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Sample records for reported adverse event

  1. Adverse Event Reporting System (AERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all...

  2. CDC Wonder Vaccine Adverse Event Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination,...

  3. [Analysis of Spontaneously Reported Adverse Events].

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    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.

  4. Consumer reporting of adverse events following immunization.

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    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 (PConsumer reports were 5% more likely to describe serious AEFI than HCP (P=0.018) and 10% more likely to result in specialist clinic attendance (Preporting 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.

  5. CDC WONDER: Vaccine Adverse Event Reporting System (VAERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination, by...

  6. FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

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

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

    2011-01-01

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

  8. Adverse events due to the immunization: Case report

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    Medić Snežana

    2012-01-01

    Full Text Available Introduction. An adverse event after immunization is a medical incident following the administration of vaccine, which can be connected with vaccine usage. This event could be a reaction to a vaccine component or lapse in vaccine handling, transport and storage or coincidental event. The assessment of severity of this reaction and the decision about prospective permanent contraindications for futher immunization are to be made by the regional expert team for permanent contraindications. This is regulated by low. Case report. A series of adverse events after immunization in three children of a single family is reported. As regulated by law, all three children were vaccinated with different vaccines, from 2007. to 2010. Although the recorded events were diverse by their nature, way of clinical manifestation and severity they all required hospitalization. In addition to being siblings, the three children had the same atopic diseases in their personal and family anamnesis. All adverse events were explored including allergological/immunological tests. Thanks to the good cooperation of involved general practicioners, pediatricians, members of expert team for permanent contraindications and clinicians, two of three children received the full series of vaccines in optimal time. Discussion. Decision making about futher immunization of children with adverse event after vaccine administration depends on the nature and severity of developed medical condition, results of medical exploration, existing immunity and personal risk of getting disease and subsequent complications. Conclusion. Bearing in mind the significance of immunization for personal and collective immunity, good cooperation of all physicians and experts involved in each single case of adverse event is required.

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

    OpenAIRE

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

    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 de...

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

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...

  11. Serious adverse events reported for anti-obesity medicines

    DEFF Research Database (Denmark)

    Aagaard, L; Hallgreen, C E; Hansen, Ebba Holme

    2016-01-01

    BACKGROUND: Use of anti-obesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after time of marketing. In Europe, information about AEs reported for anti-obesity medici......BACKGROUND: Use of anti-obesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after time of marketing. In Europe, information about AEs reported for anti......-obesity medicines can be accessed in the EudraVigilance database (EV). Therefore, we aimed to identify and characterise adverse events (AEs) associated with use of anti-obesity medicines in Europe. METHODS: AE reports submitted for anti-obesity medicines (Anatomical Therapeutic Chemical [ATC] group A08A) from 2007...... are being marketed, the utilisation of anti-obesity medicines is widespread, and therefore systematic monitoring of the safety of these medicines is necessary.International Journal of Obesity accepted article preview online, 01 August 2016. doi:10.1038/ijo.2016.135....

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    2016-01-01

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

  14. Under-reporting of Adverse Events in the Biomedical Literature

    Directory of Open Access Journals (Sweden)

    Ronald N. Kostoff

    2016-11-01

    Full Text Available Purpose: To address the under-reporting of research results, with emphasis on the underreporting/distorted reporting of adverse events in the biomedical research literature. Design/methodology/approach: A four-step approach is used:(1 To identify the characteristics of literature that make it adequate to support policy; (2 to show how each of these characteristics becomes degraded to make inadequate literature; (3 to identify incentives to prevent inadequate literature; and (4 to show policy implications of inadequate literature. Findings: This review has provided reasons for, and examples of, adverse health effects of myriad substances (1 being under-reported in the premiere biomedical literature, or (2 entering this literature in distorted form. Since there is no way to gauge the extent of this under/distorted-reporting, the quality and credibility of the ‘premiere’ biomedical literature is unknown. Therefore, any types of meta-analyses or scientometric analyses of this literature will have unknown quality and credibility. The most sophisticated scientometric analysis cannot compensate for a highly flawed database. Research limitations: The main limitation is in identifying examples of under-reporting. There are many incentives for under-reporting and few dis-incentives. Practical implications: Almost all research publications, addressing causes of disease, treatments for disease, diagnoses for disease, scientometrics of disease and health issues, and other aspects of healthcare, build upon previous healthcare-related research published. Many researchers will not have laboratories or other capabilities to replicate or validate the published research, and depend almost completely on the integrity of this literature. If the literature is distorted, then future research can be misguided, and health policy recommendations can be ineffective or worse. Originality/value: This review has examined a much wider range of technical and nontechnical

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

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region......%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. CONCLUSION: The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR...

  16. Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance.

    Science.gov (United States)

    Aagaard, L; Hallgreen, C E; Hansen, E H

    2016-11-01

    Use of antiobesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after the time of marketing. In Europe, information about AEs reported for antiobesity medicines can be accessed in the EudraVigilance (EV) database. Therefore, we aimed to identify and characterise AEs associated with the use of antiobesity medicines in Europe. AE reports submitted for antiobesity medicines (Anatomical Therapeutic Chemical (ATC) group A08A) from 2007 to 2014 and located in the EV database were analysed. AE data were categorised with respect to time, age and sex of patient/consumer, type of reporter, category and seriousness of reported AEs and medicines. Consumer AE reports were compared with reports from other types of reporters with respect to age and sex of consumer, seriousness, system organ class and medicine. The unit of analysis was one AE and one AE report, respectively. We located 4941 AE reports corresponding to 13 957 AEs for antiobesity medicines in the EV database. More than 90% of all AE cases were serious, including 159 deaths. The majority of AE cases were reported for female adults. The majority of serious AEs was reported for orlistat (37%) and rimonabant (22%). The largest share of serious AEs was of the type 'cardiac disorders' (19%) and 'psychiatric disorders' (18%). Consumer AEs reporting differed from other sources with respect to share and seriousness of AEs, type of AEs (system organ class) and medicines (ATC level 5). Many serious AEs were found for antiobesity medicines in EV, and consumers contributed with a relatively high share of reports. Although several products have been withdrawn from the market and new medicines are being marketed, the utilisation of antiobesity medicines is widespread, and therefore systematic monitoring of the safety of these medicines is necessary.

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

    Science.gov (United States)

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

    2017-01-01

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

  18. Data Collection for Adverse Events Reporting by US Dental Schools.

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    Rooney, Deborah; Barrett, Kimberly; Bufford, Blake; Hylen, Alexandra; Loomis, Matthew; Smith, Joshua; Svaan, Angela; Pinsky, Harold M; Sweier, Domenica

    2016-12-30

    Accreditation of US dental schools requires a formal system of quality assessment of clinical adverse events (AE). There is no universal system to collect, record, interpret, or release findings or trends pertaining to AEs. The objective of this study was to compare similarities and differences among the AE reporting forms used at US dental schools. Sixteen (24%) dental schools responded to a query to provide copies of their AE forms. The forms were analyzed to identify unique AE items. A total of 69 unique AE items were identified, grouped, and ranked according to frequency. Methods of AE data collection were also noted. The forms were different in organization, form, and content. The 69 AE items represented a wide variety of information, with no standardization of the type of information, how it was collected, or by whom. We identified 9 most requested AE items and 4 least requested AE items. The schools differed in how the information was obtained: 2 schools used a menu, 8 schools used free response, and 6 schools used a hybrid of both methods. We found that dental school clinic AE reporting forms are not standardized in structure, organization, or content. We conclude that a hybrid form containing both guided responses and free responses would ensure that proper information is being reported to fully understand why/how an AE occurred. In addition, dental schools need to develop a standardized method of collecting and assessing AE data which will allow for quality improvement and increased patient safety.

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

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

    2013-01-01

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

  20. Guidelines for submitting adverse event reports for publication

    NARCIS (Netherlands)

    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

  1. Guidelines for submitting adverse event reports for publication

    NARCIS (Netherlands)

    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 adve

  2. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting

    Directory of Open Access Journals (Sweden)

    Ali AK

    2012-05-01

    Full Text Available Ayad K Ali, Abraham G HartzemaDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USABackground: Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US.Methods and materials: Reports of arterial thrombotic events submitted to the US Food and Drug Administration's Adverse Event Reporting System (AERS between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio data mining algorithm. The reporting odds ratio of arterial thrombotic events for omalizumab was compared with specific asthma medications and all drugs in the AERS. Values ≥2 were considered significant safety signals. The Medical Dictionary for Regulatory Activities Preferred Terms were used to identify arterial thrombotic events (eg, stroke, myocardial infarction.Results: In total, 293,783 reports of arterial thrombotic events were retrieved (about 2% of all adverse drug reaction reports, corresponding to 2274 asthma drug-arterial thrombotic events pairs (omalizumab, 222; inhaled corticosteroids [ICS], 131; long-acting beta-agonists [LABA], 102; single-device combination ICS-LABA, 506; inhaled short-acting beta-agonists [SABA], 475; oral SABA, 6; inhaled antimuscarinics [AMC], 477; single-device combination AMC-SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4. Reporting odds ratio and 95% confidence interval values for omalizumab compared with other asthma drugs and all drugs in AERS were 2.75 (2.39–316 and 1.09 (0.95–1.24, respectively. Omalizumab ranked second after ICS in the risk of arterial thrombotic events, followed by AMC, AMC-SABA, and ICS-LABA.Conclusion: Omalizumab is

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

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    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…

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

    Science.gov (United States)

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

    2017-07-05

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

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

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    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

  6. The logic of surveillance guidelines: an analysis of vaccine adverse event reports from an ontological perspective.

    Directory of Open Access Journals (Sweden)

    Mélanie Courtot

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

  7. Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.

    Directory of Open Access Journals (Sweden)

    Toshiyuki Sakaeda

    Full Text Available 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.

  8. Reporting Vaccine Complications: What Do Obstetricians and Gynecologists Know About the Vaccine Adverse Event Reporting System?

    Directory of Open Access Journals (Sweden)

    L. O. Eckert

    2013-01-01

    Full Text Available Background. Obstetrician-gynecologists are increasingly called upon to be vaccinators as an essential part of a woman’s primary and preventive health care. Despite the established safety of vaccines, vaccine adverse events may occur. A national Vaccine Adverse Event Reporting System (VAERS is a well-established mechanism to track adverse events. However, we hypothesized that many obstetrician-gynecologists are naive to the role and use of VAERS. Methods. We devised a ten-question survey to a sample of ACOG fellows to assess their knowledge and understanding of VAERS. We performed descriptive and frequency analysis for each of the questions and used one-way analysis of variance for continuous and chi-squared for categorical variables. Results. Of the 1000 fellows who received the survey, 377 responded. Only one respondent answered all nine knowledge questions correctly, and 9.2% of physicians had used VAERS. Older physicians were less familiar with VAERS in general and with the specific objectives of VAERS in particular (χ2=10.7,P=.005. Conclusions. Obstetrician-gynecologist familiarity with VAERS is lacking. Only when the obstetrician-gynecologist is completely knowledgeable regarding standard vaccine practices, including the availability and use of programs such as VAERS, will providers be functioning as competent and complete vaccinators.

  9. Data Mining of the Public Version of the FDA Adverse Event Reporting System

    Science.gov (United States)

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

    2013-01-01

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

  10. Adverse event reporting in Slovenia - the influence of safety culture, supervisors and communication

    Directory of Open Access Journals (Sweden)

    Birk Karin

    2016-01-01

    Full Text Available Background/Aim. The provision of safe healthcare is considered a priority in European Union (EU member states. Along with other preventative measures in healthcare, the EU also strives to eliminate the “causes of harm to human health”. The aim of this survey was to determine whether safety culture, supervisors and communication between co-workers influence the number of adverse event reports submitted to the heads of clinical departments and to the management of an institution. Methods. This survey is based on cross-sectional analysis. It was carried out in the largest Slovenian university hospital. We received 235 completed questionnaires. Respondents included professionals in the fields of nursingcare, physiotherapy, occupational therapy and radiological technology. Results. Safety culture influences the number of adverse event reports submitted to the head of a clinical department from the organizational point of view. Supervisors and communication between co-workers do not influence the number of adverse event reports. Conclusion. It can be concluded that neither supervisors nor the level of communication between co-workers influence the frequency of adverse event reporting, while safety culture does influence it from an organizational point of view. The presumed factors only partly influence the number of submitted adverse event reports, thus other causes of under-reporting must be sought elsewhere.

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

    Science.gov (United States)

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

    2009-05-01

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

  12. In situ simulation: Taking reported critical incidents and adverse events back to the clinic

    DEFF Research Database (Denmark)

    Juul, Jonas; Paltved, Charlotte; Krogh, Kristian

    2014-01-01

    does not tap into situational resources, e.g. individual, team, and organisational characteristics such as routines, personal relations, distributed skill-levels etc. Therefore, it fails to fully mimic real clinical team processes. Alternatively, in situ simulation offers a unique opportunity...... improve patient safety if coupled with training and organisational support2. Insight into the nature of reported critical incidents and adverse events can be used in writing in situ simulation scenarios and thus lead to interventions that enhance patient safety. The patient safety literature emphasises...... well-developed non-technical skills in preventing medical errors3. Furthermore, critical incidents and adverse events reporting systems comprise a knowledgebase to gain in-depth insights into patient safety issues. This study explores the use of critical incidents and adverse events reports to inform...

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

    NARCIS (Netherlands)

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

    2014-01-01

    Background. Haemovigilance hinges on a systematically structured reporting system, which unfortunately does not always exist in resource-limited settings. We determined the incidence and pattern of transfusion-related adverse events reported to the National Blood Service Zimbabwe. Materials and meth

  14. Neuropsychiatric Adverse Events of Varenicline A Systematic Review of Published Reports

    NARCIS (Netherlands)

    Ahmed, Amir I. A.; Ali, Abdullah N. A.; Kramers, Cees; Harmark, Linda V. D.; Burger, David M.; Verhoeven, Willem M. A.

    Introduction: Over the past years, the impact of varenicline in patients with mental illness has been debated as serious neuropsychiatric adverse events (AEs) have been reported with varenicline use. Aim: To identify and summarize published case reports of neuropsychiatric AEs ascribed to

  15. Neuropsychiatric Adverse Events of Varenicline A Systematic Review of Published Reports

    NARCIS (Netherlands)

    Ahmed, Amir I. A.; Ali, Abdullah N. A.; Kramers, Cees; Harmark, Linda V. D.; Burger, David M.; Verhoeven, Willem M. A.

    2013-01-01

    Introduction: Over the past years, the impact of varenicline in patients with mental illness has been debated as serious neuropsychiatric adverse events (AEs) have been reported with varenicline use. Aim: To identify and summarize published case reports of neuropsychiatric AEs ascribed to vareniclin

  16. General practitioners′ attitudes toward reporting and learning from adverse events: results from a survey

    DEFF Research Database (Denmark)

    Mikkelsen, Thorbjørn H.; Sokolowski, Ineta; Olesen, Frede

    2006-01-01

    OBJECTIVE: To investigate GPs' attitudes to and willingness to report and learn from adverse events and to study how a reporting system should function. DESIGN: Survey. SETTING: General practice in Denmark. MAIN OUTCOME MEASURES: GPs' attitudes to exchange of experience with colleagues and others......, and circumstances under which such exchange is accepted. SUBJECTS: A structured questionnaire sent to 1198 GPs of whom 61% responded. RESULTS. GPs had a positive attitude towards discussing adverse events in the clinic with colleagues and staff and in their continuing medical education groups. The GPs had...

  17. Evaluation of thromboembolic events in cancer patients receiving bevacizumab according to the Japanese Adverse Drug Event Report database.

    Science.gov (United States)

    Matsumura, Chikako; Chisaki, Yugo; Sakimoto, Satoko; Sakae, Honoka; Yano, Yoshitaka

    2016-11-17

    We aimed to examine the risk factors, time of onset, incidence rates, and outcomes of thromboembolic events induced by bevacizumab in patients with cancer using the Japanese Adverse Drug Event Report (JADER) database of the Pharmaceuticals and Medical Devices Agency. Adverse event data recorded in the JADER database between January 2004 and January 2015 were used. After screening the data using the generic drug name bevacizumab, patient data were classified into two groups by age and five groups by cancer type. The histories of disorders were also categorized. Arterial thromboembolic event and venous thromboembolic event were classified as "favorable" or "unfavorable" outcomes. In total, 6076 patients were reported to have developed adverse events during the sample period, of which 233 and 453 developed arterial thromboembolic event and venous thromboembolic event, respectively. Logistic analysis suggested that the presence of cancer was a significant risk factor for both arterial thromboembolic event and venous thromboembolic event. Age (≥70 years), histories of either hypertension or diabetes mellitus were also risk factors for arterial thromboembolic event. Median cumulative times of onset for arterial thromboembolic event and venous thromboembolic event were 60 and 80 days, respectively, and were not significantly different by the log-rank test. By the chi-square test, the rate of unfavorable outcomes was found to be higher after developing arterial thromboembolic event than after venous thromboembolic event. Thromboembolism is a leading cause of mortality in patients with cancer. Patients should be monitored for the symptoms of thromboembolic events right from the initial stages of bevacizumab treatment. © The Author(s) 2016.

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

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    and analysed descriptively. RESULTS: A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11...... reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad....

  19. Antipsychotics and torsadogenic risk : Signals emerging from the US FDA adverse event reporting system database

    NARCIS (Netherlands)

    E. Poluzzi (Elisabetta); E. Raschi (Emanuel); A. Koci (Ariola); U. Moretti (Ugo); E. Spina (Edoardo); E.R. Behr (Elijah ); M.C.J.M. Sturkenboom (Miriam); F. de Ponti (Fabrizio)

    2013-01-01

    textabstractBackground: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US FDA Adverse Event Reporting System

  20. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ... of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food... Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this draft guidance is to assist sponsors or non-applicants with filling out form FDA 1932, ``Veterinary Adverse...

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    Science.gov (United States)

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

    2009-01-01

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

  4. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

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

    2016-01-01

    group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs. CONCLUSIONS: In the orlistat trials, we identified important disparities in the reporting...... 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 Pub...

  5. ADVERSE EVENT REPORTING FOR A DERMATOPHARMACOKINETIC STUDY OF DICLOFENAC SODIUM TOPICAL FORMULATIONS

    Directory of Open Access Journals (Sweden)

    Mayee Rahul

    2011-09-01

    Full Text Available In this single-dose-one arm, open label three way parallel design, pharmacokinetic study of three marketed formulations of Diclofenac Sodium using 12 healthy Indian male subjects, the pharmacokinetic parameters of three marketed Diclofenac Sodium topical formulations were compared. Marketed Diclofenac Sodium topical formulations (A, B & C were applied on the pre-marked forearms of the subjects as per the dosing schedule. Treatment sample C was used as a reference sample. Subjects received treatment A, treatment B & treatment C on both the arms simultaneously, following open label three way parallel design. Skin Stratum Corneum samples were collected in sterile glass test tubes during the study period. The samples were collected pre-dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, & 6.0 hours post-dose application. Diclofenac Sodium was estimated in Stratum Corneum using a validated Spectroscopic method and the treatments were claimed to be bio-equivalent.The aim of this article was to report the occurrence of adverse events during this study. It was observed that only a single incidence of mild adverse event was reported in two volunteers, and it involved mild laceration on the right forearm. But, the event was found to be self resolving & with the relationship of the adverse event to study medication was “unlikely” but it could be due to the ‘tape stripping method’ employed for DPK analysis.

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

    Science.gov (United States)

    2012-08-24

    evaluation, a clinician is given an opportunity to improve his or her clinical competence over a period of time as determined by the VAMC director. At... competence by a peer. GAO-12-827R Veterans Health Administration Response to Reported Adverse Events 8 concerns about clinical competence remain...the discretion of the VAMC director, this evaluation can include progressive training or proctoring aimed at helping the clinician improve clinical

  7. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Science.gov (United States)

    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...

  8. Adverse events in Public Dental Service in a Swedish county--a survey of reported cases over two years.

    Science.gov (United States)

    Jonsson, Lena; Gabre, Pia

    2014-01-01

    Adverse events cause suffering and increased costs in health care. The main way of registering adverse event is through dental personnel's reports, but reports from patients can also contribute to the knowledge of such occurrences. This study aimed to analyse the adverse events reported by dental personnel and patients in public dental service (PDS) in a Swedish county. The PDS has an electronic system for reporting and processing adverse events and, in addition, patients can report shortcomings, as regards to reception and treatment, to a patient committee or to an insurance company. The study material consisted of all adverse events reported in 2010 and 2011, including 273 events reported by dental personnel, 53 events reported by patients to the insurance company and 53 events reported by patients to the patient committee. Data concerning patients' age and gender, the nature, severity and cause of the event and the dental personnel's age gender and profession were collected and analysed. Furthermore the records describing the dental personnel's reports from 2011 were studied to investigate if the event had been documented and the patient informed. Age groups 0 to 9 and 20 to 39 years were underrepresented while those between the ages 10 to 19 and 60 to 69 years were overrepresented in dental personnel's reports. Among young patients delayed diagnosis and therapy dominated and among patients over 20 years the most frequent reports dealt with inadequate treatments, especially endodontic treatments. In 29% of the events there was no documentation of the adverse event in the records and 49% of cases had no report about patient information. The majority of the reports from dental personnel were made by dentists (69%). Reporting adverse events can be seen as a reactive way of working with patient safety, but knowledge about frequencies and causes of incidents is the basis of proactive patient safety work.

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2012-01-01

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

  12. Vaccine adverse events.

    Science.gov (United States)

    Follows, Jill

    2012-01-01

    Millions of adults are vaccinated annually against the seasonal influenza virus. An undetermined number of individuals will develop adverse events to the influenza vaccination. Those who suffer substantiated vaccine injuries, disabilities, and aggravated conditions may file a timely, no-fault and no-cost petition for financial compensation under the National Vaccine Act in the Vaccine Court. The elements of a successful vaccine injury claim are described in the context of a claim showing the seasonal influenza vaccination was the cause of Guillain-Barré syndrome.

  13. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn;

    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...... 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...

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

    Science.gov (United States)

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

    2016-08-01

    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. 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 filters, though six of seven papers

  15. Acute disseminated encephalomyelitis onset: evaluation based on vaccine adverse events reporting systems.

    Directory of Open Access Journals (Sweden)

    Paolo Pellegrino

    Full Text Available OBJECTIVE: To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM by considering data from different pharmacovigilance surveillance systems. METHODS: The Vaccine Adverse Event Reporting System (VAERS database and the EudraVigilance post-authorisation module (EVPM were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. RESULTS: We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. CONCLUSIONS: This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely not [corrected] due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction.

  16. Adverse events associated with yoga: a systematic review of published case reports and case series.

    Science.gov (United States)

    Cramer, Holger; Krucoff, Carol; Dobos, Gustav

    2013-01-01

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

  17. Auditing an Online Self-reported Interventional Radiology Adverse Event Database for Compliance and Accuracy.

    Science.gov (United States)

    Burch, Ezra A; Shyn, Paul B; Chick, Jeffrey F; Chauhan, Nikunj R

    2017-04-01

    The purpose of this study was to determine whether auditing an online self-reported interventional radiology quality assurance database improves compliance with record entry or improves the accuracy of adverse event (AE) reporting and grading. Physicians were trained in using the database before the study began. An audit of all database entries for the first 3 months, or the first quarter, was performed, at which point physicians were informed of the audit process; entries for the subsequent 3 months, or the second quarter, were again audited. Results between quarters were compared. Compliance with record entry improved from the first to second quarter, but reminders were necessary to ensure 100% compliance with record entry. Knowledge of the audit process did not significantly improve self-reporting of AE or accuracy of AE grading. However, auditing significantly changed the final AE reporting rates and grades. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

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

    2004-08-01

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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2011-01-01

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

  2. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn;

    2014-01-01

    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...

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

    Directory of Open Access Journals (Sweden)

    Emma C Davies

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

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

    Science.gov (United States)

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

    2012-01-01

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

  5. WHO efforts to promote reporting of adverse events and global learning

    Directory of Open Access Journals (Sweden)

    Itziar Larizgoitia

    2013-12-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Sevliya Öcal Demir

    2016-01-01

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

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

    Science.gov (United States)

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

    2014-11-01

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

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

    Institute of Scientific and Technical Information of China (English)

    Klaus Bielefeldt

    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 of2015.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 parameters(44.5%),which successfully addressed concerns in 35

  10. Motivating Physicians to Report Adverse Medical Events in China: Stick or Carrot?

    Science.gov (United States)

    Xue, Yajiong; Yang, Jing; Zhang, Jing; Luo, Mengyun; Zhang, Zhiruo; Liang, Huigang

    2017-02-22

    Adverse medical events (AMEs) pose serious threats to patient safety. One of the major challenges of AME reporting is low physician engagement. This study attempted to examine how punishment and reward can improve physicians' AME reporting in China. A survey was conducted in a large hospital with 1693 beds in China. Data were collected from 311 physicians. Ordinal and binary logistic regression was used for data analysis. This study reveals that both punishment and reward are positively associated with intention to report AMEs. There is a negative interaction effect between punishment and reward. Although collective punishment is positively associated with intention to report AMEs, collective reward is not. Moreover, the physicians who have fear of negative consequences of AMEs and lack knowledge of AME reporting have lower intention to report AMEs. These findings do not differ between male and female physicians. This survey suggests that punishment and reward have potential to motivate Chinese physicians to report AMEs. However, the implementation strategies of these control mechanisms may not be universally applicable and should be carefully designed on the basis of the specific characteristics of the practice site.

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

    Directory of Open Access Journals (Sweden)

    Orietta Staltari

    2013-01-01

    Full Text Available 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.

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

    Science.gov (United States)

    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.

  13. Spontaneous reporting of adverse drug events by Korean regional pharmacovigilance centers.

    Science.gov (United States)

    Shin, Yoo Seob; Lee, Yong-Won; Choi, Young Hwa; Park, Byungjoo; Jee, Young Koo; Choi, Sung-Kyu; Kim, Eung-Gyu; Park, Jung-Won; Hong, Chein-Soo

    2009-10-01

    Patterns of prescriptions are markedly influenced by regional disease entities, medical education, culture, economic status, and available pharmaceutical companies. Features of adverse drug reactions (ADRs) may vary in different countries. In this study, we analyzed the causative drugs and clinical manifestations of spontaneously reported ADRs in Korea. Six Korean Regional Pharmacovigilance Centers collected 1418 cases of spontaneously reported adverse drug events (ADEs) by doctors, pharmacists, and nurses, and the clinical features and causative drugs were evaluated. The data were collected from general hospitals (76.5%), primary clinics, and pharmacies (23.5%). Based upon the World Health Organization (WHO)-Uppsala Monitoring Center criteria (certain-13.7%, probable-46.1%, possible-32.1%), 91.9% of the collected events were suspected to be ADRs and 15.8% of patients experienced serious ADRs. The most prevalent causative drugs were antibiotics (31.6%), followed by contrast dyes (14.0%), non-steroidal anti-inflammatory drugs (NSAIDs) (11.1%), anti-psychotics (5.4%), anti-convulsants (5.2%), cardiovascular agents (4.8%), anti-neoplastics (4.6%), and opiates and non-opiate pain killers (3.5%). Among the antibiotics, cephalosporins (8.1%) were the most common, followed by anti-tuberculosis agents (5.7%), quinolones (4.0%), vancomycin (3.1%), and penicillin (2.8%). The most common side effect was skin manifestations, which were seen in 42% of the patients, followed by neurologic manifestations (14%), gastrointestinal involvements (12.9%), generalized reactions (9.4%), and respiratory involvements (4.5%). Antibiotics, contrast dyes, and NSAIDs were the most common causative drugs for ADRs, which reflects the prescription pattern and the prevalence of diseases in Korea. These data may be useful in establishing a Korean pharmacovigilance system. 2009 John Wiley & Sons, Ltd.

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

    Directory of Open Access Journals (Sweden)

    Judith U. Cope

    2015-01-01

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

  15. Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the vaccine: Adverse Event Reporting System.

    Science.gov (United States)

    Ball, Robert; Halsey, Neal; Braun, M Miles; Moulton, Lawrence H; Gale, Arnold D; Rammohan, Kottil; Wiznitzer, Max; Johnson, Richard; Salive, Marcel E

    2002-08-01

    The Vaccine Adverse Event Reporting System (VAERS), administered by the FDA and CDC, is the U.S. system for surveillance of vaccine adverse events (AE). Acute encephalopathy age or =18 months (EO > or = 18), encephalitis (EI), and multiple sclerosis (MS) after vaccination have been reported to VAERS, but reports often contain insufficient information to validate diagnoses. Standardized case definitions would enhance the utility of VAERS reports for AE surveillance. We developed practical case definitions for classification of VAERS reports, and three neurologists independently applied the definitions to reports submitted in 1993. Inter-observer agreement was assessed, and non-concordant classifications were reviewed in a follow-up conference call. Reports of EO or = 18 (n = 20), EI (n = 15), and MS (n = 16) were classified as "definite" in 7% to 30% of the cases, while 26% to 51% of reports were thought to have insufficient information to make a classification. Agreement among reviewers was good to excellent, (kappa: 0.65 to 0.85) except for EO Elsevier Science Inc.

  16. Construct and concurrent validity of a patient-reported adverse drug event questionnaire : a cross-sectional study

    NARCIS (Netherlands)

    de Vries, Sieta T.; Haaijer-Ruskamp, Flora M.; de Zeeuw, Dick; Denig, Petra

    2014-01-01

    Background: Direct patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is

  17. OAE: The Ontology of Adverse Events.

    Science.gov (United States)

    He, Yongqun; Sarntivijai, Sirarat; Lin, Yu; Xiang, Zuoshuang; Guo, Abra; Zhang, Shelley; Jagannathan, Desikan; Toldo, Luca; Tao, Cui; Smith, Barry

    2014-01-01

    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. 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. 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 adverse events and of the factors (e

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

    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.

  20. Using Probabilistic Record Linkage of Structured and Unstructured Data to Identify Duplicate Cases in Spontaneous Adverse Event Reporting Systems.

    Science.gov (United States)

    Kreimeyer, Kory; Menschik, David; Winiecki, Scott; Paul, Wendy; Barash, Faith; Woo, Emily Jane; Alimchandani, Meghna; Arya, Deepa; Zinderman, Craig; Forshee, Richard; Botsis, Taxiarchis

    2017-07-01

    Duplicate case reports in spontaneous adverse event reporting systems pose a challenge for medical reviewers to efficiently perform individual and aggregate safety analyses. Duplicate cases can bias data mining by generating spurious signals of disproportional reporting of product-adverse event pairs. We have developed a probabilistic record linkage algorithm for identifying duplicate cases in the US Vaccine Adverse Event Reporting System (VAERS) and the US Food and Drug Administration Adverse Event Reporting System (FAERS). In addition to using structured field data, the algorithm incorporates the non-structured narrative text of adverse event reports by examining clinical and temporal information extracted by the Event-based Text-mining of Health Electronic Records system, a natural language processing tool. The final component of the algorithm is a novel duplicate confidence value that is calculated by a rule-based empirical approach that looks for similarities in a number of criteria between two case reports. For VAERS, the algorithm identified 77% of known duplicate pairs with a precision (or positive predictive value) of 95%. For FAERS, it identified 13% of known duplicate pairs with a precision of 100%. The textual information did not improve the algorithm's automated classification for VAERS or FAERS. The empirical duplicate confidence value increased performance on both VAERS and FAERS, mainly by reducing the occurrence of false-positives. The algorithm was shown to be effective at identifying pre-linked duplicate VAERS reports. The narrative text was not shown to be a key component in the automated detection evaluation; however, it is essential for supporting the semi-automated approach that is likely to be deployed at the Food and Drug Administration, where medical reviewers will perform some manual review of the most highly ranked reports identified by the algorithm.

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

    Directory of Open Access Journals (Sweden)

    van der Wal Gerrit

    2011-02-01

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

  2. Detecting Signals of Disproportionate Reporting from Singapore's Spontaneous Adverse Event Reporting System: An Application of the Sequential Probability Ratio Test.

    Science.gov (United States)

    Chan, Cheng Leng; Rudrappa, Sowmya; Ang, Pei San; Li, Shu Chuen; Evans, Stephen J W

    2017-08-01

    The ability to detect safety concerns from spontaneous adverse drug reaction reports in a timely and efficient manner remains important in public health. This paper explores the behaviour of the Sequential Probability Ratio Test (SPRT) and ability to detect signals of disproportionate reporting (SDRs) in the Singapore context. We used SPRT with a combination of two hypothesised relative risks (hRRs) of 2 and 4.1 to detect signals of both common and rare adverse events in our small database. We compared SPRT with other methods in terms of number of signals detected and whether labelled adverse drug reactions were detected or the reaction terms were considered serious. The other methods used were reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Gamma Poisson Shrinker (GPS). The SPRT produced 2187 signals in common with all methods, 268 unique signals, and 70 signals in common with at least one other method, and did not produce signals in 178 cases where two other methods detected them, and there were 403 signals unique to one of the other methods. In terms of sensitivity, ROR performed better than other methods, but the SPRT method found more new signals. The performances of the methods were similar for negative predictive value and specificity. Using a combination of hRRs for SPRT could be a useful screening tool for regulatory agencies, and more detailed investigation of the medical utility of the system is merited.

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

    Science.gov (United States)

    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.

  4. Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database.

    Science.gov (United States)

    Jakobsen, Klaus D; Wallach-Kildemoes, Helle; Bruhn, Christina H; Hashemi, Nasseh; Pagsberg, Anne K; Fink-Jensen, Anders; Nielsen, Jimmi

    2017-03-01

    Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported in the European Summary of Product Characteristics (SPCs). The ADE report database at Danish Medicines Agency was searched for all quetiapine ADRs involving individuals (children and adolescents gives rise to safety concerns.

  5. 'Case reporting of rare adverse events in otolaryngology': can we defend the case report?

    LENUS (Irish Health Repository)

    Dias, Andrew

    2012-01-31

    The study of errors in medicine has proliferated since the publication of The Institute of Medicine Report \\'TO ERR IS HUMAN\\' in 2000. Case nuances and process of care issues are valuable areas to explore if the goal is to provide the health care worker with the knowledge to avoid future errors. Meta-analysis and randomized controlled trials provide a large data base of evidence towards improvement and opportunities, but it is suggested that case reports can still provide valuable clinical information. The aim is to use the published literature to produce a series of rare harm case reports in E.N.T. The methods include systematic literature review. Journals searched in PUBMED were 60. Rare harm case obtained from the search were 5,322. Rare harm case reports not reported in any other form of evidence-based medicine were 40. Yes, the case report can be defended as it is an important pillar of evidence-based medicine.

  6. Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events

    Directory of Open Access Journals (Sweden)

    McCready Mariana

    2007-05-01

    Full Text Available Abstract Background Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and/or ineffective for reviewing the data collected and improving the outcomes in patient safety. Objective To describe the Web-application Duke Surgery Patient Safety, designed for the anonymous reporting of adverse and near-miss events as well as scheduled reporting to surgeons and hospital administration. Software architecture DSPS was developed primarily using Java language running on a Tomcat server and with MySQL database as its backend. Results Formal and field usability tests were used to aid in development of DSPS. Extensive experience with DSPS at our institution indicate that DSPS is easy to learn and use, has good speed, provides needed functionality, and is well received by both adverse-event reporters and administrators. Discussion This is the first description of an open-source application for reporting patient safety, which allows the distribution of the application to other institutions in addition for its ability to adapt to the needs of different departments. DSPS provides a mechanism for anonymous reporting of adverse events and helps to administer Patient Safety initiatives. Conclusion The modifiable framework of DSPS allows adherence to evolving national data standards. The open-source design of DSPS permits surgical departments with existing reporting mechanisms to integrate them with DSPS. The DSPS application is distributed under the GNU General Public License.

  7. Patellar dislocation: a case report and a review of other uncommon adverse events associated with blood donation.

    Science.gov (United States)

    Meny, G M; Murphy, S

    2003-01-01

    Patellar dislocation is a fairly common occurrence usually associated with various activities such as sports or dancing. A case report of patellar dislocation associated with blood donation in a 17-year-old female is described. A review of uncommon adverse events associated with blood donation is also presented.

  8. Torsadogenic risk of antipsychotics: combining adverse event reports with drug utilization data across Europe.

    Directory of Open Access Journals (Sweden)

    Emanuel Raschi

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

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

    OpenAIRE

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

    2015-01-01

    Study Design Systematic review. Objectives (1) To compare the quality of adverse event (AE) methodology and reporting among randomized trials comparing lumbar fusion with lumbar total disk replacement (TDR) using established AE reporting systems; (2) to compare the AEs and reoperations of lumbar spinal fusion with those from lumbar TDR; (3) to make recommendations on how to report AEs in randomized controlled trials (RCTs) so that surgeons and patients have more-detailed and comprehensive inf...

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

    Science.gov (United States)

    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

  11. The role of media and the Internet on vaccine adverse event reporting: a case study of human papillomavirus vaccination.

    Science.gov (United States)

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

    2014-03-01

    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 United States adolescents. 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 after Food and Drug Administration approval. Compared with 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. 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. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  12. Pro-Arrhythmic Potential of Oral Antihistamines (H1): Combining Adverse Event Reports with Drug Utilization Data across Europe

    OpenAIRE

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

    2015-01-01

    textabstractBackground: There is appreciable utilisation of antihistamines (H1) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in '90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines. Aim: To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS)...

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

    Science.gov (United States)

    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

  14. Vaccine Adverse Events Reported during the First Ten Years (1998–2008 after Introduction in the State of Rondonia, Brazil

    Directory of Open Access Journals (Sweden)

    Mônica P. L. Cunha

    2013-01-01

    Full Text Available Despite good safety records, vaccines given to young children can cause adverse events. We investigated the reported adverse events following immunization (AEFI of vaccines given to children of less than seven years of age during the first ten years (1998 to 2008 in the state of Rondonia, Brazil. We worked with the events related to BCG (Bacillus Calmett-Guérin, HB (hepatitis B, DTwP/Hib (diphtheria-tetanus-pertussis+Hemophillus influenza b, DTP (diphtheria-tetanus-pertussis, MMR (mumps, measles, rubella, and YF (yellow fever vaccines because they were part of the recommended scheme. The number of doses of vaccines given was 3,231,567 with an average of AEFI of 57.2/year during the studied period. DTwP/Hib was responsible for 298 (57.8%, DTP 114 (22.9%, HB 31 (6%, MMR 28 (5.4%, BCG 24 (4.7%, and YF 20 (3.9% of the reported AEFI. The combination of the AEFI for DTwP/Hib vaccines showed the highest number of systemic (61.4% and local events (33.8%. Young children (≤1-year old were more susceptible to AEFI occurring in the 6 hours (54.2% following vaccine uptake. This study suggests significant differences in reactogenicity of vaccines and that despite limitations of the AEFI Brazilian registry system we cannot ignore underreporting and should use the system to expand our understanding of adverse events and effects.

  15. Self-reported physical activity and major adverse events in patients with atrial fibrillation

    DEFF Research Database (Denmark)

    Proietti, Marco; Boriani, Giuseppe; Laroche, Cécile;

    2016-01-01

    patients taking regular exercise were associated with a lower risk of all-cause death, even when we considered various subgroups, including gender, elderly age, symptomatic status, and stroke risk class. Efforts to increase physical activity among AF patients may improve outcomes in these patients.......AIMS: Physical activity is protective against cardiovascular (CV) events, both in general population and in high-risk CV cohorts. However, the relationship between physical activity with major adverse outcomes in atrial fibrillation (AF) is not well-established. Our aim was to analyse...... this relationship in a 'real-world' AF population. Second, we investigated the influence of physical activity on arrhythmia progression. METHODS AND RESULTS: We studied all patients enrolled in the EURObservational Research Programme on AF (EORP-AF) Pilot Survey. Physical activity was defined as 'none', 'occasional...

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Daichi Narushima

    2016-03-01

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

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

    Directory of Open Access Journals (Sweden)

    Nomura K

    2015-06-01

    Full Text Available Kaori Nomura,1 Kunihiko Takahashi,2 Yasushi Hinomura,3 Genta Kawaguchi,4 Yasuyuki Matsushita,5 Hiroko Marui,6 Tatsuhiko Anzai,7 Masayuki Hashiguchi,8 Mayumi Mochizuki8 1Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, 2Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, 3Japan Pharmaceutical Information Center, 4Global Pharmacovigilance, Kissei Pharmaceutical Co Ltd, Tokyo, 5Medical Affairs Department, Daiichi Sankyo Co Ltd, 6Drug Safety Division, Chugai Pharmaceutical Co Ltd, 7Data Science Center, EPS Corporation, 8Faculty of Pharmacy, Keio University, Tokyo, Japan Background: The use of a statistical approach to analyze cumulative adverse event (AE reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection. Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER database and the US Food and Drug Administration Adverse Event Reporting System (FAERS, and how they affect signal detection.Methods: Two AE data sources from 2010 were examined, ie, JADER cases (JP and Japanese cases extracted from the FAERS (FAERS-JP. Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS, were used on drug-event combinations for three substances frequently recorded in both systems.Results: The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37 in the JP and 3.3±3.5 (maximum 62 in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and

  1. Food and Drug Administration (FDA) postmarket reported side effects and adverse events associated with pulmonary hypertension therapy in pediatric patients.

    Science.gov (United States)

    Maxey, Dawn M; Ivy, D Dunbar; Ogawa, Michelle T; Feinstein, Jeffrey A

    2013-10-01

    Because most medications for pediatric pulmonary hypertension (PH) are used off label and based on adult trials, little information is available on pediatric-specific adverse events (AEs). Although drug manufacturers are required to submit postmarket AE reports to the Food and Drug Administration (FDA), this information is rarely transmitted to practitioners. In the setting of a recent FDA warning for sildenafil, the authors sought to give a better description of the AEs associated with current therapies in pediatric PH. In January 2010, a written request was made to the Food and Drug Administration for AE records of commonly used PH medications. Reports were screened for pediatric patients, analyzed in terms of AEs, and compared with the medical literature. Arbitrarily, AEs that could be attributed to concomitant medications were not attributed to the PH medication in question. Adverse events occurring in more than 5 % of events for each drug were assumed to be associated with the targeted PH medication. Between November 1997 and December 2009, 588 pediatric AE reports (death in 257 cases) were reported for the three most commonly used therapies: bosentan, epoprostenol, and sildenafil. Many of the AEs were similar to those reported previously. However, 27 AEs not previously reported in the literature (e.g., pulmonary hemorrhage, hemoptysis, and pneumonia) were found. The FDA postmarket records for PH medications in pediatric patients show a significant number of AEs. The discovery of AEs not previously reported will better inform those caring for these complex and critically ill children, and the large number of deaths suggest they may be underreported in current literature.

  2. Ipilimumab and immune-mediated adverse events: a case report of anti-CTLA4 induced ileitis.

    Science.gov (United States)

    Venditti, Olga; De Lisi, Delia; Caricato, Marco; Caputo, Damiano; Capolupo, Gabriella Teresa; Taffon, Chiara; Pagliara, Elisa; Battisi, Sofia; Frezza, Anna Maria; Onetti Muda, Andrea; Tonini, Giuseppe; Santini, Daniele

    2015-03-01

    Ipilimumab is a fully human monoclonal antibody directed against cytotoxic T-lymphocyte antigen-4 , a key negative regulator of T-cell activation approved by the Food and Drug Administration as of March 2011 for the treatment of metastatic melanoma. As a result of the up-regulation of the immune system, several immune-mediated adverse effects have been reported including colitis, dermatitis, hepatitis and rarely hypophysitis. The most frequent immune-mediated adverse effects described in literature include gastrointestinal toxicity such as diarrhea, colitis and case of colitis and ileitis. In this paper we report an interesting case of immune-mediate ileitis without colitis in a 54 years old woman with metastatic melanoma treated with ipilimumab. We also discuss about case management and the possible pathological mechanisms considering also previous reports. The aim of this article is to support further investigations concerning epigenetic and genetic analysis in order to personalize biological therapy and to reduce immune related adverse events observed after ipilimumab administration.

  3. Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets.

    Science.gov (United States)

    Maciejewski, Mateusz; Lounkine, Eugen; Whitebread, Steven; Farmer, Pierre; DuMouchel, William; Shoichet, Brian K; Urban, Laszlo

    2017-08-08

    The Food and Drug Administration Adverse Event Reporting System (FAERS) remains the primary source for post-marketing pharmacovigilance. The system is largely un-curated, unstandardized, and lacks a method for linking drugs to the chemical structures of their active ingredients, increasing noise and artefactual trends. To address these problems, we mapped drugs to their ingredients and used natural language processing to classify and correlate drug events. Our analysis exposed key idiosyncrasies in FAERS, for example reports of thalidomide causing a deadly ADR when used against myeloma, a likely result of the disease itself; multiplications of the same report, unjustifiably increasing its importance; correlation of reported ADRs with public events, regulatory announcements, and with publications. Comparing the pharmacological, pharmacokinetic, and clinical ADR profiles of methylphenidate, aripiprazole, and risperidone, and of kinase drugs targeting the VEGF receptor, demonstrates how underlying molecular mechanisms can emerge from ADR co-analysis. The precautions and methods we describe may enable investigators to avoid confounding chemistry-based associations and reporting biases in FAERS, and illustrate how comparative analysis of ADRs can reveal underlying mechanisms.

  4. Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets

    Science.gov (United States)

    Maciejewski, Mateusz; Lounkine, Eugen; Whitebread, Steven; Farmer, Pierre; DuMouchel, William; Shoichet, Brian K; Urban, Laszlo

    2017-01-01

    The Food and Drug Administration Adverse Event Reporting System (FAERS) remains the primary source for post-marketing pharmacovigilance. The system is largely un-curated, unstandardized, and lacks a method for linking drugs to the chemical structures of their active ingredients, increasing noise and artefactual trends. To address these problems, we mapped drugs to their ingredients and used natural language processing to classify and correlate drug events. Our analysis exposed key idiosyncrasies in FAERS, for example reports of thalidomide causing a deadly ADR when used against myeloma, a likely result of the disease itself; multiplications of the same report, unjustifiably increasing its importance; correlation of reported ADRs with public events, regulatory announcements, and with publications. Comparing the pharmacological, pharmacokinetic, and clinical ADR profiles of methylphenidate, aripiprazole, and risperidone, and of kinase drugs targeting the VEGF receptor, demonstrates how underlying molecular mechanisms can emerge from ADR co-analysis. The precautions and methods we describe may enable investigators to avoid confounding chemistry-based associations and reporting biases in FAERS, and illustrate how comparative analysis of ADRs can reveal underlying mechanisms. DOI: http://dx.doi.org/10.7554/eLife.25818.001 PMID:28786378

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

    Science.gov (United States)

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

    2013-01-01

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

  6. Adverse event reporting and patient safety at a University Hospital: Mapping, correlating and associating events for a data-based patient risk management.

    Science.gov (United States)

    Buja, Alessandra; Saieva, Anna Maria; Vinelli, Angela; Cacco, Rosaria Manola; Ottolitri, Ketty; De Battisti, Elisa; Dario, Claudio; Baldo, Vincenzo

    2016-09-17

    Reporting adverse events (AE) with a bearing on patient safety is fundamentally important to the identification and mitigation of potential clinical risks. The aim of this study was to analyze the AE reporting systems adopted at a university hospital for the purpose of enhancing the learning potential afforded by these systems. Retrospective cohort study Data were collected from different information flows (reports of incidents and falls, patients' claims and complaints, and cases of hospital-acquired infection [HAI]) at an university hospital. A composite risk indicator was developed to combine the data from the different flows. Spearman's nonparametric test was applied to investigate the correlation between the AE rates and a Poisson regression analysis to verify the association among characteristics of the wards and AE rates. Sixty-four wards at a University Hospital. There was a marked variability among wards AE rates. Correlations emerged between patients' claims with complaints and the number of incidents reported. Falls were positively associated with average length of hospital stay, number of beds, patients' mean age, and type of ward, and they were negatively associated with the average Cost Weight of the Diagnosis-related group (DRG) of patients on a given ward. Claims and complaints were associated directly with the average DRG weight of a ward's patient admissions. This study attempted to learn something useful from an analysis of the mandatory (but often little used) data flows generated on adverse events occurring at an university hospital with a view to managing the associated clinical risk to patients.

  7. Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan

    Directory of Open Access Journals (Sweden)

    Nobuhiro Handa

    2015-09-01

    Comments: Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential.

  8. [Adverse event reporting in an intensive care unit at Tunja, Colombia].

    Science.gov (United States)

    Riveros, Efraín; Amado, Paula; Zambrano, Paula

    2013-01-01

    Introducción: La seguridad de paciente en áreas hospitalarias críticas ha sido tema de diversas investigaciones. En este sentido, en Colombia está creciendo la conciencia acerca de la gestión de eventos adversos. Este estudio explora la primera fase de dicha gestión: el reporte en la unidad de cuidado intensivo de una institución privada prototipo. Objetivo: Evaluar el reporte de eventos adversos en una clínica colombiana de tercer nivel, a través de la estimación de frecuencias y categorías de los reportes. Material y Métodos: Se hizo un estudio descriptivo sobre la tasa de reporte de eventos adversos en la Clínica de los Andes de Tunja, durante 2011, a través de la estimación de frecuencias y categorías de los reportes.La tasa de reporte se definió como el número de reportes por 1000 días cama. Reportamos las categorías de los eventos adversos comomayores y menores. Resultados: Se registraron 383 admisiones a la UCI, correspondientes a 2374 días paciente. Se presentaron un total de 54 eventos adversos reportados (tasa de 22,74 por 1000 días paciente). El tipo de evento más frecuente fue el relacionado con vías intravenosas (55%)(IC 95% 50,1-58,3), seguido por desviación de procesos (22%)(IC 95% 18,2-26,1). Conclusiones: Se encontróuna tasa de reporte de eventos adversos en el rango superior de lo publicado en la literatura. Posiblemente exista aúnuna proporción no cuantificada de subregistro, que puede atribuirse principalmente a factores culturales.

  9. Childhood adversities, adulthood life events and depression.

    Science.gov (United States)

    Korkeila, Jyrki; Vahtera, Jussi; Nabi, Hermann; Kivimäki, Mika; Korkeila, Katariina; Sumanen, Markku; Koskenvuo, Karoliina; Koskenvuo, Markku

    2010-12-01

    The role of childhood adversities in predicting adulthood depression has been suggested to be complex and in need of additional comprehensive studies. This investigation set out to examine whether increased exposure to life events (LEs) in adulthood mediates the association between childhood adversities and adulthood depression. This study is based on a random health survey sample from the Finnish working-aged population (n=16,877) with a follow-up of up to 7 years. Depression was identified by Beck Depression Inventory, records of antidepressant prescriptions and hospitalization due to depression obtained from national health registers. Childhood adversities were associated with an increased likelihood of experiencing a high number of LEs in adulthood and their perceived burdensomeness. The mean number of new LEs correlated significantly (Pchildhood adversities. Reporting childhood adversities was associated with a 1.28-2.70-fold increase in the odds of depression as indicated by BDI score, a 1.29-1.94-fold increase in the rate of antidepressant prescriptions and a 1.17-4.04-fold increase in the risk of hospitalization due to depression. Adjustment for new LE attenuated these associations by 21-24%, but did not render them insignificant. Increased exposure to adult negative life events proximal to adult depression may partially explain the association between childhood adversities and adult depression. Copyright © 2010 Elsevier B.V. All rights reserved.

  10. Subdural Hematoma: An Adverse Event of Electroconvulsive Therapy—Case Report and Literature Review

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    Ranganath R. Kulkarni

    2012-01-01

    Full Text Available Electroconvulsive therapy (ECT is commonly used in the management of medication nonresponsive depressive disorder, with proven efficacy in psychiatric practice since many decades. A rare complication of intracranial bleed following this therapeutic procedure has been reported in sporadic case reports in the English literature. We report a case of such a complication in a 42-year-old male, a known case of nonorganic medication nonresponsive depressive disorder for the last two years who required ECT application. Presenting symptoms included altered mental state, urinary incontinence, and repeated episodes of vomiting; following ECT procedure with magnetic resonance imaging (MRI of the brain suggestive of bilateral acute subdural hematoma. Despite the view that it may be used in neurological conditions without raised intracranial tension, it will be worthwhile to be vigilant during post-ECT recovery for any emergent complications.

  11. Endoscopic retrograde cholangiopancreatography-related adverse events: general overview.

    Science.gov (United States)

    Rustagi, Tarun; Jamidar, Priya A

    2015-01-01

    Endoscopic retrograde cholangiopancreatography (ERCP) represents a monumental advance in the management of patients with pancreaticobiliary diseases, but is a complex and technically demanding procedure with the highest inherent risk of adverse events of all routine endoscopic procedures. Overall adverse event rates for ERCP are typically reported as 5-10%. The most commonly reported adverse events include post-ERCP pancreatitis, bleeding, perforation, infection (cholangitis), and cardiopulomary or "sedation related" events. This article evaluates patient-related and procedure-related risk factors for ERCP-related adverse events, and discusses strategies for the prevention, diagnosis and management of these events.

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

    Science.gov (United States)

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

    2013-06-01

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

  13. In situ simulation: Taking reported critical incidents and adverse events back to the clinic

    DEFF Research Database (Denmark)

    Juul, Jonas; Paltved, Charlotte; Krogh, Kristian

    2014-01-01

    Introduction In situ simulation offers a novel approach to training in the healthcare setting. It models clinical processes in a real clinical environment and provides the opportunity to correct errors and adjust team interactions without endangering patients. Training in the simulation laboratory...... does not tap into situational resources, e.g. individual, team, and organisational characteristics such as routines, personal relations, distributed skill-levels etc. Therefore, it fails to fully mimic real clinical team processes. Alternatively, in situ simulation offers a unique opportunity...... to explore and improve team processes in the clinical environment. Though research on in situ simulation in healthcare is in its infancy, literature is abundant on patient safety, medical simulation, team training and human factors1. Patient safety reporting systems that identify risks to patients can...

  14. Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination.

    Science.gov (United States)

    Parretta, Elisabetta; Ianniello, Benedetta; Ferrazin, Fernanda; Rossi, Francesco; Capuano, Annalisa

    2011-05-09

    According to European recommendations, the Italian Medicines Agency (AIFA) required close monitoring of the safety of the MF59-adjuvanted H1N1v vaccine, which was the only vaccine available in Italy for prophylaxis of the A/H1N1 (2009) pandemic influenza. From October 2009 to June 2010, the Italian Pharmacovigilance Adverse Event (AE) Spontaneous Reporting System [Rete Nazionale Farmacovigilanza] (RNF) received 1330 reports of AEs temporally related with the pandemic influenza vaccination out of a total of 924,057 doses administered. Among these, 1,162 (87.37%) AE reports were classified 'non serious', 91 (6.84%) 'serious', 3 (0.23%) had a fatal outcome and 74 (5.56%) did not include the degree of seriousness. Among the serious AE reports, some unexpected AEs emerged. Even though some typical vaccine safety issues which emerged should be further explored, such as vaccination in pregnancy, the analysis of all AE reports sent to RNF shows that the vaccine has a well-tolerated safety profile which resembles that of the already available seasonal influenza vaccines. This contrasts with the widespread public concern about its safety, which has been one of the major causes of the low vaccination rate observed in Italy, as well as in other countries.

  15. Association of different cognitive domains with lifetime history of psychosis and reported antipsychotic-treatment adverse events in bipolar disorders

    Directory of Open Access Journals (Sweden)

    Kałwa, Agnieszka

    2013-06-01

    Full Text Available Aim of the study. The present work aimed to assess the association between cognitive functions, the lifetime occurrence of psychotic symptoms, and reported adverse effects of antipsychotic treatments inpatients with bipolar disorders.Methods. In the present work, 44 bipolar disorder inpatients hospitalized in the Affective Disorders Unit of the Institute of Psychiatry and Neurology in Warsaw, were investigated. All of them met the criteria of remission and were prepared for release from the hospital unit. Twenty-two patients were hospitalized in the manic stage of the illness, and 22 were in the depressive stage of illness. Both groups were assessed using adequate psychiatric rating scales (HDRS or YMRS and CAMRS and neuropsychological tests (WCST, TMT, Stroop Test and Verbal Fluency Test.Results. Patients who had a prior history of psychotic symptoms had poorer verbal functioning in comparison to subjects without such a history. However, individuals hospitalized in the manic state of disease, and who reported more adverse events after antipsychotic medication during the whole course of illness, had worse results in some parameters of executive function measurements in the WCST test, namely occurring in a greater percentage of nonperseverative errors and a lower number of completed categories.Discussion. Generally the results confirm findings according to which, patients with the history of psychosis performe worse on neurocognitive tasks. However, the nature of dysfunctions found, generates questions about its relations with the experience of psychosis and antipsychotic treatment. Conclusion: Different aspects of cognitive dysfunctions may be related to the experience of psychosis and antipsychotic treatment in patients with bipolar disorders.

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

    Science.gov (United States)

    Xu, Rong; Wang, Quanqiu

    2014-02-01

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

  17. Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™).

    Science.gov (United States)

    Hagelstein, V; Ortland, I; Wilmer, A; Mitchell, S A; Jaehde, U

    2016-12-01

    Integrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated. A German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques. Of 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life. A set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of

  18. Adverse events following immunisation under the National Vaccination Programme of the Netherlands. Number XII - Reports in 2005

    NARCIS (Netherlands)

    Maas NAT van der; Phaff TAJ; Wesselo C; Dzaferagic A; Vermeer-de Bondt PE; CIE

    2007-01-01

    Adverse events following immunisation (AEFI) in the National Vaccination Programme of the Netherlands (RVP) have been monitored through an enhanced passive surveillance system by RIVM since 1962. From 1984 until 2003 evaluation has been done in close collaboration with the Health Council. An RIVM ex

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

    NARCIS (Netherlands)

    Chan, A.; Cameron, M.C.; Garden, B.; Boers-Doets, C.B.; Schindler, K.; Epstein, J.B.; Choi, J.; Beamer, L.; Roeland, E.; Russi, E.G.; Bensadoun, R.J.; Teo, Y.L.; Chan, R.J.; Shih, V.; Bryce, J.; Raber-Durlacher, J.; Gerber, P.A.; Freytes, C.O.; Rapoport, B.; LeBoeuf, N.; Sibaud, V.; Lacouture, M.E.

    2015-01-01

    Purpose Dermatologic adverse events (dAEs) in cancer treatment are frequent with the use of targeted therapies. These dAEs have been shown to have significant impact on health-related quality of life (HRQoL). While standardized assessment tools have been developed for physicians to assess severity o

  20. Adverse Events Following Immunisation under the National Vaccination Programme of The Netherlands Number XI - Reports in 2004

    NARCIS (Netherlands)

    Vermeer-de Bondt PE; Dzaferagic A; Phaff TAJ; Wesselo C; Maas NAT van der; CIE

    2006-01-01

    Adverse events following immunisation (AEFI) in the National Vaccination Programme of the Netherlands (RVP) have been monitored through an enhanced passive surveillance system by RIVM since 1962. From 1984 until 2003 evaluation has been done in close collaboration with the Health Council. An RIVM ex

  1. Hospital deaths and adverse events in Brazil

    Directory of Open Access Journals (Sweden)

    Pavão Ana Luiza B

    2011-09-01

    Full Text Available Abstract 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.

  2. Exploration of the association rules mining technique for the signal detection of adverse drug events in spontaneous reporting systems.

    Directory of Open Access Journals (Sweden)

    Chao Wang

    Full Text Available BACKGROUND: The detection of signals of adverse drug events (ADEs has increased because of the use of data mining algorithms in spontaneous reporting systems (SRSs. However, different data mining algorithms have different traits and conditions for application. The objective of our study was to explore the application of association rule (AR mining in ADE signal detection and to compare its performance with that of other algorithms. METHODOLOGY/PRINCIPAL FINDINGS: Monte Carlo simulation was applied to generate drug-ADE reports randomly according to the characteristics of SRS datasets. Thousand simulated datasets were mined by AR and other algorithms. On average, 108,337 reports were generated by the Monte Carlo simulation. Based on the predefined criterion that 10% of the drug-ADE combinations were true signals, with RR equaling to 10, 4.9, 1.5, and 1.2, AR detected, on average, 284 suspected associations with a minimum support of 3 and a minimum lift of 1.2. The area under the receiver operating characteristic (ROC curve of the AR was 0.788, which was equivalent to that shown for other algorithms. Additionally, AR was applied to reports submitted to the Shanghai SRS in 2009. Five hundred seventy combinations were detected using AR from 24,297 SRS reports, and they were compared with recognized ADEs identified by clinical experts and various other sources. CONCLUSIONS/SIGNIFICANCE: AR appears to be an effective method for ADE signal detection, both in simulated and real SRS datasets. The limitations of this method exposed in our study, i.e., a non-uniform thresholds setting and redundant rules, require further research.

  3. Adverse events reported for hereditary angioedema medications: a retrospective study of spontaneous reports submitted to the EudraVigilance database, 2007-2013

    Directory of Open Access Journals (Sweden)

    Aagaard L

    2016-05-01

    Full Text Available Lise Aagaard,1 Anette Bygum,2 1Section for Clinical Pharmacology, Institute of Public Health, Faculty of Health Sciences, University of Southern Denmark, 2Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark Abstract: Information about long-term safety issues from use of orphan drugs in treatment of hereditary angioedema (HAE is limited and must be studied further. As clinical trials in patients with rare diseases are limited, prescribers and patients have to rely on spontaneous adverse drug reaction (ADR reports for obtaining major information about the serious, rarely occurring, and unknown ADRs. In this study, we aimed to characterize ADRs reported for HAE medications in Europe from 2007 to 2013. ADR reports submitted for C1-inibitors and bradykinin receptor antagonists to the European ADR database, EudraVigilance (EV, were included in this study. The ADR reports were categorized with respect to age and sex of the patients, category of the reporter, type and seriousness of the reported ADRs, and medications. The unit of analysis was one adverse event (AE. Totally, 187 AEs were located in EV, and of these, 138 AEs were reported for Cinryze® (C1-inhibitor (73% of the total and 49 AEs for Firazyr® (icatibant (26% of the total AEs. Approximately 60% of all AEs were serious, including three fatal cases. Less than 5% of AEs were reported in children. In total, 62% of AEs were reported for women and 38% for men. For both Cinryze® and Firazyr®, the majority of reported AEs were of the type “general disorders and administration site conditions”. For Cinryze®, a large number of AEs of the type “HAE” and “drug ineffective” was reported, but only few of these were serious. For Firazyr®, several nonserious reports on injection site reactions were reported. In conclusion, this study showed that in EV, several ADR reports from use of HAE medications were identified, and a large number of these were

  4. Predictors of adverse events after endovascular abdominal aortic aneurysm repair: A meta-analysis of case reports

    Directory of Open Access Journals (Sweden)

    Schlösser Felix JV

    2008-09-01

    Full Text Available Abstract Introduction Endovascular abdominal aortic aneurysm repair is a life-saving intervention. Nevertheless, complications have a major impact. We review the evidence from case reports for risk factors of complications after endovascular abdominal aortic aneurysm repair. Case presentation We selected case reports from PubMed reporting original data on adverse events after endovascular abdominal aortic aneurysm repair. Extracted risk factors were: age, sex, aneurysm diameter, comorbidities, re-interventions, at least one follow-up visit being missed or refusal of a re-intervention by the patient. Extracted outcomes were: death, rupture and (non-device-related complications. In total 113 relevant articles were selected. These reported on 173 patients. A fatal outcome was reported in 15% (N = 26 of which 50% came after an aneurysm rupture (N = 13. Non-fatal aneurysm rupture occurred in 15% (N = 25. Endoleaks were reported in 52% of the patients (N = 90. In half of the patients with a rupture no prior endoleak was discovered during follow-up. In 83% of the patients one or more re-interventions were performed (N = 143. Mortality was higher among women (risk ratio 2.9; 95% confidence interval 1.4 to 6.0, while the presence of comorbidities was strongly associated with both ruptures (risk ratio 1.6; 95% confidence interval 0.9 to 2.9 and mortality (risk ratio 2.1; 95% confidence interval 1.0 to 4.7. Missing one or more follow-up visits (≥1 or refusal of a re-intervention by the patient was strongly related to both ruptures (risk ratio 4.7; 95% confidence interval 3.1 to 7.0 and mortality (risk ratio 3.8; 95% confidence interval 1.7 to 8.3. Conclusion Female gender, the presence of comorbidities and at least one follow-up visit being missed or refusal of a re-intervention by the patient appear to increase the risk for mortality after endovascular abdominal aortic aneurysm repair. Larger aneurysm diameter, higher age and multimorbidity at the time

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

    Science.gov (United States)

    Ohyama, Katsuhiro; Inoue, Michiko

    2016-01-01

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

  6. Development of a Pediatric Adverse Events Terminology

    Science.gov (United States)

    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

  7. Development of a Pediatric Adverse Events Terminology.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2013-01-01

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

  9. Pro-arrhythmic potential of oral antihistamines (H1: combining adverse event reports with drug utilization data across Europe.

    Directory of Open Access Journals (Sweden)

    Elisabetta Poluzzi

    Full Text Available There is appreciable utilisation of antihistamines (H1 in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in '90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines.To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS with drug utilization data from 13 European Countries.We identified signals of antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP, QT abnormalities (QTabn, ventricular arrhythmia (VA and sudden cardiac death/cardiac arrest (SCD/CA. Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance.Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, loratadine and 6 in weaker signals (alimemazine, carbinoxamine, cyclizine, cyproeptadine, dexchlorpheniramine and doxylamine. Exposure to antihistamines with stronger signal was markedly different across European countries and was at least 40% in each Country. Cetirizine was >29 Defined Daily Doses per 1000 inhabitants per day (DID in Norway, desloratadine >11 DID in France and loratadine >9 DID in Sweden and Croatia. Drugs with weaker signals accounted for no more than 10% (in Sweden and in most European countries their use was negligible.Some second-generation antihistamines are associated with signal of torsadogenicity and largely used in most European countries. Although confirmation by analytical studies is required, regulators

  10. Pro-Arrhythmic Potential of Oral Antihistamines (H1): Combining Adverse Event Reports with Drug Utilization Data across Europe

    Science.gov (United States)

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

    2015-01-01

    Background There is appreciable utilisation of antihistamines (H1) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in ’90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines. Aim To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS) with drug utilization data from 13 European Countries. Methods We identified signals of antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP), QT abnormalities (QTabn), ventricular arrhythmia (VA) and sudden cardiac death/cardiac arrest (SCD/CA). Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance. Results Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, loratadine) and 6 in weaker signals (alimemazine, carbinoxamine, cyclizine, cyproeptadine, dexchlorpheniramine and doxylamine). Exposure to antihistamines with stronger signal was markedly different across European countries and was at least 40% in each Country. Cetirizine was >29 Defined Daily Doses per 1000 inhabitants per day (DID) in Norway, desloratadine >11 DID in France and loratadine >9 DID in Sweden and Croatia. Drugs with weaker signals accounted for no more than 10% (in Sweden) and in most European countries their use was negligible. Conclusions Some second-generation antihistamines are associated with signal of torsadogenicity and largely used in most European countries. Although confirmation by

  11. Application and Problems of Medical Adverse Event Reporting System%医疗不良事件报告系统的应用与问题

    Institute of Scientific and Technical Information of China (English)

    王宏; 王志国; 周山; 郝秋星; 欧益伊

    2015-01-01

    目的:建立科学的医疗不良事件报告系统并使之有效运行。方法借鉴SH9医疗不良事件分级法,建立符合医院实际情况的标准化工作流程,以鼓励主动报告为手段提升上报率。结果2014年度共上报医疗不良事件289例,其中近半数为隐患事件,事件归因多集中在患者服务流程及护理服务质量方面,事件处理两周内整改完成率为86.45%,事件教训分享53例。结论统一的事件分级加归因分类、方便快捷的网报途径、自觉自愿的责任意识驱动上报、及时切实地解决问题是保障医疗不良事件报告系统有效运行的关键所在。%Objective To establish a medical adverse event reporting system and make it run efficiently. Methods Based on SH9 medical adverse events classification, the reporting system and standardized work protocol were established to process medical adverse event.Results 289 medical adverse events were reported, nearly half of the events were near-miss events.The events are mostly concentrated in the patient care process and services. 86.45%of the improvement measures were executed within two weeks, and experience of 53 events were shared. Conclusion The standards of events classification, convenient way of network reported, the sense of responsibility and timely event solve were the keys of medical adverse event reporting system.

  12. Adverse events after hepatitis A B combination vaccine.

    Science.gov (United States)

    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.

  13. FALLING OF SENILE AGE PATIENT AS AN ADVERSE EVENT ASSOCIATED WITH THE USE OF MEDICINES: CASE REPORT

    Directory of Open Access Journals (Sweden)

    E. S. Ilina

    2017-01-01

    Full Text Available The article presents a case report of 86 years old patient S. (woman, hospitalized in the ophthalmology department of the hospital with a diagnosis of “complicated immature cataract of the left eye, open-angle glaucoma, age-related macular degeneration”. The patient experienced an episode of a fall with a short-term loss of consciousness, severe hypotension (blood pressure – 40/10 mmHg, and bradycardia (heart rate – 32 beats/min while receiving a local form of beta-blocker in combination with diuretics. In this clinical case, the development of serious adverse reaction is significantly associated with adverse drug interaction (according to Horn-Hansten scale.

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

    Science.gov (United States)

    Kose, Eiji; Uno, Kana; Hayashi, Hiroyuki

    2017-01-01

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

  15. Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    DEFF Research Database (Denmark)

    Bæksted, Christina; Nissen, Aase; Pappot, Helle

    2016-01-01

    CONTEXT: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) to i......CONTEXT: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO...

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

    Science.gov (United States)

    Chamberlain, Nick

    2008-09-22

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

  17. Adverse events associated with pediatric exposures to dextromethorphan.

    Science.gov (United States)

    Paul, Ian M; Reynolds, Kate M; Kauffman, Ralph E; Banner, William; Bond, G Randall; Palmer, Robert B; Burnham, Randy I; Green, Jody L

    2017-01-01

    Dextromethorphan is the most common over-the-counter (OTC) antitussive medication. We sought to characterize adverse events associated with dextromethorphan in children <12 years old from a surveillance program of OTC cough/cold medication exposures. This is a retrospective case series of oral exposures to dextromethorphan with ≥1 adverse event from multiple U.S. sources (National Poison Data System, FDA Adverse Event Reporting System, manufacturer safety reports, news/media, medical literature) reported between 2008 and 2014. An expert panel determined the relationship between exposure and adverse events, estimated dose ingested, intent of exposure, and identified contributing factors to exposure. 1716 cases contained ≥1 adverse event deemed at least potentially related to dextromethorphan; 1417 were single product exposures. 773/1417 (55%) involved only one single-ingredient dextromethorphan product (dextromethorphan-only). Among dextromethorphan-only cases, 3% followed ingestion of a therapeutic dose; 78% followed an overdose. 69% involved unsupervised self-administration and 60% occurred in children <4 years old. No deaths or pathologic dysrhythmias occurred. Central nervous system [e.g., ataxia (N = 420)] and autonomic symptoms [e.g., tachycardia (N = 224)] were the most common adverse events. Flushing and/or urticarial rash occurred in 18.1% of patients. Dystonia occurred in 5.4%. No fatalities were identified in this multifaceted surveillance program following a dextromethorphan-only ingestion. Adverse events were predominantly associated with overdose, most commonly affecting the central nervous and autonomic systems.

  18. Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study

    OpenAIRE

    Hughes, S; Cohen, D.; Jaggi, R

    2014-01-01

    Objective: To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies. Design: Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles. Setting: Clinicalstudyresults.org, sponsored by Pharmaceutical Research and M...

  19. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax in the Vaccine Adverse Event Reporting System (VAERS in the United States, 1990‒2015.

    Directory of Open Access Journals (Sweden)

    Pedro L Moro

    2016-07-01

    Full Text Available In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur, was licensed for use in the United States.To assess adverse events (AEs after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS, a spontaneous reporting surveillance system.We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness, and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS. Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB data mining was used to identify disproportional AE reporting after HDCV.VAERS received 1,611 reports after HDCV; 93 (5.8% were serious. Among all reports, the three most common AEs included pyrexia (18.2%, headache (17.9%, and nausea (16.5%. Among serious reports, four deaths appeared to be unrelated to vaccination.This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.

  20. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015

    Science.gov (United States)

    Moro, Pedro L.; Woo, Emily Jane; Paul, Wendy; Lewis, Paige; Petersen, Brett W.; Cano, Maria

    2016-01-01

    Background In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. Objective To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990–July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. PMID:27410239

  1. Practical management of adverse events related to apomorphine therapy

    DEFF Research Database (Denmark)

    Bhidayasiri, Roongroj; Garcia Ruiz, Pedro J; Henriksen, Tove

    2016-01-01

    The potential for adverse events is often cited as a barrier to the use of subcutaneous apomorphine therapy (intermittent injections and continuous infusion) in the management of Parkinson's disease. However, with proactive management most adverse effects are manageable if reported and tackled...... titration, initiation and long-term treatment, and discuss practical management strategies....

  2. Febrile pleuropericarditis, a potentially life-threatening adverse event of balsalazide--case report and literature review of the side effects of 5-aminosalicylates.

    Science.gov (United States)

    Coman, Roxana M; Glover, Sarah C; Gjymishka, Altin

    2014-05-01

    Ulcerative colitis (UC) is an idiopathic chronic inflammatory disorder that affects the colonic mucosa. One class among the drugs used for its treatment is the 5-aminosalicylates (5-ASAs). While highly efficacious in treating mild-to-moderate UC, 5-ASAs are associated with rare but potentially life-threatening side effects such as pericarditis, myocarditis and pneumonitis. These adverse events appear to be caused by a hypersensitivity reaction and resolve after cessation of 5-ASA drugs. This article presents a case report of febrile pleuropericarditis in a UC patient treated with balsalazide, and provides a thorough literature review of the rare side effects of 5-ASAs, their incidence, clinical presentation, differential diagnosis and treatment. In conclusion, the clinicians should be aware that this type of adverse events to 5-ASA compounds can be easily overlooked but it has significant morbidity if not promptly diagnosed.

  3. Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients

    Directory of Open Access Journals (Sweden)

    Kirschner Stephan

    2010-08-01

    Full Text Available Abstract Purpose Identification of all common and potentially avoidable adverse events is crucial to further improve the quality of medical care. The intention of the current study was to evaluate a standardized physician independent survey format on adverse events in total knee arthroplasty. The protocol for reporting adverse drug events following the International Conference of Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH was adopted for adverse events occurring during surgical interventions. Material and methods Data of a prospective sequential cohort trial introducing a clinical pathway for total knee arthroplasty was analysed. Reporting of adverse events was done by a physician independent study nurse using the modified ICH-Good Clinical Practice (GCP format (Structure and Content of Clinical study reports - E3 in 260 patients. The adverse events were graded to their severity and their potential relation to surgical treatment. Results A total of 55 patients (21% suffered from an adverse event and 16 (6% from a serious adverse event. In 38 patients' one adverse event occurred, 12 patients showed 2 adverse events and 5 patients suffered from a combination of an adverse and a serious adverse event. A serious adverse event alone occurred in 11 patients. The incidence of adverse events (Fisher p = 0.448 and serious adverse (p = 0.126 events showed no significant difference between the two cohorts. The most common adverse events were deep vein thrombosis (8% and 5% followed by wound healing problems (1% and 0% and haematoma (1% and 3%. A wide range of non surgical adverse events were recorded with low incidence levels. Conclusion The use of the modified ICH-GCP format supports standardization of adverse event reporting. Routine assessment of adverse events by a study nurse revealed higher incidence rates of adverse events in total knee arthroplasty. We recommend the implementation of trained

  4. Major adverse cardiac events during endurance sports.

    Science.gov (United States)

    Belonje, Anne; Nangrahary, Mary; de Swart, Hans; Umans, Victor

    2007-03-15

    Major adverse cardiac events in endurance exercise are usually due to underlying and unsuspected heart disease. The investigators present an analysis of major adverse cardiac events that occurred during 2 consecutive annual long distance races (a 36-km beach cycling race and a 21-km half marathon) over the past 5 years. All patients with events were transported to the hospital. Most of the 62,862 participants were men (77%; mean age 40 years). Of these, 4 men (3 runners, 1 cyclist; mean age 48 years) collapsed during (n = 2) or shortly after the races, rendering a prevalence of 0.006%. Two patients collapsed after developing chest pain, 1 of whom needed resuscitation at the event site, which was successful. These patients had acute myocardial infarctions and underwent primary angioplasty. The third patient was resuscitated at the site but did not have coronary disease or inducible ventricular tachycardia or ventricular fibrillation and collapsed presumably because of catecholamine-induced ventricular fibrillation. The fourth patient experienced heat stroke and had elevated creatine kinase-MB and troponins in the absence of electrocardiographic changes. In conclusion, the risk for major adverse cardiac events during endurance sports in well-trained athletes is very low.

  5. A database in ACCESS for assessing vaccine serious adverse events

    OpenAIRE

    Thomas RE; Jackson D.

    2015-01-01

    Roger E Thomas,1 Dave Jackson2,3 1Department of Family Medicine, G012 Health Sciences Centre, University of Calgary Medical School, Calgary, AB, Canada; 2Independent Research Consultant, Calgary, AB, Canada; 3Database Consultant, University of Calgary, Calgary, AB, Canada Purpose: To provide a free flexible database for use by any researcher for assessing reports of adverse events after vaccination. Results: A database was developed in Microsoft ACCESS to assess reports of serious adverse ev...

  6. Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Science.gov (United States)

    Reeve, Bryce B.; Mitchell, Sandra A.; Clauser, Steven B.; Minasian, Lori M.; Dueck, Amylou C.; Mendoza, Tito R.; Hay, Jennifer; Atkinson, Thomas M.; Abernethy, Amy P.; Bruner, Deborah W.; Cleeland, Charles S.; Sloan, Jeff A.; Chilukuri, Ram; Baumgartner, Paul; Denicoff, Andrea; St. Germain, Diane; O’Mara, Ann M.; Chen, Alice; Kelaghan, Joseph; Bennett, Antonia V.; Sit, Laura; Rogak, Lauren; Barz, Allison; Paul, Diane B.; Schrag, Deborah

    2014-01-01

    The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute’s (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research. PMID:25265940

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

    Science.gov (United States)

    Basch, Ethan; Reeve, Bryce B; Mitchell, Sandra A; Clauser, Steven B; Minasian, Lori M; Dueck, Amylou C; Mendoza, Tito R; Hay, Jennifer; Atkinson, Thomas M; Abernethy, Amy P; Bruner, Deborah W; Cleeland, Charles S; Sloan, Jeff A; Chilukuri, Ram; Baumgartner, Paul; Denicoff, Andrea; St Germain, Diane; O'Mara, Ann M; Chen, Alice; Kelaghan, Joseph; Bennett, Antonia V; Sit, Laura; Rogak, Lauren; Barz, Allison; Paul, Diane B; Schrag, Deborah

    2014-09-01

    The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research. © The Author 2014. Published by Oxford University Press. All

  8. A database in ACCESS for assessing vaccine serious adverse events

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas,1 Dave Jackson2,3 1Department of Family Medicine, G012 Health Sciences Centre, University of Calgary Medical School, Calgary, AB, Canada; 2Independent Research Consultant, Calgary, AB, Canada; 3Database Consultant, University of Calgary, Calgary, AB, Canada Purpose: To provide a free flexible database for use by any researcher for assessing reports of adverse events after vaccination. Results: A database was developed in Microsoft ACCESS to assess reports of serious adverse events after yellow fever vaccination using Brighton Collaboration criteria. The database is partly automated (if data panels contain identical data fields the data are automatically also entered into those fields. The purpose is to provide the database free for developers to add additional panels to assess other vaccines. Keywords: serious adverse events after vaccination, database, process to assess vaccine-associated events 

  9. Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland.

    Science.gov (United States)

    Aiken, Abigail R A; Digol, Irena; Trussell, James; Gomperts, Rebecca

    2017-05-16

    Objectives To assess self reported outcomes and adverse events after self sourced medical abortion through online telemedicine.Design Population based study.Setting Republic of Ireland and Northern Ireland, where abortion is unavailable through the formal healthcare system except in a few restricted circumstances.Population 1000 women who underwent self sourced medical abortion through Women on Web (WoW), an online telemedicine service, between 1 January 2010 and 31 December 2012.Main outcome measures Successful medical abortion: the proportion of women who reported ending their pregnancy without surgical intervention. Rates of adverse events: the proportion who reported treatment for adverse events, including receipt of antibiotics and blood transfusion, and deaths reported by family members, friends, or the authorities. Care seeking for symptoms of potential complications: the frequency with which women reported experiencing symptoms of a potentially serious complication and the proportion who reported seeking medical attention as advised.Results In 2010-12, abortion medications (mifepristone and misoprostol) were sent to 1636 women and follow-up information was obtained for 1158 (71%). Among these, 1023 women confirmed use of the medications, and follow-up information was available for 1000. At the time women requested help from WoW, 781 (78%) were <7 weeks pregnant and 219 (22%) were 7-9 weeks pregnant. Overall, 94.7% (95% confidence interval 93.1% to 96.0%) reported successfully ending their pregnancy without surgical intervention. Seven women (0.7%, 0.3% to 1.5%) reported receiving a blood transfusion, and 26 (2.6%, 1.7% to 3.8%) reported receiving antibiotics (route of administration (IV or oral) could not be determined). No deaths resulting from the intervention were reported by family, friends, the authorities, or the media. Ninety three women (9.3%, 7.6% to 11.3%) reported experiencing any symptom for which they were advised to seek medical advice

  10. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium.

    Science.gov (United States)

    Cravero, Joseph P; Beach, Michael L; Blike, George T; Gallagher, Susan M; Hertzog, James H

    2009-03-01

    We used a large database of prospectively collected data on pediatric sedation/anesthesia outside the operating room provided by a wide range of pediatric specialists to delineate the nature and frequency of adverse events associated with propofol-based sedation/anesthesia care. Data were collected by the Pediatric Sedation Research Consortium, a collaborative group of institutions dedicated to improving sedation/anesthesia care for children internationally. Members prospectively enrolled consecutive patients receiving sedation or sedation/anesthesia for procedures. The primary inclusion criterion was the need for some form of sedation/anesthesia to perform a diagnostic or therapeutic procedure outside the operating room. There were no exclusion criteria. Data on demographics, primary illness, coexisting illness, procedure performed, medications used, procedure and recovery times, medication doses outcomes of anesthesia, airway interventions and adverse events were collected and reported using web-based data collection tool. For this study, we evaluated all instances where propofol was used as the primary drug in the sedation/anesthesia technique. Thirty-seven locations submitted data on 49,836 propofol sedation/anesthesia encounters during the study period from July 1, 2004 until September 1, 2007. There were no deaths. Cardiopulmonary resuscitation was required twice. Aspiration during sedation/anesthesia occurred four times. Less serious events were more common with O(2) desaturation below 90% for more than 30 s, occurring 154 times per 10,000 sedation/anesthesia administrations. Central apnea or airway obstruction occurred 575 times per 10,000 sedation/anesthesia administrations. Stridor, laryngospasm, excessive secretions, and vomiting had frequencies of 50, 96, 341, and 49 per 10,000 encounters, respectively. Unexpected admissions (increases in levels of care required) occurred at a rate of 7.1 per 10,000 encounters. In an unadjusted analysis, the rate of

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

    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).

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

    Science.gov (United States)

    Allen, Elizabeth N; Mushi, Adiel K; Massawe, Isolide S; Vestergaard, Lasse S; Lemnge, Martha; Staedke, Sarah G; Mehta, Ushma; Barnes, Karen I; Chandler, Clare I R

    2013-11-14

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

  14. Significant adverse events and outcomes after medical abortion.

    Science.gov (United States)

    Cleland, Kelly; Creinin, Mitchell D; Nucatola, Deborah; Nshom, Montsine; Trussell, James

    2013-01-01

    To analyze rates of significant adverse events and outcomes in women having a medical abortion at Planned Parenthood health centers in 2009 and 2010 and to identify changes in the rates of adverse events and outcomes between the 2 years. In this database review we analyzed data from Planned Parenthood affiliates that provided medical abortion in 2009 and 2010 almost exclusively using an evidence-based buccal misoprostol regimen. We evaluated the incidence of six clinically significant adverse events (hospital admission, blood transfusion, emergency department treatment, intravenous antibiotics administration, infection, and death) and two significant outcomes (ongoing pregnancy and ectopic pregnancy diagnosed after medical abortion treatment was initiated). We calculated an overall rate as well as rates for each event and identified changes between the 2 years. Among 233,805 medical abortions provided in 2009 and 2010, significant adverse events or outcomes were reported in 1,530 cases (0.65%). There was no statistically significant difference in overall rates between years. The most common significant outcome was ongoing intrauterine pregnancy (0.50%); significant adverse events occurred in 0.16% of cases. One patient death occurred as a result of an undiagnosed ectopic pregnancy. Only rates for emergency department treatment and blood transfusion differed by year and were slightly higher in 2010. Review of this large data set reinforces the safety of the evidence-based medical abortion regimen. III.

  15. Medical adverse events in elderly hospitalized patients: a prospective study

    Directory of Open Access Journals (Sweden)

    Claudia Szlejf

    2012-11-01

    Full Text Available OBJECTIVES: To determine the frequency of medical adverse events in elderly patients admitted to an acute care geriatric unit, the predictive factors of occurrence, and the correlation between adverse events and hospital mortality rates. METHODS: This prospective study included 171 admissions of patients aged 60 years and older in the acute care geriatric unit in a teaching hospital in Brazil between 2007 and 2008. The following variables were assessed at admission: the patient age, gender, number of prescription drugs, geriatric syndromes (e.g., immobility, postural instability, dementia, depression, delirium, and incontinence, comorbidities, functional status (evaluated with the Katz Index of Independence in Activities of Daily Living, and severity of illness (evaluated with the Simplified Acute Physiology Score Il. The incidence of delirium, infection, mortality, and the prescription of potentially inappropriate medications (based on the Beers criteria were assessed during hospitalization. An observer who was uninvolved in patient care reported the adverse events. RESULTS: The mean age of the sample was 78.12 years. A total of 187 medical adverse events occurred in 94 admissions (55%. The predictors of medical adverse events were undetermined. Compared with the patients with no adverse events, the patients with medical adverse events had a significantly longer hospital stay (21.41 ± 15.08 days versus 10.91 ± 7.21 days and a higher mortality rate (39 deaths [41.5%] versus 17 deaths [22.1%]. Mortality was significantly predicted by the Simplified Acute Physiology Score II score (odds ratio [OR] = 1.13, confidence interval [CI] 95%, 1.07 to 1.20, the Katz score (OR=1.47, CI 95%, 1.18 to 1.83, and medical adverse events (OR = 3.59, CI 95%, 1.55 to 8.30. CONCLUSION: Medical adverse events should be monitored in every elderly hospitalized patient because there is no risk profile for susceptible patients, and the consequences of adverse events are

  16. Disclosure of Adverse Events in Pediatrics.

    Science.gov (United States)

    2016-12-01

    Despite increasing attention to issues of patient safety, preventable adverse events (AEs) continue to occur, causing direct and consequential injuries to patients, families, and health care providers. Pediatricians generally agree that there is an ethical obligation to inform patients and families about preventable AEs and medical errors. Nonetheless, barriers, such as fear of liability, interfere with disclosure regarding preventable AEs. Changes to the legal system, improved communications skills, and carefully developed disclosure policies and programs can improve the quality and frequency of appropriate AE disclosure communications. Copyright © 2016 by the American Academy of Pediatrics.

  17. The contribution of the vaccine adverse event text mining system to the classification of possible Guillain-Barré syndrome reports.

    Science.gov (United States)

    Botsis, T; Woo, E J; Ball, R

    2013-01-01

    We previously demonstrated that a general purpose text mining system, the Vaccine adverse event Text Mining (VaeTM) system, could be used to automatically classify reports of an-aphylaxis for post-marketing safety surveillance of vaccines. To evaluate the ability of VaeTM to classify reports to the Vaccine Adverse Event Reporting System (VAERS) of possible Guillain-Barré Syndrome (GBS). We used VaeTM to extract the key diagnostic features from the text of reports in VAERS. Then, we applied the Brighton Collaboration (BC) case definition for GBS, and an information retrieval strategy (i.e. the vector space model) to quantify the specific information that is included in the key features extracted by VaeTM and compared it with the encoded information that is already stored in VAERS as Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs). We also evaluated the contribution of the primary (diagnosis and cause of death) and secondary (second level diagnosis and symptoms) diagnostic VaeTM-based features to the total VaeTM-based information. MedDRA captured more information and better supported the classification of reports for GBS than VaeTM (AUC: 0.904 vs. 0.777); the lower performance of VaeTM is likely due to the lack of extraction by VaeTM of specific laboratory results that are included in the BC criteria for GBS. On the other hand, the VaeTM-based classification exhibited greater specificity than the MedDRA-based approach (94.96% vs. 87.65%). Most of the VaeTM-based information was contained in the secondary diagnostic features. For GBS, clinical signs and symptoms alone are not sufficient to match MedDRA coding for purposes of case classification, but are preferred if specificity is the priority.

  18. 医疗安全(不良)事件报告制度的实施与构想%Implementation and Ideas of Medical Safety (Adverse) Event Reporting System

    Institute of Scientific and Technical Information of China (English)

    安建辉

    2015-01-01

    Objective To study the medical safety event reporting system (adverse) and the problems in the implementation effect.MethodsA retrospective analysis of hospital medical safety event reporting system (adverse), and analyze the data.Results Medical adverse events reports the number of cases is on the rise, mainly adverse report events caused no serious consequences, severe chamber and emergency proportion of adverse event reporting is significantly higher than other hospital departments, some nursing adverse event reporting is relatively high.Conclusion There are more medical hospital adverse event reports, the implementation of medical safety event reporting system (adverse), can effectively improve the hospital health care system and hospital risk prevention consciousness.%目的:研究医疗安全(不良)事件报告制度中存在的问题及实施的效果。方法回顾性分析医院医疗安全(不良)事件报告制度的实施,并分析其中的数据。结果医疗不良事件的报告例数呈上升趋势,主要是不良报告事件未造成严重的后果,重症室及急诊科的不良事件报告比例明显比医院其他的科室高,护理人员的不良事件报告相对较高。结论医院存在较多的医疗不良事件报告,实施医疗安全(不良)事件报告制度,能有效改进医院的医疗系统及医院风险防范意识。

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

    Science.gov (United States)

    Donn, Steven M; McDonnell, William M

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Alexander Rozental

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

  1. Reports of Perceived Adverse Events of Stimulant Medication on Cognition, Motivation, and Mood: Qualitative Investigation and the Generation of Items for the Medication and Cognition Rating Scale

    NARCIS (Netherlands)

    Kovshoff, H.; Banaschewski, T.; Buitelaar, J.K.; Carucci, S.; Coghill, D.; Danckaerts, M.; Dittmann, R.W.; Falissard, B.; Grimshaw, D.G.; Hollis, C.; Inglis, S.; Konrad, K.; Liddle, E.; McCarthy, S.; Nagy, P.; Thompson, M.; Wong, I.C.; Zuddas, A.; Sonuga-Barke, E.J.

    2016-01-01

    OBJECTIVE: There is no questionnaire to specifically monitor perceived adverse events of methylphenidate (MPH) on cognition, motivation, and mood. The current study therefore had two goals. First, to harvest accounts of such putative events from transcripts of interviews in samples enriched for such

  2. Sharing adverse drug event data using business intelligence technology.

    Science.gov (United States)

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

    2009-03-01

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

  3. Seamless prevention of adverse events from tattooing

    DEFF Research Database (Denmark)

    Serup, Jørgen

    2015-01-01

    The boom in tattooing has been paralleled by more frequent adverse events, which may be localised in the skin or systemic and manifested clinically or latent. Infections, allergic reactions from red-coloured tattoos and papulo-nodular reactions from black tattoos dominate. Mild complaints are very...... strategy that emphasises the customer-tattooist interaction, which is the 'engine' of tattoo safety. This strategy amalgamates the range of narrow-scope preventive instruments and shall ensure that any relevant instrument is used actively and without deficiency or drop out, thus resulting in a complete...... orchestration of a multi-targeted strategy. High-priority elements of this strategy shall facilitate a qualified 'go' or 'no go' decision by the customer before the tattoo is made and should involve informed consent, qualification of the tattooist and the parlour, including supplies of inks etc., and attention...

  4. The reasons of the nursing staff to notify adverse events

    Directory of Open Access Journals (Sweden)

    Miriam Cristina Marques da Silva de Paiva

    2014-10-01

    Full Text Available 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.

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

    Science.gov (United States)

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

    2012-05-01

    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. 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. 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. 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. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

  6. Calcaneal stress fracture: an adverse event following total hip and total knee arthroplasty: a report of five cases.

    Science.gov (United States)

    Miki, Takaaki; Miki, Takahito; Nishiyama, Akihiro

    2014-01-15

    Stress fractures have been reported to occur in the pubis, femoral neck, proximal part of the tibia, and fabella during the postoperative period following total knee or total hip arthroplasty. However, to our knowledge, calcaneal stress fractures after total hip or total knee arthroplasty have not been reported in the English-language literature. Most orthopaedic surgeons are not familiar with calcaneal stress fractures that may occur in elderly patients after a total knee or total hip arthroplasty. We retrospectively reviewed the clinical features, imaging findings, and bone mineral content of the proximal part of the femur and the distal end of the radius in five patients who had a calcaneal stress fracture after a total knee or total hip arthroplasty. All patients were women with a mean age of 76.8 years. All fractures occurred in the calcaneus on the same side as the arthroplasty. The fracture appeared at a mean of 10.2 weeks postoperatively. All patients reported heel pain on walking. Swelling and local heat were found in four and three patients, respectively. Pain was elicited by squeezing the calcaneus in all patients. Early radiographs had normal findings in two patients, and an irregular sclerotic line appeared later in the radiographs of all patients. All fractures were treated conservatively. Four fractures healed uneventfully, but one fracture displaced. All patients had osteoporosis. Calcaneal stress fractures during the postoperative period following total knee or total hip arthroplasty may not be as rare as previously thought. Because clinical symptoms of the fracture appear insidiously and radiographic findings are absent or subtle in the early stage, a high index of suspicion is needed for orthopaedic surgeons to make the correct diagnosis. Magnetic resonance imaging or repeated radiographs may be necessary to make the correct diagnosis when no abnormality is apparent on the initial radiograph.

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

    Science.gov (United States)

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

    2008-02-26

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

  8. An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination.

    Science.gov (United States)

    Wilson, Kumanan; Atkinson, Katherine M; Westeinde, Jacqueline; Bell, Cameron; Marty, Kim; Fergusson, Dean; Deeks, Shelley L; Crowcroft, Natasha; Bettinger, Julie A

    2016-07-02

    used for AEFI reporting, although download and survey completion proportions suggest potential barriers to adoption. Future studies should examine implementation of mobile reporting in a broader audience and impact on the quality of reporting of adverse events following immunization.

  9. Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis: Text mining of the Japanese postmarketing adverse event-reporting database.

    Science.gov (United States)

    Atsumi, Tatsuya; Ando, Yoshiaki; Matsuda, Shinichi; Tomizawa, Shiho; Tanaka, Riwa; Takagi, Nobuhiro; Nakasone, Ayako

    2017-09-07

    To search for signs and symptoms before serious infection (SI) occurs in tocilizumab (TCZ)-treated rheumatoid arthritis (RA) patients. Individual case safety reports, including structured (age, sex, adverse event [AE]) and unstructured (clinical narratives) data, were analyzed by automated text mining from a Japanese post-marketing AE-reporting database (16 April 2008-10 April 2015) assuming the following: treated in Japan; TCZ RA treatment; ≥1 SI; unable to exclude causality between TCZ and SIs. The database included 7653 RA patients; 1221 reports met four criteria, encompassing 1591 SIs. Frequent SIs were pneumonia (15.9%), cellulitis (9.9%), and sepsis (5.0%). Reports for 782 patients included SI onset date; 60.7% of patients had signs/symptoms ≤28 days before SI diagnosis, 32.7% had signs/symptoms with date unidentified, 1.7% were asymptomatic, and 4.9% had unknown signs/symptoms. The most frequent signs/symptoms were for skin (swelling and pain) and respiratory (cough and pyrexia) infections. Among 68 patients who had normal laboratory results for C-reactive protein, body temperature, and white blood cell count, 94.1% had signs or symptoms of infection. This study identified prodromal signs and symptoms of SIs in RA patients receiving TCZ. Data mining clinical narratives from post-marketing AE databases may be beneficial in characterizing SIs.

  10. The reporting of adverse events in oncology phase III trials: a comparison of the current status versus the expectations of the EORTC members.

    Science.gov (United States)

    Maillet, D; Blay, J Y; You, B; Rachdi, A; Gan, H K; Péron, J

    2016-01-01

    Determination of drug safety and tolerability is usually based on the frequency of certain key adverse events (AEs) rather than the frequency of all-grade toxicities. We assessed the reporting of key AEs in oncology randomized, controlled trials (RCTs) and compared that with the expectations of the European Organization for Research and Treatment of Cancer (EORTC) membership. RCTs reports published between 2007 and 2011 were reviewed regarding the reporting of key AEs, namely: grade 3/4 AEs, grade 5 AEs, and AEs resulting in study withdrawal or in dose reduction. Study characteristics associated with better reporting of key AEs were investigated. Finally, a survey was conducted among the EORTC membership to determine their expectations on key AEs reporting. Although the frequency of grade 3/4 was reported in most reports (96%), only 17% of them described the reporting threshold above which grade 3/4 AEs were included for reporting, raising the possibility that important but less frequent grade 3/4 AEs might be underreported. Frequency and nature of grade 5 AEs were adequately reported in 161 (50%) of manuscripts; AEs leading to study withdrawal in 61 manuscripts (19%); and AEs leading to dose reduction in 43 manuscripts (13%). In contrast, most EORTC members expected a comprehensive reporting of grade 5 AEs (96% of EORTC member's responses), AEs leading to study withdrawal (86%) and AEs leading to dose reduction (70%). In multivariate analysis, frequencies of grade 5 AEs were less frequently reported in European trials (P = 0.004). Frequencies of AEs leading to withdrawals were more frequently reported in trials funded by industry (P = 0.005) and in trials including patients with breast or urological cancers (P = 0.006). These findings suggest that current practice of key AEs reporting remains highly variable and sometimes inadequate in oncology RCTs reports. Current standards for safety reporting in RCTs should be revised to emphasize the importance of key AEs

  11. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China.

    Science.gov (United States)

    Guo, Biao; Page, Andrew; Wang, Huaqing; Taylor, Richard; McIntyre, Peter

    2013-01-11

    China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse. To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally. Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages. Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3-37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria-tetanus-pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3-181.1/100,000 doses for DTwP; range 3.5-92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world. Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  12. Self-reported adverse drug events and the role of illness perception and medication beliefs in ambulatory heart failure patients : A cross-sectional survey

    NARCIS (Netherlands)

    De Smedt, Ruth H. E.; Denig, Petra; van der Meer, Klaas; Haaijer-Ruskamp, Flora M.; Jaarsma, Tiny

    2011-01-01

    Background: Identifying patients with heart failure (HF) who are at risk of experiencing symptomatic adverse drug events (ADEs) is important for improving patient care and quality of life. Several demographic and clinical variables have been identified as potential risk factors for ADEs but limited

  13. Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study

    Science.gov (United States)

    Hughes, Shannon; Cohen, David; Jaggi, Rachel

    2014-01-01

    Objective To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies. Design Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles. Setting Clinicalstudyresults.org, sponsored by Pharmaceutical Research and Manufacturers of America; clinicaltrials.gov, administered by the US National Institutes of Health. Main outcome measure 3 coders extracted data on the numbers and types of SAEs. Results 244 trial summaries for six antidepressant and antipsychotic drugs were retrieved, 142 (58.2%) listing an associated article. Of 1608 SAEs in drug-treated participants according to trial summaries, 694 (43.2%) did not appear in associated articles. Nearly 60% of SAEs counted in articles and 41% in trial summaries had no description. Most cases of death (62.3%) and suicide (53.3%) were not reported in articles. Half or more of the 142 pairs were discordant in reporting the number (49.3%) or description (67.6%) of SAEs. These discrepancies resulted from journal articles’ (1) omission of complete SAE data, (2) reporting acute phase study results only and (3) more restrictive reporting criteria. Trial summaries with zero SAE were 2.35 (95% CI, 1.58 to 3.49; pjournal article. Since clinicalstudyresults.org was removed from the Internet in 2011, only 7.8% of retrieved trial summaries appear with results on clinicaltrials.gov. Conclusions Substantial discrepancies exist in SAE data found in journal articles and registered summaries of antidepressant and antipsychotic drug trials. Two main scientific sources accessible to clinicians and researchers are limited by incomplete, ambiguous and inconsistent reporting. Access to complete and accurate data from clinical trials of drugs currently in use remains a

  14. Design and Application of Medical Safety Adverse Events Internal Reporting System%医疗安全不良事件内部报告系统设计与实现

    Institute of Scientific and Technical Information of China (English)

    张怡; 李柯

    2013-01-01

    目的:设计并开发一套医疗安全不良事件内部报告系统,监控和管理医院内部医疗安全不良事件.方法:基于Java语言开发B/S架构的web应用程序,实现不良事件的上报、查询等功能.结果:医务人员通过系统及时上报医疗不良事件,管理人员根据汇总的数据进行统计分析并将信息反馈与分享.结论:该系统的运行提高了不良事件的上报效率,对提高医院医疗服务质量,保障患者安全方面有着积极意义.%Objective: To design and develop an internal reporting system of medical adverse events which can monitor and manage medical adverse events. Methods: The B/S structure is used to develop a web application which is based on Java language to support adverse events reporting, query and other functions. Results: Medical staffs report medical adverse events through this system, the managers do statistical analysis based on aggregated data and share the feedback information. Conclusion: The internal reporting system of medical adverse events is an effective way to improve reporting efficiency.

  15. Investigation and analysis of influencing factors of adverse events report intent among clinical nurses%临床护士不良事件报告习惯调查分析

    Institute of Scientific and Technical Information of China (English)

    毛秋云; 翟荣慧; 仲丽霞; 张伟

    2016-01-01

    Objective To investigate adverse events report intent and its influencing factors in clinical nurses. Methods Questionnaire investigation was conducted among 917 clinical nurses from ten hospitals in Tai'an city using the Intent to Report Questionnaire. Results The score of clinical nurses adverse events report intent was 36.80 ± 19.71. The score of each dimension in descending order were:nurses operation adverse events, system process adverse events, and patient care adverse events. Hospital levels were significant influencing factors of clinical nurses adverse events report intent. Pressure sores were the most frequently reported, and report of patient injury caused by unreasonable nurse manpower allocation was the lowest frequency. Conclusions The level of clinical nurses adverse events report intent need to be improved. Nursing managers should pay attention to improve nurse reporting adverse event in order to better promote the safety of patients and reduce occurrence of adverse event.%目的:调查临床护士不良事件报告习惯现况及其影响因素。方法采用护理不良事件报告习惯量表,对泰安市10所医院的917名临床护士进行问卷调查。结果临床护士不良事件报告习惯得分为(36.80±19.71)分;各类事件平均得分由高到低依次为:护士操作类不良事件、系统流程类不良事件和患者照护类不良事件;临床护士不良事件报告习惯的影响因素只有医院级别;压疮的报告频率最高,而护士人力配置不合理导致患者伤害的报告频率最低。结论临床护士不良事件报告习惯水平有待提高,护理管理者要注重提高护士不良事件报告习惯,主动上报不良事件,以更好地提高患者安全管理水平,降低不良事件的发生率。

  16. 21 CFR 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?

    Science.gov (United States)

    2010-04-01

    ... and therapy dates. (Do not report products that were used to treat the event.) (d) Initial reporter... narrative; and/or (11) Corrected data, including: (i) Any information missing on the user facility report...

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

    DEFF Research Database (Denmark)

    Roitmann, Eva; Eriksson, Robert; Brunak, Søren

    2014-01-01

    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...... to the identification of potentially interesting adverse event correlations that may be further investigated as well as provide further patient stratification opportunities. We have demonstrated the feasibility of a novel approach in pharmacovigilance to stratify patients based on fine-grained adverse event profiles...

  18. Analysis of Adverse Event Reports of Surgicel in MAUDE Database%MAUDE数据库中速即纱不良事件报告分析

    Institute of Scientific and Technical Information of China (English)

    李玉基; 史玉清

    2013-01-01

    Objective By analyzing the adverse everts of Surgicel which were collected from FDA MAUDE database on January 1,2008 to November 10,2012 and the characteristics of the adverse events, to provide strong technical support for the further development of adverse events of Surgicel monitoring work. Methods Statistically analyzed the collected data and discussed the safety of Surgicel. Results The manifestations of adverse events mainly included infection, incomplete absorption and allergies, possibly associated with material factor, patients factor and use factor. Conclusion By paying more attention to adverse events of absorbability hemostatic gauze, strengthening the analysis and utilization of the monitoring database, to provide effective information for the safe use of the medical device.%目的 通过对美国FDA MAUDE数据库2008年1月1日至2012年11月10日速即纱(Surgicel)不良事件情况进行统计分析,分析其不良事件特点.为进一步开展可吸收止血纱布监测工作提供有力技术支持.方法 对收集到的52份报告进行统计分析,初步探讨速即纱安全性.结果 速即纱不良事件临床表现主要以感染、不完全吸收和过敏反应居多,可能原因为纱布自身物理特性、患者自身体质、手术环境及无菌操作技术等.结论 重视可吸收止血纱不良事件监测工作,加强对监测数据的分析与利用,为公众用械安全提供保障.

  19. Linguistic validation of the Spanish version of the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Science.gov (United States)

    Arnold, Benjamin; Mitchell, Sandra A; Lent, Lauren; Mendoza, Tito R; Rogak, Lauren J; Barragán, Natalie M; Willis, Gordon; Medina, Mauricio; Lechner, Suzanne; Penedo, Frank J; Harness, Jay K; Basch, Ethan M

    2016-07-01

    The U.S. NCI's PRO-CTCAE is a library of self-report items for assessing symptomatic adverse events in cancer clinical trials from the patient perspective. The aim of this study was to translate and linguistically validate a Spanish version. PRO-CTCAE's 124 items were translated from English into Spanish using multiple forward and back translations. Native Spanish speakers undergoing cancer treatment were enrolled at six cancer treatment sites. Participants each completed approximately 50 items and were then interviewed using cognitive probes. The interviews were analyzed at the item level by linguistic themes, and responses were examined for evidence of equivalence to English. Items for which ≥20 % of participants experienced difficulties were reviewed, and phrasing was revised and then retested in subsequent interviews. Items where difficulties were also reviewed and were considered for rephrasing and retesting. One hundred nine participants from diverse Spanish-speaking countries were enrolled (77 in Round 1 and 32 in Round 2). A majority of items were well comprehended in Round 1. Two items presented difficulties in ≥20 % of participants and were revised/retested without further difficulties. Two items presented difficulties in difficulties. Two items presented difficulties in difficulties in ≤12 % and were not revised because difficulties were minor. The Spanish PRO-CTCAE has been developed and refined for use in Spanish-speaking populations, with high levels of comprehension and equivalence to the English PRO-CTCAE. ClinicalTrials.gov:NCT01436240.

  20. Patterns in neurosurgical adverse events: open cerebrovascular neurosurgery.

    Science.gov (United States)

    Wong, Judith M; Ziewacz, John E; Ho, Allen L; Panchmatia, Jaykar R; Kim, Albert H; Bader, Angela M; Thompson, B Gregory; Du, Rose; Gawande, Atul A

    2012-11-01

    As part of a project to devise evidence-based safety interventions for specialty surgery, we sought to review current evidence concerning the frequency of adverse events in open cerebrovascular neurosurgery and the state of knowledge regarding methods for their reduction. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. The authors performed a PubMed search using search terms "cerebral aneurysm", "cerebral arteriovenous malformation", "intracerebral hemorrhage", "intracranial hemorrhage", "subarachnoid hemorrhage", and "complications" or "adverse events." Only papers that specifically discussed the relevant complication rates were included. Papers were chosen to be included to maximize the range of rates of occurrence for the reported adverse events. The review revealed hemorrhage-related hyperglycemia (incidence rates ranging from 27% to 71%) and cerebral salt-wasting syndromes (34%-57%) to be the most common perioperative adverse events related to subarachnoid hemorrhage (SAH). Next in terms of frequency was new cerebral infarction associated with SAH, with a rate estimated at 40%. Many techniques are advocated for use during surgery to minimize risk of this development, including intraoperative neurophysiological monitoring, but are not universally used due to surgeon preference and variable availability of appropriate staffing and equipment. The comparative effectiveness of using or omitting monitoring technologies has not been evaluated. The incidence of perioperative seizure related to vascular neurosurgery is unknown, but reported seizure rates from observational studies range from 4% to 42%. There are no standard guidelines for the use of seizure prophylaxis in these patients, and there remains a need for prospective studies to support such

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

    Science.gov (United States)

    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. Copyright © 2016 John Wiley & Sons, Ltd.

  2. Ezetimibe: Use, costs, and adverse events in Australia.

    Science.gov (United States)

    Hollingworth, Samantha A; Ostino, Remo; David, Michael C; Martin, Jennifer H; Tett, Susan E

    2017-02-01

    To analyze the subsidized use and reported adverse events of ezetimibe, used to lower cholesterol, in Australia over the 11 years following its inclusion on the Pharmaceutical Benefits Scheme (PBS) in 2004. Pharmacoepidemiological analysis of dispensed prescriptions from Medicare Australia. Adverse event data were obtained from the Therapeutic Goods Administration. Use was measured by the defined daily dose (DDD) per 1000 population per day for each calendar year. Adverse events were counted by organ class system. Total ezetimibe use rose to 8.46 DDD/1000 population/d in the 11 years to 2015. Ezetimibe as a sole active ingredient was the most commonly dispensed formulation followed by the two combination products containing ezetimibe and 40 mg or 80 mg simvastatin. The average yearly increase in utilization was 19% with a 24% annual increase in costs to government (2006-2015) to $169.0 million in 2015. There were substantial differences in ezetimibe use between states, with no relationship to deaths from ischaemic heart disease (IHD) in each jurisdiction. The major reported adverse events were musculoskeletal and connective tissue disorders and gastrointestinal disorders. Ezetimibe use has increased rapidly in Australia since receiving public subsidy. Although the indications for subsidy are very restricted, there appears to have been widespread use, not explained by differential geographical IHD death rates. Latest guidelines still question the value of ezetimibe, so further discussion about whether the public spending on this medication for any potential improvement in population health outcomes is justified. © 2016 John Wiley & Sons Ltd.

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

    Science.gov (United States)

    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.

  4. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

    Directory of Open Access Journals (Sweden)

    Masakazu Fujiwara

    Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

  5. Patient-reported outcomes (PRO) focused on adverse events (PRO-AEs) in adjuvant and metastatic breast cancer: clinical and translational implications.

    Science.gov (United States)

    Stefanovic, Stefan; Wallwiener, Markus; Karic, Uros; Domschke, Christoph; Katic, Luka; Taran, Florin-Andrei; Pesic, Aleksandra; Hartkopf, Andreas; Hadji, Peyman; Teufel, Martin; Schuetz, Florian; Sohn, Christof; Fasching, Peter; Schneeweiss, Andreas; Brucker, Sara

    2017-02-01

    The capture of adequate treatment outcomes and quality of life (QOL) of advanced breast cancer patients in clinical routine represents a great challenge. Patient-reported outcomes (PROs) are data elements directly reported by patients about experiences with care, including symptoms, functional status, or quality of life. There is growing interest in the medical community for the evaluation and implementation of PROs of adverse events (PRO-AEs). Recent interest in PROs in health care has evolved in the context of patient centeredness. Our primary objective was to identify trials that had implemented PRO-AEs in the breast cancer treatment setting, thereby demonstrating its feasibility. We aimed to identify published studies that used patient reports to assess AEs during and after breast cancer treatment, to identify clinician underreported and modifiable AEs that are important to patients, and to analyze the feasibility and usefulness of PRO instrument implementation in everyday oncological practice with special attention given to electronic-based PRO instruments. We conducted a systematic search of PubMed for studies that used PRO instruments to assess AEs of breast cancer treatment in the metastatic and adjuvant settings. Two authors independently reviewed the search results and decided which studies fully met the predefined inclusion criteria. The search yielded 606 publications. The two reviewers found that 9 studies met the inclusion criteria. Three AEs were identified as important to patients but inadequately reported by health care providers, namely hot flushes, vaginal dryness, and weight gain. PROs and PRO-AEs are the consequence of contemporary concepts of patient-centered medicine and the growing feasibility, utility, and implications of collecting data using modern technology. Furthermore, the willingness of patients to utilize innovative applications for their own health has been increasing in parallel to the enhanced impact of the World Wide Web

  6. Post-Marketing Survey of Adverse Events Following Ocriplasmin.

    Science.gov (United States)

    Shah, Sumit P; Jeng-Miller, Karen W; Fine, Howard F; Wheatley, H Matthew; Roth, Daniel B; Prenner, Jonathan L

    2016-02-01

    To study the post-marketing safety profile of ocriplasmin (Jetrea; ThromboGenics, Iselin, NJ) as experienced by retinal physicians in the United States. Two thousand four hundred sixty-five retinal physicians were surveyed regarding their frequency of use of ocriplasmin and reports of ocular adverse events. There were 270 respondents (11%) who reported treating 1,056 eyes with ocriplasmin. The reports of adverse events (AE) were as follows: acute decline in visual acuity (16.95%), development of submacular fluid or serous retinal detachment (10.23%), dyschromatopsia (9.09%), progression of vitreomacular traction to macular hole (8.71%), development of retinal detachment (2.65%), development of retinal tear (1.99%), development of afferent pupillary defect (1.80%), electroretinography abnormalities (0.57%), crystalline lens instability (0.38%), and vasculitis (0.28%). Although the frequency of some ocular AEs reported in this study are comparable to those reported in the phase 3 registration trials, additional phase 4 safety studies are warranted to better understand the pathophysiology and clinical relevance of ocular AEs of ocriplasmin. Copyright 2016, SLACK Incorporated.

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

    DEFF Research Database (Denmark)

    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....

  8. Time-to-Onset Analysis of Drug-Induced Long QT Syndrome Based on a Spontaneous Reporting System for Adverse Drug Events

    Science.gov (United States)

    Sasaoka, Sayaka; Matsui, Toshinobu; Hane, Yuuki; Abe, Junko; Ueda, Natsumi; Motooka, Yumi; Hatahira, Haruna; Fukuda, Akiho; Naganuma, Misa; Hasegawa, Shiori; Kinosada, Yasutomi

    2016-01-01

    Long QT syndrome (LQTS) is a disorder of the heart’s electrical activity that infrequently causes severe ventricular arrhythmias such as a type of ventricular tachycardia called torsade de pointes (TdP) and ventricular fibrillation, which can be fatal. There have been no previous reports on the time-to-onset for LQTS based on data from spontaneous reporting systems. The aim of this study was to assess the time-to-onset of LQTS according to drug treatment. We analyzed the association between 113 drugs in 37 therapeutic categories and LQTS including TdP using data obtained from the Japanese Adverse Drug Event Report database. For signal detection, we used the reporting odds ratio (ROR). Furthermore, we analyzed the time-to-onset data and assessed the hazard type using the Weibull shape parameter. The RORs (95% confidence interval) for bepridil, amiodarone, pilsicainide, nilotinib, disopyramide, arsenic trioxide, clarithromycin, cibenzoline, donepezil, famotidine, sulpiride, and nifekalant were 174.4 (148.6–204.6), 17.3 (14.7–20.4), 52.0 (43.4–62.4), 13.9 (11.5–16.7), 69.3 (55.3–86.8), 54.2 (43.2–68.0), 4.7 (3.8–5.8), 19.9 (15.9–25.0), 8.1 (6.5–10.1), 3.2 (2.5–4.1), 7.1 (5.5–9.2), and 254.8 (168.5–385.4), respectively. The medians and quartiles of time-to-onset for aprindine (oral) and bepridil were 20.0 (11.0–35.8) and 18.0 (6.0–43.0) days, respectively. The lower 95% confidence interval of the shape parameter β of bepridil was over 1 and the hazard was considered to increase over time.Our study indicated that the pattern of LQTS onset might differ among drugs. Based on these results, careful long-term observation is recommended, especially for specific drugs such as bepridil and aprindine. This information may be useful for the prevention of sudden death following LQTS and for efficient therapeutic planning. PMID:27723808

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

    Science.gov (United States)

    Xu, Rong; Wang, QuanQiu

    2014-01-15

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

  10. Analysis of 41 cases of nursing adverse events reported through Intra-hospital Reporting System *%41例院内上报护理不良事件分析

    Institute of Scientific and Technical Information of China (English)

    官莉; 李晓愚; 廖璞

    2013-01-01

    目的探讨提高患者安全管理、降低护理不良事件发生率的方法。方法回顾分析重庆市第三人民医院2012年上报的41例院内护理不良事件的原因与特点,对发生不良事件的患者性别及年龄、时间地点及不良事件的结局和分类进行统计学分析。结果80~89岁和50~59岁患者不良事件发生率最高(53.6%);护理不良事件分类中,发生率最高的为跌倒、压疮和给药错误;不良事件上报率最高的科室为老年科、神内科、重症监护病房(ICU );院内不良事件发生的主要时间段为上午(08:00~12:00),夜间(00:00~08:00)和晚间(18:00~00:00);损伤结局中,跌倒是造成患者重度损伤的主要原因。结论医院应完善管理制度、明确岗位职责,合理排班和配置各项资源,提高护理人员的风险意识和护理水平,是减少护理不良事件的根本途径。%Objective To analyze the causes and characters of adverse events reported through Intra-hospital Reporting System (IHRS) .Methods A retrospective study was conducted to analyze the adverse events collected through IHRS and statistical analysis was used to analyze items ,including patients'age and sex ,time distribution and location ,classification and outcome of the adverse events .Results Incidence in old patients was the highest (55 .6% ) .The top three kinds of nursing adverse events were fall ,pressure sores and medication errors .Department of Geriatrics ,Neurology and ICU had the top three adverse event report ratio .Adverse events happened more fre-quently in daytime (8 :00 am-12 :00 am) ,nighttime (0 :00 am-8 :00 am) and evening (6 :00 pm-0 :00 am) .Fall was the main reason causing severe injury in patients .Conclusion The fundamental way of reducing the incidence of adverse events could be the improvement of management system ,the definition of responsibilities ,the arrangement of re-sources and the nurse

  11. Construction and Implementation of Active Management of Adverse Event Reporting System%不良事件主动报告制度的构建与实践

    Institute of Scientific and Technical Information of China (English)

    张小庄; 刘元铃; 罗先琼; 张国强; 闵玲; 李金柳; 黄水清; 罗坚; 叶宁

    2011-01-01

    探讨医院不良事件主动报告流程及策略,提出制定不良事件主动报告制度,设计电子报告流程,采用根本原因分析法调查不良事件,同时引入激励机制和保护机制促进不良事件的主动报告,对及时发现安全隐患、提高医疗质量具有重要意义.%Taken a hospital practice for example, the paper explored the hospital adverse event initiative reporting process and strategy. It is important for timely detection of security risks and health care quality improvement to develop active adverse e-vent reporting system, design electronic reporting process, investigate adverse events by using of root cause analysis, introduce incentives and protection mechanisms to promote the initiative reporting of adverse events.

  12. Dyspnea assessment and adverse events during sputum induction in COPD

    Directory of Open Access Journals (Sweden)

    Moschandreas Joanna

    2006-06-01

    Full Text Available Abstract Background The inhalation of normal or hypertonic saline during sputum induction (SI may act as an indirect bronchoconstrictive stimulus leading to dyspnea and lung function deterioration. Our aim was to assess dyspnea and adverse events in COPD patients who undergo SI following a safety protocol. Methods Sputum was induced by normal and hypertonic (4.5% saline solution in 65 patients with COPD of varying severity. In order to minimize saline-induced bronchoconstriction a protocol based on the European Respiratory Society sputum induction Task group report was followed. Dyspnea change was scored using the Borg scale and lung function was assessed by spirometry and oximetry. Results Borg score changes [median(IQR 1.5(0–2] were observed during SI in 40 subjects; 16 patients required temporary discontinuation of the procedure due to dyspnea-general discomfort and 2 did not complete the session due to dyspnea-wheezing. The change in Borg dyspnea score was significantly correlated with oxygen saturation and heart rate changes and with discontinuation of the procedure due to undesired symptoms. 19 subjects presented an hyperresponsive reaction (decline>20% from baseline FEV1. No significant correlation between Borg changes and FEV1decline was found. Patients with advanced COPD presented significantly greater Borg and oxygen saturation changes than patients with less severe disease (p = 0.02 and p = 0.001, respectively. Baseline FEV1, oxygen saturation and 6MWT demonstrated significant diagnostic values in distinguishing subjects who develop an adverse physiologic reaction during the procedure. Conclusion COPD patients undergoing SI following a safety protocol do not experience major adverse events. Dyspnea and oxygen desaturation is more likely to occur in patients with disease in advanced stages, leading to short discontinuation or less frequently to termination of the procedure. Baseline FEV1, oxygen saturation and 6MWT may have a

  13. Adverse Event and Complication Management in Gastrointestinal Endoscopy.

    Science.gov (United States)

    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.

  14. Xerosis and pruritus as major EGFRI-associated adverse events

    OpenAIRE

    2015-01-01

    Purpose The objective of this sub-analysis of the BeCet study (NCT01136005) was to examine health-related quality of life (HRQoL) of patients experiencing dermatological adverse events (AEs) during the first 6 weeks of epidermal growth factor receptor inhibitor (EGFRI) treatment. Methods Patients (n = 85) treated with EGFRI completed five questionnaires during the first 6 weeks of treatment. 77 patients provided enough data for the sub-analysis. Experienced AEs were reported in the Dermatolog...

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

    Science.gov (United States)

    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.

  16. Parameters from preoperative overnight oximetry predict postoperative adverse events.

    Science.gov (United States)

    Chung, F; Zhou, L; Liao, P

    2014-10-01

    Continuous home monitoring of oxygen saturation has become a reliable and feasible practice. The objective of this study was to investigate the role of preoperative overnight oximetry in predicting postoperative adverse events. Following research ethics board approval, consented patients underwent a preoperative overnight monitoring of oxygen saturation with a portable oximeter. Parameters from the oximetry data were extracted and their predictive performance for postoperative adverse events was evaluated. A total of 573 patients were studied with age: 60±12 years and 45% male. Oxygen desaturation index (ODI), cumulative time percentage with SpO2 3.0 events/h, >9.2 events/h and > 28.5 events/h; CT90: >0.1%, >1.1% and >7.2%; mean SpO2: rate of postoperative adverse events. For ODI >28.5 vs. ODI ⋝28.5 events/h, the odds ratio adjusted with age, gender, body mass index and American Society of Anesthesiologists physical status was 2.2 (95% CI: 1.3-3.9). Patients with mean preoperative overnight SpO2 28.5 events/h or CT90 >7.2% are at higher risk for postoperative adverse events. Overnight oximetry could be a useful tool to stratify patients for the risk of postoperative adverse events.

  17. 护理人员主动呈报不良事件的认知情况调查%Investigation of nurses ’ cognition about reporting adverse events voluntarily

    Institute of Scientific and Technical Information of China (English)

    杨彬

    2012-01-01

    目的 了解护理人员对不良事件的认知情况.方法 采用自行设计的问卷对500名护理人员进行调查.结果 知晓护理不良事件定义的占90.60%、管理制度的占89.80%和上报流程的占86.20%,对自己和他人发生的不良事件主动呈报的分别占49.40%和25.20%;担心报告后会受到批评与处罚占82.60%,担心影响个人发展占81.40%,认为上报后得不到表扬占80.60%,不相信无惩罚报告制度占82.20%.结论 护理人员对主动呈报不良事件关注程度较高,但仍有较多顾虑.建议加强低年资护理人员的教育和培训,建立不良事件网络直报系统,对上报者给予保护,完善上报反馈,提高不良事件主动呈报率.%Objective To investigate nurses'cognition about nursing adverse events. Methods A total of 500 nurses were investigated with a self - designed questionnaire. Results Among all the nurses, the awareness rates about the definition of adverse events, management mode and reporting process were 90. 60% ,89. 80% ,and 86. 20% .respectively. The rates of voluntarily reporting adverse events on their own and others were 49. 40% and 25. 20% ,respectively. There were 82. 6% nurses worrying about being criticized and punished,81. 40% nurses worrying affecting personal development,80. 60% nurses believing that could not be praised after reported it, 82. 20% nurses not believing the no punishment reporting system. Conclusion Nurses have a high degree of attention about reporting adverse events voluntarily, but there are still many concerns. It needs to strengthen the education and training of junior nurses, establish the direct network report system of adverse events,give protection to the reporters,and improve the reported feedback and voluntary reporting rate of adverse events.

  18. Adverse events with continuous doxapram infusion against late postoperative hypoxaemia

    DEFF Research Database (Denmark)

    Rosenberg, J; Kristensen, P A; Pedersen, M H

    1996-01-01

    OBJECTIVE: A randomized double-blind controlled trial of doxapram versus placebo against late postoperative hypoxaemia was planned to include 40 patients (2 x 20). RESULTS: After inclusion of 18 patients a serious adverse event was encountered with development of a brain stem infarction in a 90......-year-old woman receiving doxapram. At this point the randomization code was broken and we decided to terminate the trial. Three of nine patients receiving doxapram had had an adverse event whereas none of the patients receiving placebo had adverse events (P = 0.2). In the 18 patients studied...

  19. Development and Application of Reporting System for Nursing Adverse Events and Near Miss Events in Maternal and Child Health Care Institutes%妇幼保健机构护理不良事件上报系统的开发与应用

    Institute of Scientific and Technical Information of China (English)

    李渠; 蒋迎佳; 贺晓春; 梅花; 肖飞

    2014-01-01

    We developed a nursing adverse events and near miss events reporting system through cooperation with information software company. To improve the efficiency of head nurses of wards on nursing adverse events and near miss events reporting, and to provide information support for nurse administrators on analysis and dealing with adverse events and near miss events through the establishment of module for nursing adverse events and near miss events reporting in information systems. Thus to explore the root causes of nursing adverse events and maximally avoid recurrence of similar incidents.%医院与信息软件公司合作,开发了护理不良事件及接近错误事件上报系统。通过在医院信息系统中建立护理不良事件及接近错误事件上报的模块,提高病区护士长上报不良事件及接近错误事件的工作效率,为护理管理者分析、处理不良事件及接近错误事件提供信息化支持。以此寻找影响护理不良事件发生的根本原因,从而最大限度地避免类似事件的重复发生。

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

    Science.gov (United States)

    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.

  1. Analysis and countermeasures of the 282 cases of nursing adverse events with non-punitive network reported%282例非惩罚性网络上报护理不良事件的分析与对策

    Institute of Scientific and Technical Information of China (English)

    韩美玲; 王芳; 徐淑华; 陈芹; 吴菲菲

    2015-01-01

    目的:通过对282例非惩罚性网络上报护理不良事件的分析,了解护理不良事件发生的特点,并制定对策,以减少护理不良事件的发生。方法回顾性分析2013年6月—2014年6月网络上报的282例非惩罚性护理不良事件,对其进行总结、分析,探讨护理不良事件的发生特点、原因、年龄段与护士层级的关系。结果282例护理不良事件中无后果事件(Ⅲ级)占67.38%,隐患事件(Ⅳ级)占26.95%。23:00—8:00发生的护理不良事件占26.60%。警告事件(Ⅰ级)中33.3%发生在15:00—23:00、66.7%发生在23:00—8:00。发生不良事件的时间段主要集中在8:00—15:00,占52.84%(149/282)。护士层级发生不良事件的比例最高,占59.93%(169/282)。发生护理不良事件的患者年龄分布中,>60岁患者占49.29%。护理不良事件发生的原因中未严格执行查对制度占30.85%,缺乏责任心占24.11%,风险意识不强占23.76%。结论实行网络上报非惩罚性护理不良事件后,各护理单元不良事件的主动上报意识明显加强,护士层级发生不良事件的比例较高,>60岁住院患者发生率较高,警告事件(Ⅰ级)多在15:00—8:00发生。应加强年轻护士培训、老年住院患者管理及15:00—8:00的护士值班管理,以减少护理不良事件的发生。%Objective To understand the characteristics of the nursing adverse events through analysis the 282 cases of nursing adverse events, and make countermeasures to reduce the incidence of adverse events. Methods A total of 282 nursing adverse events of non-punitive network reported were collected from June 2013 to June 2014 with retrospective analysis, then we analyzed and summarized them, in order to find out the relationship between occurred characteristics, reasons, age group with the nurse hierarchy, etc. Results No consequence nursing adverse events (levelⅢ) accounted for 67. 38% of all events cases, while potential hazard

  2. Adverse events related to emergency department care: a systematic review.

    Directory of Open Access Journals (Sweden)

    Antonia S Stang

    Full Text Available OBJECTIVE: To systematically review the literature regarding the prevalence, preventability, severity and types of adverse events (AE in the Emergency Department (ED. METHODS: We systematically searched major bibliographic databases, relevant journals and conference proceedings, and completed reference reviews of primary articles. Observational studies (cohort and case-control, quasi-experimental (e.g. before/after studies and randomized controlled trials, were considered for inclusion if they examined a broad demographic group reflecting a significant proportion of ED patients and described the proportion of AE. Studies conducted outside of the ED setting, those examining only a subpopulation of patients (e.g. a specific entrance complaint or receiving a specific intervention, or examining only adverse drug events, were excluded. Two independent reviewers assessed study eligibility, completed data extraction, and assessed study quality with the Newcastle Ottawa Scale. RESULTS: Our search identified 11,624 citations. Ten articles, representing eight observational studies, were included. Methodological quality was low to moderate with weaknesses in study group comparability, follow-up, and outcome ascertainment and reporting. There was substantial variation in the proportion of patients with AE related to ED care, ranging from 0.16% (n = 9308 to 6.0% (n = 399. Similarly, the reported preventability of AE ranged from 36% (n = 250 to 71% (n = 24. The most common types of events were related to management (3 studies, diagnosis (2 studies and medication (2 studies. CONCLUSIONS: The variability in findings and lack of high quality studies on AE in the high risk ED setting highlights the need for research in this area. Further studies with rigorous, standardized outcome assessment and reporting are required.

  3. Challenges in coding adverse events in clinical trials

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Maund, Emma; Gøtzsche, Peter C

    2012-01-01

    Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation...

  4. Safety reporting and adverse-event profile of mirtazapine described in randomized controlled trials in comparison with other classes of antidepressants in the acute-phase treatment of adults with depression: systematic review and meta-analysis.

    Science.gov (United States)

    Watanabe, Norio; Omori, Ichiro M; Nakagawa, Atsuo; Cipriani, Andrea; Barbui, Corrado; McGuire, Hugh; Churchill, Rachel; Furukawa, Toshi A

    2010-01-01

    Mirtazapine has a unique mechanism of antidepressant action, and thus is thought to have a different profile of adverse events from that of other antidepressants. To present a methodologically rigorous systematic review of the adverse event profile of mirtazapine and point to possible problems with safety reporting in randomized controlled trials (RCTs) of the acute-phase treatment of major depression in adults with mirtazapine in comparison with other types of antidepressant. The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register was electronically searched using the following search terms: 'depress*', 'dysthymi*', 'adjustment disorder*', 'mood disorder*', 'affective disorder', 'affective symptoms' and 'mirtazapine'. Pharmaceutical companies and experts in this field were contacted, and the reference lists of the relevant RCTs were checked, for additional data. No language restriction was imposed. Two authors independently assessed the quality of trials for inclusion in the review. Disagreements were resolved by consensus. Two authors independently extracted data on adverse events. Disagreements were resolved by consensus. The adequacy of safety reporting was assessed by one author. Regarding the adequacy of safety reporting, the qualitative and quantitative parameters of safety reporting were determined. Regression analyses were conducted to assess characteristics of trials influencing safety reporting. The primary and secondary outcomes in the systematic review of the adverse events associated with mirtazapine were defined as the proportion of patients having each of 43 adverse events listed in the modified version of the WHO Adverse Reaction Terminology, and the proportion of patients experiencing at least one adverse event, respectively. Meta-analyses were conducted for these outcomes. Twenty-five RCTs involving 4842 patients were identified as meeting our inclusion criteria. With regard to safety reporting, only two trials and

  5. Prolactin levels and adverse events in patients treated with risperidone.

    Science.gov (United States)

    Kleinberg, D L; Davis, J M; de Coster, R; Van Baelen, B; Brecher, M

    1999-02-01

    Hyperprolactinemia is a common clinical disorder that may lead to sexual dysfunction or galactorrhea. It may arise from a variety of etiologies, including the use of antipsychotic agents, presumably because of a dopamine receptor blockade. This analysis was designed to characterize the relationship between risperidone, serum prolactin levels, and possible clinical sequelae. All data from randomized, double-blind studies of risperidone in patients with chronic schizophrenia were analyzed. The two largest studies (the North American and multinational trials) included 841 patients (259 women, 582 men) with paired prolactin level data and 1,884 patients (554 women, 1,330 men) with data on six adverse events possibly associated with increased prolactin levels (amenorrhea, galactorrhea, and decreased libido in women; erectile dysfunction, ejaculatory dysfunction, gynecomastia, and decreased libido in men). Both risperidone and haloperidol produced dose-related increases in plasma prolactin levels in men and women. Among women, the risperidone dose was not correlated with adverse events, nor were the adverse events correlated with endpoint prolactin levels. Among men, the incidence of adverse events was positively correlated with risperidone dose; however, at risperidone doses of 4 to 10 mg/day the incidence of adverse events was not significantly higher than that observed in patients receiving placebo. Furthermore, adverse events in men were unrelated to plasma prolactin levels. Risperidone-associated increase in serum prolactin levels was not significantly correlated to the emergence of possible prolactin-related side effects.

  6. Family perceptions of insulin pump adverse events in children and adolescents.

    Science.gov (United States)

    Wheeler, Benjamin J; Donaghue, Kim C; Heels, Kristine; Ambler, Geoffrey R

    2014-04-01

    Insulin pumps (for continuous subcutaneous insulin infusion [CSII]) are used widely in type 1 diabetes mellitus. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events and no data on family perceptions of adverse events and their confidence in dealing with them. We approached all families of children and adolescents ≤ 19 years of age on CSII attending the diabetes clinic over a 16-week clinic cycle. Participants completed a retrospective questionnaire examining issues over the previous 12 months. Data on pump adverse events as well as answers to questions pertaining to education and confidence were collected. Our survey received a response rate of 99%, with 235 of the 238 families approached participating. In the preceding 12 months, 104 of 230 (45%) had reported at least one pump-related adverse event (either mechanical or set-related), with an associated 52 of 229 (23%) resulting in pump replacement. This equated to a minimum incidence density of 53 adverse events/100 person-years. Additionally, 18 of 230 (8%) reported a hospital admission or emergency department attendance as a consequence. Pump malfunction and infusion set/site failures were the most common events reported, with one or more events in 58 of 104 (56%) and 47 of 104 (45%), respectively. Adverse events, excluding set/site failures, were associated with older age (13.1 ± 3.4 years vs. 11.9 ± 4 years; P = 0.02). This is the first study to look at family perceptions of adverse events while using modern CSII. It highlights a high self-reported rate of CSII-related adverse events, pump replacement, and subsequent presentation to the hospital. Potential areas for additional targeted education are identified. Further prospective study examining pump adverse event characteristics and incidence is warranted.

  7. Early adverse events, HPA activity and rostral anterior cingulate volume in MDD.

    Directory of Open Access Journals (Sweden)

    Michael T Treadway

    Full Text Available BACKGROUND: Prior studies have independently reported associations between major depressive disorder (MDD, elevated cortisol concentrations, early adverse events and region-specific decreases in grey matter volume, but the relationships among these variables are unclear. In the present study, we sought to evaluate the relationships between grey matter volume, early adverse events and cortisol levels in MDD. METHODS/RESULTS: Grey matter volume was compared between 19 controls and 19 individuals with MDD using voxel-based morphometry. A history of early adverse events was assessed using the Childhood Trauma Questionnaire. Subjects also provided salivary cortisol samples. Depressed patients showed decreased grey matter volume in the rostral ACC as compared to controls. Rostral ACC volume was inversely correlated with both cortisol and early adverse events. CONCLUSIONS: These findings suggest a key relationship between ACC morphology, a history of early adverse events and circulating cortisol in the pathophysiology of MDD.

  8. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    2014-03-01

    Full Text Available OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%, fatigue (12.3%, and chest pain (9.0%. Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases.

  9. Cutaneous adverse events of epidermal growth factor receptor inhibitors: A retrospective review of 99 cases

    Directory of Open Access Journals (Sweden)

    Kumutnart Chanprapaph

    2015-01-01

    Full Text Available Background: Previous reports regarding the cutaneous adverse events of epidermal growth factor receptor inhibitors are mostly limited to small case reports and case series, mainly involving Caucasian patients. Aims: We describe the trends in the clinical presentation of Asian patients who had cutaneous adverse events induced by epidermal growth factor receptor inhibitors and to explore the relationship between skin adverse events and tumor response. Methods: From 2006 to 2010, medical records of Thai patients with non-small cell lung cancer receiving epidermal growth factor receptor inhibitors were retrieved and analyzed. Results: In all, 99 patients were reviewed and analyzed. Erlotinib and gefitinib were commenced in 75 (75.8% and 24 (24.2% patients, respectively. Cutaneous adverse events occurred in 43 (57.3% patients receiving erlotinib and in 15 (62.5% patients receiving gefitinib. The most common adverse event was xerosis (52.5%. Less common adverse events included papulo-pustular eruption (27.3%, erythematous maculopapular rash (11.1%, mucositis (6.7%, paronychia (5.1%, and trichomegaly (2%. Elderly patients had a higher occurrence of xerosis. The presence of cutaneous adverse events was significantly higher in subjects who had a tumor response. Limitations: The limitations of study include its retrospective nature, and the initial screening of cutaneous adverse events was done by non-dermatologists. Conclusions: Cutaneous adverse events due to epidermal growth factor receptor inhibitors are not uncommon in the Asian population. We found a positive correlation between the occurrences of cutaneou adverse events and tumor response supporting the view that they are surrogate markers for therapeutic response.

  10. Mining for adverse drug events with formal concept analysis

    CERN Document Server

    Estacio-Moreno, Alexander; Bousquet, Cédric

    2009-01-01

    The pharmacovigilance databases consist of several case reports involving drugs and adverse events (AEs). Some methods are applied consistently to highlight all signals, i.e. all statistically significant associations between a drug and an AE. These methods are appropriate for verification of more complex relationships involving one or several drug(s) and AE(s) (e.g; syndromes or interactions) but do not address the identification of them. We propose a method for the extraction of these relationships based on Formal Concept Analysis (FCA) associated with disproportionality measures. This method identifies all sets of drugs and AEs which are potential signals, syndromes or interactions. Compared to a previous experience of disproportionality analysis without FCA, the addition of FCA was more efficient for identifying false positives related to concomitant drugs.

  11. Could chiropractors screen for adverse drug events in the community? Survey of US chiropractors

    Directory of Open Access Journals (Sweden)

    Bero Lisa

    2010-11-01

    Full Text Available Abstract Background The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potential adverse drug events in their chiropractic patients, and by bringing suspected adverse drug events to the attention of the prescribing clinicians. Methods Mail survey of US chiropractors about their detection of potential adverse drug events in their chiropractic patients. Results Over half of responding chiropractors (62% reported having identified a suspected adverse drug event occurring in one of their chiropractic patients. The severity of suspected drug-related events detected ranged from mild to severe. Conclusions Chiropractors or other nonprescribing clinicians may be in a position to detect potential adverse drug events in the community. These detection and reporting mechanisms should be standardized and policies related to clinical case management of suspected adverse drug events occurring in their patients should be developed.

  12. Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

    DEFF Research Database (Denmark)

    Maiers, Michele; Evans, Roni; Hartvigsen, Jan;

    2015-01-01

    Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making. This paper provides a detailed report of AE...... musculoskeletal in nature; several participants associated AE with specific exercises. One incapacitating AE occurred when a participant fell during supervised exercise session and fractured their arm. One serious adverse event of unknown relationship occurred to an individual who died from an aneurysm while...

  13. Adverse events in patients taking cephalosporins versus placebo for any indication

    DEFF Research Database (Denmark)

    McCullough, Amanda; Scott, Anna M.; Macindoe, Christopher;

    2016-01-01

    This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To quantify the incidence of any reported adverse event in patients taking cephalosporins compared with placebo for any indication.......This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To quantify the incidence of any reported adverse event in patients taking cephalosporins compared with placebo for any indication....

  14. [A systematic review of decided litigated cases on adverse drug events in Japan: classification of decided cases appearing in law reports].

    Science.gov (United States)

    Eguchi, Rika; Kato, Masahisa; Kaneko, Erina; Kusaba, Kenji; Yoshikawa, Manabu; Yamano, Toru; Seo, Takashi; Hagihara, Akihito

    2015-01-01

    Much of the damage to health caused by drugs could be prevented by appropriate care. A well-defined duty of care and further information are required for healthcare professionals. Although there are many litigation cases to use as references, neither the extent of the duty of care nor the obligation to explain medication according to the type of drug prescribed has yet been fully established. Thus, we systematically collected decided cases of adverse drug events, and assessed the degree of the duties of care and information. Specifically, we collected decided cases in which physicians, dentists, pharmacists, nurses, or hospitals had been sued. Data were derived from Bessatsu Jurist Iryo-kago Hanrei Hyakusen, Hanrei Jihou, and Hanrei Times from 1989 to November 2013, and information on precedents in the records of the Supreme Court of Japan from 2001 to November 2013. We analyzed the cases, and assessed the following according to the type of drug: (1) standards and explanations when dealing with drugs that were critical issues in litigation, and (2) the degree of the physician's or pharmacist's duties of care and information. In total, 126 cases were collected. The number of drug categories classified was 27, and 9 were considered of practical importance. After this systematic review, we found a trend in the degree of the required level of care and information on several drugs. With respect to duties of care and information, the gap between the required level and actual practice suggests that healthcare professionals must improve their care and explanations.

  15. [Nursing practice in view of adverse events following vaccination].

    Science.gov (United States)

    Bisetto, Lúcia Helena Linheira; Cubas, Marcia Regina; Malucelli, Andreia

    2011-10-01

    The objectives of this article are to identify the adverse events following vaccination, the focus if nursing practice, using the Post-Vaccination Adverse Events Information System database, and discuss on the nurses' practice on the surveillance for those events. Secondary data were those regarding the vaccines applied in the Brazilian public health system, in the period from 1999 to 2008, totaling 65,442 registers, 59,899 of which were confirmed and 1,403 were associated with another vaccine. The 16 nursing practice events totaled 21,727 registers. Although they account for 35.4% of the registers, the data do not reflect the reality, because their reliability depends on the knowledge network that comprises diagnosis, notification and inclusion in the system. Discussions were made on interventions for the most prevalent events: fever and local events. Most interventions established in the adverse events manual was in agreement with the literature, though there were differences in the content between conducts for the same event due to different vaccines.

  16. Role of systems pharmacology in understanding drug adverse events

    Science.gov (United States)

    Berger, Seth I.; Iyengar, Ravi

    2011-01-01

    Systems pharmacology involves the application of systems biology approaches, combining large-scale experimental studies with computational analyses, to the study of drugs, drug targets, and drug effects. Many of these initial studies have focused on identifying new drug targets, new uses of known drugs, and systems-level properties of existing drugs. This review focuses on systems pharmacology studies that aim to better understand drug side effects and adverse events. By studying the drugs in the context of cellular networks, these studies provide insights into adverse events caused by off-targets of drugs as well as adverse events-mediated complex network responses. This allows rapid identification of biomarkers for side effect susceptibility. In this way, systems pharmacology will lead to not only newer and more effective therapies, but safer medications with fewer side effects. PMID:20803507

  17. Systematic Review: Adverse Events of Fecal Microbiota Transplantation

    Science.gov (United States)

    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

  18. Reliability of the peer-review process for adverse event rating.

    Directory of Open Access Journals (Sweden)

    Alan J Forster

    Full Text Available BACKGROUND: Adverse events are poor patient outcomes caused by medical care. Their identification requires the peer-review of poor outcomes, which may be unreliable. Combining physician ratings might improve the accuracy of adverse event classification. OBJECTIVE: To evaluate the variation in peer-reviewer ratings of adverse outcomes; determine the impact of this variation on estimates of reviewer accuracy; and determine the number of reviewers who judge an adverse event occurred that is required to ensure that the true probability of an adverse event exceeded 50%, 75% or 95%. METHODS: Thirty physicians rated 319 case reports giving details of poor patient outcomes following hospital discharge. They rated whether medical management caused the outcome using a six-point ordinal scale. We conducted latent class analyses to estimate the prevalence of adverse events as well as the sensitivity and specificity of each reviewer. We used this model and Bayesian calculations to determine the probability that an adverse event truly occurred to each patient as function of their number of positive ratings. RESULTS: The overall median score on the 6-point ordinal scale was 3 (IQR 2,4 but the individual rater median score ranged from a minimum of 1 (in four reviewers to a maximum median score of 5. The overall percentage of cases rated as an adverse event was 39.7% (3798/9570. The median kappa for all pair-wise combinations of the 30 reviewers was 0.26 (IQR 0.16, 0.42; Min = -0.07, Max = 0.62. Reviewer sensitivity and specificity for adverse event classification ranged from 0.06 to 0.93 and 0.50 to 0.98, respectively. The estimated prevalence of adverse events using a latent class model with a common sensitivity and specificity for all reviewers (0.64 and 0.83 respectively was 47.6%. For patients to have a 95% chance of truly having an adverse event, at least 3 of 3 reviewers are required to deem the outcome an adverse event. CONCLUSION: Adverse event

  19. [Recommendations for institutional response to an adverse event].

    Science.gov (United States)

    2016-01-01

    The organizational response after an Adverse Event (AE) is critical for the patient recovery and trust restoration in the health system. It is also crucial for the involved caregiver psychological recovery. To design a frame of recommendations to help the healthcare services, institutions and organizations to provide a systematic approach to an AE. A reduced group of authors performed a non-systematic review of the literature and developed an initial draft. The draft was sent to the rest of authors, who suggested modifications in structure, content, references and style throughout successive manuscript versions until a final one was accepted. AE response includes the patient's clinical stabilization and a therapeutic plan to mitigate harm, the safeguard of used materials or health products involved, the appropriate disclosure to patient and family, the support of affected staff and their replacement if needed, the report to appropriate clinical and management heads, the event circumstances documentation and the starting of the AE investigation and analysis. Besides the professional, family and patient's trust and health recovery, the ultimate target of a correct AE response is the improvement of healthcare processes to prevent its repetition considering the AE as a system failure and learning and improving through its analysis. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

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

    Science.gov (United States)

    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.

  1. Direct medical costs of adverse events in Dutch hospitals.

    NARCIS (Netherlands)

    Hoonhout, L.H.F.; Bruijne, M.C. de; Wagner, C.; Zegers, M.; Waaijman, R.; Spreeuwenberg, P.; Asscheman, H.; Wal, G. van der; Tulder, M.W. van

    2009-01-01

    BACKGROUND: Up to now, costs attributable to adverse events (AEs) and preventable AEs in the Netherlands were unknown. We assessed the total direct medical costs associated with AEs and preventable AEs in Dutch hospitals to gain insight in opportunities for cost savings. METHODS: Trained nurses and

  2. Adverse events resulting from lasers used in urology.

    Science.gov (United States)

    Althunayan, Abdulaziz M; Elkoushy, Mohamed A; Elhilali, Mostafa M; Andonian, Sero

    2014-02-01

    To collate world reports of adverse events (AEs) resulting from lasers used in urology. The Manufacturer and User Facility Device Experience (MAUDE) database of the United States Food and Drug Administration (FDA) was searched using the term "Laser for gastro-urology use." In addition, the Rockwell Laser Industries (RLI) Laser Accident Database was searched for the following types of lasers: neodymium-doped yttrium aluminum garnet (Nd:YAG), holmium:yttrium aluminum garnet (Ho:YAG), potassium titanyl phosphate (KTP), diode and thulium:YAG (Tm:YAG). Both databases were last accessed on October 1, 2012. Overall, there were 433 AEs; 166 in MAUDE database (1992-2012) and 267 in RLI database (1964-2005). Most of the AEs (198/433 or 46%) resulted from generator failure or fiber tip breaking. Whereas there were 20 (4.6%) AEs harming medical operators, there were 159 (37%) AEs harming nonmedical operators using Nd:YAG, KTP, and diode lasers. Eye injuries ranging from mild corneal abrasions to total vision loss were reported in 164 AEs with the use of Nd:YAG, KTP, and diode lasers. Overall, there were 36 (8.3%) AEs resulting in patient harm, including 7 (1.6%) mortalities, 3 deaths from ureteral perforation using the Ho:YAG laser, and 4 deaths from air emboli using the Nd:YAG laser. Other reported patient injuries included bladder perforation resulting in urinary diversion in a patient, in addition to minor skin burns, internal burns, and bleeding in others. There were no AEs reported with the use of Tm:YAG laser. Most of the AEs reported relate to equipment failure. There were no eye injuries reported with the use of Ho:YAG lasers. Caution must be exercised when using lasers in urology, including wearing appropriate eye protection when using Nd:YAG, KTP, and diode lasers.

  3. Application of the near-miss adverse event report motivate mechanism in nursing safety management%未遂事件上报激励机制在护理安全管理中的应用

    Institute of Scientific and Technical Information of China (English)

    石贞仙; 杜巧; 徐建萍; 尉小芳

    2011-01-01

    目的:探讨上报未遂事件在护理安全管理中的作用.方法:总结2004-2005年上报护理部的资料,确定未遂事件级别,规范未遂事件分类,统一未遂事件上报程序、加分标准;采用卡方检验对2006-2010年上报护理部未遂事件资料进行统计、推断.结果:未遂事件数量大,医疗未遂事件平均占73.7%,护理未遂事件平均占19.5%;对比4年护理未遂事件,总体分布差异有统计学意义.结论:上报、分析未遂事件很有价值,未遂事件上报激励机制是营造护理安全文化的重要保证.%Objective: To explore the effect of the near-miss adverse event report motivate mechanism in nursing safety management. Methods: By summarizing the data reported to the nursing department in 2004-2005, the authors identified the levels and classification of near-miss adverse events, and developed reporting procedures and awarding standards. Near-misses reported from 2006 to 2010 was analyzed. Results: The number of near-misses was large, medical near-misses accounted for 73.7% and nursing near-misses accounted for 19.5%; there was a significant difference in the distributions of the nursing near-misses in these four years. Conclusion: It is valuable to report and analyze the near-miss adverse events. The near-miss adverse event report motivate mechanism is beneficial for cultivating nursing safe culture.

  4. Self-reported physical activity and major adverse events in patients with atrial fibrillation: a report from the EURObservational Research Programme Pilot Survey on Atrial Fibrillation (EORP-AF) General Registry.

    Science.gov (United States)

    Proietti, Marco; Boriani, Giuseppe; Laroche, Cécile; Diemberger, Igor; Popescu, Mircea I; Rasmussen, Lars H; Sinagra, Gianfranco; Dan, Gheorghe-Andrei; Maggioni, Aldo P; Tavazzi, Luigi; Lane, Deirdre A; Lip, Gregory Y H

    2017-04-01

    Physical activity is protective against cardiovascular (CV) events, both in general population and in high-risk CV cohorts. However, the relationship between physical activity with major adverse outcomes in atrial fibrillation (AF) is not well-established. Our aim was to analyse this relationship in a 'real-world' AF population. Second, we investigated the influence of physical activity on arrhythmia progression. We studied all patients enrolled in the EURObservational Research Programme on AF (EORP-AF) Pilot Survey. Physical activity was defined as 'none', 'occasional', 'regular', and 'intense', based on patient self-reporting. Data on physical activity were available for 2442 patients: 38.9% reported none, 34.7% occasional, 21.7% regular, and 4.7% intense physical activity. Prevalence of the principal CV risk factors progressively decreased from none to intense physical activity. Lower rates of CV death, all-cause death, and composite outcomes were found in AF patients who reported regular and intense physical activity (P < 0.0001). Increasing physical activity was inversely associated with CV death/any thromboembolic event (TE)/bleeding in the whole cohort, irrespective of gender, paroxysmal AF, elderly age, or high stroke risk. Any level of physical activity intensity was significantly associated with lower risk of CV death/any TE/bleeding at 1-year follow-up. Physical activity was not significantly associated with arrhythmia progression. Atrial fibrillation patients taking regular exercise were associated with a lower risk of all-cause death, even when we considered various subgroups, including gender, elderly age, symptomatic status, and stroke risk class. Efforts to increase physical activity among AF patients may improve outcomes in these patients.

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

    Science.gov (United States)

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

    2016-10-17

    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. 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. 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. 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 (Pdata suggest that age-associated adverse events should be considered in planning, monitoring, and regulating clinical trials.

  6. [Costs of serious adverse events in a community teaching hospital, in Mexico].

    Science.gov (United States)

    Gutiérrez-Mendoza, Luis Meave; Torres-Montes, Abraham; Soria-Orozco, Manuel; Padrón-Salas, Aldanely; Ramírez-Hernández, María Elizabeth

    2015-01-01

    Serious adverse events during hospital care are a worldwide reality and threaten the safety of the hospitalised patient. To identify serious adverse events related to healthcare and direct hospital costs in a Teaching Hospital in México. A study was conducted in a 250-bed Teaching Hospital in San Luis Potosi, Mexico. Data were obtained from the Quality and Patient Safety Department based on 2012 incidents report. Every event was reviewed and analysed by an expert team using the "fish bone" tool. The costs were calculated since the event took place until discharge or death of the patient. A total of 34 serious adverse events were identified. The average cost was $117,440.89 Mexican pesos (approx. €7,000). The great majority (82.35%) were largely preventable and related to the process of care. Undergraduate medical staff were involved in 58.82%, and 14.7% of patients had suffered adverse events in other hospitals. Serious adverse events in a Teaching Hospital setting need to be analysed to learn and deploy interventions to prevent and improve patient safety. The direct costs of these events are similar to those reported in developed countries. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

  7. [Evaluation of the association between the use of oral anti-hyperglycemic agents and hypoglycemia in Japan by data mining of the Japanese Adverse Drug Event Report (JADER) database].

    Science.gov (United States)

    Umetsu, Ryogo; Nishibata, Yuri; Abe, Junko; Suzuki, Yukiya; Hara, Hideaki; Nagasawa, Hideko; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2014-01-01

    Hypoglycemia due to treatment with oral anti-hyperglycemic agents (OHAs) is a major clinical problem in patients with type 2 diabetes mellitus. The aim of the present study was to evaluate the risk of hypoglycemia due to OHA use by using the Japanese Adverse Drug Event Report (JADER) database. To this end, reports of hypoglycemia events included in the JADER database between 2004 and 2012 were analyzed by calculating the reporting odds ratio (OR). The Medical Dictionary for Regulatory Activities Preferred Terms was used to identify hypoglycemia; 254392 reports were found in the JADER database, of which 13269 were excluded because the age and sex of the patient were not reported. Finally, 241123 reports were analyzed. Among OHAs, sulfonylureas showed the highest adjusted OR (adjusted OR, 10.13; 95% confidence interval, 9.08-11.26). The adjusted ORs for meglitinides, biguanide, thiazolidinedione, alpha-glucosidase inhibitors, and dipeptidyl peptidase-4 inhibitors were significantly lower than that of sulfonylureas. The adjusted OR of meglitinides (3.17; 95% confidence interval, 2.23-4.36) was significantly higher than that of alpha-glucosidase inhibitors or thiazolidinedione. We observed no difference between the adjusted ORs for biguanide, thiazolidinedione, alpha-glucosidase inhibitors, and dipeptidyl peptidase-4 inhibitors. Data mining of the JADER database was useful for analyzing OHA-associated hypoglycemia events. The results of our study suggested a low risk of hypoglycemia associated with biguanide, thiazolidinedione, alpha-glucosidase inhibitors, and dipeptidyl peptidase-4 inhibitors in clinical practice.

  8. Quantifying and characterizing adverse events in dermatologic surgery.

    Science.gov (United States)

    O'Neill, Jenna L; Lee, Yun Sun; Solomon, James A; Patel, Nikita; Shutty, Brandon; Davis, Scott A; Robins, Douglas N; Williford, Philip M; Feldman, Steven R; Pearce, Daniel J

    2013-06-01

    Although office-based dermatologic procedures are generally considered safe, there is a lack of prospective data on the rate of adverse events (AEs) associated with these procedures. To determine the frequency of AEs after dermatologic surgery and to characterize the most commonly encountered AEs. A web-based interface was designed to track AEs with the input of four dermatologic surgeons. Patient demographic and operative data were collected at the time of the dermatologic surgery procedure. AEs occurring at any time during the data collection period were logged according to an a priori categorization scheme. The AE rate was 2.0% in this series of 2,418 subjects undergoing dermatologic surgery from February 1 through December 14, 2010. The most commonly reported AEs were suspicion of infection (64%), postoperative hemorrhage (20%), and wound dehiscence (8%). Suspicion of infection was slightly less frequent in subjects who received prophylactic preoperative antibiotics (0.4%) than in those who did not (1.5%, p = .07). There were no serious AEs and no deaths. AEs are uncommon after office-based dermatologic surgery procedures. Preoperative antibiotics may further decrease the infection rate after dermatologic surgery, but the risks and benefits must be weighed given the already low AE rate. © 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

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

    Science.gov (United States)

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

    2017-01-01

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

  10. Development and Application of Nursing Adverse Events Reporting and Analysis System in the Hospital%院内护理不良事件上报分析系统的开发与应用

    Institute of Scientific and Technical Information of China (English)

    方卫青; 周奕

    2016-01-01

    为了实现院内护理不良事件的主动上报,降低填报流程中的差错率,提高工作效率,规范操作流程,自主开发了院内护理不良事件上报分析系统。系统主要功能模块包括不良事件上报模块、审核模块、分析模块,最终根据需求生成多维度的统计分析报表。系统的权限管理采用角色访问控制设计,以保证系统安全。通过2年多的运行达到了预期的效果。%In order to realize the active reporting of nursing adverse events in the hospital, reduce the error rate, improve the work efficiency, and to standardize the operation flow, we independently developed the nursing adverse event reporting and analysis system. The major function modules include the adverse reporting module, the review module and the analysis module. The system can generate the multidimensional statistical analysis report according to the requirement. The administration permission adopted the design of role based access control so as to ensure the security of the system. The application of the software achieved the expected results after 2 years of operation.

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

    Directory of Open Access Journals (Sweden)

    Naing C

    2012-08-01

    Full Text Available Cho Naing,1,3 Kyan Aung,1 Syed Imran Ahmed,2 Joon Wah Mak31School of Medical Sciences, 2School of Pharmacy and Health Sciences, 3School of Postgraduate Studies and Research, International Medical University, Kuala Lumpur, MalaysiaBackground: 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

  12. Adverse Drug Event Prevention: 2014 Action Plan Conference.

    Science.gov (United States)

    Ducoffe, Aaron R; Baehr, Avi; Peña, Juliet C; Rider, Briana B; Yang, Sandra; Hu, Dale J

    2016-09-01

    Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use.

  13. Occurrence of early adverse events after vaccination against influenza at a brazilian reference center

    Directory of Open Access Journals (Sweden)

    Marta Heloísa Lopes

    2008-01-01

    Full Text Available INTRODUCTION: Since 1999, the Ministry of Health in Brazil has conducted campaigns of vaccination against influenza targeted towards the elderly, chronically-diseased people and health care workers. The vaccine against influenza is associated with adverse events of minor importance. OBJECTIVE: To investigate the early adverse events related to the vaccine against influenza. CASUISTICS AND METHODS: One hundred and ninety seven elderly individuals and health care workers vaccinated against influenza were included. An inquiry regarding adverse events related to the vaccine was applied seven days after the vaccination. RESULTS: Local adverse events were reported by 32.5% and systemic effects by 26.4% of the vaccinated subjects. Pain in the region of the injection, headache, myalgia, malaise, and coryza were more frequent in the workers than in the elderly (p<0.05. There was no statistically significant difference in the occurrence of fever. CONCLUSIONS: The belief of part of the population that credits frequent and uncomfortable adverse events to the vaccine was not confirmed. The subjective adverse events were more frequent in the health care workers, which can influence, in a negative way, the disclosure of the benefits of this vaccine due to their role as opinion makers.

  14. 护理不良事件报告障碍与医院病人安全文化的相关性研究%The relationship between the report barrier of nursing adverse event and patient safety culture

    Institute of Scientific and Technical Information of China (English)

    周珺; 赵梅; 董旭婷; 吴淑娴

    2014-01-01

    Objective: To explore the relationship between the report barrier of nursing adverse event and patient safety culture. Methods: Totally 217 head nurses from 69 hospitals in Anhui province were investigated using the Report Barriers Questionnaire and Patient Safety Culture Assessing Scale. Results: The mean scores of the report barriers of nursing adverse event and patient safety culture were 2.48±0.39 and 3.36±0.54, respectively. They were negatively correlated with each other (r=-0.277,P<0.01). Conclusion: The level of patient safety culture is higher than the average level. Barriers of nursing adverse events report mainly relfected in punitive culture. There is a low to medium negative correlation between the report status of nursing adverse event and patient safety culture. A non-punitive reporting system for nursing adverse events should be constructed in nursing management. We should cultivated the beliefs and attitudes of nursing safety and pay more attention to the inlfuence of occupational stress to patient safety to enhance the formation of safety nursing behavior.%目的:探讨护理不良事件报告障碍与医院病人安全文化的相关性。方法:采用护理不良事件报告障碍问卷及医院护理人员病人安全文化调查表对来自于安徽省内69家医院的217名护士长进行问卷调查。结果:护理不良事件报告障碍总均分为(2.48±0.39)分,医院病人安全文化总均分为(3.36±0.54)分,护理不良事件报告障碍总均分与医院病人安全文化总均分的相关系数为-0.277(P<0.01)。结论:医院病人安全文化稍高于中等水平,护理不良事件报告障碍主要体现在惩罚性文化方面。两者之间呈显著负相关。在护理管理过程中,应构建非惩罚性不良事件报告系统,注重培养安全护理的信念和态度,关注职业压力的产生对于患者安全的影响,达到促使其形成安全护理行为的目的。

  15. Characteristics of ambulatory anticoagulant adverse drug events: a descriptive study

    Directory of Open Access Journals (Sweden)

    Eckstrand Julie

    2010-02-01

    Full Text Available Abstract Background Despite the high frequency with which adverse drug events (ADEs occur in outpatient settings, detailed information regarding these events remains limited. Anticoagulant drugs are associated with increased safety concerns and are commonly involved in outpatient ADEs. We therefore sought to evaluate ambulatory anticoagulation ADEs and the patient population in which they occurred within the Duke University Health System (Durham, NC, USA. Methods A retrospective chart review of ambulatory warfarin-related ADEs was conducted. An automated trigger surveillance system identified eligible events in ambulatory patients admitted with an International Normalized Ratio (INR >3 and administration of vitamin K. Event and patient characteristics were evaluated, and quality/process improvement strategies for ambulatory anticoagulation management are described. Results A total of 169 events in 167 patients were identified from December 1, 2006-June 30, 2008 and included in the study. A median supratherapeutic INR of 6.1 was noted, and roughly half of all events (52.1% were associated with a bleed. Nearly 74% of events resulted in a need for fresh frozen plasma; 64.8% of bleeds were classified as major. A total of 59.2% of events were at least partially responsible for hospital admission. Median patient age was 68 y (range 36-95 y with 24.9% initiating therapy within 3 months prior to the event. Of events with a prior documented patient visit (n = 157, 73.2% were seen at a Duke clinic or hospital within the previous month. Almost 80% of these patients had anticoagulation therapy addressed, but only 60.0% had a follow-up plan documented in the electronic note. Conclusions Ambulatory warfarin-related ADEs have significant patient and healthcare utilization consequences in the form of bleeding events and associated hospital admissions. Recommendations for improvement in anticoagulation management include use of information technology to assist

  16. Application of Knowledge Discovery in Databases Methodologies for Predictive Models for Pregnancy Adverse Events

    Science.gov (United States)

    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…

  17. Sacral Nerve Stimulation for Constipation: Suboptimal Outcome and Adverse Events

    DEFF Research Database (Denmark)

    Maeda, Yasuko; Lundby, Lilli; Buntzen, Steen;

    2010-01-01

    Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events.......Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events....

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

    Science.gov (United States)

    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

  19. Nursing unit teams matter: Impact of unit-level nurse practice environment, nurse work characteristics, and burnout on nurse reported job outcomes, and quality of care, and patient adverse events--a cross-sectional survey.

    Science.gov (United States)

    Van Bogaert, Peter; Timmermans, Olaf; Weeks, Susan Mace; van Heusden, Danny; Wouters, Kristien; Franck, Erik

    2014-08-01

    To investigate the impact of nurse practice environment factors, nurse work characteristics, and burnout on nurse reported job outcomes, quality of care, and patient adverse events variables at the nursing unit level. Nurse practice environment studies show growing insights and knowledge about determining factors for nurse workforce stability, quality of care, and patient safety. Until now, international studies have primarily focused on variability at the hospital level; however, insights at the nursing unit level can reveal key factors in the nurse practice environment. A cross-sectional design with a survey. In a cross-sectional survey, a sample of 1108 nurses assigned to 96 nursing units completed a structured questionnaire composed of various validated instruments measuring nurse practice environment factors, nurse work characteristics, burnout, nurse reported job outcomes, quality of care, and patient adverse events. Associations between the variables were examined using multilevel modelling techniques. Various unit-level associations (simple models) were identified between nurse practice environment factors, nurse work characteristics, burnout dimensions, and nurse reported outcome variables. Multiple multilevel models showed various independent variables such as nursing management at the unit level, social capital, emotional exhaustion, and depersonalization as important predictors of nurse reported outcome variables such job satisfaction, turnover intentions, quality of care (at the unit, the last shift, and in the hospital within the last year), patient and family complaints, patient and family verbal abuse, patient falls, nosocomial infections, and medications errors. Results suggested a stable nurse work force, with the capability to achieve superior quality and patient safety outcomes, is associated with unit-level favourable perceptions of nurse work environment factors, workload, decision latitude, and social capital, as well low levels of burnout

  20. Drug-Related Adverse Events of Osteoporosis Therapy.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  2. Challenges in coding adverse events in clinical trials: a systematic review.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    Full Text Available BACKGROUND: Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation. Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding. METHODS: Systematic review using PRISMA. We searched PubMed, EMBASE and The Cochrane Library. All studies were screened for eligibility by two authors. RESULTS: Our search returned 520 unique studies of which 12 were included. Only one study investigated interobserver variation. It reported that 12% of the codes were evaluated differently by two coders. Independent physicians found that 8% of all the codes deviated from the original description. Other studies found that product summaries could be greatly affected by the choice of dictionary. With the introduction of MedDRA, it seems to have become harder to identify adverse events statistically because each code is divided in subgroups. To account for this, lumping techniques have been developed but are rarely used, and guidance on when to use them is vague. An additional challenge is that adverse events are censored if they already occurred in the run-in period of a trial. As there are more than 26 ways of determining whether an event has already occurred, this can lead to bias, particularly because data analysis is rarely performed blindly. CONCLUSION: There is a lack of evidence that coding of adverse events is a reliable, unbiased and reproducible process. The increase in categories has made detecting adverse events harder, potentially compromising safety. It is crucial that readers of medical publications are aware of these challenges. Comprehensive interobserver

  3. Frequency of adverse events after vaccination with different vaccinia strains.

    Directory of Open Access Journals (Sweden)

    Mirjam Kretzschmar

    2006-08-01

    Full Text Available 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

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

    Science.gov (United States)

    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

  5. Critical incident stress debriefing after adverse patient safety events.

    Science.gov (United States)

    Harrison, Reema; Wu, Albert

    2017-05-01

    Adverse events (AEs) are common, estimated to occur in around 10% internationally. Although preventable harm can be minimized, when AEs occur it is important that they be managed appropriately. AEs can be traumatic not only for patients, their friends, and relatives, but also for the involved clinicians, who have been referred to as "second victims" in a growing body of international research. Despite the frequency with which AEs occur, organizational mechanisms for supporting staff in these circumstances are not routinely embedded in healthcare settings. Critical Incident Stress Debriefing (CISD) has long been provided for professionals, such as disaster workers, who are exposed to traumatic and high-stress events. CISD is considered an effective strategy to promote resilience and recovery. We explore the potential value of providing CISD for health professionals involved in patient safety-related AEs and discuss the instances in which this could be routinely implemented.

  6. Adverse events of herbal food supplements for body weight reduction: systematic review.

    Science.gov (United States)

    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.

  7. Automatic detection of adverse events to predict drug label changes using text and data mining techniques.

    Science.gov (United States)

    Gurulingappa, Harsha; Toldo, Luca; Rajput, Abdul Mateen; Kors, Jan A; Taweel, Adel; Tayrouz, Yorki

    2013-11-01

    The aim of this study was to assess the impact of automatically detected adverse event signals from text and open-source data on the prediction of drug label changes. Open-source adverse effect data were collected from FAERS, Yellow Cards and SIDER databases. A shallow linguistic relation extraction system (JSRE) was applied for extraction of adverse effects from MEDLINE case reports. Statistical approach was applied on the extracted datasets for signal detection and subsequent prediction of label changes issued for 29 drugs by the UK Regulatory Authority in 2009. 76% of drug label changes were automatically predicted. Out of these, 6% of drug label changes were detected only by text mining. JSRE enabled precise identification of four adverse drug events from MEDLINE that were undetectable otherwise. Changes in drug labels can be predicted automatically using data and text mining techniques. Text mining technology is mature and well-placed to support the pharmacovigilance tasks. Copyright © 2013 John Wiley & Sons, Ltd.

  8. 基于ASP.NET的护理高危不良事件报告系统研发与应用%Study and Application of Nursing High-risk Adverse Events Report System on ASP.NET

    Institute of Scientific and Technical Information of China (English)

    李泰环; 陆霞

    2011-01-01

    Objective: Implementation the nursing high risk adverse events reporting system, strengthen the nursing safety management. Methods: Extract data of the system needs in hospital information system (HIS), while adding part of the data tables in HIS , adopting of B/S architecture, in Visual Studio2008 development platform, using ASP. NET platform architecture and C# development language, system was developed. Result: All functions of the nursing risk adverse event reporting system was implemented, at present, the system is running stably. Conclusion: Using the system, supervision of the nursing high risk adverse events was realized, the safety management of high-risk patients was ensured, the work efficiency and management quality was improved, a strong information security was provided for the nursing department leadership decision-making, at the same time, it make information management and decision-making capacity of the nursing administrators was improved, the standardization and informatization of care management was achieved.%目的:实现护理高危不良事件报告系统,强化护理安全管理.方法:从医院信息系统(HIS)中提取该系统需要的数据,同时在HIS系统中新增部分数据表,采用B/S架构,在Visual Studio2008开发平台下,使用ASP.NET平台架构和C#开发语言进行系统的研发.结果:实现了护理高危不良事件报告系统的各项功能,目前系统在全院的各科室运行稳定.结论:利用该系统,能够实现护理高危不良事件的监管,保证了对高危病人的安全管理,提高了护理工作效率和管理质量;为护理部领导决策提供了有力的信息保障,提高了护理管理者的信息管理和决策能力,实现了护理管理的规范化和信息化.

  9. Serious adverse events associated with yellow fever vaccine.

    Science.gov (United States)

    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.

  10. Systemic adverse events following rituximab therapy in patients with Graves' disease

    DEFF Research Database (Denmark)

    El Fassi, D; Nielsen, Claus Henrik; Junker, Michael Peter;

    2011-01-01

    Background and aim: Rituximab (RTX) therapy has shown promising results in Graves´ disease (GD), with or without ophthalmopathy. We examined the occurrence of adverse events in GD patients treated with RTX. Subjects and methods: Ten patients received RTX and methimazole, while ten patients received...... had the third highest increase in immunoglobulin deposition on monocytes by day 14. The arthralgias persisted in two of the patients, despite glucocorticoid rescue therapy. Conclusions: We report articular adverse events in three and gastrointestinal symptoms in two out of ten GD patients who received...

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

    Science.gov (United States)

    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.

  12. Adverse events during a placebo phase for inpatients with chronic schizophrenia

    NARCIS (Netherlands)

    van de Laar, N; Henter, L; Bartko, JJ; Wyatt, RJ

    2001-01-01

    Background: This report builds on a previous analysis examining the long-term effects of a placebo period on a group of inpatients with chronic schizophrenia. In the present analysis, outcome was evaluated through the use of the Psychiatric Adverse Events Rating Scale. Methods: This retrospective an

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

    Science.gov (United States)

    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 =…

  14. Development and validation of a taxonomy of adverse handover events in hospital settings

    DEFF Research Database (Denmark)

    Andersen, Henning Boje; Siemsen, Inger Margrete D.; Petersen, Lene Funck

    2015-01-01

    -rater reliability and distribution of types of handover failures and causal factors. The taxonomy contains five types of failures and seven types of main causal factors. The taxonomy was validated against 432 adverse handover event descriptions contained in incident reports (stratified random sample from the Danish...

  15. Adverse events of anti-tumor necrosis factor α therapy in ankylosing spondylitis.

    Directory of Open Access Journals (Sweden)

    Qiang Tong

    Full Text Available This study aims to investigate the prevalence of short-term and long-term adverse events associated with tumor necrosis factor-α (TNF-α blocker treatment in Chinese Han patients suffering from ankylosing spondylitis (AS.The study included 402 Chinese Han AS patients treated with TNF-α blockers. Baseline data was collected. All patients were monitored for adverse events 2 hours following administration. Long-term treatment was evaluated at 8, 12, 52 and 104 weeks follow-up for 172 patients treated with TNF-α blockers.Short-term adverse events occurred in 20.15% (81/402, including rash (3.5%; 14/402, pruritus (1.2%; 5/402, nausea (2.2%; 9/402, headache (0.7%; 3/402, skin allergies (4.0%; 16/402, fever (0.5%; 2/402, palpitations (3.0%; 12/402, dyspnea (0.5%; 2/402, chest pain (0.2%; 1/402, [corrected] abdominal pain (1.0%; 4/402, hypertension (2.2%; 9/402, papilledema (0.5%; 2/402, laryngeal edema (0.2%; 1/402 and premature ventricular contraction (0.2%; 1/402. Long-term adverse events occurred in 59 (34.3%; 59/172 patients, including pneumonia (7.6%; 13/172, urinary tract infections (9.9%; 17/172, otitis media (4.7%; 8/172, tuberculosis are (3.5%; 6/172 [corrected], abscess (1.2%; 2/172, oral candidiasis (0.6%; 1/172, elevation of transaminase (1.7%; 3/172, anemia (1.2%; 2/172, hematuresis (0.6%; 1/172, constipation (2.3%; 4/172, weight loss (0.6%; 1/172, exfoliative dermatitis (0.6%; 1/172. CRP, ESR and disease duration were found to be associated with an increased risk of immediate and long-term adverse events (P<0.05. Long-term treatment with Infliximab was associated with more adverse events than rhTNFR-Fc (P<0.01.This study reports on the prevalence of adverse events in short-term and long-term treatment with TNF-α blocker monotherapy in Chinese Han AS patients. Duration of disease, erythrocyte sedimentation rate, and c-reactive protein serum levels were found to be associated with increased adverse events with anti-TNF-α therapy. Long

  16. Investigation in adverse event reporting of nurses and its influencing factors%护士对不良事件报告的现状及相关因素探讨

    Institute of Scientific and Technical Information of China (English)

    周娟; 匡莉; 翟颖娟

    2009-01-01

    目的 了解护士对不良事件报告现状及探讨相关影响因素.方法 翻译美国医院患者安全文化评估问卷,将所形成的中文版量表对801名护士进行评估.结果 82.65%的被调查护士在过去12个月内未报告过不良事件,维度"不良事件的报告频率"和"对错误的非惩罚性反应"的积极反应率分别为29.92%、29.38%.本科及以上学历护士在维度"不良事件的报告频率"的得分高于大中专护士,门诊护士的得分低于其他科室护士.结论 护士对不良事件的报告亟待提高,主要影响因素为报告文化是否具有惩罚性以及护士的学历等.%Objective To investigate the adverse event reporting of nurses and analyze the influenc-ing factors. Methods A sample of 801 nurses were assessed by completing AHRQ Hospital Survey On Patient Safety Culture (Chinese version). Results 82.65% of respondents within hospital didn't reported a single event in the past 12 months. The positive responsive rates for "frequency of event reported"and "nonpunitive response to error"was 29.92% and 29.38% respectively, where higher scores were found in the respondents possessing bachelor degrees and the average score of the respondents from out-patients unit was lower than those from other units. Conclusions The findings illustrate that it is necessary to improve the performance of event reporting of nurses and the influence factors lie in the level of the nurses' educa-tion degree and whether the event reporting system is punitive or not.

  17. Adverse childhood event experiences, fertility difficulties and menstrual cycle characteristics.

    Science.gov (United States)

    Jacobs, Marni B; Boynton-Jarrett, Renee D; Harville, Emily W

    2015-01-01

    Increased childhood adversity may be affect adult fertility, however, the mechanism through which this occurs is unclear. Menstrual cycle abnormalities are predictive of fertility difficulties, and stress influences menstrual cycle characteristics. Here, we assess whether adverse childhood experiences (ACEs) are associated with fertility difficulties and menstrual cycle dysregulation, offering a plausible mechanism for the link between lifetime stress and fertility. From April 2012 to February 2014, 742 pregnant and non-pregnant women aged 18-45 years residing in southeastern Louisiana provided information on childhood adversity and reproductive history. Associations between ACEs and fertility difficulties and menstrual cycle patterns were evaluated. As the number of ACEs increased, risk of fertility difficulties and amenorrhea increased (RR = 1.09, 95% CI 1.05-1.13 and RR = 1.07, 95% CI 1.04-1.10, respectively), while fecundability decreased [fecundability ratio (FR) = 0.97, 95% CI 0.95-1.00]. Compared to women with no adversity, women in the high adversity group were more likely to experience both infertility and amenorrhea (RR = 2.75, 95% CI 1.45-5.21 and RR = 2.54, 95% CI 1.52-4.25, respectively), and reduced fecundability (FR = 0.75, 95% CI 0.56-1.00). Although similar patterns were seen for menstrual cycle irregularity, associations were diminished. Associations did not materially change following adjustment for age, body mass index, race, education, smoking and income. Results are constrained by the self-report nature of the study and the limited generalizability of the study population. To our knowledge, this is the first study to present evidence of a link between childhood stressors, menstrual cycle disruption and fertility difficulties. The effect of childhood stress on fertility may be mediated through altered functioning of the HPA axis, acting to suppress fertility in response to less than optimal reproductive circumstances.

  18. The risk of bleeding with duloxetine treatment in patients who use nonsteroidal anti-inflammatory drugs (NSAIDs: analysis of placebo-controlled trials and post-marketing adverse event reports

    Directory of Open Access Journals (Sweden)

    Perahia DG

    2013-11-01

    Full Text Available David G Perahia,1 Mark E Bangs,2 Qi Zhang,2 Yingkai Cheng,2 Jonna Ahl,2 Elijah P Frakes,2 Michael J Adams,2 James M Martinez2 1Neurosciences, Lilly Research Centre, Windlesham, Surrey, UK; 2Neurosciences, Eli Lilly and Company, Indianapolis, IN, USA Purpose: To assess the safety of duloxetine with regards to bleeding-related events in patients who concomitantly did, versus did not, use nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin. Methods: Safety data from all placebo-controlled trials of duloxetine conducted between December 1993 and December 2010, and post-marketing reports from duloxetine-treated patients in the US Food and Drug Administration Adverse Event Reporting System (FAERS, were searched for bleeding-related treatment-emergent adverse events (TEAEs. The percentage of patients with bleeding-related TEAEs was summarized and compared between treatment groups in all the placebo-controlled studies. Differences between NSAID user and non-user subgroups from clinical trial data were analyzed by a logistic regression model that included therapy, NSAID use, and therapy-by-NSAID subgroup interaction. In addition, to determine if higher duloxetine doses are associated with an increased incidence of bleeding-related TEAEs, and whether the use of concomitant NSAIDs might influence the dose effect if one exists, placebo-controlled clinical trials with duloxetine fixed doses of 60 mg, 120 mg, and placebo were analyzed. Also, the incidence of bleeding-related TEAEs reported for duloxetine alone was compared with the incidence in patients treated with duloxetine and concomitant NSAIDs. Finally, the number of bleeding-related cases reported for duloxetine in the FAERS database was compared with the numbers reported for all other drugs. Results: Across duloxetine clinical trials, there was a significantly greater incidence of bleeding-related TEAEs in duloxetine- versus placebo-treated patients overall and also in those patients who

  19. Adverse events in children and adolescents treated with quetiapine

    DEFF Research Database (Denmark)

    Jakobsen, Klaus D; Wallach-Kildemoes, Helle; Bruhn, Christina H

    2017-01-01

    Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children and adolesc......Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children...... 10–17 years) and six patients were boys. The main reported ADEs were (i) endocrine, for example, hyperprolactinemia and hyperthyroidism, (ii) cardiac, for example, tachycardia and QT prolongation, (iii) neurological, for example, seizures and cerebral hemorrhage, and (iv) psychiatric, for example...

  20. Consumer reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Aagaard, Lise; Nielsen, Lars Hougaard; Hansen, Ebba Holme

    2009-01-01

    BACKGROUND: Reporting adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. Since 2003 in Denmark, consumers have been able to report ADRs directly to the authorities. The objective of this study was to compare ADRs reported by consumers with ADRs...... reported from other sources, in terms of their type, seriousness and the suspected medicines involved. METHODS: The number of ADRs reported to the Danish ADR database from 2004 to 2006 was analysed in terms of category of reporter, seriousness, category of ADRs by system organ class (SOC) and the suspected...... medicines on level 1 of the anatomical therapeutic chemical (ATC) classification system. ADR reports from consumers were compared with reports from other sources (physicians, pharmacists, lawyers, pharmaceutical companies and other healthcare professionals). Chi-square and odds ratios (ORs) were calculated...

  1. From big data to bedside decision-making: the case for AdverseEvents

    Directory of Open Access Journals (Sweden)

    Giuseppe Biondi Zoccai

    2013-07-01

    Full Text Available Evidence-based medicine has gained mainstream popularity, but it requires a delicate balance between clinical evidence, physician skills, patient preferences, and costs. Facing the individual patient, even a simple decision such as which antithrombotic agent should be prescribed becomes complex. There are several reasons for this conundrum, but one of the foremost is the limited external validity of pivotal randomized trials, with their extremely restrictive selection criteria. Post-marketing reporting of adverse events is a very useful and democratic means to appraise the risk-benefit profile, but to date such reports were not organized or available. The development of the Food and Drug Administration (FDA venue for such task, the FDA Adverse Event Reporting System (FAERS has substantially improved data collection. However, analysis of this extensive relational database remains complex for most but few companies or agencies. AdverseEvents is a novel online platform enabling updated and user-friendly inquiry of FAERS. Given its ease of use, flexibility and comprehensiveness, it is likely going to improve decision making for healthcare authorities and practitioners, as well as patients. This is clearly testified by the precise and informative comparative analysis that can be performed with AdverseEvents on novel antithrombotic agents.

  2. 我院护理不良事件自愿报告系统问题分析与探讨%Problem analysis of nursing related adverse events self reporting system

    Institute of Scientific and Technical Information of China (English)

    郑一宁; 孙燕

    2011-01-01

    We set up nursing related adverse events self reporting system since 2004.All reported cases from 2004 to 2010 were summarized and analyzed to improve the reporting process. We analyzed all possible problems in reporting system, including liable person, patients status, work procedure, etc. Then we improved our management system accordingly, such as standardizing work procedure, allocating reasonable human resources,specifying process standard, etc, to ensure safe and effective nursing care. As nurse managers, we also should emphasize outcome measure the same as process management.%该院自2004 年建立院内护理不良事件自愿报告系统,对报告的案例进行总结,对问题进行分析,对环节进行规范.从事件发生的责任人情况、患者情况、工作流程等进行分析.根据分析,使工作流程科学化,护理人力配置更合理,规范工作标准等,以达到临床护理工作安全、有效的目的.同时提示护理管理者在护理质量管理框架中,注重过程管理的同时,其结果指标也同样是应关注的重点和要点.

  3. Adverse events among high-risk participants in a home-based walking study: a descriptive study

    Directory of Open Access Journals (Sweden)

    Holleman Robert G

    2007-05-01

    Full Text Available Abstract Background For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients. Methods This study describes the type and severity of adverse events reported by participants with cardiovascular disease or at-risk for cardiovascular disease that occurred during an unsupervised, home-based walking study. This multi-site, randomized controlled trial tested the feasibility of a diet and lifestyle activity intervention over 1.5 years. At month 13, 274 eligible participants (male veterans were recruited who were ambulatory, BMI > 28, and reporting one or more cardiovascular disease risk factors. All participants attended five, face-to-face dietitian-delivered counseling sessions during the six-month intervention. Participants were randomized to three study arms: 1 time-based walking goals, 2 simple pedometer-based walking goals, and 3 enhanced pedometer-based walking goals with Internet-mediated feedback. Two physicians verified adverse event symptom coding. Results Enrolled participants had an average of five medical comorbidities. During 1110 person months of observation, 87 of 274 participants reported 121 adverse events. One serious study-related adverse event (atrial fibrillation was reported; the individual resumed study participation within three days. Non-serious, study related adverse events made up 12% of all symptoms – predominantly minor musculoskeletal events. Serious, non-study related adverse events represented 32% of all symptoms while non-serious, non-study related adverse events made up 56% of symptoms. Cardiovascular disease events represented over half of the non-study related adverse event symptoms followed by musculoskeletal complaints

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

    Science.gov (United States)

    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.

  5. Management of egfr tki–induced dermatologic adverse events

    Science.gov (United States)

    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

  6. Immunogenicity, efficacy and adverse events of adalimumab in RA patients.

    Science.gov (United States)

    Bender, Niko K; Heilig, Christoph E; Dröll, Benjamin; Wohlgemuth, Jessica; Armbruster, Franz-Paul; Heilig, Bernhard

    2007-01-01

    To assess the immunogenicity of adalimumab, a human anti-TNF-alpha mAb, we evaluated the formation of antibodies to adalimumab, efficacy and adverse events among 15 patients with highly active rheumatoid arthritis. Four patients were treated with adalimumab as monotherapy, and 11 patients with concomitant DMARDs. Disease activity was measured by DAS28. The antibodies were detected by ELISA. Thirteen (87%) patients withdrew from therapy within 45 weeks and overall 13 (87%) patients showed antibodies to adalimumab including 11 patients who withdrew from therapy. In four patients without concomitant DMARDs and in nine patients with concomitant DMARDs, we detected anti-adalimumab antibodies. Overall, five of seven patients with adverse drug reactions and all nine patients with lack of efficacy were associated with the formation of antibodies. Two antibody-positive patients developed an exantheme. The results indicate that adalimumab is, in spite of its fully human sequences, immunogenic and induces antibodies in a high rate of adalimumab-treated patients.

  7. Data mining for prospective early detection of safety signals in the Vaccine Adverse Event Reporting System (VAERS): a case study of febrile seizures after a 2010-2011 seasonal influenza virus vaccine.

    Science.gov (United States)

    Martin, David; Menschik, David; Bryant-Genevier, Marthe; Ball, Robert

    2013-07-01

    Reports of data mining results as an initial indication of a prospectively detected safety signal in the US Vaccine Adverse Event Reporting System (VAERS) have been limited. In April 2010 a vaccine safety signal for febrile seizures after Fluvax(®) and Fluvax(®) Junior was identified in Australia without the aid of data mining. In order to refine Northern Hemisphere influenza vaccine safety surveillance, VAERS data mining analyses based on vaccine brand name were initiated during the 2010-2011 influenza season. We describe the strategies that led to the finding of a novel safety signal using empirical Bayesian data mining. The primary US VAERS analysis calculated an empirical Bayesian geometric mean (EBGM), which was adjusted for age group, sex and year received. A secondary age-stratified analysis calculated a separate EBGM for 11 pre-defined age subsets. These bi-weekly analyses were generated with database restrictions that separated live and inactivated vaccines as well as with the US VAERS database. A cutoff of 2.0 at the fifth percentile of the confidence interval (CI) for the EBGM, the EB05, was used to identify vaccine adverse event combinations for further evaluation. Examination of potential interactions among concomitantly administered vaccines is based on the Interaction Signal Score (INTSS), which is a relative measure of how much excess disproportionality is present in the three-dimensional combination of two vaccines and one adverse event term. An INTSS >1 indicates that the CI for the three-dimensional analysis is larger than and does not overlap with the CI from the highest two-dimensional analysis. We subsequently examined the possibility of masking by removing all 2,095 Fluzone(®) 2010-2011 reports from the 10 December 2010 version of the VAERS database. In addition, we calculated relative reporting ratios to observe the relative contribution of adjustment and the Multi-Item Gamma Poisson Shrinker (MGPS) algorithm to EBGM values. On 10

  8. Inappropriate prescribing and adverse drug events in older people.

    LENUS (Irish Health Repository)

    Hamilton, Hilary J

    2009-01-01

    Inappropriate prescribing (IP) in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs), morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  9. Inappropriate prescribing and adverse drug events in older people

    Directory of Open Access Journals (Sweden)

    Gallagher Paul F

    2009-01-01

    Full Text Available Abstract Inappropriate prescribing (IP in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs, morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

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

    Science.gov (United States)

    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

  11. 78 FR 71620 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

    Science.gov (United States)

    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 Medical...

  12. Adverse events associated with ultrasonic scalers: A manufacturer and user facility device experience database analysis

    OpenAIRE

    Rajagopal Athmarao Thennukonda; Bhavani Rekha Natarajan

    2015-01-01

    Background: The present study was conducted to determine the frequency and type of adverse events (AEs) associated with ultrasonic scaler reported to the Food and Drug Administration manufacturer and user facility device experience (MAUDE) database. Materials and Methods: The authors reviewed the ultrasonic scaler units (USU) related AEs reported to MAUDE from October 1, 1995, to September 31, 2015. Analyses of details collected are presented. Results: MAUDE received a total of 667 un...

  13. Prevalence of Negative Life Events and Chronic Adversities in European Pre- and Primary-School Children

    DEFF Research Database (Denmark)

    Vanaelst, Barbara; Huybrechts, Inge; Bourdeaudhuij, Ilse

    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......- 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...... 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...

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

    Directory of Open Access Journals (Sweden)

    Deyo Richard A

    2006-06-01

    Full Text Available Abstract 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

  15. Dermatologic adverse events associated with chemotherapy and targeted anticancer therapy

    Directory of Open Access Journals (Sweden)

    Maria Kowalska

    2016-05-01

    Full Text Available Chemotherapeutic agents and drugs used for targeted tumor therapy often cause undesirable side effects of the skin which typically are toxic cutaneous reactions (toxicity grade 1 to 4. The first group of drugs that cause toxicities affecting the skin are inhibitors of epidermal growth factor receptor (EGFR. They cause a variety of skin changes (PRIDE syndrome, which are mainly manifested by papulopustular rash, also referred to as acneiform rash, occurring in 44–74% of patients. Another drug which causes cutaneous toxicities is inhibitor of CTLA4 (cytotoxic T lymphocyte-associated protein 4, which is represented by ipilimumab, used in the treatment of metastatic melanoma. The most common dermatological adverse event, observed in 40–64% of patients receiving ipilimumab, is generalized maculopapular rash with pruritus and dry skin, and in some cases vitiligo is also observed. BRAF and MEK inhibitors introduced for the treatment of advanced melanoma also cause skin rashes. BRAF inhibitors also affecting the proliferation of keratinocytes stimulate hypertrophic changes and cause the whole spectrum of lesions from benign and keratoacanthoma to squamous cell carcinoma. A hedgehog pathway inhibitor (vismodegib is used for the treatment of metastatic basal cell carcinoma. The most common adverse events it causes are reversible alopecia and dysgeusia, but it can also cause the development of keratoacanthoma and squamous cell carcinoma. Among the most common side effects of chemotherapy and targeted therapy are toxic changes within the hands and feet (hand-foot skin reaction – HFSR that early manifest as a neurological symptoms (numbness, paresthesia, and skin symptoms (erythematous swelling changes, blisters, hyperkeratosis occur later. Anti-cancer drugs can also cause serious skin diseases such as Stevens-Johnson syndrome (SJS, toxic epidermal necrolysis (TEN and DRESS (drug rash with eosinophilia and systemic symptoms, whose course and prognosis

  16. Efficacy and adverse events of cold vs hot polypectomy: A meta-analysis

    Science.gov (United States)

    Fujiya, Mikihiro; Sato, Hiroki; Ueno, Nobuhiro; Sakatani, Aki; Tanaka, Kazuyuki; Dokoshi, Tatsuya; Fujibayashi, Shugo; Nomura, Yoshiki; Kashima, Shin; Gotoh, Takuma; Sasajima, Junpei; Moriichi, Kentaro; Watari, Jiro; Kohgo, Yutaka

    2016-01-01

    AIM: To compare previously reported randomized controlled studies (RCTs) of cold and hot polypectomy, we systematically reviewed and clarify the utility of cold polypectomy over hot with respect to efficacy and adverse events. METHODS: A meta-analysis was conducted to evaluate the predominance of cold and hot polypectomy for removing colon polyps. Published articles and abstracts from worldwide conferences were searched using the keywords “cold polypectomy”. RCTs that compared either or both the effects or adverse events of cold polypectomy with those of hot polypectomy were collected. The patients’ demographics, endoscopic procedures, No. of examined lesions, lesion size, macroscopic and histologic findings, rates of incomplete resection, bleeding amount, perforation, and length of procedure were extracted from each study. A forest plot analysis was used to verify the relative strength of the effects and adverse events of each procedure. A funnel plot was generated to assess the possibility of publication bias. RESULTS: Ultimately, six RCTs were selected. No significant differences were noted in the average lesion size (less than 10 mm) between the cold and hot polypectomy groups in each study. Further, the rates of complete resection and adverse events, including delayed bleeding, did not differ markedly between cold and hot polypectomy. The average procedural time in the cold polypectomy group was significantly shorter than in the hot polypectomy group. CONCLUSION: Cold polypectomy is a time-saving procedure for removing small polyps with markedly similar curability and safety to hot polypectomy. PMID:27340361

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

    Science.gov (United States)

    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.

  18. Complement C1 esterase inhibitor levels linked to infections and contaminated heparin-associated adverse events.

    Directory of Open Access Journals (Sweden)

    Zhao-Hua Zhou

    Full Text Available Activation of kinin-kallikrein and complement pathways by oversulfated-chondroitin-sulfate (OSCS has been linked with recent heparin-associated adverse clinical events. Given the fact that the majority of patients who received contaminated heparin did not experience an adverse event, it is of particular importance to determine the circumstances that increase the risk of a clinical reaction. In this study, we demonstrated by both the addition and affinity depletion of C1inh from normal human plasma, that the level of C1inh in the plasma has a great impact on the OSCS-induced kallikrein activity and its kinetics. OSCS-induced kallikrein activity was dramatically increased after C1inh was depleted, while the addition of C1inh completely attenuated kallikrein activity. In addition, actual clinical infection can lead to increased C1inh levels. Plasma from patients with sepsis had higher average levels of functional C1inh and decreased OSCS-induced kallikrein activity. Lastly, descriptive data on adverse event reports suggest cases likely to be associated with contaminated heparin are inversely correlated with infection. Our data suggest that low C1inh levels can be a risk factor and high levels can be protective. The identification of risk factors for contact system-mediated adverse events may allow for patient screening and clinical development of prophylaxis and treatments.

  19. [Nursing role in reporting adverse drug reactions].

    Science.gov (United States)

    Zurita-Garaicoechea, Ana; Reis-Carvalho, Joana; Ripa-Aisa, Irantzu; Jiménez-Mendoza, Ana; Díaz-Balén, Almudena; Oroviogoicoechea, Cristina

    2015-01-01

    The spontaneous report system, in which suspected adverse drug reaction (ADR) are reported by healthcare workers, is currently one of the primary methods to prevent and discover new and serious ADR to marketed medicinal products. The collaboration of nursing professionals with this task makes it possible to improve patient safety and to reduce ADR costs. Although a total of 781 cases of ADR cases were reported in Navarra in 2011, only 7.33% were reported by nurses. The objectives werw to determine the factors that influence nurses in reporting of ADR, and second, to devise strategies which help to increase reporting. A bibliographic search for articles that included the words: reacciones adversas medicamentosas (adverse drug reactions), notificación (reporting) and enfermería (nursing) was conducted using the PubMed and Cinhal databases. A total of 107 articles were retrieved, of which 27 were selected according to inclusion and exclusion criteria. The conclusion learned by reading and analyzing the selected articles was that the factors that affect the notification depend on the attitude of the notifier, as well as personal and professional factors. The main strategies to encourage notification are education and training, motivation, and the availability of facilitating tools. The main factors that have an influence on under-notification are the lack of knowledge and motivation among professionals. To solve the problem of under-notification, the main actions and strategies to undertake are education, motivation and persistence. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  20. A perspective from clinical and business ethics on adverse events in hospitalized patients.

    Science.gov (United States)

    Wagner, J T; Meier, C; Higdon, T

    1997-11-01

    Adverse events occur in a significant, but undetermined, number of hospitalized patients. These types of patient injuries are more often the result of faulty systems than human maleficence. A culture exists among health care providers that discourages the reporting of such events and resists the implementation of formal efforts to eliminate them. This resistance serves to perpetuate the problem. Both business and clinical ethics argue that sound reasons exist for hospitals to reduce, if not eliminate, adverse events. To do so is cost effective, particularly in a managed care environment. It is also at the heart of responsible professional behavior. Physicians are afforded an opportunity to be at the forefront in this quality improvement effort.

  1. Impact of extended-duration shifts on medical errors, adverse events, and attentional failures.

    Directory of Open Access Journals (Sweden)

    Laura K Barger

    2006-12-01

    Full Text Available A recent randomized controlled trial in critical-care units revealed that the elimination of extended-duration work shifts (> or =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.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.In our survey, extended-duration work shifts were associated with an increased risk of significant medical

  2. 某三甲医院可疑医疗器械不良事件上报情况分析%The Analysis on Adverse Medical Device Events Reporting in a Tertiary Hospital

    Institute of Scientific and Technical Information of China (English)

    范雯怡; 周利平; 胥雪冬

    2014-01-01

    目的以某三甲医院为例,分析可疑医疗器械不良事件上报工作的情况及影响因素。方法研究采用横断面现况调查设计。采取分阶段按比例抽样方法抽取各科室的医生、护士、技师共75人参与问卷调查,调查内容包括知识、行为等。结果调查对可疑医疗器械不良事件的知识知晓程度和态度,对本院不良事件管理和执行的知晓程度均处于较低水平,主动上报很少。结论医院应采取加强组织管理体系和扩大对医务人员宣传教育等措施,提升可疑医疗器械不良事件上报工作的完成情况。%Objectives To analyze Adverse Medical Device Events (AMDE) reporting in a tertiary hospital and its determinants. Methods A cross-sectional study was designed and multi-stage proportional sampling was used to conduct the survey. In total, 75 doctors, nurses and technicians participated in the survey. The survey content included knowledge and behaviors related with AMDE. Results Knowledge of AMDE and attitude towards AMDE reporting were not good enough. So did the knowledge about administration system and regulations. Besides, AMDE was seldom initiatively reported. Conclusion Hospitals should encourage initiative cases reporting by improving administration system and enhance the publicity and education among medical personnel on AMDE.

  3. [Identification of adverse events in hospitalised influenza patients].

    Science.gov (United States)

    Aranaz-Andrés, J M; Gea-Velázquez de Castro, M T; Jiménez-Pericás, F; Balbuena-Segura, A I; Meyer-García, M C; López-Fresneña, N; Miralles-Bueno, J J; Obón-Azuara, B; Moliner-Lahoz, J; Aibar-Remón, C

    2015-01-01

    To test the inter-observer agreement in identifying adverse events (AE) in patients hospitalized by flu and undergoing precautionary isolation measures. Historical cohort study, 50 patients undergoing isolation measures due to flu, and 50 patients without any isolation measures. The AE incidence ranges from 10 to 26% depending on the observer (26% [95%CI: 17.4%-34.60%], 10% [95%CI: 4.12%-15.88%], and 23% [95%CI: 14.75%-31.25%]). It was always lower in the cohort undergoing the isolation measures. This difference is statistically significant when the accurate definition of a case is applied. The agreement as regards the screening was good (higher than 76%; Kappa index between 0.29 and 0.81). The agreement as regards the accurate identification of AE related to care was lower (from 50 to 93.3%, Kappa index from 0.20 to 0.70). Before performing an epidemiological study on AE, interobserver concordance must be analyzed to improve the accuracy of the results and the validity of the study. Studies have different levels of reliability. Kappa index shows high levels for the screening guide, but not for the identification of AE. Without a good methodology the results achieved, and thus the decisions made from them, cannot be guaranteed. Researchers have to be sure of the method used, which should be as close as possible to the optimal achievable. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

  4. [The pathology of adverse events with immune checkpoint inhibitors].

    Science.gov (United States)

    Koelzer, V H; Glatz, K; Bubendorf, L; Weber, A; Gaspert, A; Cathomas, G; Lugli, A; Zippelius, A; Kempf, W; Mertz, K D

    2017-05-01

    Immunotherapy has gained importance with the development of new effective cancer treatments. Immune checkpoint inhibitors (ICI) are monoclonal antibodies that promote T‑cell mediated tumor immune rejection. Checkpoint blockade also carries the risk of inducing autoimmune reactions ("immune related adverse events", irAEs). The diagnosis and classification of irAEs constitute a new and important field in pathology. Practice-oriented review of the diagnosis and classification of irAEs. Structured, selective literature review based on PubMed und UpToDate ® online. The most common irAEs affect the skin, the gastrointestinal tract, the liver, and the respiratory system. The correct diagnosis and classification of irAEs by an interdisciplinary care team is essential for appropriate therapy and the prevention of long-term sequelae. Other important irAEs affect the endocrine organs, the heart, the joints, the kidneys and the nervous system. Because of their rarity and/or limited options for bioptic diagnosis, only limited data on the morphology and pathophysiology of these irAEs are currently available. Autopsies carried out after ICI therapy constitute an important element of quality control and allow better documentation of the incidence and pathogenesis of irAEs. Pathology plays a central role in the diagnosis and treatment of irAEs. Future studies may contribute to a better mechanistic understanding of irAEs for individualized knowledge-based risk assessment.

  5. Rotation and Displacement Predict Adverse Events in Pediatric Supracondylar Fractures.

    Science.gov (United States)

    Flierl, Michael A; Carry, Patrick M; Scott, Frank; Georgopoulos, Gaia; Hadley-Miller, Nancy

    2015-08-01

    The goal of this study was to identify supracondylar fracture patterns that were predictive of adverse events and poor outcomes. The study consisted of a retrospective review of patients admitted for surgical treatment of a supracondylar humerus fracture between June 2008 and August 2010. Preoperative radiographs were assessed based on appearance (simple vs oblique vs comminuted), coronal plane displacement (angulated, posterior, posteromedial vs posterolateral), and rotation (rotation vs no rotation). Logistic regression models were used to examine the relationship between fracture pattern and clinical outcome parameters in 373 patients who were followed for 4 weeks or more postoperatively. Outcome parameters included postoperative complications (infection, delayed healing, pin migration, revision surgery), need for physical or occupational therapy, need for postoperative intravenous narcotics, and preoperative nerve injury. Rotation and coronal displacement patterns of the fracture segments were significantly associated with postoperative complications, postoperative need for physical or occupational therapy as a result of residual stiffness, and nerve injury (P<.05). Compared with posteriorly displaced fractures, posterolaterally displaced fractures were associated with significantly greater odds of complications (P=.045), need for physical or occupational therapy (P<.001), and nerve injury (P<.001). Additionally, fractures with rotation were associated with significantly greater odds of complications (P<.001), need for physical or occupational therapy (P<.001), and nerve injury (P<.001) compared with fractures without rotation. Rotation and coronal plane displacement were predictive of complications, need for physical or occupational therapy, and nerve injury, and thus should be considered as potential prognostic variables when evaluating the initial injury pattern.

  6. Incidence of adverse events among healthcare workers following H1N1 Mass immunization in Ghana

    DEFF Research Database (Denmark)

    Ankrah, Daniel N A; Mantel-Teeuwisse, Aukje K; De Bruin, Marie L

    2013-01-01

    in the Pandemrix(®) SPC, but while injection-site pain was the most frequent in the SPC and other foreign studies, we recorded headache as the most frequent. Even fatigue, muscle/joint aches and fever had higher incidence rates compared with injection-site pain. Tachycardia (n = 6), tinnitus (n = 1) and decreased...... appetite (n = 4) were reported although were not included in the SPC. CONCLUSION: The most prominent adverse events reported were headaches, dizziness, muscle and joint aches, weakness, fever and injection-site pain. Although similar events were reported in other studies, the incidence was different...... and there were a few differences in the most frequently reported events. More studies of a similar nature should be encouraged in low- and medium-income countries to bridge the information gap with the developed world....

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

    Science.gov (United States)

    2016-06-23

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

  8. 医疗安全不良事件主动报告系统的设计与实现%Design and Development of Medical Adverse Events Reporting System

    Institute of Scientific and Technical Information of China (English)

    袁静; 张华; 刘长兴

    2014-01-01

    The article introduce the design , workflow and the main function of Medical Adverse Events Re-porting System .The implementation of the system should prevent the hospital internal medical error ; provide the process and standard of technical means to reduce medical accidents .It also could improve hospital management and medical service quality .%本文主要介绍医疗安全不良事件报告系统的总体设计思路、实现方法及主要功能。医疗安全不良事件报告系统的实施对于医院内部防范医疗差错、减少医疗事故提供流程化、规范化的技术手段,为提高医院管理水平、促进医疗服务质量的改善提供支持。

  9. Adverse Events of Trivalent Influenza Vaccine among Health Care Workers in Iran

    Directory of Open Access Journals (Sweden)

    M Hajiabdolbaghi

    2009-06-01

    Full Text Available "nBackground: To assess the frequency and type of adverse events after influenza vaccination in Iranian adults."nMethods: Health care workers in 7 medical centers received the influenza vaccine from October 2006 to February 2007 and fol­lowed by phone regarding symptoms experienced after vaccination."nResults: Of 897 adults who participated in the study, local and systemic reactions were reported by 187 (20.8% and 198 (22.1% persons, respectively. The most common local reaction was pain (20.2%, while myalgia (15.8% was the most com­mon systemic reaction. One case of Guillain-barre syndrome was reported."nConclusion: Inactivated influenza vaccine administration did not result in potential adverse events in healthy adults.

  10. Ontology-based time information representation of vaccine adverse events in VAERS for temporal analysis

    Directory of Open Access Journals (Sweden)

    Tao Cui

    2012-12-01

    Full Text Available Abstract Background The U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS provides a valuable data source for post-vaccination adverse event analyses. The structured data in the system has been widely used, but the information in the write-up narratives is rarely included in these kinds of analyses. In fact, the unstructured nature of the narratives makes the data embedded in them difficult to be used for any further studies. Results We developed an ontology-based approach to represent the data in the narratives in a “machine-understandable” way, so that it can be easily queried and further analyzed. Our focus is the time aspect in the data for time trending analysis. The Time Event Ontology (TEO, Ontology of Adverse Events (OAE, and Vaccine Ontology (VO are leveraged for the semantic representation of this purpose. A VAERS case report is presented as a use case for the ontological representations. The advantages of using our ontology-based Semantic web representation and data analysis are emphasized. Conclusions We believe that representing both the structured data and the data from write-up narratives in an integrated, unified, and “machine-understandable” way can improve research for vaccine safety analyses, causality assessments, and retrospective studies.

  11. Risk Managers’ Descriptions of Programs to Support Second Victims after Adverse Events

    OpenAIRE

    White, Andrew A; Brock, Doug; McCotter, Patricia I.; Hofeldt, Ron; Edrees, Hanan H.; Wu, Albert W.; Shannon, Sarah; Gallagher, Thomas H.

    2015-01-01

    Guidelines call for healthcare organizations to provide emotional support for clinicians involved in adverse events, but little is known about these organizations seek to meet this need. We surveyed U.S. members of ASHRM about the presence, features, and perceived efficacy of their organization’s provider support program. The majority reported that their organization had a support program, but features varied widely and there are substantial opportunities to improve services. Provider support...

  12. Patients at high risk of adverse events from intravenous contrast media after computed tomography examination

    Energy Technology Data Exchange (ETDEWEB)

    Reddan, Donal [University College Galway Hospitals, Unit 7, Merlin Park Hospital, Galway (Ireland)]. E-mail: donal.reddan@mailn.hse.ie

    2007-05-15

    Adverse reactions to iodinated contrast media (CM) may occur and require prompt recognition and treatment. Although adverse reactions to radiocontrast agents cannot be eliminated, an important first step toward reducing their incidence is to identify patients at greatest risk. Prior to examinations using CM, patients should be adequately assessed by obtaining thorough medical histories and using simple screening tests. Studies have demonstrated that patients with a history of asthma, allergy, hyperthyroidism, and previous reaction to CM are at risk for severe reactions to iodinated CM. Renal adverse reactions reportedly occur more frequently in patients with pre-existing chronic kidney disease, especially those with diabetic nephropathy. Patients with congestive heart failure, dehydration, older age, and those who use nephrotoxic medications are also at risk for developing contrast-associated nephropathy. The occurrence of adverse events may be further increased in patients with multiple risk factors. As the number of patients undergoing computed tomography procedures continues to increase, it is essential for physicians to be able to identify patients at risk for adverse events of CM. Patient-related risk factors are discussed and simple tools for risk stratification presented.

  13. Absence of Fluoride Varnish-Related Adverse Events in Caries Prevention Trials in Young Children, United States

    OpenAIRE

    Gansky, Stuart; Garcia, RI; Gregorich, SE; Ramos-Gomez, F; Braun, PA; Wilson, A.; Albino, J; Tiwari , T.; Harper, M.; Batliner, TS; Rasmussen, M.

    2017-01-01

    Introduction Fluoride varnish is an effective prevention intervention for caries in young children. Its routine use in clinical care is supported by meta-analyses and recommended by clinical guidelines, including the US Preventive Services Task Force (B rating). This report is the first prospective systematic assessment of adverse events related to fluoride varnish treatment in young children. Methods We determined the incidence of adverse events related to fluoride varnish treatment in 3 cli...

  14. Severity and workload related to adverse events in the ICU.

    Science.gov (United States)

    Serafim, Clarita Terra Rodrigues; Dell'Acqua, Magda Cristina Queiroz; Castro, Meire Cristina Novelli E; Spiri, Wilza Carla; Nunes, Hélio Rubens de Carvalho

    2017-01-01

    To analyze whether an increase in patient severity and nursing workload are correlated to a greater incidence of adverse events (AEs) in critical patients. A prospective single cohort study was performed on a sample of 138 patients hospitalized in an intensive care unit (ICU). A total of 166 AEs, occurred, affecting 50.7% of the patients. Increased patient severity presented a direct relationship to the probability of AEs occurring. However, nursing workload did not present a statistically significant relationship with the occurrence of AEs. The results cast light on the importance of using evaluation tools by the nursing personnel in order to optimize their daily activities and focus on patient safety. Analisar se o aumento da gravidade do paciente e a carga de trabalho de enfermagem está relacionado à maior incidência de Eventos Adversos (EAs) em pacientes críticos. Estudo de coorte única, prospectivo, com amostra de 138 pacientes internados em uma Unidade de Terapia Intensiva (UTI). Ao todo, foram evidenciados 166 EAs, que acometeram 50,7% dos pacientes. O aumento da gravidade do paciente apresentou relação direta com a chance de ocorrência de EAs. Entretanto, a carga de trabalho de enfermagem não apresentou relação estatisticamente significativa, na ocorrência de EAs. Os resultados permitem refletir acerca da importância da equipe de enfermagem, em utilizar instrumentos de avaliação, com o objetivo de melhorar e planejar suas ações diárias, com foco na segurança do paciente.

  15. CLINICAL MANAGEMENT OF LOCALIZED BCG ADVERSE EVENTS IN CHILDREN

    Directory of Open Access Journals (Sweden)

    Thais das Neves Fraga MOREIRA

    Full Text Available 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.

  16. Towards an organization with a memory: exploring the organizational generation of adverse events in health care.

    Science.gov (United States)

    Smith, Denis; Toft, Brian

    2005-05-01

    The role of organizational factors in the generation of adverse events, and the manner in which such factors can also inhibit an organization's abilities to learn, have become important agenda items within health care. The government report 'An organization with a memory' highlighted many of the problems facing health care and suggested changes that need to be made if the sector is to learn effective lessons and prevent adverse events from occurring. This paper seeks to examine some of these organizational factors in more detail and suggests issues that managers need to consider as part of their wider strategies for the prevention and management of risk. The paper sets out five core elements that are held to be importance in shaping the manner in which the potential for risk is incubated within organizations. Although the paper focuses its attention on health care, the points made have validity across the public sector and into private sector organizations.

  17. Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder

    DEFF Research Database (Denmark)

    Holmskov, Mathilde; Storebø, Ole Jakob; Moreira-Maia, Carlos R

    2017-01-01

    OBJECTIVES: To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review. METHODS AND FINDINGS...... differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes. CONCLUSION: Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit......: We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were...

  18. [Analysis on the adverse events of cupping therapy in the application].

    Science.gov (United States)

    Zhou, Xin; Ruan, Jing-wen; Xing, Bing-feng

    2014-10-01

    The deep analysis has been done on the cases of adverse events and common injury of cupping therapy encountered in recent years in terms of manipulation and patient's constitution. The adverse events of cupping therapy are commonly caused by improper manipulation of medical practitioners, ignoring contraindication and patient's constitution. Clinical practitioners should use cupping therapy cautiously, follow strictly the rules of standard manipulation and medical core system, pay attention to the contraindication and take strict precautions against the occurrence of adverse events.

  19. Adverse events in families with hypertrophic or dilated cardiomyopathy and mutations in the MYBPC3 gene

    Directory of Open Access Journals (Sweden)

    Lehrke Stephanie

    2008-10-01

    Full Text Available Abstract Background Mutations in MYBPC3 encoding myosin binding protein C belong to the most frequent causes of hypertrophic cardiomyopathy (HCM and may also lead to dilated cardiomyopathy (DCM. MYBPC3 mutations initially were considered to cause a benign form of HCM. The aim of this study was to examine the clinical outcome of patients and their relatives with 18 different MYBPC3 mutations. Methods 87 patients with HCM and 71 patients with DCM were screened for MYBPC3 mutations by denaturing gradient gel electrophoresis and sequencing. Close relatives of mutation carriers were genotyped for the respective mutation. Relatives with mutation were then evaluated by echocardiography and magnetic resonance imaging. A detailed family history regarding adverse clinical events was recorded. Results In 16 HCM (18.4% and two DCM (2.8% index patients a mutation was detected. Seven mutations were novel. Mutation carriers exhibited no additional mutations in genes MYH7, TNNT2, TNNI3, ACTC and TPM1. Including relatives of twelve families, a total number of 42 mutation carriers was identified of which eleven (26.2% had at least one adverse event. Considering the twelve families and six single patients with mutations, 45 individuals with cardiomyopathy and nine with borderline phenotype were identified. Among the 45 patients, 23 (51.1% suffered from an adverse event. In eleven patients of seven families an unexplained sudden death was reported at the age between 13 and 67 years. Stroke or a transient ischemic attack occurred in six patients of five families. At least one adverse event occurred in eleven of twelve families. Conclusion MYBPC3 mutations can be associated with cardiac events such as progressive heart failure, stroke and sudden death even at younger age. Therefore, patients with MYBPC3 mutations require thorough clinical risk assessment.

  20. Plasma asymmetric dimethylarginine and adverse events in patients with atrial fibrillation referred for coronary angiogram.

    Directory of Open Access Journals (Sweden)

    Tze-Fan Chao

    Full Text Available 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.

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

    Science.gov (United States)

    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. Eventos adversos em hemodiálise: relatos de profissionais de enfermagem Eventos adversos en hemodiálisis: testimonios de profesionales de enfermería Adverse events in hemodialysis: reports of nursing professionals

    Directory of Open Access Journals (Sweden)

    Maiana Regina Gomes de Sousa

    2013-02-01

    nursing professionals regarding Adverse Events (AE in a hemodialysis unit of a teaching hospital. Data collection was performed between February and April 2011, based on interviews with 25 professionals. Data analysis identified 517 reports of 32 types of adverse events, of which the most commonly cited were: obstructed catheter, accidental withdrawal of the needle; and clotting of the extracorporeal system. Patient-related causes were mentioned in 42.8% of the reports. The main measures adopted were the implementation/ change of protocols and continuing education; the latter is the main suggestion for prevention. The results can contribute to a critical analysis of the quality of care in hemodialysis units, resulting in the development of interventions that help promote patient safety.

  3. [Perspective of nursing students on the communication and apologies to patients for adverse events: a descriptive study].

    Science.gov (United States)

    Giraldo, Priscila; Trespaderne, Isabel; Díaz, Cristina; Bardallo, María Dolores

    2015-01-01

    To describe the approach to the communication and blame of an adverse by nursing students. A descriptive study on disclosure and apologies for adverse events by nursing students in the academic years 2011-12 and 2012-13. The study included group discussion and drafting a written communication to the injured patient about adverse events during hospitalization. An ad hoc checklist was used and an analysis was performed on items related to the disclosure and apologies issues. A total of 126 nursing students were involved, and they created 21 written The facts about adverse events were reported in 81% of written communications, and 47.1% chose an abbreviated disclosure of the facts with no detailed explanation of adverse events. The facts were accurately reproduced in only 9.5% of written communications to the patients. One third (33.3%) apologized for the mistakes, and 47.6% required that the communication was signed by the Management. All (100%) of the nursing students chose not to report the health professionals who had participated during the events. There is a fear to acknowledge errors within health centers. It is recommended that tools are developed for these future nursing professionals to make an open and honest disclosure of adverse events, as well as the apologies for them. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  4. Evaluation of adverse events in cats receiving long-term piroxicam therapy for various neoplasms.

    Science.gov (United States)

    Bulman-Fleming, Julie C; Turner, T R; Rosenberg, Mona P

    2010-04-01

    The role of cyclo-oxygenase 2 (COX-2) and prostaglandins (PG) in carcinogenesis has been documented in many species. Piroxicam has shown efficacy against several neoplasms and is frequently prescribed for chronic use. There are no studies investigating chronic piroxicam administration in cats and the chronic use of non-steroidal anti-inflammatory agents in this species has long been cautioned against. This retrospective study aimed to evaluate adverse effects in cats receiving long-term daily piroxicam. Seventy-three cats received daily piroxicam at doses of 0.13-0.41mg/kg. Treatment duration ranged from 1 to 38 months. Treatment with piroxicam was found to significantly increase frequency of vomiting during the first month of therapy, though this was most significant for cats receiving concurrent chemotherapy. Piroxicam administration was not significantly associated with hematologic, renal or hepatic toxicities. Adverse events were not correlated with dosage. Adverse events were reported in 29% of cats, and were generally mild and transient. Eight percent discontinued piroxicam due to adverse reaction, and 4% due to difficult administration. This study indicates that long-term daily piroxicam is generally well tolerated in cats at conventional doses.

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

    Science.gov (United States)

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

    2007-02-01

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

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

    Science.gov (United States)

    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. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Mining severe drug-drug interaction adverse events using Semantic Web technologies: a case study.

    Science.gov (United States)

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

    2015-01-01

    Drug-drug interactions (DDIs) are a major contributing factor for unexpected adverse drug events (ADEs). However, few of knowledge resources cover the severity information of ADEs that is critical for prioritizing the medical need. The objective of the study is to develop and evaluate a Semantic Web-based approach for mining severe DDI-induced ADEs. We utilized a normalized FDA Adverse Event Report System (AERS) dataset and performed a case study of three frequently prescribed cardiovascular drugs: Warfarin, Clopidogrel and Simvastatin. We extracted putative DDI-ADE pairs and their associated outcome codes. We developed a pipeline to filter the associations using ADE datasets from SIDER and PharmGKB. We also performed a signal enrichment using electronic medical records (EMR) data. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the DDI-induced ADEs into the CTCAE in the Web Ontology Language (OWL). We identified 601 DDI-ADE pairs for the three drugs using the filtering pipeline, of which 61 pairs are in Grade 5, 56 pairs in Grade 4 and 484 pairs in Grade 3. Among 601 pairs, the signals of 59 DDI-ADE pairs were identified from the EMR data. The approach developed could be generalized to detect the signals of putative severe ADEs induced by DDIs in other drug domains and would be useful for supporting translational and pharmacovigilance study of severe ADEs.

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

    Directory of Open Access Journals (Sweden)

    Sangeeta Pahuja

    2017-01-01

    Conclusions: Awareness should be increased among clinicians to correctly prevent, identify, and report transfusion-related adverse events. These measures should be implemented to increase blood transfusion quality and safety.

  9. Investigating Adverse Event Free Admissions in Medicare Inpatients as a Patient Safety Indicator.

    Science.gov (United States)

    King, Alice; Bottle, Alex; Faiz, Omar; Aylin, Paul

    2017-05-01

    To investigate adverse event free admissions as a potential, patient-centered indicator aligned directly with the goal of patient safety-freedom from harm. Preventable adverse event rates in healthcare could be further reduced. These are generally measured separately, one adverse event at a time. However, this does not reveal whether different patients are affected or the same patients are experiencing multiple events. We examined Medicare inpatient hospital administrative datasets for 2009 to 2011, processed using standard criteria. Events were (i) death within 30 days, (ii) unplanned readmissions within 30 days, (iii) long length of stay, (iv) healthcare acquired infections, and (v) established patient safety indicators not present on admission. We defined adverse event free admissions as those without record of any of these events. National rates were calculated by diagnosis group. Risk-adjusted hospital-specific rates of adverse event free admissions were calculated using colorectal procedures as an example. There were 23,991,193 admissions after exclusions. Approximately, 64% went through the acute inpatient Medicare system without record of anything untoward. Multiple events were recorded in 22·7% admissions; 15% of these experienced more than 2 adverse events. Risk-adjusted hospital-specific rates of adverse event free admissions for colorectal procedures showed 131 out of 3786 hospitals below the 99·8% lower control limit of the national upper quartile. Overall, only 60% of admissions were recorded as adverse event free. Multiple adverse events were common. Even if events are under recorded, this measure could provide an easily understandable and useful baseline for clinicians and managers.

  10. Adverse Events of Massage Therapy in Pain-Related Conditions: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Ping Yin

    2014-01-01

    Full Text Available 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.

  11. Discontinuation of hormone replacement therapy after myocardial infarction and short term risk of adverse cardiovascular events

    DEFF Research Database (Denmark)

    Bretler, Ditte-Marie; Hansen, Peter Riis; Sørensen, Rikke;

    2012-01-01

    To assess the risk of adverse cardiovascular events in women who discontinue hormone replacement therapy after myocardial infarction compared with those who continue.......To assess the risk of adverse cardiovascular events in women who discontinue hormone replacement therapy after myocardial infarction compared with those who continue....

  12. [Assessing the economic impact of adverse events in Spanish hospitals by using administrative data].

    Science.gov (United States)

    Allué, Natalia; Chiarello, Pietro; Bernal Delgado, Enrique; Castells, Xavier; Giraldo, Priscila; Martínez, Natalia; Sarsanedas, Eugenia; Cots, Francesc

    2014-01-01

    To evaluate the incidence and costs of adverse events registered in an administrative dataset in Spanish hospitals from 2008 to 2010. A retrospective study was carried out that estimated the incremental cost per episode, depending on the presence of adverse events. Costs were obtained from the database of the Spanish Network of Hospital Costs. This database contains data from 12 hospitals that have costs per patient records based on activities and clinical records. Adverse events were identified through the Patient Safety Indicators (validated in the Spanish Health System) created by the Agency for Healthcare Research and Quality together with indicators of the EuroDRG European project. This study included 245,320 episodes with a total cost of 1,308,791,871€. Approximately 17,000 patients (6.8%) experienced an adverse event, representing 16.2% of the total cost. Adverse events, adjusted by diagnosis-related groups, added a mean incremental cost of between €5,260 and €11,905. Six of the 10 adverse events with the highest incremental cost were related to surgical interventions. The total incremental cost of adverse events was € 88,268,906, amounting to an additional 6.7% of total health expenditure. Assessment of the impact of adverse events revealed that these episodes represent significant costs that could be reduced by improving the quality and safety of the Spanish Health System. Copyright © 2013 SESPAS. Published by Elsevier Espana. All rights reserved.

  13. Adverse events of modern antifungal drugs during treatment of invasive fungal infections

    Directory of Open Access Journals (Sweden)

    N. V. Dmitrieva

    2013-01-01

    Full Text Available Characteristics of adverse events of modern antimycotics by organ systems and comparative frequency between different medicines and their groups are presented. The examples of incompatibility of antifungal drugs with other pharmacological groups are discussed. Records of adverse events and drug compatibility will allow the practitioner to prevent and timely cure possible complications, should they arise.

  14. Computerized surveillance of opioid-related adverse drug events in perioperative care: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Gattis Katherine G

    2009-08-01

    Full Text Available Abstract Background Given the complexity of surgical care, perioperative patients are at high risk of opioid-related adverse drug events. Existing methods of detection, such as trigger tools and manual chart review, are time-intensive which makes sustainability challenging. Using strategic rule design, computerized surveillance may be an efficient, pharmacist-driven model for event detection that leverages existing staff resources. Methods Computerized adverse drug event surveillance uses a logic-based rules engine to identify potential adverse drug events or evolving unsafe clinical conditions. We extended an inpatient rule (administration of naloxone to detect opioid-related oversedation and respiratory depression to perioperative care at a large academic medical center. Our primary endpoint was the adverse drug event rate. For all patients with a naloxone alert, manual chart review was performed by a perioperative clinical pharmacist to assess patient harm. In patients with confirmed oversedation, other patient safety event databases were queried to determine if they could detect duplicate, prior, or subsequent opioid-related events. Results We identified 419 cases of perioperative naloxone administration. Of these, 101 were given postoperatively and 69 were confirmed as adverse drug events after chart review yielding a rate of 1.89 adverse drug events/1000 surgical encounters across both the inpatient and ambulatory settings. Our ability to detect inpatient opioid adverse drug events increased 22.7% by expanding surveillance into perioperative care. Analysis of historical surveillance data as well as a voluntary reporting database revealed that 11 of our perioperative patients had prior or subsequent harmful oversedation. Nine of these cases received intraoperative naloxone, and 2 had received naloxone in the post-anesthesia care unit. Pharmacist effort was approximately 3 hours per week to evaluate naloxone alerts and confirm adverse drug

  15. Angiographic adverse events during percutaneous coronary intervention fail to predict creatine kinase-MB elevation.

    Science.gov (United States)

    Blankenship, James C; Islam, M Ashequl; Wood, G Craig; Iliadis, Elias A

    2004-09-01

    We attempted to determine if aggressive detection of angiographic adverse events during coronary intervention could predict subsequent creatine kinase (CK)-MB elevations. During coronary intervention, both fluoroscopy and cine angiography were used to detect angiographic adverse events. At least one angiographic adverse event occurred in 133/251 (53%) of procedures. CK-MB elevation occurred in 24% of procedures. Slow flow during the procedure (P=0.002) and chest discomfort at the end of the procedure (P=0.007) were the strongest predictors of CK-MB elevation. Among procedures with no angiographic adverse events, CK-MB elevation occurred in 15/121 (12%), accounting for 25% of CK-MB elevations. We conclude that CK-MB elevation occurs after angiographically uncomplicated coronary interventions even when angiographic adverse events are aggressively detected. Routine monitoring of cardiac enzymes is necessary to detect all patients who will experience myocardial injury after coronary intervention.

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

    Science.gov (United States)

    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.

  17. Model Building for the Behavior of Reporting Nursing Adverse Events Based on the Theory of Planned Behavior and Its Empirical Research%基于计划行为理论的护理人员不良事件报告行为模型构建及实证研究

    Institute of Scientific and Technical Information of China (English)

    曹志辉; 陈丽丽; 张金燕; 郑贺英; 陈桂芝

    2015-01-01

    目的:构建以计划行为理论为指导的护理人员不良事件报告行为模型,并进行实证研究。方法2014年4月,对河北省某医院的436名在职护理人员进行问卷调查,问卷包括:护理人员的基本情况、护士护理不良事件报告行为量表和护理不良事件报告意向量表、护士对护理不良事件报告行为的态度问卷、护理不良事件报告行为规范问卷、护理不良事件报告知觉行为控制问卷。采用Spearman秩相关和多元线性回归等统计学方法对理论模型进行验证。结果态度、描述性规范、知觉行为控制对护理不良事件报告意向的偏回归系数分别为0.278、0.193和0.315,报告意向对报告行为的偏回归系数为0.496,且均有统计学意义( P<0.05)。报告意向是态度、描述性规范、知觉行为控制影响报告行为的中介变量。结论以计划行为理论为基础的护士护理不良事件报告行为模型对护理不良事件报告行为具有较好的解释和预测作用,应从态度、指令性规范、描述性规范、知觉行为控制入手,提出有效干预策略。%Objective To build a model for the behavior of reporting nursing adverse events based on the theory of planned behavior and to conduct empirical research. Methods In April of 2014,We conducted questionnaire survey on 436 in-service nurses in a hospital of Hebei Province. The questionnaire survey included a survey on basic information of nurses,a scale of the behavior of reporting nursing adverse events, a scale of the intention of reporting nursing adverse events, a questionnaire on nurses'attitude toWards the behavior of reporting nursing adverse events,a questionnaire on the behavior norm of reporting nursing adverse events and a questionnaire on the perceived control of reporting nursing adverse events. The theoretical model Was verified using spearman rank correlation method and multiple linear regression method

  18. Post-market surveillance to detect adverse events associated with Melody® valve implantation.

    Science.gov (United States)

    Hill, Kevin D; Goldstein, Bryan H; Angtuaco, Michael J; Chu, Patricia Y; Fleming, Gregory A

    2017-08-01

    The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation. In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events. We reviewed the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody® transcatheter pulmonary valve trials. We identified 631 adverse events associated with "on-label" Melody® valve implants and 84 adverse events associated with "off-label" implants. The most frequent "on-label" adverse events were similar to those described in the prospective trials including stent fracture (n=210) and endocarditis (n=104). Previously unrecognised or under-recognised adverse events included stent fragment embolisation (n=5), device erosion (n=4), immediate post-implant severe valvar insufficiency (n=2), and late coronary compression (n=2 cases at 5 days and 3 months after implantation). Under-recognised adverse events associated with off-label implantation included early valve failure due to insufficiency when implanted in the tricuspid position (n=7) and embolisation with percutaneous implantation in the mitral position (n=5). Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with "on-label" Melody® valve implantation. Further study is needed to evaluate safety of "off-label" uses.

  19. 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.

    Science.gov (United States)

    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

  20. 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.

    Science.gov (United States)

    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

  1. Risk managers' descriptions of programs to support second victims after adverse events.

    Science.gov (United States)

    White, Andrew A; Brock, Douglas M; McCotter, Patricia I; Hofeldt, Ron; Edrees, Hanan H; Wu, Albert W; Shannon, Sarah; Gallagher, Thomas H

    2015-01-01

    Guidelines call for healthcare organizations to provide emotional support for clinicians involved in adverse events, but little is known about how these organizations seek to meet this need. We surveyed US members of the American Society for Healthcare Risk Management (ASHRM) about the presence, features, and perceived efficacy of their organization's provider support program. The majority reported that their organization had a support program, but features varied widely and there are substantial opportunities to improve services. Provider support programs should enhance referral mechanisms and peer support, critically appraise the role of employee assistance programs, and demonstrate their value to institutional leaders.

  2. Continuous active surveillance of adverse events following immunisation using SMS technology.

    Science.gov (United States)

    Westphal, Darren W; Williams, Stephanie A; Leeb, Alan; Effler, Paul V

    2016-06-17

    On-going post-licensure surveillance of adverse events following immunisation (AEFI) is critical to detecting and responding to potentially serious adverse events in a timely manner. SmartVax is a vaccine safety monitoring tool that uses automated data extraction from existing practice management software and short message service (SMS) technology to follow-up vaccinees in real-time. We report on childhood vaccine safety surveillance using SmartVax at a medical practice in Perth, Western Australia. Parents of all children under age five years who were vaccinated according to the Australian National Immunisation Schedule between November 2011 and June 2015 were sent an SMS three days post administration to enquire whether the child had experienced a suspected vaccine reaction. Affirmative replies triggered a follow-up SMS requesting details of the reaction(s) via a link to a survey that could be completed using a smartphone or the web. Rates of reported AEFI including fever, headache, fatigue, rash, vomiting, diarrhoea, rigours, seizures, and local reactions were calculated by vaccination time point. Overall, 239 (8.2%; 95% CI 7.2-9.2%) possible vaccine reactions were reported for 2897 vaccination visits over the 44 month time period. The proportion of children experiencing a possible AEFI, mostly local reactions, was significantly greater following administration of diphtheria-tetanus-pertussis-poliomyelitis vaccine at 4 years of age (77/441; 17.5%; 95% CI 13.9-21.0%) compared to the vaccinations given at 2-18 months (p<0.001). Across all time points, local reactions and fatigue were the most frequently reported AEFI. Automated SMS-based reporting can facilitate sustainable, real-time, monitoring of adverse reactions and contribute to early identification of potential vaccine safety issues. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Blunt splenic injury: are early adverse events related to trauma, nonoperative management, or surgery?

    Science.gov (United States)

    Frandon, Julien; Rodiere, Mathieu; Arvieux, Catherine; Vendrell, Anne; Boussat, Bastien; Sengel, Christian; Broux, Christophe; Bricault, Ivan; Ferretti, Gilbert; Thony, Frédéric

    2015-01-01

    We aimed to compare clinical outcomes and early adverse events of operative management (OM), nonoperative management (NOM), and NOM with splenic artery embolization (SAE) in blunt splenic injury (BSI) and identify the prognostic factors. Medical records of 136 consecutive patients with BSI admitted to a trauma center from 2005 to 2010 were retrospectively reviewed. Patients were separated into three groups: OM, NOM, and SAE. We focused on associated injuries and early adverse events. Multivariate analysis was performed on 23 prognostic factors to find predictors. The total survival rate was 97.1%, with four deaths all occurred in the OM group. The spleen salvage rate was 91% in NOM and SAE. At least one adverse event was observed in 32.8%, 62%, and 96% of patients in NOM, SAE, and OM groups, respectively (P events: simplified acute physiology score 2 ≥25 for almost all adverse events, age ≥50 years for acute respiratory syndrome, limb fracture for secondary bleeding, thoracic injury for pleural drainage, and at least one associated injury for pseudocyst. Adverse events were not related to the type of BSI management. Patients with BSI present worse outcome and more adverse events in OM, but this is related to the severity of injury. The main predictor of adverse events remains the severity of injury.

  4. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Science.gov (United States)

    2010-04-01

    ... from overdose of the product whether accidental or intentional; an adverse event occurring from abuse... inpatient hospitalization, or the development of drug dependency or drug abuse. Unexpected adverse... from http://www.fda.gov/medwatch/getforms.htm. Additional supplies of the form may be obtained from the...

  5. Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials.

    Science.gov (United States)

    Hesse, Kerrick; Fulton, Rachael L; Abdul-Rahim, Azmil H; Lees, Kennedy R

    2014-09-01

    Adverse events (AE) in trial populations present a major burden to researchers and patients, yet most events are unrelated to investigational treatment. We aimed to develop a coherent list of expected AEs, whose incidence can be predicted by patient characteristics that will inform future trials and perhaps general poststroke care. We analyzed raw AE data from patients participating in acute ischemic stroke trials. We identified events that occurred with a lower 99% confidence bound greater than nil. Among these, we applied receiver operating characteristic principles to select the fewest types of events that together represented the greatest number of reports. Using ordinal logistic regression, we modeled the incidence of these events as a function of patient age, sex, baseline National Institutes of Health Stroke Scale, and multimorbidity status, defining Pstroke. Right hemisphere (odds ratio [OR], 1.67), increasing baseline National Institutes of Health Stroke Scale (OR, 1.11), multimorbidity status (OR, 1.09 per disease), patient age (OR, 1.01 per year), height (OR, 1.01 per centimeter), diastolic blood pressure (OR, 0.99 per mm Hg), and smoking (OR, 0.82) were independently associated with developing more AEs but together explained only 13% of the variation. A list of 132 expected AEs after acute ischemic stroke may be used to simplify interpretation and reporting of complications. AEs can be modestly predicted by patient characteristics, facilitating stratification of patients by risk for poststroke complications. © 2014 American Heart Association, Inc.

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

    Science.gov (United States)

    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.

  7. Adverse events of acupuncture and occlusal splint therapy in the treatment of craniomandibular disorders.

    Science.gov (United States)

    List, T; Helkimo, M

    1992-10-01

    Occlusal splint therapy and acupuncture have been found to provide positive treatment in a number of studies. As with other therapies, adverse events may occur. In this paper, adverse event refers to any reaction to a treatment besides the intended treatment effect--irrespective of any correlation between the treatment and the reaction. This reaction can be positive, as well as negative, to the patient. In the present study, 61 patients with craniomandibular dysfunction (CMD) were treated with acupuncture or occlusal splint therapy and the adverse events were carefully recorded. The results show that the profile of the adverse events differed between the two treatment modes. Acupuncture seemed to have adverse events of a more general nature, e.g., relaxed feeling, improved sleep, temporarily increased pain; whereas, adverse events of occlusal splint therapy seemed to be more locally related to the orofacial region, e.g., increased/decreased salivation and tension in the teeth. The majority of the patients responded positively to both treatment modalities. Only in a few cases did the patients consider the treatment uncomfortable. No serious adverse event or complication was observed in this study.

  8. Can social media data lead to earlier detection of drug-related adverse events?

    Science.gov (United States)

    Duh, Mei Sheng; Cremieux, Pierre; Audenrode, Marc Van; Vekeman, Francis; Karner, Paul; Zhang, Haimin; Greenberg, Paul

    2016-12-01

    To compare the patient characteristics and the inter-temporal reporting patterns of adverse events (AEs) for atorvastatin (Lipitor(®) ) and sibutramine (Meridia(®) ) in social media (AskaPatient.com) versus the FDA Adverse Event Reporting System (FAERS). We identified clinically important AEs associated with atorvastatin (muscle pain) and sibutramine (cardiovascular AEs), compared their patterns in social media postings versus FAERS and used Granger causality tests to assess whether social media postings were useful in forecasting FAERS reports. We analyzed 998 and 270 social media postings between 2001 and 2014, 69 003 and 7383 FAERS reports between 1997 and 2014 for atorvastatin and sibutramine, respectively. Social media reporters were younger (atorvastatin: 53.9 vs. 64.0 years, p Social media reviews contained fewer serious AEs (atorvastatin, pain: 2.5% vs. 38.2%; sibutramine, cardiovascular issues: 7.9% vs. 63.0%; p social media sibutramine reviews mentioning cardiac issues helped predict those in FAERS 11 months later (p social media atorvastatin reviews did not help predict FAERS reports. Social media AE reporters were younger and focused on less-serious and fewer types of AEs than FAERS reporters. The potential for social media to provide earlier indications of AEs compared with FAERS is uncertain. Our findings highlight some of the promises and limitations of online social media versus conventional pharmacovigilance sources and the need for careful interpretation of the results. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

  9. Glycopeptide antibiotics: evolving resistance, pharmacology and adverse event profile.

    Science.gov (United States)

    Henson, Karl Evans R; Levine, Miriam T; Wong, Eunice Ann H; Levine, Donald P

    2015-01-01

    The first glycopeptide antibiotic was vancomycin, isolated from the soil in the 1950s; since then, the class has expanded to include teicoplanin and the new semisynthetic glycopeptides dalbavancin, oritavancin and telavancin. They are bactericidal, active against most Gram-positive organisms, and in a concentration-dependent manner, inhibit cell wall synthesis. Resistance to vancomycin has emerged, especially among enterococci and Staphylococcus aureus through a variety of mechanisms. This emerging resistance to vancomycin makes proper dosing and monitoring of the area under the curve/MIC critically important. The chief adverse effect of vancomycin is nephrotoxicity, which is also intricately related to its dose. The efficacy of the semisynthetic glycopeptides has been demonstrated in skin and soft-tissue infections, but remains to be seen in serious methicillin-resistant Staphylococcus aureus infections.

  10. Adverse event assessment of antimuscarinics for treating overactive bladder: a network meta-analytic approach.

    Directory of Open Access Journals (Sweden)

    Thomas M Kessler

    Full Text Available BACKGROUND: Overactive bladder (OAB affects the lives of millions of people worldwide and antimuscarinics are the pharmacological treatment of choice. Meta-analyses of all currently used antimuscarinics for treating OAB found similar efficacy, making the choice dependent on their adverse event profiles. However, conventional meta-analyses often fail to quantify and compare adverse events across different drugs, dosages, formulations, and routes of administration. In addition, the assessment of the broad variety of adverse events is dissatisfying. Our aim was to compare adverse events of antimuscarinics using a network meta-analytic approach that overcomes shortcomings of conventional analyses. METHODS: Cochrane Incontinence Group Specialized Trials Register, previous systematic reviews, conference abstracts, book chapters, and reference lists of relevant articles were searched. Eligible studies included randomized controlled trials comparing at least one antimuscarinic for treating OAB with placebo or with another antimuscarinic, and adverse events as outcome measures. Two authors independently extracted data. A network meta-analytic approach was applied allowing for joint assessment of all adverse events of all currently used antimuscarinics while fully maintaining randomization. RESULTS: 69 trials enrolling 26'229 patients were included. Similar overall adverse event profiles were found for darifenacin, fesoterodine, transdermal oxybutynin, propiverine, solifenacin, tolterodine, and trospium chloride but not for oxybutynin orally administered when currently used starting dosages were compared. CONCLUSIONS: The proposed generally applicable transparent network meta-analytic approach summarizes adverse events in an easy to grasp way allowing straightforward benchmarking of antimuscarinics for treating OAB in clinical practice. Most currently used antimuscarinics seem to be equivalent first choice drugs to start the treatment of OAB except for

  11. Adverse Event Assessment of Antimuscarinics for Treating Overactive Bladder: A Network Meta-Analytic Approach

    Science.gov (United States)

    Kessler, Thomas M.; Bachmann, Lucas M.; Minder, Christoph; Löhrer, David; Umbehr, Martin; Schünemann, Holger J.; Kessels, Alfons G. H.

    2011-01-01

    Background Overactive bladder (OAB) affects the lives of millions of people worldwide and antimuscarinics are the pharmacological treatment of choice. Meta-analyses of all currently used antimuscarinics for treating OAB found similar efficacy, making the choice dependent on their adverse event profiles. However, conventional meta-analyses often fail to quantify and compare adverse events across different drugs, dosages, formulations, and routes of administration. In addition, the assessment of the broad variety of adverse events is dissatisfying. Our aim was to compare adverse events of antimuscarinics using a network meta-analytic approach that overcomes shortcomings of conventional analyses. Methods Cochrane Incontinence Group Specialized Trials Register, previous systematic reviews, conference abstracts, book chapters, and reference lists of relevant articles were searched. Eligible studies included randomized controlled trials comparing at least one antimuscarinic for treating OAB with placebo or with another antimuscarinic, and adverse events as outcome measures. Two authors independently extracted data. A network meta-analytic approach was applied allowing for joint assessment of all adverse events of all currently used antimuscarinics while fully maintaining randomization. Results 69 trials enrolling 26′229 patients were included. Similar overall adverse event profiles were found for darifenacin, fesoterodine, transdermal oxybutynin, propiverine, solifenacin, tolterodine, and trospium chloride but not for oxybutynin orally administered when currently used starting dosages were compared. Conclusions The proposed generally applicable transparent network meta-analytic approach summarizes adverse events in an easy to grasp way allowing straightforward benchmarking of antimuscarinics for treating OAB in clinical practice. Most currently used antimuscarinics seem to be equivalent first choice drugs to start the treatment of OAB except for oral oxybutynin dosages

  12. Compliance with and short-term adverse events from clarithromycin versus placebo in patients with stable coronary heart disease: the CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, C M; Kolmos, H J; Frydendall, N

    2009-01-01

    mg of clarithromycin daily versus 2200 patients to matching placebo for 14 days. This paper presents protocol-specified analysis of the patient-reported information regarding their compliance and non-serious adverse events during the 14 days of treatment as well as serious adverse events (mortality...

  13. Bias in spontaneous reporting of adverse drug reactions in Japan.

    Directory of Open Access Journals (Sweden)

    Shinichi Matsuda

    Full Text Available Attitudes of healthcare professionals regarding spontaneous reporting of adverse drug reactions (ADRs in Japan are not well known, and Japan's unique system of surveillance, called early post-marketing phase vigilance (EPPV, may affect these reporting attitudes. Our objectives were to describe potential effects of EPPV and to test whether ADR seriousness, prominence, and frequency are related to changes in reporting over time.A manufacturer's database of spontaneous ADR reports was used to extract data from individual case safety reports for 5 drugs subject to EPPV. The trend of reporting and the time lag between ADR onset and reporting to the manufacturer were examined. The following indices for ADRs occurring with each drug were calculated and analyzed to assess reporting trends: Serious:Non-serious ratio, High prominence:Low prominence ratio, and High frequency:Low frequency ratio.For all 5 drugs, the time lag between ADR onset and reporting to the manufacturer was shorter in the EPPV period than in the post-EPPV period. All drugs showed higher Serious:Non-serious ratios in the post-EPPV period. No specific patterns were observed for the High prominence:Low prominence ratio. The High frequency:Low frequency ratio for peginterferon alpha-2a and sevelamer hydrochloride decreased steadily throughout the study period.Healthcare professionals may be more likely to report serious ADRs than to report non-serious ADRs, but the effect of event prominence on reporting trends is still unclear. Factors associated with ADR reporting attitude in Japan might be different from those in other countries because of EPPV and the involvement of medical representatives in the spontaneous reporting process. Pharmacovigilance specialists should therefore be cautious when comparing data between different time periods or different countries. Further studies are needed to elucidate the underlying mechanism of spontaneous ADR reporting in Japan.

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

    Science.gov (United States)

    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.

  15. Endotracheal Intubation in Neonates: A Prospective Study of Adverse Safety Events in 162 Infants.

    Science.gov (United States)

    Hatch, L Dupree; Grubb, Peter H; Lea, Amanda S; Walsh, William F; Markham, Melinda H; Whitney, Gina M; Slaughter, James C; Stark, Ann R; Ely, E Wesley

    2016-01-01

    To determine the rate of adverse events associated with endotracheal intubation in newborns and modifiable factors contributing to these events. We conducted a prospective, observational study in a 100-bed, academic, level IV neonatal intensive care unit from September 2013 through June 2014. We collected data on intubations using standardized data collection instruments with validation by medical record review. Intubations in the delivery or operating rooms were excluded. The primary outcome was an intubation with any adverse event. Adverse events were defined and tracked prospectively as nonsevere or severe. We measured clinical variables including number of attempts to successful intubation and intubation urgency (elective, urgent, or emergent). We used logistic regression models to estimate the association of these variables with adverse events. During the study period, 304 intubations occurred in 178 infants. Data were available for 273 intubations (90%) in 162 patients. Adverse events occurred in 107 (39%) intubations with nonsevere and severe events in 96 (35%) and 24 (8.8%) intubations, respectively. Increasing number of intubation attempts (OR 2.1, 95% CI, 1.6-2.6) and emergent intubations (OR 4.7, 95% CI, 1.7-13) were predictors of adverse events. The primary cause of emergent intubations was unplanned extubation (62%). Adverse events are common in the neonatal intensive care unit, occurring in 4 of 10 intubations. The odds of an adverse event doubled with increasing number of attempts and quadrupled in the emergent setting. Quality improvement efforts to address these factors are needed to improve patient safety. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Inês Ribeiro-Vaz

    2016-01-01

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

  17. Cost analysis of adverse events associated with non-small cell lung cancer management in France

    Directory of Open Access Journals (Sweden)

    Chouaid C

    2017-07-01

    Full Text Available Christos Chouaid,1 Delphine Loirat,2 Emilie Clay,3 Aurélie Millier,3 Chloé Godard,4 Amira Fannan,4 Laurie Lévy-Bachelot,4 Eric Angevin5 1Chest Department, Centre Hospitalier Intercommunal Créteil, Créteil, France; 2Institut Curie, Paris, France; 3Creativ-Ceutical, Paris, France; 4MSD France, Courbevoie, France; 5Institut Gustave Roussy, Villejuif, France Background: Adverse events (AEs related to medical treatments in non-small cell lung cancer (NSCLC are frequent and need an appropriate costing in health economic models. Nevertheless, data on costs associated with AEs in NSCLC are scarce, particularly since the development of immunotherapy with specific immune-related AEs.Objective: To estimate the costs of grades 3 and 4 AEs related to NSCLC treatments including immunotherapy in France.Methods: Grades 3 and 4 AEs related to treatment and reported in at least 1% of patients in Phase III clinical trials for erlotinib, ramucirumab plus docetaxel, docetaxel, pemetrexed plus carboplatin plus bevacizumab, platinum-based chemotherapies, nivolumab and pembrolizumab were identified. When no cost evaluation was reported in literature, estimates on standard treatments and medical resource use for each AE were obtained thanks to an expert panel. Total cost per AE was calculated from a French national health insurance perspective and updated in 2017 Euros. Hospital stay costs were estimated based on public and private weighted tariffs and data from the French Medical Information System (Programme de Médicalisation des Systèmes d’Information. Costs of tests, consultations and treatments were calculated based on national reimbursement tariffs.Results: Overall, costs of grades 3 and 4 AEs related to treatment ranged from €46 per event to €7,742 per year. Fourteen out of 24 AEs identified had a mean estimated cost over €2,000. The highest mean costs were related to type 1 diabetes (€7,742 per year followed by pneumonitis (€5,786 per event

  18. Five-year results of patients supported by HeartMate II: outcomes and adverse events.

    Science.gov (United States)

    Hanke, Jasmin S; Rojas, Sebastian V; Mahr, Claudius; Schmidt, Anja-Franziska; Zoch, Amelie; Dogan, Günes; Feldmann, Christina; Deniz, Ezin; Molitoris, Ullrich; Bara, Christoph; Strüber, Martin; Haverich, Axel; Schmitto, Jan D

    2017-09-02

    Improved outcomes over the past decade have increased confidence of physicians and patients in extended duration of left ventricular assist device (LVAD) support. This single-centre cohort study reports 5-year outcomes with the HeartMate II (HMII) LVAD. We describe a cohort of 89 patients who received a HMII LVAD between February 2004 and December 2010. The causes of death and adverse events were assessed by examination of medical records. A total of 202.74 patient-years were analysed. After 5 years, of the 89 patients, 15 patients remained on device therapy, 39 patients died, 28 patients underwent heart transplantation and 7 patients underwent explantation of the HMII for recovery. One year after the HMII implantation, there was a survival of 71% in the study cohort. In the following years, the survival rate was 65% in the 2nd year, 63% in the 3rd year, 56% in the 4th year and 54% after 5 years of LVAD support. Ten LVAD exchanges were performed in 8 (11%) patients. Currently (March 2017), 12 patients still remain on their original device. The longest ongoing patient on the HMII has been supported for over 11 years (4097 days). The most common adverse events were bleeding (68%; 1.5837 events per patient-year) and LVAD infection [49%; 1.0666 events per patient-year]. Seven cases of pump thrombosis were described (8%; 0.1131 events per patient-year). This is the first single-cohort study to describe a 5-year survival of HMII patients on extended duration of support. A 5-year survival of 54% was observed in this single-centre cohort.

  19. Adverse events following vaccination with an inactivated, Vero cell culture-derived Japanese encephalitis vaccine in the United States, 2009-2012.

    Science.gov (United States)

    Rabe, Ingrid B; Miller, Elaine R; Fischer, Marc; Hills, Susan L

    2015-01-29

    In March 2009, the U.S. Food and Drug Administration licensed an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC [Ixiaro]) for use in adults. The vaccine was licensed based on clinical trial safety data in 3558 JE-VC recipients. It is essential to monitor post-licensure surveillance data to evaluate the safety of JE-VC because rare adverse events may not be detected until the vaccine is administered to a larger population. We reviewed adverse events reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) for adults (≥17 years) who received JE-VC from May 2009 through April 2012. Adverse event reporting rates were calculated using 275,848 JE-VC doses distributed. Over the 3 year period, 42 adverse events following vaccination with JE-VC were reported to VAERS for an overall reporting rate of 15.2 adverse events per 100,000 doses distributed. Of the 42 total reports, 5 (12%) were classified as serious for a reporting rate of 1.8 per 100,000 doses distributed; there were no deaths. Hypersensitivity reactions (N=12) were the most commonly reported type of adverse event, with a rate of 4.4 per 100,000 doses distributed; no cases of anaphylaxis were reported. Three adverse events of the central nervous system were reported (one case of encephalitis and two seizures) for a rate of 1.1 per 100,000; all occurred after receipt of JE-VC with other vaccines. These post-marketing surveillance data suggest a good safety profile for JE-VC consistent with findings from pre-licensure clinical trials. Post-licensure safety data should continue to be monitored for any evidence of rare serious or neurologic adverse events. Published by Elsevier Ltd.

  20. 内科护士对不良事件报告执行意向的影响因素分析%Analysis of influencing factors of implementation intention of nurses on adverse event reporting in department of in-ternal medicine

    Institute of Scientific and Technical Information of China (English)

    张庆娜; 胡少华; 陆彩云; 吕冶芳; 祁金梅; 戴芬

    2015-01-01

    Objective:To understand the status quo of the cognition and attitude of nurses in internal medicine department toward the adverse event reporting,and to analyze its influencing factors,so as to provide the basis for the further improvement of nursing adverse events reporting system.Methods:A total of 436 nurses were se-lected from internal medicine department by using convenience sampling method.The self compiled question-naire of cognition and attitude toward adverse event reporting was used for investigation.Results:The positive response rate of nurses’cognition and attitude toward the adverse events was 72.5 1%,And its five dimensions including reporting cognition 80.72%.tmplementation intention 79.86%,managing expectations 70.01%,pun-ishment environmental 68.85%,department culture 63.12%.The Influencing factors of implementation inten-tion on adverse event reporting were nurse job seniority,punishment environment,department culture and re-porting cognition.Conclusion:The general cognition and attitude toward the adverse events reporting is positive. It suggests that hospitals should make personalized management on the basis of the systematic safety manage-ment,further improve the adverse event reporting system and promote the adverse events reporting behavior.%[目的]了解内科护士对不良事件报告认知与态度的现状,并分析其影响因素,为护理不良事件报告系统的进一步完善提供依据。[方法]采用便利抽样法选取我院436名内科护士,应用自行编制的不良事件报告认知与态度问卷进行调查。[结果]护士对不良事件的认知与态度的积极应答率为72.51%,5个维度的积极反应率分别为报告认知80.72%、执行意向79.86%、管理期望70.01%、惩罚环境68.85%、科室文化63.12%;不良事件报告执行意向的影响因素为护龄、惩罚环境、科室文化、报告认知。[结论]护士对不良事件报告的总体认知与态度较正向,建议医院在系统化

  1. Absence of Fluoride Varnish–Related Adverse Events in Caries Prevention Trials in Young Children, United States

    Science.gov (United States)

    Gregorich, Steven E.; Ramos-Gomez, Francisco; Braun, Patricia A.; Wilson, Anne; Albino, Judith; Tiwari, Tamanna; Harper, Maya; Batliner, Terrence S.; Rasmussen, Margaret; Cheng, Nancy F.; Santo, William; Geltman, Paul L.; Henshaw, Michelle; Gansky, Stuart A.

    2017-01-01

    Introduction Fluoride varnish is an effective prevention intervention for caries in young children. Its routine use in clinical care is supported by meta-analyses and recommended by clinical guidelines, including the US Preventive Services Task Force (B rating). This report is the first prospective systematic assessment of adverse events related to fluoride varnish treatment in young children. Methods We determined the incidence of adverse events related to fluoride varnish treatment in 3 clinical trials on the prevention of early childhood caries, conducted under the auspices of the Early Childhood Caries Collaborating Centers, an initiative sponsored by the National Institute of Dental and Craniofacial Research. Each trial incorporated use of fluoride varnish in its protocol and systematically queried all children’s parents or legal guardians about the occurrence of acute adverse events after each fluoride varnish treatment. Results A total of 2,424 community-dwelling, dentate children aged 0 to 5 years were enrolled and followed for up to 3 years. These children received a cumulative total of 10,249 fluoride varnish treatments. On average, each child received 4.2 fluoride varnish treatments. We found zero fluoride varnish–related adverse events. Conclusion Fluoride varnish was not associated with treatment-related adverse events in young children. Our findings support its safety as an effective prevention intervention for caries in young children. PMID:28207379

  2. Adverse events of statin-fenofibric acid versus statin monotherapy: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Geng, Qiang; Ren, Jingyi; Chen, Hong; Lee, Chongyou; Liang, Wenqing

    2013-03-01

    Patients with mixed dyslipidemia can benefit from the combination of fenofibric acid (FA) with statins, but concerns about adverse events make physicians reluctant to prescribe the combination therapy. In the present study, we performed a meta-analysis of randomized controlled trials (RCTs) to assess the efficacy and adverse events in patients taking statins and FA. Medline, Embase and the Cochrane Library were searched to identify studies that reported adverse events. Finally, five trials covering 2704 patients were selected in this study. There were significant decreases in TG and increases in HDL-C in patients receiving combination therapy compared with statin monotherapy. The incidence of hepatic toxicity (OR, 3.57; 95% CI, 1.17-10.83; P statin group than in the corresponding statin monotherapy. The incidence of CK elevations and muscle-associated AEs was not statistically different between the two groups. The adverse events in the FA + moderate-dose statin group were almost identical to those in the FA + low-dose statin group. In conclusion, combination therapy could improve the blood lipid profile. Addition of FA to statins therapy is more frequently associated with hepatic and renal toxicity than muscle-associated AEs. Therefore patients taking the combination of FA with statins should have liver enzyme and renal function monitored. However, we still need large-scale and long follow-up period RCTs to definitively confirm the adverse events of FA-statin therapy.

  3. Absence of Fluoride Varnish-Related Adverse Events in Caries Prevention Trials in Young Children, United States.

    Science.gov (United States)

    Garcia, Raul I; Gregorich, Steven E; Ramos-Gomez, Francisco; Braun, Patricia A; Wilson, Anne; Albino, Judith; Tiwari, Tamanna; Harper, Maya; Batliner, Terrence S; Rasmussen, Margaret; Cheng, Nancy F; Santo, William; Geltman, Paul L; Henshaw, Michelle; Gansky, Stuart A

    2017-02-16

    Fluoride varnish is an effective prevention intervention for caries in young children. Its routine use in clinical care is supported by meta-analyses and recommended by clinical guidelines, including the US Preventive Services Task Force (B rating). This report is the first prospective systematic assessment of adverse events related to fluoride varnish treatment in young children. We determined the incidence of adverse events related to fluoride varnish treatment in 3 clinical trials on the prevention of early childhood caries, conducted under the auspices of the Early Childhood Caries Collaborating Centers, an initiative sponsored by the National Institute of Dental and Craniofacial Research. Each trial incorporated use of fluoride varnish in its protocol and systematically queried all children's parents or legal guardians about the occurrence of acute adverse events after each fluoride varnish treatment. A total of 2,424 community-dwelling, dentate children aged 0 to 5 years were enrolled and followed for up to 3 years. These children received a cumulative total of 10,249 fluoride varnish treatments. On average, each child received 4.2 fluoride varnish treatments. We found zero fluoride varnish-related adverse events. Fluoride varnish was not associated with treatment-related adverse events in young children. Our findings support its safety as an effective prevention intervention for caries in young children.

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

    Science.gov (United States)

    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. Do co-intoxicants increase adverse event rates in the first 24 hours in patients resuscitated from acute opioid overdose?

    Science.gov (United States)

    Mirakbari, Seyed Mostafa; Innes, Grant D; Christenson, Jim; Tilley, Jessica; Wong, Hubert

    2003-01-01

    Patients frequently arrive in emergency departments (EDs) after being resuscitated from opioid overdose. Autopsy studies suggest that multidrug intoxication is a major risk factor for adverse outcomes after acute heroin overdose in patients. If this is true, there may be high-risk drug combinations that identify patients who require more intensive monitoring and prolonged observation. Our objective was to determine the impact of co-intoxication with alcohol, cocaine, or CNS depressant drugs on short-term adverse event rates in patients resuscitated from acute opioid overdose. Data were extracted from the database of a prospective opioid overdose cohort study conducted between May 1997 and 1999. Patients were prospectively enrolled if they received naloxone for presumed opioid overdose. Investigators gathered clinical, demographic, and other predictor variables, including co-intoxicants used. Patients were followed to identify prespecified adverse outcome events occurring within 24 h, and multiple logistic regression was used to determine the association of concomitant drug use on short-term adverse event rates. Of 1155 patients studied, 58 (5%) had pure opioid overdose and 922 (80%) reported co-intoxicants, including alcohol, cocaine, and CNS depressants. Overall, out of 1056 patients with known outcome status there were 123 major adverse events (11.6%) and 194 minor adverse events (18.4%). After adjustment for age, gender, HIV status, cardiovascular disease, pulmonary disease and diabetes, we found that coadministration of alcohol, cocaine, or CNS depressants, alone or in combination, was not associated with increased risk of death or adverse events during the 24 h follow-up period. In patients resuscitated from acute opioid overdose, short-term outcomes are similar for patients with pure opioid overdose and multidrug intoxications. A history of cointoxication cannot be used to identify high-risk patients who require more intensive ED monitoring or prolonged

  6. "All that palsies is not Bell's" - The need to define Bell's palsy as an adverse event following immunization

    NARCIS (Netherlands)

    Rath, Barbara; Linder, Thomas; Cornblath, David; Hudson, Michael; Fernandopulle, Rohini; Hartmann, Katharina; Heininger, Ulrich; Izurieta, Hector; Killion, Leslie; Kokotis, Pangiotis; Oleske, James; Vajdy, Michael; Wong, Virginia

    2007-01-01

    Bell's palsy has been reported as an adverse event following immunization (AEFI). Review of the published literature reveals that several characteristics have been used to describe Bell's palsy, which differ significantly from author to author. Evidently, the definition of "Bell's palsy" remains

  7. Effects of Extended-Release Guanfacine on ADHD Symptoms and Sedation-Related Adverse Events in Children with ADHD

    Science.gov (United States)

    Faraone, Stephen V.; Glatt, Stephen J.

    2010-01-01

    Objective: Guanfacine extended release (GXR) is a selective alpha[subscript 2A]-adrenoceptor agonist that is shown to be an effective nonstimulant treatment for the symptoms of attention-deficit/hyperactivity disorder. This report documents the time course and predictors of symptom efficacy and sedation-related adverse events (AEs) that emerge…

  8. Differences in the occurence of adverse events between discharged or deceased patients in Dutch hospitals.

    NARCIS (Netherlands)

    Zegers, M.; Bruyne, M.C.; Wagner, C.; Groenewegen, P.P.; Wal, G. van der

    2007-01-01

    An epidemiological study was initiated to (1) determine the incidence, nature, type, impact, causes, and preventability among discharged or deceased patients, (2) examine the differences of patient and admission characteristics between deceased or discharged hospitalised patients with adverse event

  9. Metamizole-Associated Adverse Events: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Fässler, Margrit; Blozik, Eva; Linde, Klaus; Jüni, Peter; Reichenbach, Stephan; Scherer, Martin

    2015-01-01

    Background Metamizole is used to treat pain in many parts of the world. Information on the safety profile of metamizole is scarce; no conclusive summary of the literature exists. Objective To determine whether metamizole is clinically safe compared to placebo and other analgesics. Methods We searched CENTRAL, MEDLINE, EMBASE, CINAHL, and several clinical trial registries. We screened the reference lists of included trials and previous systematic reviews. We included randomized controlled trials that compared the effects of metamizole, administered to adults in any form and for any indication, to other analgesics or to placebo. Two authors extracted data regarding trial design and size, indications for pain medication, patient characteristics, treatment regimens, and methodological characteristics. Adverse events (AEs), serious adverse events (SAEs), and dropouts were assessed. We conducted separate meta-analyses for each metamizole comparator, using standard inverse-variance random effects meta-analysis to pool the estimates across trials, reported as risk ratios (RRs). We calculated the DerSimonian and Laird variance estimate T2 to measure heterogeneity between trials. The pre-specified primary end point was any AE during the trial period. Results Of the 696 potentially eligible trials, 79 trials including almost 4000 patients with short-term metamizole use of less than two weeks met our inclusion criteria. Fewer AEs were reported for metamizole compared to opioids, RR = 0.79 (confidence interval 0.79 to 0.96). We found no differences between metamizole and placebo, paracetamol and NSAIDs. Only a few SAEs were reported, with no difference between metamizole and other analgesics. No agranulocytosis or deaths were reported. Our results were limited by the mediocre overall quality of the reports. Conclusion For short-term use in the hospital setting, metamizole seems to be a safe choice when compared to other widely used analgesics. High-quality, adequately sized

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

    OpenAIRE

    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 acti...

  11. Retrospective analysis of 53 cases of medical supplies quality adverse event

    Directory of Open Access Journals (Sweden)

    Cheng-zu LUO

    2014-04-01

    Full Text Available Medical supplies are the basic material for medical work in the hospital, and in relation to the patient's life.This paper analyzed retrospectively 53 cases of medical supplies quality adverse event in our hospital from 2011 to 2012.Accordingly, it was discussed how to improve the whole quality control system of medical supplies, how to ensure clinical safety, and how to reduce the incidence of adverse events.

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

    Science.gov (United States)

    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.

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

    Institute of Scientific and Technical Information of China (English)

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

    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.

  14. Chlorhexidine with or without alcohol against biofilm formation: efficacy, adverse events and taste preference.

    Science.gov (United States)

    Santos, Gabriela Otero Dos; Milanesi, Fernanda Carpes; Greggianin, Bruna Frizon; Fernandes, Marilene Issa; Oppermann, Rui Vicente; Weidlich, Patricia

    2017-05-04

    In recent years, different chlorhexidine formulations have been tested, including an alcohol-free alternative, but the effect of this solution on early biofilm formation is not clear. A crossover, randomized, double-blind clinical trial was conducted to evaluate the effect of two chlorhexidine solutions against supra- and subgingival biofilm formation (NCT#02656251). Thirty-five participants were randomized and asked to rinse twice daily with 15 ml of an alcohol-containing 0.12% chlorhexidine solution, an alcohol-free 0.12% chlorhexidine solution, or placebo. The study was conducted in three experimental periods of 4 days each, with a 10-day washout between the periods. All the experimental periods followed the same protocol, except that the solutions were switched. Biofilm distribution was evaluated every 24 hours by the Plaque-Free Zone Index, during 96 hours. Adverse events were self-reported and sensory evaluation was performed using a hedonic scale. Compared to the placebo, the chlorhexidine solutions resulted in a significantly higher number of surfaces free of plaque over 96 hours (p < 0.01), and were able to prevent subgingival biofilm formation (p < 0.01). The alcohol-free chlorhexidine solution was associated with a lower incidence of adverse events, compared with alcohol-containing chlorhexidine (p < 0.05); it also received better sensory evaluation and acceptance by trial participants, compared with the alcohol-containing chlorhexidine (p = 0.007), and had a similar inhibitory effect on the formation of supra- and subgingival biofilms.

  15. Defining molecular initiating events in the adverse outcome pathway framework for risk assessment.

    Science.gov (United States)

    Allen, Timothy E H; Goodman, Jonathan M; Gutsell, Steve; Russell, Paul J

    2014-12-15

    Consumer and environmental safety decisions are based on exposure and hazard data, interpreted using risk assessment approaches. The adverse outcome pathway (AOP) conceptual framework has been presented as a logical sequence of events or processes within biological systems which can be used to understand adverse effects and refine current risk assessment practices in ecotoxicology. This framework can also be applied to human toxicology and is explored on the basis of investigating the molecular initiating events (MIEs) of compounds. The precise definition of the MIE has yet to reach general acceptance. In this work we present a unified MIE definition: an MIE is the initial interaction between a molecule and a biomolecule or biosystem that can be causally linked to an outcome via a pathway. Case studies are presented, and issues with current definitions are addressed. With the development of a unified MIE definition, the field can look toward defining, classifying, and characterizing more MIEs and using knowledge of the chemistry of these processes to aid AOP research and toxicity risk assessment. We also present the role of MIE research in the development of in vitro and in silico toxicology and suggest how, by using a combination of biological and chemical approaches, MIEs can be identified and characterized despite a lack of detailed reports, even for some of the most studied molecules in toxicology.

  16. e-Prescription: An e-Health System for Preventing Adverse Drug Events in Community Healthcare

    Directory of Open Access Journals (Sweden)

    Irma M. Puspitasari

    2012-03-01

    Full Text Available The paper describes development activities of an e-health system for community health center (Puskesmas with integrated adverse drug events e-prescription module, consist of system design and development, human resource development, e-health system realization, laboratory and implementation test of e-health system. Some e-readiness evaluations were conducted, through a number of field visits and questionnaires. The results had been used in the e-health system design and development, installation of the internet access infrastructure, and implementation of the education and hands-on training for the medical and administrative staff of the healthcare units. After completing the e-health system design and development as well as system realization and laboratory tests stages, a series of field implementation and experiments have been successfully conducted at Puskesmas Babakansari in Bandung. A number of users feed back have been obtained and used for further improvements on both of the software and hardware modules. The e-health system with integrated e-prescription module has successfully developed and shown its expected functions in: patient registration, medical record, paperless prescription, producing the required reports and preventing possible adverse drug events.

  17. Oral Cholera Vaccine Coverage, Barriers to Vaccination, and Adverse Events following Vaccination, Haiti, 20131

    Science.gov (United States)

    François, Jeannot; Wannemuehler, Kathleen; Iyengar, Preetha; Dismer, Amber; Adrien, Paul; Hyde, Terri B.; Marston, Barbara J.; Date, Kashmira; Mintz, Eric; Katz, Mark A.

    2015-01-01

    In 2013, the first government-led oral cholera vaccination (OCV) campaign in Haiti was implemented in Petite Anse and Cerca Carvajal. To evaluate vaccination coverage, barriers to vaccination, and adverse events following vaccination, we conducted a cluster survey. We enrolled 1,121 persons from Petite Anse and 809 persons from Cerca Carvajal, categorized by 3 age groups (1–4, 5–14, >15 years). Two-dose OCV coverage was 62.5% in Petite Anse and 76.8% in Cerca Carvajal. Two-dose coverage was lowest among persons >15 years of age. In Cerca Carvajal, coverage was significantly lower for male than female respondents (69% vs. 85%; p<0.001). No major adverse events were reported. The main reason for nonvaccination was absence during the campaign. Vaccination coverage after this campaign was acceptable and comparable to that resulting from campaigns implemented by nongovernmental organizations. Future campaigns should be tailored to reach adults who are not available during daytime hours. PMID:25988350

  18. Oral Cholera Vaccine Coverage, Barriers to Vaccination, and Adverse Events following Vaccination, Haiti, 2013.

    Science.gov (United States)

    Tohme, Rania A; François, Jeannot; Wannemuehler, Kathleen; Iyengar, Preetha; Dismer, Amber; Adrien, Paul; Hyde, Terri B; Marston, Barbara J; Date, Kashmira; Mintz, Eric; Katz, Mark A

    2015-06-01

    In 2013, the first government-led oral cholera vaccination (OCV) campaign in Haiti was implemented in Petite Anse and Cerca Carvajal. To evaluate vaccination coverage, barriers to vaccination, and adverse events following vaccination, we conducted a cluster survey. We enrolled 1,121 persons from Petite Anse and 809 persons from Cerca Carvajal, categorized by 3 age groups (1-4, 5-14, >15 years). Two-dose OCV coverage was 62.5% in Petite Anse and 76.8% in Cerca Carvajal. Two-dose coverage was lowest among persons >15 years of age. In Cerca Carvajal, coverage was significantly lower for male than female respondents (69% vs. 85%; p<0.001). No major adverse events were reported. The main reason for nonvaccination was absence during the campaign. Vaccination coverage after this campaign was acceptable and comparable to that resulting from campaigns implemented by nongovernmental organizations. Future campaigns should be tailored to reach adults who are not available during daytime hours.

  19. A curated and standardized adverse drug event resource to accelerate drug safety research.

    Science.gov (United States)

    Banda, Juan M; Evans, Lee; Vanguri, Rami S; Tatonetti, Nicholas P; Ryan, Patrick B; Shah, Nigam H

    2016-05-10

    Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies.

  20. Clinical review: insulin pump-associated adverse events in adults and children.

    Science.gov (United States)

    Ross, P L; Milburn, J; Reith, D M; Wiltshire, E; Wheeler, B J

    2015-12-01

    Insulin pumps are a vital and rapidly developing tool in the treatment of type 1 diabetes mellitus in both adults and children. Many studies have highlighted outcomes and assessed their potential advantages, but much of the data on adverse outcomes are limited and often based on outdated technology. We aimed to review and summarize the available literature on insulin pump-associated adverse events in adults and children. A literature search was undertaken using PubMed, EMBASE, and the Cochrane library. Articles were then screened by title, followed by abstract, and full text as needed. A by-hand search of reference lists in identified papers was also utilised. All searches were limited to English language material, but no time limits were used. Current and past literature regarding insulin pump-associated adverse events is discussed, including potential metabolic and non-metabolic adverse events, in particular: pump malfunction; infusion set/site issues; and cutaneous problems. We show that even with modern technology, adverse events are common, occurring in over 40 % of users per year, with a minority, particularly in children, requiring hospital management. Hyperglycaemia and ketosis are now the most common consequences of adverse events and are usually associated with infusion set failure. This differs from older technology where infected infusion sites predominated. This timely review covers all potential insulin pump-associated adverse events, including their incidence, features, impacts, and contributory factors such as the pump user. The importance of ongoing anticipatory education and support for patients and families using this intensive insulin technology is highlighted, which if done well should improve the overall experience of pump therapy for users, and hopefully reduce the incidence and impact of severe adverse events.

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

    Science.gov (United States)

    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.

  2. Insulin pump-associated adverse events in children and adolescents--a prospective study.

    Science.gov (United States)

    Wheeler, Benjamin J; Heels, Kristine; Donaghue, Kim C; Reith, David M; Ambler, Geoffrey R

    2014-09-01

    Intensive insulin regimens are now the mainstay of modern, type 1 diabetes mellitus management. Insulin pumps (CSII) are a key technique used. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events (AEs) and their incidence and characteristics. Phone calls to our 24-h diabetes support service were screened for CSII-associated AEs. Phone interviews were conducted with the parent/patient, within 96 h of the event. Interviews explored AE characteristics and the role of the user, as well as questions relating to outcome and the impact to the family and patient. Comparisons were made with clinic CSII patients not reporting an AE. Over a 16-week study period, 50 confirmed AEs occurred in 45 of 405 (11.1%) patients. This was annualized to an AE incidence of 40 AEs/100 person-years. Pump malfunction and infusion set/site failures were the most common events reported, occurring in 27 (54.0%) and 18 (36.0%) AEs, respectively. A user- or education-related issue was implicated in 22 (44.0%) events. Pump replacement occurred in 19 of 50 occurrences (38.0%). Additionally, 16 (32.0%) reported a hospital admission or emergency department attendance as a consequence. When compared with those on CSII not reporting an AE, AEs were associated with age pumping duration. This is the first prospective study to look at AEs in modern-generation insulin pumps. AEs appear common and should be anticipated. Their origin is multifactorial, with the pump, associated consumables, and the user all being important factors. Ongoing support and anticipatory education are essential to minimize pump-associated AEs and their impact.

  3. Adverse events with use of antiepileptic drugs: a prescription and event symmetry analysis

    DEFF Research Database (Denmark)

    Tsiropoulos, Ioannis; Andersen, Morten; Hallas, Jesper

    2009-01-01

    .5-448), of gabapentin with glaucoma (ASR 8.0; 95%CI 1.1-355) and of valproic acid with hypothyroidism (ASR 8.0; 95%CI 1.1-355). CONCLUSIONS: Few unsuspected adverse AED effects were recognized in our study. Sequence symmetry analysis is a feasible method of monitoring for adverse AED effects. Copyright (c) 2009 John...

  4. Adaptation options for wheat in Europe will be limited by increased adverse weather events under climate change.

    Science.gov (United States)

    Trnka, Miroslav; Hlavinka, Petr; Semenov, Mikhail A

    2015-11-06

    Ways of increasing the production of wheat, the most widely grown cereal crop, will need to be found to meet the increasing demand caused by human population growth in the coming decades. This increase must occur despite the decrease in yield gains now being reported in some regions, increased price volatility and the expected increase in the frequency of adverse weather events that can reduce yields. However, if and how the frequency of adverse weather events will change over Europe, the most important wheat-growing area, has not yet been analysed. Here, we show that the accumulated probability of 11 adverse weather events with the potential to significantly reduce yield will increase markedly across all of Europe. We found that by the end of the century, the exposure of the key European wheat-growing areas, where most wheat production is currently concentrated, may increase more than twofold. However, if we consider the entire arable land area of Europe, a greater than threefold increase in risk was predicted. Therefore, shifting wheat production to new producing regions to reduce the risk might not be possible as the risk of adverse events beyond the key wheat-growing areas increases even more. Furthermore, we found a marked increase in wheat exposure to high temperatures, severe droughts and field inaccessibility compared with other types of adverse events. Our results also showed the limitations of some of the presently debated adaptation options and demonstrated the need for development of region-specific strategies. Other regions of the world could be affected by adverse weather events in the future in a way different from that considered here for Europe. This observation emphasizes the importance of conducting similar analyses for other major wheat regions.

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

    Science.gov (United States)

    Kabiru, Caroline W; Elung'ata, Patricia; Mojola, Sanyu A; Beguy, Donatien

    2014-01-01

    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? 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. 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). 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, religiosity, and self-esteem may

  6. Higher risk of offspring schizophrenia following antenatal maternal exposure to severe adverse life events

    DEFF Research Database (Denmark)

    Khashan, Ali; Abel, Kathryn; McNamee, R.

    2008-01-01

    CONTEXT: Most societies believe that a mother's psychological state can influence her unborn baby. Severe adverse life events during pregnancy have been consistently associated with an elevated risk of low birth weight and prematurity. Such events during the first trimester have also been associa...... and suggests that environment may influence neurodevelopment at the feto-placental-maternal interface...

  7. Investigation on nurses' adverse events reporting and the influence factors in 3A-grade general hospitals,Hunan Province%湖南省三甲医院护士不良事件的报告现状及影响因素调查

    Institute of Scientific and Technical Information of China (English)

    刘玉娥; 罗敏; 欧阳庆; 王波兰; 王晖; 成放群; 戴利

    2013-01-01

    Objective To investigate the nursing adverse events reporting status and their influence factors of nurses in 3A-grade general hospitals,so as to provide evidence for the developmental measures to improve nursing adverse events reporting.Methods The questionnaires of Patient Safety Culture Assessment Scale about Clinical Nurses and Nurses' Cognitive of Adverse Event Reporting were used to survey 1 866 nurses from six 3A-grade general hospitals in Hunan Province.Results The rate of nurses reported voluntarily adverse events was 24.71%.There were statistically significant in different groups divided by age,educational background,position,professional title,service years,type of recruitment and department(P < 0.05).Logistic regression analysis showed that nurses' perception of patient safety culture,the cognition of nursing adverse event report and nurses' professional title entered into the regression equation with the values OR were 177.004,1.813,1.533,R2 =0.554,P < 0.01.Conclusions The rate of nurses reported voluntarily adverse events is low.With the age growing,the service years lengthening,the position heightening,educational background and professional title raising,the rate of nursing adverse events reporting is upgrade.The rate of nursing adverse events reporting of head nurse is significantly higher than general nurses,formal recruitment nurse is higher than no formal.The rate of nursing adverse events reporting of outpatient department nurse is the highest,and ICU,emergency department,gynecology and obstetrics department nurse is significantly lower than that of others.Nurses' perception of patient safety culture,the cognition of nursing adverse event reporting and professional titles are the main influence factors of nursing adverse events reporting.%目的 探讨湖南省三级甲等医院护士不良事件报告现状及其影响因素,为制订促进护士自愿报告不良事件的措施提供依据.方法 采用医院护士的患者安全文化

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

    Directory of Open Access Journals (Sweden)

    Dag Ø. Nordanger

    2014-05-01

    Full Text Available 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.

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

    Science.gov (United States)

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

    2014-01-01

    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. To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. 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. 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. 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.

  10. An analysis of risk factors and adverse events in ambulatory surgery

    Directory of Open Access Journals (Sweden)

    Kent C

    2014-06-01

    Full Text Available Christopher Kent, Julia Metzner, Laurent BollagDepartment of Anesthesiology and Pain Medicine, University of Washington Medical Center, Seattle, WA, USAAbstract: Care for patients undergoing ambulatory procedures is a broad and expanding area of anesthetic and surgical practice. There were over 35 million ambulatory surgical procedures performed in the US in 2006. Ambulatory procedures are diverse in both type and setting, as they span the range from biopsies performed under local anesthesia to intra-abdominal laparoscopic procedures, and are performed in offices, freestanding ambulatory surgery centers, and ambulatory units of hospitals. The information on adverse events from these varied settings comes largely from retrospective reviews of sources, such as quality-assurance databases and closed malpractice claims. Very few if any ambulatory procedures are emergent, and in comparison to the inpatient population, ambulatory surgical patients are generally healthier. They are still however subject to most of the same types of adverse events as patients undergoing inpatient surgery, albeit at a lower frequency. The only adverse events that could be considered to be unique to ambulatory surgery are those that arise out of the circumstance of discharging a postoperative patient to an environment lacking skilled nursing care. There is limited information on these types of discharge-related adverse events, but the data that are available are reviewed in an attempt to assist the practitioner in patient selection and discharge decision making. Among ambulatory surgical patients, particularly those undergoing screening or cosmetic procedures, expectations from all parties involved are high, and a definition of adverse events can be expanded to include any occurrence that interrupts the rapid throughput of patients or interferes with early discharge and optimal patient satisfaction. This review covers all types of adverse events, but focuses on the more

  11. Quality indicators of preventable adverse drug events in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard

    drug events in the primary care setting (Article 1). Construction of the preventable adverse drug events assessment model required four steps. The first step consisted of the development, validation, and feasibility of preventable adverse drug event indicators for type 2 diabetes (Articles 2 and 3...... associated with HbA1c monitoring and treatment was determined using logistic regression. The fourth step in the model was a health economic evaluation of the cost-effectiveness of shifting patients from inadequate to adequate medical treatment. The database used for the AMI indicator study formed...... in patients with type 2 diabetes, and apply a new register-based model with the ability to assess the epidemiology and economic impact of preventable adverse drug events in patients with type 2 diabetes, in order to give health care decision makers a clinical and health economic rationale for prioritizing...

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

    DEFF Research Database (Denmark)

    Bergink, Veerle; Tidselbak Larsen, Janne; Hillegers, M H J

    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...... 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...... 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...

  13. [Something is wrong in the way we inform patients of an adverse event].

    Science.gov (United States)

    Mira, José Joaquín; Lorenzo, Susana

    2015-01-01

    To analyze which actions are carried out in hospitals and primary care to ensure open disclosure to the patient after an adverse event (AE). We surveyed 633 managers and patient safety coordinates (staff) and 1340 physicians and nurses from eight autonomous communities. The level of implementation of open disclosure recommendations was explored. A total of 112 (27.9%) staff and 386 (35.9%) professionals considered that patients were correctly informed after an EA; 30 (7.4%) staff claimed to have a guideline on how to report EA; only 92 medical professionals (17.4%) and 93 nurses (19.1%) had received training on open disclosure. There are gaps in the way of planning, organizing and ensuring that patients who suffer an AE will receive an apology with honest information about what has happened and what could subsequently happen. Copyright © 2015 SESPAS. Published by Elsevier Espana. All rights reserved.

  14. Two Cases of Nivolumab Re-Administration after Pneumonitis as Immune-Related Adverse Events

    Directory of Open Access Journals (Sweden)

    Keisuke Imafuku

    2017-04-01

    Full Text Available Nivolumab is a recently approved medication for the treatment of unresectable malignant melanoma. Many immune-related adverse events (irAEs associated with nivolumab have been reported, such as pneumonitis, hepatitis, dermatitis, and thyroiditis. Prednisolone can effectively treat irAEs. However, it is unclear how or if nivolumab should be administered to patients after they have experienced an irAE. Herein, we show 2 patients who underwent pneumonitis as irAE. Case 1 demonstrated a cryptogenic organizing pneumonia pattern in the CT scan and case 2 had a diffuse alveolar damage (DAD pattern. Oral corticosteroids improved chest shadow of CT scan in both cases. However, when nivolumab was re-administrated, case 1 demonstrated no symptoms, but case 2 demonstrated pneumonia again. From our cases, it is difficult to re-administrate nivolumab for the patients with pneumonitis which shows a DAD pattern in CT, even if oral corticosteroids improve their symptoms.

  15. Contribution of pharmacists to the reporting of adverse drug reactions

    NARCIS (Netherlands)

    van Grootheest, AC; van Puijenbroek, EP; de Jong-van den Berg, LTW

    2002-01-01

    Purpose The aim of the study is to get a better view about the possible contribution of pharmacists' reports to the quantity and the quality of reports and in this way to the quality of a voluntary reporting system of adverse drug reactions. Methods A total of 15 293 reports, sent to the Netherlands

  16. [Meta-analysis of blood system adverse events of Tripterygium wilfordii].

    Science.gov (United States)

    Li, Zhi-xia; Ma, Dong-mei; Yang, Xing-hua; Sun, Feng; Yu, Kai; Zhan, Si-yan

    2015-01-01

    A systematic review was undertaken, including studies that evaluated the incidence of the blood system adverse events of Tripterygium wilfordii (TWP). Medline, Embase and the Cochrane library were searched for relevant studies, including RCT, cohort studies and case series, of patients treated with TWP published in English and Chinese from inception up until May 25th, 2013 with the keywords including "Tripterygium wilfordii", "toxicity", "reproductive", "side effect", "adverse", "safety" and "tolerability". Relevant information was extracted and the incidence of the blood system adverse events was pooled with MetaAnalyst software. Besides, subgroup and sensitivity analyses were performed based on age, mode of medicine, observation time and disease system. According to inclusion and exclusion criteria, a total of 49 articles were included in the meta-analysis, they were split into 54 researches incorporated in the analysis. There is a large degree of heterogeneity among the studies, so data was analyzed using random-effects model and the summary estimates of incidence of the blood system adverse events was 6.1%. The weighted combined incidence of three major blood system adverse events were white-blood cells decreasing 5.6% (95% CI, 4.3% - 7.3%), hemoglobin decreasing 1.7% (95% CI, 0.5% - 5.0%) and platelet decreasing 1.8% (95% CI, 1.0% - 3.1%), respectively . Sensitivity analyses based on 45 studies with high quality showed the combined value was close to the summary estimate of total 54 studies. The current evidence indicates that the incidence of the blood system adverse events induced by TWP was high; attentions should be paid on to the prevention and treatment of the blood system adverse events.

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

    Science.gov (United States)

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

    2017-01-01

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

  18. A prognostic model for short term adverse events in normotensive patients with pulmonary embolism.

    Science.gov (United States)

    Agterof, Mariette J; Schutgens, Roger E G; Moumli, Noureddine; Eijkemans, M J C; van der Griend, René; Tromp, Ellen A M; Biesma, Douwe H

    2011-08-01

    Risk stratification of patients with PE has gained interest in terms of the identification of patients in whom treatment on an outpatient base can be considered. Previous studies are of limited value due to their focus on adverse clinical events within several months after diagnosis of PE. We developed a prognostic model, based on easily accessible, clinical, and laboratory parameters, to predict adverse events during the first 10 days after the diagnosis of acute PE. We have analyzed the data of 210 outpatients with confirmed PE. Collected data included medical history, pulse rate, blood pressure, NT-proBNP, and D-dimer concentrations. The primary outcome was the occurrence of adverse clinical events in a 10 day follow-up period. Our final prognostic model to predict short-term adverse events consists of NT-proBNP levels, D-dimer concentrations, pulse rate, and the occurrence of active malignancy; the total score ranges from 0 to 37 points. Patients with a low score (no active malignancy, pulse rate rate, D-dimer concentrations, and NT-proBNP levels. Our prognostic model, once prospectively validated in an independent sample of patients, can be used in the early risk stratification of PE to estimate the risk of adverse events and to differentiate between candidates for in- or out- hospital treatment. Copyright © 2011 Wiley-Liss, Inc.

  19. Adverse event detection using the FDA post-marketing drug safety surveillance system: Cardiotoxicity associated with loperamide abuse and misuse.

    Science.gov (United States)

    Swank, Kimberley A; Wu, Eileen; Kortepeter, Cindy; McAninch, Jana; Levin, Robert L

    The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016. Forty-eight cases of serious cardiac adverse events associated with loperamide use composed the case series. The most frequently reported cardiac adverse events were syncope (n = 24), cardiac arrest (n = 13), QT-interval prolongation (n = 13), ventricular tachycardia (n = 10), and TdP (n = 7). There were 10 cases that resulted in death. Of the 48 cases, the most commonly reported reasons for use can be characterized as drug abuse (n = 22) and diarrhea treatment (n = 17). More than one-half of the 48 cases were reported after 2010. Of the 22 drug abuse cases, the median daily dose was 250 mg (range 70 mg to 1600 mg) and events occurred as early as 6 hours after a dose and as long as 18 months after initiation of loperamide. Thirteen of the 22 cases reported using loperamide for euphoric or analgesic effects, and 9 reported use to prevent opioid withdrawal symptoms. The FAERS case reports provide evidence to suggest that high doses of loperamide are associated with TdP and other serious cardiac adverse events. The majority of cases in this series occurred in the setting of drug abuse for the purpose of preventing opioid withdrawal or to produce euphoric effects. It is important for both clinicians and patients to be aware of this potential risk, because prompt therapy and discontinuation of the offending agent are often essential to

  20. Adverse event following immunization (AEFI) surveillance in India, position paper of Indian Academy of Pediatrics,2013.

    Science.gov (United States)

    Chitkara, A J; Thacker, N; Vashishtha, V M; Bansal, C P; Gupta, S G

    2013-08-01

    Adverse event following immunization (AEFI) is a critical component of immunization program. The risk of AEFI with vaccination is always weighed against the risk of not immunizing a child. There is an evolving AEFI surveillance system in India for the vaccines delivered through universal immunization program (UIP) of government sector, but the reporting remained suboptimal for long in the country, and there is almost no participation from private sector. The AEFI reporting from private sector will provide vital information on the safety of new and underutilized vaccines, not part of the UIP in India. The national guidelines are recently revised and updated. The Indian Academy of Pediatrics believes that pediatricians, especially in private sector have a crucial role to play with reporting of AEFI with newer/underutilized vaccines. Programmatic error, vaccine reaction, injection reactions, coincidental and unknown are the five broad categories of AEFI for programmatic purposes. The serious AEFIs (death, disability, cluster and hospitalization) need to be reported immediately and investigated in detail as per the laid down procedures. Once a serious AEFI happens, primary or urban health centre should be immediately informed by the pediatricians practicing in rural or urban areas, respectively. This advocacy paper from the academy provides guidelines to practitioners on how to report cases, and suggests ways for IAP members to help in ongoing efforts of the government in improving AEFI surveillance in the country. The details about the diagnosis and management of known/expected AEFI with UIP and newer vaccines shall be published later.

  1. A Critical Approach to Evaluating Clinical Efficacy, Adverse Events and Drug Interactions of Herbal Remedies.

    Science.gov (United States)

    Izzo, Angelo A; Hoon-Kim, Sung; Radhakrishnan, Rajan; Williamson, Elizabeth M

    2016-05-01

    Systematic reviews and meta-analyses represent the uppermost ladders in the hierarchy of evidence. Systematic reviews/meta-analyses suggest preliminary or satisfactory clinical evidence for agnus castus (Vitex agnus castus) for premenstrual complaints, flaxseed (Linum usitatissimum) for hypertension, feverfew (Tanacetum partenium) for migraine prevention, ginger (Zingiber officinalis) for pregnancy-induced nausea, ginseng (Panax ginseng) for improving fasting glucose levels as well as phytoestrogens and St John's wort (Hypericum perforatum) for the relief of some symptoms in menopause. However, firm conclusions of efficacy cannot be generally drawn. On the other hand, inconclusive evidence of efficacy or contradictory results have been reported for Aloe vera in the treatment of psoriasis, cranberry (Vaccinium macrocarpon) in cystitis prevention, ginkgo (Ginkgo biloba) for tinnitus and intermittent claudication, echinacea (Echinacea spp.) for the prevention of common cold and pomegranate (Punica granatum) for the prevention/treatment of cardiovascular diseases. A critical evaluation of the clinical data regarding the adverse effects has shown that herbal remedies are generally better tolerated than synthetic medications. Nevertheless, potentially serious adverse events, including herb-drug interactions, have been described. This suggests the need to be vigilant when using herbal remedies, particularly in specific conditions, such as during pregnancy and in the paediatric population. Copyright © 2016 John Wiley & Sons, Ltd.

  2. Withdrawal-related adverse events from clinical trials of clobazam in Lennox-Gastaut syndrome.

    Science.gov (United States)

    Tolbert, Dwain; Harris, Stuart I; Bekersky, Ihor; Lee, Deborah; Isojarvi, Jouko

    2014-08-01

    To assess withdrawal-related adverse event (AE) rates following abrupt clobazam discontinuation in Phase I trials and gradual clobazam tapering (2-3 weeks) following discontinuation from III trials met the criteria for potential/III trials, we evaluated AE data from four multiple-dosage Phase I trials (duration: 8-34 days). Therapeutic (20 and 40 mg/day) and supratherapeutic clobazam dosages (120 and 160 mg/day) were administered. Adverse events (AEs) were also assessed for patients with Lennox-Gastaut syndrome enrolled in Phase II (OV-1002) and Phase III (OV-1012) studies (duration ≤15 weeks) and in the open-label extension (OLE) trial OV-1004 (≤5 years). Potential withdrawal-related AEs were identified by preferred terms, provided that the AEs occurred ≥1 day following and ≤30 days after the last clobazam doses, or were deemed withdrawal symptoms by investigators. Clinical Institute Withdrawal Assessment for Benzodiazepines (CIWA-B) scale was used to evaluate withdrawal intensity in three of the four Phase I trials. A total of 207 participants in Phase I trials received steady-state clobazam dosages of 20-160 mg/day, 182 received clobazam dosages of ≥40 mg/day, and 94 received clobazam dosages of ≥120 mg/day. Abrupt clobazam discontinuation led to 193 withdrawal-related AEs for 68 Phase I participants. Nearly 50% of AEs occurred after discontinuation of clobazam dosages of ≥120 mg/day. Adverse events were mild or moderate and included headache (14% of Phase I participants), insomnia (12.6%), tremor (10.1%), and anxiety (8.7%). The CIWA-B scores varied (range: 0-59). Most scores were clobazam dosages of ≤40 mg/day, and those in the OLE trial received clobazam dosages of ≤80 mg/day. Eighty-seven patients discontinued clobazam and were gradually tapered. No withdrawal-related AEs or incidences of status epilepticus were reported. Withdrawal-related AEs observed in Phase I studies following abrupt clobazam discontinuation at therapeutic and

  3. Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

    NARCIS (Netherlands)

    van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

    2003-01-01

    The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the

  4. Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

    NARCIS (Netherlands)

    van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

    2003-01-01

    The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the worl

  5. Risk factors associated with the occurrence of adverse events in plateletpheresis donation

    Directory of Open Access Journals (Sweden)

    Maria Helena Barbosa

    2014-06-01

    Full Text Available OBJECTIVE: To recognize the profile of platelet donors and the profile of the plateletpheresis session as well as to investigate the main adverse events of platelet donation using plateletpheresis and associated risk factors.METHODS: This retrospective, cross-sectional and analytical study was performed with a quantitative approach by analyzing 316 donation files from February 2010 to December 2011. The IBM SPSS Statistics program was used for data processing and analysis. The chi-square test was used to verify whether there was an association between factors related to the procedure and the donor, and the adverse events that occurred.RESULTS: The mean age of platelet donors was 40 years old (standard deviation = 8.9, with the prevalent age group being between 40 and 49 years old; the prevalent blood type was O positive (53.8%, the mean duration of the procedure was 73 min and the mean amount of anticoagulant used was 360 mL. The association between procedure duration and the volume of anticoagulant was inverse and statistically significant; the longer the procedure and the greater the volume of anticoagulant used, the less adverse reactions occurred.CONCLUSION: The low incidence of adverse events indicates that the procedure is well tolerated by donors. Obtaining data regarding the incidence of adverse events is a way of promoting a dynamic review of medical and nursing teams to improve the safety and comfort of the donor.

  6. Neurological adverse events associated with immune checkpoint inhibitors: Review of the literature.

    Science.gov (United States)

    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. Comparative treatment-related adverse event cost burden in immune thrombocytopenic purpura.

    Science.gov (United States)

    Donga, Prina Z; Bilir, Sara P; Little, Gregg; Babinchak, Tim; Munakata, Julie

    2017-09-08

    Real-world evidence on the safety profile and costs associated with immune thrombocytopenic purpura (ITP) treatment in adults is lacking. This study quantifies and compares adverse event (AE) crude rates and costs associated with ITP treatments as found in claims data. A retrospective claims-based analysis was conducted using IMS Pharmetrics Plus database. Included patients were ≥18 years old, with a diagnosis of ITP (2007-2012); an ITP-related claim for anti-D, intravenous immunoglobulin (IVIG), rituximab, romiplostim, or eltrombopag; and 1-year continuous enrollment (3-years for rituximab) during follow-up. AEs and event costs were identified during active treatment, defined from the first claim of each drug to a pre-defined treatment gap or end of study period. Descriptive statistics were reported with Wilcoxon rank-sum significance tests. A total of 2,518 patients were identified (mean age = 50.8 (±16.3 years); 55.8% male). Of all patients, 22.8% experienced any AE. Significantly fewer anti-D patients had any AE (13.8% vs IVIG: 21.1%, rituximab: 29.4%, romiplostim: 28.1%, eltrombopag: 22.4%). Nausea/vomiting and arthralgia/musculoskeletal pain were most common across treatments, and hemolytic events did not differ significantly across treatments. Most costly AEs were urinary tract infection, aseptic meningitis, and fever ($5000+/case); headache, nasal congestion, and hemolytic event were $4,000-5,000/case. Cost per AE did not differ by treatment. Although lower than trial-based AE rates, claims for ITP treatment-related AEs are common, with higher numbers for rituximab and lower numbers for anti-D. This disparity suggests a possible differential cost burden overall that future analysis should explore.

  8. Pediatric Use of Insulin Pump Technology: A Retrospective Study of Adverse Events in Children Ages 1–12 Years

    Science.gov (United States)

    Cope, Judith U.; Samuels-Reid, Joy H.; Morrison, Audrey E.

    2012-01-01

    Background Growing technological improvements in insulin pump design have increased the use of these devices in young children. To better understand the types of infusion pump-related problems and associated adverse events in this age group, we performed a comprehensive evaluation of pump-related adverse event reports received by the U.S. Food and Drug Administration (FDA) for children ages 1–12 years. Methods A query was conducted of FDA‘s Manufacturer and User Facility Device Experience database from January 1, 1996, through December 31, 2009, in children ages 1–12 years involving insulin pumps. Report narratives were individually reviewed for age, gender, and seriousness of outcomes. Device or patient problems and potential contributory factors were assessed. Results Over the past 14 years, 1774 (7%) of all insulin pump adverse event reports were identified in children ages 1–12. Of these reports, 777 (43%) resulted in hospitalization. In hospitalized cases (n = 614), diabetic ketoacidosis and/or hyperglycemia were the predominant patient problems, and in other cases (n = 98), hypoglycemia was evident. There were 106 emergency room visits, 19 cases requiring paramedic attention, and five deaths. The majority of reports indicated that the devices were not returned to the manufacturer, and root causes were not always confirmed. Conclusions Younger children with diabetes deserve careful consideration of the risk and benefit of insulin pump technology. Studies are needed to better understand pediatric safety issues and to identify the root cause of adverse events. Problems related to patient education, device misuse, and malfunctions were found, highlighting the need to strengthen user training for children and their caregivers. PMID:23063031

  9. Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years.

    Science.gov (United States)

    Cope, Judith U; Samuels-Reid, Joy H; Morrison, Audrey E

    2012-09-01

    Growing technological improvements in insulin pump design have increased the use of these devices in young children. To better understand the types of infusion pump-related problems and associated adverse events in this age group, we performed a comprehensive evaluation of pump-related adverse event reports received by the U.S. Food and Drug Administration (FDA) for children ages 1-12 years. A query was conducted of FDA's Manufacturer and User Facility Device Experience database from January 1, 1996, through December 31, 2009, in children ages 1-12 years involving insulin pumps. Report narratives were individually reviewed for age, gender, and seriousness of outcomes. Device or patient problems and potential contributory factors were assessed. Over the past 14 years, 1774 (7%) of all insulin pump adverse event reports were identified in children ages 1-12. Of these reports, 777 (43%) resulted in hospitalization. In hospitalized cases (n = 614), diabetic ketoacidosis and/or hyperglycemia were the predominant patient problems, and in other cases (n = 98), hypoglycemia was evident. There were 106 emergency room visits, 19 cases requiring paramedic attention, and five deaths. The majority of reports indicated that the devices were not returned to the manufacturer, and root causes were not always confirmed. Younger children with diabetes deserve careful consideration of the risk and benefit of insulin pump technology. Studies are needed to better understand pediatric safety issues and to identify the root cause of adverse events. Problems related to patient education, device misuse, and malfunctions were found, highlighting the need to strengthen user training for children and their caregivers. © 2012 Diabetes Technology Society.

  10. 护理不良事件管理体系的构建和成效%The construction and effects of nursing adverse events management system

    Institute of Scientific and Technical Information of China (English)

    肖雪莲; 谌永毅; 卿利敏

    2015-01-01

    Objective To construct a standard nursing adverse events management system in order to improve the management level and ensure patient safety. Methods A nursing adverse events management system which is in accordance with JCI standards was constructed. The measures included setting up a nursing adverse events man-agement committee and quality control team,improving adverse events reporting system and providing adverse events training for all medical staff. Results The reporting rate of nursing adverse events increased from 6.02% to 10.68%. After the implementation of adverse events management system,the knowledge score of adverse events and adverse events check practice among medical staff were significantly improved than before(P<0.01). Conclusion The construction of nursing adverse events management system can effectively increase the reporting rate of adverse events,improve medical staff's adverse events related knowledge and practice,and contribute to patient safety and high-quality nursing care.%目的:构建一套标准的不良事件管理体系,以提升医院管理水平,保障患者安全。方法成立护理不良事件管理委员会和质量管理小组,完善护理不良事件报告系统,开展全员医护人员不良事件培训,形成一套符合JCI评审标准的不良事件管理体系。结果护理不良事件上报从2014年1月份的80例(6.02%)上升到2014年12月份的142例(10.68%)。不良事件管理系统实施后,医护人员不良事件知识理论知识得分及不良事件督查得分均较实施前提高(P<0.01)。结论护理不良事件管理体系的构建有利于促进医护人员上报不良事件,提高医护人员不良事件管理理论知识水平和督查得分,对维护患者安全和提高护理质量有促进作用,值得进一步推广和应用。

  11. Non-healing tongue ulcer in a rheumatoid arthritis patient medicated with leflunomide. An adverse drug event?

    OpenAIRE

    Eleni-Marina KALOGIROU; Katsoulas, Nikolaos; Tosios, Konstantinos I.; Lazaris, Andreas C; Alexandra SKLAVOUNOU

    2017-01-01

    Leflunomide is a member of the disease modifying anti-rheumatic drugs group used as a treatment modality in active rheumatoid and psoriatic arthritis. “Oral ulcers” are reported in 3-5% of leflunomide medicated rheumatoid arthritis patients with adverse events, but they are not described in detail in the literature. We present a case of an ulcer in the tongue of a rheumatoid arthritis patient managed with leflunomide and contemplate on its pathogenesis. Key words:Leflunomide, oral ulcer, DHOD...

  12. Non-healing tongue ulcer in a rheumatoid arthritis patient medicated with leflunomide. An adverse drug event?

    Science.gov (United States)

    Kalogirou, Eleni-Marina; Katsoulas, Nikolaos; Tosios, Konstantinos I; Lazaris, Andreas C; Sklavounou, Alexandra

    2017-02-01

    Leflunomide is a member of the disease modifying anti-rheumatic drugs group used as a treatment modality in active rheumatoid and psoriatic arthritis. "Oral ulcers" are reported in 3-5% of leflunomide medicated rheumatoid arthritis patients with adverse events, but they are not described in detail in the literature. We present a case of an ulcer in the tongue of a rheumatoid arthritis patient managed with leflunomide and contemplate on its pathogenesis. Key words:Leflunomide, oral ulcer, DHODH.

  13. Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists

    Science.gov (United States)

    Brady, Sarah; McEvoy, Johnson; Dommerholt, Jan; Doody, Catherine

    2014-01-01

    Objectives: Trigger point dry needling (TrP-DN) is commonly used to treat persons with myofascial pain, but no studies currently exist investigating its safety. The aim of this study was to determine the incidence of Adverse Events (AEs) associated with the use of TrP-DN by a sample of physiotherapists in Ireland. Methods: A prospective survey was undertaken consisting of two forms recording mild and significant AEs. Physiotherapists who had completed TrP-DN training with the David G Simons Academy (DGSA) were eligible to take part in the study. Data were collected over a ten-month period. Results: In the study, 39 physiotherapists participated and 1463 (19.18%) mild AEs were reported in 7629 treatments with TrP-DN. No significant AEs were reported giving an estimated upper risk rate for significant AEs of less than or equal to (≤) 0.04%. Common AEs included bruising (7.55%), bleeding (4.65%), pain during treatment (3.01%), and pain after treatment (2.19%). Uncommon AEs were aggravation of symptoms (0.88%), drowsiness (0.26%), headache (0.14%), and nausea (0.13%). Rare AEs were fatigue (0.04%), altered emotions (0.04%), shaking, itching, claustrophobia, and numbness, all 0.01%. Discussion: While mild AEs were very commonly reported in this study of TrP-DN, no significant AEs occurred. For the physiotherapists surveyed, TrP-DN appeared to be a safe treatment. PMID:25125935

  14. Adverse events from spinal manipulation in the pregnant and postpartum periods: a critical review of the literature

    Directory of Open Access Journals (Sweden)

    Stuber Kent

    2012-03-01

    Full Text Available Abstract 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.

  15. Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

    Directory of Open Access Journals (Sweden)

    Keith B. Hoffman

    2013-07-01

    Full Text Available Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs across best-selling drug classes [sometimes many years after winning Food and Drug Administration (FDA approval] underscores the limitations of current clinical trial processes and reinforces the need for careful post-approval pharmacovigilance. The FDA’s sizeable repository of patient case reports linking AEs to approved drugs is the Adverse Event Reporting System (FAERS. We believe that open and user-friendly access to the millions of case reports in FAERS would help advance the field of post-marketing pharmacovigilance. However, FAERS data are virtually inaccessible to most physicians, pharmacists, and consumers. Accordingly, we have recently launched a big data platform (www.AdverseEvents.com that, unlike previous efforts, provides on-demand, user-friendly, and high-impact access to FAERS data. Bringing the power of big data to regular users, such as clinicians, pharmacists, and patients, is the logical next step in the transformation of health care to a model of shared decision making between consumers and the system.

  16. Diversity and intensity of adverse events in the treatment of hypertension with barnidipine.

    Science.gov (United States)

    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.

  17. Epidermal Growth Factor Receptor Inhibitors: A Review of Cutaneous Adverse Events and Management

    Directory of Open Access Journals (Sweden)

    K. Chanprapaph

    2014-01-01

    Full Text Available Epidermal growth factor inhibitors (EGFRI, the first targeted cancer therapy, are currently an essential treatment for many advance-stage epithelial cancers. These agents have the superior ability to target cancers cells and better safety profile compared to conventional chemotherapies. However, cutaneous adverse events are common due to the interference of epidermal growth factor receptor (EGFR signaling in the skin. Cutaneous toxicities lead to poor compliance, drug cessation, and psychosocial discomfort. This paper summarizes the current knowledge concerning the presentation and management of skin toxicity from EGFRI. The common dermatologic adverse events are papulopustules and xerosis. Less common findings are paronychia, regulatory abnormalities of hair growth, maculopapular rash, mucositis, and postinflammatory hyperpigmentation. Radiation enhances EGFRI rash due to synergistic toxicity. There is a positive correlation between the occurrence and severity of cutaneous adverse effects and tumor response. To date, prophylactic systemic tetracycline and tetracycline class antibiotics have proven to be the most effective treatment regime.

  18. The Relationship between Adverse Childhood Events, Resiliency and Health among Children with Autism

    Science.gov (United States)

    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.…

  19. Clinical rules in hospital pharmacy practice to prevent adverse drug events

    NARCIS (Netherlands)

    Rommers, Mirjam Kristien

    2014-01-01

    Adverse drug events (ADEs) refer to any injury from the use of a drug. ADEs occur frequently in hospitalized patients and a substantial proportion are considered preventable. A method to prevent ADEs is computerized physician order entry (CPOE) combined with a clinical decision support system

  20. Population-based assessment of adverse events associated with long-term glucocorticoid use

    NARCIS (Netherlands)

    Curtis, [No Value; Westfall, AO; Allison, J; Bijlsma, JW; Freeman, A; George, [No Value; Kovac, SH; Spettell, CM; Saag, KG

    2006-01-01

    The frequency of many adverse events (AEs) associated with low-dose glucocorticoid use is unclear. We sought to determine the prevalence of glucocorticoid-associated AEs in a large US managed care population., Methods. Using linked administrative and pharmacy claims, adults receiving >= 60 days of g

  1. Variation in rates of adverse events between hospitals and hospital departments

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Spreeuwenberg, P.; Wagner, C.; van der Wal, G.; Groenewegen, P.P.

    2011-01-01

    Objective. The objective of this study was to analyze the variation in the rates of adverse events (AEs), and preventable AEs, between hospitals and hospital departments in order to investigate the room for improvement in reducing AEs at both levels. In addition, we explored the extent to which

  2. Variation in the rates of adverse events between hospitals and hospital departments.

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Spreeuwenberg, P.; Wagner, C.; Wal, G. van der; Groenewegen, P.P.

    2011-01-01

    Objective: The objective of this study was to analyze the variation in the rates of adverse events (AEs), and preventable AEs, between hospitals and hospital departments in order to investigate the room for improvement in reducing AEs at both levels. In addition, we explored the extent to which

  3. Adverse Events Associated with Methimazole Therapy of Graves' Disease in Children

    Directory of Open Access Journals (Sweden)

    Kerry Stephenson

    2010-01-01

    Full Text Available Objective. Graves' disease is the most common cause of hyperthyroidism in the pediatric population. Antithyroid medications used in children and adults include propylthiouracil (PTU and methimazole (MMI. At our center we have routinely used MMI for Graves' disease therapy. Our goals are to provide insights into adverse events that can be associated with MMI use. Methods. We reviewed the adverse events associated with MMI use in our last one hundred consecutive pediatric patients treated with this medication. Results. The range in the patient age was 3.5 to 18 years. The patients were treated with an average daily dose of MMI of 0.3±0.2 mg/kg/day. Adverse events attributed to the use of the medication were seen in 19 patients at 17±7 weeks of therapy. The most common side effects included pruritus and hives, which were seen in 8 patients. Three patients developed diffuse arthralgia and joint pain. Two patients developed neutropenia. Three patients developed Stevens-Johnson syndrome, requiring hospitalization in 1 child. Cholestatic jaundice was observed in 1 patient. No specific risk-factors for the development of adverse events were identified. Conclusions. MMI use in children is associated with a low but real risk of minor and major side effects.

  4. Vandetanib in advanced medullary thyroid cancer: review of adverse event management strategies

    DEFF Research Database (Denmark)

    Grande, Enrique; Kreissl, Michael C; Filetti, Sebastiano

    2013-01-01

    Vandetanib has recently demonstrated clinically meaningful benefits in patients with unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). Given the potential for long-term vandetanib therapy in this setting, in addition to treatment for disease-related symptoms, effective ...... management of related adverse events (AEs) is vital to ensure patient compliance and maximize clinical benefit with vandetanib therapy....

  5. Risk factors for adverse events after vaccinations performed during the initial hospitalization of infants born prematurely.

    Science.gov (United States)

    Wilińska, Maria; Warakomska, Małgorzata; Głuszczak-Idziakowska, Ewa; Jackowska, Teresa

    There are significant delays in implementing vaccination among preterm infants. Description of the frequency and kinds of adverse events following immunization in preterms. Establishment of the group of preterms who will distinctively be susceptible to adverse events. Demographical, clinical data and the occurrence of adverse events after DTaP, HIB and pneumococcal vaccination among preterms during their initial hospitalization were prospectively collected with the use of an electronic data form between 1st June 2011 and 31st May 2015. The analysis was conducted on 138 patients. The groups were divided according to maturity (I: ≤ GA 28w n=73 and GA 29-36 w n=65). There were no statistically significant differences between the groups in the occurrence of adverse events. Out of the total group, following vaccination apnoea developed in 6 newborns (4%) and activity dysfunctions were observed in 13 newborns (10%). The occurrence of apnoea after vaccination positively correlated with the time of non-invasive ventilation and the occurrence of late infection. There were no statistically significant demographical or clinical risk factors for the development of activity dysfunctions following vaccination. Term vaccination in clinically stable preterm infants is a safe medical procedure. However, long-term non-invasive respiratory support and late infections are risk factors for apnea following vaccinations. In these patients vaccinations should be considered during hospitalization.

  6. [Consensus conference on providing information of adverse events to patients and relatives].

    Science.gov (United States)

    Martín-Delgado, M C; Fernández-Maillo, M; Bañeres-Amella, J; Campillo-Artero, C; Cabré-Pericas, L; Anglés-Coll, R; Gutiérrez-Fernández, R; Aranaz-Andrés, J M; Pardo-Hernández, A; Wu, A

    2013-01-01

    To develop recommendations regarding «Information about adverse events to patients and their families», through the implementation of a consensus conference. A literature review was conducted to identify all relevant articles, the major policies and international guidelines, and the specific legislation developed in some countries on this process. The literature review was the basis for responding to a series of questions posed in a public session. A group of experts presented the best available evidence, interacting with stakeholders. At the end of the session, an interdisciplinary and multi-professional jury established the final recommendations of the consensus conference. The main recommendations advocate the need to develop policies and institutional guidelines in our field, favouring the patient adverse events disclosure process. The recommendations emphasize the need for the training of professionals in communication skills and patient safety, as well as the development of strategies for supporting professionals who are involved in an adverse event. The assessment of the interest and impact of specific legislation that would help the implementation of these policies was also considered. A cultural change is needed at all levels, nuanced and adapted to the specific social and cultural aspects of our social and health spheres, and involves all stakeholders in the system to create a framework of trust and credibility in which the processing of information about adverse events may become effective. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

  7. Developing a Veterans Health Administration (VHA) Serious Injury Surveillance System that Includes Adverse Event Hospitalizations

    Science.gov (United States)

    2005-05-01

    types fractures ; sprains; wounds; complications due to procedures or use of medical devices; and medication and other poisoning-related discharges...total discharges coded with an inpatient death over the 5-year period were associated with intracranial injuries (10.6 percent), hip fractures (6...with medication adverse events were associated with psychotropic drugs. Poisonings due to benzodiazepine tranquilizers consistently ranked as the

  8. Clinical roundtable monograph. New alternatives in CLL therapy: managing adverse events.

    Science.gov (United States)

    Chanan-Khan, Asher; Kipps, Thomas; Stilgenbauer, Stephan

    2010-08-01

    Chronic lymphocytic leukemia (CLL) is a B-cell leukemia mainly affecting older adults. Historically, CLL has been regarded as an incurable disease, and treatment has been confined to cytotoxic chemotherapy regimens. However, prognosis for patients treated with these agents remained poor, prompting the development of new, targeted agents. The introduction of rituximab, a CD20-targeted monoclonal antibody, revolutionized the treatment for this disease. Rituximab in combination with fludarabine improved response rates and length of progression-free survival. The success of rituximab in this setting has prompted the development of many more investigational agents for CLL, including other antibody agents. However, as with any medication, the potential benefit achieved with CLL therapies is mitigated by the safety risk for the patient. These agents have been associated with adverse events such as immunosuppression, reactivation of cytomegalovirus, and infusion-related reactions that can occur with antibody administration. Adverse events can greatly affect the patient’s quality of life and ability to tolerate therapy. Management of adverse events is a critical component of the overall treatment strategy for CLL, particularly in elderly patients. In this clinical roundtable monograph, 3 expert physicians discuss the latest clinical studies evaluating the treatment of CLL, focusing on the adverse events associated with each agent and the potential interventions that can be used to manage their occurrence.

  9. Reliability of the assessment of preventable adverse drug events in daily clinical practice

    NARCIS (Netherlands)

    van Doormaal, J.E.; Mol, P.G.; van den Bemt, P.M.; Egberts, A.C.; Kosterink, J.G.; Haaijer-Ruskamp, F.M.; Zaal, Rianne J.

    2008-01-01

    Purpose To determine the reliability of the assessment of preventable adverse drug events (ADES) in daily practice and to explore the impact of the assessors' professional background and the case characteristics on reliability. Methods We used a combination of the simplified Yale algorithm and the N

  10. Adverse events during pediatric dental anesthesia and sedation: a review of closed malpractice insurance claims.

    Science.gov (United States)

    Chicka, Maggie C; Dembo, Jeffrey B; Mathu-Muju, Kavita R; Nash, David A; Bush, Heather M

    2012-01-01

    The purpose of this study of closed malpractice insurance claims was to provide descriptive data of adverse events related to child sedation and anesthesia in the dental office. The malpractice claims databases of two professional liability carriers were searched using pre-determined keywords for all closed claims involving anesthesia in pediatric dental patients from 1993-2007. The database searches resulted in 17 claims dealing with adverse anesthesia events of which 13 involved sedation, 3 involved local anesthesia alone, and 1 involved general anesthesia. Fifty-three percent of the claims involved patient death or permanent brain damage; in these claims, the average patient age was 3.6 years, 6 involved general dentists as the anesthesia provider, and 2 involved local anesthesia alone. Local anesthetic overdoses were observed in 41% of the claims. The location of adverse event occurrence was in the dental office where care was being provided in 71% of the claims. Of the 13 claims involving sedation, only 1 claim involved the use of physiologic monitoring. Very young patients (≤ 3-years-old) are at greatest risk during administration of sedative and/or local anesthetic agents. Some practitioners are inadequately monitoring patients during sedation procedures. Adverse events have a high chance of occurring at the dental office where care is being provided.

  11. The Relationship between Adverse Childhood Events, Resiliency and Health among Children with Autism

    Science.gov (United States)

    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.…

  12. Excess length of stay and economic consequences of adverse events in Dutch hospital patients.

    NARCIS (Netherlands)

    Hoogervorst-Schilp, J.; Langelaan, M.; Spreeuwenberg, P.; Bruijne, M.C. de; Wagner, C.

    2015-01-01

    Background: To investigate the average and extrapolated excess length of stay and direct costs of adverse events (AEs) and preventable AEs in Dutch hospitals, and to evaluate patient characteristics associated with excess length of stay and costs. Methods: Data of a large retrospective patient recor

  13. Adverse events following vaccination against human papillomavirus : Results of the 2010 campaign in the Netherlands

    NARCIS (Netherlands)

    van ' t Klooster TM; Kemmeren JM; Vermeer-de Bondt PE; Oostvogels B; Phaff T; de Melker HE; van der Maas NAT; EPI; cib

    2011-01-01

    In 2010 werden er minder bijwerkingen gemeld na vaccinatie tegen HPV dan in 2009. Ook zijn er in 2010, net als in 2009, geen onverwachte of volgens de criteria ernstige bijwerkingen (Serious Adverse Events) gemeld die door het vaccin zijn veroorzaakt.

    In 2010 zijn meisjes die geb

  14. Clinical rules in hospital pharmacy practice to prevent adverse drug events

    NARCIS (Netherlands)

    Rommers, Mirjam Kristien

    2014-01-01

    Adverse drug events (ADEs) refer to any injury from the use of a drug. ADEs occur frequently in hospitalized patients and a substantial proportion are considered preventable. A method to prevent ADEs is computerized physician order entry (CPOE) combined with a clinical decision support system (CDSS)

  15. Perceived Adverse Drug Events in Heart Failure Patients' Perception and Related Factors

    NARCIS (Netherlands)

    De Smedt, Ruth H. E.; Haaijer-Ruskamp, Flora M.; Groenier, Klaas H.; van der Meer, Klaas; Jaarsma, Tiny

    2011-01-01

    Background: Patients with heart failure (HF) often perceive adverse drug events (ADEs), affecting quality of life. For weighing the benefits and burden of medication in HF care, knowledge on patients' perception of ADEs is needed. Our aim was to assess these ADE perceptions and to identify factors r

  16. Targeted therapies for renal cell carcinoma: review of adverse event management strategies.

    NARCIS (Netherlands)

    Eisen, T.; Sternberg, C.N.; Robert, C.; Mulders, P.F.; Pyle, L.; Zbinden, S.; Izzedine, H.; Escudier, B.

    2012-01-01

    With the advent of targeted agents for the treatment of renal cell carcinoma (RCC), overall survival has improved, and patients are being treated continuously for increasingly long periods of time. This has raised challenges in the management of adverse events (AEs) associated with the six targeted

  17. An adverse event of suprapubic catheter SPC insertion. A call for updating the existing guidelines.

    Science.gov (United States)

    Jalil, Rozh; Mukundan, Chandrika; Bhatti, Tahir S

    2012-11-15

    The suprapubic catheter (SPC) is a useful and widely used tool in urological practice. However, complications can arise from its insertion or ongoing care. We add to the literature a case of an adverse event of its insertion where it has gone through a vascular graft and recommending updating the SPC insertion guidelines.

  18. Incremental Hospital Cost and Length-of-Stay Associated With Treating Adverse Events Among Medicare Beneficiaries Undergoing Lumbar Spinal Fusion During Fiscal Year 2013.

    Science.gov (United States)

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

    2016-10-15

    A retrospective study. To report the incremental hospital resource consumption associated with treating selected adverse events experienced by Medicare beneficiaries undergoing a two- or three-level lumbar spinal fusion. Hospitals are increasingly at financial risk for the incremental resources consumed in treating patients experiencing adverse events because of public and private third-party payers' efforts to base hospital reimbursement on "pay for performance" measures. However, little is known about average incremental resources consumed in treating patients experiencing adverse events following lumbar spinal fusions. The 2013 fiscal year Medicare Provider Analysis and Review file was used to identify 83,658 Medicare beneficiaries who underwent two- or three vertebrae-level lumbar spinal fusion. International Classification of Diseases-9th-Clinical Modification diagnostic and procedure codes were used to identify the frequencies of nine adverse events. This study estimated both the observed and risk-adjusted incremental hospital resources consumed (cost and length of stay [LOS]) in treating Medicare beneficiaries experiencing each adverse event. Overall, 17.7% of Medicare beneficiaries undergoing lumbar spinal fusion experienced at least one of the study's adverse events. Medicare beneficiaries experiencing any complication consumed significantly more hospital resources (incremental cost of $8911) and had longer LOS (incremental stays of 5.7 days). After adjusting for patient demographics and comorbid conditions, incremental cost of treating adverse events ranged from a high of $32,049 (infection) to a low of $9976 (transfusion). Adverse events frequently occur and add substantially to the hospital resource costs of patients undergoing spinal fusion. Shared decision-making instruments should clearly provide these risk estimates to the patient before surgical consideration. Investment in activities that have been shown to reduce specific adverse events is

  19. The Incremental Hospital Cost and Length-of-Stay Associated with Treating Adverse Events Among Medicare Beneficiaries Undergoing Cervical Spinal Fusion during Fiscal Year 2013 and 2014.

    Science.gov (United States)

    Culler, Steven D; McGuire, Kevin J; Little, Kenneth M; Jevsevar, David; Shea, Kevin; Schlosser, Michael; Ambrose, Karen E; Simon, April W

    2017-06-06

    A retrospective study. To report the incremental hospital resources consumed with treating adverse events experienced by Medicare beneficiaries undergoing a two or three vertebrae level cervical spinal fusion. Hospitals are increasingly at financial risk for patients experiencing adverse events due "pay for performance". Little is known about incremental resources consumed when treating patients who experienced an adverse event following cervical spinal fusions. Fiscal years 2013 and 2014 Medicare Provider Analysis and Review file was used to identify 86,265 beneficiaries who underwent 2 or 3 vertebrae level cervical spinal fusion. International Classification of Diseases-9-Clinical Modification diagnostic and procedure codes were used to identify ten adverse events. This study estimated both the observed and risk-adjusted incremental hospital resources consumed (cost (2014 US $) and length-of-stay [LOS]) in treating beneficiaries experiencing each adverse event. Overall, 6.2% of beneficiaries undergoing cervical spinal fusion experienced at least one of the study's adverse events. Beneficiaries experiencing any complication consumed significantly more hospital resources (incremental cost of $28,638) and had longer LOS (incremental stays of 9.1 days). After adjusting for patient demographics and comorbid conditions, incremental cost of treating adverse events ranged from a high of $42,358 (infection) to a low of $10,100 (dural tear). Adverse events frequently occur and add substantially to the hospital costs of patients undergoing cervical spinal fusion. Shared decision-making instruments should clearly provide these risk estimates to the patient prior to surgical consideration. Investment in activities that have been shown to reduce specific adverse events is warranted, and this study may allow health systems to prioritize performance improvement areas. 3.

  20. Are the true impacts of adverse events considered in economic models of antineoplastic drugs? A systematic review.

    Science.gov (United States)

    Pearce, Alison; Haas, Marion; Viney, Rosalie

    2013-12-01

    Antineoplastic drugs for cancer are often associated with adverse events, which influence patients' physical health, quality of life and survival. However, the modelling of adverse events in cost-effectiveness analyses of antineoplastic drugs has not been examined. This article reviews published economic evaluations that include a calculated cost for adverse events of antineoplastic drugs. The aim is to identify how existing models manage four issues specific to antineoplastic drug adverse events: the selection of adverse events for inclusion in models, the influence of dose modifications on drug quantity and survival outcomes, the influence of adverse events on quality of life and the consideration of multiple simultaneous or recurring adverse events. A systematic literature search was conducted using MESH headings and key words in multiple electronic databases, covering the years 1999-2009. Inclusion criteria for eligibility were papers covering a population of adults with solid tumour cancers, the inclusion of at least one adverse event and the resource use and/or costs of adverse event treatment. From 4,985 citations, 26 eligible articles were identified. Studies were generally of moderate quality and addressed a range of cancers and treatment types. While the four issues specific to antineoplastic drug adverse events were addressed by some studies, no study addressed all of the issues in the same model. This review indicates that current modelling assumptions may restrict our understanding of the true impact of adverse events on cost effectiveness of antineoplastic drugs. This understanding could be improved through consideration of the selection of adverse events, dose modifications, multiple events and quality of life in cost-effectiveness studies.

  1. Biological treatment in rheumatic diseases: results from a longitudinal surveillance: adverse events.

    Science.gov (United States)

    Konttinen, L; Honkanen, V; Uotila, T; Pöllänen, J; Waahtera, M; Romu, M; Puolakka, K; Vasala, M; Karjalainen, A; Luukkainen, R; Nordström, D C

    2006-08-01

    The objective of this study was to assess the long-term safety and tolerability of biologicals in a clinical setting. Data on adverse events (AEs) have been collected over a 5-year period by means of detailed reports sent in to the National Register of Biological Treatment in Finland (ROB-FIN) and validated by information collected by the National Agency for Medicines. Three hundred and eight reports on AEs were filed, concerning a total of 248 patients; this corresponds to 17% of all patients in the ROB-FIN register who started biological treatments. Skin reactions and infections comprised 35 and 28% of the AEs, respectively. Some cases of tuberculosis and other infections, heart failure and demyelinating conditions were seen. Our work demonstrates no unexpected AEs in a Finnish patient cohort consisting of rheumatoid arthritis and spondylarthropathy patients, although many of them were treated with combination treatments in common use in Finland. Biological treatment appears safe in the hands of the Finnish rheumatologists.

  2. Adverse drug events and associated factors in heart failure therapy among the very elderly.

    Science.gov (United States)

    Sztramko, Richard; Chau, Vicky; Wong, Roger

    2011-12-01

    Heart failure (HF) is common in older adults and standard therapy involves the use of multiple medications. We assessed the nature, frequency, and factors associated with adverse drug events (ADEs) associated with standard HF therapy among older adults greater than 75 years of age. The efficacy and predictors of ADEs were assessed in this patient population, as well. Systematic review using standardized databases including MEDLINE, Ageline, and CINAHL from January 1st 1988 to January 1st, 2010 and references from published literature. Randomized trials and studies with observational, cohort, and cross-sectional design were included. Two investigators independently selected the studies and extracted the data (kappa = 0.86). Twenty-five studies were identified. ADEs were reported in 13/23 (57%) studies. Syncope, bradycardia, and hypotension as a result of beta blockers occurred in greater frequency compared to younger populations. Spironolactone therapy resulted in increased rates of hyperkalemia, acute renal failure, and medication discontinuation. Factors associated with ADEs included advanced age, poor left ventricular function, and increasing New York Heart Association Class. Efficacy of beta blockers and ACE inhibitors appears to extend to the elderly population, but the magnitude of effect size is unclear. Very few studies reported associations between ADE and patients' comorbidities (4/13 studies, 31%) or functional status (3/13 studies, 23%). ADEs in CHF therapy among the very elderly occurred at a greater frequency, but were generally poorly characterized in the literature despite a relatively common occurrence. Further studies are warranted.

  3. What to do in the event of an adverse anaesthetic event or medical ...

    African Journals Online (AJOL)

    Apologise for the incident by saying: “We ... Debrief someone, i.e. the head of department, or a senior consultant or registrar .... signs of stress in other health providers, and not to be ... always easy to do, but it is essential that the critical event is.

  4. Serious adverse events in a hospital using early warning score - what went wrong?

    DEFF Research Database (Denmark)

    Petersen, John Asger; Mackel, Rebecca; Antonsen, Kristian

    2014-01-01

    AIM: To evaluate the performance of a new early warning score (EWS) system by reviewing all serious adverse events in our hospital over a 6-month time period. METHOD: All incidents of unexpected death (UD), cardiac arrest (CA) and unanticipated intensive care unit admission(UICU) of adult patients...... of EWS were recorded in 87, 94 and 75% of UICU, CA and UD. Patients were monitored according to the escalation protocol in 13, 31 and 13% of UICU, CA and UD. Nurses escalated care and contacted physicians in 64% and 60% of events of UICU and the corresponding proportions for CO were 58% and 55%. On call...... physicians provided adequate care in 49% of cases of UICU and 29% of cases of the CO. Senior staff was involved according to protocol in 53% and 36% of cases of UICU and CO, respectively. CONCLUSION: Poor compliance with the escalation protocol was commonly found when serious adverse events occurred...

  5. Patient knowledge on reporting adverse drug reactions in Poland

    Science.gov (United States)

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

    2017-01-01

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

  6. Serum interleukin-10 levels and adverse events in patients with acute coronary syndrome: a systematic review and meta-analysis

    Institute of Scientific and Technical Information of China (English)

    Liu Jun; Jia Yanjun; Li Xiaolin; Xu Ruixia; Zhu Chenggang; Guo Yuanlin; Wu Naqiong

    2014-01-01

    Background Several studies investigating the prognostic utility of interleukin-10 (IL-10) in patients with acute coronary syndrome (ACS) have provided conflicting findings.The aim of the study was to assess the existing evidence regarding association between serum IL-10 levels and adverse events.Methods Literature search was performed in PubMed,EMBASE,and Cochrane Trials Register databases from their inception to September 30,2012.In addition,reference lists of the included articles and their related citations in PubMed were also reviewed for additional pertinent studies.Results A total of 12 eligible studies comprising a total of 5882 patients were identified.The pooled relative risks for both studies reporting the risk estimates by IL-10 categories and studies reporting the risk estimates by unit IL-10 indicated an association between high IL-10 levels and adverse events.Sensitivity and subgroup analysis indicated that the results obtained in IL-10 categories were not stable.Conclusions Data from our meta-analysis supported the existence of a relationship between high serum IL-10 levels and adverse events in patients with ACS.Large study with longer follow-up is needed to confirm the findings.

  7. HOSPITALIZATIONS DUE TO ADVERSE DRUG EVENTS IN THE ELDERLY – A RETROSPECTIVE REGISTER STUDY

    Directory of Open Access Journals (Sweden)

    Outi Laatikainen

    2016-10-01

    Full Text Available 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.

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

    Science.gov (United States)

    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

  9. Association of atherosclerotic renal artery stenosis with major adverse cardiovascular events after acute myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    Zheng Bin; Liu Jinghua; Ma Qin; Zhao Donghui; Wang Xin; Zheng Ze

    2014-01-01

    Background Patients with atherosclerotic renal artery stenosis (ARAS) are in substantial risk of cardiovascular adverse events.We investigated whether myocardial infarction patients with ARAS are in additional risk of cardiovascular events.Methods In this retrospective study,257 patients with type 1 myocardial infarction were enrolled.Median follow-up was 42 months.Composite endpoint events are analyzed by definitions of ARAS as ≥50% or ≥70% diameter stenosis.Results Defining ARAS as ≥70% diameter stenosis,ARAS was a significant predictor for composite endpoint events including death,non-fatal myocardial infarction,ischaemic stroke and intracranial haemorrhage,rehospitalisation for cardiac failure (HR:4.381; 95% Cl:1.770-10.842) by Cox regression analysis,but not for death.Diabetes mellitus was also a significant predictor for composite endpoint events (HR:2.756; 95% Cl:1.295-5.863).However,defining ARAS ≥50% diameter stenosis,ARAS was no longer a significant predictor for composite endpoint events or death.Conclusions Although not associated with mortality,ARAS ≥70% is associated with major adverse cardiac events after acute myocardial infarction.For prognosis,≥70% diameter stenosis is a more appropriate criteria for ARAS definition than ≥50% diameter stenosis.

  10. Adverse event management in mass drug administration for neglected tropical diseases.

    Science.gov (United States)

    Caplan, Arthur; Zink, Amanda

    2014-03-01

    The ethical challenges of reporting and managing adverse events (AEs) and serious AEs (SAEs) in the context of mass drug administration (MDA) for the treatment of neglected tropical diseases (NTDs) require reassessment of domestic and international policies on a global scale. Although the World Health Organization has set forth AE/SAE guidelines specifically for NTD MDA that incorporate suspected causality, and recommends that only SAEs get reported in this setting, most regulatory agencies continue to require the reporting of all SAEs exhibiting even a merely temporal relationship to activities associated with an MDA program. This greatly increases the potential for excess "noise" and undue risk aversion and is not only impractical but arguably unethical where huge proportions of populations are being treated for devastating diseases, and no good baseline exists against which to compare possible AE/SAE reports. Other population-specific variables that might change the way drug safety ought to be assessed include differing efficacy rates of a drug, background morbidity/mortality rates of the target disease in question, the growth rate of the incidence of disease, the availability of rescue or salvage therapies, and the willingness of local populations to take risks that other populations might not. The fact that NTDs are controllable and potentially eradicable with well-tolerated, effective, existing drugs might further alter our assessment of MDA safety and AE/SAE tolerability. At the same time, diffuseness of population, communication barriers, lack of resources, and other difficult surveillance challenges may present in NTD-affected settings. These limitations could impair the ability to monitor an MDA program's success, as well as hinder efforts to obtain informed consent or provide rescue therapy. Denying beneficial research interventions and MDA programs intended to benefit millions requires sound ethical justification based on more than the identification of

  11. Are adverse effects of antiepileptic drugs different in symptomatic partial and idiopathic generalized epilepsies? The Portuguese-Brazilian validation of the Liverpool Adverse Events Profile.

    Science.gov (United States)

    Martins, H H; Alonso, N B; Vidal-Dourado, M; Carbonel, T D; de Araújo Filho, G M; Caboclo, L O; Yacubian, E M; Guilhoto, L M

    2011-11-01

    We report the results of administration of the Portuguese-Brazilian translation of the Liverpool Adverse Events Profile (LAEP) to 100 patients (mean age=34.5, SD=12.12; 56 females), 61 with symptomatic partial epilepsy (SPE) and 39 with idiopathic generalized epilepsy (IGE) (ILAE, 1989) who were on a stable antiepileptic drug (AED) regimen and being treated in a Brazilian tertiary epilepsy center. Carbamazepine was the most commonly used AED (43.0%), followed by valproic acid (32.0%). Two or more AEDs were used by 69.0% of patients. The mean LAEP score (19 questions) was 37.6 (SD=13.35). The most common adverse effects were sleepiness (35.0%), memory problems (35.0%), and difficulty in concentrating (25.0%). Higher LAEP scores were associated with polytherapy with three or more AEDs (P=0.005), female gender (P0.001) and Hospital Anxiety and Depression Scale (Depression: r=0.637, P<0.001; Anxiety: r=0.621, P<0.001) dimensions. LAEP overall scores were similar in people with SPE and IGE and were not helpful in differentiating adverse effects in these two groups. Clinical variables that influenced global LAEP were seizure frequency (P=0.050) and generalized tonic-clonic seizures in the last month (P=0.031) in the IGE group, and polytherapy with three or more AEDs (P=0.003 and P=0.003) in both IGE and SPE groups.

  12. Is overweight a risk factor for adverse events during removal of impacted lower third molars?

    Science.gov (United States)

    de Carvalho, Ricardo Wathson Feitosa; do Egito Vasconcelos, Belmiro Cavalcanti

    2014-01-01

    Being overweight is recognised as a significant risk factor for several morbidities; however, the experience of the dentistry faculties focusing on this population is still low. The aim of the present study was to determine the occurrence of adverse events during removal of impacted lower third molars in overweight patients. A prospective cohort study was carried out involving overweight patients subjected to surgical removal of impacted lower third molar as part of a line of research on third molar surgery. Predictor variables indicative of the occurrence of adverse events during surgery were classified by their demographic, clinical, radiographic, and surgical aspects. Descriptive and bivariate statistics were computed. In total, 140 patients fulfilled the eligibility criteria, and 280 surgeries were performed. Patients' mean age was 25.1±2.2 years, and the proportion of women to men was 3:1. Eight different adverse events during surgery were recorded. These events occurred in approximately 29.3% of cases and were significantly associated with predictor variables (Pimpacted third molar surgery. The study suggests that overweight patients are highly likely to experience morbidities.

  13. Becoming a "second victim" in health care: Pathway of recovery after adverse event.

    Science.gov (United States)

    Rinaldi, C; Leigheb, F; Vanhaecht, K; Donnarumma, C; Panella, M

    2016-07-01

    The healthcare worker involved in an unanticipated adverse patient event can become second victim. These workers suffer physically and psycho-socially and try to overcome the post-event emotional stress by obtaining emotional support in a variety of ways. The goal of this research was to study second victims among health care providers in Italy. This contribution contains the results of 33 interviews of nurses, physicians and other healthcare workers. After institutional approval, the semi-structured interview, composed of 25 questions, was translated from English into Italian. The audio-interviews were transcribed on paper verbatim by the interviewer. It was then verified if the interviewees experienced the six post-event stages of second victim recovery previously described within the literature. The interviewees described the post-event recovery stages described by literature but stages were not detailed in the exact succession order as the American study. All participants clearly remembered the adverse event and referred the physical and psycho-social symptoms. The psychological support obtained by second victims was described as poor and inefficient. The post-event recovery pathway is predictable but not always clearly respected as defined within this Italian sample. Future study of the second-victim phenomenon and desired supportive interventions is necessary to understand the experience and interventions to mitigate harm of future clinicians. Every day healthcare workers become second victims and, considering that human resources are the most important heritage of healthcare infrastructures, after an adverse event it is very important to execute valid interventional programs to support and train these workers. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  14. Do pharmacists' reports of adverse drug reactions reflect patients' concerns?

    NARCIS (Netherlands)

    van Grootheest, A.C.; van Puijenbroek, E.P.; de Jong-van den Berg, Lolkje Theodora Wilhelmina

    2004-01-01

    Aim: The aim of the present study was to investigate whether the concerns patients express to a Drug Information Line about possible adverse drug reactions (ADRs) they have experienced, are sufficiently reflected by the ADR reports submitted by pharmacists to the Netherlands Pharmacovigilance Centre

  15. Empirical evidence suggests adverse climate events have not affected Australian women's health and well-being.

    Science.gov (United States)

    Powers, Jennifer R; Loxton, Deborah; Baker, Jeanine; Rich, Jane L; Dobson, Annette J

    2012-10-01

    To compare the health and well-being of women by exposure to adverse climate events. An Exceptional Circumstance declaration (EC) was used as a proxy for adverse climate events. The Australian government may provide financial support to people living in EC areas, i.e. areas experiencing a one in 20-25 year event (drought, flood or fire) that results in a severe, extended downturn in farm or farm-related income. Data from 6,584 53-58 year old non-metropolitan women participating in the 2004 survey of the Australian Longitudinal Study on Women's Health (ALSWH) were linked to EC data. Generalised linear models were used to analyse differences in SF-36 General Health (GH) and Mental Health (MH) and perceived stress by EC for all women. Models were adjusted for demographic, health-related and psychosocial factors potentially on the pathway between EC and health. Given that the effects on health were expected to be greater in vulnerable people, analyses were repeated for women with worse socioeconomic circumstances. GH, MH and stress did not differ for the 3,366 women in EC areas and 3,218 women in non-EC areas. GH, MH and stress were worse among vulnerable women (who had difficulty managing on available income) regardless of EC. This research adds to the existing literature on climate change, associated adverse climate events and health, by suggesting that multiple resources available in high income countries, including government support and individual psychosocial resources may mitigate some of the health impacts of adverse climate events, even among vulnerable people. © 2012 The Authors. ANZJPH © 2012 Public Health Association of Australia.

  16. Extreme Energy Events Monitoring report

    CERN Document Server

    Baimukhamedova, Nigina

    2015-01-01

    Following paper reflects the progress I made on Summer Student Program within Extreme Energy Events Monitor project I was working on. During 8 week period I managed to build a simple detector system that is capable of triggering events similar to explosions (sudden change in sound levels) and measuring approximate location of the event. Source codes are available upon request and settings described further.

  17. Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review.

    Science.gov (United States)

    Warms, Catherine A; Backus, Deborah; Rajan, Suparna; Bombardier, Charles H; Schomer, Katherine G; Burns, Stephen P

    2014-11-01

    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. To systematically review published evidence to identify and enumerate reports of adverse events or AEs associated with training in persons with SCI. 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. 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. 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.

  18. Gender Differences in Associations Between Intraprocedural Thrombotic Events During Percutaneous Coronary Intervention and Adverse Outcomes

    DEFF Research Database (Denmark)

    Schoos, Mikkel; Mehran, Roxana; Dangas, George D

    2016-01-01

    Women are frequently reported to have increased morbidity after presentation with acute coronary syndromes and myocardial infarction; however, whether a greater thrombotic tendency contributes to gender differences in clinical outcomes of urgent percutaneous coronary intervention is unknown...... quantitative coronary angiography (QCA) analysis, from the ACUITY and HORIZONS-AMI trials. We compared major adverse cardiac events (MACE) at in-hospital, 30-day, and 1-year follow-up and major bleeding at 30 days according to gender and the presence or absence of IPTE. IPTE was identified in 507 patients (7.......7%), with 119 of 1,744 (6.8%) occurring in women and 388 of 4,847 (8.0%) in men (p = 0.12). IPTE, but not gender, was independently associated with MACE at in-hospital and 30-day follow-up. At 1-year follow-up, the adjusted hazard of MACE was higher in women and in patients with IPTE; however, the risk of MACE...

  19. Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials.

    Science.gov (United States)

    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.

  20. What, who, when, where and how to inform patients after an adverse event: a qualitative study.

    Science.gov (United States)

    Mira, José Joaquín; Ferrús, Lena; Silvestre, Carmen; Olivera, Guadalupe

    To explore suggestions and recommendations for conducting open disclosure with a patient after an adverse event in a setting without professionals' legal privileges. Qualitative study conducting focus groups/Metaplan. This study was conducted with physicians and nurses from Primary Care and Hospitals working in the public health system in Spain. Twenty-seven professionals were involved 8-30 years of experience, 15 (56%) medical and 12 (44%) nurses, 13 (48%) worked in hospitals. Consensus was obtained on: how (honesty and open and direct language), where (avoid corridors, with privacy), and when to disclose (with agility but without precipitation, once information is obtained, and after reflecting on the most suitable according to the nature of the AE). There was controversy as to what to say to the patient when the AE had serious consequences and doubts about what type of incidents must be reported; who should be required to disclose (the professional involved in the AE or other professional related to the patient, the role of the staff and the management team); and in which cases an apology can be a problem. The severity of the AE determines who should talk with the patient in both hospital and primary care. The most appropriate way to convey an apology to the patient depends of the AE. An early, direct, empathetic and proactive action accompanied by information about compensation for the harm suffered could reduce the litigation intention. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  1. Aluminium adjuvants and adverse events in sub-cutaneous allergy immunotherapy.

    Science.gov (United States)

    Exley, Christopher

    2014-01-20

    Sub-cutaneous immunotherapy is an effective treatment for allergy. It works by helping to modify or re-balance an individual's immune response to allergens and its efficacy is greatly improved by the use of adjuvants, most commonly, aluminium hydroxide. Aluminium salts have been used in allergy therapy for many decades and are assumed to be safe with few established side-effects. This assumption belies their potency as adjuvants and their potential for biological reactivity both at injection sites and elsewhere in the body. There are very few data purporting to the safety of aluminium adjuvants in allergy immunotherapy and particularly so in relation to longer term health effects. There are, if only few, published reports of adverse events following allergy immunotherapy and aluminium adjuvants are the prime suspects in the majority of such incidents. Aluminium adjuvants are clearly capable of initiating unwanted side effects in recipients of immunotherapy and while there is as yet no evidence that such are commonplace it is complacent to consider aluminium salts as harmless constituents of allergy therapies. Future research should establish the safety of the use of aluminium adjuvants in sub-cutaneous allergy immunotherapy.

  2. 78 FR 9743 - Event Reporting Guidelines

    Science.gov (United States)

    2013-02-11

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

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

    Science.gov (United States)

    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 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.

  4. Adverse<