR data in the form of clinical notes, where clinicians may describe and reason around suspected ADEs. In this study, we report on the creation of an annotated corpus of Swedish health records for the purpose of learning to identify information pertaining to ADEs present in clinical notes. To this end, three key tasks are tackled: recognizing relevant named entities (disorders, symptoms, drugs), labeling attributes of the recognized entities (negation, speculation, temporality), and relationships between them (indication, adverse drug event). For each of the three tasks, leveraging models of distributional semantics - i.e., unsupervised methods that exploit co-occurrence information to model, typically in vector space, the meaning of words - and, in particular, combinations of such models, is shown to improve the predictive performance. The ability to make use of such unsupervised methods is critical when faced with large amounts of sparse and high-dimensional data, especially in domains where annotated resources are scarce.

  3. Social Involvement Modulates the Response to Novel and Adverse Life Events in Mice

    PubMed Central

    Colnaghi, Luca; Clemenza, Kelly; Groleau, Sarah E.; Weiss, Shira; Snyder, Anna M.; Lopez-Rosas, Mariana; Levine, Amir A.

    2016-01-01

    Epidemiological findings suggest that social involvement plays a major role in establishing resilience to adversity, however, the neurobiology by which social involvement confers protection is not well understood. Hypothesizing that social involvement confers resilience by changing the way adverse life events are encoded, we designed a series of behavioral tests in mice that utilize the presence or absence of conspecific cage mates in measuring response to novel and adverse events. We found that the presence of cage mates increased movement after exposure to a novel environment, increased time spent in the open arms of the elevated plus maze, and decreased freezing time after a foot shock as well as expedited fear extinction, therefore significantly changing the response to adversity. This is a first description of a mouse model for the effects of social involvement on adverse life events. Understanding how social involvement provides resilience to adversity may contribute to the future treatment and prevention of mental and physical illness. PMID:27632422

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

    PubMed

    Howson, C P; Fineberg, H V

    1992-01-15

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

  5. How Usability of a Web-Based Clinical Decision Support System Has the Potential to Contribute to Adverse Medical Events

    PubMed Central

    Graham, Timothy A.D.; Kushniruk, Andre W.; Bullard, Michael J.; Holroyd, Brian R.; Meurer, David P.; Rowe, Brian H.

    2008-01-01

    Introduction Clinical decision support systems (CDSS) have the potential to reduce adverse medical events, but improper design can introduce new forms of error. CDSS pertaining to community acquired pneumonia and neutropenic fever were studied to determine whether usability of the graphical user interface might contribute to potential adverse medical events. Methods Automated screen capture of 4 CDSS being used by volunteer emergency physicians was analyzed using structured methods. Results 422 events were recorded over 56 sessions. In total, 169 negative comments, 55 positive comments, 130 neutral comments, 21 application events, 34 problems, 6 slips, and 5 mistakes were identified. Three mistakes could have had life-threatening consequences. Conclusion Evaluation of CDSS will be of utmost importance in the future with increasing use of electronic health records. Usability engineering principles can identify interface problems that may lead to potential medical adverse events, and should be incorporated early in the software design phase. PMID:18998968

  6. The Evaluation of a Pulmonary Display to Detect Adverse Respiratory Events Using High Resolution Human Simulator

    PubMed Central

    Wachter, S. Blake; Johnson, Ken; Albert, Robert; Syroid, Noah; Drews, Frank; Westenskow, Dwayne

    2006-01-01

    Objective Authors developed a picture-graphics display for pulmonary function to present typical respiratory data used in perioperative and intensive care environments. The display utilizes color, shape and emergent alerting to highlight abnormal pulmonary physiology. The display serves as an adjunct to traditional operating room displays and monitors. Design To evaluate the prototype, nineteen clinician volunteers each managed four adverse respiratory events and one normal event using a high-resolution patient simulator which included the new displays (intervention subjects) and traditional displays (control subjects). Between-group comparisons included (i) time to diagnosis and treatment for each adverse respiratory event; (ii) the number of unnecessary treatments during the normal scenario; and (iii) self-reported workload estimates while managing study events. Measurements Two expert anesthesiologists reviewed video-taped transcriptions of the volunteers to determine time to treat and time to diagnosis. Time values were then compared between groups using a Mann-Whitney-U Test. Estimated workload for both groups was assessed using the NASA-TLX and compared between groups using an ANOVA. P-values < 0.05 were considered significant. Results Clinician volunteers detected and treated obstructed endotracheal tubes and intrinsic PEEP problems faster with graphical rather than conventional displays (p < 0.05). During the normal scenario simulation, 3 clinicians using the graphical display, and 5 clinicians using the conventional display gave unnecessary treatments. Clinician-volunteers reported significantly lower subjective workloads using the graphical display for the obstructed endotracheal tube scenario (p < 0.001) and the intrinsic PEEP scenario (p < 0.03). Conclusion Authors conclude that the graphical pulmonary display may serve as a useful adjunct to traditional displays in identifying adverse respiratory events. PMID:16929038

  7. The Prevalence of Childhood Adversity among Healthcare Workers and Its Relationship to Adult Life Events, Distress and Impairment

    ERIC Educational Resources Information Center

    Maunder, Robert G.; Peladeau, Nathalie; Savage, Diane; Lancee, William J.

    2010-01-01

    Objective: We investigated the prevalence of childhood adversity among healthcare workers and if such experiences affect responses to adult life stress. Methods: A secondary analysis was conducted of a 2003 study of 176 hospital-based healthcare workers, which surveyed lifetime traumatic events, recent life events, psychological distress, coping,…

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

    PubMed Central

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

    1998-01-01

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

  9. Prognostic Value of Combined CT Angiography and Myocardial Perfusion Imaging versus Invasive Coronary Angiography and Nuclear Stress Perfusion Imaging in the Prediction of Major Adverse Cardiovascular Events: The CORE320 Multicenter Study.

    PubMed

    Chen, Marcus Y; Rochitte, Carlos E; Arbab-Zadeh, Armin; Dewey, Marc; George, Richard T; Miller, Julie M; Niinuma, Hiroyuki; Yoshioka, Kunihiro; Kitagawa, Kakuya; Sakuma, Hajime; Laham, Roger; Vavere, Andrea L; Cerci, Rodrigo J; Mehra, Vishal C; Nomura, Cesar; Kofoed, Klaus F; Jinzaki, Masahiro; Kuribayashi, Sachio; Scholte, Arthur J; Laule, Michael; Tan, Swee Yaw; Hoe, John; Paul, Narinder; Rybicki, Frank J; Brinker, Jeffrey A; Arai, Andrew E; Matheson, Matthew B; Cox, Christopher; Clouse, Melvin E; Di Carli, Marcelo F; Lima, João A C

    2017-03-14

    Purpose To compare the prognostic importance (time to major adverse cardiovascular event [MACE]) of combined computed tomography (CT) angiography and CT myocardial stress perfusion imaging with that of combined invasive coronary angiography (ICA) and stress single photon emission CT myocardial perfusion imaging. Materials and Methods This study was approved by all institutional review boards, and written informed consent was obtained. Between November 2009 and July 2011, 381 participants clinically referred for ICA and aged 45-85 years were enrolled in the Combined Noninvasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Row Computed Tomography (CORE320) prospective multicenter diagnostic study. All images were analyzed in blinded independent core laboratories, and a panel of physicians adjudicated all adverse events. MACE was defined as revascularization (>30 days after index ICA), myocardial infarction, or cardiac death; hospitalization for chest pain or congestive heart failure; or arrhythmia. Late MACE was defined similarly, except for patients who underwent revascularization within the first 182 days after ICA, who were excluded. Comparisons of 2-year survival (time to MACE) used standard Kaplan-Meier curves and restricted mean survival times bootstrapped with 2000 replicates. Results An MACE (49 revascularizations, five myocardial infarctions, one cardiac death, nine hospitalizations for chest pain or congestive heart failure, and one arrhythmia) occurred in 51 of 379 patients (13.5%). The 2-year MACE-free rates for combined CT angiography and CT perfusion findings were 94% negative for coronary artery disease (CAD) versus 82% positive for CAD and were similar to combined ICA and single photon emission CT findings (93% negative for CAD vs 77% positive for CAD, P < .001 for both). Event-free rates for CT angiography and CT perfusion versus ICA and single photon emission CT for either positive or negative results were not

  10. Yellow fever vaccine-associated adverse events following extensive immunization in Argentina.

    PubMed

    Biscayart, Cristián; Carrega, María Eugenia Pérez; Sagradini, Sandra; Gentile, Angela; Stecher, Daniel; Orduna, Tomás; Bentancourt, Silvia; Jiménez, Salvador García; Flynn, Luis Pedro; Arce, Gabriel Pirán; Uboldi, María Andrea; Bugna, Laura; Morales, María Alejandra; Digilio, Clara; Fabbri, Cintia; Enría, Delia; Diosque, Máximo; Vizzotti, Carla

    2014-03-05

    As a consequence of YF outbreaks that hit Brazil, Argentina, and Paraguay in 2008-2009, a significant demand for YF vaccination was subsequently observed in Argentina, a country where the usual vaccine recommendations are restricted to provinces that border Brazil, Paraguay, and Bolivia. The goal of this paper is to describe the adverse events following immunization (AEFI) against YF in Argentina during the outbreak in the northeastern province of Misiones, which occurred from January 2008 to January 2009. During this time, a total of nine cases were reported, almost two million doses of vaccine were administered, and a total of 165 AEFI were reported from different provinces. Case study analyses were performed using two AEFI classifications. Forty-nine events were classified as related to the YF vaccine (24 serious and 1 fatal case), and 12 events were classified as inconclusive. As the use of the YF 17D vaccine can be a challenge to health systems of countries with different endemicity patterns, a careful clinical and epidemiological evaluation should be performed before its prescription to minimize serious adverse events.

  11. ACCEPT: Introduction of the Adverse Condition and Critical Event Prediction Toolbox

    NASA Technical Reports Server (NTRS)

    Martin, Rodney A.; Santanu, Das; Janakiraman, Vijay Manikandan; Hosein, Stefan

    2015-01-01

    The prediction of anomalies or adverse events is a challenging task, and there are a variety of methods which can be used to address the problem. In this paper, we introduce a generic framework developed in MATLAB (sup registered mark) called ACCEPT (Adverse Condition and Critical Event Prediction Toolbox). ACCEPT is an architectural framework designed to compare and contrast the performance of a variety of machine learning and early warning algorithms, and tests the capability of these algorithms to robustly predict the onset of adverse events in any time-series data generating systems or processes.

  12. 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.

  13. Effectiveness and adverse events of tolvaptan in octogenarians with heart failure. Interim analyses of Samsca Post-Marketing Surveillance In Heart faiLurE (SMILE study).

    PubMed

    Kinugawa, Koichiro; Inomata, Takayuki; Sato, Naoki; Yasuda, Moriyoshi; Shimakawa, Toshiyuki; Bando, Kosuke; Mizuguchi, Kazuki

    2015-01-01

    The vasopressin receptor 2 (V2) receptor antagonist tolvaptan is an aquaretic agent that has been found to improve symptoms in patients with congestive heart failure. In this study (SMILE study), we administered tolvaptan to patients aged ≥ 80 years with heart failure accompanied by congestive symptoms and compared its effectiveness and safety profiles in this group with those in patients < 80 years (U-80). The results showed that the effectiveness of tolvaptan in the aged patients was similar to that in U-80 patients. In the safety profile, the incidence rate of thirst was lower in the aged patients than that in U-80 patients (9.6% versus 11.6%, P = 0.0023). Furthermore, the incidence of hypernatremia, defined as ≥ 150 mEq/L in aged patients, was comparable with that in U-80 patients (2.9% versus 3.6%, respectively, P = 0.3657). Based on these findings, tolvaptan has similar effectiveness and safety profiles in aged patients compared with U-80 patients. In addition, we found that a higher starting dose of tolvaptan was markedly associated with the occurrence of hypernatremia exclusively in the aged population; therefore, we recommend that tolvaptan should be started at lower doses in aged patients.

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

    PubMed Central

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

    2017-01-01

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

  15. Workload Intensity, The Nursing Practice Environment, and Adverse Events

    DTIC Science & Technology

    2014-01-05

    satisfaction data, and annual unit-level pressure ulcer prevalence data. Sample: The dataset contained 111,500 shifts, 1,586 nurses and 1,643...magnitude and direction differed by event type and staffing measure. Hospital acquired pressure ulcers (HAPUs) were significantly associated with licensed...level pressure ulcer prevalence data. Sample: The dataset contained 111 ,500 shifts , 1,586 nurses and 1,643 patients from 57 units of 13 hospitals

  16. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  17. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  18. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  19. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  20. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  1. Timing of prenatal maternal exposure to severe life events and adverse pregnancy outcomes: A population study of 2.6 million pregnancies

    PubMed Central

    Class, Quetzal A.; Lichtenstein, Paul; Långström, Niklas; D'Onofrio, Brian M.

    2011-01-01

    Objective To identify the impact of timing of prenatal stress exposure on offspring risk for shortened gestational age (GA), preterm birth (PTB), low birth weight (LBW), and small for gestational age (SGA) using a population-based sample. Methods Swedish longitudinal population registries were linked to study all individuals born in Sweden 1973–2004. Prenatal maternal stress exposure was defined as death of the father of the child or first degree relative of the mother. Using linear and logistic regression, timing of stress exposure was examined across pregnancy, by month, and by novel periods created based on month of stress exposure findings. Results A total of 2,618,777 live-born, singleton infants without congenital anomalies were included; 32,286 exposed to prenatal maternal stress. Examining associations between stress exposure and outcome by the month revealed that risk increases mid-gestation, particularly following months 5 and 6. Combining months 1–4, 5 and 6, and 7–9 as potential periods of differing vulnerability, it was found that stress during period 2 (months 5 and 6) was associated with the greatest risk for shortened GA (−0.52 days, SE=0.15, p=0.0006), PTB (OR=1.24, 99% CI=1.08–1.42), LBW (OR=1.38, 99% CI=1.19–1.61), and SGA (OR=1.25, 99% CI=1.05–1.49). Conclusions Risk for shortened GA, PTB, LBW, and SGA are greater following stress exposure during the 5th and/or 6th month of pregnancy. It may be beneficial to refine future analyses to these months. Possible mechanisms include alterations in the hypothalamic-pituitary-adrenal axis and associated stress-responsive molecular regulators. PMID:21321257

  2. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    NASA Astrophysics Data System (ADS)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-03-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  3. 3D pharmacophoric similarity improves multi adverse drug event identification in pharmacovigilance.

    PubMed

    Vilar, Santiago; Tatonetti, Nicholas P; Hripcsak, George

    2015-03-06

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  4. Toxicogenomics of nevirapine-associated cutaneous and hepatic adverse events among populations of African, Asian, and European descent

    PubMed Central

    Yuan, Jing; Guo, Sheng; Hall, David; Cammett, Anna M.; Jayadev, Supriya; Distel, Manuel; Storfer, Stephen; Huang, Zimei; Mootsikapun, Piroon; Ruxrungtham, Kiat; Podzamczer, Daniel; Haas, David W.

    2012-01-01

    Objective Nevirapine is widely prescribed for HIV-1 infection. We characterized relationships between nevirapine-associated cutaneous and hepatic adverse events and genetic variants among HIV-infected adults. Design We retrospectively identified cases and controls. Cases experienced symptomatic nevirapine-associated severe (grade III/IV) cutaneous and/or hepatic adverse events within 8 weeks of initiating nevirapine. Controls did not experience adverse events during more than 18 weeks of nevirapine therapy. Methods Cases and controls were matched 1 : 2 on baseline CD4 T-cell count, sex, and race. Individuals with 150 or less CD4 T cells/μl at baseline were excluded. We characterized 123 human leukocyte antigen (HLA) alleles and 2744 single-nucleotide polymorphisms in major histocompatibility complex (MHC) and drug metabolism and transport genes. Results We studied 276 evaluable cases (175 cutaneous adverse events, 101 hepatic adverse events) and 587 controls. Cutaneous adverse events were associated with CYP2B6 516G→T (OR 1.66, all), HLA-Cw*04 (OR 2.51, all), and HLA-B*35 (OR 3.47, Asians; 5.65, Thais). Risk for cutaneous adverse events was particularly high among Blacks with CYP2B6 516TT and HLA-Cw*04 (OR 18.90) and Asians with HLA-B*35 and HLA-Cw*04 (OR 18.34). Hepatic adverse events were associated with HLA-DRB*01 (OR 3.02, Whites), but not CYP2B6 genotypes. Associations differed by population, at least in part reflecting allele frequencies. Conclusion Among patients with at least 150 CD4 T cells/μl, polymorphisms in drug metabolism and immune response pathways were associated with greater likelihood of risk for nevirapine-related adverse events. Results suggest fundamentally different mechanisms of adverse events: cutaneous, most likely MHC class I-mediated, influenced by nevirapine CYP2B6 metabolism; hepatic, most likely MHC class II-mediated and unaffected by such metabolism. These risk variants are insensitive for routine clinical screening. PMID

  5. The impact of adverse events on health care costs for older adults undergoing nonelective abdominal surgery

    PubMed Central

    Bailey, Jonathan G.; Davis, Philip J.B.; Levy, Adrian R.; Molinari, Michele; Johnson, Paul M.

    2016-01-01

    Background Postoperative complications have been identified as an important and potentially preventable cause of increased hospital costs. While older adults are at increased risk of experiencing complications and other adverse events, very little research has specifically examined how these events impact inpatient costs. We sought to examine the association between postoperative complications, hospital mortality and loss of independence and direct inpatient health care costs in patients 70 years or older who underwent nonelective abdominal surgery. Methods We prospectively enrolled consecutive patients 70 years or older who underwent nonelective abdominal surgery between July 1, 2011, and Sept. 30, 2012. Detailed patient-level data were collected regarding demographics, diagnosis, treatment and outcomes. Patient-level resource tracking was used to calculate direct hospital costs (2012 $CDN). We examined the association between complications, hospital mortality and loss of independence cost using multiple linear regression. Results During the study period 212 patients underwent surgery. Overall, 51.9% of patients experienced a nonfatal complication (32.5% minor and 19.4% major), 6.6% died in hospital and 22.6% experienced a loss of independence. On multivariate analysis nonfatal complications (p < 0.001), hospital mortality (p = 0.021) and loss of independence at discharge (p < 0.001) were independently associated with health care costs. These adverse events respectively accounted for 30%, 4% and 10% of the total costs of hospital care. Conclusion Adverse events were common after abdominal surgery in older adults and accounted for 44% of overall costs. This represents a substantial opportunity for better patient outcomes and cost savings with quality improvement strategies tailored to the needs of this high-risk surgical population. PMID:26999476

  6. The Incremental Hospital Cost and Length-of-Stay Associated With Treating Adverse Events Among Medicare Beneficiaries Undergoing THA During Fiscal Year 2013.

    PubMed

    Culler, Steven D; Jevsevar, David S; Shea, Kevin G; McGuire, Kevin J; Wright, Kimberly K; Simon, April W

    2016-01-01

    This paper estimates the incremental hospital resource consumption associated with treating selected adverse events experienced by Medicare beneficiaries (MBs) undergoing total hip arthroplasty (THA). This retrospective study, using the Medicare Provider Analysis and Review file, identified 174,167 MBs who underwent THA in 2013. Overall, 20.16% of MB undergoing THA experienced at least one adverse event. MB experiencing any adverse event consumed significantly higher hospital cost ($3429) and had longer length of stays (1.0 day). The risk-adjusted incremental cost of treating adverse events ranged from a high of $27,116 (pneumonia) to a low of $2626 (hemorrhage or post-operative shock requiring transfusion). Most major adverse events occurred infrequently, however when adverse events occurred, they add substantially to the hospital resource costs of treating MB.

  7. [Epidemiology of the hospital adverse events in Catalonia, Spain: a first step for the patient safety improvement].

    PubMed

    Bañeres, Joaquim; Orrego, Carola; Navarro, Laura; Casas, Lidia; Banqué, Marta; Suñol, Rosa

    2014-07-01

    It has been published that hospital adverse events are an important source of morbidity and mortality in different countries and settings. The aim of this study was to evaluate the frequency, magnitude, distribution and degree of preventability of adverse events in the Autonomous Community of Catalonia (Spain). We conducted a retrospective cohort study of 4,790 hospital discharges that were selected by simple random sampling after stratified multistage sampling in 15 hospitals in Catalonia. 38.25% of patients had positive risk criteria (screening phase). We identified 356 cases of adverse events, which represent a 7.4% (95%CI: 6.7% to 8.1%). Of these, 43.5% (155 cases) were considered preventable. This study confirms that adverse events in hospitals in Catalonia are frequent, and generate a significant impact on morbidity and mortality. As in other studies, corroborated that a high proportion of these adverse events are considered preventable. It was possible to identify priority areas to focus improvement efforts.

  8. Systematic investigation of time windows for adverse event data mining for recently approved drugs.

    PubMed

    Hochberg, Alan M; Hauben, Manfred; Pearson, Ronald K; O'Hara, Donald J; Reisinger, Stephanie J

    2009-06-01

    The optimum timing of drug safety data mining for a new drug is uncertain. The objective of this study was to compare cumulative data mining versus mining with sliding time windows. Adverse Event Reporting System data (2001-2005) were studied for 27 drugs. A literature database was used to evaluate signals of disproportionate reporting (SDRs) from an urn model data-mining algorithm. Data mining was applied cumulatively and with sliding time windows from 1 to 4 years in width. Time from SDR generation to the appearance of a publication describing the corresponding adverse event was calculated. Cumulative data mining and 1- to 2-year sliding windows produced the most SDRs for recently approved drugs. In the first postmarketing year, data mining produced SDRs an average of 800 days in advance of publications regarding the corresponding drug-event combination. However, this timing advantage reduced to zero by year 4. The optimum window width for sliding windows should increase with time on the market. Data mining may be most useful for early signal detection during the first 3 years of a drug's postmarketing life. Beyond that, it may be most useful for supporting or weakening hypotheses.

  9. Epidemiologists and adverse event data--a challenge to the field.

    PubMed

    Bortnichak, E A; Dai, W S

    1999-10-01

    Spontaneous adverse event reports, albeit biased and incomplete data, remain very important and, frequently, are the sole data source to rely on during the postmarketing phase for regulatory decision making. However, little progress has been made in the past decade to improve the utility of these essential data. Further research that helps to improve our understanding of the extent and characteristics of adverse event reporting should be done to ensure the maximum, appropriate utilization of this highly cost-efficient data source. In addition, the authors challenge that research can and should be done to advance our understanding of the behaviour and motivations of those who report adverse events so as to improve the quality and the quantity of meaningful spontaneous adverse event reports.

  10. Characterization of currently marketed heparin products: adverse event relevant bioassays.

    PubMed

    Sommers, Cynthia D; Montpas, Nicolas; Adam, Albert; Keire, David A

    2012-01-01

    The polyanion oversulfated chondroitin sulfate (OSCS) was identified as a contaminant in heparin products and was associated with severe hypotensive responses and other symptoms in patients receiving the drug. The OSCS associated adverse reactions were attributed to activation of the contact system via the plasma mediator, activated factor XII (FXIIa), which triggers kallikrein (KK) activity. Unlike heparin alone, OSCS, is able to activate FXII in plasma and stably bind to FXIIa enhancing plasma KK activity and the induction of vasoactive mediators such as bradykinin (BK), C3a and C5a. Similarly OSCS can interfere with heparin neutralization by the polycationic drug protamine. Here, we assess heparin (heparin sodium, dalteparin, tinzaparin or enoxaparin)-protamine complex formation and plasma based bioassays of KK, BK and C5a in a 96-well plate format. We establish the normal range of variation in the optimized bioassays across multiple lots from 9 manufacturers. In addition, because other oversulfated (OS) glycosaminoglycans (GAGs) besides OSCS could also serve as possible economically motivated adulterants (EMAs) to heparin, we characterize OS-dermatan sulfate (OSDS), OS-heparan sulfate (OSHS) and their native forms in the same assays. For the protamine test, OS-GAGs could be distinguished from heparin. For the KK assay, OSCS and OSDS were most potent followed by OSHS, and all had similar efficacies. Finally, OSDS had a greater efficacy in the C5a and BK assays followed by OSCS then OSHS. These data established the normal range of response of heparin products in these assays and the alteration in the responses in the presence of possible EMAs.

  11. Wheeze as an Adverse Event in Pediatric Vaccine and Drug Randomized Controlled Trials: A Systematic Review

    PubMed Central

    Marangu, Diana; Kovacs, Stephanie; Walson, Judd; Bonhoeffer, Jan; Ortiz, Justin R.; John-Stewart, Grace; Horne, David J.

    2016-01-01

    Introduction Wheeze is an important sign indicating a potentially severe adverse event in vaccine and drug trials, particularly in children. However, there are currently no consensus definitions of wheeze or associated respiratory compromise in randomized controlled trials (RCTs). Objective To identify definitions and severity grading scales of wheeze as an adverse event in vaccine and drug RCTs enrolling children <5 years and to determine their diagnostic performance based on sensitivity, specificity and inter-observer agreement. Methods We performed a systematic review of electronic databases and reference lists with restrictions for trial settings, English language and publication date ≥ 1970. Wheeze definitions and severity grading were abstracted and ranked by a diagnostic certainty score based on sensitivity, specificity and inter-observer agreement. Results Of 1,205 articles identified using our broad search terms, we identified 58 eligible trials conducted in 38 countries, mainly in high-income settings. Vaccines made up the majority (90%) of interventions, particularly influenza vaccines (65%). Only 15 trials provided explicit definitions of wheeze. Of 24 studies that described severity, 11 described wheeze severity in the context of an explicit wheeze definition. The remaining 13 studies described wheeze severity where wheeze was defined as part of a respiratory illness or a wheeze equivalent. Wheeze descriptions were elicited from caregiver reports (14%), physical examination by a health worker (45%) or a combination (41%). There were 21/58 studies in which wheeze definitions included combined caregiver report and healthcare worker assessment. The use of these two methods appeared to have the highest combined sensitivity and specificity. Conclusion Standardized wheeze definitions and severity grading scales for use in pediatric vaccine or drug trials are lacking. Standardized definitions of wheeze are needed for assessment of possible adverse events as

  12. Adverse events in bevacizumab and chemotherapy: patient management.

    PubMed

    Blowers, Elaine; Hall, Kate

    Bevacizumab (Avastin) is an anti-angiogenic agent recently approved for the treatment of metastatic breast cancer in combination with paclitaxel. It is important that nurses are familiar with the side-effects associated with this agent--several of which differ from those seen with traditional chemotherapy agents--and how these can be optimally identified, monitored and managed. Side-effects associated with bevacizumab include hypertension, proteinuria, thromboembolic events, bleeding, cardiac toxicity, wound-healing complications and gastrointestinal perforations. Many of these are easily manageable, often without the need to discontinue bevacizumab therapy. This article, the second in a series, provides nurses with management recommendations for these toxicities in order to deliver optimal patient care and improve patients quality of life.

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

    DTIC Science & Technology

    2012-08-24

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

  14. The role of the Immunisation Adverse Events Clinic at The Children's Hospital at Westmead.

    PubMed

    Wood, Nicholas J

    2010-01-01

    Specialist immunisation clinics review and manage children who have experienced an adverse event following immunisation and provide advice to parents and health care providers regarding the revaccination of these children. Information collected by these clinics supplement passive surveillance data and allow the investigation of suspected safety signals associated with the delivery of immunisation programs. This paper reviews the role and experience of the Immunisation Adverse Events Clinic at The Children's Hospital at Westmead and identifies areas for development.

  15. Borrowing to cope with adverse health events: liquidity constraints, insurance coverage, and unsecured debt.

    PubMed

    Babiarz, Patryk; Widdows, Richard; Yilmazer, Tansel

    2013-10-01

    This article uses data from the Health and Retirement Study for 1998-2010 to investigate whether households respond to the financial stress caused by health problems by increasing their unsecured debt. Results show both the probability of having unsecured debt and the amount of debt increase after an adverse health event among households with low financial assets, who are uninsured, or who have less generous health insurance. The effect of health problems on borrowing is caused by both medical expenditures and disruptions to the income stream. Unsecured debt seems to remain on some households' balance sheets for an extended period.

  16. Adverse events with bismuth salts for Helicobacter pylori eradication: Systematic review and meta-analysis

    PubMed Central

    Ford, Alexander C; Malfertheiner, Peter; Giguère, Monique; Santana, José; Khan, Mostafizur; Moayyedi, Paul

    2008-01-01

    AIM: To assess the safety of bismuth used in Helicobacter pylori (H pylori) eradication therapy regimens. METHODS: We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched (up to October 2007) to identify randomised controlled trials comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppression. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals (CI). RESULTS: We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth [relative risk (RR) = 1.01; 95% CI: 0.87-1.16], specific individual adverse events, with the exception of dark stools (RR = 5.06; 95% CI: 1.59-16.12), or adverse events leading to withdrawal of therapy (RR = 0.86; 95% CI: 0.54-1.37). CONCLUSION: Bismuth for the treatment of H pylori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools. PMID:19109870

  17. The association between B vitamins supplementation and adverse cardiovascular events: a meta-analysis

    PubMed Central

    Li, Wen-Feng; Zhang, Dan-Dan; Xia, Ji-Tian; Wen, Shan-Fan; Guo, Jun; Li, Zi-Cheng

    2014-01-01

    This study is to explore the association of adverse cardiovascular events with B vitamins supplementation. Rev.Man 5.1 and Stata 11.0 software were applied for the meta-analysis. The number of cardiovascular events was collected and calculated using indicates of odds ratio and 95% confidence intervals in a fixed-effects or a random-effects model when appropriate. The study includes 15 studies which consists of 37,358 study objects (experimental group: 19,601; control group: 17,757). This study showed that the pooled ORs was 1.01 (95% CI = 0.96~1.06, P > 0.05) for objects with Experimental group (B vitamins supplementation) vs. Control group (placebo or regular treatment), which suggests no significant differences were found in the overall effect of the number of cardiovascular events between the two groups. Further stratification of subgroup analysis indicates no significant differences were found between the two groups as well. There were also no publication bias existing by the Egger’s linear regression test (P > 0.05). Our result indicates that the number of cardiovascular events in experimental group using B vitamins supplementation during the treatment is equal to placebo or regular treatment group thus further studies is necessary. PMID:25232372

  18. Adverse events associated with complementary and alternative medicine use in ovarian cancer patients

    PubMed Central

    Sweet, Erin S.; Standish, Leanna J.; Goff, Barbara; Andersen, M. Robyn

    2015-01-01

    Many women with ovarian cancer are choosing to include complementary and alternative medicine (CAM) substances in conjunction with their conventional treatment for ovarian cancer. A 2004 study by Navo et al., found between 44% and 53% of women with ovarian cancer use some form of CAM. Many oncologists express concern about the concomitant use of CAM during conventional treatment, particularly during chemotherapy. Specifically, some providers theorize that the adjunct use of CAM substances may be detrimental to the achievement of therapeutic levels of chemotherapy by inhibiting or inducing cytochrome P450 enzyme activity leading to increases in drug toxicity, under-treatment of disease or other adverse events. Chemotherapeutic agents have complex pharmacological profiles and narrow therapeutic windows and many factors can affect the pharmacodynamics of these drugs. In an effort to ascertain the extent of the potential problem with simultaneous use of CAM with conventional treatment we undertook comprehensive systematic review of published case reports describing CAM-related adverse events among ovarian cancer patients. Study design This article describes a systematic literature review. Methods The Natural Medicines Comprehensive Database (NMCD). PubMed, EMBASE® and the Cochrane Central Register of Controlled Trials (CCTR) were systematically reviewed for research articles pertaining to known CYP mediated CAM-drug interactions; case reports describing adverse events in patients, and clinical trials which examined the effects of herbs and supplements used during cancer treatment. Results Only one case report and one clinical trial were identified which met our inclusion criteria and were relevant to the current investigation. Conclusion Although there are concerns about the potential for adverse events related to concurrent use of CAM substances during conventional treatment we found few case reports and clinical trials in the literature which support this. However

  19. Managing patients with side effects and adverse events to immunoglobulin therapy.

    PubMed

    Azizi, Gholamreza; Abolhassani, Hassan; Asgardoon, Mohammad Hossein; Shaghaghi, Shiva; Negahdari, Babak; Mohammadi, Javad; Rezaei, Nima; Aghamohammadi, Asghar

    2016-01-01

    Immunoglobulin therapy has not only served as a lifesaving approach for the prevention and treatment of infections in primary and secondary immunodeficiency diseases, but has also been used as an immunomodulatory agent for autoimmune and inflammatory disorders and to provide passive immunity for some infectious diseases. Most of the adverse effects associated with immunoglobulin therapy are mild, transient and self-limiting. However, serious side effects also occur. Therefore, to minimize the adverse events of immunoglobulin therapy, specialist review of patient clinical status and immunoglobulin products, in addition to selection of appropriate treatment strategy for the management of patients with associated side effects and adverse events, are crucial.

  20. 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

  1. Systematic review of methods used in meta-analyses where a primary outcome is an adverse or unintended event

    PubMed Central

    2012-01-01

    Background Adverse consequences of medical interventions are a source of concern, but clinical trials may lack power to detect elevated rates of such events, while observational studies have inherent limitations. Meta-analysis allows the combination of individual studies, which can increase power and provide stronger evidence relating to adverse events. However, meta-analysis of adverse events has associated methodological challenges. The aim of this study was to systematically identify and review the methodology used in meta-analyses where a primary outcome is an adverse or unintended event, following a therapeutic intervention. Methods Using a collection of reviews identified previously, 166 references including a meta-analysis were selected for review. At least one of the primary outcomes in each review was an adverse or unintended event. The nature of the intervention, source of funding, number of individual meta-analyses performed, number of primary studies included in the review, and use of meta-analytic methods were all recorded. Specific areas of interest relating to the methods used included the choice of outcome metric, methods of dealing with sparse events, heterogeneity, publication bias and use of individual patient data. Results The 166 included reviews were published between 1994 and 2006. Interventions included drugs and surgery among other interventions. Many of the references being reviewed included multiple meta-analyses with 44.6% (74/166) including more than ten. Randomised trials only were included in 42.2% of meta-analyses (70/166), observational studies only in 33.7% (56/166) and a mix of observational studies and trials in 15.7% (26/166). Sparse data, in the form of zero events in one or both arms where the outcome was a count of events, was found in 64 reviews of two-arm studies, of which 41 (64.1%) had zero events in both arms. Conclusions Meta-analyses of adverse events data are common and useful in terms of increasing the power to

  2. 5 CFR 295.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 295.210 Section 295.210 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 295.210 Procedure in the event...

  3. 6 CFR 5.47 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 6 Domestic Security 1 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 5.47 Section 5.47 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY DISCLOSURE OF RECORDS AND INFORMATION Disclosure of Information in Litigation § 5.47 Procedure in the event...

  4. 5 CFR 295.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Procedure in the event of an adverse ruling. 295.210 Section 295.210 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 295.210 Procedure in the event...

  5. 5 CFR 295.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 295.210 Section 295.210 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 295.210 Procedure in the event...

  6. 5 CFR 2417.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 2417.210 Section 2417.210 Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY, GENERAL... PROCEEDINGS Demands or Requests for Testimony and Production of Documents § 2417.210 Procedure in the event...

  7. 6 CFR 5.47 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 6 Domestic Security 1 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 5.47 Section 5.47 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY DISCLOSURE OF RECORDS AND INFORMATION Disclosure of Information in Litigation § 5.47 Procedure in the event...

  8. 5 CFR 295.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 295.210 Section 295.210 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 295.210 Procedure in the event...

  9. Periodontal Treatment Reduces Risk of Adverse Respiratory Events in Patients With Chronic Obstructive Pulmonary Disease

    PubMed Central

    Shen, Te-Chun; Chang, Pei-Ying; Lin, Cheng-Li; Chen, Chia-Hung; Tu, Chih-Yen; Hsia, Te-Chun; Shih, Chuen-Ming; Hsu, Wu-Huei; Sung, Fung-Chang; Kao, Chia-Hung

    2016-01-01

    Abstract Treatment of periodontal diseases has been associated with benefit outcomes for patients with chronic obstructive pulmonary disease (COPD). However, no population-based cohort study has been conducted. We evaluated this relationship by retrospective cohort study using a large population data. Using the National Health Insurance claims data of Taiwan, we identified 5562 COPD patients with periodontal diseases who had received periodontal treatment as the treatment group. The comparison group was selected at a 1:1 ratio matched by the propensity score estimated with age, sex, date of COPD diagnosis and periodontal treatment, and comorbidities. Both groups were followed up for 5 years to compare risks of acute exacerbation, pneumonia, and acute respiratory failure. The incidence rates of adverse respiratory events were significantly lower in the treatment group than in the comparison group: 3.79 versus 4.21 per 100 person-years for emergency room visits, 2.75 versus 3.65 per 100 person-years for hospitalizations, and 0.66 versus 0.75 per 100 person-years for intensive care unit admissions. The treatment group also had a 37% reduced risk of deaths (1.81 vs 2.87 per 100 person-years), with an adjusted hazard ratio of 0.57 (95% confidence interval 0.52–0.62). Periodontal treatment for COPD patients could reduce the risk of adverse respiratory events and mortality. The adequate periodontal health care is important for COPD patients with periodontal diseases. PMID:27196497

  10. Adverse drug reactions – examples of detection of rare events using databases

    PubMed Central

    Chan, Esther W; Liu, Kirin Q L; Chui, Celine S L; Sing, Chor-Wing; Wong, Lisa Y L; Wong, Ian C K

    2015-01-01

    It is recognised that randomised controlled trials are not feasible for capturing rare adverse events. There is an increasing trend towards observational research methodologies using large population-based health databases. These databases offer more scope for adequate sample sizes, allowing for comprehensive patient characterisation and assessment of the associated factors. While direct causality cannot be established and confounders cannot be ignored, databases present an opportunity to explore and quantify rare events. The use of databases for the detection of rare adverse events in the following conditions, sudden death associated with attention deficit hyperactivity disorder (ADHD) treatment, retinal detachment associated with the use of fluoroquinolones and toxic epidermal necrolysis associated with drug exposure, are discussed as examples. In general, rare adverse events tend to have immediate and important clinical implications and may be life-threatening. An understanding of the causative factors is therefore important, in addition to the research methodologies and database platforms that enable the undertaking of the research. PMID:25060360

  11. Age-related risk of major adverse cardiac event risk and coronary artery disease extent and severity by coronary CT angiography: results from 15 187 patients from the International Multisite CONFIRM Study

    PubMed Central

    Nakazato, Ryo; Arsanjani, Reza; Achenbach, Stephan; Gransar, Heidi; Cheng, Victor Y.; Dunning, Allison; Lin, Fay Y.; Al-Mallah, Mouaz; Budoff, Matthew J.; Callister, Tracy Q.; Chang, Hyuk-Jae; Cademartiri, Filippo; Chinnaiyan, Kavitha; Chow, Benjamin J.W.; DeLago, Augustin; Hadamitzky, Martin; Hausleiter, Joerg; Kaufmann, Philipp; Raff, Gilbert; Shaw, Leslee J.; Villines, Todd; Cury, Ricardo C.; Feuchtner, Gudrun; Kim, Yong-Jin; Leipsic, Jonathon; Berman, Daniel S.; Min, James K.

    2014-01-01

    Aims Prior studies evaluating the prognostic utility of cardiac CT angiography (CCTA) have been largely constrained to an all-cause mortality endpoint, with other cardiac endpoints generally not reported. To this end, we sought to determine the relationship of extent and severity of coronary artery disease (CAD) by CCTA to risk of incident major adverse cardiac events (MACEs) (defined as death, myocardial infarction, and late revascularization). Methods and results We identified subjects without prior known CAD who underwent CCTA and were followed for MACE. CAD by CCTA was defined as none (0% luminal stenosis), mild (1–49% luminal stenosis), moderate (50–69% luminal stenosis), or severe (≥70% luminal stenosis), and ≥50% luminal stenosis was considered as obstructive. CAD severity was judged on per-patient, per-vessel, and per-segment basis. Time to MACE was estimated using univariable and multivariable Cox proportional hazards models. Among 15 187 patients (57 ± 12 years, 55% male), 595 MACE events (3.9%) occurred at a 2.4 ± 1.2 year follow-up. In multivariable analyses, an increased risk of MACE was observed for both non-obstructive [hazard ratio (HR) 2.43, P < 0.001] and obstructive CAD (HR: 11.21, P < 0.001) when compared with patients with normal CCTA. Risk-adjusted MACE increased in a dose–response relationship based on the number of vessels with obstructive CAD ≥50%, with increasing hazards observed for non-obstructive (HR: 2.54, P < 0.001), obstructive one-vessel (HR: 9.15, P < 0.001), two-vessel (HR: 15.00, P < 0.001), or three-vessel or left main (HR: 24.53, P < 0.001) CAD. Among patients stratified by age <65 vs. ≥65 years, older individuals experienced higher risk-adjusted hazards for MACE for non-obstructive, one-, and two-vessel, with similar event rates for three-vessel or left main (P < 0.001 for all) compared with normal individuals age <65. Finally, there was a dose relationship of CAD findings by CCTA and MACE event rates with each

  12. Adverse events in allergy sufferers wearing contact lenses

    PubMed Central

    Urgacz, Agnieszka; Mrukwa, Ewa

    2015-01-01

    Allergy is the fifth leading chronic condition in industrialized countries among all ages, and the third most common chronic disease among children under 18 years old. Many of allergic patients also have problems with vision and want to improve their quality of life by wearing contact lenses. They are most frequently young and active individuals, for whom contact lenses provide greater convenience and more satisfying vision correction than spectacles. However, application of high quality and immunologically neutral products do not protect from allergic side reactions. Nowadays, eye-related allergy and contact lens wear concern larger and larger populations worldwide. The purpose of this review is to summarize the studies on ocular complications associated with wearing contact lenses. The article presents indications for allergic patients especially on the care system and wear schedule. PMID:26161062

  13. Low Prevalance of Major Events Adverse to Exercise Stress Echocardiography

    PubMed Central

    Andrade, Stephanie Macedo; Telino, Caio José Coutinho Leal; Sousa, Antônio Carlos Sobral; de Melo, Enaldo Vieira; Teixeira, Carla Carolina Cardoso; Teixeira, Clarissa Karine Cardoso; Santana, Jaquiele Santos; Mota, Igor Larchert; de Matos, Carlos José Oliveira; Oliveira, Joselina Luzia Menezes

    2016-01-01

    Background: Stress echocardiography is well validated for diagnosis and risk stratification of coronary artery disease. Exercise stress echocardiography (ESE) has been shown to be the most physiological among the modalities of stress, but its safety is not well established. Objective: To study the complications related to ESE and clinical and echocardiographic variables most commonly associated with their occurrence. Methods: Cross-sectional study consisting of 10250 patients submitted to ESE for convenience, from January 2000 to June 2014. Cardiac Arrhythmias (CA) were the most frequent complications observed during the examination. The volunteers were divided into two groups according to the occurrence of CA during ESE: G1 group, composed of patients who have CA, and G2 formed by individuals who did not show such complication. Results: Group G1, consisting of 2843 patients (27.7%), and Group G2 consisting of 7407 patients (72.3%). There was no death, acute myocardial infarction, ventricular fibrillation or asystole. Predominant CAs were: supraventricular extrasystoles (13.7%), and ventricular extrasystoles (11.5%). G1 group had a higher mean age, higher frequency of hypertension and smoking, larger aortic roots and left atrium (LA) and lower ejection fraction than G2. G1 group also had more ischemic changes (p < 0.001). The predictor variables were age (RR 1.04; [CI] 95% from 1.038 to 1.049) and LA (RR 1.64; [CI] 95% from 1.448 to 1.872). Conclusion: ESE proved to be a safe modality of stress, with non-fatal complications only. Advanced age and enlargement of the left atrium are predictive of cardiac arrhythmias. PMID:27355587

  14. Nature of preventable adverse drug events in hospitals: a literature review.

    PubMed

    Kanjanarat, Penkarn; Winterstein, Almut G; Johns, Thomas E; Hatton, Randy C; Gonzalez-Rothi, Ricardo; Segal, Richard

    2003-09-01

    A literature review was conducted to identify the drug classes, types of errors, and types of adverse outcomes related to preventable adverse drug events (pADEs). Studies were identified by keyword search of MEDLINE and International Pharmaceutical Abstracts and by a manual search. The search was limited to peer-reviewed literature reporting pADEs in hospitalized patients and the frequencies of at least one pADE characteristic. The frequencies of pADEs and their characteristics were summarized using median and range. Ten studies published between 1994 and 2001 were included in the review. The reported median frequency of pADEs was 1.8% (range, 1.3-7.8%), and the median preventability rate of ADEs in the hospitals was 35.2% (range, 18.7-73.2%). Cardiovascular drugs were implicated for 17.9% of pADEs (range, 4.3-28.1%). Most pADEs occurred in the prescribing stage of the medication-use process and were dose related. Inappropriate prescribing decisions and patient monitoring were the most frequently identified causes of pADEs. The most common adverse outcomes were allergic reactions, hepatic or renal problems, cardiovascular problems, hematologic problems and bleeding, and central nervous system problems. Frequently reported examples of pADEs included antihypertensive overdose associated with bradycardia or hypotension, antiinfectives prescribed despite a history of allergy, warfarin overdose and inappropriate monitoring resulting in hemorrhage, and opioid overdose or underdose associated with respiratory depression or poor pain control, respectively. Despite the heterogeneity of pADEs, the results of this literature review suggest that a few types of drugs, errors, and adverse outcomes constitute a substantial proportion of pADEs. Targeting these high-priority areas could significantly reduce the overall frequency of pADEs.

  15. Role of pre-procedural C-reactive protein level in the prediction of major adverse cardiac events in patients undergoing percutaneous coronary intervention: a meta-analysisof longitudinal studies.

    PubMed

    Bibek, Singh-Baniya; Xie, Yong; Gao, Jia-Jia; Wang, Zhi; Wang, Jing-Feng; Geng, Deng-Feng

    2015-02-01

    Numerous studies have reported the relation between pre-procedural C-reactive protein (CRP) levels and the risk of major adverse cardiac events (MACEs) in patients undergoing percutaneous coronary intervention (PCI). However, the results across the studies were inconsistent. The aim of this study was to evaluate the predictive effect of pre-procedural CRP levels and the risk of MACEs in patients undergoing PCI. Longitudinal studies on the association between pre-procedural CRP levels and MACEs were identified by electronic and manual searches. Summary risk ratios (RRs) and 95 % confidence intervals (CI) were calculated employing an inverse variance random-effects model irrespective of between-study heterogeneity. Thirty-three studies involving 34,367 patients with 4119 MACEs were included in this study. High CRP level was associated with increased incidences of MACEs, all-cause death, myocardial infarction, coronary revascularization, and clinical restenosis, with pooled RRs of 1.97 (95 % CI, 1.65, 2.35), 2.88 (95 % CI, 2.15, 3.86), 1.81 (95 % CI, 1.48, 2.21), 1.31 (95 % CI, 1.11, 1.56), and 1.45 (95 % CI, 1.07, 1.96), respectively. Dose-response analysis showed that every 1 mg/L increment in pre-procedural serum CRP level was associated with a significant 12 % increase in the risk of MACEs. In spite of heterogeneity across the included studies, this meta-analysis suggests that pre-procedural serum CRP level is a valuable predictor of MACEs in patients undergoing PCI.

  16. Long-Term Safety and Adverse Events of Risperidone in Children, Adolescents, and Adults with Pervasive Developmental Disorders

    ERIC Educational Resources Information Center

    Hellings, Jessica A.; Cardona, Alicia M.; Schroeder, Stephen R.

    2010-01-01

    The objective of this study was to examine long-term adverse events of risperidone in 19 children, adolescents, and adults with Pervasive Developmental Disorders and intellectual disability, continuing risperidone for a mean of 186.5 weeks, following a 46-week risperidone study. Nineteen individuals continued long-term follow-up after our…

  17. Biometrical issues in the analysis of adverse events within the benefit assessment of drugs.

    PubMed

    Bender, Ralf; Beckmann, Lars; Lange, Stefan

    2016-07-01

    The analysis of adverse events plays an important role in the benefit assessment of drugs. Consequently, results on adverse events are an integral part of reimbursement dossiers submitted by pharmaceutical companies to health policy decision-makers. Methods applied in the analysis of adverse events commonly include simple standard methods for contingency tables. However, the results produced may be misleading if observations are censored at the time of discontinuation due to treatment switching or noncompliance, resulting in unequal follow-up periods. In this paper, we present examples to show that the application of inadequate methods for the analysis of adverse events in the reimbursement dossier can lead to a downgrading of the evidence on a drug's benefit in the subsequent assessment, as greater harm from the drug cannot be excluded with sufficient certainty. Legal regulations on the benefit assessment of drugs in Germany are presented, in particular, with regard to the analysis of adverse events. Differences in safety considerations between the drug approval process and the benefit assessment are discussed. We show that the naive application of simple proportions in reimbursement dossiers frequently leads to uninterpretable results if observations are censored and the average follow-up periods differ between treatment groups. Likewise, the application of incidence rates may be misleading in the case of recurrent events and unequal follow-up periods. To allow for an appropriate benefit assessment of drugs, adequate survival time methods accounting for time dependencies and duration of follow-up are required, not only for time-to-event efficacy endpoints but also for adverse events. © 2016 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd.

  18. Adverse Events in Healthy Individuals and MDR-TB Contacts Treated with Anti-Tuberculosis Drugs Potentially Effective for Preventing Development of MDR-TB: A Systematic Review

    PubMed Central

    Langendam, Miranda W.; Tiemersma, Edine W.; van der Werf, Marieke J.; Sandgren, Andreas

    2013-01-01

    A recent systematic review concluded that there is insufficient evidence on the effectiveness to support or reject preventive therapy for treatment of contacts of patients with multidrug resistant tuberculosis (MDR-TB). Whether preventive therapy is favorable depends both on the effectiveness and the adverse events of the drugs used. We performed a systematic review to assess adverse events in healthy individuals and MDR-TB contacts treated with anti-tuberculosis drugs potentially effective for preventing development of MDR-TB. We searched MEDLINE, EMBASE, and other databases (August 2011). Record selection, data extraction, and study quality assessment were done in duplicate. The quality of evidence was assessed using the GRADE approach. Of 6,901 identified references, 20 studies were eligible. Among the 16 studies in healthy volunteers (a total of 87 persons on either levofloxacin, moxifloxacin, ofloxacin, or rifabutin, mostly for 1 week), serious adverse events and treatment discontinuation due to adverse events were rare (<1 and <5%, respectively), but mild adverse events frequently occurred. Due to small sample sizes of the levofloxacin and ofloxacin studies an increased frequency of mild adverse events compared to placebo could not be demonstrated or excluded. For moxifloxacin the comparative results were inconsistent. In four studies describing preventive therapy of MDR-TB contacts, therapy was stopped for 58–100% of the included persons because of the occurrence of adverse events ranging from mild adverse events such as nausea and dizziness to serious events requiring treatment. The quality of the evidence was very low. Although the number of publications and quality of evidence are low, the available evidence suggests that shortly after starting treatment the occurrence of serious adverse events is rare. Mild adverse events occur more frequently and may be of importance because these may provoke treatment interruption. PMID:23326464

  19. Adverse events in healthy individuals and MDR-TB contacts treated with anti-tuberculosis drugs potentially effective for preventing development of MDR-TB: a systematic review.

    PubMed

    Langendam, Miranda W; Tiemersma, Edine W; van der Werf, Marieke J; Sandgren, Andreas

    2013-01-01

    A recent systematic review concluded that there is insufficient evidence on the effectiveness to support or reject preventive therapy for treatment of contacts of patients with multidrug resistant tuberculosis (MDR-TB). Whether preventive therapy is favorable depends both on the effectiveness and the adverse events of the drugs used. We performed a systematic review to assess adverse events in healthy individuals and MDR-TB contacts treated with anti-tuberculosis drugs potentially effective for preventing development of MDR-TB. We searched MEDLINE, EMBASE, and other databases (August 2011). Record selection, data extraction, and study quality assessment were done in duplicate. The quality of evidence was assessed using the GRADE approach. Of 6,901 identified references, 20 studies were eligible. Among the 16 studies in healthy volunteers (a total of 87 persons on either levofloxacin, moxifloxacin, ofloxacin, or rifabutin, mostly for 1 week), serious adverse events and treatment discontinuation due to adverse events were rare (<1 and <5%, respectively), but mild adverse events frequently occurred. Due to small sample sizes of the levofloxacin and ofloxacin studies an increased frequency of mild adverse events compared to placebo could not be demonstrated or excluded. For moxifloxacin the comparative results were inconsistent. In four studies describing preventive therapy of MDR-TB contacts, therapy was stopped for 58-100% of the included persons because of the occurrence of adverse events ranging from mild adverse events such as nausea and dizziness to serious events requiring treatment. The quality of the evidence was very low. Although the number of publications and quality of evidence are low, the available evidence suggests that shortly after starting treatment the occurrence of serious adverse events is rare. Mild adverse events occur more frequently and may be of importance because these may provoke treatment interruption.

  20. Persistent constipation and abdominal adverse events with newer treatments for constipation

    PubMed Central

    Sonu, Irene; Triadafilopoulos, George; Gardner, Jerry D

    2016-01-01

    Background Clinical trials of several new treatments for opioid-induced constipation (OIC), chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome (IBS-C) have focused on differences between subjects relieved of constipation with placebo and active treatment. Patients and clinicians however, are more interested in the probability these treatments provide actual relief of constipation and its associated symptoms. Methods We searched the medical literature using MEDLINE and Cochrane central register of controlled trials. Randomised, placebo-controlled trials that examined the use of methylnaltrexone, naloxegol, lubiprostone, prucalopride or linaclotide in adults with OIC, CIC and IBS-C were eligible for inclusion. The primary efficacy measure was relief of constipation. Adverse event data for abdominal symptoms were also analysed. Key results and findings 25 publications were included in our analyses. The proportion of constipated individuals with active treatment was significantly lower than the proportion with placebo; however, in 15 of these 20 trials analysed, a majority of patients remained constipated with active treatment. Analyses of adverse event data revealed that the percentage of participants who experienced abdominal pain, diarrhoea and flatulence with active treatment was higher than that with placebo in the majority of trials analysed. Conclusions Newer pharmacological treatments for constipation are superior to placebo in relieving constipation, but many patients receiving active treatment may remain constipated. In addition, all 5 of the treatments studied are accompanied by no change or a possible increase in the prevalence of abdominal symptoms, such as abdominal pain, diarrhoea and flatulence. PMID:27486521

  1. Antiretroviral Drug-Related Liver Mortality Among HIV-Positive Persons in the Absence of Hepatitis B or C Virus Coinfection: The Data Collection on Adverse Events of Anti-HIV Drugs Study

    PubMed Central

    Kovari, Helen; Sabin, Caroline A.; Ledergerber, Bruno; Ryom, Lene; Worm, Signe W.; Smith, Colette; Phillips, Andrew; Reiss, Peter; Fontas, Eric; Petoumenos, Kathy; De Wit, Stéphane; Morlat, Philippe; Lundgren, Jens D.; Weber, Rainer

    2013-01-01

    Background. Liver diseases are the leading causes of death in human immunodeficiency virus (HIV)–positive persons since the widespread use of combination antiretroviral treatment (cART). Most of these deaths are due to hepatitis C (HCV) or B (HBV) virus coinfections. Little is known about other causes. Prolonged exposure to some antiretroviral drugs might increase hepatic mortality. Methods. All patients in the Data Collection on Adverse Events of Anti-HIV Drugs study without HCV or HBV coinfection were prospectively followed from date of entry until death or last follow-up. In patients with liver-related death, clinical charts were reviewed using a structured questionnaire. Results. We followed 22 910 participants without hepatitis virus coinfection for 114 478 person-years. There were 12 liver-related deaths (incidence, 0.10/1000 person-years); 7 due to severe alcohol use and 5 due to established ART-related toxicity. The rate of ART-related deaths in treatment-experienced persons was 0.04/1000 person-years (95% confidence interval, .01, .10). Conclusions. We found a low incidence of liver-related deaths in HIV-infected persons without HCV or HBV coinfection. Liver-related mortality because of ART-related toxicity was rare. PMID:23090925

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

    PubMed

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

    2004-08-01

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

  3. Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

    PubMed

    Du, Dongyi; Goldsmith, John; Aikin, Kathryn J; Encinosa, William E; Nardinelli, Clark

    2012-05-01

    In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

  4. Risk prediction models for major adverse cardiac event (MACE) following percutaneous coronary intervention (PCI): A review

    NASA Astrophysics Data System (ADS)

    Manan, Norhafizah A.; Abidin, Basir

    2015-02-01

    Five percent of patients who went through Percutaneous Coronary Intervention (PCI) experienced Major Adverse Cardiac Events (MACE) after PCI procedure. Risk prediction of MACE following a PCI procedure therefore is helpful. This work describes a review of such prediction models currently in use. Literature search was done on PubMed and SCOPUS database. Thirty literatures were found but only 4 studies were chosen based on the data used, design, and outcome of the study. Particular emphasis was given and commented on the study design, population, sample size, modeling method, predictors, outcomes, discrimination and calibration of the model. All the models had acceptable discrimination ability (C-statistics >0.7) and good calibration (Hosmer-Lameshow P-value >0.05). Most common model used was multivariate logistic regression and most popular predictor was age.

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

    PubMed

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

    2017-01-01

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

  6. Developing a national system for dealing with adverse events following immunization.

    PubMed Central

    Mehta, U.; Milstien, J. B.; Duclos, P.; Folb, P. I.

    2000-01-01

    Although vaccines are among the safest of pharmaceuticals, the occasional severe adverse event or cluster of adverse events associated with their use may rapidly become a serious threat to public health. It is essential that national monitoring and reporting systems for vaccine safety are efficient and adequately coordinated with those that conventionally deal with non-vaccine pharmaceuticals. Equally important is the need for an enlightened and informed national system to be in place to deal with public concerns and rapid evaluation of the risk to public safety when adverse events occur. Described in this article is the outcome of efforts by the WHO Global Training Network to describe a simple national system for dealing with vaccine safety and with emergencies as they arise. The goals of a training programme designed to help develop such a system are also outlined. PMID:10743281

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

    PubMed

    Liu, Xiao; Chen, Hsinchun

    2015-12-01

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

  8. Prevalence and Predictors of Adverse Events in Older Surgical Patients: Impact of the Present on Admission Indicator

    ERIC Educational Resources Information Center

    Kim, Hongsoo; Capezuti, Elizabeth; Kovner, Christine; Zhao, Zhonglin; Boockvar, Kenneth

    2010-01-01

    Purpose of the Study: To examine the effects of the present on admission (POA) indicator on the prevalence of and factors associated with postsurgical adverse events in older patients. Design and Methods: This is a secondary data analysis of 82,898 surgical patients aged 65 years or older in 252 acute care hospitals in California in 2004. Four…

  9. Using the Personal Background Preparation Survey to Identify Health Science Professions Students at Risk for Adverse Academic Events

    ERIC Educational Resources Information Center

    Johnson, Craig W.; Johnson, Ronald; McKee, John C.; Kim, Mira

    2009-01-01

    In the first predictive validity study of a diagnostic and prescriptive instrument for averting adverse academic status events (AASE) among multiple populations of diverse health science professions students, entering matriculates' personal background and preparation survey (PBPS) scores consistently significantly predicted 1st- or 2nd-year AASE.…

  10. [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.

  11. Mobility therapy and central or peripheral catheter-related adverse events in an ICU in Brazil*

    PubMed Central

    Lima, Natália Pontes; da Silva, Gregório Marques Cardim; Park, Marcelo; Pires-Neto, Ruy Camargo

    2015-01-01

    OBJECTIVE: To determine whether mobility therapy is associated with central or peripheral catheter-related adverse events in critically ill patients in an ICU in Brazil. METHODS: A retrospective analysis of the daily medical records of patients admitted to the Clinical Emergency ICU of the University of São Paulo School of Medicine Hospital das Clínicas Central Institute between December of 2009 and April of 2011. In addition to the demographic and clinical characteristics of the patients, we collected data related to central venous catheters (CVCs), hemodialysis (HD) catheters and indwelling arterial catheters (IACs): insertion site; number of catheter days; and types of adverse events. We also characterized the mobility therapy provided. RESULTS: Among the 275 patients evaluated, CVCs were used in 49%, HD catheters were used in 26%, and IACs were used in 29%. A total of 1,268 mobility therapy sessions were provided to patients while they had a catheter in place. Catheter-related adverse events occurred in 20 patients (a total of 22 adverse events): 32%, infection; 32%, obstruction; and 32%, accidental dislodgement. We found that mobility therapy was not significantly associated with any catheter-related adverse event, regardless of the type of catheter employed: CVC-OR = 0.8; 95% CI: 0.7-1.0; p = 0.14; HD catheter-OR = 1.04; 95% CI: 0.89-1.21; p = 0.56; or IAC-OR = 1.74; 95% CI: 0.94-3.23; p = 0.07. CONCLUSIONS: In critically ill patients, mobility therapy is not associated with the incidence of adverse events involving CVCs, HD catheters, or IACs. PMID:26176520

  12. Acute adverse event signalling scheme using the Saskatchewan Administrative health care utilization datafiles: results for two benzodiazepines.

    PubMed

    Rawson, N S; Rawson, M J

    1999-01-01

    Linked administrative health care utilization databases offer potential benefits for postmarketing surveillance. The value of the Saskatchewan datafiles in an acute adverse event signalling scheme has been evaluated using two benzodiazepines. The first 20,000 patients dispensed lorazepam and the first 8525 patients dispensed alprazolam were followed through the datafiles over the year after their initial prescription of the relevant drug, and all medical services occurring during treatment were recorded. The most frequent adverse drug reactions to benzodiazepines are drowsiness, depression, impaired intellectual function and memory, lethargy, impaired coordination, dizziness, nausea and/or vomiting, skin rash, and respiratory disturbance. Data from our study showed that sleep disorders, depressive disorders, dizziness and/or vertigo, respiratory symptoms, esophagus and stomach disorders, and inflammatory skin conditions occurred significantly more often in the first 30 days after the initial prescription than in the succeeding six months in both drug groups, indicating that they are important adverse events. There are several limitations to the methodology; however, the results of the analysis indicate that the use of administrative health care utilization datafiles in a systematic assessment to signal potential acute adverse drug reactions is a feasible proposition, but further studies are required to assess whether events are real adverse reactions.

  13. Detecting adverse drug events in discharge summaries using variations on the simple Bayes model.

    PubMed

    Visweswaran, Shyam; Hanbury, Paul; Saul, Melissa; Cooper, Gregory F

    2003-01-01

    Detection and prevention of adverse events and, in particular, adverse drug events (ADEs), is an important problem in health care today. We describe the implementation and evaluation of four variations on the simple Bayes model for identifying ADE-related discharge summaries. Our results show that these probabilistic techniques achieve an ROC curve area of up to 0.77 in correctly determining which patient cases should be assigned an ADE-related ICD-9-CM code. These results suggest a potential for these techniques to contribute to the development of an automated system that helps identify ADEs, as a step toward further understanding and preventing them.

  14. Using Structured Telephone Follow-up Assessments to Improve Suicide-related Adverse Event Detection

    PubMed Central

    Arias, Sarah A.; Zhang, Zi; Hillerns, Carla; Sullivan, Ashley F.; Boudreaux, Edwin D.; Miller, Ivan; Camargo, Carlos A.

    2014-01-01

    Adverse event (AE) detection and reporting practices were compared during the first phase of the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE), a suicide intervention study. Data were collected using a combination of chart reviews and structured telephone follow-up assessments post-enrollment. Beyond chart reviews, structured telephone follow-up assessments identified 45% of the total AEs in our study. Notably, detection of suicide attempts significantly varied by approach with 53 (18%) detected by chart review, 173 (59%) by structured telephone follow-up assessments, and 69 (23%) marked as duplicates. Findings provide support for utilizing multiple methods for more robust AE detection in suicide research. PMID:24588679

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

    PubMed

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

    2007-07-01

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

  16. Adverse events risk associated with anti-VEGFR agents in the treatment of advanced nonsmall-cell lung cancer

    PubMed Central

    Gu, Biao; Gao, WenChuang; Chu, HongJun; Gao, Jian; Fu, Zhi; Ding, Hui; Lv, JunJie; Wu, QingQuan

    2016-01-01

    Abstract To perform this meta-analysis, we investigated the risk of the most clinically relevant adverse events related to antivascular endothelial growth factor receptor (VEGFR) agents in advanced nonsmall-cell lung cancer (NSCLC). A comprehensive literature search for studies published up to October 2015 was performed. Prospective randomized controlled phase II/III clinical trials that comparing therapy with or without anti-VEGFR agents for advanced NSCLC were included for analysis. Summary relative risk (RR) and 95% confidence intervals (CIs) were calculated using random effects or fixed effects according to the heterogeneity among included trials. A total of 11,701 patients from 18 clinical trials were included for analysis. Pooled RR showed that the use of anti-VEGFR agents significantly increased the risk of developing hypertension (RR 4.71, 95% CI 3.29–6.73, P < 0.001) and fatal adverse events (RR 1.33, 95% CI 1.12–1.58, P = 0.001). No statistically significant differences were found for gastrointestinal (GI) perforation (P = 0.41), arterial or venous thromboembolic events (P = 0.49 and P = 0.16, respectively), or hemorrhagic events (P = 0.81). Sensitive analysis indicated that the significance estimate of pooled RR of fatal adverse event (FAEs) was not significantly influenced by omitting any single study. The use of anti-VEGFR agents in advanced NSCLC does significantly increase the risk of hypertension and fatal adverse events, but not for arterial or venous thromboembolic events, GI perforation, or hemorrhagic events. PMID:27902583

  17. Stepped-wedge cluster randomised controlled trial to assess the effectiveness of an electronic medication management system to reduce medication errors, adverse drug events and average length of stay at two paediatric hospitals: a study protocol

    PubMed Central

    Westbrook, J I; Li, L; Raban, M Z; Baysari, M T; Prgomet, M; Georgiou, A; Kim, T; Lake, R; McCullagh, C; Dalla-Pozza, L; Karnon, J; O'Brien, T A; Ambler, G; Day, R; Cowell, C T; Gazarian, M; Worthington, R; Lehmann, C U; White, L; Barbaric, D; Gardo, A; Kelly, M; Kennedy, P

    2016-01-01

    Introduction Medication errors are the most frequent cause of preventable harm in hospitals. Medication management in paediatric patients is particularly complex and consequently potential for harms are greater than in adults. Electronic medication management (eMM) systems are heralded as a highly effective intervention to reduce adverse drug events (ADEs), yet internationally evidence of their effectiveness in paediatric populations is limited. This study will assess the effectiveness of an eMM system to reduce medication errors, ADEs and length of stay (LOS). The study will also investigate system impact on clinical work processes. Methods and analysis A stepped-wedge cluster randomised controlled trial (SWCRCT) will measure changes pre-eMM and post-eMM system implementation in prescribing and medication administration error (MAE) rates, potential and actual ADEs, and average LOS. In stage 1, 8 wards within the first paediatric hospital will be randomised to receive the eMM system 1 week apart. In stage 2, the second paediatric hospital will randomise implementation of a modified eMM and outcomes will be assessed. Prescribing errors will be identified through record reviews, and MAEs through direct observation of nurses and record reviews. Actual and potential severity will be assigned. Outcomes will be assessed at the patient-level using mixed models, taking into account correlation of admissions within wards and multiple admissions for the same patient, with adjustment for potential confounders. Interviews and direct observation of clinicians will investigate the effects of the system on workflow. Data from site 1 will be used to develop improvements in the eMM and implemented at site 2, where the SWCRCT design will be repeated (stage 2). Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospitals Network and Macquarie University. Results will be reported through academic journals and

  18. Risk of fatal adverse events associated with 17DD yellow fever vaccine.

    PubMed Central

    Struchiner, C. J.; Luz, P. M.; Dourado, I.; Sato, H. K.; Aguiar, S. G.; Ribeiro, J. G. L.; Soares, R. C. R.; Codeço, C. T.

    2004-01-01

    Yellow fever (YF), an acute infectious disease, is endemic in the north and central-west of Brazil. This disease can be prevented by the use of a vaccine. In Brazil, four fatal adverse events have been associated with the YF vaccine used in the country (17DD vaccine). We briefly describe the last two fatalities, and estimate the risk of 17DD-associated fatal adverse events under different epidemiological scenarios. Controversies regarding the appropriate denominator that enters the estimation of risk serve as a motivation for each proposed scenario. The statistical procedures used show optimum behaviour when assessing the risk of rare events. Risk estimates vary from 0.043 (95 % CI 0.017-0.110) to 2.131 (95 % CI 0.109-12.071) fatalities per million doses administered. The robust estimates of the risk of fatal adverse events we present constitute an important element in future risk-benefit analysis and point to the need for good quality vaccine coverage and adverse-events surveillance data to assess the risk of vaccination. Although vaccination of YF endemic regions is necessary to maintain low disease prevalence, preventive administration of YF vaccine to the entire population should be cautiously analysed. PMID:15473158

  19. 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

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

    PubMed

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

    2013-12-01

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

  1. Childhood Adversities and Traumata in Lebanon: A National Study

    PubMed Central

    Itani, Lynn; Haddad, Youmna C; Fayyad, John; Karam, Aimee; Karam, Elie

    2014-01-01

    Background: The goal of this paper is to map the total occurrence and evaluate the risk of co-occurrence of childhood adversities (CA) and a wide variety of childhood traumatic events (including war) in a national sample. Method: The nationally representative sample included 2,857 respondents and the instrument used was the Composite International Diagnostic Interview which screened for all CAs and traumatic events. Results: 27.9% experienced CAs; the most common were parental death and parental mental/substance use disorder. 70.6% experienced a war-related traumatic event during their lifetime, and around half of them (38.1%) experienced it below the age of 18 years. 51.3% of the subjects experienced a traumatic event not related to war during their lifetime, and 19.2% experienced it before the age of 18 years. Sexual abuse, being a refugee during war, and experiencing a natural disaster were associated with female gender. Having any CA was associated with active war exposure (OR: 4.2, CI: 2.0-8.6); war-related direct personal trauma (OR: 3.9, CI: 1.5-10.0); war-related trauma to others (OR: 2.4, CI: 1.3-4.4); non-war direct personal trauma (OR: 3.8, CI: 2.0-7.4); and any non-war childhood traumatic event (OR: 1.9, CI: 1.1-3.1). Conclusion:Childhood is awash with adversities and traumatic events that co-occur and should be measured simultaneously; otherwise, the effects of a subset of traumata or adversities could be wrongly thought to be the contributor to negative outcomes under study. PMID:25356085

  2. High-Performance Signal Detection for Adverse Drug Events using MapReduce Paradigm.

    PubMed

    Fan, Kai; Sun, Xingzhi; Tao, Ying; Xu, Linhao; Wang, Chen; Mao, Xianling; Peng, Bo; Pan, Yue

    2010-11-13

    Post-marketing pharmacovigilance is important for public health, as many Adverse Drug Events (ADEs) are unknown when those drugs were approved for marketing. However, due to the large number of reported drugs and drug combinations, detecting ADE signals by mining these reports is becoming a challenging task in terms of computational complexity. Recently, a parallel programming model, MapReduce has been introduced by Google to support large-scale data intensive applications. In this study, we proposed a MapReduce-based algorithm, for common ADE detection approach, Proportional Reporting Ratio (PRR), and tested it in mining spontaneous ADE reports from FDA. The purpose is to investigate the possibility of using MapReduce principle to speed up biomedical data mining tasks using this pharmacovigilance case as one specific example. The results demonstrated that MapReduce programming model could improve the performance of common signal detection algorithm for pharmacovigilance in a distributed computation environment at approximately liner speedup rates.

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

    PubMed

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

    2010-03-01

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

  4. Adverse Events during 2 Years of Daily Wear of Silicone Hydrogels in Children

    PubMed Central

    Sankaridurg, Padmaja; Chen, Xiang; Naduvilath, Thomas; de la Jara, Percy Lazon; Lin, Zhi; Li, Li; Smith, Earl L.; Ge, Jian; Holden, Brien A.

    2015-01-01

    Purpose Type and incidence of adverse events and rate of discontinuations for 2 years of daily wear with silicone hydrogel contact lenses in Chinese children with myopia. Methods Two hundred forty children aged 7 to 14 years were enrolled in a prospective randomized clinical trial from November 2008 to April 2009. Children with myopia of up to −3.50 diopters (D) spherical equivalent with astigmatism less than or equal to −0.75 D were randomized to one commercial and three experimental lens designs of Lotrafilcon B silicone hydrogel lenses (four groups) used bilaterally on a daily wear, monthly replacement schedule. The main outcome measures were incidence per 100 patient-years (incidence, in percentage) of adverse events and rate of discontinuations. Results There were no events of microbial keratitis. Fifty-five adverse events (incidence, 14.2%) were seen. There were also 12 recurrent events. The type and incidence percentage were contact lens papillary conjunctivitis (16 events, 4.1%), superior epithelial arcuate lesions (SEALs, six events, 1.5%), corneal erosions (eight events, 2.1%), infiltrative keratitis (five events, 1.3%), asymptomatic infiltrative keratitis (seven events, 1.8%), and asymptomatic infiltrates (13 events, 3.42%). There were differences in the incidence of SEALs between groups (p = 0.023), with the incidence of SEALs being greater with one of the experimental designs. No event resulted in any vision loss. Seventy participants (29.2%) discontinued, with one-third (26 participants, 10.8%) occurring in the first month of lens wear. Discomfort and non–lens-related reasons such as safety concern and disinterest were frequently cited reasons for discontinuations. Conclusions Adverse events with daily wear of silicone hydrogels in children were mainly mechanical in nature, and significant infiltrative events were few. The large number of dropouts in the early days of lens wear and their reasons for discontinuation suggest that adaptation and

  5. Defining risks and predicting adverse events after lower extremity bypass for critical limb ischemia

    PubMed Central

    Siracuse, Jeffrey J; Huang, Zhen S; Gill, Heather L; Parrack, Inkyong; Schneider, Darren B; Connolly, Peter H; Meltzer, Andrew J

    2014-01-01

    Successful treatment of patients with critical limb ischemia (CLI), hinges on the adequacy of revascularization. However, CLI is associated with a severe burden of systemic atherosclerosis, and patients often suffer from multiple cardiovascular comorbidities. Therefore, CLI patients in general represent a cohort at increased risk for procedural complications and adverse events. Although endovascular therapy represents a minimally invasive alternative to open surgical bypass, the durability of surgical reconstruction is superior, and it remains the “gold standard” approach to revascularization in CLI. Therefore, selection of the optimal treatment modality for individual patients requires careful consideration of the procedural risks and likelihood of adverse events associated with surgery. Individualized decision-making with regard to revascularization strategy requires a comprehensive understanding of the likelihood of adverse outcomes after major surgery. Here we review the risks of surgical bypass in patients with CLI, with particular emphasis on the identification of preoperative variables that predict poor outcome. PMID:25018636

  6. Diversity and intensity of adverse events in the treatment of hypertension with barnidipine.

    PubMed

    van der Velden, J W; Beudeker, H J; Nishi, M

    1998-01-01

    Calcium antagonists (CaAs) are divided into three structural classes, typically represented by verapamil, diltiazem and nifedipine. As a group, the principal (type I) adverse effects of these drugs relate to the pharmacological action of calcium channel blockade, namely vasodilation, and include dizziness, flushing, palpitations and peripheral oedema. The clinical safety of the new dihydropyridine CaA, barnidipine, has been assessed in more than 12 clinical trials, including 2041 patients who have been treated with one or more doses of barnidipine (dose of up to 50 mg). Adverse events with barnidipine are of mild to moderate intensity, most commonly of type I, occurring in the early phase of treatment. The incidence of serious adverse events and the rate of withdrawals are low. Hence, barnidipine is likely to be well tolerated in general clinical use.

  7. Acute adverse events from over-the-counter Chinese herbal medicines: a population-based survey of Hong Kong Chinese

    PubMed Central

    2013-01-01

    Background Although over-the-counter traditional Chinese herbal medicine (COTC) is commonly used to treat everyday illness in many parts of the world, no population-based study has been done to examine the prevalence and factors associated with COTC-related adverse events. Methods A cross-sectional telephone survey was conducted among Hong Kong Chinese adults in 2011 (n = 1100) with informed verbal consent. Stepwise logistic regression of demographic, attitudinal and behavioral variables was used to determine factors associated with past-year adverse events. Results Of study respondents, 71.7% (789/1100) reported past-year COTC use and 2.3% (25/1100) reported at least one COTC-related adverse event in the past year. Of the 27 adverse events cases reported among COTC users, the most common were allergic reactions (n = 11) dizziness (n = 5), and gastro-intestinal problems (n = 4). Pills/capsules were the dosage form that caused the highest proportion of adverse events (n = 10), followed by plasters (n = 7), creams/ointments (n = 5), and ingestible powders (n = 2). Although COTC users reporting adverse events were more likely to report greater practices to avoid adverse events (OR = 6.47; 95% CI: 1.38-30.3); they were also more likely to possess lower education levels (OR = 9.64, 95% CI: 2.20-42.3) and to have received COTC information from non-reliable, mass-media information sources such as magazines (OR = 3.32; 95% CI: 1.01-8.50) or television (OR = 2.93; 95% CI: 1.03-10.7). Package labels were also felt to be unclear by 42.9% of COTC users. A large proportion of COTC users demonstrated low levels of COTC-related knowledge, while the main impediment to greater information-seeking was the belief that reliable COTC information is not obtainable from Western health professionals. Conclusions Despite global movements toward more stringent complementary medicine regulation, the limited accessibility of reliable information

  8. Comparison of Increasingly Detailed Elicitation Methods for the Assessment of Adverse Events in Pediatric Psychopharmacology.

    ERIC Educational Resources Information Center

    Greenhill, Laurence L.; Vitiello, Benedetto; Fisher, Prudence; Levine, Jerome; Davies, Mark; Abikoff, Howard; Chrisman, Allan K.; Chuang, Shirley; Findling, Robert L.; March, John; Scahill, Lawrence; Walkup, John; Riddle, Mark A.

    2004-01-01

    Objective: To improve the gathering of adverse events (AEs) in pediatric psychopharmacology by examining the value and acceptability of increasingly detailed elicitation methods. Method: Trained clinicians administered the Safety Monitoring Uniform Report Form (SMURF) to 59 parents and outpatients (mean age [+ or -] SD = 11.9 [+ or -] 3.2 years)…

  9. Hepatitis B vaccine adverse events in China: risk control and regulation.

    PubMed

    Meina, Li; Xiaodong, Liu; Lulu, Zhang

    2014-01-01

    The death of 17 children raised public fears over infant hepatitis B vaccination in China. Though the relation between hepatitis B and children's death was denied after prudent investigation, the negative impact remained. In order to prevent or minimize adverse events after vaccination, special strategy including regulation and reimbursement should be developed.

  10. Childhood Adverse Events and Health Outcomes among Methamphetamine-Dependent Men and Women

    ERIC Educational Resources Information Center

    Messina, Nena P.; Marinelli-Casey, Patricia; Hillhouse, Maureen; Ang, Alfonso; Hunter, Jeremy; Rawson, Richard

    2008-01-01

    To describe the prevalence of childhood adverse events (CAEs) among methamphetamine-dependent men and women, and assess the relationship of cumulative CAEs to health problems. Data for 236 men and 351 women were analyzed assessing CAEs. Dependent variables included 14 self-reported health problems or psychiatric symptom domains. Mental health was…

  11. 5 CFR 2608.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 2608.210 Section 2608.210 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 2608.210 Procedure in the...

  12. 14 CFR 1263.108 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 1263.108 Section 1263.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEMAND FOR INFORMATION OR TESTIMONY SERVED ON AGENCY EMPLOYEES; PROCEDURES § 1263.108 Procedure in the...

  13. 14 CFR 1263.108 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Procedure in the event of an adverse ruling. 1263.108 Section 1263.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEMAND FOR INFORMATION OR TESTIMONY SERVED ON AGENCY EMPLOYEES; PROCEDURES § 1263.108 Procedure in the...

  14. 41 CFR 105-60.607 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 105-60.607 Section 105-60.607 Public Contracts and Property Management Federal... Subpoenas or Similar Demands in Judicial or Administrative Proceedings § 105-60.607 Procedure in the...

  15. 41 CFR 105-60.607 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 105-60.607 Section 105-60.607 Public Contracts and Property Management Federal... Subpoenas or Similar Demands in Judicial or Administrative Proceedings § 105-60.607 Procedure in the...

  16. An Educational Program to Prevent Adverse Events in Neonates : a Randomised Trial.

    ClinicalTrials.gov

    2016-10-20

    Intensive Care Units, Neonatal; Misadventures to Patients During Surgical and Medical Care; Catheter-related Bloodstream Infection (CRBSI) Nos; Quality of Healthcare; Ventilator Adverse Event; Nosocomial Pneumonia; Immature Newborn; Skin Lesion; Extravasation Injury; Nasal Injury; Intubation Complication; Medication Administered in Error; IV Catheter Nos Deep Venous Thrombosis

  17. 14 CFR 1263.108 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1263.108 Section 1263.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEMAND FOR INFORMATION OR TESTIMONY SERVED ON AGENCY EMPLOYEES; PROCEDURES § 1263.108 Procedure in the...

  18. 22 CFR 206.5 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Procedure in the event of an adverse ruling. 206.5 Section 206.5 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT TESTIMONY BY EMPLOYEES AND THE PRODUCTION OF DOCUMENTS IN PROCEEDINGS WHERE A.I.D. IS NOT A PARTY § 206.5 Procedure in the...

  19. 14 CFR 1263.108 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 1263.108 Section 1263.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEMAND FOR INFORMATION OR TESTIMONY SERVED ON AGENCY EMPLOYEES; PROCEDURES § 1263.108 Procedure in the...

  20. 22 CFR 206.5 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Procedure in the event of an adverse ruling. 206.5 Section 206.5 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT TESTIMONY BY EMPLOYEES AND THE PRODUCTION OF DOCUMENTS IN PROCEEDINGS WHERE A.I.D. IS NOT A PARTY § 206.5 Procedure in the...

  1. Application of Knowledge Discovery in Databases Methodologies for Predictive Models for Pregnancy Adverse Events

    ERIC Educational Resources Information Center

    Taft, Laritza M.

    2010-01-01

    In its report "To Err is Human", The Institute of Medicine recommended the implementation of internal and external voluntary and mandatory automatic reporting systems to increase detection of adverse events. Knowledge Discovery in Databases (KDD) allows the detection of patterns and trends that would be hidden or less detectable if analyzed by…

  2. Adverse events of herbal food supplements for body weight reduction: systematic review.

    PubMed

    Pittler, M H; Schmidt, K; Ernst, E

    2005-05-01

    Herbal weight-loss supplements are marketed with claims of effectiveness. Our earlier systematic review identified data from double-blind, randomized controlled trials for a number of herbal supplements. The aim of this systematic review was to assess all clinical evidence of adverse events of herbal food supplements for body weight reduction for which effectiveness data from rigorous clinical trials exist. We assessed Ephedra sinica, Garcinia cambogia, Paullinia cupana, guar gum, Plantago psyllium, Ilex paraguariensis and Pausinystalia yohimbe. Literature searches were conducted on Medline, Embase, Amed and The Cochrane Library. Data were also requested from the spontaneous reporting scheme of the World Health Organization. We hand-searched relevant medical journals and our own files. There were no restrictions regarding the language of publication. The results show that adverse events including hepatic injury and death have been reported with the use of some herbal food supplements. For herbal ephedra and ephedrine-containing food supplements an increased risk of psychiatric, autonomic or gastrointestinal adverse events and heart palpitations has been reported. In conclusion, adverse events are reported for a number of herbal food supplements, which are used for reducing body weight. Although the quality of the data does not justify definitive attribution of causality in most cases, the reported risks are sufficient to shift the risk-benefit balance against the use of most of the reviewed herbal weight-loss supplements. Exceptions are Garcinia cambogia and yerba mate, which merit further investigation.

  3. The Relationship between Adverse Childhood Events, Resiliency and Health among Children with Autism

    ERIC Educational Resources Information Center

    Rigles, Bethany

    2017-01-01

    Previous research has shown a negative relationship between adverse childhood events (ACEs) and health and resiliency among the general population, but has not examined these associations among children with autism. Purpose: To determine the prevalence of ACEs among children with autism and how ACEs are associated with resiliency and health.…

  4. 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…

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

    ERIC Educational Resources Information Center

    Fedor, Carol; Cola, Philip; Polites, Stephanie

    2007-01-01

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

  6. 10 CFR 9.204 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9.204 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Production or Disclosure in Response to Subpoenas or Demands of Courts or Other Authorities § 9.204 Procedure in the event of an adverse ruling. If the court or other judicial or quasi-judicial authority declines to stay the effect of the demand...

  7. 41 CFR 105-60.607 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-Production or Disclosure by Present or Former General Services Administration Employees in Response to Subpoenas or Similar Demands in Judicial or Administrative Proceedings § 105-60.607 Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect of the demand...

  8. Aspirin Resistance Predicts Adverse Cardiovascular Events in Patients with Symptomatic Peripheral Artery Disease

    PubMed Central

    Pasala, Tilak; Hoo, Jennifer Soo; Lockhart, Mary Kate; Waheed, Rehan; Sengodan, Prasanna; Alexander, Jeffrey

    2016-01-01

    Antiplatelet therapy reduces the risk of myocardial infarction, stroke, and vascular death in patients who have symptomatic peripheral artery disease. However, a subset of patients who take aspirin continues to have recurrent cardiovascular events. There are few data on cardiovascular outcomes in patients with peripheral artery disease who manifest aspirin resistance. Patients with peripheral artery disease on long-term aspirin therapy (≥4 wk) were tested for aspirin responsiveness by means of the VerifyNow Aspirin Assay. The mean follow-up duration was 22.6 ± 8.3 months. The primary endpoint was a composite of death, myocardial infarction, or ischemic stroke. Secondary endpoints were the incidence of vascular interventions (surgical or percutaneous), or of amputation or gangrene caused by vascular disease. Of the 120 patients enrolled in the study, 31 (25.8%) were aspirin-resistant and 89 (74.2%) were aspirin-responsive. The primary endpoint occurred in 10 (32.3%) patients in the aspirin-resistant group and in 13 (14.6%) patients in the aspirin-responsive group (hazard ratio=2.48; 95% confidence interval, 1.08–5.66; P=0.03). There was no significant difference in the secondary outcome of revascularization or tissue loss. By multivariate analysis, aspirin resistance and history of chronic kidney disease were the only independent predictors of long-term adverse cardiovascular events. Aspirin resistance is highly prevalent in patients with symptomatic peripheral artery disease and is an independent predictor of adverse cardiovascular risk. Whether intervening in these patients with additional antiplatelet therapies would improve outcomes needs to be explored. PMID:28100965

  9. Association of hypothyroidism with adverse events in patients with heart failure receiving cardiac resynchronization therapy.

    PubMed

    Sharma, Ajay K; Vegh, Eszter; Orencole, Mary; Miller, Alexandra; Blendea, Dan; Moore, Stephanie; Lewis, Gregory D; Singh, Jagmeet P; Parks, Kimberly A; Heist, E Kevin

    2015-05-01

    Hypothyroidism is associated with an adverse prognosis in cardiac patients in general and in particular in patients with heart failure (HF). The aim of this study was to evaluate the impact of hypothyroidism on patients with HF receiving cardiac resynchronization therapy (CRT). Additionally, the impact of level of control of hypothyroidism on risk of adverse events after CRT implantation was also evaluated. We included consecutive patients in whom a CRT device was implanted from April 2004 to April 2010 at our institution with sufficient follow-up data available for analysis; 511 patients were included (age 68.5±12.4 years, women 20.4%); 84 patients with a clinical history of hypothyroidism, on treatment with thyroid hormone repletion or serum thyroid-stimulating hormone level≥5.00 μU/ml, were included in the hypothyroid group. The patients were followed for up to 3 years after implant for a composite end point of hospitalization for HF, left ventricular assist device placement, or heart transplant and cardiac death; 215 composite end point events were noted in this period. In a multivariate model, hypothyroidism (hazard ratio [HR] 1.46, 95% confidence interval [CI] 1.027 to 2.085, p=0.035), female gender (HR 0.64, 95% CI 0.428 to 0.963, p=0.032), and creatinine (HR 1.26, 95% CI 1.145 to 1.382, p<0.001) were significantly associated with occurrence of the composite end point; 53.6% of patients with hypothyroidism at baseline developed the composite end point compared with 39.8% of those with euthyroidism (p=0.02). In conclusion, hypothyroidism is associated with a worse prognosis after CRT implantation.

  10. Vaccine adverse events in the new millennium: is there reason for concern?

    PubMed Central

    Ward, B. J.

    2000-01-01

    As more and more infectious agents become targets for immunization programmes, the spectrum of adverse events linked to vaccines has been widening. Although some of these links are tenuous, relatively little is known about the immunopathogenesis of even the best characterized vaccine-associated adverse events (VAAEs). The range of possible use of active immunization is rapidly expanding to include vaccines against infectious diseases that require cellular responses to provide protection (e.g. tuberculosis, herpes viral infections), therapeutic vaccines for chronic infections (e.g. human immunodeficiency virus (HIV) infection, viral hepatitis B and C), and vaccines against non-infectious conditions (e.g. cancer, autoimmune diseases). Less virulent pathogens (e.g. varicella, rotavirus in the developed world) are also beginning to be targeted, and vaccine use is being justified in terms of societal and parental "costs" rather than in straightforward morbidity and mortality costs. In the developed world the paediatric immunization schedule is becoming crowded, with pressure to administer increasing numbers of antigens simultaneously in ever simpler forms (e.g. subcomponent, peptide, and DNA vaccines). This trend, while attractive in many ways, brings hypothetical risks (e.g. genetic restriction, narrowed shield of protection, and loss of randomness), which will need to be evaluated and monitored. The available epidemiological and laboratory tools to address the issues outlined above are somewhat limited. As immunological and genetic tools improve in the years ahead, it is likely that we shall be able to explain the immunopathogenesis of many VAAEs and perhaps even anticipate and avoid some of them. However, this will only happen if the human and financial resources needed for monitoring and studying vaccine safety stay in step with the accelerating pace of vaccine development. Failure to make such a commitment would put all immunization programmes at risk. PMID

  11. Clinical features associated with adverse events in patients with post-pericardiotomy syndrome following cardiac surgery.

    PubMed

    Alraies, M Chadi; Al Jaroudi, Wael; Shabrang, Cyrus; Yarmohammadi, Hirad; Klein, Allan L; Tamarappoo, Balaji K

    2014-11-01

    Postpericardiotomy syndrome (PPS) may be associated with tamponade and pericardial constriction that may require procedural intervention. The aim of this study was to identify clinical features associated with adverse events requiring procedural intervention in patients with PPS. A total of 239 patients who developed PPS after cardiac surgery were monitored for 12 months. PPS was diagnosed if 2 of the 5 following findings were present: fever without infection, pleuritic pain, friction rub, pleural effusion, and pericardial effusion (<60 days after surgery). The primary end point was the development of pericardial effusion or pericardial constriction requiring procedural intervention. Among 239 patients with PPS, 75 (31%) required procedural intervention. In a univariate analysis, the odds of a procedural intervention were decreased with older age (odds ratio [OR] 0.98, 95% confidence interval [CI] 0.96 to 0.99) and with colchicine used in combination with anti-inflammatory agents (OR 0.45, 95% CI 0.26 to 0.79). However, the odds were increased in patients with preoperative heart failure (OR 1.84, 95% CI 1 to 3.39) and early postoperative constrictive physiology (OR 5.77, 95% CI 2.62 to 12.7). After multivariate adjustment, treatment with colchicine along with anti-inflammatory agents was associated with lower odds of requiring intervention (OR 0.43, 95% CI 0.95 to 0.99). Independent positive predictors of procedural intervention included age (OR 0.97, 95% CI 0.95 to 0.99), time to PPS (OR 0.97, 95% CI 0.95 to 0.99), and early postoperative constrictive physiology (OR 6.23, 95% CI 2.04 to 19.07). In conclusion, younger age, early-onset PPS, and postoperative constrictive physiology were associated with the need for procedural intervention in patients with PPS, whereas colchicine was associated with reduced odds of adverse events and procedural intervention.

  12. Transfusion-related adverse events at the tertiary care center in North India: An institutional hemovigilance effort

    PubMed Central

    Bhattacharya, Prasun; Marwaha, Neelam; Dhawan, Hari Krishan; Roy, Pallab; Sharma, R. R.

    2011-01-01

    Aim: This study was designed to analyze the incidence and spectrum of adverse effects of blood transfusion so as to initiate measures to minimize risks and improve overall transfusion safety in the institute. Materials and Methods: During the period from July 2002 to July 2003 all the adverse events related to transfusion of blood and blood components in various clinical specialties were recorded. They were analyzed and classified on the basis of their clinical features and laboratory tests. Attempt was also made to study the predisposing risk factors. Results: During the study period 56,503 blood and blood components were issued to 29,720 patients. A total of 105 adverse reactions due to transfusion were observed during the study period. A majority of the adverse reactions was observed in hemato-oncology patients 43% (n = 45) and in presensitized patient groups 63% (n = 66). FNHTR 41% (n = 43) and allergic reactions 34% (n = 36) were the most common of all types of adverse transfusion reactions, followed by AcHTR 8.56% (n = 9). Majority of these AcHTR were due to unmonitored storage of blood in the refrigerator of wards resulting in hemolysis due to thermal injury. Less frequently observed reactions were anaphylactoid reactions (n = 4), bacterial sepsis (n = 4), hypervolemia (n = 2), hypocalcemia (n = 2), TRALI (n = 1), DHTR (n = 1), and TAGvHD (n = 1). Conclusion: Analysis of transfusion-related adverse outcomes is essential for improving safety. Factors such as improvement of blood storage conditions outside the blood bank, improvement in cross-matching techniques, careful donor screening, adherence to good manufacturing practices while component preparation, bedside monitoring of transfusion, and documentation of adverse events will help in reducing transfusion-related morbidity and mortality. PMID:21897598

  13. Applicability, reliability, sensitivity, and specificity of six Brighton Collaboration standardized case definitions for adverse events following immunization.

    PubMed

    Kohl, Katrin S; Magnus, Manya; Ball, Robert; Halsey, Neal; Shadomy, Sean; Farley, Thomas A

    2008-11-25

    We evaluated the applicability, reliability, sensitivity, and specificity of six standardized case definitions for adverse events following immunization (AEFI) (for fever, generalized convulsive seizure, hypotonic-hyporesponsive episode, intussusception, nodule, and persistent crying) developed by the Brighton Collaboration using the U.S. Vaccine Adverse Event Reporting System (VAERS). The evaluation included: (a) the development of codified search strings using standardized coding terminology, and (b) for sensitivity and specificity analyses, the development of a "gold standard" for case determination by clinical expert reviews, and its comparison against the application of the definitions to VAERS reports by nonclinicians. Application of the case definitions in an automated approach proved to be valid, feasible, and unlikely to miss confirmed cases of the reported clinical event. The definitions had variable but generally high sensitivity and specificity compared to clinician review, which in itself yielded inconsistent case determination. The study demonstrated the need for the developed standardized definitions for AEFI and their usefulness in passive surveillance.

  14. Prevalence and nature of adverse medical device events in hospitalized children.

    PubMed

    Brady, Patrick W; Varadarajan, Kartik; Peterson, Laura E; Lannon, Carole; Gross, Thomas

    2013-07-01

    Our objective was to describe the prevalence and nature of adverse medical device events (AMDEs) in tertiary care children's hospitals. In our retrospective cohort study of patients at 44 children's hospitals in the Pediatric Health Information System (PHIS), we included all inpatient stays with an AMDE-related diagnosis from January 1, 2004 to December 31, 2011. We identified AMDEs by diagnoses that specified a device in their definition. We included events present on admission as well as those complicating hospital stays. We described the characteristics of these admissions and patients, and stratified analysis by device category and presence of a complex chronic condition. Of 4,115,755 admissions in the PHIS database during the study period, 136,465 (3.3%) had at least 1 AMDE. Vascular access and nervous system devices together represented 44.4% of pediatric AMDE admissions. The majority (75.5%) of AMDE admissions were of children with complex chronic conditions. The most common age group was patients aged 2 years or less at the time of their first AMDE-related admission. AMDEs occur commonly in a population cared for in tertiary children's hospitals. Research to more specifically delineate AMDEs and their predictors are next steps to understand and improve device safety in children.

  15. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-04-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error, or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilized due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices [EUDAMED]) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to "predicate" products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  16. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-05-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  17. Changes in Disability Levels Among Older Adults Experiencing Adverse Events in Postacute Rehabilitation Care

    PubMed Central

    Gacto-Sánchez, Mariano; Medina-Mirapeix, Francesc; Navarro-Pujalte, Esther; Escolar-Reina, Pilar

    2015-01-01

    Abstract This study aimed to assess the relationship between adverse events (AEs) and changes in the levels of disability from admission to discharge during inpatient rehabilitation programs. A prospective cohort study was conducted among a cohort of inpatients (216 older adults) admitted to a rehabilitation unit. The occurrences of any AE were reported. The level of disability regarding mobility activities was estimated using the disability qualifiers from the International Classification of Functioning, Disability, and Health. Changes in the levels of disability between admission and discharge were assessed. Baseline-measured covariates were also selected. Regarding all 4 disability levels (“no limitation,” “mild,” “moderate,” “severe,” and “complete disability”), a total of 159 participants experienced an improvement at discharge (126 participants progressed 1 level, whereas 33 improved 2 disability levels), 56 made no change, and no participants experienced a decline. The occurrence of fall-related events and the diagnostic group (musculoskeletal system) are specific predictive factors of change in the level of disability. The odds of undergoing a change in any disability level between admission and discharge decreases by 68% (1–0.32) when patients experience fall-related events (odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.11–0.97, P = 0.041) and increases for individuals with musculoskeletal conditions (OR = 3.91, 95% CI = 1.34–11.38, P = 0.012). Our findings suggest that increased efforts to prevent the occurrence of these AEs, together with early interventions suited to the diagnosis of the affected system, may have a positive influence on the improvement of disability. Further studies should evaluate disability over time after discharge to obtain a better sense of how transient or permanent the associated disability may be. PMID:25715255

  18. [Variations in the epidemiolgy of adverse events: methodology of the Harvard Medical Practice Design].

    PubMed

    Lessing, C; Schmitz, A; Schrappe, M

    2012-02-01

    The Harvard Medical Practice (HMP) Design is based on a multi-staged retrospective review of inpatient records and is used to assess the frequency of (preventable) adverse events ([P]AE) in large study populations. Up to now HMP studies have been conducted in 9 countries. Results differ largely from 2.9% to 3.7% of patients with AE in the USA up to 16.6% in Australia. In our analysis we systematically compare the methodology of 9 HMP studies published in the English language and discuss possible impacts on reported frequencies. Modifications in HMP studies can be individualised from each stage of planning, conducting, and reporting results. In doing so 2 studies from the USA with lowest rates of AE can be characterised by their context of liability and the absence of screening for nosocomial infections. Studies with a high proportion of AE are marked by an intense training of reviewers. Further conclusions are hindered by divergences in defining periods of observation, by presenting frequencies as cumulative prevalences, and differences in the reporting of study results. As a consequence future HMP studies should go for complete, consistent and transparent coverage. Further research should concentrate on advancing methods for collecting data on (P)AE.

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

    PubMed

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

    2006-01-01

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

  20. Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective.

    PubMed

    Carlesso, Lisa C; Cairney, John; Dolovich, Lisa; Hoogenes, Jennifer

    2011-10-01

    Rare, serious, and common, benign adverse events (AE) are associated with MT techniques. A proposed standard for defining AE in manual therapy (MT) practise has been published but it did not include the patient perspective. Research comparing clinician and patient reporting of AE demonstrates that several differences exist; for example, the reporting of objective versus subjective events. The objective of this study was to describe how patients define AE associated with MT techniques. A descriptive qualitative design was employed. Semi-structured interviews were used with a purposive sample of patients (n = 13) receiving MT, from physiotherapy, chiropractic and osteopathic practises in Ontario, Canada. The interview guide was informed by existing evidence and consultation with content and methodological experts. Interviews were audiotaped and transcribed verbatim. Date were analysed by two independent team members using thematic content analysis. A key finding was that patients defined mild, moderate and major AE by pain/symptom severity, functional impact, duration and by ruling out of alternative causes. An overarching theme identified multiple factors that influence how the AE is perceived. These concepts differ from the previously proposed framework for defining AE that did not include the patient perspective. Future processes to create standard definitions or measures should include the patient viewpoint to provide a broader, client-centred foundation.

  1. Surveillance for Adverse Events following Immunization from 2008 to 2011 in Zhejiang Province, China

    PubMed Central

    Li, Qian; Lin, Luoya; Chen, Enfu; Chen, Yaping; Qi, Xiaohua

    2013-01-01

    This study summarizes passive surveillance data for adverse events following immunization (AEFI) reported to the National AEFI Surveillance System (NASS) in Zhejiang province and describes reporting trends from 2008 to 2011. AEFI reporting rates were calculated using denominator data from the Individual Immunization Information System and the Zhejiang provincial Bureau of Statistics. A total of 6,265 AEFI records were reported; the overall reporting rate was 9.2 per 100,000 doses. There were two peaks of reporting rates, which were associated mainly with the introduction of the pandemic H1N1 influenza virus vaccine (pH1N1) in 2009 and the measles-mumps vaccine (MM) campaign in 2010. The majority of the AEFI described nonserious events. Fifteen deaths were recorded, but only one was possibly related to immunization. The most frequently reported reactions were fever and injection site reaction. Vaccines distributed in Zhejiang province have proven to be generally safe. The data on AEFI surveillance provide a reference point for ongoing reporting of trends and illustrate the value of the NASS database as a surveillance tool for monitoring of AEFI. PMID:23239804

  2. Who will pay for the adverse events resulting from smallpox vaccination? Liability and compensation issues.

    PubMed

    Strongin, Robin J; Salinsky, Eileen

    2003-03-12

    This paper summarizes liability and compensation concerns surrounding the smallpox vaccination program announced by President Bush on December 13, 2002. The paper examines the nature of adverse health events that are likely to occur in connection with the smallpox vaccine, assesses the liability protections that have been established for organizations and individuals participating in the vaccination program, and discusses the compensation mechanisms being considered to address the damages incurred by volunteers who may suffer from adverse vaccine reactions. Specifically, the implications of the Federal Tort Claims Act, workers' compensation programs, and the creation of a new no-fault compensation fund are explored.

  3. Circulating Endothelial Cells and Endothelial Function predict Major Adverse Cardiac Events and Early Adverse Left Ventricular Remodeling in Patients with ST-Segment Elevation Myocardial Infarction

    PubMed Central

    Magdy, Abdel Hamid; Bakhoum, Sameh; Sharaf, Yasser; Sabry, Dina; El-Gengehe, Ahmed T; Abdel-Latif, Ahmed

    2016-01-01

    Endothelial progenitor cells (EPCs) and circulating endothelial cells (CECs) are mobilized from the bone marrow and increase in the early phase after ST-elevation myocardial infarction (STEMI). The aim of this study was to assess the prognostic significance of CECs and indices of endothelial dysfunction in patients with STEMI. In 78 patients with acute STEMI, characterization of CD34+/VEGFR2+ CECs, and indices of endothelial damage/dysfunction such as brachial artery flow mediated dilatation (FMD) were determined. Blood samples for CECs assessment and quantification were obtained within 24 hours of admission and FMD was assessed during the index hospitalization. At 30 days follow up, the primary composite end point of major cardiac adverse events (MACE) consisting of all-cause mortality, recurrent non-fatal MI, or heart failure and the secondary endpoint of early adverse left ventricular (LV) remodeling were analyzed. The 17 patients (22%) who developed MACE had significantly higher CEC level (P = 0.004), vWF level (P =0.028), and significantly lower FMD (P = 0.006) compared to the remaining patients. Logistic regression analysis showed that CECs level and LV ejection fraction were independent predictors of MACE. The areas under the receiver operating characteristic curves (ROC) for CEC level, FMD, and the logistic model with both markers were 0.73, 0.75, and 0.82 respectively for prediction of the MACE. The 16 patients who developed the secondary endpoint had significantly higher CEC level compared to remaining patients (p =0.038). In conclusion, increased circulating endothelial cells and endothelial dysfunction predicted the occurrence of major adverse cardiac events and adverse cardiac remodeling in patients with STEMI. PMID:26864952

  4. Antiretroviral Drugs and Risk of Chronic Alanine Aminotransferase Elevation in Human Immunodeficiency Virus (HIV)-Monoinfected Persons: The Data Collection on Adverse Events of Anti-HIV Drugs Study

    PubMed Central

    Kovari, Helen; Sabin, Caroline A.; Ledergerber, Bruno; Ryom, Lene; Reiss, Peter; Law, Matthew; Pradier, Christian; Dabis, Francois; d'Arminio Monforte, Antonella; Smith, Colette; de Wit, Stephane; Kirk, Ole; Lundgren, Jens D.; Weber, Rainer

    2016-01-01

    Background. Although human immunodeficiency virus (HIV)-positive persons on antiretroviral therapy (ART) frequently have chronic liver enzyme elevation (cLEE), the underlying cause is often unclear. Methods. Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study participants without chronic viral hepatitis were observed to the earliest of cLEE (elevated aminotransferase ≥6 months), death, last follow-up, or January 2, 2014. Antiretroviral treatment exposure was categorized as follows: no exposure and ongoing short- and long-term exposure (<2 or ≥2 years) after initiation. Association between development of cLEE and ART exposure was investigated using Poisson regression. Results. Among 21 485 participants observed for 105 413 person-years (PY), 6368 developed cLEE (incidence 6.04/100 PY; 95% confidence interval [CI], 5.89–6.19). Chronic liver enzyme elevation was associated with short-and long-term exposure to didanosine (<2 years rate ratio [RR] = 1.29, 95% CI, 1.11–1.49; >2 years RR = 1.26, 95% CI, 1.13–1.41); stavudine (<2 years RR = 1.51, 95% CI, 1.26–1.81; >2 years RR = 1.17, 95% CI, 1.03–1.32), and tenofovir disoproxil fumarate (<2 years RR = 1.55, 95% CI, 1.40–1.72; >2 years RR = 1.18, 95% CI, 1.05–1.32), but only short-term exposure to nevirapine (<2 years RR = 1.44, 95% CI, 1.29–1.61), efavirenz (<2 years RR = 1.14, 95% CI, 1.03–1.26), emtricitabine (<2 years RR = 1.18, 95% CI, 1.04–1.33), and atazanavir (<2 years RR = 1.20, 95% CI, 1.04–1.38). Chronic liver enzyme elevation was not associated with use of lamivudine, abacavir, and other protease inhibitors. Mortality did not differ between participants with and without cLEE. Conclusions. Although didanosine, stavudine, nevirapine, and efavirenz have been described to be hepatotoxic, we additionally observed a consistent association between tenofovir and cLEE emerging within the first 2 years after drug initiation. This novel tenofovir-cLEE signal should be

  5. 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

  6. Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy. The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain. In addition women and men were compared regarding the occurrence of adverse events. Methods Participants were recruited among patients, ages 18–65, seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 767) were randomized to one of three treatment arms 1) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249), 2) manual therapy excluding spinal manipulation (n = 258) and 3) manual therapy excluding stretching (n = 260). Treatments were provided by students in the seventh semester of total eight. Adverse events were measured with a questionnaire after each return visit and categorized in to five levels; 1) short minor, 2) long minor, 3) short moderate, 4) long moderate and 5) serious adverse events, based on the duration and/or severity of the event. Generalized estimating equations were used to examine the association between adverse event and treatments arms. Results The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events (OR = 2.19 (95% CI: 1.52-3.15)), and long moderate adverse events (OR = 2.49 (95% CI

  7. Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department

    PubMed Central

    Genco, Emma K.; Forster, Jeri E.; Flaten, Hanna; Goss, Foster; Heard, Kennon J.; Hoppe, Jason; Monte, Andrew A.

    2016-01-01

    Study objective We examine the characteristics of clinical decision support alerts triggered when opioids are prescribed, including alert type, override rates, adverse drug events associated with opioids, and preventable adverse drug events. Methods This was a retrospective chart review study assessing adverse drug event occurrences for emergency department (ED) visits in a large urban academic medical center using a commercial electronic health record system with clinical decision support. Participants include those aged 18 to 89 years who arrived to the ED every fifth day between September 2012 and January 2013. The main outcome was characteristics of opioid drug alerts, including alert type, override rates, opioid-related adverse drug events, and adverse drug event preventability by clinical decision support. Results Opioid drug alerts were more likely to be overridden than nonopioid alerts (relative risk 1.35; 95% confidence interval [CI] 1.21 to 1.50). Opioid drug-allergy alerts were twice as likely to be overridden (relative risk 2.24; 95% CI 1.74 to 2.89). Opioid duplicate therapy alerts were 1.57 times as likely to be overridden (95% CI 1.30 to 1.89). Fourteen of 4,581 patients experienced an adverse drug event (0.31%; 95% CI 0.15% to 0.47%), and 8 were due to opioids (57.1%). None of the adverse drug events were preventable by clinical decision support. However, 46 alerts were accepted for 38 patients that averted a potential adverse drug event. Overall, 98.9% of opioid alerts did not result in an actual or averted adverse drug event, and 96.3% of opioid alerts were overridden. Conclusion Overridden opioid alerts did not result in adverse drug events. Clinical decision support successfully prevented adverse drug events at the expense of generating a large volume of inconsequential alerts. To prevent 1 adverse drug event, providers dealt with more than 123 unnecessary alerts. It is essential to refine clinical decision support alerting systems to eliminate

  8. Evaluation of Late Adverse Events in Long-Term Wilms' Tumor Survivors

    SciTech Connect

    Dijk, Irma van; Oldenburger, Foppe; Cardous-Ubbink, Mathilde C.; Geenen, Maud M.

    2010-10-01

    Purpose: To evaluate the prevalence and severity of adverse events (AEs) and treatment-related risk factors in long-term Wilms' tumor (WT) survivors, with special attention to radiotherapy. Methods and Materials: The single-center study cohort consisted of 185 WT survivors treated between 1966 and 1996, who survived at least 5 years after diagnosis. All survivors were invited to a late-effects clinic for medical assessment of AEs. AEs were graded for severity in a standardized manner. Detailed radiotherapy data enabled us to calculate the equivalent dose in 2 Gy fractions (EQD{sub 2}) to compare radiation doses in a uniform way. Risk factors were evaluated with multivariate logistic regression analysis. Results: Medical follow-up was complete for 98% of survivors (median follow-up, 18.9 years; median attained age, 22.9 years); 123 survivors had 462 AEs, of which 392 had Grade 1 or 2 events. Radiotherapy to flank/abdomen increased the risk of any AE (OR, 1.08 Gy{sup -1} [CI, 1.04-1.13]). Furthermore, radiotherapy to flank/abdomen was associated with orthopedic events (OR, 1.09 Gy{sup -1} [CI, 1.05-1.13]) and second tumors (OR, 1.11 Gy{sup -1} [CI, 1.03-1.19]). Chest irradiation increased the risk of pulmonary events (OR, 1.14 Gy{sup -1} [CI, 1.06-1.21]). Both flank/abdominal and chest irradiation were associated with cardiovascular events (OR, 1.05 Gy{sup -1} [CI, 1.00-1.10], OR, 1.06 Gy{sup -1} [CI, 1.01-1.12]) and tissue hypoplasia (OR, 1.17 Gy{sup -1} [CI, 1.10-1.24], OR 1.10 Gy{sup -1} [CI, 1.03-1.18]). Conclusion: The majority of AEs, overall as well as in irradiated survivors, were mild to moderate. Nevertheless, the large amount of AEs emphasizes the importance of follow-up programs for WT survivors.

  9. Adverse Events in Connective Tissue Disease–Associated Pulmonary Arterial Hypertension

    PubMed Central

    Rhee, Rennie L.; Gabler, Nicole B.; Praestgaard, Amy; Merkel, Peter A.; Kawut, Steven M.

    2016-01-01

    Objective Patients with connective tissue disease (CTD)–associated pulmonary arterial hypertension (PAH) have a poorer prognosis compared to those with idiopathic PAH, but little is known about the differences in treatment-related adverse events (AEs) and serious adverse events (SAEs) between these groups. This study was undertaken to characterize these differences. Methods Individual patient-level data from 10 randomized controlled trials of therapies for PAH were obtained from the US Food and Drug Administration. Patients diagnosed as having either CTD-associated PAH or idiopathic PAH were included. A treatment-by-diagnosis interaction term was used to examine whether the effect of treatment on occurrence of AEs differed between patients with CTD-associated PAH and those with idiopathic PAH. Studies were pooled using fixed-effect models. Results The study sample included 2,370 participants: 716 with CTD-associated PAH and 1,654 with idiopathic PAH. In the active treatment group compared to the placebo group, the risk of AEs was higher among patients with CTD-associated PAH than among those with idiopathic PAH (odds ratio [OR] 1.57, 95% confidence interval [95% CI] 1.00–2.47 versus OR 0.94, 95% CI 0.69–1.26; P for interaction = 0.061), but there was no difference in the risk of SAEs in analyses adjusted for age, race, sex, hemodynamic findings, and laboratory values. Despite the higher occurrence of AEs in patients with CTD-associated PAH assigned to active therapy compared to those receiving placebo, the risk of drug discontinuation due to an AE was similar to that in patients with idiopathic PAH assigned to active therapy (P for interaction = 0.27). Conclusion Patients with CTD-associated PAH experienced more treatment-related AEs compared to those with idiopathic PAH in therapeutic clinical trials. These findings suggest that the overall benefit of advanced therapies for PAH may be attenuated by the greater frequency of AEs. PMID:26016953

  10. Understanding How to Prevent and Treat Adverse Events of Fillers and Neuromodulators

    PubMed Central

    2016-01-01

    Summary: Experience teaches cosmetic surgeons to become good, but avoiding and treating adverse events make them great. In no area is this more true than in cosmetic procedures involving fillers and neuromodulators. By utilizing knowledge of materials and anatomy involved, specialists seek to avoid complications. A well-trained physician is able to reduce the sequelae from an adverse event by acting promptly using algorithms and a methodical approach to treatments. In this article I discuss the difference between perceived and true complications from fillers and neuromodulators, how to avoid, what to look for and how to treat to provide patients with the best possible outcomes, and make the physicians life less stressful. PMID:28018772

  11. Challenges in disclosure of adverse events and errors in surgery; perspectives from sub-Saharan Africa.

    PubMed

    Ibrahim, Abdulrasheed; Garba, Ekundayo Stephen; Asuku, Malachy Eneye

    2012-01-01

    Surgery in sub-Saharan Africa is widely known to be done against a background of poverty and illiteracy, late presentation with complicated pathologies, and a desperate lack of infrastructure. In addition, patient autonomy and self determination are highly flavored by cultural practices and religious beliefs. Any of these factors can influence the pattern and disclosure of adverse events and errors. The impact of these in the relationships between surgeons and patients, and between health institutions and patients must be considered as it may affect disclosure and response to errors. This article identifies the peculiar socioeconomic and cultural challenges that may hinder disclosure and proposes strategies for instituting disclosure of errors and adverse events services in Sub-Saharan Africa.

  12. Amenorrhea as a rare drug-related adverse event associated with everolimus for pancreatic neuroendocrine tumors.

    PubMed

    Kawaguchi, Yoshiaki; Maruno, Atsuko; Kawashima, Yohei; Ito, Hiroyuki; Ogawa, Masami; Mine, Tetsuya

    2014-11-14

    The patient was an asymptomatic 43-year-old woman. Abdominal ultrasonography and enhanced computed tomography showed a tumor lesion accompanied by multiple cystic changes in the liver and the pancreatic tail. Endoscopic ultrasound-fine needle aspiration was performed on the pancreatic tumor lesion and revealed pancreatic neuroendocrine tumor (PNET). As it was unresectable due to multiple liver metastases, the decision was made to initiate treatment with everolimus and transcatheter arterial chemoembolization. The patient ceased menstruating after the start of everolimus administration. When the administration was discontinued due to interstitial lung disease, menstruation resumed, but then again stopped with everolimus resumption. An association between everolimus and amenorrhea was highly suspected. Amenorrhea occurred as a rare adverse event of everolimus. As the younger women might be included in PNETs patients, we should put this adverse event into consideration.

  13. Adverse events associated with ephedrine-containing products--Texas, December 1993-September 1995.

    PubMed

    1996-08-16

    During December 1993-September 1995, the Bureau of Food and Drug Safety, Texas Department of Health (TDH), received approximately 500 reports of adverse events in persons who consumed dietary supplement products containing ephedrine and associated alkaloids (pseudoephedrine, norephedrine, and N-methyl ephedrine). This total included reports by individuals and reports identified by the Bureau of Epidemiology, TDH, in a review of records from the six centers of the Texas Poison Center Network. Reported adverse events ranged in severity from tremor and headache to death in eight ephedrine users and included reports of stroke, myocardial infarction, chest pain, seizures, insomnia, nausea and vomiting, fatigue, and dizziness. Seven of the eight reported fatalities were attributed to myocardial infarction or cerebrovascular accident. This report describes three patients in which the recommended dosage for the dietary supplements reportedly was not exceeded, summarizes results from ongoing investigations, and underscores the potential health risks associated with the use of products containing ephedrine.

  14. Managing adverse events associated with vismodegib in the treatment of basal cell carcinoma.

    PubMed

    Fife, Kate; Herd, Robert; Lalondrelle, Susan; Plummer, Ruth; Strong, Amy; Jones, Sarah; Lear, John T

    2017-01-01

    Basal cell carcinomas are the most common form of skin cancer. Some develop into advanced cases not suitable for standard therapy. Vismodegib is the first-in-class oral hedgehog pathway inhibitor (which is dysregulated in 90% of basal cell carcinomas), and has demonstrated efficacy for advanced disease in clinical trials. An UK expert panel met to discuss management strategies for adverse events associated with vismodegib (most commonly taste disturbances, muscle cramps and alopecia). Managing patient expectations and implementing treatment breaks were considered important strategies. Quinine was useful to alleviate muscle cramps. For taste disturbances, food swaps alongside dietician referral were suggested. The experts concluded that these common adverse events can be successfully managed to allow optimum treatment duration of vismodegib.

  15. 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

  16. Impact of Adverse Events Following Immunization in Viet Nam in 2013 on chronic hepatitis B infection.

    PubMed

    Li, Xi; Wiesen, Eric; Diorditsa, Sergey; Toda, Kohei; Duong, Thi Hong; Nguyen, Lien Huong; Nguyen, Van Cuong; Nguyen, Tran Hien

    2016-02-03

    Adverse Events Following Immunization in Viet Nam in 2013 led to substantial reductions in hepatitis B vaccination coverage (both the birth dose and the three-dose series). In order to estimate the impact of the reduction in vaccination coverage on hepatitis B transmission and future mortality, a widely-used mathematical model was applied to the data from Viet Nam. Using the model, we estimated the number of chronic infections and deaths that are expected to occur in the birth cohort in 2013 and the number of excessive infections and deaths attributable to the drop in immunization coverage in 2013. An excess of 90,137 chronic infections and 17,456 future deaths were estimated to occur in the 2013 birth cohort due to the drop in vaccination coverage. This analysis highlights the importance of maintaining high vaccination coverage and swiftly responding to reported Adverse Events Following Immunization in order to regain consumer confidence in the hepatitis B vaccine.

  17. Data mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination.

    PubMed

    Niu, M T; Erwin, D E; Braun, M M

    2001-09-14

    The Vaccine Adverse Event Reporting System (VAERS) is the US passive surveillance system monitoring vaccine safety. A major limitation of VAERS is the lack of denominator data (number of doses of administered vaccine), an element necessary for calculating reporting rates. Empirical Bayesian data mining, a data analysis method, utilizes the number of events reported for each vaccine and statistically screens the database for higher than expected vaccine-event combinations signaling a potential vaccine-associated event. This is the first study of data mining in VAERS designed to test the utility of this method to detect retrospectively a known side effect of vaccination-intussusception following rotavirus (RV) vaccine. From October 1998 to December 1999, 112 cases of intussusception were reported. The data mining method was able to detect a signal for RV-intussusception in February 1999 when only four cases were reported. These results demonstrate the utility of data mining to detect significant vaccine-associated events at early date. Data mining appears to be an efficient and effective computer-based program that may enhance early detection of adverse events in passive surveillance systems.

  18. Cumulative adversity and depressive symptoms among older adults in Israel: the differential roles of self-oriented versus other-oriented events of potential trauma

    PubMed Central

    Shmotkin, Dov; Litwin, Howard

    2013-01-01

    Background The study examined the association between cumulative adversity and current depressive symptoms in a national sample of Israelis aged 50+. Referring to cumulative adversity as exposure to potentially traumatic events along life, the study distinguished between events primarily inflicted upon the self (self-oriented adversity) versus upon another person (other-oriented adversity). Method Data were drawn from the Israeli component of the Survey of Health, Aging and Retirement in Europe (SHARE). During 2005–2006, 1710 Jews and Arabs completed an inventory of potentially traumatic events and two measures of depressive symptoms: the European Depression scale (Euro-D) and the Adapted Center for Epidemiological Studies—Depression scale (ACES-D). The Euro-D is more detailed in querying cognitions and motivations while the ACES-D is more detailed in querying feelings and social alienation. Results In line with the hypothesis, self-oriented adversity had a positive association with depressive symptoms whereas other-oriented adversity had either no association or an inverse association with depressive symptoms. Sociodemographic characteristics and perceived health were controlled in the multivariate regressions. Conclusions The differential association of self- versus other-oriented adversity with depressive symptoms may be explained in terms of social commitments that are inherent in other-oriented adversity and incompatible with depressive symptoms. The study points to the variations in the symptom compositions represented by the Euro-D and ACES-D, with the latter better capturing the difference between self- and other-oriented adversities. PMID:19288036

  19. Measuring Adverse Drug Events on Hospital Medicine Units with the Institute for Healthcare Improvement Trigger Tool: A Chart Review

    PubMed Central

    Lau, Iris; Kirkwood, Allison

    2014-01-01

    Background: An adverse drug event (ADE) is a noxious, unintended response to a drug, occurring at doses used in humans for prophylaxis, diagnosis, or treatment of disease or for modification of physiological function. ADEs account for about one-quarter of all adverse events in Canadian hospitals. Canadian data on specific types of ADEs and commonly implicated drugs are lacking. In particular, there is a paucity of data on ADEs that occur during hospital admissions. Objectives: The primary objective was to identify the incidence of ADEs in a sample of adult general medicine inpatients over a 1-year period. The secondary objective was to identify the 5 drugs most frequently responsible for ADEs in this setting. Methods: A retrospective chart analysis was conducted for general medicine patients discharged from St Paul’s Hospital in Vancouver, British Columbia, from January to December 2011. ADEs were identified using the Institute for Healthcare Improvement (IHI) Trigger Tool for Measuring Adverse Drug Events. The Naranjo criteria were applied to assess causality, and a physician independently authenticated the ADEs for preventability and harm using the categories of harm set out by the US National Coordinating Council for Medication Error Reporting and Prevention. Results: Of the 204 patient encounters reviewed, 15 involved ADEs, which represented an incidence of 7% over the 1-year study period. The 5 drugs most frequently implicated in ADEs were vancomycin, ciprofloxacin, ceftriaxone, piperacillin–tazobactam, and moxifloxacin. Conclusions: The rate of ADEs during hospital admissions was substantial. These events may necessitate additional investigations and interventions and may prolong the hospital stay. The authors do not recommend the IHI Trigger Tool for Measuring Adverse Drug Events for efficient prospective detection of ADEs in manual chart reviews. Possible modifications to improve the utility of this tool might include incorporating it into a compatible

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

    PubMed

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

    2003-01-01

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

  1. Novel data-mining methodologies for adverse drug event discovery and analysis.

    PubMed

    Harpaz, R; DuMouchel, W; Shah, N H; Madigan, D; Ryan, P; Friedman, C

    2012-06-01

    An important goal of the health system is to identify new adverse drug events (ADEs) in the postapproval period. Datamining methods that can transform data into meaningful knowledge to inform patient safety have proven essential for this purpose. New opportunities have emerged to harness data sources that have not been used within the traditional framework. This article provides an overview of recent methodological innovations and data sources used to support ADE discovery and analysis.

  2. Novel Data Mining Methodologies for Adverse Drug Event Discovery and Analysis

    PubMed Central

    Harpaz, Rave; DuMouchel, William; Shah, Nigam H.; Madigan, David; Ryan, Patrick; Friedman, Carol

    2013-01-01

    Introduction Discovery of new adverse drug events (ADEs) in the post-approval period is an important goal of the health system. Data mining methods that can transform data into meaningful knowledge to inform patient safety have proven to be essential. New opportunities have emerged to harness data sources that have not been used within the traditional framework. This article provides an overview of recent methodological innovations and data sources used in support of ADE discovery and analysis. PMID:22549283

  3. Negative Emotionality and Disconstraint Influence PTSD Symptom Course via Exposure to New Major Adverse Life Events

    PubMed Central

    Sadeh, Naomi; Miller, Mark W.; Wolf, Erika J.; Harkness, Kate L.

    2015-01-01

    Identifying the factors that influence stability and change in chronic posttraumatic stress disorder (PTSD) is important for improving clinical outcomes. Using a cross-lagged design, we analyzed the reciprocal effects of personality and PTSD symptoms over time and their effects on stress exposure in a sample of 222 trauma-exposed veterans (ages 23 – 68; 90.5% male). Personality functioning and PTSD were measured approximately 4 years apart, and self-reported exposure to major adverse life events during the interim was also assessed. Negative emotionality positively predicted future PTSD symptoms, and this effect was partially mediated by exposure to new events. Constraint (negatively) indirectly affected PTSD via its association with exposure to new events. There were no significant effects of positive emotionality nor did PTSD symptom severity exert influences on personality over time. Results indicate that high negative affect and disconstraint influence the course of PTSD symptoms by increasing exposure to stressful life events. PMID:25659969

  4. Integrated Analysis of Genetic and Proteomic Data Identifies Biomarkers Associated with Adverse Events Following Smallpox Vaccination

    EPA Science Inventory

    Complex clinical outcomes, such as adverse reaction to vaccination, arise from the concerted interactions among the myriad components of a biological system. Therefore, comprehensive etiological models can be developed only through the integrated study of multiple types of experi...

  5. Risk factors for treatment-related adverse events in cancer-bearing dogs receiving piroxicam.

    PubMed

    Eichstadt, L R; Moore, G E; Childress, M O

    2016-10-06

    Piroxicam has antitumour effects in dogs with cancer, although side effects may limit its use. The purpose of this study was to retrospectively identify factors predisposing cancer-bearing dogs to adverse events (AEs) following piroxicam therapy. Medical records of dogs presented to the Purdue Veterinary Teaching Hospital between 2005 and 2015 were reviewed, and 137 dogs met the criteria for study inclusion. Toxic effects of piroxicam in these dogs were graded according to an established system. Multivariate logistic regression was used to estimate the extent to which certain factors affected the risk for AEs. Age [odds ratio (OR) 1.250, P = 0.009; 95% confidence interval (CI) 1.057-1.479] and concurrent use of gastroprotectant medications (OR 2.612, P = 0.025; 95% CI 1.127-6.056) significantly increased the risk for gastrointestinal AEs. The results of this study may help inform the risk versus benefit calculation for clinicians considering the use of piroxicam to treat dogs with cancer.

  6. Surveillance of methadone-related adverse drug events using multiple public health data sources.

    PubMed

    Sims, Shannon A; Snow, Laverne A; Porucznik, Christina A

    2007-08-01

    Healthcare safety and quality surveillance is increasingly conducted by public health agencies. We describe a biomedical informatics method that uses multiple public health data sources to perform surveillance of methadone-related adverse drug events. Data from Utah medical examiner records, vital statistics, emergency department encounter administrative data and a database of controlled substances prescriptions are used to examine trends in state-wide adverse events related to methadone. From 1997 to 2004, population-adjusted methadone prescriptions increased 727%, with evidence to suggest the rise in the methadone prescription rate is for treatment of pain, not addiction therapy. During the same period of time, population adjusted, accidental methadone-related deaths in medical examiner data increased 1770%. Population adjusted methadone-related emergency department encounters rose 612% from 1997 to 2003. Our results suggest that the increase in methadone prescription rates from 1997 to 2004 was accompanied by a concurrent increase in methadone-related morbidity and mortality. Although patient data is not linked between data sources, our results demonstrate that utilizing multiple public health data sources captures more cases and provides more clinical detail than individual data sources alone. Our approach is a successful biomedical informatics approach for surveillance of adverse events and utilizes widely available public health data sources, as well as an emerging source of public health data, controlled substance prescription registries.

  7. Using Temporal Patterns in Medical Records to Discern Adverse Drug Events from Indications

    PubMed Central

    Liu, Yi; LePendu, Paea; Iyer, Srinivasan; Shah, Nigam H.

    2012-01-01

    Researchers estimate that electronic health record systems record roughly 2-million ambulatory adverse drug events and that patients suffer from adverse drug events in roughly 30% of hospital stays. Some have used structured databases of patient medical records and health insurance claims recently—going beyond the current paradigm of using spontaneous reporting systems like AERS—to detect drug-safety signals. However, most efforts do not use the free-text from clinical notes in monitoring for drug-safety signals. We hypothesize that drug–disease co-occurrences, extracted from ontology-based annotations of the clinical notes, can be examined for statistical enrichment and used for drug safety surveillance. When analyzing such co-occurrences of drugs and diseases, one major challenge is to differentiate whether the disease in a drug–disease pair represents an indication or an adverse event. We demonstrate that it is possible to make this distinction by combining the frequency distribution of the drug, the disease, and the drug-disease pair as well as the temporal ordering of the drugs and diseases in each pair across more than one million patients. PMID:22779050

  8. An update on predictive biomarkers for major adverse cardiovascular events in patients undergoing vascular surgery.

    PubMed

    Patelis, Nikolaos; Kouvelos, George N; Koutsoumpelis, Andreas; Moris, Demetrios; Matsagkas, Miltiadis I; Arnaoutoglou, Eleni

    2016-09-01

    Cardiovascular complications signify a major cause of morbidity and mortality in patients undergoing vascular surgery adversely affecting both short- and long-term prognosis. During the last decade, unmet needs for a distinct cardiovascular risk assessment have led to an intensive research for establishment of biomarkers with sufficient predictive value. This literature review aims in examining the value of several biomarkers in predicting the incidence of major adverse cardiac events in vascular surgery patients. We reviewed the English language literature and analyzed the biomarkers as independent predictors or in correlation with other factors. We found several biomarkers showing a significant predictive value for a major adverse cardiovascular event in patients undergoing vascular surgery. These biomarkers can be used in clinical practice as outcome predictors, although sensitivity and specificity varies. Detection of subclinical cardiovascular damage may improve total risk estimation and facilitate clinical assessment of patients at risk for future cardiovascular events. The wide variety of sensitivity and specificity in predicting a MACE of these biomarkers exert the need for future trials in which these markers will be tested as adjunctive tools of cardiovascular risk estimation scoring systems.

  9. Photoselective vaporization of the prostate: outcomes and adverse events of 220 consecutive patients

    NASA Astrophysics Data System (ADS)

    Robson, C.; Mueller, E. J.

    2010-02-01

    Purpose: To evaluate the short term outcomes of 220 consecutive patients who underwent the 532 nm KTP photoselective vaporization of the prostate (PVP) procedure and to evaluate and categorize the complications of the procedure. Materials and Methods: A total of 220 patients with symptomatic benign prostatic obstruction were treated with KTP photoselective vaporization of the prostate. Evaluation measures included the AUA Symptom Score (AUASS)/Quality of Life Score (QOL), peak urinary flow rate (Qmax), post void residual urine (PVR) and adverse events. Results: Symptoms were evaluated at 3 months and adverse events at 1 and 3 months. 181 patients returned for their 1 month visit and 152 returned for their 3 month visit. The American Urological Association Symptom Score (AUASS) decreased from 21.8 to 6.7. The Quality of Life Score (QOL) decreased from 3.8 to 0.7. The peak urinary flow rate (Qmax) increased from 10.7 cc/sec to 22.7 cc/sec. And the post void residual urine (PVR) decreased from 262 cc to 105 cc. Most common adverse events lasting more than 10 days were mild hematuria in 45%, dysuria in 32%, and urgency/frequency in31%. Conclusion: These results confirm that photoselective vaporization of the prostate (PVP) is a safe and effective therapy for benign prostatic obstruction. However, there is frequent, but mild, hematuria and irritative voiding symptoms during the early postoperative period.

  10. Adverse events from spinal manipulation in the pregnant and postpartum periods: a critical review of the literature

    PubMed Central

    2012-01-01

    Background The safety of spinal manipulation during pregnancy and the postpartum periods has been a matter of debate among manual therapists. Spinal manipulative therapy during these periods is a commonly performed intervention as musculoskeletal pain is common in these patients. To date there has not been an evaluation of the literature on this topic exclusively. Methods A literature search was conducted on PubMed, CINAHL and the Index to Chiropractic Literature along with reference searching for articles published in English and French in the peer-reviewed literature that documented adverse effects of spinal manipulation during either pregnancy or postpartum. Case reports, case series, and any other clinical study designs were deemed acceptable for inclusion, as were systematic reviews. The appropriate Scottish Intercollegiate Guidelines Network (SIGN) tools were used to rate included articles for quality when applicable. Results Five articles identifying adverse events in seven subjects following spinal manipulation were included in this review, along with two systematic reviews. The articles were published between 1978 and 2009. Two articles describing adverse effects from spinal manipulation on two postpartum patients were included, while the remaining three articles on five patients with adverse effects following spinal manipulation were on pregnant patients. Injury severity ranged from minor injury such as increasing pain after treatment that resolved within a few days to more severe injuries including fracture, stroke, and epidural hematoma. SIGN scores of the prospective observational cohort study and systematic reviews indicated acceptable quality. Conclusions There are only a few reported cases of adverse events following spinal manipulation during pregnancy and the postpartum period identified in the literature. While improved reporting of such events is required in the future, it may be that such injuries are relatively rare. PMID:22455720

  11. Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children.

    PubMed

    Tseng, Hung Fu; Sy, Lina S; Liu, In-Lu Amy; Qian, Lei; Marcy, S Michael; Weintraub, Eric; Yih, Katherine; Baxter, Roger; Glanz, Jason M; Donahue, James; Naleway, Allison; Nordin, James; Jacobsen, Steven J

    2013-05-24

    Although no increased risk was detected for serious adverse events in the prelicensure trials for the 13-valent pneumococcal vaccine, Prevnar 13(®) (PCV13), continued monitoring of rare but serious adverse events is necessary. A surveillance system using cohort study design was set up to monitor safety of PCV13 immediately after it was included in the childhood immunization program in the United States. The exposed population included children of 1 month to 2 years old who received PCV13 from April, 2010 to January, 2012 from the eight managed care organizations participating in the Vaccine Safety Datalink Project in the United States. The historical unexposed population was children of the same age who received the 7-valent pneumococcal conjugate vaccine Prevnar 7(®) (PCV7) in 2007 (or 2005 depending on the outcome of interest) to 2009. The risk of pre-specified adverse events in the risk window following PCV13 was repeatedly compared to that in the historical comparison group. The number of doses included in the study was 599,229. No increased risk was found for febrile seizures, urticaria or angioneurotic edema, asthma, thrombocytopenia, or anaphylaxis. An increased risk for encephalopathy was not confirmed following the medical record review. The relative risk for Kawasaki disease in 0-28 days following vaccination was 1.94 (95% confidence interval: 0.79-4.86), comparing PCV13 to PCV7. Comparing to PCV7 vaccine, we identified no significant increased risk of pre-specified adverse events in the Vaccine Safety Datalink study cohort. The possible association between PCV13 and Kawasaki disease may deserve further investigation.

  12. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

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

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

    PubMed

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

    2007-04-30

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

  14. 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

  15. Methemoglobinemia and adverse events in Plasmodium vivax malaria patients associated with high doses of primaquine treatment.

    PubMed

    Carmona-Fonseca, Jaime; Alvarez, Gonzalo; Maestre, Amanda

    2009-02-01

    Primaquine (PQ) is recommended to prevent relapses in patients with Plasmodium vivax malaria infection. However, treatment with PQ causes methemoglobinemia. In this study, we measured the methemoglobin (MetHB) levels in three groups of subjects who received PQ treatment at 0.58, 0.83, or 1.17 mg/kg/d. A total of 112 subjects were studied. MetHB levels were detected at > or = 4% in 46-50% 1 day after PQ treatment in all three groups and 4-9% of subjects had MetHB levels > or = 4% 15 days after treatment. Only subjects receiving the highest doses of PQ had mild and brief adverse events, and 17% of them were associated with treatment. We conclude that when PQ is administered under certain conditions (i.e., normal glucose-6-phosphate dehydrogenase activity, in non-pregnant subjects and with a light meal), daily doses as high as 1.17 mg/kg do not represent a serious risk of high MetHB levels to patients.

  16. Clinical predictors of thiopurine-related adverse events in Crohn's disease

    PubMed Central

    Moran, Gordon W; Dubeau, Marie-France; Kaplan, Gilaad G; Yang, Hong; Eksteen, Bertus; Ghosh, Subrata; Panaccione, Remo

    2015-01-01

    AIM: To determine the incidence and predictors of thiopurine-related adverse events. METHODS: Subjects with Crohn’s disease who were followed in the Alberta Inflammatory Bowel Disease Consortium patient database registry were identified. Retrospective chart review was conducted between August 5th, 2010 and June 1st, 2012. We collected data on: age at diagnosis; sex; disease location and behaviour at time of prescribing thiopurine; perianal fistulising disease at or prior to thiopurine prescription; smoking status at time of thiopurine prescription, use of corticosteroid within 6 mo of diagnosis; dosage, age at onset, and cessation of 5-aminosalicyclic acid (5-ASA); anti-tumour necrosis factor medication exposure and intestinal resection before thiopurine prescription. The primary outcome of interest was the first adverse event that led to discontinuation of the first thiopurine medication used. Logistic regression models were used to associate clinical characteristics with outcomes after adjusting for potential confounders. Risk estimates were presented as odds ratios (OR) with 95% CI. Effect modification by age and sex were explored. RESULTS: Our cohort had a median follow-up duration of 5.8 years [interquartile range (IQR 25th-75th) 2.7-9.1]. Thiopurine therapy was discontinued in 31.3% of patients because of: hypersensitivity reactions (7.1%), acute pancreatitis (6.2%), gastrointestinal intolerance (5.4%), leucopenia (3.7%), hepatotoxicity (3.4%), infection (1.1%) and other reasons (4.3%). A higher incidence of thiopurine withdrawal was observed in patients over the age of 40 (39.4%, P = 0.007). A sex-by-age interaction (P = 0.04) was observed. Females older than 40 years of age had an increased risk of thiopurine discontinuation due to an adverse event (age above 40 vs age below 40, adjusted OR = 2.8; 95%CI: 1.4-5.6). In contrast, age did not influence thiopurine withdrawal in males (age above 40 vs below 40, adjusted OR = 0.9; 95%CI: 0.4-2.1). Other clinical

  17. Is detection of adverse events affected by record review methodology? an evaluation of the “Harvard Medical Practice Study” method and the “Global Trigger Tool”

    PubMed Central

    2013-01-01

    Background There has been a theoretical debate as to which retrospective record review method is the most valid, reliable, cost efficient and feasible for detecting adverse events. The aim of the present study was to evaluate the feasibility and capability of two common retrospective record review methods, the “Harvard Medical Practice Study” method and the “Global Trigger Tool” in detecting adverse events in adult orthopaedic inpatients. Methods We performed a three-stage structured retrospective record review process in a random sample of 350 orthopaedic admissions during 2009 at a Swedish university hospital. Two teams comprised each of a registered nurse and two physicians were assigned, one to each method. All records were primarily reviewed by registered nurses. Records containing a potential adverse event were forwarded to physicians for review in stage 2. Physicians made an independent review regarding, for example, healthcare causation, preventability and severity. In the third review stage all adverse events that were found with the two methods together were compared and all discrepancies after review stage 2 were analysed. Events that had not been identified by one of the methods in the first two review stages were reviewed by the respective physicians. Results Altogether, 160 different adverse events were identified in 105 (30.0%) of the 350 records with both methods combined. The “Harvard Medical Practice Study” method identified 155 of the 160 (96.9%, 95% CI: 92.9-99.0) adverse events in 104 (29.7%) records compared with 137 (85.6%, 95% CI: 79.2-90.7) adverse events in 98 (28.0%) records using the “Global Trigger Tool”. Adverse events “causing harm without permanent disability” accounted for most of the observed difference. The overall positive predictive value for criteria and triggers using the “Harvard Medical Practice Study” method and the “Global Trigger Tool” was 40.3% and 30.4%, respectively. Conclusions More adverse

  18. Knowledge-based extraction of adverse drug events from biomedical text

    PubMed Central

    2014-01-01

    Background Many biomedical relation extraction systems are machine-learning based and have to be trained on large annotated corpora that are expensive and cumbersome to construct. We developed a knowledge-based relation extraction system that requires minimal training data, and applied the system for the extraction of adverse drug events from biomedical text. The system consists of a concept recognition module that identifies drugs and adverse effects in sentences, and a knowledge-base module that establishes whether a relation exists between the recognized concepts. The knowledge base was filled with information from the Unified Medical Language System. The performance of the system was evaluated on the ADE corpus, consisting of 1644 abstracts with manually annotated adverse drug events. Fifty abstracts were used for training, the remaining abstracts were used for testing. Results The knowledge-based system obtained an F-score of 50.5%, which was 34.4 percentage points better than the co-occurrence baseline. Increasing the training set to 400 abstracts improved the F-score to 54.3%. When the system was compared with a machine-learning system, jSRE, on a subset of the sentences in the ADE corpus, our knowledge-based system achieved an F-score that is 7 percentage points higher than the F-score of jSRE trained on 50 abstracts, and still 2 percentage points higher than jSRE trained on 90% of the corpus. Conclusion A knowledge-based approach can be successfully used to extract adverse drug events from biomedical text without need for a large training set. Whether use of a knowledge base is equally advantageous for other biomedical relation-extraction tasks remains to be investigated. PMID:24593054

  19. Single center experience on dosing and adverse events of recombinant factor seven use for bleeding after congenital heart surgery

    PubMed Central

    Kurkluoglu, Mustafa; Engle, Alyson M.; Costello, John P.; Hibino, Narutoshi; Zurakowski, David; Jonas, Richard A.; Berger, John T.; Nath, Dilip S.

    2014-01-01

    There are limited data on the relationship between the administered dose of recombinant factor seven (rFVIIa) and the development of adverse clinical outcomes after congenital heart surgery. This single institution case series reports on dosing, adverse events, and blood product usage after the administration of rFVIIa in the congenital heart surgery patient population. A retrospective review identified 16 consecutive pediatric patients at an academic, free-standing, children’s hospital who received rFVIIa to curtail bleeding following congenital heart surgery between April 2004 and June 2012. Patients were assessed for survival to hospital discharge versus in-hospital mortality and the presence or absence of a major neurological event during inpatient hospitalization. The median age at surgery was 6.8 months (range: 3 days–42 years). Seven patients (44%) survived to hospital discharge and nine patients (56%) died. The cause of mortality included major neurological events (44%), uncontrolled bleeding (33%), and sepsis (23%). Eight patients (50%) required extracorporeal membrane oxygenation support following congenital heart surgery. The median cumulative rFVIIa dose administered was 97 mcg/kg, and the median cumulative amount of blood products administered was 452 ml/kg. In conclusion, this case series underscores the need to prospectively evaluate the effect that rFVIIa has on patient survival and the incidence of adverse events, including thrombotic and major neurological events, in congenital heart surgery patients. Ideally, a randomized, multicenter study would provide the sufficient numbers of patients and events to test these relationships. PMID:25544818

  20. Family medicine residents’ risk of adverse motor vehicle events: a comparison between rural and urban placements

    PubMed Central

    Janke, Fred; Dobbs, Bonnie; McKay, Rhianne; Linsdell, Meghan; Babenko, Oksana

    2013-01-01

    Background Sleep deprivation and fatigue are associated with long and irregular work hours. These work patterns are common to medical residents. Motor vehicle crashes (MVCs) are a leading cause of injury related deaths in Canada, with MVC fatality rates in rural areas up to three times higher than in urban areas. Objectives To: 1) examine the number of adverse motor vehicle events (AMVEs) in family medicine residents in Canada; 2) assess whether residents with rural placements are at greater risk of experiencing AMVEs than urban residents; and 3) determine if family medicine residency programs across Canada have travel policies in place. Methodology A prospective, cross-sectional study, using a national survey of second-year family medicine residents. Results A higher percentage of rural residents reported AMVEs than urban residents. The trend was for rural residents to be involved in more MVCs during residency, while urban residents were more likely to be involved in close calls. The majority of Canadian medical schools do not have resident travel policies in place. Conclusion AMVEs are common in family medicine residents, with a trend for the number of MVCs to be greater for rural residents. These data support the need for development and incorporation of travel policies by medical schools. PMID:26451211

  1. Assessment of three systems to empower the patient and decrease the risk of adverse drug events.

    PubMed

    Lawton, Kitta; Skjoet, Peter

    2011-01-01

    One way to reduce adverse drug events (ADEs) is to empower the patient to participate in the control of medication. This empowerment can be supported in different ways by making knowledge and information available to the patient. This study examines the usefulness and safety of two different systems on the background of a paper-based medication list presenting prescribed medicine presently used in hospitals in Copenhagen. Each of the systems examined aims to reduce ADEs but presents information in different levels of detail, and anticipates different level of prior knowledge from the patient: a Web-based prototype presenting medication, lab-results and alerts, and a cell phone-based prototype presenting alerts. Six patients were introduced to each of the systems by performing small tasks and subsequently interviewed. The patients found the paper-based medication list useful and comprehensive for control of own prescribed medication. The Web-based prototype also proved to be useful, but drug and lab values were hard to correlate, and the alerts were hard to understand. The cell phone-based prototype proved less useful as the patients were challenged to vision the applicability of the system. Furthermore, it is a safety issue that the information the alert is based upon, stems from the patient alone. We conclude that, in order for the Web-based system as well as the cell phone system to empower patient and increase patient safety, further development of the systems is necessary.

  2. Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials

    PubMed Central

    Federer, Callie; Yoo, Minjae

    2016-01-01

    Abstract Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov (https://clinicaltrials.gov/), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov. Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs. PMID:27631620

  3. Relationship between dose of antithyroid drugs and adverse events in pediatric patients with Graves’ disease

    PubMed Central

    Yasuda, Kie; Miyoshi, Yoko; Tachibana, Makiko; Namba, Noriyuki; Miki, Kazunori; Nakata, Yukiko; Takano, Toru; Ozono, Keiichi

    2017-01-01

    Abstract. Graves’ disease (GD) accounts for a large proportion of pediatric hyperthyroidism, and the first-line treatment is antithyroid drug (ATD) therapy. Methimazole (MMI) is effective in most patients but is associated with significant adverse events (AEs). We reviewed the medical records of GD patients (n = 56) with onset age of <15 yr and investigated the relationship between MMI dose and AEs. The study population comprised 11 male and 45 female patients and the median age at diagnosis was 11 yr. All patients were initially treated with ATDs. Among the 52 patients initially treated with MMI, 20 received a low dose, and 32 received a high dose of MMI (< 0.7 vs ≥ 0.7 mg/kg/day, respectively). AEs occurred in 20% of the patients in the low-dose MMI group, and in 50% patients in the high-dose MMI group (p = 0.031). A greater variety of AEs was observed in the high-dose group. Neutropenia and rash were observed in both groups. With treatment transition to low-dose MMI according to the Japanese Society for Pediatric Endocrinology guidelines, we expect a decrease in the incidence of AEs in future. However, we should be careful as neutropenia and rash can occur independently of the MMI dose. PMID:28203042

  4. Adverse Events in Treating Smear-Positive Tuberculosis Patients in China

    PubMed Central

    Zhang, Tao; Du, Jian; Yin, Xiaoyan; Xue, Fuzhong; Liu, Yanxun; Li, Runzi; Luo, Cheng; Li, Liang; Li, Xiujun

    2015-01-01

    This study aimed to estimate the adverse events (AE) rate during anti-tuberculosis treatment and to explore AE-related risk factors. New and previously treated smear-positive tuberculosis (TB) cases were enrolled from eight regions in China between April 2009 and October 2010. The AE rate was estimated, and AE risk factors during anti-TB treatment were assessed using Cox proportional models. Among 2091 Chinese subjects with anti-TB treatment, 462 (22.1%, 95% confidence interval (CI), 20.3–23.9) patients developed AE, with liver injury and gastrointestinal reactions constituting the most common AE. Specifically, 9.8% (95% CI, 8.5–11.1) and 6.3% (95% CI, 5.3–7.4) developed liver injuries and gastrointestinal reactions, respectively. We found that AE rate differed by regions, TB knowledge score, symptoms score and smoking status. Liver injuries were associated with age, sex and smoking status; gastrointestinal reactions were associated with education level and symptom score. Improving patients’ knowledge on TB could reduce AE rate. PMID:26729141

  5. Adverse Events in Treating Smear-Positive Tuberculosis Patients in China.

    PubMed

    Zhang, Tao; Du, Jian; Yin, Xiaoyan; Xue, Fuzhong; Liu, Yanxun; Li, Runzi; Luo, Cheng; Li, Liang; Li, Xiujun

    2015-12-29

    This study aimed to estimate the adverse events (AE) rate during anti-tuberculosis treatment and to explore AE-related risk factors. New and previously treated smear-positive tuberculosis (TB) cases were enrolled from eight regions in China between April 2009 and October 2010. The AE rate was estimated, and AE risk factors during anti-TB treatment were assessed using Cox proportional models. Among 2091 Chinese subjects with anti-TB treatment, 462 (22.1%, 95% confidence interval (CI), 20.3-23.9) patients developed AE, with liver injury and gastrointestinal reactions constituting the most common AE. Specifically, 9.8% (95% CI, 8.5-11.1) and 6.3% (95% CI, 5.3-7.4) developed liver injuries and gastrointestinal reactions, respectively. We found that AE rate differed by regions, TB knowledge score, symptoms score and smoking status. Liver injuries were associated with age, sex and smoking status; gastrointestinal reactions were associated with education level and symptom score. Improving patients' knowledge on TB could reduce AE rate.

  6. Neurological adverse events associated with immune checkpoint inhibitors: Review of the literature.

    PubMed

    Cuzzubbo, S; Javeri, F; Tissier, M; Roumi, A; Barlog, C; Doridam, J; Lebbe, C; Belin, C; Ursu, R; Carpentier, A F

    2017-03-01

    Immune checkpoint inhibitors (ICIs) targeting CTLA4 and PD1 constitute a promising class of cancer treatment but are associated with several immune-related disorders. We here review the literature reporting neurological adverse events (nAEs) associated with ICIs. A systematic search of literature, up to February 2016, mentioning nAEs in patients treated with ICIs was conducted. Eligible studies included case reports and prospective trials. One case seen in our ward was also added. Within the 59 clinical trials (totalling 9208 patients) analysed, the overall incidence of nAEs was 3.8% with anti-CTLA4 antibodies, 6.1% with anti-PD1 antibodies, and 12.0% with the combination of both. The clinical spectrum of neurological disorders was highly heterogeneous. Most of these nAEs were grade 1-2 and consisted of non-specific symptoms such as headache (55%). The incidence of high grade nAEs was below 1% for all types of treatment. Headaches, encephalopathies and meningitis were the most commonly reported (21%, 19% and 15%, respectively). Among the 27 case reports, the most common nAEs were encephalopathies, meningoradiculoneuritis, Guillain-Barré like syndromes and myasthenic syndromes. The median time of nAEs onset was 6 weeks. In most cases, drug interruption and steroids led to neurological recovery, even in conditions where steroids are not usually recommended such as Guillain-Barré syndrome.

  7. Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials.

    PubMed

    Federer, Callie; Yoo, Minjae; Tan, Aik Choon

    2016-12-01

    Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov ( https://clinicaltrials.gov/ ), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov . Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs.

  8. 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.

  9. Lifespan adversity and later adulthood telomere length in the nationally representative US Health and Retirement Study

    PubMed Central

    Gemmill, Alison; Weir, David; Adler, Nancy E.; Prather, Aric A.

    2016-01-01

    Stress over the lifespan is thought to promote accelerated aging and early disease. Telomere length is a marker of cell aging that appears to be one mediator of this relationship. Telomere length is associated with early adversity and with chronic stressors in adulthood in many studies. Although cumulative lifespan adversity should have bigger impacts than single events, it is also possible that adversity in childhood has larger effects on later life health than adult stressors, as suggested by models of biological embedding in early life. No studies have examined the individual vs. cumulative effects of childhood and adulthood adversities on adult telomere length. Here, we examined the relationship between cumulative childhood and adulthood adversity, adding up a range of severe financial, traumatic, and social exposures, as well as comparing them to each other, in relation to salivary telomere length. We examined 4,598 men and women from the US Health and Retirement Study. Single adversities tended to have nonsignificant relations with telomere length. In adjusted models, lifetime cumulative adversity predicted 6% greater odds of shorter telomere length. This result was mainly due to childhood adversity. In adjusted models for cumulative childhood adversity, the occurrence of each additional childhood event predicted 11% increased odds of having short telomeres. This result appeared mainly because of social/traumatic exposures rather than financial exposures. This study suggests that the shadow of childhood adversity may reach far into later adulthood in part through cellular aging. PMID:27698131

  10. The impact of outpatient chemotherapy-related adverse events on the quality of life of breast cancer patients.

    PubMed

    Tachi, Tomoya; Teramachi, Hitomi; Tanaka, Kazuhide; Asano, Shoko; Osawa, Tomohiro; Kawashima, Azusa; Yasuda, Masahiro; Mizui, Takashi; Nakada, Takumi; Noguchi, Yoshihiro; Tsuchiya, Teruo; Goto, Chitoshi

    2015-01-01

    The objective of our study was to clarify the impact of adverse events associated with the initial course of outpatient chemotherapy on the quality of life of breast cancer patients. We conducted a survey to assess the quality of life in 48 breast cancer patients before and after receiving their first course of outpatient chemotherapy at Gifu Municipal Hospital. Patients completed the European Quality of Life 5 Dimensions and Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs before and after 1 course of outpatient chemotherapy. European Quality of Life 5 Dimensions utility value and Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs total score decreased significantly after chemotherapy (p<0.001 and p = 0.018, respectively). The mean scores for the activity, physical condition, and psychological condition subscales of the Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs decreased significantly after chemotherapy (p = 0.003, p<0.001, and p = 0.032, respectively), whereas the social relationships score increased significantly (p<0.001). Furthermore, in the evaluation of quality of life according to individual adverse events, the decrease in quality of life after chemotherapy in terms of the European Quality of Life 5 Dimensions utility value and the Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs total score was greater in anorexic patients than in non-anorexic patients (p = 0.009 and p<0.001, respectively). This suggests that anorexia greatly reduces quality of life. Our findings reveal that anticancer drug-related adverse events, particularly anorexia, reduce overall quality of life following the first course of outpatient chemotherapy in current breast cancer patients. These findings are extremely useful and important in understanding the impact of anticancer drug-related adverse events on quality of life.

  11. 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.

  12. Decreasing Adverse Events through Night Talks: An Interdisciplinary, Hospital-Based Quality Improvement Project

    PubMed Central

    White, Christine; del Rey, Javier Gonzalez

    2009-01-01

    Background: The majority of medical adverse events are secondary to errors in communication. The Joint Commission (known until 2007 as the Joint Commission on the Accreditation of Healthcare Organizations) reports that 70% of sentinel events are the result of communication failures. Review of nonperioperative adverse events at Cincinnati Children's Hospital Medical Center in 2007 found similar statistics: 57% were related to failure to recognize abnormal vital signs and to communicate or address parents’ or nurses’ concerns. Objective: To increase by 80% the number of days between near misses in pediatric neurosurgical patients because of failure to address abnormal vital signs or parents’ or nurses’ concerns during the night shift. Materials and Methods: Baseline data on near misses from the previous night were collected with the use of a written questionnaire completed the next morning by the interns, patient-care facilitators or charge nurse, and attending physicians. Laminated cards with three standardized questions were created to guide a late-evening review of patients’ status by residents, attending physicians, and nurses: the Night Talks discussion. After initiation of Night Talks, data were collected for issues addressed by Night Talks as well as for preventable adverse events. Main Outcome Measure: Number of days between near misses. Results: During a two-month period before the introduction of Night Talks, there was an average of 3.8 days between near misses on neurosurgery patients. After the initiation of Night Talks, days between near misses due to the failure to address abnormal vital signs or parents’ or nurses’ concerns increased to 201 days, a 5360% change. Conclusion: Instituting standardized Night Talks substantially reduced near misses in neurosurgical patients at our institution at night. PMID:20740098

  13. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches

    PubMed Central

    Funt, David; Pavicic, Tatjana

    2013-01-01

    Background The ever-expanding range of dermal filler products for aesthetic soft tissue augmentation is of benefit for patients and physicians, but as indications and the number of procedures performed increase, the number of complications will likely also increase. Objective To describe potential adverse events associated with dermal fillers and to provide structured and clear guidance on their treatment and avoidance. Methods Reports of dermal filler complications in the medical literature were reviewed and, based on the publications retrieved and the authors’ extensive experience, recommendations for avoiding and managing complications are provided. Results Different dermal fillers have widely varying properties, associated risks, and injection requirements. All dermal fillers have the potential to cause complications. Most are related to volume and technique, though some are associated with the material itself. The majority of adverse reactions are mild and transient, such as bruising and trauma-related edema. Serious adverse events are rare, and most are avoidable with proper planning and technique. Conclusion For optimum outcomes, aesthetic physicians should have a detailed understanding of facial anatomy; the individual characteristics of available fillers; their indications, contraindications, benefits, and drawbacks; and ways to prevent and avoid potential complications. PMID:24363560

  14. Blood rheology at term in normal pregnancy and in patients with adverse outcome events.

    PubMed

    von Tempelhoff, Georg-Friedrich; Velten, Eva; Yilmaz, Asli; Hommel, Gerhard; Heilmann, Lothar; Koscielny, Jürgen

    2009-01-01

    Plasma volume expansion of more than 1.5 l and sustainable activation of the hemostatic system that results in a steady rise of the fibrinogen/fibrin turnover are contemporary physiological events during normal pregnancy. In contrast, adverse outcome of pregnancy i.e. pre-eclampsia commonly coincide with hemo concentration and over activation of blood coagulation both of which alter blood rheology. On the basis of 4,985 consecutively recorded singleton pregnancies values range of blood rheological parameters in women with normal and complicated outcome of pregnancy at the time of their delivery were compared. Plasma viscosity (pv) was determined using KSPV 1 Fresenius and RBC aggregation (stasis: E0 and low shear: E1) using MA1-Aggregometer; Myrenne. Seventy-nine point four percent (n=3,959) had normal pregnancy outcome and 1,026 with adverse outcome of pregnancy had pre-eclampsia (8.4%; n=423), had newborn with a birth-weight < 2,500 g (9.5%; n=473), had early-birth before week 37 (9.3%; n=464), and/or were diagnosed with intra uterine growth retardation (IUGR) (5.0%; n=250). In women with normal pregnancy outcome mean (+/-SD) of pv was 1.31+/-0.09 mPa s, of E0 was 21.6+/-5.3, and of E1 was 38.4+/-7.9 while in women with adverse outcome means for rheological parameters were statistically significantly different i.e. pv: 1.32+/-0.08 mPa s; p=0.006, E0: 22.1+/-5.5; p=0.002 and E1: 39.5+/-8.5; p=0.0006. Subgroup analysis revealed statistical significant lower pv in women who either had pre term delivery or a low birth-weight child (p<0.005) as compared to women who had normal pregnancy outcome while patients with pre-eclampsia had markedly higher low shear and stasis RBC aggregation (p<0.0001). None of the rheological results at term were correlated with either maternal age (r<0.04), BMI (r<0.09), maternal weight gain until delivery (r<0.04), or fetal outcome such as APGAR-score (r<0.09) art. pH in the umbilical cord (-0.05

  15. Evaluating the Capability of Information Technology to Prevent Adverse Drug Events: A Computer Simulation Approach

    PubMed Central

    Anderson, James G.; Jay, Stephen J.; Anderson, Marilyn; Hunt, Thaddeus J.

    2002-01-01

    Background: The annual cost of morbidity and mortality due to medication errors in the U.S. has been estimated at $76.6 billion. Information technology implemented systematically has the potential to significantly reduce medication errors that result in adverse drug events (ADEs). Objective: To develop a computer simulation model that can be used to evaluate the effectiveness of information technology applications designed to detect and prevent medication errors that result in adverse drug effects. Methods: A computer simulation model was constructed representing the medication delivery system in a hospital. STELLA, a continuous simulation software package, was used to construct the model. Parameters of the model were estimated from a study of prescription errors on two hospital medical/surgical units and used in the baseline simulation. Five prevention strategies were simulated based on information obtained from the literature. Results: The model simulates the four stages of the medication delivery system: prescribing, transcribing, dispensing, and administering drugs. We simulated interventions that have been demonstrated in prior studies to decrease error rates. The results suggest that an integrated medication delivery system can save up to 1,226 days of excess hospitalization and $1.4 million in associated costs annually in a large hospital. The results of the analyses regarding the effects of the interventions on the additional hospital costs associated with ADEs are somewhat sensitive to the distribution of errors in the hospital, more sensitive to the costs of an ADE, and most sensitive to the proportion of medication errors resulting in ADEs. Conclusions: The results suggest that clinical information systems are potentially a cost-effective means of preventing ADEs in hospitals and demonstrate the importance of viewing medication errors from a systems perspective. Prevention efforts that focus on a single stage of the process had limited impact on the

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

    PubMed

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

    2008-03-01

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

  17. Adverse life events and emotional and behavioral problems in adolescence: the role of non-verbal cognitive ability and negative cognitive errors.

    PubMed

    Flouri, Eirini; Panourgia, Constantina

    2011-07-01

    The aim of this study was to test whether negative cognitive errors (overgeneralizing, catastrophizing, selective abstraction, and personalizing) mediate the moderator effect of non-verbal cognitive ability on the association between adverse life events (life stress) and emotional and behavioral problems in adolescence. The sample consisted of 430 children (aged 11-15 years) from three state secondary schools in disadvantaged areas in one county in the South East of England. Total difficulties (i.e., emotional symptoms, peer problems, hyperactivity, and conduct problems) were assessed with the Strengths and Difficulties Questionnaire. Adjustment was made for gender, age, ethnicity, special educational needs, exclusion history, family structure, and family socio-economic disadvantage. Adverse life events were measured with Tiet et al.'s (Journal of the American Academy of Child & Adolescent Psychiatry, 37, 1191-1200, 1998) Adverse Life Events Scale. Non-verbal cognitive ability was measured with Raven's Standard Progressive Matrices Plus. Non-verbal cognitive ability moderated the effect of adverse life events both on total difficulties and on emotional symptoms. Overgeneralizing mediated the moderator effect of non-verbal cognitive ability on the association between adverse life events and total difficulties. Adverse life events were related to a tendency to overgeneralize which was associated with emotional and behavioral problems, but particularly among those adolescents with lower non-verbal cognitive ability.

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

    PubMed

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

    2014-01-01

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

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

    PubMed

    Galip, Nilufer; Bahceciler, Nerin

    2015-01-01

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

  20. Comparative optimism among patients with coronary heart disease (CHD) is associated with fewer adverse clinical events 12 months later.

    PubMed

    Hevey, David; McGee, Hannah M; Horgan, John H

    2014-04-01

    The current study evaluates the levels of comparative optimism among patients with coronary heart disease (CHD) and examines its relationship to health outcomes 12 months later. 164 patients completed self-report questionnaires at the end of cardiac rehabilitation and the number of adverse clinical events in the following 12 months were recorded. Comparative optimism was assessed in relation to a typical other who has not had cardiac event, a typical other who has had the same cardiac event as the respondent, and a typical member of the cardiac rehabilitation class. Clinical-demographic details and distress were assessed. Participants were comparatively optimistic in all three ratings. Logistic regression (controlling for age, gender, co-morbidities, and distress) revealed that higher levels of adverse events were associated with older age, being male, and lower levels of overall comparative optimism. Comparative optimism was associated with decreased risk of adverse clinical events in the year following cardiac rehabilitation attendance.

  1. VKORC1 and CYP2C9 polymorphisms related to adverse events in case-control cohort of anticoagulated patients

    PubMed Central

    Misasi, Silvia; Martini, Giuliana; Paoletti, Oriana; Calza, Stefano; Scovoli, Giovanni; Marengoni, Alessandra; Testa, Sophie; Caimi, Luigi; Marchina, Eleonora

    2016-01-01

    Abstract Vitamin K antagonists (VKAs) are highly effective but have a narrow therapeutic index and require routine monitoring of the INR. The primary aim of pharmacogenetics (PGx) is to optimize patient care, achieving drug treatments that are personalized according to the genetic profile of each patient. The best-characterized genes involved in VKA PGx involve pharmacokinetics (VKORC1) and pharmacodynamics (CYP2C9) of VKA metabolism. The role of these genes in clinical outcomes (bleeding and thrombosis) during oral anticoagulant (OAC) therapy is controversial. The aim of the present study was to evaluate any potential association between genotype VKORC1 and CYP2C9 and adverse events (hemorrhagic and/or thrombotic), during initiation and long-term VKA treatment, in Caucasian patients. Furthermore, we aimed to determine if the concomitant prescription of other selected drugs affected the association between genotype and adverse events. We performed a retrospective, matched case-control study to determine associations between multiple gene variants, drug intake, and any major adverse effects in anticoagulated patients, monitored in 2 Italian anticoagulation clinics. Our results show that anticoagulated patients have a high risk of adverse events if they are carriers of 1 or more genetic polymorphisms in the VKORC1 (rs9923231) and CYP2C9 (rs1799853 and rs1057910) genes. Information on CYP2C9 and VKORC1 variants may be useful to identify individualized oral anticoagulant treatment for each patient, improve management and quality of VKA anticoagulation control, and monitor drug surveillance in pharmacovigilance programs. PMID:28033245

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

    PubMed

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

    2016-09-30

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

  3. Risk of Stroke and Post-Stroke Adverse Events in Patients with Exacerbations of Chronic Obstructive Pulmonary Disease

    PubMed Central

    Lin, Chao-Shun; Shih, Chun-Chuan; Yeh, Chun-Chieh; Hu, Chaur-Jong; Chung, Chi-Li

    2017-01-01

    Background The risk and outcomes of stroke in patients with chronic obstructive pulmonary disease exacerbations (COPDe) remain unclear. We examined whether patients with COPDe faced increased risk of stroke or post-stroke outcomes. Methods Using Taiwan’s National Health Insurance Research Database, we identified 1918 adults with COPDe and selected comparison cohorts of 3836 adults with COPD no exacerbations and 7672 adults without COPD who were frequency matched by age and sex in 2000–2008 (Study 1). Stroke event was identified during 2000–2013 follow-up period. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) of stroke associated with COPDe were calculated. In a nested cohort study (Study 2) of 261686 new-diagnosed stroke patients in 2000–2009, we calculated adjusted odds ratios (ORs) and 95% CIs of adverse events after stroke in patients with COPDe. Results Patients with COPDe had increased stroke incidence, with an adjusted HR of 1.28 (95% CI, 1.03–1.59). In the Study 2, COPDe were associated with post-stroke mortality (OR, 1.34, 95% CI 1.20–1.52), epilepsy (OR, 1.43; 95% CI, (1.22–1.67), and pneumonia (OR, 1.50; 95% CI, 1.39–1.62). Previous intubation for COPD and inpatient admissions due to COPD were factors associated with post-stroke adverse events. Conclusion Patients who have had COPDe face increased risks of stroke and post-stroke adverse events. PMID:28060955

  4. Comparison of the Adverse Event Profile of TheraSphere(®) with SIR-Spheres(®) for the Treatment of Unresectable Hepatocellular Carcinoma: A Systematic Review.

    PubMed

    Kallini, Joseph Ralph; Gabr, Ahmed; Thorlund, Kristian; Balijepalli, Chakrapani; Ayres, Dieter; Kanters, Steve; Ebrahim, Shanil; Mills, Edward; Lewandowski, Robert J; Salem, Riad

    2017-02-28

    To compare the safety profiles of TheraSphere(®) (glass) and SIR-Spheres(®) (resin) Y90 microspheres for the treatment of hepatocellular carcinoma. A systematic review was conducted using the databases MEDLINE, Embase, and Cochrane Trials Register to identify all relevant studies. Baseline characteristics and adverse events of all grades related to gastrointestinal, hepatobiliary, and respiratory systems were collected along with commonly reported outcomes related to post-embolization syndrome. For all outcomes, data from each study were tabulated for each intervention. Adverse events and patients were summed across studies on TheraSphere(®) and SIR-Spheres(®), respectively, and the resulting proportion of patients experiencing an outcome for both interventions was calculated. Thirty-one observational studies were included in the review. In the adverse events of all grades, more patients treated with resin microspheres reported gastric ulcers, hepatic encephalopathy, cholecystitis, hepatic failure, and pleural effusion. Patients treated with resin microspheres also had more hepatobiliary adverse events of grade 3 or higher. In the events related to post-embolization syndrome, glass microspheres exhibited a similar safety profile compared to resin microspheres. Ascites and nausea grade 3 or higher were recorded more frequently with glass microsphere treatment. Based on this review of the published literature, glass microspheres exhibit a safety profile with fewer gastrointestinal and pulmonary adverse events compared to resin microspheres in the treatment of hepatocellular carcinoma.

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

    PubMed Central

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

    2017-01-01

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

  6. Active assessment of adverse events following yellow fever vaccination of persons aged 60 years and more

    PubMed Central

    Miyaji, Karina Takesaki; Luiz, André Machado; Lara, Amanda Nazareth; do Socorro Souza Chaves, Tania; Piorelli, Roberta de Oliveira; Lopes, Marta Heloisa; Sartori, Ana Marli Christovam

    2013-01-01

    Introduction: Older age has been associated to serious adverse events (AE) following yellow fever (YF) vaccination in passive surveillance studies, but few prospective studies involving seniors have been published. Results: A total of 906 persons were evaluated; 78 were not vaccinated and 828 received the vaccine; 700 (84.7%) were interviewed after vaccination: 593 (84.7%) did not report any symptoms or signs following YF vaccine; 107 (15.3%) reported at least one AE temporally associated to YF vaccination: 97 (13.9%) had systemic AE and 17 (2.4%) reported AE at the injection site (7 had both systemic and local AE). Data regarding previous vaccination was available for 655 subjects. Statistically significant higher rates of systemic AE were observed among subjects who received the first YF vaccination (17.5%) in comparison to persons who had been previously vaccinated (9.5%). Methods: This observational prospective study aimed to describe AE following YF vaccination in persons aged ≥ 60 y. From March 2009 to April 2010, seniors who sought YF vaccination at a reference Immunization Center in São Paulo city, Brazil, were included. Demographic and clinical data, previous YF vaccination, travel destination and the final decision regarding YF vaccination or not were collected from standardized medical records. Active AE assessment was done through telephone or electronic mail interview performed approximately 14 d after immunization. Conclusion: Most persons aged ≥ 60 y may be safely vaccinated against YF. Before vaccination, they must be carefully screened for conditions associated to altered immunocompetence and for risk of exposure to YF. PMID:23291944

  7. Clinical Risk Factors for In-Hospital Adverse Cardiovascular Events After Acute Drug Overdose

    PubMed Central

    Manini, Alex F.; Hoffman, Robert S.; Stimmel, Barry; Vlahov, David

    2015-01-01

    Objectives It was recently demonstrated that adverse cardiovascular events (ACVE) complicate a high proportion of hospitalizations for patients with acute drug overdoses. The aim of this study was to derive independent clinical risk factors for ACVE in patients with acute drug overdoses. Methods This prospective cohort study was conducted over 3 years at two urban university hospitals. Patients were adults with acute drug overdoses enrolled from the ED. In-hospital ACVE was defined as any of myocardial injury, shock, ventricular dysrhythmia, or cardiac arrest. Results There were 1,562 patients meeting inclusion/exclusion criteria (mean age, 41.8 years; female, 46%; suicidal, 38%). ACVE occurred in 82 (5.7%) patients (myocardial injury, 61; shock, 37; dysrhythmia, 23; cardiac arrests, 22) and there were 18 (1.2%) deaths. On univariate analysis, ACVE risk increased with age, lower serum bicarbonate, prolonged QTc interval, prior cardiac disease, and altered mental status. In a multivariable model adjusting for these factors as well as patient sex and hospital site, independent predictors were: QTc > 500 msec (3.8% prevalence, odds ratio [OR] 27.6), bicarbonate < 20 mEql/L (5.4% prevalence, OR 4.4), and prior cardiac disease (7.1% prevalence, OR 9.5). The derived prediction rule had 51.6% sensitivity, 93.7% specificity, and 97.1% negative predictive value; while presence of two or more risk factors had 90.9% positive predictive value. Conclusions The authors derived independent clinical risk factors for ACVE in patients with acute drug overdose, which should be validated in future studies as a prediction rule in distinct patient populations and clinical settings. PMID:25903997

  8. Usefulness of clinical and electrocardiographic data for predicting adverse cardiac events in patients with myotonic dystrophy

    PubMed Central

    Breton, Robert; Mathieu, Jean

    2009-01-01

    BACKGROUND: Myotonic dystrophy type 1 (DM1) has been associated with an increased risk of sudden death, either by heart block or malignant ventricular arrhythmias. Identifying patients at risk remains difficult and no consensus has been reached regarding the best approach for follow-up and prevention of sudden death. OBJECTIVES: To identify noninvasive clinical and electrocardiographic predictors of adverse cardiac events in patients with DM1. METHODS: Clinical and serial electrocardiographic data on 428 patients with a DNA-proven diagnosis of DM1, followed during a mean period of 11.7 years, were reviewed. Variables associated with adverse cardiac events were identified. RESULTS: Eleven patients (2.6%) experienced sudden death and 13 (3.0%) required implantation of a pacemaker. On univariate analysis, adverse events were associated with advancing age, prolongation of the PR, QRS and corrected QT (QTc) intervals, as well as the degree of neuromuscular impairment. No such relationship was found with the extent of genetic anomaly (number of cytosine-thymine-guanine repeats). However, multivariate analysis using Cox proportional hazards models showed that only baseline PR and QTc intervals were significantly linked to the end points of sudden death or pacemaker implantation; the age-adjusted RR was 3.7 (95% CI 1.5 to 8.6) if baseline PR was 200 ms or longer (P=0.003), and 3.0 (95% CI 1.0 to 8.8) if the baseline QTc was 450 ms or longer (P=0.047). CONCLUSIONS: In a large unselected cohort of 428 patients with DM1, the cumulative incidence of sudden death was relatively low, and the delayed conduction on surface electrocardiogram was found to be potentially helpful for identifying patients at risk for sudden death or pacemaker implantation. PMID:19214296

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

    PubMed Central

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

    2016-01-01

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

  10. Adverse events in cardiovascular-related training programs in people with spinal cord injury: A systematic review

    PubMed Central

    Warms, Catherine A.; Backus, Deborah; Rajan, Suparna; Bombardier, Charles H.; Schomer, Katherine G.; Burns, Stephen P.

    2014-01-01

    Context There are anecdotal reports of adverse events (AEs) associated with exercise in people with spinal cord injury (SCI) and consequent concern by people with SCI and their providers about potential risks of exercise. Enumeration of specific events has never been performed and the extent of risk of exercise to people with SCI is not understood. Objective To systematically review published evidence to identify and enumerate reports of adverse events or AEs associated with training in persons with SCI. Methods Review was limited to peer-reviewed studies published in English from 1970 to 2011: (1) in adults with SCI, (2) evaluating training protocols consisting of repeated sessions over at least 4 weeks to maintain or improve cardiovascular health, (3) including volitional exercise modalities and functional electrical stimulation (FES)-enhanced exercise modalities, and (4) including a specific statement about AEs. Trained reviewers initially identified a total of 145 studies. After further screening, 38 studies were included in the review. Quality of evidence was evaluated using established procedures. Results There were no serious AEs reported. There were no common AEs reported across most types of interventions, except for musculoskeletal AEs related to FES walking. There were few AEs in volitional exercise studies. Conclusion There is no evidence to suggest that cardiovascular exercise done according to guidelines and established safety precautions is harmful. To improve the strength of these conclusions, future publications should include definition of AEs, information about pre-intervention screening, and statements of the nature and extent of AEs. PMID:24090603

  11. Adverse Events of Massage Therapy in Pain-Related Conditions: A Systematic Review

    PubMed Central

    Yin, Ping; Gao, Ningyang; Wu, Junyi; Xu, Shifen

    2014-01-01

    Pain-related massage, important in traditional Eastern medicine, is increasingly used in the Western world. So the widening acceptance demands continual safety assessment. This review is an evaluation of the frequency and severity of adverse events (AEs) reported mainly for pain-related massage between 2003 and 2013. Relevant all-languages reports in 6 databases were identified and assessed by two coauthors. During the 11-year period, 40 reports of 138 AEs were associated with massage. Author, year of publication, country of occurrence, participant related (age, sex) or number of patients affected, the details of manual therapy, and clinician type were extracted. Disc herniation, soft tissue trauma, neurologic compromise, spinal cord injury, dissection of the vertebral arteries, and others were the main complications of massage. Spinal manipulation in massage has repeatedly been associated with serious AEs especially. Clearly, massage therapies are not totally devoid of risks. But the incidence of such events is low. PMID:25197310

  12. PROPOFOL-FENTANYL VERSUS PROPOFOL ALONE FOR LUMBAR PUNCTURE SEDATION IN CHILDREN WITH ACUTE HEMATOLOGIC MALIGNANCIES: PROPOFOL DOSING AND ADVERSE EVENTS

    PubMed Central

    Hollman, Gregory A.; Schultz, Meredith M; Eickhoff, Jens C; Christenson, Devon K

    2011-01-01

    Objective We sought to determine whether the combination of propofol and fentanyl results in lower propofol doses and fewer adverse cardiopulmonary events than propofol and placebo for lumbar puncture (LP) in children with acute hematologic malignancies. Design Randomized, controlled, double blind, crossover study. Setting Pediatric Sedation Program Patients Children with acute leukemia or lymphoma receiving sedation for LP. Interventions Each patient received two sedations in random order, one with propofol/placebo and one with propofol/fentanyl. The study investigator and patient/parent were blinded to placebo or fentanyl. Data collected included patient age and diagnosis, propofol dose and adverse events. Adverse events included oxygen saturation < 94%, airway obstruction, apnea, hypotension and bradycardia (< 5% mean for age). Logistic regression analysis was utilized to assess probability of adverse events and the Wilcoxon Signed Rank and McNemar’s tests were used for paired comparisons. Measurements and Main Results Twenty-two patients were enrolled. Fourteen patients were male and 8 were female. Each patient was studied twice for a total of 44 sedations. The median age was 5.0 years (range 2.2–17.2 years). All procedures were successfully completed. The median total dose of propofol was 5.05 mg/kg (range 2.4–10.2 mg/kg) for propofol/placebo versus 3.00 mg/kg (range 1.4–10.5 mg/kg) for propofol/fentanyl (p < 0.001). Twelve adverse events occurred in 11 of 22 patients (50.0%) propofol/placebo compared to 6 of 22 (18.2%) propofol/fentanyl (p= 0.02). The most common adverse event was hypotension. Conclusions The combination of propofol and fentanyl versus propofol alone for LP sedation in children with acute hematologic malignancies resulted in lower propofol doses and fewer adverse events. PMID:18838923

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

    PubMed Central

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

    2013-01-01

    Introduction: Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. Materials and Methods: We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. Results: A total number of 461 ADRs have be