WorldWideScience

Sample records for reported adverse health

  1. 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

  2. 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...

  3. 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,...

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 Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review

    Science.gov (United States)

    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median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents.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

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

    Science.gov (United States)

    2010-01-28

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

  6. WindVOiCe, a Self-Reporting Survey: Adverse Health Effects, Industrial Wind Turbines, and the Need for Vigilance Monitoring

    Science.gov (United States)

    Krogh, Carmen M. E.; Gillis, Lorrie; Kouwen, Nicholas; Aramini, Jeff

    2011-01-01

    Industrial wind turbines have been operating in many parts of the globe. Anecdotal reports of perceived adverse health effects relating to industrial wind turbines have been published in the media and on the Internet. Based on these reports, indications were that some residents perceived they were experiencing adverse health effects. The purpose…

  7. 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.

  8. 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...

  9. 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...

  10. [Suspected adverse reactions after vaccination. Results from the German Health Interview and Examination Survey for Children and Adolescents. Part 2: predictors of parental reporting of suspected adverse reactions after vaccinations].

    Science.gov (United States)

    Poethko-Müller, C; Atzpodien, K; Schmitz, R; Schlaud, M

    2011-03-01

    Each method to monitor vaccine safety has strengths and limitations. Therefore, vaccine safety monitoring should rely on different types of data sources. Methods commonly rely on patient-reported adverse reactions. Little is, however, known about factors that may affect the probability with which patients report adverse reactions to vaccines. From 2003-2006, the representative National Health Interview and Examination Survey for Children and Adolescents ("Kinder- und Jugendgesundheitssurvey", KiGGS) retrospectively collected information about vaccines, vaccination dates, and suspected vaccine related adverse reactions from a total of 17,641 participants (vaccinations were more likely reported from parents living in former West Germany compared to former East Germany (OR 1.61; 95% CI 1.08-2.39), parents of children with special health care needs (OR 1.49; 95% CI 1.08-2.04), and from parents reporting reservations against vaccinations (OR 3.29; 95% CI 2.28-4.75). Parental reporting of adverse vaccine reactions appears to be associated with parental perception and assessment of possible adverse vaccine reactions, as well as with the parents' attitude towards immunization in general.

  11. Consumer reporting of adverse events following immunization.

    Science.gov (United States)

    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.

  12. Increased risk of coronary heart disease among individuals reporting adverse impact of stress on their health: the Whitehall II prospective cohort study

    Science.gov (United States)

    Nabi, Hermann; Kivimäki, Mika; Batty, G. David; Shipley, Martin J.; Britton, Annie; Brunner, Eric J.; Vahtera, Jussi; Lemogne, Cédric; Elbaz, Alexis; Singh-Manoux, Archana

    2013-01-01

    Aim Response to stress can vary greatly between individuals. However, it remains unknown whether perceived impact of stress on health is associated with adverse health outcomes. We examined whether individuals who report that stress adversely affects their health are at increased risk of coronary heart disease (CHD) compared with those who report that stress has no adverse health impact. Methods and results Analyses are based on 7268 men and women (mean age: 49.5 years, interquartile range: 11 years) from the British Whitehall II cohort study. Over 18 years of follow-up, there were 352 coronary deaths or first non-fatal myocardial infarction (MI) events. After adjustment for sociodemographic characteristics, participants who reported at baseline that stress has affected their health ‘a lot or extremely’ had a 2.12 times higher (95% CI 1.52–2.98) risk of coronary death or incident non-fatal MI when compared with those who reported no effect of stress on their health. This association was attenuated but remained statistically significant after adjustment for biological, behavioural, and other psychological risk factors including perceived stress levels, and measures of social support; fully adjusted hazard ratio: 1.49 (95% CI 1.01–2.22). Conclusions In this prospective cohort study, the perception that stress affects health, different from perceived stress levels, was associated with an increased risk of coronary heart disease. Randomized controlled trials are needed to determine whether disease risk can be reduced by increasing clinical attention to those who complain that stress greatly affects their health. PMID:23804585

  13. Reported Adverse Health Effects in Children from Ingestion of Alcohol-Based Hand Sanitizers - United States, 2011-2014.

    Science.gov (United States)

    Santos, Cynthia; Kieszak, Stephanie; Wang, Alice; Law, Royal; Schier, Joshua; Wolkin, Amy

    2017-03-03

    Hand sanitizers are effective and inexpensive products that can reduce microorganisms on the skin, but ingestion or improper use can be associated with health risks. Many hand sanitizers contain up to 60%-95% ethanol or isopropyl alcohol by volume, and are often combined with scents that might be appealing to young children. Recent reports have identified serious consequences, including apnea, acidosis, and coma in young children who swallowed alcohol-based (alcohol) hand sanitizer (1-3). Poison control centers collect data on intentional and unintentional exposures to hand sanitizer solutions resulting from various routes of exposure, including ingestion, inhalation, and dermal and ocular exposures. To characterize exposures of children aged ≤12 years to alcohol hand sanitizers, CDC analyzed data reported to the National Poison Data System (NPDS).* The major route of exposure to both alcohol and nonalcohol-based (nonalcohol) hand sanitizers was ingestion. The majority of intentional exposures to alcohol hand sanitizers occurred in children aged 6-12 years. Alcohol hand sanitizer exposures were associated with worse outcomes than were nonalcohol hand sanitizer exposures. Caregivers and health care providers should be aware of the potential dangers associated with hand sanitizer ingestion. Children using alcohol hand sanitizers should be supervised and these products should be kept out of reach from children when not in use.

  14. Do studies reporting ‘U’-shaped serum 25-hydroxyvitamin D–health outcome relationships reflect adverse effects?

    Science.gov (United States)

    Grant, William B.; Karras, Spyridon N.; Bischoff-Ferrari, Heike A.; Annweiler, Cedric; Boucher, Barbara J.; Juzeniene, Asta; Garland, Cedric F.; Holick, Michael F.

    2016-01-01

    ABSTRACT Several reports describe U-shaped 25-hydroxyvitamin D [25(OH)D] concentration–health outcomes, including musculo-skeletal disorders such as falls and fractures, several cancers, cardiovascular disease (CVD), cognitive function, all-cause mortality rates, birth outcomes, allergic reactions, frailty, and some other disorders. This paper reviews reports of U-shaped outcome associations with vitamin D status for evidence of underlying pathophysiological processes, or of confounding, finding that some U-shaped associations appear to be biologically meaningful, but that many could well reflect confounding by factors such as lifestyle, or hypovitaminosis D-related disease onset being masked by self-supplementation that was begun too late to correct developing health problems but before baseline vitamin D status assessment. However, the various U-shaped associations for allergic reactions may be due to vitamin D modulation of the phenotype of the immune response, shifting the Th1-Th2 balance toward Th2 formation. For prostate cancer, there seems to be little effect of 25(OH)D concentration on incidence; however, there is an inverse correlation between 25(OH)D concentration and mortality rates. Future observational studies, and randomized controlled trial data analyses, should include adjustment for data collected on prior long-term vitamin D supplementation and solar UVB exposure, as well as other potential confounders. PMID:27489574

  15. Do studies reporting 'U'-shaped serum 25-hydroxyvitamin D-health outcome relationships reflect adverse effects?

    Science.gov (United States)

    Grant, William B; Karras, Spyridon N; Bischoff-Ferrari, Heike A; Annweiler, Cedric; Boucher, Barbara J; Juzeniene, Asta; Garland, Cedric F; Holick, Michael F

    2016-01-01

    Several reports describe U-shaped 25-hydroxyvitamin D [25(OH)D] concentration-health outcomes, including musculo-skeletal disorders such as falls and fractures, several cancers, cardiovascular disease (CVD), cognitive function, all-cause mortality rates, birth outcomes, allergic reactions, frailty, and some other disorders. This paper reviews reports of U-shaped outcome associations with vitamin D status for evidence of underlying pathophysiological processes, or of confounding, finding that some U-shaped associations appear to be biologically meaningful, but that many could well reflect confounding by factors such as lifestyle, or hypovitaminosis D-related disease onset being masked by self-supplementation that was begun too late to correct developing health problems but before baseline vitamin D status assessment. However, the various U-shaped associations for allergic reactions may be due to vitamin D modulation of the phenotype of the immune response, shifting the Th1-Th2 balance toward Th2 formation. For prostate cancer, there seems to be little effect of 25(OH)D concentration on incidence; however, there is an inverse correlation between 25(OH)D concentration and mortality rates. Future observational studies, and randomized controlled trial data analyses, should include adjustment for data collected on prior long-term vitamin D supplementation and solar UVB exposure, as well as other potential confounders.

  16. The Public Health Burden of Early Adversity

    Science.gov (United States)

    Schlueter, Lisa J.; Watamura, Sarah Enos

    2017-01-01

    Severe and chronic stress in early childhood has enormous physical and mental health costs across an individual's lifespan. Unfortunately, exposure to early life adversity is common, and costs accrue to individuals and society. This article highlights several promising approaches to buffer children from the negative health consequences associated…

  17. The Public Health Burden of Early Adversity

    Science.gov (United States)

    Schlueter, Lisa J.; Watamura, Sarah Enos

    2017-01-01

    Severe and chronic stress in early childhood has enormous physical and mental health costs across an individual's lifespan. Unfortunately, exposure to early life adversity is common, and costs accrue to individuals and society. This article highlights several promising approaches to buffer children from the negative health consequences associated…

  18. 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.

  19. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

    OpenAIRE

    Bruland, P; McGilchrist, M.; Zapletal, E.; Acosta, D.; Proeve, J.; Askin, S.; Ganslandt, T.; Doods, J.; Dugas, M.

    2016-01-01

    BACKGROUND: Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems...

  20. [Analysis of Spontaneously Reported Adverse Events].

    Science.gov (United States)

    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.

  1. 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...

  2. SSRI'S and other antidepressant use during pregnancy and potential neonatal adverse effects: Impact of a public health advisory and subsequent reports in the news media

    NARCIS (Netherlands)

    Einarson, Adrienne; Schachtschneider, A.-M.; Halil, R.; Bollano, E.; Koren, G.

    2005-01-01

    Background: On Aug 9th 2004 Health Canada released an advisory, which followed a similar one from the FDA regarding the use of SSRI’s and other antidepressants during pregnancy and potential adverse effects on newborns. In neither advisory was it stated that women should discontinue their antidep

  3. Information about adverse drug reactions reported in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Christensen, Arne; Hansen, Ebba Holme

    2010-01-01

    provided by health care professionals, although parents also contributed reports. CONCLUSIONS: We found a higher incidence rate of ADRs in hospitalized children and outpatients than in national databases. There seems to be considerable potential for increasing the knowledge of ADRs by advocating...... the submission of reports to the spontaneous reporting systems. Our study underscores that ADRs in children constitute a significant public health problem.......AIM: To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS: Medline and Embase databases were searched from origin and updated until February 2010. We...

  4. 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. .

  5. [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.

  6. Association between self-reported general and mental health and adverse outcomes: a retrospective cohort study of 19,625 Scottish adults.

    Directory of Open Access Journals (Sweden)

    Zia Ul-Haq

    Full Text Available OBJECTIVE: Self-reported general health and mental health are independent predictors of all-cause mortality. This study examines whether they are also independent predictors of incident cancer, coronary heart disease and psychiatric hospitalisation. METHODS: We conducted a retrospective, population cohort study by linking the 19 625 Scottish adults who participated in the Scottish Health Surveys 1995-2003, to hospital admissions, cancer registration and death certificate records. We conducted Cox proportional hazard models adjusting for potential confounders including age, sex, socioeconomic status, alcohol, smoking status, body mass index, hypertension and diabetes. RESULTS: Poor general health was reported by 1215 (6.2% participants and was associated with cancer registrations (adjusted Hazard Ratio [HR] 1.30, 95% CI 1.10, 1.55, coronary heart disease events (adjusted HR 2.30, 95% CI 1.86, 2.84 and psychiatric hospitalisations (adjusted HR 2.42, 95% CI 1.65, 3.56. There was evidence of dose relationships and the associations remained significant after adjustment for mental health. 3172 (16% participants had poor mental health (GHQ ≥ 4. After adjustment for general health, the associations between poor mental health and coronary heart disease events (adjusted HR 1.36, 95% CI 1.13, 1.63 and all-cause death (adjusted HR 1.38, 95% CI 1.23, 1.55 became non-significant, but mental health remained associated with psychiatric hospitalisations (fully adjusted HR 2.02, 95% CI 1.48, 2.75. CONCLUSION: Self-reported general health is a significant predictor of a range of clinical outcomes independent of mental health. The association between mental health and non-psychiatric outcomes is mediated by general health but it is an independent predictor of psychiatric outcome. Individuals with poor general health or mental health warrant close attention.

  7. Improving reporting of adverse drug reactions: Systematic review

    Directory of Open Access Journals (Sweden)

    Mariam Molokhia

    2009-05-01

    Full Text Available Mariam Molokhia1, Shivani Tanna2, Derek Bell31Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK; 2Department of Primary Care and Social Medicine, Imperial College, London, UK; 3Division of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UKBackground: Adverse drug reactions (ADRs are a significant cause of morbidity and mortality, with many being identified post-marketing. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health.Objectives: To evaluate methods to improve ADR reporting via a systematic literature review.Methods: Data sources were Medline, Embase, Cochrane Library and National Library for health searches on ADR reporting (January 1997 to August 2007 including cross-referenced articles. Twenty-four out of 260 eligible studies were identified and critically assessed. Studies were grouped as follows: i spontaneous reporting (11; ii medical chart/note review (2; iii patient interviews/questionnaires (3; and iv combination methods including computer-assisted methods (8.Results: Using computerized monitoring systems (CMS to generate signals associated with changes in laboratory results with other methods can improve ADR reporting. Educational interventions combined with reminders and/or prescription card reports can improve hospitalbased ADR reporting, and showed short to medium term improvement.Conclusions: The use of electronic health data combined with other methods for ADR reporting can improve efficiency and accuracy for detecting ADRs and can be extended to other health care settings. Although methods with educational intervention appear to be effective, few studies have reviewed long-term effects to assess if the improvements can be sustained. Keywords: adverse drug reaction, reporting, ADR

  8. 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

  9. Health care provider beliefs concerning the adverse health effects of environmental and ecosystem degradation.

    Science.gov (United States)

    Truckner, Robert T

    2009-01-01

    Little is known about health care provider interest, knowledge, and beliefs regarding the health effects of human-induced environmental degradation (HIED). A survey was created and distributed to better characterize health provider beliefs about the adverse health effects of HIED. An invitation to participate in an online 24-question survey was e-mailed to 2177 members of the Wilderness Medical Society to characterize experience with health effects of HIED, types of health effects attributed to HIED, attitudes toward HIED, and educational sources about HIED. Data were analyzed from 665 responses, a response rate of 35%. Results demonstrate that health care providers identify a large number and variety of health effects associated with HIED, although exacerbation of asthma, reactive airways disease, and chronic obstructive pulmonary disease were most commonly identified. Over 80% report that HIED has affected the health of a patient they have cared for; 60% report patients have asked about HIED effects on health; and 93% report that they do not distribute information to patients about HIED. Over 75% of respondents believe there is an unfulfilled need for information and education about the adverse health effects of HIED. Respondents report continuing medical education, journal articles, and medical schools/residency programs as the best methods for education and for raising awareness of the health effects of HIED. Results indicate strong health professional belief in health effects of HIED, patient concern related to the health effects of HIED, and a need to educate both health care providers and patients on the adverse health effects of HIED.

  10. Adverse Selection in Health Insurance Markets: A Classroom Experiment

    Science.gov (United States)

    Hodgson, Ashley

    2014-01-01

    Adverse selection as it relates to health care policy will be a key economic issue in many upcoming elections. In this article, the author lays out a 30-minute classroom experiment designed for students to experience the kind of elevated prices and market collapse that can result from adverse selection in health insurance markets. The students…

  11. 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....

  12. Adverse childhood experiences and health anxiety in adulthood.

    Science.gov (United States)

    Reiser, Sarah J; McMillan, Katherine A; Wright, Kristi D; Asmundson, Gordon J G

    2014-03-01

    Childhood experiences are thought to predispose a person to the development of health anxiety later in life. However, there is a lack of research investigating the influence of specific adverse experiences (e.g., childhood abuse, household dysfunction) on this condition. The current study examined the cumulative influence of multiple types of childhood adversities on health anxiety in adulthood. Adults 18-59 years of age (N=264) completed a battery of measures to assess adverse childhood experiences, health anxiety, and associated constructs (i.e., negative affect and trait anxiety). Significant associations were observed between adverse childhood experiences, health anxiety, and associated constructs. Hierarchical multiple regression analysis indicted that adverse childhood experiences were predictive of health anxiety in adulthood; however, the unique contribution of these experience were no longer significant following the inclusion of the other variables of interest. Subsequently, mediation analyses indicated that both negative affect and trait anxiety independently mediated the relationship between adverse childhood experiences and health anxiety in adulthood. Increased exposure to adverse childhood experiences is associated with higher levels of health anxiety in adulthood; this relationship is mediated through negative affect and trait anxiety. Findings support the long-term negative impact of cumulative adverse childhood experiences and emphasize the importance of addressing negative affect and trait anxiety in efforts to prevent and treat health anxiety.

  13. Intimate Partner Violence, PTSD, and Adverse Health Outcomes

    Science.gov (United States)

    Dutton, Mary Ann; Green, Bonnie L.; Kaltman, Stacey I.; Roesch, Darren M.; Zeffiro, Thomas A.; Krause, Elizabeth D.

    2006-01-01

    The high prevalence of adverse health outcomes related to intimate partner violence (IPV) is well documented. Yet we know little about the pathways that lead to adverse health outcomes. Research concerning the psychological, biological, neurological, behavioral, and physiological alterations following exposure to IPV--many of which are associated…

  14. Canada's Adverse Drug Reaction Reporting System: A Failing Grade.

    Science.gov (United States)

    Rawson, Nigel S B

    2015-01-01

    An article in the National Post on suicidal effects associated with varenicline (Champix) highlights deficiencies in the Canadian spontaneous reporting system (SRS) for adverse drug reactions (ADRs). The issues of under-reporting, poor quality information, duplication of reports and lack of a population denominator of drug use are discussed. Canada's SRS is deficient. There are immediate and medium-term actions that could be instituted that would improve pharmacovigilance in Canada. However, education about appropriate prescribing, the recognition of ADRs, and the duty to report them is a key long-term strategy to improving the pharmacovigilance system and should be included at every opportunity in the training of healthcare professionals so that life-long habits are developed. In addition to changes at Health Canada, greater emphasis needs to be placed on training in therapeutics, understanding drug safety, and the responsibility of healthcare providers in reporting risks in the curricula of medical and nursing schools.

  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...

  16. Basic Versus Supplementary Health Insurance : Moral Hazard and Adverse Selection

    NARCIS (Netherlands)

    Boone, J.

    2014-01-01

    This paper introduces a tractable model of health insurance with both moral hazard and adverse selection. We show that government sponsored universal basic insurance should cover treatments with the biggest adverse selection problems. Treatments not covered by basic insurance can be covered on the

  17. Basic versus supplementary health insurance : Moral hazard and adverse selection

    NARCIS (Netherlands)

    Boone, J.

    This paper introduces a tractable model of health insurance with both moral hazard and adverse selection. We show that government sponsored universal basic insurance should cover treatments with the biggest adverse selection problems. Treatments not covered by basic insurance can be covered on the

  18. Basic Versus Supplementary Health Insurance : Moral Hazard and Adverse Selection

    NARCIS (Netherlands)

    Boone, J.

    2014-01-01

    This paper introduces a tractable model of health insurance with both moral hazard and adverse selection. We show that government sponsored universal basic insurance should cover treatments with the biggest adverse selection problems. Treatments not covered by basic insurance can be covered on the p

  19. Basic versus supplementary health insurance : Moral hazard and adverse selection

    NARCIS (Netherlands)

    Boone, J.

    2015-01-01

    This paper introduces a tractable model of health insurance with both moral hazard and adverse selection. We show that government sponsored universal basic insurance should cover treatments with the biggest adverse selection problems. Treatments not covered by basic insurance can be covered on the p

  20. Basic versus supplementary health insurance : Moral hazard and adverse selection

    NARCIS (Netherlands)

    Boone, J.

    2015-01-01

    This paper introduces a tractable model of health insurance with both moral hazard and adverse selection. We show that government sponsored universal basic insurance should cover treatments with the biggest adverse selection problems. Treatments not covered by basic insurance can be covered on the p

  1. Basic Versus Supplementary Health Insurance : Moral Hazard and Adverse Selection

    NARCIS (Netherlands)

    Boone, J.

    2014-01-01

    This paper introduces a tractable model of health insurance with both moral hazard and adverse selection. We show that government sponsored universal basic insurance should cover treatments with the biggest adverse selection problems. Treatments not covered by basic insurance can be covered on the p

  2. Brief Report: Examining the Association of Autism and Adverse Childhood Experiences in the National Survey of Children's Health: The Important Role of Income and Co-Occurring Mental Health Conditions

    Science.gov (United States)

    Kerns, Connor Morrow; Newschaffer, Craig J.; Berkowitz, Steven; Lee, Brian K.

    2017-01-01

    Adverse childhood experiences (ACEs) are risk factors for mental and physical illness and more likely to occur for children with autism spectrum disorder (ASD). The present study aimed to clarify the contribution of poverty, intellectual disability and mental health conditions to this disparity. Data on child and family characteristics, mental…

  3. Evidence of Adverse Selection in Iranian Supplementary Health Insurance Market

    Directory of Open Access Journals (Sweden)

    Gh Mahdavi

    2012-07-01

    Full Text Available Background: Existence or non-existence of adverse selection in insurance market is one of the important cases that have always been considered by insurers. Adverse selection is one of the consequences of asymmetric information. Theory of adverse selection states that high-risk individuals demand the insurance service more than low risk individuals do.Methods: The presence of adverse selection in Irans supplementary health insurance market is tested in this paper. The study group consists of 420 practitioner individuals aged 20 to 59. We estimate two logistic regression models in order to determine the effect of individual's characteristics on decision to purchase health insurance coverage and loss occurrence. Using the correlation between claim occurrence and decision to purchase health insurance, the adverse selection problem in Iranian supplementary health insurance market is examined.Results: Individuals with higher level of education and income level purchase less supplementary health insurance and make fewer claims than others make and there is positive correlation between claim occurrence and decision to purchase supplementary health insurance.Conclusion: Our findings prove the evidence of the presence of adverse selection in Iranian supplementary health insurance market.

  4. 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...

  5. Premium subsidies for health insurance: excessive coverage vs. adverse selection.

    Science.gov (United States)

    Selden, T M

    1999-12-01

    The tax subsidy for employment-related health insurance can lead to excessive coverage and excessive spending on medical care. Yet, the potential also exists for adverse selection to result in the opposite problem-insufficient coverage and underconsumption of medical care. This paper uses the model of Rothschild and Stiglitz (R-S) to show that a simple linear premium subsidy can correct market failure due to adverse selection. The optimal linear subsidy balances welfare losses from excessive coverage against welfare gains from reduced adverse selection. Indeed, a capped premium subsidy may mitigate adverse selection without creating incentives for excessive coverage.

  6. Do oral health conditions adversely impact young adults?

    NARCIS (Netherlands)

    J.C. Carvalho; H.D. Mestrinho; S. Stevens; A.J. van Wijk

    2015-01-01

    This study assessed the extent to which clinically measured oral health conditions, adjusted for sociodemographic and oral health behavior determinants, impact adversely on the oral health-related quality of life (OHRQoL) in a sample of Belgian young adults. The null hypothesis was that, among young

  7. 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.

  8. 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...

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Abdullahi Rabiu Abubakar

    2015-01-01

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

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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

  16. Separate and Cumulative Effects of Adverse Childhood Experiences in Predicting Adult Health and Health Care Utilization

    Science.gov (United States)

    Chartier, Mariette J.; Walker, John R.; Naimark, Barbara

    2010-01-01

    Objectives: Objectives of this population-based study were: (1) to examine the relative contribution of childhood abuse and other adverse childhood experiences to poor adult health and increased health care utilization and (2) to examine the cumulative effects of adverse childhood experiences on adult health and health care utilization. Methods:…

  17. Separate and Cumulative Effects of Adverse Childhood Experiences in Predicting Adult Health and Health Care Utilization

    Science.gov (United States)

    Chartier, Mariette J.; Walker, John R.; Naimark, Barbara

    2010-01-01

    Objectives: Objectives of this population-based study were: (1) to examine the relative contribution of childhood abuse and other adverse childhood experiences to poor adult health and increased health care utilization and (2) to examine the cumulative effects of adverse childhood experiences on adult health and health care utilization. Methods:…

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

    Science.gov (United States)

    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

  19. Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two "challenging" case reports

    Directory of Open Access Journals (Sweden)

    Caterina Palleria

    2013-01-01

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

  20. 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

  1. 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

  2. Study of resilience and environmental adversity in midlife health (STREAM)

    OpenAIRE

    Velthorst, Eva; Reichenberg, Abraham; Rabinowitz, Jonathan; Levine, Stephen Z.

    2015-01-01

    Purpose The Jerusalem study of resilience and environmental adversity in midlife health (STREAM) was established to examine the prevalence of common mental and physical health issues in mid-adulthood in the inner city of Jerusalem, and to examine their association with lifespan psychosocial factors of vulnerability and resilience. Method Participants were 811 randomly selected individuals from 7000 individuals who were born and grew up in inner-Jerusalem. Participants were 34–44 years old dur...

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

    Science.gov (United States)

    Fan, P L; Meyer, D M

    2007-02-01

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

  4. Excessive folic acid intake and relation to adverse health outcome.

    Science.gov (United States)

    Selhub, Jacob; Rosenberg, Irwin H

    2016-07-01

    The recent increase in the intake of folic acid by the general public through fortified foods and supplements, has raised safety concern based on early reports of adverse health outcome in elderly with low B12 status who took high doses of folic acid. These safety concerns are contrary to the 2015 WHO statement that "high folic acid intake has not reliably been shown to be associated with negative healeffects". In the folic acid post-fortification era, we have shown that in elderly participants in NHANES 1999-2002, high plasma folate level is associated with exacerbation of both clinical (anemia and cognitive impairment) and biochemical (high MMA and high Hcy plasma levels) signs of vitamin B12 deficiency. Adverse clinical outcomes in association with high folate intake were also seen among elderly with low plasma B12 levels from the Framingham Original Cohort and in a study from Australia which combined three elderly cohorts. Relation between high folate and adverse biochemical outcomes were also seen in the Sacramento Area Latino Study on Aging (High Hcy, high MMA and lower TC2) and at an outpatient clinic at Yale University where high folate is associated with higher MMA in the elderly but not in the young. Potential detrimental effects of high folic acid intake may not be limited to the elderly nor to those with B12 deficiency. A study from India linked maternal high RBC folate to increased insulin resistance in offspring. Our study suggested that excessive folic acid intake is associated with lower natural killer cells activity in elderly women. In a recent study we found that the risk for unilateral retinoblastoma in offspring is 4 fold higher in women that are homozygotes for the 19 bp deletion in the DHFR gene and took folic acid supplement during pregnancy. In the elderly this polymorphism is associated with lower memory and executive scores, both being significantly worse in those with high plasma folate. These and other data strongly imply that

  5. Health Reports.

    Science.gov (United States)

    1992-09-01

    Futui’e Structure of Veterans’ Health Program (Aug. 11, 1992, GAO/T-HRD-92-53). Recombinant Bovine Growth Hormone: FDA Approval Should be Withheld Until...the Mastitis Issue Is Resolved (Aug. 6, 1992, GAO/PEMD-92-26). VA Health Care: Inadequate Controls Over Scarce Medical Specialist Contracts (Aug. 5

  6. Energy Drink Consumption: Beneficial and Adverse Health Effects.

    Science.gov (United States)

    Alsunni, Ahmed Abdulrahman

    2015-10-01

    Consumption of energy drinks has been increasing dramatically in the last two decades, particularly amongst adolescents and young adults. Energy drinks are aggressively marketed with the claim that these products give an energy boost to improve physical and cognitive performance. However, studies supporting these claims are limited. In fact, several adverse health effects have been related to energy drink; this has raised the question of whether these beverages are safe. This review was carried out to identify and discuss the published articles that examined the beneficial and adverse health effects related to energy drink. It is concluded that although energy drink may have beneficial effects on physical performance, these products also have possible detrimental health consequences. Marketing of energy drinks should be limited or forbidden until independent research confirms their safety, particularly among adolescents.

  7. 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

  8. Health Reports.

    Science.gov (United States)

    1992-12-01

    Mar. 18, 1992, GAO/IMTEC-92-41). Testimony on same topic (Mar. 18, 1992, GAO/T-IMTEU-92-1 I). Cross Design Synthesis : A New Strategy for Medical... Synthesis : A New Strategy for Medical Effectiveness Research (Report, Mar. 17, 1992, GAO/PEMD-92-18). Medical Technology: Quality Assurance Needs Stronger... Methadone Maintenance: Some Treatment Programs Are Not Effective; Greater Federal Oversight Needed (Testimony, Mar. 23, 1990, GA(Orr-IIRI)-90-19). Report on

  9. Energy Drink Consumption: Beneficial and Adverse Health Effects

    OpenAIRE

    Alsunni, Ahmed Abdulrahman

    2015-01-01

    Consumption of energy drinks has been increasing dramatically in the last two decades, particularly amongst adolescents and young adults. Energy drinks are aggressively marketed with the claim that these products give an energy boost to improve physical and cognitive performance. However, studies supporting these claims are limited. In fact, several adverse health effects have been related to energy drink; this has raised the question of whether these beverages are safe. This review was carri...

  10. Neighborhood adversity, child health, and the role for community development.

    Science.gov (United States)

    Jutte, Douglas P; Miller, Jennifer L; Erickson, David J

    2015-03-01

    Despite medical advances, childhood health and well-being have not been broadly achieved due to rising chronic diseases and conditions related to child poverty. Family and neighborhood living conditions can have lasting consequences for health, with community adversity affecting health outcomes in significant part through stress response and increased allostatic load. Exposure to this "toxic stress" influences gene expression and brain development with direct and indirect negative consequences for health. Ensuring healthy child development requires improving conditions in distressed, high-poverty neighborhoods by reducing children's exposure to neighborhood stressors and supporting good family and caregiver functioning. The community development industry invests more than $200 billion annually in low-income neighborhoods, with the goal of improving living conditions for residents. The most impactful investments have transformed neighborhoods by integrating across sectors to address both the built environment and the social and service environment. By addressing many facets of the social determinants of health at once, these efforts suggest substantial results for children, but health outcomes generally have not been considered or evaluated. Increased partnership between the health sector and community development can bring health outcomes explicitly into focus for community development investments, help optimize intervention strategies for health, and provide natural experiments to build the evidence base for holistic interventions for disadvantaged children. The problems and potential solutions are beyond the scope of practicing pediatricians, but the community development sector stands ready to engage in shared efforts to improve the health and development of our most at-risk children.

  11. 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

  12. Energy drinks and their adverse health effects: A systematic review of the current evidence.

    Science.gov (United States)

    Ali, Fahad; Rehman, Hiba; Babayan, Zaruhi; Stapleton, Dwight; Joshi, Divya-Devi

    2015-04-01

    With the rising consumption of so-called energy drinks over the last few years, there has been a growing body of literature describing significant adverse health events after the ingestion of these beverages. To gain further insight about the clinical spectrum of these adverse events, we conducted a literature review. Using PubMed and Google-Scholar, we searched the literature from January 1980 through May 2014 for articles on the adverse health effects of energy drinks. A total of 2097 publications were found. We then excluded molecular and industry-related studies, popular media reports, and case reports of isolated caffeine toxicity, yielding 43 reports. Energy drink consumption is a health issue primarily of the adolescent and young adult male population. It is linked to increased substance abuse and risk-taking behaviors. The most common adverse events affect the cardiovascular and neurological systems. The most common ingredient in energy drinks is caffeine, and it is believed that the adverse events are related to its effects, as well as potentiating effects of other stimulants in these drinks. Education, regulation, and further studies are required.

  13. Adverse health effects of cigarette smoke: aldehydes Crotonaldehyde, butyraldehyde, hexanal and malonaldehyde

    NARCIS (Netherlands)

    Andel I van; Sleijffers A; Schenk E; Rambali B; Wolterink G; Werken G van de; Aerts LAGJM van; Vleeming W; Amsterdam JGC van; TOX

    2006-01-01

    Crotonaldehyde in cigarette smoke can be concluded to induce airway damage in humans. This is one conclusion derived from the existing data found in the literature and reported here in the discussion on adverse health effects and possible addictive effects due to the exposure of crotonaldehyde, buty

  14. Adverse health effects of cigarette smoke: aldehydes Crotonaldehyde, butyraldehyde, hexanal and malonaldehyde

    NARCIS (Netherlands)

    Andel I van; Sleijffers A; Schenk E; Rambali B; Wolterink G; Werken G van de; Aerts LAGJM van; Vleeming W; Amsterdam JGC van; TOX

    2006-01-01

    Crotonaldehyde in cigarette smoke can be concluded to induce airway damage in humans. This is one conclusion derived from the existing data found in the literature and reported here in the discussion on adverse health effects and possible addictive effects due to the exposure of crotonaldehyde, buty

  15. ADVERSE REACTION TO LATEX CONTAINING MATERIALS IN HEALTH CARE WORKERS

    Directory of Open Access Journals (Sweden)

    Gh. Pouryaghoub

    2008-04-01

    Full Text Available Latex allergy has become an occupational hazard among healthcare workers. Atopy, intensity and duration of exposure have been recognized as predisposing factors for latex sensitization. Frequency of sensitization varies among countries. So we decided to investigate the prevalence of latex sensitization and potential risk factors among healthcare workers in a general hospital. In a cross sectional study by distributing a questionnaire among 876 employees of a general hospital, we investigated the prevalence of latex allergy and the potential risk factors for latex sensitization. We collected information about occupational history, including specific tasks performed, time of first exposure to latex, number of pairs of gloves used, and duration of weekly exposure. We also investigated the interval between first exposure and onset of symptoms. We asked about pre-existing rhinoconjuctivitis, asthma, atopic and contact dermatitis, hay fever, autoimmune diseases, and food allergies. This survey documented a high prevalence of adverse reaction to all latex containing materials (52.5%. 37.7% of responder had adverse reaction to latex gloves. The highest prevalence of adverse reaction to all latex containing materials was found in the surgical operating room, followed by emergency unit and internal medicine wards. According to this study, frequency of adverse reaction to latex was high among health care workers. This may be due to relatively low response rate, low quality of latex products in Iran, and the method of measurement. Whenever, the need for implementing prevention program, using latex-free methods and training of employees to reduce adverse reaction to latex is apparent.

  16. 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.

  17. 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....

  18. ADVERSE DRUG REACTION REPORTS IN MALAYSIA: COMPARISON OF CAUSALITY ASSESSMENTS

    Directory of Open Access Journals (Sweden)

    HOE SEE LEI

    2007-01-01

    Full Text Available Causality assessment of reported adverse drug reactions (ADR is an important component of pharmacovigilance as they contribute to better evaluation of the risk-benefit profile of drugs. The main objective of the present study was to evaluate the agreement of causality assessments of ADR between the spontaneous ADR reporters, the expert panel and the Naranjo algorithm. We retrospectively reviewed ADR reports received by the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC between January to June 2003. Causality assessments were categorized as Certain, Probable, Possible, Unlikely and Unclassifiable. A total of 384 reports were included. Spontaneous reporters assessed 30.4% as Certain, 46.1% as Probable, 21.9% as Possible and 1.6% as Unlikely. MADRAC panel assessed 21.9%, 13.0%, 64.6% and 0.5% as Certain, Probable, Possible and Unlikely, respectively. Using the algorithm, 16.4%, 83.1% and 0.5% were categorized as Probable, Possible and Unlikely, respectively. No reports achieved the Certain/Definite category using the algorithm. The total percentage of agreement between spontaneous reporters, MADRAC and Naranjo’s algorithm in causality assessment was 15.1%. Among the three groups, no agreement was found in the Certain and Unlikely categories. Spontaneous reporters attributed a higher level of causality compared to MADRAC and Naranjo’s algorithm. The difference in aims and methods in causality assessment among the three methods of assessment could be the main reason of disagreement.

  19. Adverse events due to the immunization: Case report

    Directory of Open Access Journals (Sweden)

    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.

  20. 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

  1. Adverse Childhood Experiences and the Health of University Students in Eight Provinces of Vietnam.

    Science.gov (United States)

    Tran, Quynh Anh; Dunne, Michael P; Vo, Thang Van; Luu, Ngoc Hoat

    2015-11-01

    Recent systematic reviews have emphasized the need for more research into the health and social impacts of adverse childhood experiences (ACEs) in the Asia-Pacific region. This cross-sectional study was conducted with 2099 young adult students in 8 medical universities throughout Vietnam. An anonymous, self-report questionnaire included the World Health Organization ACE-International Questionnaire and standardized measures of mental and physical health. Three quarters (76%) of the students reported at least one exposure to ACEs; 21% had 4 or more ACEs. The most commonly reported adversities were emotional abuse, physical abuse, and witnessing a household member being treated violently (42.3%, 39.9%, and 34.6%, respectively). Co-occurrence of ACEs had dose-response relationships with poor mental health, suicidal ideation, and low physical health-related quality of life. This first multisite study of ACEs among Vietnamese university students provided evidence that childhood adversity is common and is significantly linked with impaired health and well-being into the early adult years. © 2015 APJPH.

  2. Adverse health effects of high-effort/low-reward conditions.

    Science.gov (United States)

    Siegrist, J

    1996-01-01

    In addition to the person-environment fit model (J. R. French, R. D. Caplan, & R. V. Harrison, 1982) and the demand-control model (R. A. Karasek & T. Theorell, 1990), a third theoretical concept is proposed to assess adverse health effects of stressful experience at work: the effort-reward imbalance model. The focus of this model is on reciprocity of exchange in occupational life where high-cost/low-gain conditions are considered particularly stressful. Variables measuring low reward in terms of low status control (e.g., lack of promotion prospects, job insecurity) in association with high extrinsic (e.g., work pressure) or intrinsic (personal coping pattern, e.g., high need for control) effort independently predict new cardiovascular events in a prospective study on blue-collar men. Furthermore, these variables partly explain prevalence of cardiovascular risk factors (hypertension, atherogenic lipids) in 2 independent studies. Studying adverse health effects of high-effort/low-reward conditions seems well justified, especially in view of recent developments of the labor market.

  3. 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.

  4. [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.

  5. 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.

  6. Movement Behaviors in Children and Indicators of Adverse Health

    DEFF Research Database (Denmark)

    Hjorth, Mads Fiil

    The prevalence of overweight children is high and increasing numbers of children now show features of metabolic syndrome. Various aspects of physical activity, sedentary behavior, and lack of good-quality sleep have all been linked to this recent development of overweight and cardio-metabolic risk...... at reducing obesity and its associated metabolic complications in adulthood. In my PhD thesis I assessed objectively measured physical activity, sedentary behavior, and sleep in 8- to 11-year-old Danish children and related these movement behaviors to indicators of adverse health (dietary intake, adiposity...... of the children did not meet international screen time, physical activity, and sleep recommendations. Physical activity was lower and sedentary time was higher during winter and during weekends and sleep duration was also lowest during weekends indicating that these periods might serve as key intervention periods...

  7. Movement Behaviors in Children and Indicators of Adverse Health

    DEFF Research Database (Denmark)

    Hjorth, Mads Fiil

    to promote a healthy lifestyle. Thirdly, short sleep duration and a high variability in sleep duration, as well as sleep problems, were associated with an obesity-promoting diet. Short sleep duration was also associated with a higher fat mass index and increased cardio-metabolic risk. Furthermore, a decline......The prevalence of overweight children is high and increasing numbers of children now show features of metabolic syndrome. Various aspects of physical activity, sedentary behavior, and lack of good-quality sleep have all been linked to this recent development of overweight and cardio-metabolic risk...... at reducing obesity and its associated metabolic complications in adulthood. In my PhD thesis I assessed objectively measured physical activity, sedentary behavior, and sleep in 8- to 11-year-old Danish children and related these movement behaviors to indicators of adverse health (dietary intake, adiposity...

  8. Searching for Adverse Effects in MEDLINE and EMBASE Requires a Combined Approach for Efficient Retrieval, A review of: Golder, Su, Heather M. McIntosh, Steve Duffy, and Julie Glanville. “Developing Efficient Search Strategies to Identify Reports of Adverse Effects in MEDLINE and EMBASE.” Health Information & Libraries Journal 23.1 (Mar. 2006: 3-12.

    Directory of Open Access Journals (Sweden)

    Marcy L. Brown

    2006-09-01

    and Loke searches were tested separately. Main Results – Sensitivity and precision were determined for each combination. Formulas used to calculate sensitivity and precision were provided. In MEDLINE, search strategies using floating subheadings achieved the highest sensitivity. The most useful single subheading in both MEDLINE and EMBASE was “adverse effects,” with 79.1% and 79.5% sensitivity respectively. Of the more than 300 combinations tested, the most sensitive combination in MEDLINE included specified adverse effects in combination with the floating subheadings “adverse effects,” “complications,” and “drug effects,” together with text words for adverse effects. This strategy had 97.0% sensitivity, but low precision at 2.8%. The highest precision was achieved by using subheadings attached to drug indexing terms. In EMBASE, the strategy of Loke et al. provided the highest sensitivity at 86.3% and precision of 2.0%. Since researchers are not likely to know in advance all of the reported adverse effects of a particular drug therapy, the most sensitive strategies without specific adverse events were also identified. The search with the highest sensitivity in MEDLINE had 95.5% sensitivity, and 97.3% sensitivity in EMBASE. Conclusion – Searching for adverse effects requires a combination of approaches in both MEDLINE and EMBASE. In MEDLINE, the most sensitive combination yielded 97.0% sensitivity. Regardless of the approach used, precision remains low. An effective generic search filter for adverse effects searches may not yet be feasible. More research is needed on search strategies, as well as more consistent methods of reporting and indexing adverse effects.

  9. 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.

  10. 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.

  11. Adverse drug reactions to ibuprofen: a case report

    Directory of Open Access Journals (Sweden)

    Khobragade Yadneshwar

    2016-02-01

    Full Text Available Ibuprofen is a commonly used drug available by prescription and over the counter for treatment of fever, joint pain, headache, migraine, inflammatory states. It is available in combination with paracetamol and various other drugs. Side effects associated with aspirin and non-steroidal anti-inflammatory drugs (NSAIDs are rash, gastrointestinal ulcers, hepatic toxicity, Steven Johnson syndrome, respiratory skin rashes, acute exacerbation of asthma and anaphylaxis. We have reported here severe distress hypersensitive reaction with ibuprofen induced hypersensitivity syndrome. Within two hours of consumption of ibuprofen patient developed severe bronchospasm, throat and laryngeal oedema leading to respiratory distress. He was treated with salbutamol, hydrocortisone, deriphylline and supportive oxygen, but did not respond and went into coma. Unlike acetaminophen, ibuprofen does not have any antidote hence managing adverse drug reactions (ADR due to ibuprofen is big challenge. Therefore understanding pathophysiology of ADR to Ibuprofen is necessary to manage the patient. Literature in the field of allergic drug reaction shows that epinephrine, a physiological antagonist of histamine is the first drug of choice for the treatment of allergic or drug induced angioedema, laryngeal oedema and bronchospasm due to its direct action on target organs. Such reactions should therefore be managed by epinephrine without loss of time. ADR due to ibuprofen could be prevented by (a avoiding unnecessary intake of drug, (b educating patients / families and public about adverse drug reactions (c surveillance and monitoring of drug reactions (d record keeping (e drug audit and (f reporting of ADR to state/central pharmacovigilance agency. We do observe doctors having misconception about adrenaline, its actions, usage and side effects especially cardio-vascular, hence are reluctant to use. But in severe violent adverse drug reaction we have to use our wisdom and judgement

  12. Self-Reported Benefits and Adverse Outcomes of Hot Yoga Participation.

    Science.gov (United States)

    Mace, Casey; Eggleston, Brandon

    2016-08-15

    There is little to no scientific data about the health benefits or risks to participating in hot yoga, in particular distinguishing it from the practice of non-hot yoga. This study aims to provide some preliminary evidence about the risks and benefits of participating in hot yoga. Future studies will be able to build off the findings herein. This study utilized online survey software (Qualtrics) and recruited participants through convenience sampling (n = 157) by targeting yoga websites and online forums. As there is currently no known questionnaire that has been developed to assess the risks and benefits of hot yoga participation, an exploratory measure was designed to gain more detailed responses from participants. Descriptive epidemiological analyses we re conducted. Participants of hot yoga had a number of pre-existing health conditions. Both benefits and adverse outcomes were reported. The most frequently reported health benefits of hot yoga in this sample included increased flexibility (63%), improved mood (58%), increased fitness (43%), and improved stamina (42%). Just over half of the participants reported some sort of adverse event during a hot yoga session (n = 82). The most commonly reported adverse events included dizziness (60%), feeling light headed (61%), nausea (35%), and dehydration (34%), amongst others. Further study on the risks and benefits of hot yoga participation is required.

  13. 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.

  14. Health Clinic Cost Reports

    Data.gov (United States)

    U.S. Department of Health & Human Services — Healthcare Cost Report Information System (HCRIS) Dataset - Independent Rural Health Clinic and Freestanding Federally Qualified Health Center (HCLINIC).This data...

  15. 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

  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. Self-Focused and Other-Focused Resiliency: Plausible Mechanisms Linking Early Family Adversity to Health Problems in College Women

    Science.gov (United States)

    Coleman, Sulamunn R. M.; Zawadzki, Matthew J.; Heron, Kristin E.; Vartanian, Lenny R.; Smyth, Joshua M.

    2016-01-01

    Objectives: This study examined whether self-focused and other-focused resiliency help explain how early family adversity relates to perceived stress, subjective health, and health behaviors in college women. Participants: Female students (N = 795) participated between October 2009 and May 2010. Methods: Participants completed self-report measures…

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

    Science.gov (United States)

    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

    Science.gov (United States)

    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. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; Wilkes, Sarah; Grootheest, Kees van; Puijenbroek, Eugène van

    2015-01-01

    PURPOSE: This study aims to explore the differences in reported information between adverse drug reaction (ADR) reports of patient and healthcare professionals (HCPs), and, in addition, to explore possible correlation between the reported elements of information. METHODS: This retrospective study co

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

    Science.gov (United States)

    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…

  2. 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.

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

    Directory of Open Access Journals (Sweden)

    Lense Temesgen Gurmesa

    2016-01-01

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

  4. Toward a Case Definition of Adverse Health Effects in the Environs of Industrial Wind Turbines: Facilitating a Clinical Diagnosis

    Science.gov (United States)

    McMurtry, Robert Y.

    2011-01-01

    Internationally, there are reports of adverse health effects (AHE) in the environs of industrial wind turbines (IWT). There was multidisciplinary confirmation of the key characteristics of the AHE at the first international symposium on AHE/IWT. The symptoms being reported are consistent internationally and are characterized by crossover findings…

  5. Home Health PPS - Reports

    Data.gov (United States)

    U.S. Department of Health & Human Services — Abt Associates July 21, 2010 Analysis of 2000-2008 Home Health Case-mix Change Report estimates the extent to which the observed increases in average case-mix were...

  6. 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...

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

    Science.gov (United States)

    Royer, R J; Benichou, C

    1991-01-01

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

  8. Motives for reporting adverse drug reactions by patient-reporters in the Netherlands

    NARCIS (Netherlands)

    van Hunsel, Florence; van der Welle, Christine; Passier, Anneke; van Puijenbroek, Eugene; van Grootheest, Kees

    2010-01-01

    The aim of this study was to quantify the reasons and opinions of patients who reported adverse drug reactions (ADRs) in the Netherlands to a pharmacovigilance centre. A web-based questionnaire was sent to 1370 patients who had previously reported an ADR to a pharmacovigilance centre. The data were

  9. The concept of adverse drug reaction reporting: awareness among pharmacy students in a Nigerian university

    Directory of Open Access Journals (Sweden)

    Johnson Segun Showande

    2013-01-01

    Full Text Available Adverse drug reaction (ADR is poorly reported globally but more in developing countries with poor participation by health professionals. Currently, there is no known literature on the Nigerian pharmacy students’ knowledge on ADR reporting. Hence the purpose of this study was to find out the level of knowledge of pharmacy students on the concept of pharmacovigilance and adverse drug reaction reporting and also to evaluate their opinions on the National Pharmacovigilance Centre guidelines on adverse drug reaction reporting. A pretested 34-item semi-structured questionnaire was administered among 69 pharmacy undergraduate students in their penultimate and final years that consented to take part in the study, in one of the universities in Nigeria. The study was carried out strictly adhering to the principles outlined in the Helsinki declaration of 1964, which was revised in 1975. The questionnaire used had four sections which included a section on biographical data, a section which evaluated the students knowledge on the concept of pharmacovigilance and adverse drug reaction reporting, a section on students personal experiences of adverse drug reactions and modes of reporting them and the final section of the questionnaire evaluated the students’ opinions on the National Pharmacovigilance Centre guidelines for reporting adverse drug reactions. Descriptive statistics, Mann-Whitney U and Kruskal Wallis statistical tests were used to analyze the data obtained. None of the participants knew the sequence of reporting ADR. More than half, 40(58.0% had heard about pharmacovigilance at symposiums, 7(10.1% during clinical clerkship program and 18(26.1% from media jingles. Twenty nine (42.0% agreed that pharmacovigilance was in their curriculum, however only 16(23.2% could define the term correctly. None of the participants had seen or used an ADR form prior to the study, but the students could easily identify and describe the type of ADR they had

  10. Reported adverse drug reactions during the use of inhaled steroids in children with asthma in the Netherlands

    NARCIS (Netherlands)

    de Vries, T.W.; de Langen-Wouterse, J J; van Puijenbroek, E; Duiverman, E J; de Jong-Van den Berg, L T W

    2006-01-01

    Objective: Inhaled corticosteroids (ICS) are widely used in the treatment of asthma. We studied the suspected adverse drug reactions (sADRs) reported during the use of ICS in the Netherlands. Methods: In the Netherlands, health professionals and patients can report suspected ADRs to the Pharmacovigi

  11. 45 CFR 60.11 - Reporting adverse actions on clinical privileges.

    Science.gov (United States)

    2010-10-01

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

  12. The educational patterning of health-related adversities in individuals with major depression

    NARCIS (Netherlands)

    Klabbers, G.; Bosma, H.; Van der Does, A. J. W.; Vogelzangs, N.; Kempen, G. I. J. M.; Van Eijk, J. Th. M.; Penninx, B. W. J. H.

    2010-01-01

    Background: Major depressive disorder and depression severity are socially patterned, disfavouring individuals from lower socioeconomic groups. Depressive disorders are associated with several adverse health-related outcomes. We examined the educational patterning of somatic health, lifestyles,

  13. 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.

  14. Surveillance of suspected adverse reactions to natural health products: the case of propolis.

    Science.gov (United States)

    Menniti-Ippolito, Francesca; Mazzanti, Gabriela; Vitalone, Annabella; Firenzuoli, Fabio; Santuccio, Carmela

    2008-01-01

    Natural health products are promoted to the public as equally or more effective and less toxic than conventional drugs. However, some 'natural' medicines are known to have adverse effects. From April 2002 to August 2007, 18 suspected adverse reactions associated with propolis-containing products were reported to the national surveillance system of natural health products, coordinated by the Italian National Health Institute. Sixteen reports concerned allergic reactions (with dermatological or respiratory symptoms), while two concerned the digestive tract. Some of the reactions were serious: six patients were admitted to hospital or visited an emergency department and in two of these a life-threatening event was reported. In seven patients (four of whom were children), an allergic predisposition was indicated. Propolis, a resinous substance collected by honeybees from the buds of living plants, has been used for several purposes (dermatitis, laryngitis, oral ulcers) because of its wide range of suggested activities (antibacterial, antiviral, antifungal, anti-inflammatory, antioxidant and chemopreventive actions). However, propolis is also a potent sensitizer and should not be used in patients with an allergic predisposition, in particular an allergy to pollen. In Italy, products containing bee derivatives (bee pollen, royal jelly or propolis) are available to the public as food supplements. No label warning of possible adverse reactions is found on the packaging, although it is well known that atopic and asthmatic individuals may be at an increased risk of allergic reactions after using these products. The public and healthcare practitioners should be aware of the risk of allergic reactions to products derived from bees and a warning should be added to the packaging of these products.

  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

    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....

  16. Pathways from childhood abuse and other adversities to adult health risks: The role of adult socioeconomic conditions.

    Science.gov (United States)

    Font, Sarah A; Maguire-Jack, Kathryn

    2016-01-01

    Adverse childhood experiences (ACEs), including child abuse, have been linked with poor health outcomes in adulthood. The mechanisms that explain these relations are less understood. This study assesses whether associations of ACEs and health risks are mediated by adult socioeconomic conditions, and whether these pathways are different for maltreatment than for other types of adversities. Using the Behavioral Risk Factor Surveillance System 2012 survey (N=29,229), we employ structural equation modeling to (1) estimate associations of the number and type of ACEs with five health risks-depression, obesity, tobacco use, binge drinking, and self-reported sub-optimal health; and (2) assess whether adult socioeconomic conditions-marriage, divorce and separation, educational attainment, income and insurance status-mediate those associations. Findings suggest both direct and indirect associations between ACEs and health risks. At high numbers of ACEs, 15-20% of the association between number of ACEs and adult health risks was attributable to socioeconomic conditions. Associations of three ACEs (exposure to domestic violence, parental divorce, and residing with a person who was incarcerated) with health risks were nearly entirely explained by socioeconomic conditions in adulthood. However, child physical, emotional, and sexual abuse were significantly associated with several adult health risks, beyond the effects of other adversities, and socioeconomic conditions explained only a small portion of these associations. These findings suggest that the pathways to poor adult health differ by types of ACEs, and that childhood abuse is more likely than other adversities to have a direct impact.

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

    Science.gov (United States)

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

    2016-01-01

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

  18. Equilibria in health exchanges: Adverse selection vs. reclassification risk

    OpenAIRE

    Van Handel, Ben; Hendel, Igal; Michael D. Whinston

    2015-01-01

    This paper studies regulated health insurance markets known as exchanges, motivated by their inclusion in the Affordable Care Act (ACA). We use detailed health plan choice and utilization data to model individual-level projected health risk and risk preferences. We combine the estimated joint distribution of risk and risk preferences with a model of competitive insurance markets to predict outcomes under different regulations that govern insurers' ability to use health status information in p...

  19. Risky music listening, permanent tinnitus and depression, anxiety, thoughts about suicide and adverse general health.

    Directory of Open Access Journals (Sweden)

    Ineke Vogel

    Full Text Available OBJECTIVE: To estimate the extent to which exposure to music through earphones or headphones with MP3 players or at discotheques and pop/rock concerts exceeded current occupational safety standards for noise exposure, to examine the extent to which temporary and permanent hearing-related symptoms were reported, and to examine whether the experience of permanent symptoms was associated with adverse perceived general and mental health, symptoms of depression, and thoughts about suicide. METHODS: A total of 943 students in Dutch inner-city senior-secondary vocational schools completed questionnaires about their sociodemographics, music listening behaviors and health. Multiple logistic regression analyses were used to examine associations. RESULTS: About 60% exceeded safety standards for occupational noise exposure; about one third as a result of listening to MP3 players. About 10% of the participants experienced permanent hearing-related symptoms. Temporary hearing symptoms that occurred after using an MP3 player or going to a discotheque or pop/rock concert were associated with exposure to high-volume music. However, compared to participants not experiencing permanent hearing-related symptoms, those experiencing permanent symptoms were less often exposed to high volume music. Furthermore, they reported at least two times more often symptoms of depression, thoughts about suicide and adverse self-assessed general and mental health. CONCLUSIONS: Risky music-listening behaviors continue up to at least the age of 25 years. Permanent hearing-related symptoms are associated with people's health and wellbeing. Participants experiencing such symptoms appeared to have changed their behavior to be less risky. In order to induce behavior change before permanent and irreversible hearing-related symptoms occur, preventive measurements concerning hearing health are needed.

  20. Awareness among nurses about reporting of adverse drug reactions in Sweden

    Science.gov (United States)

    Ekman, Elisabet; Petersson, Göran; Tågerud, Sven; Bäckström, Martin

    2012-01-01

    Background The purpose of this study was to investigate awareness among nurses regarding their new role as reporters of adverse drug reactions in Sweden and factors that may influence reporting by nurses. Methods In 2007, all nurses were included in the adverse drug reaction reporting scheme in Sweden. A questionnaire was sent to 753 randomly selected nurses in September 2010. Results Of the 453 (60%) responding nurses, 265 (58%) were aware that nurses were included in the reporting of adverse drug reactions. Sixty-one nurses (14%) stated that they had reported an adverse drug reaction. Fifteen percent (n = 70) of the respondents had received training about reporting of adverse drug reactions. Almost one third of these (n = 21, 30%) had reported an adverse drug reaction on at least one occasion. Among nurses without training, a smaller proportion (n = 40, 11%, P < 0.05) had reported an adverse drug reaction on at least one occasion. The two factors considered most important by nurses for reporting were the severity of the adverse drug reaction and if the reaction was to a newly approved drug. A majority of the nurses (n = 397, 88%) were interested in a training course in pharmacology as part of their ongoing professional development. One third (32%) of all nurses stated that one reason for not reporting a suspected adverse drug reaction was that the physician responsible did not regard the reaction necessary to report. Conclusion We found that more than half of the study population of nurses in Sweden were aware of their new role as reporters of adverse drug reactions, but few of the responding nurses had reported an adverse drug reaction. Given that training seems to be associated with high reporting frequency, we suggest more training in pharmacovigilance for nurses. PMID:22826643

  1. 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.

  2. Between Pregnancy and Motherhood: Identifying Unmet Mental Health Needs in Pregnant Women with Lifetime Adversity

    Science.gov (United States)

    Narayan, Angela J.; Thomas, Melanie; Nau, Melissa; Rivera, Luisa M.; Harris, William W.; Bernstein, Rosemary E.; Castro, Gloria; Lieberman, Alicia F.; Gantt, Tahnee

    2017-01-01

    The prenatal period represents an opportunity to buffer the intergenerational transmission of adversity through integrated, comprehensive perinatal health services for women experiencing high levels of adversity and clinical symptoms. This article presents preliminary descriptive data, drawn from an ongoing clinical research study, on prenatal…

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

    Science.gov (United States)

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

    2015-06-09

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

  4. Adverse medical complications: an under-reported contributory cause of death in New York City.

    Science.gov (United States)

    Gill, J R; Ely, S F; Toriello, A; Hirsch, C S

    2014-04-01

    The current death certification system in the USA fails to accurately track deaths due to adverse medical events. The aim of this study was to demonstrate the under-reporting of deaths due to adverse medical events due to limitations in the current death certification/reporting system, and the benefits of using the term 'therapeutic complication' as the manner of death. Retrospective review and comparison of death certificates and vital statistical coding. The manner of death is certified as a therapeutic complication when death is caused by predictable complications of appropriate therapy, and would not have occurred but for the medical intervention. Based on medical examiner records, complications that caused or contributed to deaths over a five-year period were examined retrospectively. These fatalities were compared with deaths coded as medical and surgical complications by the New York City Bureau of Vital Statistics. The Medical Examiner's Office certified 2471 deaths as therapeutic complications and 312 deaths as accidents occurring in healthcare facilities. In contrast, the New York City Bureau of Vital Statistics reported 188 deaths due to complications of medical and surgical care. Use of the term 'therapeutic complication' as the manner of death identified nearly 14 times more deaths than were reported by the New York City Bureau of Vital Statistics. If these therapeutic complications and medical accidents were considered as a 'disease', they would rank as the 10th leading cause of death in New York City, surpassing homicides and suicides in some years. Nationwide policy shifts that use the term 'therapeutic complication' would improve the capture and reporting of these deaths, thus allowing better identification of fatal adverse medical events in order to focus on and assess preventative strategies. Copyright © 2013 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    Dos Santos Mesquita, Cristina; da Costa Maia, Ângela

    2016-12-01

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

  6. The Observatory Health Report

    Directory of Open Access Journals (Sweden)

    Laura Murianni

    2008-06-01

    Full Text Available

    Background: The number of indicators aiming to provide a clear picture of healthcare needs and the quality and efficiency of healthcare systems and services has proliferated in recent years. The activity of the National Observatory on Health Status in the Italian Regions is multidisciplinary, involving around 280 public health care experts, clinicians, demographers, epidemiologists, mathematicians, statisticians and economists who with their different competencies, and scientific interests aim to improve the collective health of individuals and their conditions through the use of “core indicators”. The main outcome of the National Observatory on Health Status in the Italian Regions is the “Osservasalute Report – a report on health status and the quality of healthcare assistance in the Italian Regions”.

    Methods: The Report adopts a comparative analysis, methodology and internationally validated indicators.

    Results: The results of Observatory Report show it is necessary:

    • to improve the monitoring of primary health care services (where the chronic disease could be cared through implementation of clinical path;

     • to improve in certain areas of hospital care such as caesarean deliveries, as well as the average length of stay in the pre-intervention phase, etc.;

    • to try to be more focused on the patients/citizens in our health care services; • to practice more geographical interventions to reduce the North-South divide as well as reduce gender inequity.

    Conclusions: The health status of Italian people is good with positive results and outcomes, but in the meantime some further efforts should be done especially in the South that still has to improve the quality and the organization of health care services. There are huge differences in accuracy and therefore usefulness of the reported data, both between diseases and between

  7. Adverse health outcomes in offspring of mothers with cosmetic breast implants : A review

    NARCIS (Netherlands)

    Kjoller, Kim; Friis, Soren; Lipworth, Loren; McLaughlin, Joseph K.; Olsen, Jorgen H.

    2007-01-01

    Background: To assess whether maternal cosmetic breast implants are associated with adverse health outcomes among offspring, the authors examined published findings of epidemiologic studies that addressed this hypothesis. Methods: Four epidemiologic studies, ail from Scandinavia, were identified. Wo

  8. Adverse effects of depression on glycemic control and health outcomes in people with diabetes

    DEFF Research Database (Denmark)

    Pouwer, Francois; Nefs, Giesje; Nouwen, Arie

    2013-01-01

    In the past decades, important advances have been achieved in the psychological aspects of diabetes. This article reviews the associations between diabetes, depression, and adverse health outcomes. The article provides an update on the literature regarding the prevalence of depression in diabetes......, discusses the impact of depression on diabetes self-care and glycemic control in people with diabetes, and summarizes the results of longitudinal studies that have investigated depression as a risk factor for adverse health outcomes....

  9. Rate of influenza vaccination and its adverse reactions seen in health care personnel in a single tertiary hospital in Korea.

    Science.gov (United States)

    Lee, Chang-Seop; Lee, Kang-Hyu; Jung, Min-Hee; Lee, Heung-Bum

    2008-11-01

    To determine the vaccination rate and its adverse reactions after influenza vaccination, we administered an anonymous questionnaire survey during the last three influenza seasons from 2005-2006 to 2007-2008. In total, the rate of Influenza vaccination was 82.3% in health-care personnel. Dividing the subjects into four groups by work category, the vaccine coverage rates were as follows: physicians 67.9%; nurses and nursing assistants 91.2%; technicians, pharmacists, therapists, and administrative personnel 80.2%; and other personnel not directly involved in patient care but having the potential of being exposed to infectious agents 89%. The most frequent adverse reaction after vaccination was soreness at the injection site in 33.4%, followed by skin redness in 18.1%, myalgia in 17.7%, fatigue in 17%, and febrile sensation in 15.2%. After vaccination, such adverse reactions began within 24 h in 70.6% of subjects. Eighty-nine percent of those adverse reactions persisted for 1-3 days, but 11% persisted more than 4 days. Serious adverse reactions were not noted; the reported adverse reactions were relatively minor and transient. Surprisingly, among those who were vaccinated, the physicians' participation was the lowest. We believe that influenza vaccination is safe and that physicians should be more concerned with influenza vaccination and its impact on the health-care community.

  10. Exploring the relationship between childhood adversity and oral health: An anecdotal approach and integrative view.

    Science.gov (United States)

    Kirkengen, Anna Luise; Lygre, Henning

    2015-08-01

    During the past two decades, increasing recognition has been given to a relationship between oral health and systemic diseases. Associated systemic conditions include cardiovascular disease, diabetes, low birth weight and preterm births, respiratory diseases, rheumatoid arthritis, obesity, osteoporosis, and, in particular among oral conditions, periodontal disease. Low-grade inflammation is a common denominator linking these disorders. Applying an anecdotal approach and an integrative view, the medical and dental histories of two women document increasing ill health subsequent to incidences of maltreatment and sexual abuse, including oral penetration, at an early age. Comprehensive oral rehabilitation was required in both cases. These cases open for medical insight with regard to their implicit patho-physiology, when integrated with current evidence from neuroscience, endocrinology, and immunology, converging in the concepts of allostasis and allostatic load. In cases such as those presented in this paper, primary care physicians (family doctors, General Practitioners) and dentists may be the first to identify an etiological pattern. This report underlines the importance of increased and enhanced multidisciplinary research cooperation among health professionals. Our hypothesis is that childhood adversity may affect all aspects of human health, including adult oral health.

  11. Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Maša Amrain

    2014-09-01

    Full Text Available Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR reporting was performed.Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.Results: Of the 1000 respondents, 870 (87% completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH. Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4% of surveyed health care professionals reported adverse drug reaction.Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

  12. 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.

  13. The uses and adverse effects of beryllium on health

    DEFF Research Database (Denmark)

    Cooper, Ross G.; Harrison, Adrian Paul

    2009-01-01

    Context: This review describes the health effects of beryllium exposure in the workplace and the environment. Aim: To collate information on the consequences of occupational and environmental exposure to beryllium on physiological function and well being. Materials and Methods: The criteria used...... in the current review for selecting articles were adopted from proposed criteria in The International Classification of Functioning, Disability, and Health. Articles were classified based on acute and chronic exposure and toxicity of beryllium. Results: The proportions of utilized and nonutilized articles were...... published in sources unobtainable through requests at the British Library, and some had no impact factor and were excluded. Conclusion: Beryllium has some useful but undoubtedly harmful effects on health and well-being. Measures needed to be taken to prevent hazardous exposure to this element, making its...

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

    OpenAIRE

    Puspitasari, Irma M.; Soegijardjo Soegijoko

    2012-01-01

    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, installa...

  15. Adverse health effects of ethylene oxide and occupational exposure limits.

    Science.gov (United States)

    Sheikh, K

    1984-01-01

    The proposed revision of the US standard for occupational exposure to ethylene oxide has recently been topical and controversial. Most of the recent experimental and epidemiological evidence of health effects, which provoked lowering the permissible exposure limit, appears to be unreliable and insufficient for risk assessment.

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

    Science.gov (United States)

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

    2010-11-01

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

  17. The attitudes of pharmacists and physicians in Bosnia and Herzegovina towards adverse drug reaction reporting

    Directory of Open Access Journals (Sweden)

    Tarik Catic

    2016-04-01

    Full Text Available Introduction: Adverse drug reactions (ADRs are threat to the patient’s safety and the quality of life, and they increase the cost of health care. Spontaneous ADR reporting system mainly relies on physicians, but also pharmacists, nurses, and even patients. The aim of this study was to explore attitudes, barriers, and possible improvements to ADR reporting practices in Bosnia and Herzegovina.Methods: A self-reported questionnaire was developed to collect data on the perception of pharmacovigilance practice and ADR reporting. The survey was conducted in the period between September, 2014 and October, 2014.Results: The response rate was 73% (44 of 60 and 93% (148 of 160 among the pharmacist and family medicine physician groups, respectively. Regarding the attitudes to pharmacovigilance practice and reporting, both the pharmacists and physicians found the practices important. The majority of pharmacists and physicians in year 2014 did not report any ADR, while 18% of the pharmacists and 12% of the physicians, who participated in this study, reported one ADR. Reporting procedure, uncertainty, and their exposure were the main barriers to reporting ADRs for the pharmacists. The physicians claimed lack of knowledge to whom to report an ADR as the main barrier. A significant number of the respondents thought that additional education in ADR reporting would have a positive impact, and would increase the ADR reporting rate.Conclusions: Despite the overall positive attitude towards ADR reporting, the reporting rate in Bosnia and Herzegovina is still low. Different barriers to the ADR reporting have been identified, and there is also the need for improvements in the traditional education in this field.

  18. Attention-deficit/hyperactivity disorder and adverse health outcomes

    Science.gov (United States)

    Nigg, Joel

    2015-01-01

    Attention-deficit/hyperactivity disorder (ADHD) is defined by extreme levels of inattention–disorganization and/or hyperactivity–impulsivity. In DSM-IV, the diagnostic criteria required impairment in social, academic, or occupational functioning. With DSM-5 publication imminent in 2013, further evaluation of impairment in ADHD is timely. This article reviews the current state of knowledge on health-related impairments of ADHD, including smoking, drug abuse, accidental injury, sleep, obesity, hypertension, diabetes, and suicidal behavior. It concludes by suggesting the need for new avenues of research on mechanisms of association and the potential for ADHD to be an early warning sign for secondary prevention of some poor health outcomes. PMID:23298633

  19. School health report card.

    Science.gov (United States)

    Presswood, Rebecca F

    2005-09-01

    School nurses all across the nation perform valuable screenings every year for the students in their schools. These screenings identify abnormalities that have the potential to affect their education. With skill and determination, a variety of health screenings are performed and the results communicated with the parents of the children. A health "report card" is a proposed method of communicating vital health screening information, including the height, weight, and BMI of every student. This is directly related to the epidemic of childhood obesity. Current life styles promote minimal exercise and increased consumption of food that has minor nutritional value. It is time to identify affected children and become engaged in resolving this health crisis, by teaching this nation's children behaviors that will result in optimal health.

  20. Adverse selection: does it preclude a competitive health insurance market?

    Science.gov (United States)

    Sloan, F A

    1992-10-01

    In sum, although fixed dollar subsidies have the great virtue of ferreting out cross subsidies, society may not be satisfied with the results. The scenario described by Marquis is only one of many. People seem to want lifetime insurance offering low premiums if things go bad rather than premiums that change annually as health outcomes are realized [see, e.g., Light (1992)]. But nondiversible risk may be too great for a market in life contracts to exist.

  1. Adverse health outcome of cosmetologists and hairdressers : a systematic review

    OpenAIRE

    2015-01-01

    Introduction: The number of cosmetologists and hairdressers is increasing. According to the data of US Bureau of Labor Statistics in 1991, there were more than half million people worked as cosmetologists in America. The number is keeping increasing during decades. In 2008, the number of licensed manicurists has increased by 345%, to more than 393000 since 1991 and the 10-year employment growth of nail technicians is 28%. The booming of cosmetologists leads to many potential health problems. ...

  2. The uses and adverse effects of beryllium on health

    Directory of Open Access Journals (Sweden)

    Cooper Ross

    2009-01-01

    Full Text Available Context: This review describes the health effects of beryllium exposure in the workplace and the environment. Aim: To collate information on the consequences of occupational and environmental exposure to beryllium on physiological function and well being. Materials and Methods: The criteria used in the current review for selecting articles were adopted from proposed criteria in The International Classification of Functioning, Disability, and Health. Articles were classified based on acute and chronic exposure and toxicity of beryllium. Results: The proportions of utilized and nonutilized articles were tabulated. Years 2001-10 gave the greatest match (45.9% for methodological parameters, followed by 27.71% for 1991-2000. Years 1971-80 and 1981-90 were not significantly different in the information published and available whereas years 1951-1960 showed a lack of suitable articles. Some articles were published in sources unobtainable through requests at the British Library, and some had no impact factor and were excluded. Conclusion: Beryllium has some useful but undoubtedly harmful effects on health and well-being. Measures need to be taken to prevent hazardous exposure to this element, making its biological monitoring in the workplace essential.

  3. Optimal quality reporting in markets for health plans.

    Science.gov (United States)

    Glazer, Jacob; McGuire, Thomas G

    2006-03-01

    Quality reports about health plans and providers are becoming more prevalent in health care markets. This paper casts the decision about what information to report to consumers about health plans as a policy decision. In a market with adverse selection, complete information about quality leads to inefficient outcomes. In a Rothschild-Stiglitz model, we show that averaging quality information into a summary report can enforce pooling in health insurance, and by choice of the right weights in the averaged report, a payer or regulator can induce first-best quality choices. The optimal quality report is as powerful as optimal risk adjustment in correcting adverse selection inefficiencies.

  4. Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.

    Science.gov (United States)

    Kalaiselvan, Vivekanandan; Sharma, Surbhi; Singh, Gyanendra Nath

    2014-09-01

    Contrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval. Our objective was to identify the pattern and characteristics of adverse reactions attributed to contrast media in the Indian population reported to the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI). Individual case safety reports (ICSRs) attributed to contrast media submitted spontaneously to the NCC-PvPI were extracted from the database for July 2010 to September 2013. We analysed these reports for information related to reporter's professional category, patient's age and sex, reporter's diagnosis of the reaction, seriousness of the reaction, type of contrast media exposure, system organ class (SOC) affected (as described in World Health Organization Adverse Reaction Terminology [WHO-ART]) and outcome. Of the total 59,915 ICSRs in the database, 415 (0.7%) were suspected adverse reactions to contrast media; 44 reports were serious, including three fatal cases. The most affected SOCs were skin and appendage disorders, body as a whole-general disorders, gastrointestinal system disorders and respiratory system disorders. Hypersensitivity reactions were reported in the majority of ICSRs. The contrast media with the highest number of reports were iohexol (40.7%), iomeprol (17.8%), iopamidol (12%) and diatrizoate (12%). Most of the reactions to contrast media were allergic-like, and no previously unrecognised adverse reactions were observed in the Indian population. Further data and increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions attributed to contrast media.

  5. Mobile phone base stations and adverse health effects: phase 1 of a population-based, cross-sectional study in Germany

    DEFF Research Database (Denmark)

    Blettner, M; Schlehofer, B; Breckenkamp, J

    2009-01-01

    .7% of participants were concerned about adverse health effects of mobile phone base stations, while an additional 10.3% attributed their personal adverse health effects to the exposure from them. Participants who were concerned about or attributed adverse health effects to mobile phone base stations and those living...... in the vicinity of a mobile phone base station (500 m) reported slightly more health complaints than others. CONCLUSIONS: A substantial proportion of the German population is concerned about adverse health effects caused by exposure from mobile phone base stations. The observed slightly higher prevalence......OBJECTIVE: The aim of this first phase of a cross-sectional study from Germany was to investigate whether proximity of residence to mobile phone base stations as well as risk perception is associated with health complaints. METHODS: The researchers conducted a population-based, multi-phase, cross...

  6. Adverse effects of methylmercury: environmental health research implications

    DEFF Research Database (Denmark)

    Grandjean, Philippe; Satoh, Hiroshi; Murata, Katsuyuki;

    2010-01-01

    the recognition of methylmercury as a cause of serious human poisonings in Minamata, Japan. Developmental neurotoxicity was first reported in 1952, but despite accumulating evidence, the vulnerability of the developing nervous system was not taken into account in risk assessment internationally until...

  7. How is leflunomide prescribed and used in Australia? Analysis of prescribing and adverse effect reporting.

    Science.gov (United States)

    Chan, Vivien; Tett, Susan E

    2006-07-01

    To evaluate the use of leflunomide in the Australian community since introduction in 2000. Trends in adverse drug reaction (ADR) reporting were also studied. Annual Australian prescription and dispensing statistics were analysed. Drug utilisation was estimated as defined daily doses (DDD)/1000 inhabitants/day. ADR data from the Therapeutic Goods Administration's Adverse Drug Reactions Advisory Committee (ADRAC) national monitoring system were compared with the World Health Organisation (WHO) Vigibase records. Leflunomide use in Australia (dispensing data) increased from 0.2 in 2000 to 0.4 DDD/1000 inhabitants/day in 2002. The same overall pattern was observed in the 'authority to prescribe' data. From 2000-2002, prescribing of the starter pack (3 x 100 mg loading dose plus 30 x 20 mg tablets) declined (down 74%); likewise for the 20 mg (30 tablets) pack. Gradual increases were noted for the 10 mg (30 tablets) pack (up 40%). Approximately 135 reports, detailing about 370 individual ADR, were generated annually. Gastro-intestinal disorders predominated, accounting for 24% of reactions reported to ADRAC. Skin and appendages disorders constituted 14% of reported reactions. Deaths in leflunomide users were attributed to a combination of haematological and gastro-intestinal complications, but it was not possible to ascertain other medication usage or contributing factors. Trends observed with the ADRAC reports were consistent with the WHO database. Leflunomide was the first registered DMARD in Australia in over a decade and its use has increased within the community. The ADR reports might have contributed to Australian rheumatologists gradually abandoning loading patients with high doses of leflunomide in favour of starting therapy at lower doses. Copyright (c) 2006 John Wiley & Sons, Ltd.

  8. A joint ERS/ATS policy statement: what constitutes an adverse health effect of air pollution? An analytical framework.

    Science.gov (United States)

    Thurston, George D; Kipen, Howard; Annesi-Maesano, Isabella; Balmes, John; Brook, Robert D; Cromar, Kevin; De Matteis, Sara; Forastiere, Francesco; Forsberg, Bertil; Frampton, Mark W; Grigg, Jonathan; Heederik, Dick; Kelly, Frank J; Kuenzli, Nino; Laumbach, Robert; Peters, Annette; Rajagopalan, Sanjay T; Rich, David; Ritz, Beate; Samet, Jonathan M; Sandstrom, Thomas; Sigsgaard, Torben; Sunyer, Jordi; Brunekreef, Bert

    2017-01-01

    The American Thoracic Society has previously published statements on what constitutes an adverse effect on health of air pollution in 1985 and 2000. We set out to update and broaden these past statements that focused primarily on effects on the respiratory system. Since then, many studies have documented effects of air pollution on other organ systems, such as on the cardiovascular and central nervous systems. In addition, many new biomarkers of effects have been developed and applied in air pollution studies.This current report seeks to integrate the latest science into a general framework for interpreting the adversity of the human health effects of air pollution. Rather than trying to provide a catalogue of what is and what is not an adverse effect of air pollution, we propose a set of considerations that can be applied in forming judgments of the adversity of not only currently documented, but also emerging and future effects of air pollution on human health. These considerations are illustrated by the inclusion of examples for different types of health effects of air pollution. Copyright ©ERS 2017.

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

    Directory of Open Access Journals (Sweden)

    Rosliana Rosli

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

  10. 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.…

  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. Cumulative Adverse Financial Circumstances: Associations with Patient Health Status and Behaviors

    Science.gov (United States)

    Bisgaier, Joanna; Rhodes, Karin V.

    2011-01-01

    This article examines associations between cumulative adverse financial circumstances and patient health in a sample of 1,506 urban emergency department (ED) patients. Study participants completed a previously validated Social Health Survey between May and October 2009. Five categories of economic deprivation were studied: food insecurity, housing…

  13. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

    OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs

  14. 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

  15. 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

  16. Knowledge, Attitude, and Practice towards Medication Errors and Adverse Drug Reaction Reporting among Medicine Students

    Directory of Open Access Journals (Sweden)

    Maryam Aghakouchakzadeh

    2017-03-01

    Full Text Available Background: The most common types of medical error are medication errors (MEs which defined as any preventable event that may be caused by an inappropriate medication usage and lead to an adverse drug reaction (ADR event in patients. In recent years, different approaches have been proposed to reduce MEs, one of which is reporting ADRs. The present study was designed to assess the Knowledge, Attitude and Practice (KAP of medicine students towards MEs and ADRs reporting.Method: The validated 12-item questionnaire included subsequently 4 questions, 5 items and the final 3 questions related to the knowledge, attitude, and practice that was given to each participant before and after of the clerkship course. The study population were 40 students of fourth-year of medicine.Results: Demographic features of the participants have no significant difference. Medicine students had a poor KAP towards MEs. Only 8% of respondents had general knowledge about MEs and 50% of students believed MEs are inevitable events, less than 20% of them were acquainted with 5 rules of prescriptions. Students had good knowledge and attitude but poor practice towards ADRs reporting. 55% of participants were aware of their responsibility of ADRs reporting but only 5% of respondents were acquainted with ADRs reporting method and the ADR center in the hospitals.Conclusion: The educational intervention, alteration in medicine student’s curriculum, and hold the interactive clerkship for health care professionals can improve the KAP towards ADRs reporting and diminish of the preventable medication errors.

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

    Science.gov (United States)

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

    2016-01-01

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

  18. 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.

  19. Poor social relations and adverse health behaviour: stronger associations in low socioeconomic groups?

    Science.gov (United States)

    Weyers, Simone; Dragano, Nico; Möbus, Susanne; Beck, Eva-Maria; Stang, Andreas; Möhlenkamp, Stephan; Jöckel, Karl Heinz; Erbel, Raimund; Siegrist, Johannes

    2010-02-01

    Poor social relations are supposed to contribute to adverse health behaviour. We examined this association and the role of low socio-economic position. We regressed health behaviour on composite variables of the two exposures of social relations and socio-economic position (SEP). Social relations included networks and support; health behaviour was analysed in terms of smoking, poor nutrition and physical inactivity; socio-economic position comprised of income and education. Cross sectional data from a population based epidemiological study in German (4,814 men and women aged 45-75) was analysed. Among the indicators for social relations, social isolation was consistently associated with adverse health behaviour; social support showed modest effect. A combination of poor social relations and low SEP displayed stronger (additive) associations with adverse health behaviour than each factor alone. However, superadditivity was excluded. Given the important role of health adverse behaviour in chronic disease development, results underline the relevance of social environment and socio-economic structure in Public Health interventions.

  20. Self-reported drunkenness among adolescents in four sub-Saharan African countries: associations with adverse childhood experiences

    Directory of Open Access Journals (Sweden)

    Crichton Joanna

    2010-06-01

    Full Text Available Abstract Background Consumption of alcohol is associated with acute and chronic adverse health outcomes. There is a paucity of studies that explore the determinants of alcohol use among adolescents in sub-Saharan Africa and, in particular, that examine the effects of adverse childhood experiences on alcohol use. Methods The paper draws on nationally-representative data from 9,819 adolescents aged 12-19 years from Burkina Faso, Ghana, Malawi, and Uganda. Logistic regression models were employed to identify correlates of self-reported past-year drunkenness. Exposure to four adverse childhood experiences comprised the primary independent variables: living in a food-insecure household, living with a problem drinker, having been physically abused, and having been coerced into having sex. We controlled for age, religiosity, current schooling status, the household head's sex, living arrangements, place of residence, marital status, and country of survey. All analyses were conducted separately for males and females. Results At the bivariate level, all independent variables (except for coerced sex among males were associated with the outcome variable. Overall, 9% of adolescents reported that they had been drunk in the 12 months preceding the survey. In general, respondents who had experienced an adverse event during childhood were more likely to report drunkenness. In the multivariate analysis, only two adverse childhood events emerged as significant predictors of self-reported past-year drunkenness among males: living in a household with a problem drinker before age 10, and being physically abused before age 10. For females, exposure to family-alcoholism, experience of physical abuse, and coerced sex increased the likelihood of reporting drunkenness in the last 12 months. The association between adverse events and reported drunkenness was more pronounced for females. For both males and females there was a graded relationship between the number of

  1. A prospective analysis of the preventability of adverse drug reactions reported in Sweden.

    Science.gov (United States)

    Lövborg, Henrik; Eriksson, Linda Ring; Jönsson, Anna K; Bradley, Thomas; Hägg, Staffan

    2012-08-01

    Adverse drug reactions (ADRs) are a major patient safety issue, and a substantial proportion of ADRs are, in fact, preventable. The aim of this study was to describe the proportion and pattern of preventable ADRs in spontaneously reported suspected ADRs and to study the feasibility of using data from an ADR reporting system for this purpose. All reports of ADRs, except those in which a vaccine was the suspected drug, submitted to the regional pharmacovigilance center of southeastern Sweden between 2008 and 2009 were analyzed. Causality between the suspected ADR and the medication was assessed using the World Health Organization (WHO) criteria, and preventability was assessed using Hallas criteria. During the study period, 1,290 ADRs were received and 1,255 were classified as having at least a possible causality between a reaction and a drug. Of these, 172 (14%) ADRs were considered preventable, 35 (20%) were classified as definitely preventable, and 137 (80%) as possibly preventable. Of all preventable ADRs, 96 (56%) were related to prescribing, 35 (20%) to administration, and 41 (24%) to clinical and laboratory monitoring of treatment. Warfarin, oxycodone, and ioversol were the most common drugs with preventable ADRs. This study found that a substantial part of reported ADRs are preventable. Most of these are related to drug prescription, suggesting that interventions aiming to reduce preventable ADRs should focus on this process. Moreover, systems for ADR reporting may be useful in the mission of reducing the unsafe use of drugs.

  2. 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.

  3. Adverse health effects of occupational exposure to radiofrequency radiation in airport surveillance radar operators

    Directory of Open Access Journals (Sweden)

    Naser Dehghan

    2013-01-01

    Full Text Available Introduction: Radar workers are exposed to pulsed high frequency electromagnetic fields. In this study, health effects of these radiations in personnel who routinely work with radar systems are investigated. Materials and Methods: The 28-item General Health Questionnaire was used as a self-administered tool for assessment of general mental health and mental distress. One hundred workers occupationally exposed to radar radiations (14-18 GHz participated in the study. Visual reaction time was recorded with a simple blind computer-assisted-visual reaction time test. To assess the short-term memory, Wechsler Memory Scale-III test was performed. Results: Twenty to 39% of the radar workers reported different problems such as needing a good tonic, feeling run down and out of sorts, headache, tightness or pressure in the head, insomnia, getting edgy and bad-tempered. Furthermore, 47% of the radar workers reported feeling under strain. In response to this question that if they have been able to enjoy their normal day-to-day activities, 31% responded "less than usual". It was also shown that work experience had significant relationships with reaction time and short-term memory indices i.e., forward digit span, reverse digit span, word recognition and paired words. Conclusion: To the best of our knowledge, this is the first study to show that occupational exposure to radar microwave radiation leads to changes in somatic symptoms, anxiety and insomnia, social dysfunction, and severe depression. Altogether these results indicate that occupational exposure to radar microwave radiations may be linked to some adverse health effects.

  4. What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? : Experiences from reports to consumer association

    OpenAIRE

    2011-01-01

    Background According to the World Health Organization (WHO) the cost of adverse drug reactions   (ADRs) in the general population is high and under-reporting by health professionals   is a well-recognized problem. Another way to increase ADR reporting is to let the   consumers themselves report directly to the authorities. In Sweden it is mandatory   for prescribers to report serious ADRs to the Medical Products Agency (MPA), but there   are no such regulations for consumers. The non-profit a...

  5. 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.

  6. 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.

  7. The Yin: An adverse health perspective of nanoceria: uptake, distribution, accumulation, and mechanisms of its toxicity.

    Science.gov (United States)

    Yokel, Robert A; Hussain, Salik; Garantziotis, Stavros; Demokritou, Philip; Castranova, Vincent; Cassee, Flemming R

    2014-10-01

    This critical review evolved from a SNO Special Workshop on Nanoceria panel presentation addressing the toxicological risks of nanoceria: accumulation, target organs, and issues of clearance; how exposure dose/concentration, exposure route, and experimental preparation/model influence the different reported effects of nanoceria; and how can safer by design concepts be applied to nanoceria? It focuses on the most relevant routes of human nanoceria exposure and uptake, disposition, persistence, and resultant adverse effects. The pulmonary, oral, dermal, and topical ocular exposure routes are addressed as well as the intravenous route, as the latter provides a reference for the pharmacokinetic fate of nanoceria once introduced into blood. Nanoceria reaching the blood is primarily distributed to mononuclear phagocytic system organs. Available data suggest nanoceria's distribution is not greatly affected by dose, shape, or dosing schedule. Significant attention has been paid to the inhalation exposure route. Nanoceria distribution from the lung to the rest of the body is less than 1% of the deposited dose, and from the gastrointestinal tract even less. Intracellular nanoceria and organ burdens persist for at least months, suggesting very slow clearance rates. The acute toxicity of nanoceria is very low. However, large/accumulated doses produce granuloma in the lung and liver, and fibrosis in the lung. Toxicity, including genotoxicity, increases with exposure time; the effects disappear slowly, possibly due to nanoceria's biopersistence. Nanoceria may exert toxicity through oxidative stress. Adverse effects seen at sites distal to exposure may be due to nanoceria translocation or released biomolecules. An example is elevated oxidative stress indicators in the brain, in the absence of appreciable brain nanoceria. Nanoceria may change its nature in biological environments and cause changes in biological molecules. Increased toxicity has been related to greater surface Ce(3

  8. Developing efficient search strategies to identify reports of adverse effects in MEDLINE and EMBASE.

    Science.gov (United States)

    Golder, Su; McIntosh, Heather M; Duffy, Steve; Glanville, Julie

    2006-03-01

    This study aimed to assess the performance, in terms of sensitivity and precision, of different approaches to searching MEDLINE and EMBASE to identify studies of adverse effects. Five approaches to searching for adverse effects evidence were identified: approach 1, using specified adverse effects; approach 2, using subheadings/qualifiers; approach 3, using text words; approach 4, using indexing terms; approach 5, searching for specific study designs. The sensitivity and precision of these five approaches, and combinations of these approaches, were compared in a case study using a systematic review of the adverse effects of seven anti-epileptic drugs. The most sensitive search strategy in MEDLINE (97.0%) required a combination of terms for specified adverse effects, floating subheadings, and text words for 'adverse effects'. In EMBASE, a combination of terms for specified adverse effects and text words for 'adverse effects' provided the most sensitive search strategy (98.6%). Both these search strategies yielded low precision (2.8%). A highly sensitive search in either database requires a combination of approaches, and has low precision. This suggests that better reporting and indexing of adverse effects is required and that an effective generic search filter may not yet be feasible.

  9. 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.

  10. A cross-cultural longitudinal examination of the effect of cumulative adversity on the mental and physical health of older adults.

    Science.gov (United States)

    Palgi, Yuval; Shrira, Amit

    2016-03-01

    Self-oriented adversity refers to traumatic events that primarily inflict the self, whereas other-oriented adversity refers to events that affect the self by primarily targeting others. The present study aimed to examine whether cultural background moderates the effects of self-oriented and other-oriented adversity on mental and physical health of older adults. Using longitudinal data from the Israeli component of the Survey of Health and Retirement, we focused on 370 Jews and 239 Arabs who reported their exposure to various adversities across the life span, and completed questionnaires regarding mental and physical health. Results showed that the effect of self-oriented adversity on health did not differ among Jews and Arabs. However, other-oriented adversity showed a stronger effect on Arabs' mental and physical health than on Jews' health. Our findings suggest that the accumulation of adverse events that affect the self by primarily targeting others may have a stronger impact in collectivist cultures than in individualist cultures.

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

    Science.gov (United States)

    Babiarz, Patryk; Widdows, Richard; Yilmazer, Tansel

    2013-10-01

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

  12. 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.

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European...... consumer for nervous system medications....

  14. Adverse drug reaction reporting by patients in the Netherlands - Three years of experience

    NARCIS (Netherlands)

    de Langen, Joyce; van Hunsel, Florence; Passier, Anneke; de Jong-van den Berg, Lolkje; van Grootheest, Kees

    2008-01-01

    Background: There has been discussion about the acceptance of adverse drug reactions (ADRs) reported by patients to spontaneous reporting systems. Lack of experience with patient reporting in real life was one of the main drawbacks in this debate. This study covers 3 years of experience with patient

  15. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2004 - February 2006 : report

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2006-06-01

    Full Text Available The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2004 to February 2006 is presented. A total of 21 reports was received in the 2-year period, continuing the decline in the number of reports to a lower figure than in any previous year. This is surprising considering the legal obligation of the veterinary professionals to report all adverse drug reactions. Once again the majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were stock remedies. Veterinarians predominantly administered these products.

  16. 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.

  17. Health Monitoring and Management for Manufacturing Workers in Adverse Working Conditions.

    Science.gov (United States)

    Xu, Xiaoya; Zhong, Miao; Wan, Jiafu; Yi, Minglun; Gao, Tiancheng

    2016-10-01

    In adverse working conditions, environmental parameters such as metallic dust, noise, and environmental temperature, directly affect the health condition of manufacturing workers. It is therefore important to implement health monitoring and management based on important physiological parameters (e.g., heart rate, blood pressure, and body temperature). In recent years, new technologies, such as body area networks, cloud computing, and smart clothing, have allowed the improvement of the quality of services. In this article, we first give five-layer architecture for health monitoring and management of manufacturing workers. Then, we analyze the system implementation process, including environmental data processing, physical condition monitoring and system services and management, and present the corresponding algorithms. Finally, we carry out an evaluation and analysis from the perspective of insurance and compensation for manufacturing workers in adverse working conditions. The proposed scheme will contribute to the improvement of workplace conditions, realize health monitoring and management, and protect the interests of manufacturing workers.

  18. Adverse childhood experiences and trauma informed care: the future of health care.

    Science.gov (United States)

    Oral, Resmiye; Ramirez, Marizen; Coohey, Carol; Nakada, Stephanie; Walz, Amy; Kuntz, Angela; Benoit, Jenna; Peek-Asa, Corinne

    2016-01-01

    Adverse childhood experiences (ACEs) are related to short- and long-term negative physical and mental health consequences among children and adults. Studies of the last three decades on ACEs and traumatic stress have emphasized their impact and the importance of preventing and addressing trauma across all service systems utilizing universal systemic approaches. Current developments on the implementation of trauma informed care (TIC) in a variety of service systems call for the surveillance of trauma, resiliency, functional capacity, and health impact of ACEs. Despite such efforts in adult medical care, early identification of childhood trauma in children still remains a significant public health need. This article reviews childhood adversity and traumatic toxic stress, presents epidemiologic data on the prevalence of ACEs and their physical and mental health impacts, and discusses intervention modalities for prevention.

  19. '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.

  20. The economic cost of adverse health effects from wildfire-smoke exposure: A review

    Science.gov (United States)

    Ikuho Kochi; Geoffrey H. Donovan; Patricia A. Champ; John B. Loomis

    2010-01-01

    The economic costs of adverse health effects associated with exposure to wildfire smoke should be given serious consideration in determining the optimal wildfire management policy. Unfortunately, the literature in this research area is thin. In an effort to better understand the nature of these economic costs, we review and synthesise the relevant literature in three...

  1. Classification of Chemical Substances and Adverse Effects of Chemical Substances on Human Health

    OpenAIRE

    Söyleriz, Yüksel

    2015-01-01

    In this study, classification of chemical substances and adverse effects of chemical substances on human health in European Union and Turkey are assessed. Method In this study, national and international legislation and practices in the countries of the European Union are reviewed.

  2. Interventions in health organisations to reduce the impact of adverse events in second and third victims

    OpenAIRE

    Mira, José Joaquín; Lorenzo, Susana; Carrillo, Irene; Ferrús, Lena; Pérez-Pérez, Pastora; Iglesias, Fuencisla; Silvestre, Carmen; Olivera, Guadalupe; Zavala, Elena; Nuño-Solinís, Roberto; Maderuelo-Fernández, José Ángel; Vitaller, Julián; Astier, Pilar; ,

    2015-01-01

    Background Adverse events (AE) are also the cause of suffering in health professionals involved. This study was designed to identify and analyse organization-level strategies adopted in both primary care and hospitals in Spain to address the impact of serious AE on second and third victims. Methods A cross-sectional study was conducted in healthcare organizations assessing: safety culture; health organization crisis management plans for serious AE; actions planned to ensure transparency in co...

  3. 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.

  4. Medicinal plant reported with adverse reactions in Cuba: potential interactions with conventional drugs

    Directory of Open Access Journals (Sweden)

    Ioanna Martínez

    2015-04-01

    Full Text Available Context: Herbal drugs are a mixture of active compounds and the chemical complexity of each formulation increase with the possibility of interactions between them and conventional drugs. Many mechanisms are implicated in the interactions; scientific community has dedicated the attentions to enzymes as P-gp and CYP450. Aims: To investigate in the literature the principal plants with suspicions of adverse reactions in Cuba and their potential interactions with conventional drugs. Methods: PubMed was the database used as source of information until February 2014. Key words: Herb-Drug, Drug-Plant, Herbal–Drug, Interactions with scientific names of plants was used. Information was structured and analysed with EndNote X4. Analysis and integration of the information: Allium sativum L. (garlic was the plant with the high number of studies related with CYP450 and P-gp. Plants with great demand as Morinda citrifolia L. (noni, Psidium guajava L. (guayaba, Zingiber officinale Roscoe (ginger and Eucalyptus spp. (eucalyptus have a very small number of studies. The professionals of the health should keep in mind the possibility of interactions between herbal products and conventional drugs to increase the effectiveness of phytotherapy. Conclusions: It is necessary enhance reports and investigations and to put to disposition of the system of health information on the interactions of plants and to stimulate the investigation that offers information for the rational use of our medicinal plants.

  5. Stress, Health Behavior, and Sleep as Mediators of the Association between Loneliness and Adverse Health Conditions among Older People

    DEFF Research Database (Denmark)

    Christiansen, Julie

    Prior research has established an association between loneliness and a variety of negative health conditions among older people. However, little is known about the mechanisms underlying the association. The Loneliness Model seeks to explain the mechanisms through which chronic loneliness might...... affect the development of adverse health conditions. The present study was designed to test the explanation proposed by the Loneliness Model. The sample consisted of 8.593 elderly ranging from 65 to 103 years participating in the 2013 Public Health Survey; “How are you?”. Results showed that loneliness...... was significantly associated with poor self-rated health, cardiovascular disease, diabetes, and migraine. In addition, high perceived stress, physical inactivity, problems with alcohol, and poor sleep demonstrated an indirect effect on the association between loneliness and adverse health conditions. The findings...

  6. [The history of adverse drug reactions, relief for these health damage and safety measures in Japan].

    Science.gov (United States)

    Takahashi, Haruo

    2009-01-01

    The first remarkable adverse drug reaction (ADR) reported in Japan was anaphylactic shock caused by penicillin. Although intradermal testing for antibiotics had been exercised as prediction method of anaphylactic shock for a long time, it was discontinued in 2004 because of no evidence for prediction. The malformation of limbs, etc. caused by thalidomide was a global problem, and thalidomide was withdrawn from the market. Teratogenicity testing during new drug development has been implemented since 1963. Chinoform (clioquinol)-iron chelate was detected from green tongue and green urine in patients with subacute myelo-optic neuropathy (SMON) and identified as a causal material of SMON in 1970. Chinoform was withdrawn from the market, and a fund for relief the health damage caused by ADR was established in 1979. The co-administration of sorivudine and fluorouracil anticancer agents induced fatal agranulocytosis, and sorivudine was withdrawn from the market after being on sale for one month in 1993. The guidelines for package inserts were corrected with this opportunity, and early phase pharmacovigilance of new drugs was introduced later. Since acquired immune deficiency syndrome, and hepatitis B and C were driven by virus-infected blood products, the Ministry of Health, Labor and Welfare tightened regulations regarding biological products in 2003, and a fund for relief of health damage caused by infections driven from biological products was established in 2004. The other remarkable ADRs were quadriceps contracture induced by the repeated administration of muscular injection products and Creutzfeldt-Jakob disease caused by the transplantation of human dry cranial dura matter, etc. The significance of safety measures for drugs based on experiences related to ADRs is worthy of notice. New drugs are approved based on a benefit-risk assessment, if the expected therapeutic benefits outweigh the possible risks associated with treatment. Since unexpected, rare and serious

  7. 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

  8. 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

  9. 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

  10. Determinants of signal selection in a spontaneous reporting system for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, E P; van Grootheest, K; Diemont, W L; Leufkens, H G; Egberts, A C

    2001-01-01

    AIMS: Detection of new adverse drug reactions (ADR) after marketing is often based on a manual review of reports sent to a Spontaneous Reporting System (SRS). Among the many potential signals that are identified, only a limited number are important enough to require further attention. The goal of th

  11. Expectations for feedback in adverse drug reporting by healthcare professionals in the Netherlands

    NARCIS (Netherlands)

    Oosterhuis, Ingrid; van Hunsel, Florence P. A. M.; van Puijenbroek, Eugene P.

    2012-01-01

    Background: In 2010, the Netherlands Pharmacovigilance Centre Lareb received more than 4000 reports from healthcare professionals (HCPs). All HCPs received individual personal feedback containing information about the reported drug-adverse drug reaction (ADR) association. It is unclear what type of

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

    NARCIS (Netherlands)

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

    2003-01-01

    The primary aim of spontaneous reporting systems (SRSs) is the timely detection of unknown adverse drug reactions (ADRs), or signal detection. Generally this is carried out by a systematic manual review of every report sent to an SRS. Statistical analysis of the data sets of an SRS, or quantitative

  13. Determinants of signal selection in a spontaneous reporting system for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, E P; van Grootheest, K; Diemont, W L; Leufkens, H G; Egberts, A C

    2001-01-01

    AIMS: Detection of new adverse drug reactions (ADR) after marketing is often based on a manual review of reports sent to a Spontaneous Reporting System (SRS). Among the many potential signals that are identified, only a limited number are important enough to require further attention. The goal of

  14. Reactions to adverse incidents in the health services on Twitter: a mixed methods study

    Directory of Open Access Journals (Sweden)

    Sarah Meaney

    2015-10-01

    Full Text Available Background: Participation in social networking is commonplace and social media is transforming both health and health related research. Of the various social media platforms, Twitter must be considered a platform for rapid and immediate communication. There has been considerable national and international media coverage reporting a number of adverse incidents in the Irish maternity services. The media coverage of these adverse incidents, most recently about a cluster of perinatal deaths, stimulated much public debate including debate online. Aim: Our study aimed to explore the Twitter status updates, and subsequent responses, relating to a number of perinatal deaths which occurred in a maternity unit with approximately 2,000 births per year. Method: As this study examined Twitter status updates in relation to reported perinatal death a mixed methods approach was adopted. Firstly, status updates in English were searched utilising the Twitter search function on its website. A search was undertaken on all public status updates from January 29th 2014 to March 31st 2014 relating to the perinatal deaths. Data were quantitatively analysed in order to assess the frequency of status updates, the demographic profiles of users and to ascertain the potential reach of the status updates. Secondly qualitative analysis was employed to generate themes from the content that twitter users shared publically. Results: From January 29th 2014 to March 31st 2014, 3,577 Twitter status updates from 1,276 profiles relating to the perinatal deaths were identified. Of these, 54.1% (n=1615 were tweets, 38.9% (n=1392 were retweets and 15.9% (n=570 were replies. Over one third of all updates (36.8%; n=1317 were from profiles which identified the user as either a media outlet or media personnel. One in 10 (11.8%; 424 status updates were by those who self-identified as a parent. Twitter was not utilised as a platform by any healthcare authority to release a statement in

  15. 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...

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

    Science.gov (United States)

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

    2011-01-01

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

  17. The Identification of a Threshold of Long Work Hours for Predicting Elevated Risks of Adverse Health Outcomes.

    Science.gov (United States)

    Conway, Sadie H; Pompeii, Lisa A; Gimeno Ruiz de Porras, David; Follis, Jack L; Roberts, Robert E

    2017-07-15

    Working long hours has been associated with adverse health outcomes. However, a definition of long work hours relative to adverse health risk has not been established. Repeated measures of work hours among approximately 2,000 participants from the Panel Study of Income Dynamics (1986-2011), conducted in the United States, were retrospectively analyzed to derive statistically optimized cutpoints of long work hours that best predicted three health outcomes. Work-hours cutpoints were assessed for model fit, calibration, and discrimination separately for the outcomes of poor self-reported general health, incident cardiovascular disease, and incident cancer. For each outcome, the work-hours threshold that best predicted increased risk was 52 hours per week or more for a minimum of 10 years. Workers exposed at this level had a higher risk of poor self-reported general health (relative risk (RR) = 1.28; 95% confidence interval (CI): 1.06, 1.53), cardiovascular disease (RR = 1.42; 95% CI: 1.24, 1.63), and cancer (RR = 1.62; 95% CI: 1.22, 2.17) compared with those working 35-51 hours per week for the same duration. This study provides the first health risk-based definition of long work hours. Further examination of the predictive power of this cutpoint on other health outcomes and in other study populations is needed. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. 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...

  19. Asymmetric Information in Iranian’s Health Insurance Market: Testing of Adverse Selection and Moral Hazard

    Science.gov (United States)

    Lotfi, Farhad; Gorji, Hassan Abolghasem; Mahdavi, Ghadir; Hadian, Mohammad

    2015-01-01

    Background: Asymmetric information is one of the most important issues in insurance market which occurred due to inherent characteristics of one of the agents involved in insurance contracts; hence its management requires designing appropriate policies. This phenomenon can lead to the failure of insurance market via its two consequences, namely, adverse selection and moral hazard. Objective: This study was aimed to evaluate the status of asymmetric information in Iran’s health insurance market with respect to the demand for outpatient services. Materials/sPatients and Methods: This research is a cross sectional study conducted on households living in Iran. The data of the research was extracted from the information on household’s budget survey collected by the Statistical Center of Iran in 2012. In this study, the Generalized Method of Moment model was used and the status of adverse selection and moral hazard was evaluated through calculating the latent health status of individuals in each insurance category. To analyze the data, Excel, Eviews and stata11 software were used. Results: The estimation of parameters of the utility function of the demand for outpatient services (visit, medicine, and Para-clinical services) showed that households were more risk averse in the use of outpatient care than other goods and services. After estimating the health status of households based on their health insurance categories, the results showed that rural-insured people had the best health status and people with supplementary insurance had the worst health status. In addition, the comparison of the conditional distribution of latent health status approved the phenomenon of adverse selection in all insurance groups, with the exception of rural insurance. Moreover, calculation of the elasticity of medical expenses to reimbursement rate confirmed the existence of moral hazard phenomenon. Conclusions: Due to the existence of the phenomena of adverse selection and moral hazard

  20. Asymmetric Information in Iranian's Health Insurance Market: Testing of Adverse Selection and Moral Hazard.

    Science.gov (United States)

    Lotfi, Farhad; Abolghasem Gorji, Hassan; Mahdavi, Ghadir; Hadian, Mohammad

    2015-04-19

    Asymmetric information is one of the most important issues in insurance market which occurred due to inherent characteristics of one of the agents involved in insurance contracts; hence its management requires designing appropriate policies. This phenomenon can lead to the failure of insurance market via its two consequences, namely, adverse selection and moral hazard. This study was aimed to evaluate the status of asymmetric information in Iran's health insurance market with respect to the demand for outpatient services. This research is a cross sectional study conducted on households living in Iran. The data of the research was extracted from the information on household's budget survey collected by the Statistical Center of Iran in 2012. In this study, the Generalized Method of Moment model was used and the status of adverse selection and moral hazard was evaluated through calculating the latent health status of individuals in each insurance category. To analyze the data, Excel, Eviews and stata11 software were used. The estimation of parameters of the utility function of the demand for outpatient services (visit, medicine, and Para-clinical services) showed that households were more risk averse in the use of outpatient care than other goods and services. After estimating the health status of households based on their health insurance categories, the results showed that rural-insured people had the best health status and people with supplementary insurance had the worst health status. In addition, the comparison of the conditional distribution of latent health status approved the phenomenon of adverse selection in all insurance groups, with the exception of rural insurance. Moreover, calculation of the elasticity of medical expenses to reimbursement rate confirmed the existence of moral hazard phenomenon. Due to the existence of the phenomena of adverse selection and moral hazard in most of health insurances categories, policymakers need to adjust contracts so

  1. 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...

  2. Adverse Health Effects and Unhealthy Behaviors among Medical Students Using Facebook

    Directory of Open Access Journals (Sweden)

    Sami Abdo Radman Al-Dubai

    2013-01-01

    Full Text Available Little is known about the relationships between adverse health effects and unhealthy behaviors among medical students using Facebook. The aim of this study was to determine the associations between adverse health effects and unhealthy behaviors with Facebook use. A cross-sectional study was conducted in a private university in Malaysia among 316 medical students. A self-administered questionnaire was used. It included questions on sociodemographics, pattern of Facebook use, social relationship, unhealthy behaviors, and health effects. Mean age was 20.5 (±2.7 years. All students had a Facebook account. The average daily Facebook surfing hours were 2.5 (±1.7. Significant associations were found between average hours of Facebook surfing and the following factors: isolation from family members and community, refusing to answer calls, musculoskeletal pain, headache, and eye irritation (P<0.005. The average hours spent on Facebook were significantly associated with holding urination and defecation while online, surfing Facebook until midnight, and postponing, forgetting, or skipping meals (P<0.005. The average hours spent on Facebook were associated with adverse health effects and unhealthy behaviors among medical students, as well as social isolation from the family and community.

  3. Adverse health effects and unhealthy behaviors among medical students using Facebook.

    Science.gov (United States)

    Al-Dubai, Sami Abdo Radman; Ganasegeran, Kurubaran; Al-Shagga, Mustafa Ahmed Mahdi; Yadav, Hematram; Arokiasamy, John T

    2013-01-01

    Little is known about the relationships between adverse health effects and unhealthy behaviors among medical students using Facebook. The aim of this study was to determine the associations between adverse health effects and unhealthy behaviors with Facebook use. A cross-sectional study was conducted in a private university in Malaysia among 316 medical students. A self-administered questionnaire was used. It included questions on sociodemographics, pattern of Facebook use, social relationship, unhealthy behaviors, and health effects. Mean age was 20.5 (±2.7) years. All students had a Facebook account. The average daily Facebook surfing hours were 2.5 (±1.7). Significant associations were found between average hours of Facebook surfing and the following factors: isolation from family members and community, refusing to answer calls, musculoskeletal pain, headache, and eye irritation (P Facebook were significantly associated with holding urination and defecation while online, surfing Facebook until midnight, and postponing, forgetting, or skipping meals (P Facebook were associated with adverse health effects and unhealthy behaviors among medical students, as well as social isolation from the family and community.

  4. Vaginal douching (vd practice and adverse health effects of 15-49 years married women

    Directory of Open Access Journals (Sweden)

    Emel Ege

    2006-12-01

    Full Text Available OBJECTİVE: The purpose of the study is to explore the vaginal douching practice and adverse health effects of the 15-49 age, married women in Konya. MATERIAL AND METHOD: The population of this descriptive- cross-sectional study is 15-49 age, married women who recruited in the number 15 health-center region. The sample consisted of 183 women who were selected with systematic sampling method. A questionnaire designed with researcher based on literature which was 30 questions include fertility characteristics, VD practice and adverse health effects was used to collect data. The data were collected by the researcher with home visiting between April-May 2005. Descriptive statistics and X² test were used to analysis data. RESULTS: The mean age of women in the study group is 33.5±7.86, 87. 4 % has primary school education, 68.3 % middle income, 54.6 % practice VD. The mean year of VD practice is 12.9±8.8 and 65.1 % douche at least once a week. The reasons of the women’s VD practices are religious practice (45.4 %, cleaning (41.5% and preventing pregnancy(13.1% and, 68.9 % of women don’t know harmfull efects of VD. There was no difference between history of sterility, extopic pregnancy, abortus, low birth weigh, symptoms of genito-urinary infection and its frequency and VD in the X² test. There was a difference between contraceptive method used and VD. CONCLUSION: Sterility, extopic pregnancy, abortus, low birth weigh, symptoms of genito-urinary infection and its frequency were not related to VD. We suggest that the women have been educated about adverse health effects of VD and analytic researches may be planned for causal relationship between adverse health effects and VD.

  5. Nutrient- and non-nutrient-based natural health product (NHP) use in adults with mood disorders: prevalence, characteristics and potential for exposure to adverse events.

    Science.gov (United States)

    Davison, Karen M; Kaplan, Bonnie J

    2013-04-09

    To address knowledge gaps regarding natural health product (NHP) usage in mental health populations, we examined their use in adults with mood disorders, and explored the potential for adverse events. Food and NHP intake was obtained from 97 adults with mood disorders. NHP data was used to compare prevalence with population norms (British Columbia Nutrition Survey; BCNS). Bivariate and regression analyses examined factors associated with NHP use. Assessment of potential adverse effects of NHP use was based on comparing nutrient intakes from food plus supplements with the Dietary Reference Intakes and by reviewing databases for reported adverse health effects. Two-thirds (66%; 95% CI 56 to 75) were taking at least one NHP; 58% (95% CI 47 to 68) were taking NHPs in combination with psychiatric medications. The proportion of each type of NHP used was generally higher than the BCNS (range of p's food and NHP sources were combined, a small proportion exceeded any Lowest-Observed-Adverse-Effect-Levels: only for niacin (n = 17) and magnesium (n = 6), two nutrients for which the potential for adverse effects is minimal. Conversely, about 38% (95% CI 28 to 49) of the sample were taking a non-nutrient based NHP for which previous adverse events had been documented. The prevalent use of NHPs in this population suggests that health care providers need to be knowledgeable about their characteristics. The efficacy and safety of NHPs in relation to mental health warrants further investigation.

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

    Science.gov (United States)

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

    1990-04-01

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

  7. 75 FR 4655 - National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care...

    Science.gov (United States)

    2010-01-28

    .... Individual health care practitioners and entities can self-query. The reporting of information under section... 1921 specifically requires the reporting of a health care practitioner who, or entity that, voluntarily... in Sec. 60.3), respectively. With respect to reporting by private accreditation entities, we...

  8. 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.

  9. 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.

  10. Exploring the Prevalence of Adverse Childhood Experiences in Soldiers Seeking Behavioral Health Care During a Combat Deployment.

    Science.gov (United States)

    Applewhite, Larry; Arincorayan, Derrick; Adams, Barry

    2016-10-01

    This exploratory study examines the prevalence of adverse childhood experiences (ACEs) in soldiers who sought behavioral health support during a combat deployment. We conducted a secondary analysis of data extracted from two studies on the basis of retrospective reviews of behavioral health records of soldiers deployed to Iraq or Afghanistan. Of 162 clinical samples, 135 (83%) reported at least one type of childhood adversity. ACE scores ranged from 0 to 9 with a mean of 3 (standard deviation = 2.4) and mode of 0. A total of 65 (40%) experienced four or more ACEs. Parental divorce or separation was the most frequently reported childhood experience and was associated with witnessing domestic violence, having a member of the household abuse substances, and being physically and psychologically abused as a child. A sizeable proportion lived with a household member who had been in prison. Soldiers with an extensive history of ACEs may benefit from additional mentoring from frontline leaders and prevention measures instituted by unit behavioral health personnel. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

  11. Dual use of Medicare and the Veterans Health Administration: are there adverse health outcomes?

    Directory of Open Access Journals (Sweden)

    Brezinski Paul R

    2006-10-01

    Full Text Available Abstract Background Millions of veterans are eligible to use the Veterans Health Administration (VHA and Medicare because of their military service and age. This article examines whether an indirect measure of dual use based on inpatient services is associated with increased mortality risk. Methods Data on 1,566 self-responding men (weighted N = 1,522 from the Survey of Assets and Health Dynamics among the Oldest Old (AHEAD were linked to Medicare claims and the National Death Index. Dual use was indirectly indicated when the self-reported number of hospital episodes in the 12 months prior to baseline was greater than that observed in the Medicare claims. The independent association of dual use with mortality was estimated using proportional hazards regression. Results 96 (11% of the veterans were classified as dual users. 766 men (50.3% had died by December 31, 2002, including 64.9% of the dual users and 49.3% of all others, for an attributable mortality risk of 15.6% (p Conclusion An indirect measure of veterans' dual use of the VHA and Medicare systems, based on inpatient services, was associated with an increased risk of death. Further examination of dual use, especially in the outpatient setting, is needed, because dual inpatient and dual outpatient use may be different phenomena.

  12. Analysis of spontaneous reports of thromboembolic adverse drug reactions associated with cyproterone/ethinylestradiol

    NARCIS (Netherlands)

    Van Hunsel, F.; Van Puijenbroek, E.

    2013-01-01

    Introduction: After media attention on thromboembolic adverse drug reactions (ADRs) and the use of cyproterone/ethinylestradiol [1], the Netherlands Pharmacovigilance Centre Lareb received a high number of reports about this association, which called for a more detailed analyses. Aim: To provide an

  13. Pharmacogenetics of drug-induced arrhythmias : a feasibility study using spontaneous adverse drug reactions reporting data

    NARCIS (Netherlands)

    De Bruin, Marie L; van Puijenbroek, Eugene P; Bracke, Madelon; Hoes, Arno W; Leufkens, Hubert G M

    2006-01-01

    PURPOSE: The bottleneck in pharmacogenetic research on rare adverse drug reactions (ADR) is retrieval of patients. Spontaneous reports of ADRs may form a useful source of patients. We investigated the feasibility of a pharmacogenetic study, in which cases were selected from the database of a spontan

  14. 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

  15. Pre-vaccination care-seeking in females reporting severe adverse reactions to HPV vaccine. A registry based case-control study

    DEFF Research Database (Denmark)

    Mølbak, Kåre; Hansen, Niels Dalum; Valentiner-Branth, Palle

    2016-01-01

    to the DMA of suspected severe adverse reactions.We selected controls without reports of adverse reactions from the Danish vaccination registry and matched by year of vaccination, age of vaccination, and municipality, and obtained from the Danish National Patient Registry and The National Health Insurance...... Service Register the history of health care usage two years prior to the first vaccine. We analysed the data by logistic regression while adjusting for the matching variables. Results The study included 316 cases who received first HPV vaccine between 2006 and 2014. Age range of cases was 11 to 52 years...... vaccination programme has declined. The aim of the present study was to determine health care-seeking prior to the first HPV vaccination among females who suspected adverse reactions to HPV vaccine. Methods In this registry-based case-control study, we included as cases vaccinated females with reports...

  16. The adverse effects of International Monetary Fund programs on the health and education workforce.

    Science.gov (United States)

    Marphatia, Akanksha A

    2010-01-01

    Decades of underinvestment in public sectors and in teachers and health workers have adversely affected the health and educational outcomes of women. This is partly explained by a general lack of resources. However, the amount a country can spend on social sectors, including teachers and health workers, is also determined by its macroeconomic framework, which is set in agreement with the International Monetary Fund. There is now ample evidence of how IMF-imposed wage ceilings have constrained the ability of governments to hire adequate numbers of trained professionals and increase investment in social sectors. Though the IMF has recently removed wage ceilings from its basket of conditions, little change has taken place to ensure that women are better supported by macroeconomic policies or, at the least, are less adversely affected. Thus far, the IMF's neoliberal policies have either ignored gender concerns or instrumentalized equity, health, and education to support economic development. Unless macroeconomic policies are more flexible and deliberately take into account the different needs of women and men, social outcomes will continue to be poor and inequitable. Governments must pursue alternative, feminist policies that put the goals of social equity at the center of macroeconomic policy. These policies can facilitate increased investment in education and health care, which are vital measures for achieving gender equality and providing both women and men with the skills and training needed to soften the impact of the current economic crisis.

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

    Science.gov (United States)

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

    2016-06-22

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

  18. Improving the quality of adverse drug reaction reporting by 4th-year medical students.

    Science.gov (United States)

    Rosebraugh, Curtis J; Tsong, Yi; Zhou, Feng; Chen, Min; Mackey, Ann Corken; Flowers, Charlene; Toyer, Denise; Flockhart, David A; Honig, Peter K

    2003-03-01

    Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms. Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group-B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA. Seventy-eight MedWatch forms were evaluated (Group-A = 40, Group B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non-intervention group (p students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students.

  19. 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.

  20. 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

  1. 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.

  2. Mobile phone base stations and adverse health effects: phase 2 of a cross-sectional study with measured radio frequency electromagnetic fields

    DEFF Research Database (Denmark)

    Berg-Beckhoff, Gabriele; Blettner, M; Kowall, B

    2009-01-01

    affected their health and they gave information on sleep disturbances, headaches, health complaints and mental and physical health using standardised health questionnaires. Information on stress was also collected. Multiple linear regression models were used with health outcomes as dependent variables (n...... = 1326). RESULTS: For the five health scores used, no differences in their medians were observed for exposed versus non-exposed participants. People who attributed adverse health effects to mobile phone base stations reported significantly more sleep disturbances and health complaints, but they did...... not report more headaches or less mental and physical health. Individuals concerned about mobile phone base stations did not have different well-being scores compared with those who were not concerned. CONCLUSIONS: In this large population-based study, measured RF-EMFs emitted from mobile phone base stations...

  3. Noise monitoring and adverse health effects in residents in different functional areas of Luzhou, China.

    Science.gov (United States)

    Han, Zhi-Xia; Lei, Zhang-Heng; Zhang, Chun-Lian; Xiong, Wei; Gan, Zhong-Lin; Hu, Ping; Zhang, Qing-Bi

    2015-03-01

    The purpose of the study was to investigate the noise pollution situation and the resulting adverse effect on residents' health in Luzhou, China, to provide data for noise pollution prevention policies and interventions. Four different functional areas (commercial, construction, residential, and transportation hub areas) were chosen to monitor noise level for 3 months. The survey was performed by questionnaire on the spot on randomly selected individuals; it collected data on the impact of noise on residents' health (quality of sleep, high blood pressure, subjective feeling of nervous system damage, and attention) as well as the knowledge of noise-induced health damage, the degree of adaptation to noise, and their solutions. The noise levels of residential, commercial, transportation, and construction areas exceeded the national standards (P noise; 64.57% of residents have adapted to the current noise environment. Most of them have to close the doors and windows to reduce noise. The noise pollution situation in Luzhou, China, is serious, especially the traffic noise pollution. Residents pay less attention to it and adopt single measures to reduce the noise. We should work toward the prevention and control of traffic noise and improve the residents' awareness to reduce the adverse health effects of noise.

  4. Health Plans - Trend Reports

    Data.gov (United States)

    U.S. Department of Health & Human Services — This page contains several useful trend and competition indicators. Certain files will be updated monthly while others will be updated quarterly. The files are the...

  5. 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

  6. 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。

  7. Adverse health effects of experiencing food insecurity among Greenlandic school children

    OpenAIRE

    Niclasen, Birgit; Petzold, Max; Schnohr, Christina W

    2013-01-01

    Background. In vulnerable populations, food security in children has been found to be associated with negative health effects. Still, little is known about whether the negative health effects can be retrieved in children at the population level. Objective. To examine food insecurity reported by Greenlandic school children as a predictor for perceived health, physical symptoms and medicine use.Design. The study is based on the Greenlandic part of the Health Behaviour in School-aged Children su...

  8. Adverse childhood experiences, mental health, and quality of life of Chilean girls placed in foster care: An exploratory study.

    Science.gov (United States)

    Seiler, Annina; Kohler, Stefanie; Ruf-Leuschner, Martina; Landolt, Markus A

    2016-03-01

    In Latin America, little research has been conducted regarding exposure to adverse childhood experiences (ACEs), mental health, and health-related quality of life (HRQoL) among foster children. This study examined the association between ACEs and mental health, posttraumatic stress disorder (PTSD), and HRQoL in Chilean foster girls relative to age-matched Chilean family girls. Data were obtained from 27 Chilean foster girls and 27 Chilean girls ages 6 to 17 years living in family homes. Standardized self- and proxy-report measures were used. Foster girls reported more ACEs than controls in terms of familial and nonfamilial sexual abuse and both emotional and physical neglect. Girls living in foster care had a significantly higher rate of PTSD, displayed greater behavioral and emotional problems, and reported a lower HRQoL. Analysis confirmed the well-known cumulative risk hypothesis by demonstrating a significant positive association between the number of ACEs and PTSD symptom severity and a significant negative association with HRQoL. Chilean foster girls endured more ACEs that impair mental health and HRQoL than age-matched peers living with their families. These findings have implications for out-of-home care services in Latin America, highlighting the need to implement not only appropriate trauma-focused treatments but also appropriate prevention strategies. (c) 2016 APA, all rights reserved).

  9. Mouth breathing: adverse effects on facial growth, health, academics, and behavior.

    Science.gov (United States)

    Jefferson, Yosh

    2010-01-01

    The vast majority of health care professionals are unaware of the negative impact of upper airway obstruction (mouth breathing) on normal facial growth and physiologic health. Children whose mouth breathing is untreated may develop long, narrow faces, narrow mouths, high palatal vaults, dental malocclusion, gummy smiles, and many other unattractive facial features, such as skeletal Class II or Class III facial profiles. These children do not sleep well at night due to obstructed airways; this lack of sleep can adversely affect their growth and academic performance. Many of these children are misdiagnosed with attention deficit disorder (ADD) and hyperactivity. It is important for the entire health care community (including general and pediatric dentists) to screen and diagnose for mouth breathing in adults and in children as young as 5 years of age. If mouth breathing is treated early, its negative effect on facial and dental development and the medical and social problems associated with it can be reduced or averted.

  10. Predicting Adverse Health Outcomes in Long-Term Survivors of a Childhood Cancer

    Directory of Open Access Journals (Sweden)

    Chaya S. Moskowitz

    2014-07-01

    Full Text Available More than 80% of children and young adults diagnosed with invasive cancer will survive five or more years beyond their cancer diagnosis. This population has an increased risk for serious illness- and treatment-related morbidity and premature mortality. A number of these adverse health outcomes, such as cardiovascular disease and some second primary neoplasms, either have modifiable risk factors or can be successfully treated if detected early. Absolute risk models that project a personalized risk of developing a health outcome can be useful in patient counseling, in designing intervention studies, in forming prevention strategies, and in deciding upon surveillance programs. Here, we review existing absolute risk prediction models that are directly applicable to survivors of a childhood cancer, discuss the concepts and interpretation of absolute risk models, and examine ways in which these models can be used applied in clinical practice and public health.

  11. Adverse Childhood Experiences (ACEs), Stress and Mental Health in College Students.

    Science.gov (United States)

    Karatekin, Canan

    2017-05-16

    The goal of this short-term longitudinal study was to examine whether adverse childhood experiences (ACEs) could be used to identify college students at risk for mental health problems and whether current level of stress mediates the relationship between ACEs and mental health. Data on ACEs and mental health (depression, anxiety and suicidality) were collected at the beginning of the semester, and data on current stressors and mental health were collected toward the end of the semester (n = 239). Findings indicated that ACEs predicted worsening of mental health over the course of a semester and suggested current number of stressors as a mediator of the relationship between ACEs and mental health. Results suggest that screening for ACEs might be useful to identify students at high risk for deterioration in mental health. Results further suggest that stress-related interventions would be beneficial for students with high levels of ACEs and point to the need for more research and strategies to increase help-seeking in college students. Copyright © 2017 John Wiley & Sons, Ltd.

  12. Quality review of an adverse incident reporting system and root cause analysis of serious adverse surgical incidents in a teaching hospital of Scotland

    Directory of Open Access Journals (Sweden)

    Khorsandi Maziar

    2012-08-01

    Full Text Available Abstract Background A significant proportion of surgical patients are unintentionally harmed during their hospital stay. Root Cause Analysis (RCA aims to determine the aetiology of adverse incidents that lead to patient harm and produce a series of recommendations, which would minimise the risk of recurrence of similar events, if appropriately applied to clinical practice. A review of the quality of the adverse incident reporting system and the RCA of serious adverse incidents at the Department of Surgery of Ninewells hospital, in Dundee, United Kingdom was performed. Methods The Adverse Incident Management (AIM database of the Department of Surgery of Ninewells Hospital was retrospectively reviewed. Details of all serious (red, sentinel incidents recorded between May 2004 and December 2009, including the RCA reports and outcomes, where applicable, were reviewed. Additional related information was gathered by interviewing the involved members of staff. Results The total number of reported surgical incidents was 3142, of which 81 (2.58% cases had been reported as red or sentinel. 19 of the 81 incidents (23.4% had been inappropriately reported as red. In 31 reports (38.2% vital information with regards to the details of the adverse incidents had not been recorded. In 12 cases (14.8% the description of incidents was of poor quality. RCA was performed for 47 cases (58% and only 12 cases (15% received recommendations aiming to improve clinical practice. Conclusion The results of our study demonstrate the need for improvement in the quality of incident reporting. There are enormous benefits to be gained by this time and resource consuming process, however appropriate staff training on the use of this system is a pre-requisite. Furthermore, sufficient support and resources are required for the implementation of RCA recommendations in clinical practice.

  13. Knowledge, Attitude and Practices towards Pharmacovigilance and Adverse Drug Reactions in health care professional of Tertiary Care Hospital, Bhavnagar

    Directory of Open Access Journals (Sweden)

    Dr.Mukeshkumar B Vora

    2014-11-01

    Full Text Available Purpose: Adverse drug reactions (ADRs are adverse consequences of drug therapy. ADRs are representing a major concern of health systems in terms of early recognition, proper management and prevention. Under reporting of Adverse Drug Reactions (ADRs is a common problem in Pharmacovigilance programs. Poor perceptions of doctors about ADRs and risk management have contributed to high rate of ADR under-reporting in India. Underreporting has also been attributed to lack of time to doctor, misconceptions about spontaneous reporting and lack of information on how to report, where to report and a lack of availability of report forms, and also physicians' attitudes to ADRs. The objective of our study was to evaluate the knowledge, attitude and practices (KAP of health care professional towards Pharmacovigilance and adverse drug reactions in a tertiary care hospital, Bhavnagar, Gujarat, India. Methods: A cross-sectional questionnaires based study was carried out in Post graduate students and faculties of tertiary care hospital attached with Govt. Medical College, Bhavnagar, Gujarat. Post graduate students and faculties of different clinical subjects working in the tertiary care teaching hospital, Bhavnagar, Gujarat (India were enrolled and present throughout in study. 22 questionnaires about knowledge, attitude and practices towards ADRs and Pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from Pharmacology department. We were contacted directly to post graduate students and faculties of respective clinical department, questionnaires were distributed, 30 minutes time given to filled form. Any clarification and extra time was needed, provided to them. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft excel spread sheet and online statistical software. Results: In study, postgraduate residents (n=81 and faculties (n=63 from different clinical

  14. Adverse drug reactions in children reported by European consumers from 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    Background Information about medicines safety in children is very limited. Consumer adverse drug reaction (ADR) reports can provide information about serious and unknown ADRs from medicine use in children. Objective To characterize ADRs in children reported by consumers in Europe from 2007 to 2011...... of the general type (20 %) and nervous system disorders (15 %). The largest share of serious ADRs was of the type nervous system disorders (17 % of all serious). Three cases of death were reported. Vaccines and anti-infectives for systemic use contributed to 30 % of ADRs, antineoplastic and immunomodulating...

  15. [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.

  16. 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...

  17. Polybrominated diphenyl ether (PBDE) flame retardants: environmental contamination, human body burden and potential adverse health effects.

    Science.gov (United States)

    Costa, Lucio G; Giordano, Gennaro; Tagliaferri, Sara; Caglieri, Andrea; Mutti, Antonio

    2008-12-01

    Polybrominated diphenyl ethers (PBDEs) are an important class of flame retardants, widely used in a variety of consumer products. In the past several years, PBDEs have become widespread environmental pollutants, and have been detected in water, soil, air, animals and human tissues. Exposure occurs in particular through the diet and the indoor environment. Infants and toddlers have the highest body burden, due to exposure via maternal milk and through house dust. Tetra-, penta- and hexa-BDEs are the congeners most commonly found in humans. Recent concerns on possible adverse health effects of PBDEs are focusing on their potential endocrine disrupting effects and on developmental neurotoxicity.

  18. The aftermath of adverse events in Spanish primary care and hospital health professionals

    OpenAIRE

    Mira, José Joaquín; Carrillo, Irene; Lorenzo, Susana; Ferrús, Lena; Silvestre, Carmen; Pérez-Pérez, Pastora; Olivera, Guadalupe; Iglesias, Fuencisla; Zavala, Elena; Maderuelo-Fernández, José Ángel; Vitaller, Julián; Nuño-Solinís, Roberto; Astier, Pilar; ,

    2015-01-01

    Background Adverse events (AEs) cause harm in patients and disturbance for the professionals involved in the event (second victims). This study assessed the impact of AEs in primary care (PC) and hospitals in Spain on second victims. Methods A cross-sectional study was conducted. We carried out a survey based on a random sample of doctors and nurses from PC and hospital settings in Spain. A total of 1087 health professionals responded, 610 from PC and 477 from hospitals. Results A total of 43...

  19. Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan

    Directory of Open Access Journals (Sweden)

    Yamamoto M

    2015-01-01

    Full Text Available Michiko Yamamoto,1 Kiyoshi Kubota,2 Mitsuhiro Okazaki,3 Akira Dobashi,3 Masayuki Hashiguchi,4 Hirohisa Doi,1 Machi Suka,5 Mayumi Mochizuki4 1Education Center for Clinical Pharmacy Practice, Showa Pharmaceutical University, Tokyo, Japan; 2Department of Pharmacoepidemiology, Graduate School of Medicine, University of Tokyo, Japan; 3Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan; 4Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy, Keio University, Tokyo, Japan; 5Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, Tokyo, Japan Background: Patients have been allowed to report adverse drug reactions (ADRs directly to the government in some countries, which would contribute to pharmacovigilance.Objective: We started a pilot study to determine whether web-based patient ADR reporting would work in Japan. This article aims to describe the characteristics of the patient reporters, and to clarify patient views and experiences of reporting.Methods: Patients who submitted online ADR reports were contacted to respond to an ADR reporting questionnaire; only consenting reporters were included. Subjects with multiple responses were excluded from analysis. The questionnaire consisted of both closed and open questions. Questionnaire responses were examined using Pearson’s chi-squared test.Results: A total of 220 web-based ADR reports were collected from January to December 2011; questionnaires were sent to 190 reporters, excluding those who gave multiple reports and those that refused to be contacted. Responses were obtained from 94 individuals (effective response rate: 49.5%. The median respondent age was 46.0 years. Sixty-three respondents found out about this pilot study on the Internet (67.0%. The numbers of respondents claiming that they had difficulty recalling the time/date of ADR occurrence were 16 patient

  20. 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.

  1. 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

  2. ACTUAL WAYS FOR OVERCOMING THE FACTORS ADVERSELY AFFECTING THE CHILDREN AND ADOLESCENTS’ HEALTH IN EDUCATIONAL INSTITUTIONS

    Directory of Open Access Journals (Sweden)

    N. N. Malyarchuk

    2014-01-01

    Full Text Available The paper analyzes a widely discussed problem of the negative health dynamics of the growing generation, and points out the necessity of complex consideration of all the factors adversely affecting children’s health. The special emphasis is on the fallowing harmful factors: intensification of training process; discrepancy between the applied training methods and techniques on the one side, and children’s age, sex and functional specifics and capabilities on the other side; shortcomings in organizing children’s physical activities; limitations of the expositive illustrative methods for developing the healthy lifestyle habits. The other group of factors is related to the teaching style and professional characteristics of the teachers. They include the common practice of «stress» tactics; incompetence in health saving technologies; personal indisposition and psychological drawbacks. The situation is exacerbated by the absence of psychologists and pediatricians in educational institutions. The multilevel approach to solving the problems of students’ health preservation and promotion involves the elicitation of objective, subjective, inschool and out-of-school health determining factors. The paper denotes the actual ways of children’s health preservation at the level of related ministries, departments, and educational institutions.

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

    Science.gov (United States)

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

    2017-01-01

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

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

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    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

  5. Adverse or acceptable: negotiating access to a post-apartheid health care contract.

    Science.gov (United States)

    Harris, Bronwyn; Eyles, John; Penn-Kekana, Loveday; Thomas, Liz; Goudge, Jane

    2014-05-15

    As in many fragile and post-conflict countries, South Africa's social contract has formally changed from authoritarianism to democracy, yet access to services, including health care, remains inequitable and contested. We examine access barriers to quality health services and draw on social contract theory to explore ways in which a post-apartheid health care contract is narrated, practiced and negotiated by patients and providers. We consider implications for conceptualizing and promoting more inclusive, equitable health services in a post-conflict setting. Using in-depth interviews with 45 patients and 67 providers, and field observations from twelve health facilities in one rural and two urban sub-districts, we explore access narratives of those seeking and delivering - negotiating - maternal health, tuberculosis and antiretroviral services in South Africa. Although South Africa's right to access to health care is constitutionally guaranteed, in practice, a post-apartheid health care contract is not automatically or unconditionally inclusive. Access barriers, including poverty, an under-resourced, hierarchical health system, the nature of illness and treatment, and negative attitudes and actions, create conditions for insecure or adverse incorporation into this contract, or even exclusion (sometimes temporary) from health care services. Such barriers are exacerbated by differences in the expectations that patients and providers have of each other and the contract, leading to differing, potentially conflicting, identities of inclusion and exclusion: defaulting versus suffering patients, uncaring versus overstretched providers. Conversely, caring, respectful communication, individual acts of kindness, and institutional flexibility and leadership may mitigate key access barriers and limit threats to the contract, fostering more positive forms of inclusion and facilitating easier access to health care. Building health in fragile and post-conflict societies requires

  6. Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries.

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    Patrizia Restani

    Full Text Available The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS have been described.To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011-2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey.From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS.Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8% and 4 as probable (4.6%. Considering the most frequently cited botanicals, eight cases were due to Valeriana officinalis (garden valerian; seven to Camellia sinensis (tea; six to Ginkgo biloba (Maidenhair tree and Paullinia cupana (guarana. Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems.Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors to become aware of possible new problems associated with the increasing use of food supplements containing botanicals.

  7. Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries

    Science.gov (United States)

    Restani, Patrizia; Di Lorenzo, Chiara; Garcia-Alvarez, Alicia; Badea, Mihaela; Ceschi, Alessandro; Egan, Bernadette; Dima, Lorena; Lüde, Saskia; Maggi, Franco M.; Marculescu, Angela; Milà-Villarroel, Raimon; Raats, Monique M.; Ribas-Barba, Lourdes; Uusitalo, Liisa; Serra-Majem, Lluís

    2016-01-01

    Background The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS) have been described. Objectives To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011–2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey. Subjects/Setting From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS. Results Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8%) and 4 as probable (4.6%). Considering the most frequently cited botanicals, eight cases were due to Valeriana officinalis (garden valerian); seven to Camellia sinensis (tea); six to Ginkgo biloba (Maidenhair tree) and Paullinia cupana (guarana). Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems. Conclusions Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors) to become aware of possible new problems associated with the increasing use of food supplements containing botanicals. PMID:26928206

  8. Knowledge of adverse drug reaction reporting in first year postgraduate doctors in a medical college

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    Upadhyaya P

    2012-06-01

    Full Text Available Prerna Upadhyaya,1 Vikas Seth,2 Vijay V Moghe,1 Monika Sharma,1 Mushtaq Ahmed11Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur, Rajasthan, 2Department of Pharmacology, Hind Institute of Medical Sciences, Safedabad, Barabanki, Lucknow, Uttar Pradesh, IndiaIntroduction: Poor reporting of adverse drug reactions (ADRs by doctors is a major hindrance to successful pharmacovigilance. The present study was designed to assess first-year residents’ knowledge of ADR reporting.Methods: First-year postgraduate doctors at a private medical college completed a structured questionnaire. The responses were analyzed by nonparametric methods.Results: All doctors were aware of the term “adverse drug reactions.” Fifty percent of the doctors reported being taught about ADR reporting during their undergraduate teaching, and 50% had witnessed ADRs in their internship training. Ten percent of patients suffering an ADR observed and reported by doctors required prolonged hospitalization for treatment as a result. Only 40% of interns reported the ADRs that they observed, while 60% did not report them. Twenty-eight percent reported ADRs to the head of the department, 8% to an ADR monitoring committee, and 4% to the pharmacovigilance center. Eighty-six percent of the doctors surveyed felt that a good knowledge of undergraduate clinical pharmacology therapeutics would have improved the level of ADR reporting.Conclusion: The knowledge of first-year doctors regarding ADR reporting is quite poor. There is a dire need to incorporate ADR reporting into undergraduate teaching, and to reinforce this during internships and periodically thereafter.Keywords: ADR reporting, pharmacovigilance, first-year postgraduate doctors

  9. 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...

  10. Psychoneuroimmunology in Pregnancy: Immune Pathways Linking Stress with Maternal Health, Adverse Birth Outcomes, and Fetal Development

    Science.gov (United States)

    Christian, Lisa M.

    2011-01-01

    It is well-established that psychological stress promotes immune dysregulation in nonpregnant humans and animals. Stress promotes inflammation, impairs antibody responses to vaccination, slows wound healing, and suppresses cell-mediated immune function. Importantly, the immune system changes substantially to support healthy pregnancy, with attenuation of inflammatory responses and impairment of cell-mediated immunity. This adaptation is postulated to protect the fetus from rejection by the maternal immune system. Thus, stress-induced immune dysregulation during pregnancy has unique implications for both maternal and fetal health, particularly preterm birth. However, very limited research has examined stress-immune relationships in pregnancy. The application of psychoneuroimmunology research models to the perinatal period holds great promise for elucidating biological pathways by which stress may affect adverse pregnancy outcomes, maternal health, and fetal development. PMID:21787802

  11. Diagnostic criteria for adverse health effects in the environs of wind turbines.

    Science.gov (United States)

    McMurtry, Robert Y; Krogh, Carmen Me

    2014-10-01

    In an effort to address climate change, governments have pursued policies that seek to reduce greenhouse gases. Alternative energy, including wind power, has been proposed by some as the preferred approach. Few would debate the need to reduce air pollution, but the means of achieving this reduction is important not only for efficiency but also for health protection. The topic of adverse health effects in the environs of industrial wind turbines (AHE/IWT) has proven to be controversial and can present physicians with challenges regarding the management of an exposure to IWT. Rural physicians in particular must be aware of the possibility of people presenting to their practices with a variety of sometimes confusing complaints. An earlier version of the diagnostic criteria for AHE/IWT was published in August 2011. A revised case definition and a model for a study to establish a confirmed diagnosis is proposed.

  12. Oculocutaneous albinism in sub-Saharan Africa: adverse sun-associated health effects and photoprotection.

    Science.gov (United States)

    Wright, Caradee Y; Norval, Mary; Hertle, Richard W

    2015-01-01

    Oculocutaneous albinism (OCA) is a genetically inherited autosomal recessive condition. Individuals with OCA lack melanin and therefore are susceptible to the harmful effects of solar ultraviolet radiation, including extreme sun sensitivity, photophobia and skin cancer. OCA is a grave public health issue in sub-Saharan Africa with a prevalence as high as 1 in 1000 in some tribes. This article considers the characteristics and prevalence of OCA in sub-Saharan African countries. Sun-induced adverse health effects in the skin and eyes of OCA individuals are reviewed. Sun exposure behavior and the use of photoprotection for the skin and eyes are discussed to highlight the major challenges experienced by these at-risk individuals and how these might be best resolved. © 2014 The American Society of Photobiology.

  13. Psychoneuroimmunology in pregnancy: immune pathways linking stress with maternal health, adverse birth outcomes, and fetal development.

    Science.gov (United States)

    Christian, Lisa M

    2012-01-01

    It is well-established that psychological stress promotes immune dysregulation in nonpregnant humans and animals. Stress promotes inflammation, impairs antibody responses to vaccination, slows wound healing, and suppresses cell-mediated immune function. Importantly, the immune system changes substantially to support healthy pregnancy, with attenuation of inflammatory responses and impairment of cell-mediated immunity. This adaptation is postulated to protect the fetus from rejection by the maternal immune system. Thus, stress-induced immune dysregulation during pregnancy has unique implications for both maternal and fetal health, particularly preterm birth. However, very limited research has examined stress-immune relationships in pregnancy. The application of psychoneuroimmunology research models to the perinatal period holds great promise for elucidating biological pathways by which stress may affect adverse pregnancy outcomes, maternal health, and fetal development.

  14. Adverse childhood experiences: assessing the impact on health and school engagement and the mitigating role of resilience.

    Science.gov (United States)

    Bethell, Christina D; Newacheck, Paul; Hawes, Eva; Halfon, Neal

    2014-12-01

    The ongoing longitudinal Adverse Childhood Experiences Study of adults has found significant associations between chronic conditions; quality of life and life expectancy in adulthood; and the trauma and stress associated with adverse childhood experiences, including physical or emotional abuse or neglect, deprivation, or exposure to violence. Less is known about the population-based epidemiology of adverse childhood experiences among US children. Using the 2011-12 National Survey of Children's Health, we assessed the prevalence of adverse childhood experiences and associations between them and factors affecting children's development and lifelong health. After we adjusted for confounding factors, we found lower rates of school engagement and higher rates of chronic disease among children with adverse childhood experiences. Our findings suggest that building resilience-defined in the survey as "staying calm and in control when faced with a challenge," for children ages 6-17-can ameliorate the negative impact of adverse childhood experiences. We found higher rates of school engagement among children with adverse childhood experiences who demonstrated resilience, as well as higher rates of resilience among children with such experiences who received care in a family-centered medical home. We recommend a coordinated effort to fill knowledge gaps and translate existing knowledge about adverse childhood experiences and resilience into national, state, and local policies, with a focus on addressing childhood trauma in health systems as they evolve during ongoing reform.

  15. Organophosphate pesticides exposure among farmworkers: pathways and risk of adverse health effects.

    Science.gov (United States)

    Suratman, Suratman; Edwards, John William; Babina, Kateryna

    2015-01-01

    Organophosphate (OP) compounds are the most widely used pesticides with more than 100 OP compounds in use around the world. The high-intensity use of OP pesticides contributes to morbidity and mortality in farmworkers and their families through acute or chronic pesticides-related illnesses. Many factors contributing to adverse health effects have been investigated by researchers to determine pathways of OP-pesticide exposure among farmers in developed and developing countries. Factors like wind/agricultural pesticide drift, mixing and spraying pesticides, use of personal protective equipment (PPE), knowledge, perceptions, washing hands, taking a shower, wearing contaminated clothes, eating, drinking, smoking, and hot weather are common in both groups of countries. Factors including low socioeconomic status areas, workplace conditions, duration of exposure, pesticide safety training, frequency of applying pesticides, spraying against the wind, and reuse of pesticide containers for storage are specific contributors in developing countries, whereas housing conditions, social contextual factors, and mechanical equipment were specific pathways in developed countries. This paper compares existing research in environmental and behavioural exposure modifying factors and biological monitoring between developing and developed countries. The main objective of this review is to explore the current depth of understanding of exposure pathways and factors increasing the risk of exposure potentially leading to adverse health effects specific to each group of countries.

  16. Standard practice for labeling ceramic art materials for chronic adverse health hazards

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This practice describes a procedure for developing precautionary labels for ceramic art materials and provides hazard and precautionary statements based upon knowledge that exists in the scientific and medical communities. This practice concerns those chronic adverse health hazards known to be associated with a product or product component(s), when the component(s) is present in a physical form, volume, or concentration that in the opinion of a toxicologist has the potential to produce a chronic adverse health effect(s). 1.2 This practice is intended to apply exclusively to ceramic art materials which are packaged in sizes intended for use by artists or crafts people, either individually, or in a small group or class. 1.3 This practice applies to developing precautionary labeling for ceramic art materials intended for adult usage. Conformance to this practice does not imply that ceramic art materials will necessarily be labeled adequately or safe for use by children. Labeling determinations should conside...

  17. Feature Selection in Detection of Adverse Drug Reactions from the Health Improvement Network (THIN Database

    Directory of Open Access Journals (Sweden)

    Yihui Liu

    2015-02-01

    Full Text Available Adverse drug reaction (ADR is widely concerned for public health issue. ADRs are one of most common causes to withdraw some drugs from market. Prescription event monitoring (PEM is an important approach to detect the adverse drug reactions. The main problem to deal with this method is how to automatically extract the medical events or side effects from high-throughput medical events, which are collected from day to day clinical practice. In this study we propose a novel concept of feature matrix to detect the ADRs. Feature matrix, which is extracted from big medical data from The Health Improvement Network (THIN database, is created to characterize the medical events for the patients who take drugs. Feature matrix builds the foundation for the irregular and big medical data. Then feature selection methods are performed on feature matrix to detect the significant features. Finally the ADRs can be located based on the significant features. The experiments are carried out on three drugs: Atorvastatin, Alendronate, and Metoclopramide. Major side effects for each drug are detected and better performance is achieved compared to other computerized methods. The detected ADRs are based on computerized methods, further investigation is needed.

  18. Uncertainty quantification of adverse human health effects from continuously released contaminant sources in groundwater systems

    Science.gov (United States)

    Zarlenga, Antonio; de Barros, Felipe P. J.; Fiori, Aldo

    2016-10-01

    We propose a computationally efficient probabilistic modeling methodology to estimate the adverse effects on humans of exposure to contaminated groundwater. Our work is aligned with the standard suggested by the regulatory agencies and allows to propagate uncertainty from hydrogeological, toxicological and behavioral parameters to the final health risk endpoint. The problem under consideration consists of a contaminated aquifer supplying water to a population. Contamination stems from a continuous source that feeds a steady plume which constitutes the hazard source. This scenario is particularly suited for NAPL pollutants. The erratic displacement of the contaminant plume in groundwater, due to the spatial variability of hydraulic conductivity, is characterized within the Lagrangian stochastic framework which enables the complete probabilistic characterization of the contaminant concentration at an environmentally sensitive location. Following the probabilistic characterization of flow and transport, we quantify the adverse health effects on humans. The dose response assessment involves the estimation of the uncertain effects of the exposure to a given contaminant while accounting for the exposed individual's metabolism. The model integrates groundwater transport, exposure and human metabolism in a comprehensive probabilistic framework which allows the assessment of the risk probability through a novel simple analytical solution. Aside from its computational efficiency, the analytical features of the framework allows the assessment of uncertainty arising from the hydrogeological parameters.

  19. Oral health status and adverse pregnancy outcomes among pregnant women in Haryana, India: A prospective study

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    Puneet Singh Talwar

    2015-01-01

    Full Text Available Background: Women′s oral health is affected by certain conditions such as pregnancy, puberty, menstrual cycle, menopause and nonphysiological conditions such as hormonal contraception and hormonal therapy. This study was conducted to assess the oral health status and treatment needs of pregnant women and to correlate periodontal health with adverse pregnancy outcomes like preterm birth (PTB and low birth weight (LBW. Materials and Methods: A prospective study was undertaken at a Government Hospital in Haryana. Pregnant women who were in their third trimester of pregnancy and visited the hospital for routine ante-natal check-up constituted the final sample size (223. Dental caries and periodontal status were assessed using a WHO Proforma-1997. None of the subjects were in the habit of taking alcohol, chewing and smoking tobacco. The main outcome measures were gestational age and weight of the newborn. Data were analyzed using SPSS package version 13. Results: Decayed, missing and filled teeth index of the subjects was 2.87. Extraction was indicated in younger subjects when compared to the older ones. Bleeding was the main finding, which was present in 47.5% of the study subjects, followed by calculus. 63 more than 60% of subjects of subjects with 4-5 mm attachment loss belonged to 20-24 years age-group. There was a statistically significant association of probing depths and attachment loss with adverse pregnancy outcomes (P < 0.05 (PTB and LBW. Conclusion: There is a significant association between maternal periodontitis and pregnancy outcomes in the present study. It is recommended that suitable measures be undertaken by various health organizations to prevent periodontal problems among this particular group.

  20. Gender differences in health status and adverse outcomes among patients with peripheral arterial disease

    NARCIS (Netherlands)

    Dreyer, R.P.; van Zitteren, M.; Beltrame, J.F.; Fitridge, R.; Denollet, J.; Spertus, J.A.; Smolderen, K.G.E.

    2015-01-01

    Background Few studies have examined gender differences in health status and cardiovascular outcomes in patients with peripheral artery disease (PAD). This study assessed (1) self‐reported health status at PAD diagnosis and 12‐months later, and explored (2) whether outcomes in women with PAD differ

  1. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2002 – February 2003

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2003-07-01

    Full Text Available The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2002 to February 2003 is given. In total, 40 reports were received. This had declined from the previous year. Most reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were Stock Remedies. The animal owner predominantly administered these products. Only 1 report was received from a veterinary pharmaceutical company. Increasing numbers of reports are being received from veterinarians.

  2. 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.

  3. Adverse health effects of lead exposure on children and exploration to internal lead indicator

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Q.; Zhao, H.H. [Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030 (China); Chen, J.W.; Gu, K.D.; Zhang, Y.Z.; Zhu, Y.X.; Zhou, Y.K. [Minitry of Environmental Protection Key Lab of Environment, Wuhan 430030 (China); Ye, L.X., E-mail: yelx2004@163.com [Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030 (China)

    2009-11-15

    Our research on adverse effects of lead exposures on physical and neurobehavioral health of children aged 6-12 years in 4 villages, labeled as K, M, L, and X, in rural China, was reported in this article. Lead in blood (PbB), urine (PbU), hairs (PbH), and nails (PbN) were measured by graphite furnace atomic absorption spectrometry. Abbreviated Symptom Questionnaire of Conner's instruments and Revised Raven's Standard Progressive Matrices were applied to evaluate childhood attention deficit/hyperactivity disorders (ADHD) and intelligences. Geometric means (SD) of PbB, PbU, PbH and PbN concentrations were 71.2 {mu}g/L (1.56), 11.7 {mu}g/g (1.75), 12.5 {mu}g/g (2.82), and 25.3 {mu}g/g (2.79), respectively. 54 (17.0%) children had PbB levels of {>=} 100 {mu}g/L. Boys, the 6-10 years old, and living in village K were 2.11, 2.48, and 9.16 times, respectively, more likely to be poisoned by lead than girls, aged 11-12 years, and residing in X. 18 (5.7%) and 37 (11.7%) subjects had ADHD and mental retardations, respectively. Inverse relationships between intelligences and natural log transformed PbU and PbH levels were observed with respective odds ratios (95%CI) of 1.79 (1.00-3.22) and 1.46 (1.06-2.03) or 1.28 (1.04-1.58) and 1.73 (1.18-2.52) by binary or ordinal logistic regression modeling. ADHD prevalence was different by gender and age of subjects. PbU, PbH, and PbN related to PbB positively with respective correlation coefficients of 0.530, 0.477, and 0.181. Receiver operating characteristic (ROC) curves of the three measurements reveled areas under curves (AUCs) being 0.829, 0.758, and 0.687, respectively. In conclusion, children had moderate levels of lead exposures in this rural area. Intelligence declines were associated with internal lead levels among children. ROC analysis suggests PbU an internal lead indicator close to PbB.

  4. 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.

  5. 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.

  6. Are food insecurity's health impacts underestimated in the U.S. population? Marginal food security also predicts adverse health outcomes in young U.S. children and mothers.

    Science.gov (United States)

    Cook, John T; Black, Maureen; Chilton, Mariana; Cutts, Diana; Ettinger de Cuba, Stephanie; Heeren, Timothy C; Rose-Jacobs, Ruth; Sandel, Megan; Casey, Patrick H; Coleman, Sharon; Weiss, Ingrid; Frank, Deborah A

    2013-01-01

    This review addresses epidemiological, public health, and social policy implications of categorizing young children and their adult female caregivers in the United States as food secure when they live in households with "marginal food security," as indicated by the U.S. Household Food Security Survey Module. Existing literature shows that households in the US with marginal food security are more like food-insecure households than food-secure households. Similarities include socio-demographic characteristics, psychosocial profiles, and patterns of disease and health risk. Building on existing knowledge, we present new research on associations of marginal food security with health and developmental risks in young children (food security is positively associated with adverse health outcomes compared with food security, but the strength of the associations is weaker than that for food insecurity as usually defined in the US. Nonoverlapping CIs, when comparing odds of marginally food-secure children's fair/poor health and developmental risk and caregivers' depressive symptoms and fair/poor health with those in food-secure and -insecure families, indicate associations of marginal food security significantly and distinctly intermediate between those of food security and food insecurity. Evidence from reviewed research and the new research presented indicates that households with marginal food security should not be classified as food secure, as is the current practice, but should be reported in a separate discrete category. These findings highlight the potential underestimation of the prevalence of adverse health outcomes associated with exposure to lack of enough food for an active, healthy life in the US and indicate an even greater need for preventive action and policies to limit and reduce exposure among children and mothers.

  7. 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

  8. Rebound effect of modern drugs: serious adverse event unknown by health professionals.

    Science.gov (United States)

    Teixeira, Marcus Zulian

    2013-01-01

    Supported in the Hippocratic aphorism primum non nocere, the bioethical principle of non-maleficence pray that the medical act cause the least damage or injury to the health of the patient, leaving it to the doctor to assess the risks of a particular therapy through knowledge of possible adverse events of drugs. Among these, the rebound effect represents a common side effect to numerous classes of modern drugs, may cause serious and fatal disorders in patients. This review aims to clarify the health professionals on clinical and epidemiological aspects of rebound phenomenon. A qualitative, exploratory and bibliographic review was held in the PubMed database using the keywords 'rebound', 'withdrawal', 'paradoxical', 'acetylsalicylic acid', 'anti-inflammatory', 'bronchodilator', 'antidepressant', 'statin', 'proton pump inhibitor' and 'bisphosphonate'. The rebound effect occurs after discontinuation of numerous classes of drugs that act contrary to the disease disorders, exacerbating them at levels above those prior to treatment. Regardless of the disease, the drug and duration of treatment, the phenomenon manifests itself in a small proportion of susceptible individuals. However, it may cause serious and fatal adverse events should be considered a public health problem in view of the enormous consumption of drugs by population. Bringing together a growing and unquestionable body of evidence, the physician needs to have knowledge of the consequences of the rebound effect and how to minimize it, increasing safety in the management of modern drugs. On the other hand, this rebound can be used in a curative way, broadening the spectrum of the modern therapeutics. Copyright © 2012 Elsevier Editora Ltda. All rights reserved.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Early childhood adversity, toxic stress, and the role of the pediatrician: translating developmental science into lifelong health.

    Science.gov (United States)

    Garner, Andrew S; Shonkoff, Jack P

    2012-01-01

    Advances in a wide range of biological, behavioral, and social sciences are expanding our understanding of how early environmental influences (the ecology) and genetic predispositions (the biologic program) affect learning capacities, adaptive behaviors, lifelong physical and mental health, and adult productivity. A supporting technical report from the American Academy of Pediatrics (AAP) presents an integrated ecobiodevelopmental framework to assist in translating these dramatic advances in developmental science into improved health across the life span. Pediatricians are now armed with new information about the adverse effects of toxic stress on brain development, as well as a deeper understanding of the early life origins of many adult diseases. As trusted authorities in child health and development, pediatric providers must now complement the early identification of developmental concerns with a greater focus on those interventions and community investments that reduce external threats to healthy brain growth. To this end, AAP endorses a developing leadership role for the entire pediatric community-one that mobilizes the scientific expertise of both basic and clinical researchers, the family-centered care of the pediatric medical home, and the public influence of AAP and its state chapters-to catalyze fundamental change in early childhood policy and services. AAP is committed to leveraging science to inform the development of innovative strategies to reduce the precipitants of toxic stress in young children and to mitigate their negative effects on the course of development and health across the life span.

  15. Adverse childhood experiences, health perception, and the role of shared familial factors in adult twins.

    Science.gov (United States)

    Mostoufi, Sheeva M; Strachan, Eric; Chopko, Laura; Succop, Annemarie; Martinez, Beatrice; Ahumada, Sandra M; Afari, Niloofar

    2013-11-01

    To examine the relationship between adverse childhood experiences (ACE) and health perception in adulthood, and to explore the contribution of shared familial factors to these associations. Data were collected from 180 female twins (90 pairs) from the community-based University of Washington Twin Registry. Participants completed questionnaires including the modified ACE Questionnaire, Traumatic Life Events Questionnaire, McGill Pain Questionnaire-Short Form, and the SF-36. Mixed effects linear regression modeling investigated the effects of ACE on indices of health perception controlling for correlated twin data. Additional models examined the associations while controlling for the experience of physical and/or sexual abuse in childhood; within-twin pair models that inherently adjust for familial factors explored shared familial influences. After controlling for relevant demographic variables, more ACE was associated with worse perceptions of general health (p=.01) and vitality (p=.05) on the SF-36. After controlling for childhood physical and/or sexual abuse, the relationship between ACE and general health remained significant (p=.01) while vitality was no longer significant. None of the associations remained significant after accounting for the influence of familial factors. These results support previous findings on the negative link between ACE and perceived health in adulthood. The detrimental effects of ACE on vitality may be accounted for by the experience of childhood physical and/or sexual abuse. Shared familial factors might play a partial role in the relationship between ACE and health perception. Future research should further investigate the genetic and environmental mechanisms that may explain this relationship. Published by Elsevier Ltd.

  16. Short-term adverse health effects in a community exposed to a large polyvinylchloride plastics fire.

    Science.gov (United States)

    Upshur, R; James, M L; Richardson, E; Brunton, G; Hunter, W; Chambers, L

    2001-01-01

    The purpose of this study was the documentation of the short-term morbidity and mortality experiences of an urban community exposed to the airborne byproducts of a large polyvinylchloride plastics fire. The authors administered a survey to representatives of each household who had lived in an area evacuated during the fire. A time-series analysis was performed on emergency room visits and admissions for all hospitals in the city. Chloracne surveillance was instituted. Sixty-two percent of the individuals surveyed from the evacuation area reported no health concerns or symptoms related to the fire. Thirty-eight percent of the residents reported symptoms, and less than 2% of those surveyed reported that they sought medical attention for their health concerns. There was no evidence of increased hospital admissions or emergency room use during and immediately following the fire. No cases of chloracne were reported, and no deaths or serious injuries occurred during the fire. Polyvinylchloride plastics recycling plants pose potential health hazards to civilian populations. Public health authorities should be prepared to assess population health status rapidly and to disseminate relevant health information in a timely way during a crisis.

  17. Lead-induced oxidative stress adversely affects health of the occupational workers.

    Science.gov (United States)

    Khan, D A; Qayyum, S; Saleem, S; Khan, F A

    2008-10-01

    Lead is a persistent toxic metal and associated with impairment of various body functions in occupational workers. The main objective was to determine the lead-induced oxidative stress and adverse health effects by biochemical markers in industrial workers. One hundred and forty-eight males consisting of 87 lead-exposed industrial workers and 61 controls were included. Blood lead level (BLL) was determined on a 3010B ESA lead analyzer. Blood complete counts were done on a hematology analyzer. Biochemical markers including serum uric acid, urea, creatinine, phosphate, alanine aminotransferase (ALT), and gamma glutamyltransferase (GGT) were measured on a Selectra E auto analyzer. Serum malondialdehyde (MDA) was measured spectrophotometrically and C-reactive protein (CRP) on Immulite-1000. Results revealed that lead-exposed workers had significantly high BLLs, median (range), 29.1 (9.0-61.1) microg/dL compared with controls, 8.3 (1.0-21.7) microg/dL. Oxidative stress (MDA, GGT) and inflammatory markers (high-sensitivity CRP) were significantly increased (P stress that correlates with adverse changes in hematological, renal, and hepatic function in the occupational workers. Elevated blood lead has positive correlation with oxidative stress, inflammatory and biochemical markers that might be used to detect impairment in the body function in lead exposed workers.

  18. 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.

  19. 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.

  20. Causes for the underreporting of adverse drug events by health professionals: a systematic review

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    2014-08-01

    Full Text Available Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29 for physicians (22/29, and pharmacists (10/29. The main causes related to underreporting were ignorance (24/29, insecurity (24/29 and indifference (23/29. Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

  1. Adverse health effects in Canada geese (Branta canadensis) associated with waste from zinc and lead mines in the Tri-State Mining District (Kansas, Oklahoma, and Missouri, USA).

    Science.gov (United States)

    van der Merwe, Deon; Carpenter, James W; Nietfeld, Jerome C; Miesner, John F

    2011-07-01

    Lead and zinc poisoning have been recorded in a variety of bird species, including migrating waterfowl such as Canada Geese (Branta canadensis), at sites contaminated with mine waste from lead and zinc mines in the Tri-State Mining District, Kansas, Oklahoma, and Missouri, USA. The adverse health impacts from mine waste on these birds may, however, be more extensive than is apparent from incidental reports of clinical disease. To characterize health impacts from mine waste on Canada Geese that do not have observable signs of poisoning, four to eight apparently healthy birds per site were collected from four contaminated sites and an uncontaminated reference site, and examined for physical and physiologic evidence of metals poisoning. Tissue concentrations of silver, aluminum, arsenic, barium, cadmium, cobalt, chromium, copper, iron, magnesium, manganese, molybdenum, nickel, lead, selenium, thallium, vanadium, and zinc were determined by inductively coupled plasma mass spectroscopy. Adverse health effects due to lead were characterized by assessing blood δ-aminolevulinic acid dehydratase (ALAD) enzyme activity. Adverse effects associated with zinc poisoning were determined from histologic examination of pancreas tissues. Elevated tissue lead concentrations and inhibited blood ALAD enzyme activities were consistently found in birds at all contaminated sites. Histopathologic signs of zinc poisoning, including fibrosis and vacuolization, were associated with elevated pancreatic zinc concentrations at one of the study sites. Adverse health effects associated with other analyzed elements, or tissue concentrations indicating potentially toxic exposure levels to these elements, were not observed.

  2. Adverse drug reaction (ADR reporting in India: a long way to go

    Directory of Open Access Journals (Sweden)

    Anant D. Patil

    2013-12-01

    Full Text Available New drugs are regularly introduced for treatment, diagnosis or prevention of diseases. Adverse drug reactions (ADR can be seen in clinical practice with both new as well as marketed medicines. Spontaneous reporting of ADR is commonly practiced method for monitoring of ADR. Healthcare practitioners have an important role in pharmacovigilance and ADR reporting. Many studies have been conducted to understand the knowledge, attitude and practice of ADR reporting among healthcare practitioners in India. The population surveyed in these studied ranged between 90-1200. One large study4 included population of 1200 physicians across India out of which 1000 were contacted for study participation. [Int J Basic Clin Pharmacol 2013; 2(6.000: 846-848

  3. 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...

  4. Report of the Eye Bank Association of America Medical Review Subcommittee on Adverse Reactions Reported From 2007 to 2014.

    Science.gov (United States)

    Edelstein, Sean L; DeMatteo, Jennifer; Stoeger, Christopher G; Macsai, Marian S; Wang, Chi-Hsiung

    2016-07-01

    To investigate the incidence of adverse reactions after corneal transplantation, reported to the Eye Bank Association of America. Incidence of adverse reactions from January 1, 2007, to December 31, 2014, was analyzed. Of the 354,930 transplants performed in the United States, adverse reactions were reported in 494 cases (0.139%). Primary graft failure (PGF) predominated (n = 319; 0.09%) followed by endophthalmitis (n = 99; 0.028%) and keratitis (n = 66; 0.019%). The procedure type predominantly associated with PGF was endothelial keratoplasty (EK) in 56% (n = 180; 11 per 10,000 grafts), followed by penetrating keratoplasty (PK) in 42% (n = 135; 6.9 per 10,000 grafts). The procedure type predominantly associated with endophthalmitis and keratitis was EK in 63% (n = 104; 6.3 per 10,000 grafts) followed by PK in 34% (n = 56; 2.8 per 10,000 grafts), anterior lamellar keratoplasty in 1% (n = 2; 2.7 per 10,000 grafts), and keratoprosthesis in 1% (n = 2; 12.4 per 10,000 grafts). Although the incidence of PGF and endophthalmitis between PK and EK was noteworthy, the difference was not statistically significant (P = 0.098). Endophthalmitis-associated pathogens were isolated in 78% of cases: predominantly Candida species (65%), gram-positive organisms (33%), and gram-negative rods (2%). Keratitis-associated pathogens were isolated in 64% of cases: predominantly Candida species (81%), Herpes simplex virus (7%), gram-negative organisms (7%), and gram-positive organisms (5%). PGF was the most commonly reported adverse reaction, disproportionately associated with EK. An increasingtrend in the rate of endophthalmitis and keratitis was observed, disproportionately associated with EK and Candida species.

  5. Immunomodulation by dietary long chain omega-3 fatty acids and the potential for adverse health outcomes.

    Science.gov (United States)

    Fenton, Jenifer I; Hord, Norman G; Ghosh, Sanjoy; Gurzell, Eric A

    2013-01-01

    Recommendations to consume fish for prevention of cardiovascular disease (CVD), along with the U.S. Food and Drug Administration-approved generally recognized as safe (GRAS) status for long chain omega-3 fatty acids, may have had the unanticipated consequence of encouraging long-chain omega-3 (ω-3) fatty acid [(eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] supplementation and fortification practices. While there is evidence supporting a protective role for EPA/DHA supplementation in reducing sudden cardiac events, the safety and efficacy of supplementation with LCω-3PUFA in the context of other disease outcomes is unclear. Recent studies of bacterial, viral, and fungal infections in animal models of infectious disease demonstrate that LCω-3PUFA intake dampens immunity and alters pathogen clearance and can result in reduced survival. The same physiological properties of EPA/DHA that are responsible for the amelioration of inflammation associated with chronic cardiovascular pathology or autoimmune states, may impair pathogen clearance during acute infections by decreasing host resistance or interfere with tumor surveillance resulting in adverse health outcomes. Recent observations that high serum LCω-3PUFA levels are associated with higher risk of prostate cancer and atrial fibrillation raise concern for adverse outcomes. Given the widespread use of supplements and fortification of common food items with LCω-3PUFA, this review focuses on the immunomodulatory effects of the dietary LCω-3PUFAs, EPA and DHA, the mechanistic basis for potential negative health outcomes, and calls for biomarker development and validation as rational first steps towards setting recommended dietary intake levels.

  6. 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

  7. 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.

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

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    Guenka Petrova

    2017-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

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    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.

  13. 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.

  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.

    2016-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  16. Health surveillance under adverse ergonomics conditions--validity of a screening method adapted for the occupational health service.

    Science.gov (United States)

    Jonker, Dirk; Gustafsson, Ewa; Rolander, Bo; Arvidsson, Inger; Nordander, Catarina

    2015-01-01

    A new health surveillance protocol for work-related upper-extremity musculoskeletal disorders has been validated by comparing the results with a reference protocol. The studied protocol, Health Surveillance in Adverse Ergonomics Conditions (HECO), is a new version of the reference protocol modified for application in the Occupational Health Service (OHS). The HECO protocol contains both a screening part and a diagnosing part. Sixty-three employees were examined. The screening in HECO did not miss any diagnosis found when using the reference protocol, but in comparison to the reference protocol considerable time savings could be achieved. Fair to good agreement between the protocols was obtained for one or more diagnoses in neck/shoulders (86%, k = 0.62) and elbow/hands (84%, k = 0.49). Therefore, the results obtained using the HECO protocol can be compared with a reference material collected with the reference protocol, and thus provide information of the magnitude of disorders in an examined work group. Practitioner Summary: The HECO protocol is a relatively simple physical examination protocol for identification of musculoskeletal disorders in the neck and upper extremities. The protocol is a reliable and cost-effective tool for the OHS to use for occupational health surveillance in order to detect workplaces at high risk for developing musculoskeletal disorders.

  17. Arsenic exposure and adverse health effects: A review of recent findings from arsenic and health studies in Matlab, Bangladesh

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    Mohammad Yunus

    2011-09-01

    Full Text Available The recent discovery of large-scale arsenic (As contamination of groundwater has raised much concern in Bangladesh. Reliable estimates of the magnitude of As exposure and related health problems have not been comprehensively investigated in Bangladesh. A large population-based study on As and health consequences in Matlab (AsMat was done in Matlab field site where International Centre for Diarrhoeal Disease Research, Bangladesh has maintained a health and demographic surveillance system registering prospectively all vital events. Taking advantage of the health and demographic surveillance system and collecting data on detailed individual level As exposure using water and urine samples, AsMat investigated the morbidity and mortality associated with As exposure. Reviews of findings to date suggest the adverse effects of As exposure on the risk of skin lesions, high blood pressure, diabetes mellitus, chronic disease, and all-cause infant and adult disease mortality. Future studies of clinical endpoints will enhance our knowledge gaps and will give directions for disease prevention and mitigations.

  18. Childhood adversities and adult psychopathology in the WHO World Mental Health Surveys

    NARCIS (Netherlands)

    Kessler, Ronald C.; McLaughlin, Katie A.; Green, Jennifer Greif; Gruber, Michael J.; Sampson, Nancy A.; Zaslavsky, Alan M.; Aguilar-Gaxiola, Sergio; Alhamzawi, Ali Obaid; Alonso, Jordi; Angermeyer, Matthias; Benjet, Corina; Bromet, Evelyn; Chatterji, Somnath; de Girolamo, Giovanni; Demyttenaere, Koen; Fayyad, John; Florescu, Silvia; Gal, Gilad; Gureje, Oye; Maria Haro, Josep; Hu, Chi-yi; Karam, Elie G.; Kawakami, Norito; Lee, Sing; Lepine, Jean-Pierre; Ormel, Johan; Posada-Villa, Jose; Sagar, Rajesh; Tsang, Adley; Uestuen, T. Bedirhan; Vassilev, Svetlozar; Viana, Maria Carmen; Williams, David R.

    2010-01-01

    Background Although significant associations of childhood adversities with adult mental disorders are widely documented, most studies focus on single childhood adversities predicting single disorders. Aims To examine joint associations of 12 childhood adversities with first onset of 20 DSM-IV disord

  19. Severe cutaneous adverse drug reaction to leflunomide: A report of five cases

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    Shastri Veeranna

    2006-01-01

    Full Text Available Medications used to treat human ailments are known to cause cutaneous reactions which may vary in their severity. Leflunomide, an immunomodulating agent recently introduced to treat rheumatoid arthritis, is reported to cause severe cutaneous reactions. We are reporting five such cases. All our patients were started on leflunomide for rheumatoid arthritis, 4-6 weeks before the onset of cutaneous reaction and were admitted to the hospital with the common complaints of fever, skin rash and generalized weakness. All of them had characteristic pattern of events such as delayed onset of reaction, widespread and long lasting skin rash and internal organ involvement. These features suggest a possibility of drug hypersensitivity syndrome to leflunomide. Careful dosing and periodic monitoring of patients treated with leflunomide for possible adverse drug reaction is recommended.

  20. Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy.

    Science.gov (United States)

    Motola, Domenico; Vargiu, Antonio; Leone, Roberto; Conforti, Anita; Moretti, Ugo; Vaccheri, Alberto; Velo, Giampaolo; Montanaro, Nicola

    2008-01-01

    The reporting of adverse drug reactions (ADRs) is the mainstay of post-marketing surveillance systems. Under-reporting and selective reporting are considered the main limitations of a spontaneous reporting-based pharmacovigilance system. However, excessive reporting induced by external events may also impair signal detection by increasing the noise level. The aim of this study was to examine the influence of regulatory measures and other external factors on the rate of ADR reporting in Italy, focusing on four situations occurring in the last 10 years: ACE inhibitor-induced cough; HMG-CoA reductase inhibitors ('statins') and rhabdomyolysis; nimesulide and hepatic toxicity; and cyclo-oxygenase (COX)-2 selective inhibitors ('coxibs') and increase in cardiovascular risk. The study was based on data from spontaneous reporting in six Italian regions collected from January 1995 to December 2005. We analysed a 10-year period as a reasonable time interval around the four situations of interest, highlighting the influence of regulatory measures on the rate of ADR reporting (number of reports per million inhabitants). Chi-squared tests were used to assess the statistical significance of any changes in ADR reporting. Drug sales data were also studied to examine possible changes in drug use. Sales data were expressed as daily defined dose per 1000 inhabitants per day. ACE inhibitors: a 5-fold increase in the reporting rate of ACE inhibitor-induced cough was observed in 1998 and 1999 following a restriction on reimbursement for angiotensin receptor blockers introduced in 1998 and removed at the end of 1999. Statins: after the withdrawal of cerivastatin in 2001, the ADR reporting rate increased more than 4-fold, with musculoskeletal ADRs representing about 60% of all the ADRs reported in that year, and progressively decreased in the following years. Nimesulide: an increase in hepatic ADR reporting was observed after withdrawal of the drug from the Finnish and Spanish markets in

  1. The Development of Countermeasures for Space Radiation Induced Adverse Health Effects

    Science.gov (United States)

    Kennedy, Ann

    The Development of Countermeasures for Space Radiation Induced Adverse Health Effects Ann R. Kennedy Department of Radiation Oncology, University of Pennsylvania School of Medicine, 195 John Morgan Building, 3620 Hamilton Walk, Philadelphia, PA, United States 19104-6072 The development of countermeasures for radiation induced adverse health effects is a lengthy process, particularly when the countermeasure/drug has not yet been evaluated in human trials. One example of a drug developed from the bench to the clinic is the soybean-derived Bowman-Birk inhibitor (BBI), which has been developed as a countermeasure for radiation induced cancer. It was originally identified as a compound/drug that could prevent the radiation induced carcinogenic process in an in vitro assay system in 1975. The first observation that BBI could inhibit carcinogenesis in animals was in 1985. BBI received Investigational New Drug (IND) Status with the U.S. Food and Drug Administration (FDA) in 1992 (after several years of negotiation with the FDA about the potential IND status of the drug), and human trials began at that time. Phase I, II and III human trials utilizing BBI have been performed under several INDs with the FDA, and an ongoing Phase III trial will be ending in the very near future. Thus, the drug has been in development for 35 years at this point, and it is still not a prescription drug on the market which is available for human use. A somewhat less time-consuming process is to evaluate compounds that are on the GRAS (Generally Recognized as Safe) list. These compounds would include some over-the-counter medications, such as antioxidant vitamins utilized in human trials at the levels for which Recommended Dietary Allowances (RDAs) have been established. To determine whether GRAS substances are able to have beneficial effects on radiation induced adverse health effects, it is still likely to be a lengthy process involving many years to potentially decades of human trial work. The

  2. Striving against adversity: the dynamics of migration, health and poverty in rural South Africa

    Directory of Open Access Journals (Sweden)

    Mark A. Collinson

    2010-06-01

    Full Text Available This article is a review of the PhD thesis of Mark Collinson, titled, ‘Striving against adversity: the dynamics of migration, health and poverty in rural South Africa’. The findings show that in rural South Africa, temporary migration has a major impact on household well-being and health. Remittances from migrants make a significant difference to socioeconomic status (SES in households left behind by the migrant. For the poorest households the key factors improving SES are government grants and female temporary migration, while for the less poor it is male temporary migration and local employment. Migration is associated with HIV but not in straightforward ways. Migrants that return more frequently may be less exposed to outside partners and therefore less implicated in the HIV epidemic. There are links between migration and mortality patterns, including a higher risk of dying for returnee migrants compared with permanent residents. A mother's migration impacts significantly on child survival for South African and former refugee parents, but there is an additional mortality risk for children of Mozambican former refugees. It is recommended that national censuses and surveys account for temporary migration when collecting information on household membership, because different migration types have different outcomes. Without discriminating between different migration types, the implications for sending and receiving communities will remain lost to policy-makers.

  3. Striving against adversity: the dynamics of migration, health and poverty in rural South Africa.

    Science.gov (United States)

    Collinson, Mark A

    2010-06-03

    This article is a review of the PhD thesis of Mark Collinson, titled, 'Striving against adversity: the dynamics of migration, health and poverty in rural South Africa'. The findings show that in rural South Africa, temporary migration has a major impact on household well-being and health. Remittances from migrants make a significant difference to socioeconomic status (SES) in households left behind by the migrant. For the poorest households the key factors improving SES are government grants and female temporary migration, while for the less poor it is male temporary migration and local employment. Migration is associated with HIV but not in straightforward ways. Migrants that return more frequently may be less exposed to outside partners and therefore less implicated in the HIV epidemic. There are links between migration and mortality patterns, including a higher risk of dying for returnee migrants compared with permanent residents. A mother's migration impacts significantly on child survival for South African and former refugee parents, but there is an additional mortality risk for children of Mozambican former refugees. It is recommended that national censuses and surveys account for temporary migration when collecting information on household membership, because different migration types have different outcomes. Without discriminating between different migration types, the implications for sending and receiving communities will remain lost to policy-makers.

  4. Adverse health effects of experiencing food insecurity among Greenlandic school children

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    Birgit Niclasen

    2013-08-01

    Full Text Available Background. In vulnerable populations, food security in children has been found to be associated with negative health effects. Still, little is known about whether the negative health effects can be retrieved in children at the population level. Objective. To examine food insecurity reported by Greenlandic school children as a predictor for perceived health, physical symptoms and medicine use. Design. The study is based on the Greenlandic part of the Health Behaviour in School-aged Children survey. The 2010 survey included 2,254 students corresponding to 40% of all Greenlandic school children in Grade 5 through 10. The participation rate in the participating schools was 65%. Food insecurity was measured as going to bed or to school hungry because there was no food at home. Results. Boys, the youngest children (11–12 year-olds, and children from low affluence homes were at increased risk for food insecurity. Poor or fair self-rated health, medicine use last month and physical symptoms during the last 6 months were all more frequent in children reporting food insecurity. Controlling for age, gender and family affluence odds ratio (OR for self-rated health was 1.60 (95% confidence interval (CI 1.23–2.06 (p<0.001, for reporting physical symptoms 1.34 (95% CI 1.06–1.68 (p=0.01 and for medicine use 1.79 (95% CI 1.42–2.26 (p<0.001. Stratification on age groups suggested that children in different age groups experience different health consequences of food insecurity. The oldest children reported food insecurity less often and experienced less negative health effects compared to the younger children. Conclusions. All 3 measures of health were negatively associated to the occurrence of food insecurity in Greenlandic school children aged 11–17. Food security must be seen as a public health issue of concern, and policies should be enforced to prevent food poverty particularly among boys, younger school children and children from low affluence

  5. Adverse Effects of Tattoos and Piercing on Parent/Patient Confidence in Health Care Providers.

    Science.gov (United States)

    Johnson, Scarlett C; Doi, Maegan L M; Yamamoto, Loren G

    2016-09-01

    First impressions based on practitioner appearance often form the basis for preliminary assumptions regarding trust, confidence, and competence, especially in situations where patients or family members do not have an established relationship with the physician. Given their growing prevalence, we strove to further investigate whether visible tattoos or piercings on a medical provider affects a patient's perception of the provider's capabilities and their trust in the care that would be provided. A survey using photographs of simulated practitioners was administered to 314 participants split between rural and urban locations. Study volunteers rated tattooed practitioners with lower confidence ratings when compared with nontattooed practitioners and reported greater degrees of discomfort with greater degrees of facial piercing. We concluded that these factors adversely affect the clinical confidence ratings of practitioners, regardless of the gender, age group, or location of participants.

  6. Adverse human health effects associated with molds in the indoor environment.

    Science.gov (United States)

    Hardin, Bryan D; Kelman, Bruce J; Saxon, Andrew

    2003-05-01

    inhalation exposure to fungi, bacteria, and other organic matter, usually in industrial or agricultural settings. Molds growing indoors are believed by some to cause building-related symptoms. Despite a voluminous literature on the subject, the causal association remains weak and unproven, particularly with respect to causation by mycotoxins. One mold in particular, Stachybotrys chartarum, is blamed for a diverse array of maladies when it is found indoors. Despite its well-known ability to produce mycotoxins under appropriate growth conditions, years of intensive study have failed to establish exposure to S. chartarum in home, school, or office environments as a cause of adverse human health effects. Levels of exposure in the indoor environment, dose-response data in animals, and dose-rate considerations suggest that delivery by the inhalation route of a toxic dose of mycotoxins in the indoor environment is highly unlikely at best, even for the hypothetically most vulnerable subpopulations. Mold spores are present in all indoor environments and cannot be eliminated from them. Normal building materials and furnishings provide ample nutrition for many species of molds, but they can grow and amplify indoors only when there is an adequate supply of moisture. Where mold grows indoors there is an inappropriate source of water that must be corrected before remediation of the mold colonization can succeed. Mold growth in the home, school, or office environment should not be tolerated because mold physically destroys the building materials on which it grows, mold growth is unsightly and may produce offensive odors, and mold is likely to sensitize and produce allergic responses in allergic individuals. Except for persons with severely impaired immune systems, indoor mold is not a source of fungal infections. Current scientific evidence does not support the proposition that human health has been adversely affected by inhaled mycotoxins in home, school, or office environments.

  7. Adverse health effects of experiencing food insecurity among Greenlandic school children

    DEFF Research Database (Denmark)

    Niclasen, B.; Petzold, M.; Schnohr, C. W.

    2013-01-01

    Background. In vulnerable populations, food security in children has been found to be associated with negative health effects. Still, little is known about whether the negative health effects can be retrieved in children at the population level. Objective. To examine food insecurity reported...... by Greenlandic school children as a predictor for perceived health, physical symptoms and medicine use. Design. The study is based on the Greenlandic part of the Health Behavior in School-aged Children survey. The 2010 survey included 2,254 students corresponding to 40% of all Greenlandic school children...... in Grade 5 through 10. The participation rate in the participating schools was 65%. Food insecurity was measured as going to bed or to school hungry because there was no food at home. Results. Boys, the youngest children (11-12 year-olds), and children from low affluence homes were at increased risk...

  8. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    李青; 张素敏; 陈华庭; 方世平; 于星; 刘东; 施侣元; 曾繁典

    2004-01-01

    Background A voluntary procedure for reporting adverse drug reactions (ADRs) was formally put in place in 1989. However, only a small proportion of ADR reports are actually forwarded to the national monitoring center. To identify the reasons for underreporting, the authors investigated the awareness and attitudes of healthcare professionals (doctors, nurses, and administrators) toward the ADR system in China. In addition, the authors sought to formulate approaches to improve the current ADR reporting system.Methods Structured interviews were carried out in 16 hospitals selected from 27 municipal hospitals in Wuhan, Hubei Province, China. A questionnaire survey of a stratified random sample of approximately 15% of healthcare professionals in each selected hospital was conducted during February to March 2003.Results The response rate of this survey was 85%. One thousand six hundred and fifty-three questionnaires were used in the final analysis. Only 2.7% of the healthcare professionals had a correct understanding to the definition of ADR. Eighty-nine point two percent of the healthcare professionals had encountered ADRs. Ninety-four percent of them were aware of the need to report these to the ADR monitoring center. However, only 28.5% of doctors, 22.8% of nurses, and 29.7% of administrators actually submitted a report. For the most part, they reported ADRs to the hospital pharmacy (66.0%), to other departments in the hospital (72.5%), and to the pharmaceutical industry (23.0%), rather than to the national monitoring center (2.9%) or regional monitoring center (9.5%). Severe or rare ADRs and ADRs to new products were generally perceived to be significant enough to report. Sixty-two point one percent of the healthcare professionals had encountered ADRs, yet not reported them to anybody. The major reasons for not reporting included no knowledge of the reporting procedure (71.4%), unavailability of the reporting center mailing address (67.9%), unavailability of the ADR

  9. Risk of Adverse Health Outcomes and Decrements in Performance Due to In-flight Medical Conditions

    Science.gov (United States)

    Antonsen,Erik

    2017-01-01

    The drive to undertake long-duration space exploration missions at greater distances from Earth gives rise to many challenges concerning human performance under extreme conditions. At NASA, the Human Research Program (HRP) has been established to investigate the specific risks to astronaut health and performance presented by space exploration, in addition to developing necessary countermeasures and technology to reduce risk and facilitate safer, more productive missions in space (NASA Human Research Program 2009). The HRP is divided into five subsections, covering behavioral health, space radiation, habitability, and other areas of interest. Within this structure is the ExMC Element, whose research contributes to the overall development of new technologies to overcome the challenges of expanding human exploration and habitation of space. The risk statement provided by the HRP to the ExMC Element states: "Given that medical conditions/events will occur during human spaceflight missions, there is a possibility of adverse health outcomes and decrements in performance in mission and for long term health" (NASA Human Research Program 2016). Within this risk context, the Exploration Medical Capabilities (ExMC) Element is specifically concerned with establishing evidenced-based methods of monitoring and maintaining astronaut health. Essential to completing this task is the advancement in techniques that identify, prevent, and treat any health threats that may occur during space missions. The ultimate goal of the ExMC Element is to develop and demonstrate a pathway for medical system integration into vehicle and mission design to mitigate the risk of medical issues. Integral to this effort is inclusion of an evidence-based medical and data handling system appropriate for long-duration, exploration-class missions. This requires a clear Concept of Operations, quantitative risk metrics or other tools to address changing risk throughout a mission, and system scoping and system

  10. Frequent Mental Distress, Chronic Conditions, and Adverse Health Behaviors in the Behavioral Risk Factor Surveillance Survey, Jordan, 2007

    Directory of Open Access Journals (Sweden)

    Mohannad Al-Nsour, MD, MSc

    2013-08-01

    Full Text Available Introduction Recent evidence indicates that chronic diseases and mental illness are associated. In the Middle Eastern country of Jordan, chronic diseases and frequent mental distress (FMD are increasing; however, the capacity for mental health care is limited. The objective of this study was to determine the association between FMD, chronic conditions, and adverse health behaviors in Jordan. Methods The third cycle of the Jordan Behavioral Risk Factor Surveillance Survey (2007 served as the data source for this study. The sample consisted of 3,612 noninstitutionalized Jordanian adults aged 18 years or older. Logistic regression was used to obtain odds ratios for the association between chronic conditions, health behaviors, and FMD adjusted for age, sex, marital status, education, income, and employment. Results In the adjusted models, people with hypertension (adjusted odds ratio [AOR], 2.0; 95% confidence interval [CI], 1.6–2.7, high cholesterol (AOR, 2.3; 95% CI, 1.6–3.2, diabetes (AOR, 1.6; 95% CI, 1.1–2.4, and asthma (AOR, 2.2; 95% CI, 1.5–3.1 and smokers (AOR, 1.5; 95% CI, 1.1–2.0 were more likely to have FMD than people without each of these conditions. Adults who reported vigorous physical activity were less likely to have FMD (AOR, 0.6; 95% CI, 0.4–0.9 than their less active counterparts. Conclusions In Jordan, FMD was associated with several chronic conditions. As a result, we suggest additional research to examine the complex relationship between FMD and chronic conditions. More doctors in the primary health care system should be trained in mental health.

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

    Directory of Open Access Journals (Sweden)

    Supratim Datta

    2015-01-01

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

  12. 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

  13. 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.

  14. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting.

    Science.gov (United States)

    Kharkar, Mala; Bowalekar, Suresh

    2012-07-01

    The objective was to assess knowledge, attitude and perceptions/practices (KAP) of medical practitioners (MPs) in India towards Adverse Drug Reaction (ADR) reporting. A questionnaire was designed for assessment of KAP of medical practitioners in India toward ADR reporting. This questionnaire was administered to 2-3 medical practitioners from each zone prior to administering final questionnaire which was approved by Disha Independent Ethics Committee, Mumbai. 1200 medical practitioners (about 300 from each zone) from India were selected randomly. 1000 medical practitioners out of 1200 (90%), selected at random were approached. A total of 870 provided responses to the questionnaire, giving a response rate of 73% of 1200 selected randomly. A total of 47.5% respondents reported that they were aware of Government ADR centers. A total of 59.2% reported that they are familiar with the procedure of reporting ADRs to Government centers. However, only 18.5% of MPs have reported the observed ADRs to Government ADR centers. As against this relatively large number of MPs (87.9%) have reported ADRs observed during their routine practice to medical representatives of pharmaceutical company and NGOs (non-Govt. Organizations). A total of 80.5% of respondents agreed that safety plays an important role and 96% reported that ADR centers are useful. However, only 55.6% of respondents have reported that there is a need for ADR centers. The study reveals that practitioners are aware of ADR reporting; their perception toward ADR reporting is right but it is not reflected when it comes to the act of reporting of ADRs. In our sample of 870 respondents only 18.5 % reported ADRs to some organizations. Only 5% of respondents recorded the details of ADR and reported to the manufacturer and 1% of respondents to government health ministry. Thus, medical practitioners in India appear to have a good knowledge about ADR reporting, the right perception toward ADR reporting. However, as far as

  15. 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

  16. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Science.gov (United States)

    2010-04-01

    ... occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse... abuse. Unexpected adverse drug experience. Any adverse drug experience that is not listed in the current... and instructions for completing the form are available on the Internet at http://www.fda.gov/medwatch...

  17. Knowledge, attitude and performance of pharmacists and nurses in Mazandaran province, Iran regarding adverse drug reaction and its reporting, 2005.

    Directory of Open Access Journals (Sweden)

    Kh. Gholami

    2007-01-01

    Full Text Available AbstractBackground and purpose: Pharmacovigilance is a science that focuses on the detection, assessment, and prevention of adverse drug reactions (ADRs in the post-marketing phase. Its back bone is spontaneous reporting by health care workers via completing the yellow cards. Due to the low reporting of ADRs in the Mazandaran province, this study was designed to evaluate the knowledge, attitude and performance of pharmacists and nurses regarding ADRs reporting.Materials and Methods: This descriptive study was done on 286 health care workers including 67 pharmacists and 219 nurses, selected randomly from different cities of the province. The standard questionnaire of European pharmacovigilance research group was used as the data collection tool. In the field of knowledge, definition of pharmacovigilance, awareness of the national criteria for reporting the ADRs and awareness about the terminology occurrence rates of ADRs were questioned. To evaluate the attitude, reaction of subjects to the some simulated ADRs and reasons of underreporting were assessed. In the field of performance, numbers of reported ADRs and also the sites where reports sent from were asked. Data were analyzed using independent sample t-test for quantitative variables and Chi-square and Kendall’s tau-b for nominal and ordinal variables, respectively using SPSS software. P< 0.05 was considered as significant level.Results: There was no satisfying knowledge in each of the two groups. In spite of exposure of more than 80% of subjects to the ADRs, the mean reported ADRs values for pharmacists and nurses were very low as 0.72 ± 2.8 and 0.17 ± 0.67 respectively (P<0.01. Nurses liked to report most of ADRs to the physicians, nursing stations and pharmacist in spite of the national center. Considering these reports, they were more active than the pharmacists (P<0.001. The main causes of underreporting of the suspected ADRs were not being sure about the causative effect of the drug

  18. Contesting facts about wind farms in Australia and the legitimacy of adverse health effects.

    Science.gov (United States)

    Clark, Shannon; Botterill, Linda Courtenay

    2017-02-01

    The development of wind energy in Australia has been subject to ongoing public debate and has been characterised by concerns over the health impacts of wind turbines. Using discursive psychology, we examine 'wind turbine syndrome' as a contested illness and analyse how people build and undermine divergent arguments about wind-farm health effects. This article explores two facets of the dispute. First, we consider how participants construct 'facts' about the health effects of wind farms. We examine rhetorical resources used to construct wind farms as harmful or benign. Second, we examine the local negotiation of the legitimacy of health complaints. In the research interviews examined, even though interviewees treat those who report experiencing symptoms from wind farms as having primary rights to narrate their own experience, this epistemic primacy does not extend to the ability to 'correctly' identify symptoms' cause. As a result, the legitimacy of health complaints is undermined. Wind turbine syndrome is an example of a contested illness that is politically controversial. We show how stake, interest and legitimacy are particularly relevant for participants' competing descriptions about the 'facts' of wind turbine health effects.

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

    Directory of Open Access Journals (Sweden)

    Anshi Singh

    2012-01-01

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

  20. 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.

  1. Do community pharmacists in Nepal have a role in adverse drug reaction reporting systems?

    Directory of Open Access Journals (Sweden)

    Bhuvan K C

    2013-02-01

    Full Text Available Community pharmacies in Nepal serve both rural and urban populations and are an integral part of the Nepalese healthcare system. These community pharmacies are run by non-pharmacist professionals with orientation training on pharmacology and drug dispensing. Graduate pharmacists’ involvement in community pharmacy will help with patient counselling, dispensing of medication and promotion of safe and appropriate medicine use. Nepal has an organised pharmacovigilance system which incorporates adverse drug reaction (ADRs from hospitals and tertiary care centres but not from the community. Involvement of pharmacists in community pharmacy will help in ADR reporting and, monitoring at community level and will help in promoting medication safety in the community. This article describes the community pharmacovigilance program in Nepal and the prospects for community pharmacists.

  2. A review of low-level air pollution and adverse effects on human health: implications for epidemiological studies and public policy

    Science.gov (United States)

    Olmo, Neide Regina Simões; do Nascimento Saldiva, Paulo Hilário; Braga, Alfésio Luís Ferreira; Lin, Chin An; de Paula Santos, Ubiratan; Pereira, Luiz Alberto Amador

    2011-01-01

    The aim of this study was to review original scientific articles describing the relationship between atmospheric pollution and damage to human health. We also aimed to determine which of these studies mentioned public policy issues. Original articles relating to atmospheric pollution and human health published between 1995 and 2009 were retrieved from the PubMed database and analyzed. This study included only articles dealing with atmospheric pollutants resulting primarily from vehicle emissions. Three researchers were involved in the final selection of the studies, and the chosen articles were approved by at least two of the three researchers. Of the 84 non-Brazilian studies analyzed, 80 showed an association between atmospheric pollution and adverse effects on human health. Moreover, 66 showed evidence of adverse effects on human health, even at levels below the permitted emission standards. Three studies mentioned public policies aimed at changing emission standards. Similarly, the 29 selected Brazilian studies reported adverse associations with human health, and 27 showed evidence of adverse effects even at levels below the legally permitted emission standards. Of these studies, 16 mentioned public policies aimed at changing emission standards. Based on the Brazilian and non-Brazilian scientific studies that have been conducted, it can be concluded that, even under conditions that are compliant with Brazilian air quality standards, the concentration of atmospheric pollutants in Brazil can negatively affect human health. However, as little discussion of this topic has been generated, this finding demonstrates the need to incorporate epidemiological evidence into decisions regarding legal regulations and to discuss the public policy implications in epidemiological studies. PMID:21655765

  3. A review of low-level air pollution and adverse effects on human health: implications for epidemiological studies and public policy

    Directory of Open Access Journals (Sweden)

    Neide Regina Simoes Olmo

    2011-01-01

    Full Text Available The aim of this study was to review original scientific articles describing the relationship between atmospheric pollution and damage to human health. We also aimed to determine which of these studies mentioned public policy issues. Original articles relating to atmospheric pollution and human health published between 1995 and 2009 were retrieved from the PubMed database and analyzed. This study included only articles dealing with atmospheric pollutants resulting primarily from vehicle emissions. Three researchers were involved in the final selection of the studies, and the chosen articles were approved by at least two of the three researchers. Of the 84 non-Brazilian studies analyzed, 80 showed an association between atmospheric pollution and adverse effects on human health. Moreover, 66 showed evidence of adverse effects on human health, even at levels below the permitted emission standards. Three studies mentioned public policies aimed at changing emission standards. Similarly, the 29 selected Brazilian studies reported adverse associations with human health, and 27 showed evidence of adverse effects even at levels below the legally permitted emission standards. Of these studies, 16 mentioned public policies aimed at changing emission standards. Based on the Brazilian and non-Brazilian scientific studies that have been conducted, it can be concluded that, even under conditions that are compliant with Brazilian air quality standards, the concentration of atmospheric pollutants in Brazil can negatively affect human health. However, as little discussion of this topic has been generated, this finding demonstrates the need to incorporate epidemiological evidence into decisions regarding legal regulations and to discuss the public policy implications in epidemiological studies.

  4. 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

  5. Multi-Institutional Assessment of Adverse Health Outcomes Among North American Testicular Cancer Survivors After Modern Cisplatin-Based Chemotherapy.

    Science.gov (United States)

    Fung, Chunkit; Sesso, Howard D; Williams, Annalynn M; Kerns, Sarah L; Monahan, Patrick; Abu Zaid, Mohammad; Feldman, Darren R; Hamilton, Robert J; Vaughn, David J; Beard, Clair J; Kollmannsberger, Christian K; Cook, Ryan; Althouse, Sandra; Ardeshir-Rouhani-Fard, Shirin; Lipshultz, Steve E; Einhorn, Lawrence H; Fossa, Sophie D; Travis, Lois B

    2017-04-10

    Purpose To provide new information on adverse health outcomes (AHOs) in testicular cancer survivors (TCSs) after four cycles of etoposide and cisplatin (EPX4) or three or four cycles of bleomycin, etoposide, cisplatin (BEPX3/BEPX4). Methods Nine hundred fifty-two TCSs > 1 year postchemotherapy underwent physical examination and completed a questionnaire. Multinomial logistic regression estimated AHOs odds ratios (ORs) in relation to age, cumulative cisplatin and/or bleomycin dose, time since chemotherapy, sociodemographic factors, and health behaviors. Results Median age at evaluation was 37 years; median time since chemotherapy was 4.3 years. Chemotherapy consisted largely of BEPX3 (38.2%), EPX4 (30.9%), and BEPX4 (17.9%). None, one to two, three to four, or five or more AHOs were reported by 20.4%, 42.0%, 25.1%, and 12.5% of TCSs, respectively. Median number after EPX4 or BEPX3 was two (range, zero to nine and zero to 11, respectively; P > .05) and two (range, zero to 10) after BEPX4. When comparing individual AHOs for EPX4 versus BEPX3, Raynaud phenomenon (11.6% v 21.4%; P physical activity was protective (OR, 0.62, 0.51, and 0.41, respectively; P < .05). Significant risk factors for three to four and five or more AHOs included current (OR, 3.05 and 3.73) or former (OR, 1.61 and 1.76) smoking ( P < .05). Self-reported health was excellent/very good in 59.9% of TCSs but decreased as AHOs increased ( P < .001). Conclusion Numbers of AHOs after EPX4 or BEPX3 appear similar, with median follow-up of 4.3 years. A healthy lifestyle was associated with reduced number of AHOs.

  6. 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

  7. Spontaneous adverse event signaling methods: classification and use with health care treatment products.

    Science.gov (United States)

    Clark, J A; Klincewicz, S L; Stang, P E

    2001-01-01

    AE signal detection and its techniques are part of the continuum of public health surveillance, borrowing from both its theory and application (171). Like public health surveillance networks, whose major goals are to identify early signs of new outbreaks, pinpoint new organisms, and monitor designated illnesses, AE signaling and surveillance systems attempt to provide early warnings of previously unsuspected product-AE pairs, hypothesize potential drug-event relations, identify populations "at risk," and facilitate case ascertainment and definition. In both examples, definitive research is often subsequently undertaken to quantify the strength of relations that may be proposed. As with any public health surveillance effort, AE surveillance provides an infrastructure for the ongoing collection of health data and its direct integration into the health regulatory policy (172), including its keystone role in risk assessment and management. However, unlike many surveillance systems, postmarketing AE systems collect case information that is often relatively incomplete and imperfect, estimate exposure based on surrogate values (e.g., sales data), and are used by both governmental and the private sector for preventive planning. These factors make AE signaling and surveillance more ambiguous, regulatory oriented, and complex than its disease counterparts (173). Despite such issues, AE signaling methods continue to evolve in extent, complexity, and acceptance (4, 131, 174). Undoubtedly, this is largely due to the widespread practical experience that has been gained with spontaneous reporting systems over the past 4 decades and the cumulative usefulness that has been demonstrated.

  8. Adverse reactions to sulfites

    Science.gov (United States)

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

    1985-01-01

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

  9. Adverse effects on health and wellbeing of working as a doctor: views of the UK medical graduates of 1974 and 1977 surveyed in 2014.

    Science.gov (United States)

    Smith, Fay; Goldacre, Michael J; Lambert, Trevor W

    2017-05-01

    Objective To report on any adverse effects on health and wellbeing of working as a doctor, as described by senior doctors. Design Questionnaires sent in 2014 to all medical graduates of 1974 and 1977. Participants 3695 UK medical graduates. Setting United Kingdom. Main outcome measures Statements about adverse effects upon health, wellbeing and career. Results The aggregated response rate from contactable doctors was 84.6% (3695/4369). In response to the question 'Do you feel that working as a doctor has had any adverse effects on your own health or wellbeing?', 44% of doctors answered 'yes'. More GPs (47%) than hospital doctors (42%) specified that this was the case. Three-quarters of doctors who answered 'yes' cited 'stress/work-life balance/workload' as an adverse effect, and 45% mentioned illness. In response to the statement 'The NHS of today is a good employer when doctors become ill themselves', 28% of doctors agreed, 29% neither agreed nor disagreed and 43% disagreed. More women doctors (49%) than men doctors (40%) disagreed with this statement. More general practitioners (49%) disagreed than hospital doctors (37%). Conclusions Chronic stress and illness, which these doctors attributed to their work, were widely reported. Although recent changes may have alleviated some of these issues, there are lessons for the present and future if the NHS is to ensure that its medical workforce receives the support which enables current doctors to enjoy a full and satisfying career and to contribute fully to health service provision in the UK. Older doctors, in particular, need support to be able to continue successfully in their careers.

  10. Beyond PM2.5: The role of ultrafine particles on adverse health effects of air pollution.

    Science.gov (United States)

    Chen, Rui; Hu, Bin; Liu, Ying; Xu, Jianxun; Yang, Guosheng; Xu, Diandou; Chen, Chunying

    2016-12-01

    Air pollution constitutes the major threat to human health, whereas their adverse impacts and underlying mechanisms of different particular matters are not clearly defined. Ultrafine particles (UFPs) are high related to the anthropogenic emission sources, i.e. combustion engines and power plants. Their composition, source, typical characters, oxidative effects, potential exposure routes and health risks were thoroughly reviewed. UFPs play a major role in adverse impacts on human health and require further investigations in future toxicological research of air pollution. Unlike PM2.5, UFPs may have much more impacts on human health considering loads of evidences emerging from particulate matters and nanotoxicology research fields. The knowledge of nanotoxicology contributes to the understanding of toxicity mechanisms of airborne UFPs in air pollution. This article is part of a Special Issue entitled Air Pollution, edited by Wenjun Ding, Andrew J. Ghio and Weidong Wu. Copyright © 2016 Elsevier B.V. All rights reserved.

  11. 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...

  12. (Un)Healthy in the city : Adverse health effects of traffic-related noise and air pollution

    NARCIS (Netherlands)

    Zijlema, Wilma

    2016-01-01

    We investigated the adverse health effects of urbanity, traffic-related noise and air pollution. We used harmonized data from multiple European cohort studies: LifeLines, HUNT, FINRISK, EPIC-Oxford and KORA. Based on our studies, we concluded that the living environment may be associated with advers

  13. Taxation of the fat content of foods for reducing their consumption and preventing obesity or other adverse health outcomes

    OpenAIRE

    Lhachimi, Stefan K.; Pega, Frank; Heise, Thomas L.; Fenton, Candida; Gartlehner, Gerald; Griebler, Ursula; Sommer, Isolde; Pfinder, Manuela; Katikireddi, Srinivasa Vittal

    2016-01-01

    This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:\\ud \\ud To assess the effects of taxation of fat content in food on consumption of total fat and saturated fat, energy intake, overweight, obesity, and other adverse health outcomes in the general population.

  14. Juvenile Male Rats Exposed to a Low-Dose Mixture of Twenty-Seven Environmental Chemicals Display Adverse Health Effects

    DEFF Research Database (Denmark)

    Hadrup, Niels; Svingen, Terje; Egebjerg, Karen Mandrup

    2016-01-01

    Humans are exposed to a large number of environmental chemicals in their daily life, many of which are readily detectable in blood or urine. It remains uncertain if these chemicals can cause adverse health effects when present together at low doses. In this study we have tested whether a mixture...

  15. A critical assessment of shrinkage-based regression approaches for estimating the adverse health effects of multiple air pollutants

    Science.gov (United States)

    Roberts, Steven; Martin, Michael

    Most investigations of the adverse health effects of multiple air pollutants analyse the time series involved by simultaneously entering the multiple pollutants into a Poisson log-linear model. Concerns have been raised about this type of analysis, and it has been stated that new methodology or models should be developed for investigating the adverse health effects of multiple air pollutants. In this paper, we introduce the use of the lasso for this purpose and compare its statistical properties to those of ridge regression and the Poisson log-linear model. Ridge regression has been used in time series analyses on the adverse health effects of multiple air pollutants but its properties for this purpose have not been investigated. A series of simulation studies was used to compare the performance of the lasso, ridge regression, and the Poisson log-linear model. In these simulations, realistic mortality time series were generated with known air pollution mortality effects permitting the performance of the three models to be compared. Both the lasso and ridge regression produced more accurate estimates of the adverse health effects of the multiple air pollutants than those produced using the Poisson log-linear model. This increase in accuracy came at the expense of increased bias. Ridge regression produced more accurate estimates than the lasso, but the lasso produced more interpretable models. The lasso and ridge regression offer a flexible way of obtaining more accurate estimation of pollutant effects than that provided by the standard Poisson log-linear model.

  16. Establishment of Exposure-response Functions of Air Particulate Matter and Adverse Health Outcomes in China and Worldwide

    Institute of Scientific and Technical Information of China (English)

    HAI-DONG KAN; BING-HENG CHEN; CHANG-HONG CHEN; BING-YAN WANG; QING-YAN FU

    2005-01-01

    Objective To obtain the exposure-response functions that could be used in health-based risk assessment of particulate air pollution in China. Methods Meta analysis was conducted on the literatures on air particulate matter and its adverse health outcomes in China and worldwide. Results For each health outcome from morbidity to mortality changes, the relative risks were estimated when the concentration of air particulate matter increased to some certain units. Conclusion The exposure-response functions recommended here can be further applied to health risk assessment of air particulate matter in China.

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2003-01-01

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

  19. Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality.

    Science.gov (United States)

    Necyk, Candace; Tsuyuki, Ross T; Boon, Heather; Foster, Brian C; Legatt, Don; Cembrowski, George; Murty, Mano; Barnes, Joanne; Charrois, Theresa L; Arnason, John T; Ware, Mark A; Rosychuk, Rhonda J; Vohra, Sunita

    2014-03-28

    To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies. Cross-sectional study of screened patients. 10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011. The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications. Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality. Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; ppharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE. A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based.

  20. Risk of Adverse Health and Performance Effects of Celestial Dust Exposure

    Science.gov (United States)

    Scully, Robert R.; Meyers, Valerie E.

    2015-01-01

    silica (Permissible Exposure Limit [PEL] 0.05 mg/m3) but more toxic than the nuisance dust titanium dioxide (TiO2 [PEL 5.0 mg/m3]). A PEL for episodic exposure to airborne lunar dust during a six-month stay on the lunar surface was established, in consultation with an independent, extramural panel of expert pulmonary toxicologists, at 0.3 mg/m3. The PEL provided for lunar dust is limited to the conditions and exposure specified therefore additional research remains to be accomplished with lunar dust to further address the issues of activation, address other areas of more unique lunar geology (Glotch et al., 2010; Greenhagen et al., 2010), examine potential toxicological effects of inhaled or ingested dust upon other organ systems, such cardiovascular, nervous systems, and examine effects of acute exposure to massive doses of dust such as may occur during off-nominal situations. Work to support the establishment of PELs for Martian dust and dusts of asteroids remains to be accomplished. The literature that describes health effects of exposure to toxic terrestrial dusts provides substantial basis for concern that prolonged exposure to respirable celestial dust could be detrimental to human health. Celestial bodies where a substantial portion of the dust is in the respirable range or where the dusts have large reactive surface areas or contain transition metals or volatile organics, represent greater risks of adverse effects from exposure to the dust. It is possible that in addition to adverse effects to the respiratory system, inhalation and ingestion of celestial dusts could pose risks to other systems

  1. Adverse Health Complaints of Adults Exposed to Benzene After a Flaring Disaster at the BP Refinery Facility in Texas City, Texas.

    Science.gov (United States)

    D'Andrea, Mark A; Reddy, G Kesava

    2017-09-07

    The objective of this study was to assess the adverse health symptoms experienced by adult subjects who were exposed to benzene after a flaring disaster at the BP refinery in Texas City, Texas. A total of 2162 adults aged 18 years or older and exposed to benzene were included. Using the patients' medical charts, we collected and analyzed data on health complaints as well as the patients' serum levels of beta-2-microglobulin and urinary excretion of phenol. A total of 11,368 health symptom complaints were reported in 2162 adults exposed to benzene. Neurological symptoms occurred most frequently (174%), followed upper respiratory symptoms (115%), cough (31%), painful joints (30%), cardiac symptoms (28%), dermatological symptoms (28%), gastrointestinal symptoms (27%), diarrhea (25%), vision symptoms (21%), and nausea/vomiting (19%). Logistic regression analysis indicated that urinary symptoms (R2=0.65) and painful joints (R2=0.44) were positively associated with increasing age in benzene-exposed subjects. Adult subjects exposed to benzene experience a range of adverse health symptoms and an altered profile of urinary phenol, thus indicating they are at high risk of developing serious future health complications. (Disaster Med Public Health Preparedness. 2017;page 1 of 9).

  2. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, Eugène P; Bate, Andrew; Leufkens, Hubert G M; Lindquist, Marie; Orre, Roland; Egberts, Antoine C G

    2002-01-01

    PURPOSE: A continuous systematic review of all combinations of drugs and suspected adverse reactions (ADRs) reported to a spontaneous reporting system, is necessary to optimize signal detection. To focus attention of human reviewers, quantitative procedures can be used to sift data in different ways

  3. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, Eugène P; Bate, Andrew; Leufkens, Hubert G M; Lindquist, Marie; Orre, Roland; Egberts, Antoine C G

    2002-01-01

    PURPOSE: A continuous systematic review of all combinations of drugs and suspected adverse reactions (ADRs) reported to a spontaneous reporting system, is necessary to optimize signal detection. To focus attention of human reviewers, quantitative procedures can be used to sift data in different ways

  4. Adverse events and patients’ perceived health-related quality of life at the end of multidrug-resistant tuberculosis treatment in Namibia

    Science.gov (United States)

    Sagwa, Evans L; Ruswa, Nunurai; Mavhunga, Farai; Rennie, Timothy; Leufkens, Hubert GM; Mantel-Teeuwisse, Aukje K

    2016-01-01

    Purpose The health-related quality of life (HRQoL) of patients completing multidrug-resistant tuberculosis (MDR-TB) treatment in Namibia and whether the occurrence of adverse events influenced patients’ rating of their HRQoL was evaluated. Patients and methods A cross-sectional analytic survey of patients completing or who recently completed MDR-TB treatment was conducted. The patients rated their HRQoL using the simplified Short Form-™ (SF-8) questionnaire consisting of eight Likert-type questions. Three supplemental questions on the adverse events that the patients may have experienced during their MDR-TB treatment were also included. Scoring of HRQoL ratings was norm-based (mean =50, standard deviation =10) ranging from 20 (worst health) to 80 (best health), rather than the conventional 0–100 scores. We evaluated the internal consistency of the scale items using the Cronbach’s alpha, performed descriptive analyses, and analyzed the association between the patients’ HRQoL scores and adverse events. Results Overall, 36 patients (20 males, 56%) aged 17–54 years (median =40 years) responded to the questionnaire. The median (range) HRQoL score for the physical component summary was 58.6 (35.3–60.5), while the median score for the mental component summary was 59.3 (26.6–61.9), indicating not-so-high self-rating of health. There was good internal consistency of the scale scores, with a Cronbach’s alpha value of >0.80. In all, 32 (89%) of the 36 patients experienced at least one adverse drug event of any severity during their treatment (median events =3, range 1–6), of which none was life-threatening. The occurrence of adverse events was not related to HRQoL scores. For patients reporting zero to two events, the median (range) HRQoL score was 56.8 (44.4–56.8), while for those reporting three or more events, the median score was 55.2 (38.6–56.8); P=0.34 for difference between these scores. Conclusion Patients completing treatment for MDR-TB in

  5. 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

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

    Science.gov (United States)

    2010-04-01

    ... experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... adverse drug experiences on marketed prescription drugs for human use without approved new drug...

  7. 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

  8. 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

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

    Directory of Open Access Journals (Sweden)

    Yun Mi Yu

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

  10. Adverse Reproductive and Developmental Health Outcomes Following Prenatal Exposure to a Hydraulic Fracturing Chemical Mixture in Female C57Bl/6 Mice.

    Science.gov (United States)

    Kassotis, Christopher D; Bromfield, John J; Klemp, Kara C; Meng, Chun-Xia; Wolfe, Andrew; Zoeller, R Thomas; Balise, Victoria D; Isiguzo, Chiamaka J; Tillitt, Donald E; Nagel, Susan C

    2016-09-01

    Unconventional oil and gas operations using hydraulic fracturing can contaminate surface and groundwater with endocrine-disrupting chemicals. We have previously shown that 23 of 24 commonly used hydraulic fracturing chemicals can activate or inhibit the estrogen, androgen, glucocorticoid, progesterone, and/or thyroid receptors in a human endometrial cancer cell reporter gene assay and that mixtures can behave synergistically, additively, or antagonistically on these receptors. In the current study, pregnant female C57Bl/6 dams were exposed to a mixture of 23 commonly used unconventional oil and gas chemicals at approximately 3, 30, 300, and 3000 μg/kg·d, flutamide at 50 mg/kg·d, or a 0.2% ethanol control vehicle via their drinking water from gestational day 11 through birth. This prenatal exposure to oil and gas operation chemicals suppressed pituitary hormone concentrations across experimental groups (prolactin, LH, FSH, and others), increased body weights, altered uterine and ovary weights, increased heart weights and collagen deposition, disrupted folliculogenesis, and other adverse health effects. This work suggests potential adverse developmental and reproductive health outcomes in humans and animals exposed to these oil and gas operation chemicals, with adverse outcomes observed even in the lowest dose group tested, equivalent to concentrations reported in drinking water sources. These endpoints suggest potential impacts on fertility, as previously observed in the male siblings, which require careful assessment in future studies.

  11. 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

  12. Endocrine-disrupting activity of hydraulic fracturing chemicals and adverse health outcomes after prenatal exposure in male mice

    Science.gov (United States)

    Kassotis, Christopher D.; Klemp, Kara C.; Vu, Danh C.; Lin, Chung-Ho; Meng, Chun-Xia; Besch-Williford, Cynthia L.; Pinatti, Lisa; Zoeller, R. Thomas; Drobnis, Erma Z.; Balise, Victoria D.; Isiguzo, Chiamaka J.; Williams, Michelle A.; Tillitt, Donald E.; Nagel, Susan C.

    2015-01-01

    Oil and natural gas operations have been shown to contaminate surface and ground water with endocrine-disrupting chemicals. In the current study, we fill several gaps in our understanding of the potential environmental impacts related to this process. We measured the endocrine-disrupting activities of 24 chemicals used and/or produced by oil and gas operations for five nuclear receptors using a reporter gene assay in human endometrial cancer cells. We also quantified the concentration of 16 of these chemicals in oil and gas wastewater samples. Finally, we assessed reproductive and developmental outcomes in male C57BL/6J mice after the prenatal exposure to a mixture of these chemicals. We found that 23 commonly used oil and natural gas operation chemicals can activate or inhibit the estrogen, androgen, glucocorticoid, progesterone, and/or thyroid receptors, and mixtures of these chemicals can behave synergistically, additively, or antagonistically in vitro. Prenatal exposure to a mixture of 23 oil and gas operation chemicals at 3, 30, and 300 μg/kg · d caused decreased sperm counts and increased testes, body, heart, and thymus weights and increased serum testosterone in male mice, suggesting multiple organ system impacts. Our results suggest possible adverse developmental and reproductive health outcomes in humans and animals exposed to potential environmentally relevant levels of oil and gas operation chemicals.

  13. Endocrine-Disrupting Activity of Hydraulic Fracturing Chemicals and Adverse Health Outcomes After Prenatal Exposure in Male Mice.

    Science.gov (United States)

    Kassotis, Christopher D; Klemp, Kara C; Vu, Danh C; Lin, Chung-Ho; Meng, Chun-Xia; Besch-Williford, Cynthia L; Pinatti, Lisa; Zoeller, R Thomas; Drobnis, Erma Z; Balise, Victoria D; Isiguzo, Chiamaka J; Williams, Michelle A; Tillitt, Donald E; Nagel, Susan C

    2015-12-01

    Oil and natural gas operations have been shown to contaminate surface and ground water with endocrine-disrupting chemicals. In the current study, we fill several gaps in our understanding of the potential environmental impacts related to this process. We measured the endocrine-disrupting activities of 24 chemicals used and/or produced by oil and gas operations for five nuclear receptors using a reporter gene assay in human endometrial cancer cells. We also quantified the concentration of 16 of these chemicals in oil and gas wastewater samples. Finally, we assessed reproductive and developmental outcomes in male C57BL/6J mice after the prenatal exposure to a mixture of these chemicals. We found that 23 commonly used oil and natural gas operation chemicals can activate or inhibit the estrogen, androgen, glucocorticoid, progesterone, and/or thyroid receptors, and mixtures of these chemicals can behave synergistically, additively, or antagonistically in vitro. Prenatal exposure to a mixture of 23 oil and gas operation chemicals at 3, 30, and 300 μg/kg · d caused decreased sperm counts and increased testes, body, heart, and thymus weights and increased serum testosterone in male mice, suggesting multiple organ system impacts. Our results suggest possible adverse developmental and reproductive health outcomes in humans and animals exposed to potential environmentally relevant levels of oil and gas operation chemicals.

  14. Knowledge, attitude and practice of General Practitioners towards adverse drug reaction reporting in South of Iran, Shiraz (Pharmacoepidemiology report).

    Science.gov (United States)

    Peymani, Payam; Tabrizi, Reza; Afifi, Saba; Namazi, Soha; Heydari, Seyed Taghi; Shirazi, Mohammad Khabaz; Nouraei, Hasti; Sadeghi, Elham; Lankarani, Kamran B; Maharlouei, Najmeh

    2016-03-16

    An adverse drug reaction (ADRs) is linked with the use of medications and unpredictable negative consequences. The Iranian Pharmacovigilance center (IPC) has reported that the rate of ADR is very low. Thus, this study was performed to find the reasons for this under-reporting, and investigate the level of knowledge, attitude and practice (KAP) of General Practitioners (GPs) about spontaneous reporting system in Shiraz. The present cross-sectional study was conducted on 350 general practitioners (GPs) working in Shiraz, Iran from Oct 2014 to March 2015. A semi-structured questionnaire was used which included demographic features, and evaluated KAPs of GPs regarding ADRs, Pharmacovigilance, and yellow card reporting. Statistical analysis was done by descriptive and analytical statistics (frequency, Mean±SD, Student t-test, Chi-square) using SPSS version 16. Of 350 (95.1%) GPs, 333 completed the questionnaire. The respondents aged from 26 to76 years, of whom 176 (52.9%) were males with mean age 39.6±8.8 SD years. In regard to work place, 85 (25.5%) had their own office, and 112 (33.7%), 101 (30.9%), and 35 (10.5%) worked in private hospitals, in governmental hospitals, and in more than one place, respectively. Work experience mean was 13.3±8.2SD years and median was 12 years (range 1-50 years). Although, less than half of the participants (n = 151; 45.3%) described ADR correctly, 215 (64.6%) respondents claimed that they were not familiar with physician's responsibility regarding ADR reporting. Overall, few of the participants were aware of the steps in either ADR reporting or using Yellow Card System. On the whole, 100 (30%) respondents achieved acceptable knowledge score, while the median score was 9 out of 14 and minimum and maximum being 5 and 14, respectively. The physicians in Shiraz have poor knowledge of the pharmacovigilance system; however self-education leads to a better knowledge and positive attitude regarding ADRs reporting system. National

  15. Planned Repeat Cesarean Section at Term and Adverse Childhood Health Outcomes: A Record-Linkage Study.

    Directory of Open Access Journals (Sweden)

    Mairead Black

    2016-03-01

    Full Text Available Global cesarean section (CS rates range from 1% to 52%, with a previous CS being the commonest indication. Labour following a previous CS carries risk of scar rupture, with potential for offspring hypoxic brain injury, leading to high rates of repeat elective CS. However, the effect of delivery by CS on long-term outcomes in children is unclear. Increasing evidence suggests that in avoiding exposure to maternal bowel flora during labour or vaginal birth, offspring delivered by CS may be adversely affected in terms of energy uptake from the gut and immune development, increasing obesity and asthma risks, respectively. This study aimed to address the evidence gap on long-term childhood outcomes following repeat CS by comparing adverse childhood health outcomes after (1 planned repeat CS and (2 unscheduled repeat CS with those that follow vaginal birth after CS (VBAC.A data-linkage cohort study was performed. All second-born, term, singleton offspring delivered between 1 January 1993 and 31 December 2007 in Scotland, UK, to women with a history of CS (n = 40,145 were followed up until 31 January 2015. Outcomes assessed included obesity at age 5 y, hospitalisation with asthma, learning disability, cerebral palsy, and death. Cox regression and binary logistic regression were used as appropriate to compare outcomes following planned repeat CS (n = 17,919 and unscheduled repeat CS (n = 8,847 with those following VBAC (n = 13,379. Risk of hospitalisation with asthma was greater following both unscheduled repeat CS (3.7% versus 3.3%, adjusted hazard ratio [HR] 1.18, 95% CI 1.05-1.33 and planned repeat CS (3.6% versus 3.3%, adjusted HR 1.24, 95% CI 1.09-1.42 compared with VBAC. Learning disability and death were more common following unscheduled repeat CS compared with VBAC (3.7% versus 2.3%, adjusted odds ratio 1.64, 95% CI 1.17-2.29, and 0.5% versus 0.4%, adjusted HR 1.50, 95% CI 1.00-2.25, respectively. Risk of obesity at age 5 y and risk of cerebral

  16. Bariatric surgery results: reporting clinical characteristics and adverse outcomes from an integrated healthcare delivery system.

    Science.gov (United States)

    Li, Robert A; Fisher, David P; Dutta, Sanjoy; O'Brien, Rebecca M; Ackerson, Lynn M; Sorel, Michael E; Sidney, Stephen

    2015-01-01

    Limited data have been reported on bariatric surgery within a large, high-volume regional multicenter integrated healthcare delivery system. Review clinical characteristics and short- and intermediate-term outcomes and adverse events from a bariatric surgery program within an integrated healthcare delivery system. Single high-volume, multicenter regional integrated healthcare delivery system. Adult patients who underwent primary bariatric surgery during 2010-2011 were reviewed. Clinical characteristics, outcomes, and weight loss results were extracted from the electronic medical record. A total of 2399 patients were identified within the study period. The 30-day rates of clinical outcomes for Roux-en-Y gastric bypass (RYGB; n = 1313) and sleeve gastrectomy (SG; n = 1018) were 2.9% for readmission, 3.0% for major complications, .8% for reoperation, and 0% for mortality. One-year and 2-year weight loss results were as follows: percent weight loss (%WL) was 31.4 (±SD 8.5) and 34.2±12.0% for SG and 34.1±9.3 and 39.1±11.9 for RYGB; percent excess weight loss (%EBWL) was 64.2±18.0 and 69.8±23.7 for SG and 68.0±19.3 and 77.8±23.7 for RYGB; percent excess body mass index loss (%EBMIL) was 72.9±21.0 and 77.7±22.4 for SG and 76.6±22.1% and 85.6±21.6 for RYGB. Follow-up for each procedure at 1 year was 76% for SG (n = 778) and 80% for RYGB (n = 1052) and at 2 years was 65% for SG (n = 659) and 67% for RYGB (n = 875). A large regional high-volume multicenter bariatric program within an integrated healthcare delivery system can produce excellent short-term results with low rates of short- and intermediate-term adverse outcomes. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  17. Community Mental Health Clinic Cost Reports

    Data.gov (United States)

    U.S. Department of Health & Human Services — Healthcare Cost Report Information System (HCRIS) Dataset - Community Mental Health Center (CMHC). This data was reported on form CMS-2088-92. The data in this...

  18. 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.

  19. The nineteenth report on survey of the adverse reaction to radiopharmaceuticals. The 22nd survey in 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-03-01

    The report included cases of adverse reaction to radiopharmaceuticals and of drug defect which had occurred from April 1, 1996 to March 31, 1997. The survey was done by the questionnaire to 1,182 nuclear medicine facilities in Japan and 961 answers (81.3%) were obtained. Thirty one cases of adverse reactions were reported from 31 facilities in 1,264,865 cases to that radiopharmaceuticals had been administered and 7 cases of drug defect were reported from 7 facilities. Adverse reactions involved 8 vasovagal reactions, 14 allergic reactions and 9 others for {sup 99m}Tc-MAA (adverse reaction rate in %: 0.0025), -PYP (0.0352), -HM-PAO (0.0025), -MDP{center_dot}HMDP (0.0008), -DTPA (0.0189), -HSA (0.0086), -MIBI (0.0066), -tetrofosmin (0.0032), -MAG{sub 3} (0.0147), {sup 201}Tl-TlCl2 (0.0014), {sup 123}I-NaI capsule (0.0068), -IMP (0.0016), {sup 131}I-NaI capsule (0.0128) and -iodomethyl-norcholesterol (0.2752). Drug defects involved 1 incomplete radio-labeling, 3 broken or contaminated vials and 3 others. Relative to those hitherto, adverse reaction cases tended to be decreasing and drug defect cases clearly decreased. (K.H.)

  20. Health risk characterization for exposure to benzene in service stations and petroleum refineries environments using human adverse response data

    Directory of Open Access Journals (Sweden)

    Benjamin Edokpolo

    2015-01-01

    Full Text Available Health risk characterization of exposure to benzene in service stations and petroleum refineries has been carried out in previous studies using guideline values set by various agencies. In this work, health risk was characterized with the exposure data as cumulative probability distribution (CPD plots but using human epidemiological data. This was achieved by using lowest observable adverse effects levels (LOAEL data plotted as cumulative probability lowest effects distribution (CPLED. The health risk due to benzene was characterized by using probabilistic methods of hazard quotient (HQ50/50 and HQ95/5, Monte-Carlo simulation (MCS and overall risk probability (ORP. CPD relationships of adverse health effects relationships and exposure data were in terms of average daily dose (ADD and lifetime average daily dose (LADD for benzene. For service station environments HQ50/50 and HQ95/5 were in a range of 0.000071–0.055 and 0.0049–21, respectively. On the other hand, the risk estimated for petroleum refinery environments suggests higher risk with HQ50/50 and HQ95/5 values ranging from 0.0012 to 77 and 0.17 to 560, respectively. The results of Monte-Carlo risk probability (MRP and ORP indicated that workers in petroleum refineries (MRP of 2.9–56% and ORP of 4.6–52% of the affected population were at a higher risk of adverse health effects from exposure to benzene as compared to exposure to benzene in service station environments (MRP of 0.051 –3.4% and ORP of 0.35–2.7% affected population. The adverse effect risk probabilities estimated by using the Monte-Carlo simulation technique and the ORP method were found to be generally consistent.

  1. 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

  2. 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...

  3. Severe Cholestatic Hepatitis due to Temozolomide: An Adverse Drug Effect to Keep in Mind. Case Report and Review of Literature

    OpenAIRE

    Grieco, Antonio; Tafuri, Maria Antonietta; Biolato, Marco; Diletto, Barbara; Di Napoli, Nicola; Balducci, Nicola; Vecchio, Fabio Maria; Miele, Luca

    2015-01-01

    Abstract Temozolomide is the current standard of therapy for postoperative patients with glioblastoma starting adjuvant radiotherapy. Hematologic adverse events are the most frequent side effects of temozolomide, while liver toxicity has been reported only in the post-marketing period. Here we report a case of severe temozolomide-induced liver injury during concurrent radiotherapy treatment, at a dose level of 75 mg/m2. The aim of this case report is to focus on the problems of temozolomide-i...

  4. Nutrient- and non-nutrient-based natural health product (NHP) use in adults with mood disorders: prevalence, characteristics and potential for exposure to adverse events

    National Research Council Canada - National Science Library

    Davison, Karen M; Kaplan, Bonnie J

    2013-01-01

    To address knowledge gaps regarding natural health product (NHP) usage in mental health populations, we examined their use in adults with mood disorders, and explored the potential for adverse events...

  5. Identifying systematic reviews of the adverse effects of health care interventions

    Directory of Open Access Journals (Sweden)

    McIntosh Heather M

    2006-05-01

    Full Text Available Abstract Background In order to carry out a methodological research survey of systematic reviews of adverse effects we needed to retrieve a sample of systematic reviews in which the primary outcome is an adverse effect or effects. Methods We carried out searches of the Database of Abstracts of Reviews of Effects (DARE and the Cochrane Database of Systematic Reviews (CDSR for systematic reviews of adverse effects published between 1994 to 2005. The search strategies used a combination of text words in the title and abstract, Medical Subject Headings (MeSH and subheadings/qualifiers. In addition, DARE records in progress were hand searched. No language restrictions were placed on any of the searches. The performance, in terms of sensitivity and precision, of the search strategies and their combinations were tested in DARE and CDSR. Results In total 3635 records were screened of which 257 met our inclusion criteria. The precision of the searches in CDSR was low (0% to 3%, and no one search strategy could retrieve all the relevant records in either DARE or CDSR. Hand searching the records from DARE and CDSR not retrieved by our searches indicated that we had missed relevant systematic reviews in both DARE and CDSR. The sensitivities of many of the search combinations were comparable to those found when searching for primary studies in which adverse effects are secondary outcomes. Conclusion Searching major databases of systematic reviews, for systematic reviews of adverse effects, proved more difficult than anticipated due to a lack of standard terminology used by the authors, inadequate indexing and the variations in the search interfaces of the databases. At present hand searching all records in DARE and CDSR seems to be the only way to ensure retrieval of all systematic reviews of adverse effects in these databases.

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

    Directory of Open Access Journals (Sweden)

    Perrone V

    2014-12-01

    Full Text Available Valentina Perrone,1,* Valentino Conti,2,* Mauro Venegoni,2 Stefania Scotto,2 Luca Degli Esposti,3 Diego Sangiorgi,3 Lucia Prestini,4 Sonia Radice,1 Emilio Clementi,5,6 Giuseppe Vighi,2,4 1Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy; 2Regional Centre for Pharmacovigilance, Lombardy, Milan, Italy; 3CliCon Srl, Health, Economics and Outcomes Research, Ravenna, Italy; 4Unit of Clinical Pharmacology and Pharmacovigilance, Niguarda Ca’Granda Hospital, Milan, Italy; 5Unit of Clinical Pharmacology, CNR Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy; 6Scientific Institute, IRCCS Eugenio Medea, Lecco, Italy *These authors contributed equally to the work Objective: The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs reported in emergency departments (EDs and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods: This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results: 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal

  8. Adverse psychological outcomes in long-term survivors of hematopoietic cell transplantation: a report from the Bone Marrow Transplant Survivor Study (BMTSS).

    Science.gov (United States)

    Sun, Can-Lan; Francisco, Liton; Baker, K Scott; Weisdorf, Daniel J; Forman, Stephen J; Bhatia, Smita

    2011-10-27

    Little information exists regarding long-term psychological health of hematopoietic cell transplantation (HCT) survivors. Using resources offered by the Bone Marrow Transplant Survivor Study (BMTSS), we evaluated adverse psychological outcomes in 1065 long-term HCT survivors and a healthy comparison group composed of siblings. Psychological health status was evaluated using the Brief Symptom Inventory-18. Twenty-two percent of the HCT survivors reported adverse psychological outcomes, compared with 8% of the siblings. Exposure to prednisone was associated with psychological distress across all domains (anxiety, depression, and somatic distress). Fifteen percent of the HCT survivors reported somatic distress, representing an almost 3-fold higher risk comparing to siblings. Among survivors, in addition to low annual household income and self-reported poor health, having severe/life-threatening conditions and presence of active chronic GVHD were associated with a 2-fold increased risk for somatic distress. Seven percent of the HCT survivors expressed suicidal ideation; patients with higher scores on depression subscale were most vulnerable. This study demonstrates that somatic distress is the biggest challenge faced by survivors long after HCT. These results identify vulnerable subpopulations and provide patients, families, and healthcare providers with necessary information to plan for post-HCT needs many years after HCT.

  9. Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study.

    Science.gov (United States)

    de Vries, Sieta T; Wong, Lisa; Sutcliffe, Alastair; Houÿez, François; Ruiz, Carmen Lasheras; Mol, Peter G M

    2017-05-01

    A mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. Factors that influence the use of an app for such two-way risk communication need to be considered at the development stage. Our aim was to reveal the factors that may influence healthcare professionals (HCPs) and patients to use an app for two-way risk communication. Focus group discussions and face-to-face interviews were conducted in the Netherlands, Spain and the UK. Patients with type 2 diabetes mellitus, patients with a rare disease or their caregivers and adolescents with health conditions were eligible to participate. HCPs included pharmacists, paediatricians, general practitioners, internists, practice nurses and professionals caring for patients with a rare disease. Patients and HCPs were recruited through various channels. The recorded discussions and interviews were transcribed verbatim. The dataset was analysed using thematic analysis and arranged according to the Unified Theory of Acceptance and Use of Technology. Seven focus group discussions and 13 interviews were conducted. In total, 21 HCPs and 50 patients participated. Identified factors that may influence the use of the app were the type of feedback given on reported ADRs, how ADR reports are stored and the type of drug news. Also mentioned were other functions of the app, ease of use, type of language, the source of safety information provided through the app, security of the app, layout, the operating systems on which the app can be used and the costs. Further research is needed to assess associations between user characteristics and the direction (positive or negative) of the factors potentially influencing app use.

  10. Diabetes mellitus and hypertension have comparable adverse effects on health-related quality of life

    Directory of Open Access Journals (Sweden)

    Metelko Željko

    2010-01-01

    Full Text Available Abstract Background We aimed to assess health-related quality of life (HRQoL among people with diabetes or hypertension, estimate the effect of cardiovascular comorbidities on HRQoL as well as compare HRQoL in these groups with that of healthy individuals. Methods A total of 9,070 respondents aged 18 years and over were assessed for HRQoL. Data were obtained from the Croatian Adult Health Survey. Respondents were divided into five groups according to their medical history: participants with hypertension (RR, hypertension and cardiovascular comorbidities (RR+, diabetes mellitus (DM, diabetes and cardiovascular comorbidities (DM+ and participants free of these conditions (healthy individuals, HI. HRQoL was assessed on 8 dimensions of the SF-36 questionnaire. Results Participants with diabetes and those with hypertension reported comparably limited (p > 0.05 HRQoL in all dimensions of SF-36, compared with healthy individuals (p 0.05 than participants without such comorbidities (p Conclusion Diabetes and hypertension seem to comparably impair HRQoL. Cardiovascular comorbidities further reduce HRQoL in participants with both chronic conditions. Future research of interventions aimed at improving these participants' HRQoL is needed.

  11. Energy Drink Consumption in Europe: A Review of the Risks, Adverse Health Effects, and Policy Options to Respond

    Science.gov (United States)

    Breda, João Joaquim; Whiting, Stephen Hugh; Encarnação, Ricardo; Norberg, Stina; Jones, Rebecca; Reinap, Marge; Jewell, Jo

    2014-01-01

    With the worldwide consumption of energy drinks increasing in recent years, concerns have been raised both in the scientific community and among the general public about the health effects of these products. Recent studies provide data on consumption patterns in Europe; however, more research is needed to determine the potential for adverse health effects related to the increasing consumption of energy drinks, particularly among young people. A review of the literature was conducted to identify published articles that examined the health risks, consequences, and policies related to energy drink consumption. The health risks associated with energy drink consumption are primarily related to their caffeine content, but more research is needed that evaluates the long-term effects of consuming common energy drink ingredients. The evidence indicating adverse health effects due to the consumption of energy drinks with alcohol is growing. The risks of heavy consumption of energy drinks among young people have largely gone unaddressed and are poised to become a significant public health problem in the future. PMID:25360435

  12. Energy drink consumption in Europe: A review of the risks, adverse health effects and policy options to respond

    Directory of Open Access Journals (Sweden)

    João Joaquim Breda

    2014-10-01

    Full Text Available With the worldwide consumption of energy drinks increasing in recent years, concerns have been raised both in the scientific community and among the general public about the health effects of these products. Recent studies provide data on consumption patterns in Europe however more research is needed to determine the potential for adverse health effects related to the increasing consumption of energy drinks, particularly among young people. A review of the literature was conducted to identify published articles that examined the health risks, consequences and policies related to energy drink consumption. The health risks associated with energy drink consumption are primarily related to their caffeine content, but more research is needed that evaluates the long term effects of consuming common energy drink ingredients. The evidence indicating adverse health effects due to the consumption of energy drinks with alcohol is growing. The risks of heavy consumption of energy drinks among young people have largely gone unaddressed and are poised to become a significant public health problem in the future.

  13. Energy drink consumption in europe: a review of the risks, adverse health effects, and policy options to respond.

    Science.gov (United States)

    Breda, João Joaquim; Whiting, Stephen Hugh; Encarnação, Ricardo; Norberg, Stina; Jones, Rebecca; Reinap, Marge; Jewell, Jo

    2014-01-01

    With the worldwide consumption of energy drinks increasing in recent years, concerns have been raised both in the scientific community and among the general public about the health effects of these products. Recent studies provide data on consumption patterns in Europe; however, more research is needed to determine the potential for adverse health effects related to the increasing consumption of energy drinks, particularly among young people. A review of the literature was conducted to identify published articles that examined the health risks, consequences, and policies related to energy drink consumption. The health risks associated with energy drink consumption are primarily related to their caffeine content, but more research is needed that evaluates the long-term effects of consuming common energy drink ingredients. The evidence indicating adverse health effects due to the consumption of energy drinks with alcohol is growing. The risks of heavy consumption of energy drinks among young people have largely gone unaddressed and are poised to become a significant public health problem in the future.

  14. A review of primary care interventions to improve health outcomes in adult survivors of adverse childhood experiences.

    Science.gov (United States)

    Korotana, Laurel M; Dobson, Keith S; Pusch, Dennis; Josephson, Trevor

    2016-06-01

    Research has consistently demonstrated a link between the experience of adverse childhood experiences (ACEs) and adult health conditions, including mental and physical health problems. While a focus on the prevention or mitigation of adversity in childhood is an important direction of many programs, many individuals do not access support services until adulthood, when health problems may be fairly engrained. It is not clear which interventions have the strongest evidence base to support the many adults who present to services with a history of ACEs. The current review examines the evidence base for psychosocial interventions for adults with a history of ACEs. The review focuses on interventions that may be provided in primary care, as that is the setting where most patients will first present and are most likely to receive treatment. A systematic review of the literature was completed using PsycInfo and PubMed databases, with 99 studies identified that met inclusion and exclusion criteria. These studies evaluated a range of interventions with varying levels of supportive evidence. Overall, cognitive-behavioral therapies (CBT) have the most evidence for improving health problems - in particular, improving mental health and reducing health-risk behaviors - in adults with a history of ACEs. Expressive writing and mindfulness-based therapies also show promise, whereas other treatments have less supportive evidence. Limitations of the current literature base are discussed and research directions for the field are provided.

  15. A joint ERS/ATS policy statement: what constitutes an adverse health effect of air pollution? An analytical framework.

    OpenAIRE

    Thurston, GD; Kipen, H; Annesi-Maesano, I; Balmes, J; Brook, RD; Cromar, K; DE MATTEIS, S.; Forastiere, F; Forsberg, B; Frampton, MW; Grigg, J.; Heederik, D.; Kelly, FJ; Kuenzli, N; Laumbach, R

    2017-01-01

    The American Thoracic Society has previously published statements on what constitutes an adverse effect on health of air pollution in 1985 and 2000. We set out to update and broaden these past statements that focused primarily on effects on the respiratory system. Since then, many studies have documented effects of air pollution on other organ systems, such as on the cardiovascular and central nervous systems. In addition, many new biomarkers of effects have been developed and applied in air ...

  16. Mechanisms Underlying the Association Between Early-Life Adversity and Physical Health: Charting a Course for the Future.

    Science.gov (United States)

    Bush, Nicole R; Lane, Richard D; McLaughlin, Katie A

    Early-life adversities (ELA) are associated with subsequent pervasive alterations across a wide range of neurobiological systems and psychosocial factors that contribute to accelerated onset of health problems and diseases. In this article, we provide an integrated perspective on recent developments in research on ELA, based on the articles published in this Special Issue of Psychosomatic Medicine. We focus on the following: 1) the distinction between specific versus general aspects of ELA with regard to the nature of exposure (e.g., physical and sexual abuse, emotional abuse or neglect, relative socioeconomic deprivation), biological and behavioral correlates of ELA, and differences across diseases; 2) the importance of timing in the critical phases of exposure to ELA; and 3) adaptive versus dysfunctional responses to ELA and their consequences for biological and behavioral risk factors for adverse health outcomes. This article concludes with outlining important new targets for research in this area, including the neurobiology of affect as a mechanism linking ELA to adverse health outcomes, and the need for large-scale longitudinal investigations of multisystem processes relevant to ELA in diverse samples, starting prenatally, continuing to late adolescence, and with long-term follow-up assessments that enable evaluation of incident disease outcomes.

  17. Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information : A Qualitative Study

    NARCIS (Netherlands)

    de Vries, Sieta T.; Wong, Lisa; Sutcliffe, Alastair; Houyez, Francois; Ruiz, Carmen Lasheras; Mol, Peter G.M.

    Introduction A mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. Factors that influence the use of an app for such two-way risk communication need to be considered at the development stage. Objective Our aim was to

  18. 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.

  19. 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

  20. THE ADVERSE OUTCOME PATHWAY (AOP) FRAMEWORK: A FRAMEWORK FOR ORGANIZING BIOLOGICAL KNOWLEDGE LEADING TO HEALTH RISKS.

    Science.gov (United States)

    An Adverse Outcome Pathway (AOP) represents the organization of current and newly acquired knowledge of biological pathways. These pathways contain a series of nodes (Key Events, KEs) that when sufficiently altered influence the next node on the pathway, beginning from an Molecul...

  1. [Legitimizing and responsibilities of public health reports: public health reports or social court reports?].

    Science.gov (United States)

    Borgers, D; Streich, W

    1996-11-01

    Since 1970 various initiatives have been taken to improve the information bases of health reporting. However, the efforts made up to now by the Länder, the Federal Government and its corporate bodies are characterised by a lack of experience and shortage of resources; moreover, they are viewed with a critical eye by the public and in the political area. In this contribution the authors describe various topics and delimitations of a health reporting system which go far beyond health statistics and health programmes altogether. The chances of a national health reporting system are based on the assumption that an objective judgement based on expert knowledge and science will be possible and that beyond all particularistic interests, expert knowledge can be organised in a democratic process. Public health reporting varies between two extremes: On the one hand, the current reporting in the media on health-related subjects which is characterised by disagreement among experts, particularistic interests and emotions, and on the other hand the national health reporting, which, on the platform of policy marketing and political image shaping, is suspected of degenerating to a kind of "royal court reporting". A health reporting system based on expert knowledge and characterised by topics with relevance to health policy, expert quality of its information and neutrality to particularistic interests, should go beyond these two extremes. Given the political conditions of budgeting and distribution conflicts, health reporting has to deal with two main aspects: effectiveness and efficiency of employed resources and with the problems of a fair distribution of these resources to provide equal chances in the health sector. What cannot be solved, by questions of procedure, however, is the problem of truth and objective knowledge as well as the problem of confidence. If the general public lacks confidence in national expert knowledge, a society discourse will not lead to political

  2. 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)...

  3. Household and community-level Adverse Childhood Experiences and adult health outcomes in a diverse urban population.

    Science.gov (United States)

    Wade, Roy; Cronholm, Peter F; Fein, Joel A; Forke, Christine M; Davis, Martha B; Harkins-Schwarz, Mary; Pachter, Lee M; Bair-Merritt, Megan H

    2016-02-01

    Adverse Childhood Experiences (ACEs), which include family dysfunction and community-level stressors, negatively impact the health and well being of children throughout the life course. While several studies have examined the impact of these childhood exposures amongst racially and socially diverse populations, the contribution of ACEs in the persistence of socioeconomic disparities in health is poorly understood. To determine the association between ACEs and health outcomes amongst a sample of adults living in Philadelphia and examine the moderating effect of Socioeconomic Status (SES) on this association, we conducted a cross-sectional survey of 1,784 Philadelphia adults, ages 18 and older, using random digit dialing methodology to assess Conventional ACEs (experiences related to family dysfunction), Expanded ACEs (community-level stressors), and health outcomes. Using weighted, multivariable logistic regression analyses along with SES stratified models, we examined the relationship between ACEs and health outcomes as well as the modifying effect of current SES. High Conventional ACE scores were significantly associated with health risk behaviors, physical and mental illness, while elevated Expanded ACE scores were associated only with substance abuse history and sexually transmitted infections. ACEs did have some differential impacts on health outcomes based on SES. Given the robust impact of Conventional ACEs on health, our results support prior research highlighting the primacy of family relationships on a child's life course trajectory and the importance of interventions designed to support families. Our findings related to the modifying effect of SES may provide additional insight into the complex relationship between poverty and childhood adversity. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Sources of patients' knowledge of the adverse effects of psychotropic medication and the perceived influence of adverse effects on compliance among service users attending community mental health services.

    LENUS (Irish Health Repository)

    Agyapong, Vincent I O

    2009-12-01

    Noncompliance with medication has been a complex issue with patients with severe mental illness during the last few decades, and adverse effects of medication have been identified as a major contributor to noncompliance.

  5. Decisions in drug adverse reactions, intoxications and unexpected responses to herbal medicines as public health problems

    OpenAIRE

    Álvarez-Falconí, Pedro P.; Médico Farmacólogo, Bachiller en Derecho, Doctor en Medicina. Centro Nacional de Salud Pública, Instituto Nacional de Salud. Lima, Perú. Laboratorio de Investigación en Plantas Medicinales, Instituto Nacional de Salud. Lima, Perú.

    2007-01-01

    This review evaluates the relevant information on a variety of adverse drug reactions serious, real or potential, attributed to some drugs relatively recent introduction into the world market, in addition, on some intoxications by contaminated medicines, all of which contributed to decision-making in the past and present, by regulatory authorities in drugs in several countries. It explores the broad strategies related to the pillars of the drug policies, the historical and current events ...

  6. 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

  7. 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。

  8. Adverse events and patients’ perceived health-related quality of life at the end of multidrug-resistant tuberculosis treatment in Namibia

    Directory of Open Access Journals (Sweden)

    Sagwa EL

    2016-11-01

    >0.80. In all, 32 (89% of the 36 patients experienced at least one adverse drug event of any severity during their treatment (median events =3, range 1–6, of which none was life-threatening. The occurrence of adverse events was not related to HRQoL scores. For patients reporting zero to two events, the median (range HRQoL score was 56.8 (44.4–56.8, while for those reporting three or more events, the median score was 55.2 (38.6–56.8; P=0.34 for difference between these scores. Conclusion: Patients completing treatment for MDR-TB in Namibia tended to score moderately low on their HRQoL, using the generic SF-8 questionnaire. The occurrence of adverse events did not lead to lower HRQoL scores upon treatment completion. Keywords: drug safety, patient-reported health outcomes, SF-8™ questionnaire, second-line tuberculosis drugs, Namibia

  9. mHealth to promote pregnancy and interconception health among African-American women at risk for adverse birth outcomes: a pilot study.

    Science.gov (United States)

    Foster, Jennifer; Miller, Lindsey; Isbell, Sheila; Shields, Tekesia; Worthy, Natasha; Dunlop, Anne Lang

    2015-01-01

    The use of mobile phone applications (mHealth) to provide health education and behavioral prompts is 1 of the 12 common mHealth functions identified by the World Health Organization as innovations to strengthen health systems. Among low-income pregnant and parenting women, health education is widely recognized as a way to improve maternal and infant health outcomes, but the efficacy of written health education materials to change knowledge and behavior for this population is questionable. mHealth prompts, in contrast, is a promising alternative. A team of researchers in medicine/epidemiology, anthropology/midwifery, computer science/sensors, and community-based case management created and pilot tested a mHealth application (mHealth app) for African-American women at high risk for adverse birth outcomes. We tested the acceptability and feasibility of the interactive application among women during the reproductive stages of early and late pregnancy, postpartum, and interconception. Interview data from 14 women in the various reproductive stages revealed that most women found the mHealth messages helpful. Also, 62 Ob-Gyn physicians and nurses and 19 Family Medicine residents provided feedback. Women's responses to specific messages trended down over time. Women in the postpartum phase had the highest response rate to particular text messages, followed by those in the pregnancy phase. Responses dropped off dramatically during the interconception period. About 21% of women lost their phones. Unexpected findings were that all participants already had smartphones, women wanted messages about depression, and clinicians wanted the app to link to case management for individualized medical care. Logistical challenges to app management were limitations but are useful for consideration before scale-up. This study corroborates findings in the health literacy literature that women most at risk for adverse birth outcomes need additional face-to-face support with mHealth

  10. Forest health monitoring: 2006 national technical report

    Science.gov (United States)

    Mark J. Ambrose; Barbara L. Conkling

    2009-01-01

    The Forest Health Monitoring Program’s annual national technical reportpresents results of forest health analyses from a national perspective usingdata from a variety of sources. The report is organized according to the

  11. Forest health monitoring: 2003 national technical report

    Science.gov (United States)

    John W. Coulston; Mark J. Ambrose; Kurt H. Riitters; Barbara L. Conkling; William D. Smith

    2005-01-01

    The Forest Health Monitoring Program’s annual national reports present results from forest health data analyses focusing on a national perspective. The Criteria and Indicators for the Conservation and Sustainable Management of Temperate and Boreal Forests are used as a reporting framework. This report has five main sections. The first contains introductory material....

  12. Perceived Adverse Health Effects of Heat and Their Determinants in Deprived Neighbourhoods: A Cross-Sectional Survey of Nine Cities in Canada

    Directory of Open Access Journals (Sweden)

    Diane Bélanger

    2014-10-01

    Full Text Available This study identifies several characteristics of individuals who report their physical and/or mental health as being adversely affected by summertime heat and humidity, within the most disadvantaged neighbourhoods of the nine largest cities of Québec (Canada. The study is cross-sectional by stratified representative sample; 3485 people were interviewed in their residence. The prevalence of reported impacts was 46%, mostly physical health. Female gender and long-term medical leave are two impact risk indicators in people <65 years of age. Low income and air conditioning at home are risk indicators at all ages. Results for having ≥2 diagnoses of chronic diseases, particularly for people self-describing as in poor health (odds ratio, OR<65 = 5.6; OR≥65 = 4.2, and perceiving daily stress, are independent of age. The prevalence of reported heat-related health impacts is thus very high in those inner cities, with notable differences according to age, stress levels and long-term medical leave, previously unmentioned in the literature. Finally, the total number of pre-existing medical conditions seems to be a preponderant risk factor. This study complements the epidemiologic studies based on mortality or severe morbidity and shows that the heat-related burden of disease appears very important in those communities, affecting several subgroups differentially.

  13. Valproate-related erythrodermia with reversible encephalopathy: a rare but serious adverse reaction, case report.

    Science.gov (United States)

    Rener-Primec, Zvonka; Balkovec, Valerija

    2014-01-01

    Cutaneous adverse reactions to antiepileptic drugs (AEDs) are usually easily recognized in daily clinical practice when they manifest as a morbilliform or maculopapular rash within the first few weeks after introducing an AED. Valproate (VPA)-induced encephalopathy is a rare but serious complication, presenting with impaired consciousness, with or without hyperammonemia, normal liver enzymes, and normal serum level of VPA. A 2-year-old Caucasian boy with severe developmental disability and pharmacoresistant epilepsy presented with fever, generalized erythrodermia, and encephalopathy, which resolved after discontinuation of valproate. Sodium valproate (30 mg/kg/day) was introduced 5 months previously, as the third drug in combination with vigabatrin and levetiracetam, due to frequent daily seizures. The clinical condition of generalized erythrodermia and encephalopathy was recognized by the treating physician as a possible adverse reaction to VPA: with the Naranjo scale it was probably associated with VPA (six points) and possibly associated with vigabatrin and levetiracetam (three and two points, respectively). After valproate withdrawal, the patient recovered completely. This case is of interest because erythrodermia was a clue to the recognition of valproate-related adverse reaction with severe central nervous system involvement without hyperammonemia and with normal liver enzymes--a very rare occurrence.

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

    Science.gov (United States)

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

    2014-09-01

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

  15. Adverse reproductive and developmental health outcomes following prenatal exposure to a 2 hydraulic fracturing chemical mixture in female C57Bl/6 mice

    Science.gov (United States)

    Kassotis, Christopher D.; Bromfield, John J.; Klemp, Kara C.; Meng, Chun-Xia; Wolfe, Andrew R.; Zoeller, Thomas; Balise, Victoria D.; Isiguzo, Chiamaka J.; Tillitt, Donald E.; Nagel, Susan C.

    2016-01-01

    Unconventional oil and gas operations using hydraulic fracturing can contaminate surface and groundwater with endocrine-disrupting chemicals. We have previously shown that 23 of 24 commonly used hydraulic fracturing chemicals can activate or inhibit the estrogen, androgen, glucocorticoid, progesterone, and/or thyroid receptors in a human endometrial cancer cell reporter gene assay and that mixtures can behave synergistically, additively, or antagonistically on these receptors. In the current study, pregnant female C57Bl/6 dams were exposed to a mixture of 23 commonly used unconventional oil and gas chemicals at approximately 3, 30, 300, and 3000 μg/kg·d, flutamide at 50 mg/kg·d, or a 0.2% ethanol control vehicle via their drinking water from gestational day 11 through birth. This prenatal exposure to oil and gas operation chemicals suppressed pituitary hormone concentrations across experimental groups (prolactin, LH, FSH, and others), increased body weights, altered uterine and ovary weights, increased heart weights and collagen deposition, disrupted folliculogenesis, and other adverse health effects. This work suggests potential adverse developmental and reproductive health outcomes in humans and animals exposed to these oil and gas operation chemicals, with adverse outcomes observed even in the lowest dose group tested, equivalent to concentrations reported in drinking water sources. These endpoints suggest potential impacts on fertility, as previously observed in the male siblings, which require careful assessment in future studies. - See more at: http://press.endocrine.org/doi/10.1210/en.2016-1242#sthash.9kqfLvXg.dpuf

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

    LENUS (Irish Health Repository)

    Collins, C

    2008-11-01

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

  17. A public health achievement under adversity: the eradication of poliomyelitis from Peru, 1991.

    Science.gov (United States)

    Sobti, Deepak; Cueto, Marcos; He, Yuan

    2014-12-01

    The fight to achieve global eradication of poliomyelitis continues. Although native transmission of poliovirus was halted in the Western Hemisphere by the early 1990s, and only a few cases have been imported in the past few years, much of Latin America's story remains to be told. Peru conducted a successful flexible, or flattened, vertical campaign in 1991. The initial disease-oriented programs began to collaborate with community-oriented primary health care systems, thus strengthening public-private partnerships and enabling the common goal of poliomyelitis eradication to prevail despite rampant terrorism, economic instability, and political turmoil. Committed leaders in Peru's Ministry of Health, the Pan American Health Organization, and Rotary International, as well as dedicated health workers who acted with missionary zeal, facilitated acquisition of adequate technologies, coordinated work at the local level, and increased community engagement, despite sometimes being unable to institutionalize public health improvements.

  18. Founding an adverse drug reaction (ADR) network: a method for improving doctors spontaneous ADR reporting in a general hospital.

    Science.gov (United States)

    Goldstein, Lee Hilary; Berlin, Maya; Saliba, Walid; Elias, Mazen; Berkovitch, Matitiyahu

    2013-11-01

    Adverse drug reactions (ADR) are underreported by doctors despite numerous efforts. We aimed to determine if establishing an "ADR reporting doctor's network" within a hospital would increase the quantity of ADRs reported by hospital doctors. One hundred hospital doctors joined the network. Email reminders were sent to network members during the 1 year study period, conveying information about ADRs reported, amusingly and pleasantly reminding them to report ADRs in minimal detail, by phone, email, text message or mail to the Clinical Pharmacology Unit, who would further complete the report. A total of 114 ADRs were reported during the study period in comparison to 48, 26, and 17 in the previous 3 years (2008, 2009, 2010, respectively). In the 3 years prior, doctors reported 41.7% of the reported ADRs whereas in the study period, doctors reported 74.3% of ADRs (P reports. Ninety seven percent of doctors' reports were of ADR network members. Thirty-four (34%) network members reported an ADR during the study period and 31 of the 34 reporters had never reported ADRs before becoming network members. Establishing an ADR network of doctors substantially increases ADR reporting amongst its members.

  19. 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

  20. 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

  1. Planned Cesarean Delivery at Term and Adverse Outcomes in Childhood Health

    Science.gov (United States)

    Black, Mairead; Bhattacharya, Siladitya; Philip, Sam; Norman, Jane E.; McLernon, David J.

    2016-01-01

    Importance Planned cesarean delivery comprises a significant proportion of births globally, with combined rates of planned and unscheduled cesarean delivery in a number of regions approaching 50%. Observational studies have shown that offspring born by cesarean delivery are at increased risk of ill health in childhood, but these studies have been unable to adjust for some key confounding variables. Additionally, risk of death beyond the neonatal period has not yet been reported for offspring born by planned cesarean delivery. Objective To investigate the relationship between planned cesarean delivery and offspring health problems or death in childhood. Design, Setting, and Participants Population-based data-linkage study of 321 287 term singleton first-born offspring born in Scotland, United Kingdom, between 1993 and 2007, with follow-up until February 2015. Exposures Offspring born by planned cesarean delivery in a first pregnancy were compared with offspring born by unscheduled cesarean delivery and with offspring delivered vaginally. Main Outcomes and Measures The primary outcome was asthma requiring hospital admission; secondary outcomes were salbutamol inhaler prescription at age 5 years, obesity at age 5 years, inflammatory bowel disease, type 1 diabetes, cancer, and death. Results Compared with offspring born by unscheduled cesarean delivery (n = 56 015 [17.4%]), those born by planned cesarean delivery (12 355 [3.8%]) were at no significantly different risk of asthma requiring hospital admission, salbutamol inhaler prescription at age 5 years, obesity at age 5 years, inflammatory bowel disease, cancer, or death but were at increased risk of type 1 diabetes (0.66% vs 0.44%; difference, 0.22% [95% CI, 0.13%-0.31%]; adjusted hazard ratio [HR], 1.35 [95% CI, 1.05-1.75]). In comparison with children born vaginally (n = 252 917 [78.7%]), offspring born by planned cesarean delivery were at increased risk of asthma requiring hospital admission (3.73% vs 3

  2. Triumph and adversity: Exploring the complexities of consumer storytelling in mental health nursing education.

    Science.gov (United States)

    Happell, Brenda; Bennetts, Wanda

    2016-12-01

    Consumer participation in the education of health professionals is increasing, particularly in mental health nursing education and storytelling remains the most frequent approach to consumer involvement. The use of story has tended to be accepted as a legitimate educational tool with limited critique or consideration of its potential consequences presented within the academic literature. A qualitative exploratory research study was undertaken with mental health nurse academics (n = 34) and consumer educators and academics (n = 12), to investigate the perceptions and experiences of mental health nurses and consumers regarding the involvement of consumers in mental health nursing education. Data were analysed thematically. Story was a major theme to emerge from consumer participants and received some attention from nurse academics. Consumers and nurses both referred to the power of story to convey the human experience of mental illness diagnosis and service use; and the vulnerability that can result from storytelling. Consumers also described: story as expectation; preparation and support; and the politics of story. All participants supported the value of storytelling in mental health nursing education. Consumers had considered the complexities in far greater detail. The ongoing value of story as an educational technique requires further research. Equally important is considering a broader range of educational roles for mental health consumers.

  3. 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.

  4. 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.

  5. Understanding the organisational context for adverse events in the health services: the role of cultural censorship.

    Science.gov (United States)

    Hart, E; Hazelgrove, J

    2001-12-01

    This paper responds to the current emphasis on organisational learning in the NHS as a means of improving healthcare systems and making hospitals safer places for patients. Conspiracies of silence have been identified as obstacles to organisational learning, covering error and hampering communication. In this paper we question the usefulness of the term and suggest that "cultural censorship", a concept developed by the anthropologist Robin Sherriff, provides a much needed insight into cultures of silence within the NHS. Drawing on a number of illustrations, but in particular the Ritchie inquiry into the disgraced gynaecologist Rodney Ledward, we show how the defining characteristics of cultural censorship can help us to understand how adverse events get pushed underground, only to flourish in the underside of organisational life.

  6. Intra-hospital transfers and adverse patient outcomes: An analysis of administrative health data.

    Science.gov (United States)

    Blay, Nicole; Roche, Michael; Duffield, Christine; Xu, Xiaoyue

    2017-07-26

    To determine whether there was an association between intra-hospital transfers and adverse outcomes. Transfers between clinical units and between beds on the same unit are routine aspects of an episode of care in acute hospitals. The rate of these transfers per episode has increased in response to high occupancy levels, a decline in bed numbers, and increased demand for hospital services. The impact of the number of transfers between both wards and beds on patient outcomes is not widely explored. retrospective cross sectional design using hospital administrative data. Data were extracted from existing hospital administrative datasets for one large metropolitan hospital for the financial year 2008-09 in Australia (n=14,133). Descriptive analyses and logistic regression models were developed for each of 3 selected patient outcomes. Nearly one-tenth of patients (9.2%) experienced a fall with injury, 3.8% of surgical patients a wound infection and 0.1% a complication from medication errors. For each bed or ward transfer, the odds of falls and wound infections increased. Medication errors were not associated with either bed or ward moves. Hospitals should minimise the number of bed and ward transfers per episode of care in order to reduce the likelihood of adverse patient outcomes. Current bed management policies and practices should be evaluated and further refined to address this need. Additional strategies include improving coordination and communication during and after transfer. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  7. Understanding and Mitigating Adverse Health Effects in Space Using A System Physiology Software Project

    Data.gov (United States)

    National Aeronautics and Space Administration — NASA's vision for Space Exploration aims for human interplanetary missions that have significant challenges on crew health and safety including fluid shifts, and...

  8. Adverse Health Consequences of Performance-Enhancing Drugs: An Endocrine Society Scientific Statement

    National Research Council Canada - National Science Library

    Pope, Harrison G; Wood, Ruth I; Rogol, Alan; Nyberg, Fred; Bowers, Larry; Bhasin, Shalender

    2014-01-01

    Despite the high prevalence of performance-enhancing drug (PED) use, media attention has focused almost entirely on PED use by elite athletes to illicitly gain a competitive advantage in sports, and not on the health risks of PEDs...

  9. Preventing Heart Attacks and Strokes: Increasing Awareness of the Adverse Cardiovascular Health Impacts of Air Pollution

    Science.gov (United States)

    Summary: Chronic cardiovascular disease imposes a significant health and economic burden on individuals and communities. Despite decades of improvement in cardiovascular mortality, cardiovascular disease and stroke remain the leading cause of death in the U.S. and disparities i...

  10. Nutrient supplementation may adversely affect maternal oral health--a randomised controlled trial in rural Malawi.

    Science.gov (United States)

    Harjunmaa, Ulla; Järnstedt, Jorma; Dewey, Kathryn G; Ashorn, Ulla; Maleta, Kenneth; Vosti, Stephen A; Ashorn, Per

    2016-01-01

    Nutritional supplementation during pregnancy is increasingly recommended especially in low-resource settings, but its oral health impacts have not been studied. Our aim was to examine whether supplementation with multiple micronutrients (MMN) or small-quantity lipid-based nutrient supplements affects dental caries development or periodontal health in a rural Malawian population. The study was embedded in a controlled iLiNS-DYAD trial that enrolled 1391 pregnant women groups were similar at baseline in average socio-economic, nutritional and health status. At the end of the intervention, the prevalence of caries was 56.7%, 69.1% and 63.3% (P = 0.004), and periodontitis 34.9%, 29.8% and 31.2% (P = 0.338) in the IFA, MMN and LNS groups, respectively. Compared with the IFA group, women in the MMN group had 0.60 (0.18-1.02) and in the LNS group 0.59 (0.17-1.01) higher mean number of caries lesions. In the absence of baseline oral health data, firm conclusions on causality cannot be drawn. However, although not confirmatory, the findings are consistent with a possibility that provision of MMN or LNS may have increased the caries incidence in this target population. Because of the potential public health impacts, further research on the association between gestational nutrient interventions and oral health in low-income settings is needed.

  11. Forest health monitoring: 2001 national technical report

    Science.gov (United States)

    Barbara L. Conkling; John W. Coulston; Mark J. Ambrose

    2005-01-01

    The Forest Health Monitoring (FHM) Program’s annual national report uses FHM data, as well as data from a variety of other programs, to provide an overview of forest health based on the criteria and indicators of sustainable forestry framework of the Santiago Declaration. It presents information about the status of and trends in various forest health indicators...

  12. Patch testing with own cosmetics-- prospective study of testing and reporting of adverse effects to the Swedish Medical Products Agency.

    Science.gov (United States)

    Tammela, Monica; Lindberg, Magnus; Isaksson, Marléne; Inerot, Annica; Rudel, Jana; Berne, Berit

    2012-07-01

    The Swedish Medical Products Agency (MPA) provides a voluntary reporting system for adverse reactions to cosmetics. However, the reporting is sparse, and the products involved are sometimes difficult to identify. To investigate how often patients referred for patch testing were tested with the cosmetic products that they had been using themselves, and to improve the reporting to the MPA by the use of photographic documentation of product labels. Consecutive patients at five dermatology departments who were patch tested with their own cosmetics were included. Reports including protocols of positive patch test results for the patients' own cosmetics and photographs/photocopies of product labels were sent to the MPA. Three hundred and sixteen of 948 patients (33%) were tested with their own cosmetics, and 15% of these tested positive with one or more products. The number of reports was more than three times higher than in corresponding periods in earlier years. For 79% of the products, photographs/photocopies of the containers were submitted, and for 30%, batch numbers were submitted. For a substantial number of patients, their own cosmetics were suspected of causing adverse reactions and were therefore tested. During the study, the number of reports to the MPA tripled, and the relevant products were easier to identify. © 2012 John Wiley & Sons A/S.

  13. The Medtronic Sprint Fidelis Lead Advisory Notification has no adverse impact on patient reported outcomes in Danish implantable cardioverter defibrillator patients

    DEFF Research Database (Denmark)

    Pedersen, Susanne Møller; Versteeg, Henneke; Nielsen, Jens C.

    The Medtronic Sprint Fidelis Lead Advisory Notification has no adverse impact on patient reported outcomes in Danish implantable cardioverter defibrillator patients.......The Medtronic Sprint Fidelis Lead Advisory Notification has no adverse impact on patient reported outcomes in Danish implantable cardioverter defibrillator patients....

  14. The Medtronic Sprint Fidelis Lead Advisory Notification Has No Adverse Impact on Patient Reported Outcomes in Danish Implantable Cardioverter Defibrillator Patients

    DEFF Research Database (Denmark)

    Pedersen, Susanne Møller; Versteeg, Henneke; Nielsen, Jens C.

    The Medtronic Sprint Fidelis Lead Advisory Notification Has No Adverse Impact on Patient Reported Outcomes in Danish Implantable Cardioverter Defibrillator Patients.......The Medtronic Sprint Fidelis Lead Advisory Notification Has No Adverse Impact on Patient Reported Outcomes in Danish Implantable Cardioverter Defibrillator Patients....

  15. Dutch health care performance report 2008.

    NARCIS (Netherlands)

    Westert, G.P.; Berg, M.J. van den; Koolman, X.; Verkleij, H.

    2008-01-01

    This is the second national report on the performance of the Dutch health care system. Its focus is on quality, access and costs in 2006/7. The Dutch Health Care Performance Report presents a broad picture based on 110 indicators. Where possible, comparisons in time and between countries are

  16. Unintended Pregnancy and Its Adverse Social and Economic Consequences on Health System: A Narrative Review Article.

    Directory of Open Access Journals (Sweden)

    Mansureh Yazdkhasti

    2015-01-01

    Full Text Available Unintended pregnancy is among the most troubling public health problems and a major reproductive health issue worldwide imposing appreciable socioeconomic burden on individuals and society. Governments generally plan to control growth of births (especially wanted births as well as orphans and illegitimate births imposing extra burden on public funding of the governments which inevitably affects economic efficiency and leads to economic slowdown, too. The present narrative review focuses on socioeconomic impacts of unintended pregnancy from the health system perspective. Follow of Computerized searches of Academic, 53 scientific journals were found in various databases including PubMed, EMBASE, ISI, Iranian databases, IPPE, UNFPA (1985-2013. Original articles, review articles, published books about the purpose of the paper were used. During this search, 20 studies were found which met the inclusion criteria. Unintended pregnancy is one of the most critical challenges facing the public health system that imposes substantial financial and social costs on society. On the other hand, affecting fertility indicators, it causes reduced quality of life and workforce efficiency. Therefore lowering the incidence of intended pregnancies correlates with elevating economic growth, socio-economic development and promoting public health. Regarding recent policy changes in Iran on family planning programs and adopting a new approach in increasing population may place the country at a higher risk of increasing the rate of unintended pregnancy. Hence, all governmental plans and initiatives of public policy must be regulated intelligently and logically aiming to make saving in public spending and reduce healthcare cost inflation.

  17. Forest health monitoring: 2004 national technical report

    Science.gov (United States)

    John W. Coulston; Mark J. Ambrose; Kurt H. Riitters; Barbara L. Conkling

    2005-01-01

    The Forest Health Monitoring (FHM) Program’s annual national technical report presents results of forest health analyses from a national perspective using data from a variety of sources. Results presented in the report pertain to the Santiago Declaration’s Criterion 1— Conservation of Biological Diversity and Criterion 3—Maintenance of Forest Ecosystem Health and...

  18. Forest health monitoring: 2002 national technical report

    Science.gov (United States)

    John W. Coulston; Mark J. Ambrose; Kurt H. Riitters; Barbara L. Conkling

    2005-01-01

    The Forest Health Monitoring (FHM) Program’s annual national technical report presents results of forest health analyses from a national perspective using data from a variety of sources. This annual report focuses on “Criterion 3—Maintenance of Forest Ecosystem Health and Vitality” from the “Criteria and Indicators of Sustainable Forestry of the Santiago Declaration”...

  19. Agricultural sources of contaminants of emerging concern and adverse health effects on freshwater fish

    Science.gov (United States)

    Tillitt, Donald E.; Buxton, Herbert T.

    2011-01-01

    Agricultural contaminants of emerging concern (CECs) are generally thought of as certain classes of chemicals associated with animal feeding and production facilities. Veterinary pharmaceuticals used in animal food production systems represent one of the largest groups of CECs. In our review, we discuss the extensive increase in use of antibiotics in animal feeding operations (AFOs) around the world. AFOs are a major consumer of antibiotics and other veterinary pharmaceuticals and over the past decade there has been growing information on the occurrence, release, and fate of CECs from animal food production operations, including the application of pharmaceutical-containing manure to agricultural fields and releases from waste lagoons. Concentrations of CECs in surface and ground water in proximity to AFOs correspond to their presence in the AFO wastes. In many cases, the environmental concentrations of agriculturally-derived CECs are below toxicity thresholds. Hormones and hormone replacement compounds are a notable exception, where chemical concentrations near AFOs can exceed concentrations known to cause adverse effects on endocrine-related functions in fish. In addition, some agricultural pesticides, once thought to be safe to non-target organisms, have demonstrated endocrine-related effects that may pose threats to fish populations in agricultural regions. That is, we have pesticides with emerging concerns, thus, the concern is emerging and not necessarily the chemical. In this light, one must consider certain agricultural pesticides to be included in the list of CECs. Even though agricultural pesticides are routinely evaluated in regulatory testing schemes which have been used for decades, the potential hazards of some pesticides have only recently been emerging. Emerging concerns of pesticides in fish include interference with hormone signaling pathways; additive (or more than additive) effects from pesticide mixtures; and adverse population-level effects at

  20. 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.

  1. Health-related quality of life in childhood epilepsy: Moving beyond 'seizure control with minimal adverse effects'

    Directory of Open Access Journals (Sweden)

    Rosenbaum Peter

    2003-08-01

    Full Text Available Abstract Childhood epilepsy is one of the most important and prevalent neurological conditions in the developing years. Persons with childhood onset epilepsy are at a high risk for poor psychosocial outcomes, even without experiencing co-morbidities. The goal of management of children with epilepsy should be to enable the child and the family to lead a life as free as possible from the medical and psychosocial complications of epilepsy. This comprehensive care needs to go beyond simply trying to control seizures with minimal adverse drug reactions. Seizure frequency and severity is only one important outcome variable. Other factors such as social, psychological, behavioural, educational, and cultural dimensions of their lives affect children with epilepsy, their families and their close social networks. A number of epilepsy-specific health-related quality of life (HRQL scales for children have been developed with the aim to include and measure accurately the impact and burden of epilepsy. Their target populations, details of the origin of the items, and psychometric properties vary significantly. Their strengths and weaknesses will be identified more clearly through their continued use in the clinical setting and in research studies. Only a few studies to date have utilized these or generic HRQL measures to assess the HRQL of specific populations with epilepsy. Future research needs to develop theory driven models of HRQL and identify measurable factors that have important correlations with outcomes. Since biomedical variables like seizure frequency and severity have only moderate correlations with HRQL, other independent factors including the child's resilience, co-morbid conditions, parental well-being, family factors and societal/cultural variables may play a major role. We also need to learn what encompasses comprehensive patient care, define the goals of management and evaluate the impact of different interventions. Future studies need to

  2. 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.

  3. Behavioral and physiologic adverse effects in adolescent and young adult emergency department patients reporting use of energy drinks and caffeine.

    Science.gov (United States)

    Jackson, Deidrya A E; Cotter, Bradford V; Merchant, Roland C; Babu, Kavita M; Baird, Janette R; Nirenberg, Ted; Linakis, James G

    2013-08-01

    This pilot study assessed the prevalence of physiologic and behavioral adverse effects among adolescent (13-17 years) and adult (18-25 years) emergency department patients who reported energy drink and/or caffeinated-only beverage use within the 30 days prior to emergency department presentation. It was hypothesized that energy drink users would report more adverse effects than those who used only traditional caffeinated beverages such as coffee, tea, or soft drinks. This cross-sectional pilot study was conducted in two urban emergency departments, one adult and one pediatric. Eligible patients were enrolled during a 6-week period between June and August 2010. Participants completed a tablet computer-based, self-administered, anonymous questionnaire about their past 30-day energy drink and/or caffeinated-only beverage use, substance use, and experience of 10 physiologic and 10 behavioral symptoms. Multivariable logistic regression and negative binomial regression models, adjusted for age, gender, and substance use, were created to compare the occurrence of each adverse effect between energy drink and caffeinated-only beverage users. Odds ratios (ORs) and incidence rate ratios (IRRs) were estimated. Of those enrolled, 53.3% reported consuming energy drinks, 39.1% caffeinated-only beverages, and 7.6% no energy drinks or caffeinated-only beverages within the past 30 days. In multivariable logistic regression models, energy drink users were more likely than caffeinated-only beverage users to report having "gotten into trouble at home, school, or work" in the past 30 days (OR: 3.12 [1.24-7.88]). In the negative binomial regression multivariable models, more behavioral effects were reported among drug users (IRR: 1.50 [1.18-1.93]), and more physiologic effects were reported among tobacco users (IRR: 1.42 [1.13-1.80]) and females (IRR: 1.48 [1.21-1.80]), but not among energy drink users. Energy drink users and substance users are more likely to report specific physiologic

  4. Climate change and adverse health events: community perceptions from the Tanahu district of Nepal

    Science.gov (United States)

    Mishra, Shiva Raj; Mani Bhandari, Parash; Issa, Rita; Neupane, Dinesh; Gurung, Swadesh; Khanal, Vishnu

    2015-03-01

    Nepal is a country economically dependent on climate-sensitive industries. It is highly vulnerable to the environmental, social, economic and health impacts of climate change. The objective of this study is to explore community perceptions of climate variability and human health risks. In this letter, we present a cross sectional study conducted between August 2013 and July 2014 in the Tanahu district of Nepal. Our analysis is based on 258 face-to-face interviews with household heads utilizing structured questionnaires. Over half of the respondents (54.7%) had perceived a change in climate, 53.9% had perceived an increase in temperature in the summer and 49.2% had perceived an increase in rainfall during the rainy season. Half of the respondents perceived an increase in the number of diseases during the summer, 46.5% perceived an increase during the rainy season and 48.8% during winter. Only 8.9% of the respondents felt that the government was doing enough to prevent climate change and its impact on their community. Belonging to the Janajati (indigenous) ethnic group, living in a pakki, super-pakki house and belonging to poor or mid-level income were related to higher odds of perceiving climate variability. Illiterates were less likely to perceive climate variability. Respondents living in a pakki house, super-pakki, or those who were poor were more likely to perceive health risks. Illiterates were less likely to perceive health risks.

  5. Risk of Performance Decrements and Adverse Health Outcomes Resulting from Sleep Loss, Circadian Desynchronization, and Work Overload

    Science.gov (United States)

    Flynn-Evans, Erin; Gregory, Kevin; Arsintescu, Lucia; Whitmire, Alexandra

    2016-01-01

    Sleep loss, circadian desynchronization, and work overload occur to some extent for ground and flight crews, prior to and during spaceflight missions. Ground evidence indicates that such risk factors may lead to performance decrements and adverse health outcomes, which could potentially compromise mission objectives. Efforts are needed to identify the environmental and mission conditions that interfere with sleep and circadian alignment, as well as individual differences in vulnerability and resiliency to sleep loss and circadian desynchronization. Specifically, this report highlights a collection of new evidence to better characterize the risk and reveals new gaps in this risk as follows: Sleep loss is apparent during spaceflight. Astronauts consistently average less sleep during spaceflight relative to on the ground. The causes of this sleep loss remain unknown, however ground-based evidence suggests that the sleep duration of astronauts is likely to lead to performance impairment and short and long-term health consequences. Further research is needed in this area in order to develop screening tools to assess individual astronaut sleep need in order to quantify the magnitude of sleep loss during spaceflight; current and planned efforts in BHP's research portfolio address this need. In addition, it is still unclear whether the conditions of spaceflight environment lead to sleep loss or whether other factors, such as work overload lead to the reduced sleep duration. Future data mining efforts and continued data collection on the ISS will help to further characterize factors contributing to sleep loss. Sleep inertia has not been evaluated during spaceflight. Ground-based studies confirm that it takes two to four hours to achieve optimal performance after waking from a sleep episode. Sleep inertia has been associated with increased accidents and reduced performance in operational environments. Sleep inertia poses considerable risk during spaceflight when emergency

  6. 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...

  7. Experiences with Adverse Drug Reaction Reporting by Patients An 11-Country Survey

    NARCIS (Netherlands)

    van Hunsel, Florence; Haermark, Linda; Pal, Shanthi; Olsson, Sten; van Grootheest, Kees

    2012-01-01

    Background: Patients are important stakeholders in pharmacovigilance; however, little formal evaluation has been undertaken of existing patient reporting schemes within and outside Europe. If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology

  8. Individual and health facility factors and the risk for obstructed labour and its adverse outcomes in south-western Uganda

    Directory of Open Access Journals (Sweden)

    Turyakira Eleanor

    2011-10-01

    Full Text Available Abstract Background Obstructed labour is still a major cause of maternal morbidity and mortality and of adverse outcome for newborns in low-income countries. The aim of this study was to investigate the role of individual and health facility factors and the risk for obstructed labour and its adverse outcomes in south-western Uganda. Methods A review was performed on 12,463 obstetric records for the year 2006 from six hospitals located in south-western Uganda and 11,180 women records were analysed. Multivariate logistic regression analyses were applied to control for probable confounders. Results Prevalence of obstructed labour for the six hospitals was 10.5% and the main causes were cephalopelvic disproportion (63.3%, malpresentation or malposition (36.4% and hydrocephalus (0.3%. The risk of obstructed labour was statistically significantly associated with being resident of a particular district [Isingiro] (AOR 1.39, 95% CI: 1.04-1.86, with nulliparous status (AOR 1.47, 95% CI: 1.22-1.78, having delivered once before (AOR 1.57, 95% CI: 1.30-1.91 and age group 15-19 years (AOR 1.21, 95% CI: 1.02-1.45. The risk for perinatal death as an adverse outcome was statistically significantly associated with districts other than five comprising the study area (AOR 2.85, 95% CI: 1.60-5.08 and grand multiparous status (AOR 1.89, 95% CI: 1.11-3.22. Women who lacked paid employment were at increased risk of obstructed labour. Perinatal mortality rate was 142/1000 total births in women with obstructed labour compared to 65/1000 total births in women without the condition. The odds of having maternal complications in women with obstructed labour were 8 times those without the condition. The case fatality rate for obstructed labour was 1.2%. Conclusions Individual socio-demographic and health system factors are strongly associated with obstructed labour and its adverse outcome in south-western Uganda. Our study provides baseline information which may be used by

  9. Effect of adverse childhood experiences on physical health in adulthood: Results of a study conducted in Baghdad city

    Directory of Open Access Journals (Sweden)

    Ameel F Al-Shawi

    2015-01-01

    Full Text Available Background: Studies have revealed a powerful relationship between adverse childhood experiences (ACEs and physical and mental health in adulthood. Literature documents the conversion of traumatic emotional experiences in childhood into organic disease later in life. Objective: The aim was to estimate the effect of childhood experiences on the physical health of adults in Baghdad city. Subjects and Methods: A cross-sectional study was conducted from January 2013 to January 2014. The study sample was drawn from Baghdad city. Multistage sampling techniques were used in choosing 13 primary health care centers and eight colleges of three universities in Baghdad. In addition, teachers of seven primary schools and two secondary schools were chosen by a convenient method. Childhood experiences were measured by applying a modified standardized ACEs-International Questionnaire form and with questions for bonding to family and parental monitoring. Physical health assessment was measured by a modified questionnaire derived from Health Appraisal Questionnaire of Centers for Disease Control and Prevention. The questionnaire includes questions on cerebrovascular diseases, diabetes mellitus, tumor, respiratory and gastrointestinal diseases. Results: Logistic regression model showed that a higher level of bonding to family (fourth quartile is expected to reduce the risk of chronic physical diseases by almost the half (odds ratio = 0.57 and exposure to a high level of household dysfunction and abuse (fourth quartile is expected to increase the risk of chronic physical diseases by 81%. Conclusion: Childhood experiences play a major role in the determination of health outcomes in adulthood, and early prevention of ACEs. Encouraging strong family bonding can promote physical health in later life.

  10. 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

  11. Children's health insurance program premiums adversely affect enrollment, especially among lower-income children.

    Science.gov (United States)

    Abdus, Salam; Hudson, Julie; Hill, Steven C; Selden, Thomas M

    2014-08-01

    Both Medicaid and the Children's Health Insurance Program (CHIP), which are run by the states and funded by federal and state dollars, offer health insurance coverage for low-income children. Thirty-three states charged premiums for children at some income ranges in CHIP or Medicaid in 2013. Using data from the 1999-2010 Medical Expenditure Panel Surveys, we show that the relationship between premiums and coverage varies considerably by income level and by parental access to employer-sponsored insurance. Among children with family incomes above 150 percent of the federal poverty level, a $10 increase in monthly premiums is associated with a 1.6-percentage-point reduction in Medicaid or CHIP coverage. In this income range, the increase in uninsurance may be higher among those children whose parents lack an offer of employer-sponsored insurance than among those whose parents have such an offer. Among children with family incomes of 101-150 percent of poverty, a $10 increase in monthly premiums is associated with a 6.7-percentage-point reduction in Medicaid or CHIP coverage and a 3.3-percentage-point increase in uninsurance. In this income range, the increase in uninsurance is even larger among children whose parents lack offers of employer coverage. Project HOPE—The People-to-People Health Foundation, Inc.

  12. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Chetna K Desai

    2011-01-01

    Full Text Available Objectives: Spontaneous reporting is an important tool in pharmacovigilance. However, its success depends on cooperative and motivated prescribers. Under-reporting of adverse drug reactions (ADRs by prescribers is a common problem. The present study was undertaken to evaluate the knowledge, attitude, and practices (KAP regarding ADR reporting among prescribers at the Civil Hospital, Ahmedabad, to get an insight into the causes of under-reporting of ADRs. Materials and Methods: A pretested KAP questionnaire comprising of 15 questions (knowledge 6, attitude 5, and practice 4 was administered to 436 prescribers. The questionnaires were assessed for their completeness (maximum score 20 and the type of responses regarding ADR reporting. Microsoft Excel worksheet (Microsoft Office 2007 and Chi-Square test were used for statistical analysis. Results: A total of 260 (61% prescribers completed the questionnaire (mean score of completion 18.04. The response rate of resident doctors (70.7% was better than consultants (34.5% (P < 0.001. ADR reporting was considered important by 97.3% of the respondents; primarily for improving patient safety (28.8% and identifying new ADRs (24.6%. A majority of the respondents opined that they would like to report serious ADRs (56%. However, only 15% of the prescribers had reported ADRs previously. The reasons cited for this were lack of information on where (70% and how (68% to report and the lack of access to reporting forms (49.2%. Preferred methods for reporting were e-mail (56% and personal communication (42%. Conclusion: The prescribers are aware of the ADRs and the importance of their reporting. However, under reporting and lack of knowledge about the reporting system are clearly evident. Creating awareness about ADR reporting and devising means to make it easy and convenient may aid in improving spontaneous reporting.

  13. Reporting guidelines in health research: A review.

    Science.gov (United States)

    Simon, Arun K; Rao, Ashwini; Rajesh, Gururaghavendran; Shenoy, Ramya; Pai, Mithun B

    2015-01-01

    Contemporary health research has come under close scrutiny, exposing alarming flaws in the reporting of research. The reporting guidelines can aid in identification of poorly reported studies and can bring transparency to health research. The guidelines also help journal editors, peer reviewers, funding agencies, and readers to better discern health research. Reporting guidelines encourage accurate and thorough reporting of fundamental aspects of health research so that the results of studies can be replicated by others. Reporting guidelines are potent tools to improve the practice of research and in reducing reporting bias. For the present review, both electronic and manual literature search was carried out. Electronic databases like PubMed, MEDLINE, EBSCO host, and Science Direct were searched for extracting relevant articles. Various key words and their combinations were used for literature search like reporting guidelines, checklist, research, publishing standards, study design, medicine, and dentistry. The search results were scrutinized for relevance to the topic and only full text articles in English were incorporated. Various reporting guidelines were identified and grouped under headings based on study design. This review article attempts to highlight the various reporting guidelines in literature relating to health research, its potential applications, and its limitations.

  14. Impacts of adverse childhood experiences on health, mental health, and substance use in early adulthood: a cohort study of an urban, minority sample in the U.S.

    Science.gov (United States)

    Mersky, J P; Topitzes, J; Reynolds, A J

    2013-11-01

    Research has shown that adverse childhood experiences (ACEs) increase the risk of poor health-related outcomes in later life. Less is known about the consequences of ACEs in early adulthood or among diverse samples. Therefore, we investigated the impacts of differential exposure to ACEs on an urban, minority sample of young adults. Health, mental health, and substance use outcomes were examined alone and in aggregate. Potential moderating effects of sex were also explored. Data were derived from the Chicago Longitudinal Study, a panel investigation of individuals who were born in 1979 or 1980. Main-effect analyses were conducted with multivariate logistic and OLS regression. Sex differences were explored with stratified analysis, followed by tests of interaction effects with the full sample. Results confirmed that there was a robust association between ACEs and poor outcomes in early adulthood. Greater levels of adversity were associated with poorer self-rated health and life satisfaction, as well as more frequent depressive symptoms, anxiety, tobacco use, alcohol use, and marijuana use. Cumulative adversity also was associated with cumulative effects across domains. For instance, compared to individuals without an ACE, individuals exposed to multiple ACEs were more likely to have three or more poor outcomes (OR range=2.75-10.15) and four or more poor outcomes (OR range=3.93-15.18). No significant differences between males and females were detected. Given that the consequences of ACEs in early adulthood may lead to later morbidity and mortality, increased investment in programs and policies that prevent ACEs and ameliorate their impacts is warranted.

  15. Using the stress and adversity inventory as a teaching tool leads to significant learning gains in two courses on stress and health.

    Science.gov (United States)

    Slavich, George M; Toussaint, Loren

    2014-10-01

    The ability to measure cumulative stress exposure is important for research and teaching in stress and health, but until recently, no structured system has existed for assessing exposure to stress over the lifespan. Here, we report the results of two experimental studies that examined the pedagogical efficacy of using an automated system for assessing life stress, called the Stress and Adversity Inventory (STRAIN), for teaching courses on stress and health. In Study 1, a randomized, wait-list controlled experiment was conducted with 20 college students to test whether the STRAIN, coupled with a related lecture and discussion, promoted learning about stress and health. Results showed that this experiential lesson led to significant learning gains. To disentangle the effects of completing the STRAIN from participating in the lecture and discussion, we subsequently conducted Study 2 on 144 students using a 2 (STRAIN versus control activity) by 2 (STRAIN-specific lecture versus general stress lecture) repeated-measures design. Although the STRAIN-specific lecture was sufficient for promoting learning, completing the STRAIN also generated significant learning gains when paired with only the general stress lecture. Together, these studies suggest that the STRAIN is an effective tool for promoting experiential learning and teaching students about stress and health.

  16. European Nutrition and Health Report 2009

    DEFF Research Database (Denmark)

    Elmadfa, Ibrahim; Meyer, A.; Nowak, V.

    The general aim of the ENHR II project is to provide a comprehensive and up-to-date report on the nutrition and health situation in Europe that focuses on diet, physical activity, tobacco use and alcohol consumption. The European Nutrition and Health Report 2009 will contribute to the identificat......The general aim of the ENHR II project is to provide a comprehensive and up-to-date report on the nutrition and health situation in Europe that focuses on diet, physical activity, tobacco use and alcohol consumption. The European Nutrition and Health Report 2009 will contribute...... to the identification of major nutrition and health problems in the EU regions and to the monitoring and evaluation of food and nutrition policies already in place within the Member States. The method implies collecting and critically reviewing available data on the most common indicators used for the assessment...... of nutrition and health situation of 25 European countries. The European Nutrition and Health Report 2009 will provide information on dietary habits, diet related health indicators as well as established food and nutrition policies in European countries....

  17. 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.

  18. Biopersistence and potential adverse health impacts of fibrous nanomaterials: what have we learned from asbestos?

    Science.gov (United States)

    Sanchez, Vanesa C; Pietruska, Jodie R; Miselis, Nathan R; Hurt, Robert H; Kane, Agnes B

    2009-01-01

    Human diseases associated with exposure to asbestos fibers include pleural fibrosis and plaques, pulmonary fibrosis (asbestosis), lung cancer, and diffuse malignant mesothelioma. The critical determinants of fiber bioactivity and toxicity include not only fiber dimensions, but also shape, surface reactivity, crystallinity, chemical composition, and presence of transition metals. Depending on their size and dimensions, inhaled fibers can penetrate the respiratory tract to the distal airways and into the alveolar spaces. Fibers can be cleared by several mechanisms, including the mucociliary escalator, engulfment, and removal by macrophages, or through splitting and chemical modification. Biopersistence of long asbestos fibers can lead to inflammation, granuloma formation, fibrosis, and cancer. Exposure to synthetic carbon nanomaterials, including carbon nanofibers and carbon nanotubes (CNTs), is considered a potential health hazard because of their physical similarities with asbestos fibers. Respiratory exposure to CNTs can produce an inflammatory response, diffuse interstitial fibrosis, and formation of fibrotic granulomas similar to that observed in asbestos-exposed animals and humans. Given the known cytotoxic and carcinogenic properties of asbestos fibers, toxicity of fibrous nanomaterials is a topic of intense study. The mechanisms of nanomaterial toxicity remain to be fully elucidated, but recent evidence suggests points of similarity with asbestos fibers, including a role for generation of reactive oxygen species, oxidative stress, and genotoxicity. Considering the rapid increase in production and use of fibrous nanomaterials, it is imperative to gain a thorough understanding of their biologic activity to avoid the human health catastrophe that has resulted from widespread use of asbestos fibers.

  19. 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

  20. [Policy counselling through public health reporting?].

    Science.gov (United States)

    Brand, H; Michelsen, K

    2007-10-01

    For about 20 years public health reporting has increasingly been developed as a resource in health policy counselling. Both with regard to its use as well as its further development it is important to reflect on the possibilities and limits of this resource. A basis for this is provided by theories, models and hypotheses derived from the discussion about scientific policy counselling. In early conceptual reflections on the organisation of health reporting a technocratic use was rejected. This is reflected by the ideas and views about the institutional embedding of health reporting activities. Against the background of diverging opinions about the political dimensions of health reporting activities, reflections were guided by the decisionistic and pragmatic model of the "scientification of politics". Public health reporting must provide the possibility for being used in a flexible way in order to add a pragmatistic component to its decisionistic and strategic uses. For action-oriented, pragmatistic and scientific policy counselling through the health reporting discipline it is important to link "information about politically relevant facts" with the "targeted processing of knowledge geared towards problems in the field of decision-making processes" (expertise).

  1. Mental Health Program Reports - 4.

    Science.gov (United States)

    National Inst. of Mental Health (DHEW), Chevy Chase, MD. National Clearinghouse for Mental Health Information.

    The emphasis of this NIMH report is to improve our understanding of the origins of violence and to suggest ways of acting on that knowledge to reduce the incidence of crime and violence in American society. Also included in this volume are details of work aimed at reducing the toll of such problems as alcoholism and suicide among our citizens; a…

  2. 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

  3. Carer-Reported Contemporary Health Problems in People with Severe and Profound Intellectual Disability and Genetic Syndromes

    Science.gov (United States)

    Berg, Katy; Arron, Kate; Burbidge, Cheryl; Moss, Joanna; Oliver, Chris

    2007-01-01

    Identifying health problems in people with severe and profound disabilities and genetic syndromes can be problematic, and unidentified or unmanaged health problems may adversely impact an individual's quality of life. The authors studied carer-reported contemporary health problems in three genetic syndromes (Angelman, Cornelia de Lange, and Cri du…

  4. [Adverse drug reactions of hydroxymethylglutaryl-CoA reductase inhibitors reported to agency for medicinal products and medical devices].

    Science.gov (United States)

    Skvrce, Nikica Mirosević; Bozina, Nada; Sarinić, Viola Macolić; Tomić, Sinisa

    2010-01-01

    Hydroxymethylglutaryl-CoA reductase inhibitors (statins) are drugs used in the treatment of chronic diseases and frequently in concomitant therapy with many other drugs. Therefore, the risk of adverse drug reactions (ADRs), especially those caused by interactions is high. Aim of the study was to describe and analyze ADRs caused by statins reported to Croatian Agency from March 2005 to December 2008, and to emphasize reasons of their occurrence. 136 of statin ADRs were reported. 12 % of all reported statins' ADRs were caused by interactions, which is higher than percent (5.6%) of interactions caused by all other drugs in 2005 and 2006. Proportion of serious ADRs related to administered dose and thus preventable was higher than proportion of all ADRs caused by statins (p = 0.003). Most serious ADRs could have been prevented with better understanding of interactions and by use of pharmacogenomics in identifying patients that are because of genetic predisposition more sensitive to standard doses.

  5. Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

    Science.gov (United States)

    Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L

    2017-01-01

    A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women.

  6. The mental health of prisoners: a review of prevalence, adverse outcomes and interventions

    Science.gov (United States)

    Fazel, Seena; Hayes, Adrian J; Bartellas, Katrina; Clerici, Massimo; Trestman, Robert

    2016-01-01

    There are more than 10 million prisoners worldwide, and the prevalence of all investigated mental disorders is higher than general population comparisons. Although the extent to which prison increases the incidence of mental disorders is uncertain, there is considerable evidence of low rates of identification and treatment of psychiatric disorders. Prisoners are also at increased risk of all-cause mortality, suicide, self-harm, violence, and victimization, and research has outlined some modifiable risk factors. High quality treatment trials for psychiatric disorders in prisoners have been limited. Despite this, it has been shown in trials that opiate substitution treatments reduce substance misuse relapse and possibly reoffending. The mental health needs of women and older adults in prison are distinct, and national policies should be developed to meet these. Clinical, research, and policy recommendations to improve prison mental healthcare are presented. National attempts to meet these recommendations should be annually surveyed. PMID:27426440

  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. The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective

    National Research Council Canada - National Science Library

    Anderson, Claire; Krska, Janet; Murphy, Elizabeth; Avery, Anthony

    2011-01-01

    .... WHAT THIS STUDY ADDS • Direct patient reporting through the Yellow Card Scheme is viewed as important by those who have used the scheme, in order to provide the patient experience for the benefit of pharmacovigilance...

  9. [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.

  10. Abuse of methylphenidate in Germany: data from spontaneous reports of adverse drug reactions.

    Science.gov (United States)

    Gahr, Maximilian; Freudenmann, Roland W; Hiemke, Christoph; Kölle, Markus A; Schönfeldt-Lecuona, Carlos

    2014-01-30

    To retrieve insights into abuse/dependence of methylphenidate (MPH) in Germany, a query of a pharmacovigilance database was performed (observation interval: 1993 until 2012). From 1190 reports of any ADR related to MPH, n=23 (2%) cases of MPH abuse were identified (mean age 29 years; male sex 78%; mean daily MPH-dosage 111 ± 126.6 mg). As oral application was predominant (70%), the majority of reported cases of MPH abuse might be due to pharmacologic neuroenhancement.

  11. Health physics 1992 progress report

    Energy Technology Data Exchange (ETDEWEB)

    1994-04-01

    At Los Alamos National Laboratory, radiation protection services are provided by ESH-1, -4, and -12, and technical support is provided by ESH-6 to Laboratory groups that work with significant quantities of fissile material. The mission of all these groups is to protect Laboratory workers, the public, and the environment from radiation associated with Laboratory operations. In this report, 1992 radiation protection performance trends are presented. These data show that, in general, the collective external dose equivalent quantities from penetrating (gamma, x-ray, and neutron) radiation and from nonpenetrating (beta and low-energy photon) radiation showed a slight downward trend during 1992. The number of confirmed contaminations of skin and personal clothing decreased in 1992 when compared to the previous year. Finally, there was one reportable DOE 5000.3A internal contamination event in 1992. The 1992 radiation protection activities of the Laboratory, conducted at both the Nevada Test Site and at Los Alamos, are presented and discussed. These activities include external dosimetry, internal dosimetry, radiation-monitoring instrumentation, sample analysis, workplace radiological monitoring, nuclear criticality safety, hazardous materials response, radiological training, and radiological records. This report details routine activities, including any significant changes and improvements in 1992; additional activities, including special investigations, studies, and reviews; publications and presentations; and professional activities, including professional memberships, training received, and conferences attended.

  12. Inactive matrix Gla protein is causally related to adverse health outcomes: a Mendelian randomization study in a Flemish population.

    Science.gov (United States)

    Liu, Yan-Ping; Gu, Yu-Mei; Thijs, Lutgarde; Knapen, Marjo H J; Salvi, Erika; Citterio, Lorena; Petit, Thibault; Carpini, Simona Delli; Zhang, Zhenyu; Jacobs, Lotte; Jin, Yu; Barlassina, Cristina; Manunta, Paolo; Kuznetsova, Tatiana; Verhamme, Peter; Struijker-Boudier, Harry A; Cusi, Daniele; Vermeer, Cees; Staessen, Jan A

    2015-02-01

    Matrix Gla-protein is a vitamin K-dependent protein that strongly inhibits arterial calcification. Vitamin K deficiency leads to production of inactive nonphosphorylated and uncarboxylated matrix Gla protein (dp-ucMGP). The risk associated with dp-ucMGP in the population is unknown. In a Flemish population study, we measured circulating dp-ucMGP at baseline (1996-2011), genotyped MGP, recorded adverse health outcomes until December 31, 2012, and assessed the multivariable-adjusted associations of adverse health outcomes with dp-ucMGP. We applied a Mendelian randomization analysis using MGP genotypes as instrumental variables. Among 2318 participants, baseline dp-ucMGP averaged 3.61 μg/L. Over 14.1 years (median), 197 deaths occurred, 58 from cancer and 70 from cardiovascular disease; 85 participants experienced a coronary event. The risk of death and non-cancer mortality curvilinearly increased (P≤0.008) by 15.0% (95% confidence interval, 6.9-25.3) and by 21.5% (11.1-32.9) for a doubling of the nadir (1.43 and 0.97 μg/L, respectively). With higher dp-ucMGP, cardiovascular mortality log-linearly increased (hazard ratio for dp-ucMGP doubling, 1.14 [1.01-1.28]; P=0.027), but coronary events log-linearly decreased (0.93 [0.88-0.99]; P=0.021). dp-ucMGP levels were associated (P≤0.001) with MGP variants rs2098435, rs4236, and rs2430692. For non-cancer mortality and coronary events (P≤0.022), but not for total and cardiovascular mortality (P≥0.13), the Mendelian randomization analysis suggested causality. Higher dp-ucMGP predicts total, non-cancer and cardiovascular mortality, but lower coronary risk. For non-cancer mortality and coronary events, these associations are likely causal.

  13. A STUDY TO ASSESS KNOWLEDGE , ATTITUDE AND PRACTICE OF ADVERSE DRUG REACTION REPORTING AMONG PHYSICIANS IN A TERTIARY CARE HOSPITAL

    Directory of Open Access Journals (Sweden)

    Jyotirmoy

    2013-02-01

    Full Text Available ABSTRACT: BACKGROUND: Adverse drug reaction (ADR monitoring and reporting activity is in its infancy in India. Spontaneous reporting of adverse drug reactions (AD R is an important method in pharmacovigilance, but under-reporting is a major limitation. AIMS: Physicians being frontline caregivers this study was conducted to assess the knowledge, a ttitude and practice (KAP of ADR reporting among physicians in a tertiar y care hospital. SETTING AND DESIGN: This cross sectional, questionnaire based study was carried out amongst all the physicians working at Rajarajeswari Medical College & hospital, Bangalore over a period of 1 month. MATERIALS AND METHODS: A questionnaire was prepared after a initial pilot st udy and was distributed among all the physicians. For every Phys ician 30 minutes was given to fill up the questionnaire. Later on the filled questionnaires w ere collected and analyzed as per the study objectives. RESULTS: A questionnaire was distributed to 189 physicians, but only 122 returned the questionnaire (response rate of 70.9% . This study revealed inadequate knowledge and poor practice of ADR reporting. Though 56.8% physician felt that they encountered ADRs, only 22.1% had actually ever reported an ADR. The most co mmon reasons of under reporting were lack of time(34.5%, followed by lack of knowledge of reporting procedure (30.4%. But the physicians showed positive attitude towards ADR report ing. 95.0% felt that that ADR reporting is necessary and 79.5% supported for establishing ADR monitoring centre in e very hospital. Most of the physicians (95.9% suggested that continuous medical education and training on ADR reporting is necessary for overcoming the problem of underreporting of ADRs. CONCLUSION: The study results revealed the existence of underr eporting of ADRs, but also the willingness of clinicians to be trained in ADR repor ting and contributing to the pharmacovigilance programme. It is desirable to initi ate workshops and

  14. Health council report 'Antimicrobial growth promoters'.

    NARCIS (Netherlands)

    Goettsch, W; Degener, JE

    1999-01-01

    The Health Council of the Netherlands has issued a report on the risk of development of resistance among bacteria as result of the use of antibiotics as growth promotors in livestock farming. The committee appointed by the Health Council conclude that the use of antimicrobial growth promotors contri

  15. Spanking and adult mental health impairment: The case for the designation of spanking as an adverse childhood experience.

    Science.gov (United States)

    Afifi, Tracie O; Ford, Derek; Gershoff, Elizabeth T; Merrick, Melissa; Grogan-Kaylor, Andrew; Ports, Katie A; MacMillan, Harriet L; Holden, George W; Taylor, Catherine A; Lee, Shawna J; Peters Bennett, Robbyn

    2017-01-23

    Adverse Childhood Experiences (ACEs) such as child abuse are related to poor health outcomes. Spanking has indicated a similar association with health outcomes, but to date has not been considered an ACE. Physical and emotional abuse have been shown in previous research to correlate highly and may be similar in nature to spanking. To determine if spanking should be considered an ACE, this study aimed to examine 1): the grouping of spanking with physical and emotional abuse; and 2) if spanking has similar associations with poor adult health problems and accounts for additional model variance. Adult mental health problems included depressive affect, suicide attempts, moderate to heavy drinking, and street drug use. Data were from the CDC-Kaiser ACE study (N=8316, response rate=65%). Spanking loaded on the same factor as the physical and emotional abuse items. Additionally, spanking was associated with increased odds of suicide attempts (Adjusted Odds Ratios (AOR)=1.37; 95% CI=1.02 to1.86), moderate to heavy drinking (AOR)=1.23; 95% CI=1.07 to 1.41), and the use of street drugs (AOR)=1.32; 95% CI=1.4 to 1.52) in adulthood over and above experiencing physical and emotional abuse. This indicates spanking accounts for additional model variance and improves our understanding of these outcomes. Thus, spanking is empirically similar to physical and emotional abuse and including spanking with abuse adds to our understanding of these mental health problems. Spanking should also be considered an ACE and addressed in efforts to prevent violence.

  16. Adverse impacts of chronic pain on health-related quality of life, work productivity, depression and anxiety in a community-based study.

    Science.gov (United States)

    Kawai, Kosuke; Kawai, Alison Tse; Wollan, Peter; Yawn, Barbara P

    2017-04-22

    Chronic pain has major clinical and social consequences. Few studies have examined any variation in the extent of impairment on quality of life and work productivity by site and type of chronic pain. The objective of our study is to examine adverse impacts of chronic pain on physical and psychological health and work productivity. Our community-population study was based on a phone-interview of adults with chronic pain, residing in Olmsted County, MN. Chronic pain groups were categorized into abdominal pain, back pain, joint pain, multisite pain, neuropathic pain or no chronic pain. We used standardized instruments, including the Brief Pain Inventory, the Patients Health Questionnair-9, and Work Productivity and Activity Impairment Questionnaire. We evaluated 591 patients suffering from chronic pain and 150 participants with no chronic pain. Almost one third of patients with multisite pain (33%) and neuropathic pain (32%) reported mild/major depressive symptoms. Patients suffering from chronic pain, particularly from multisite pain and neuropathic pain, reported significant pain interferences with daily activities and impairments in physical function. Chronic pain was significantly associated with reduced performance at work but not with missed work hours. The average reported reduction in work productivity ranged from 2.4 hours (±5.6) per week for adults with joint chronic pain to 9.8 hours (±11.1) per week for adults with multisite chronic pain. Chronic pain, particularly multisite pain and neuropathic pain, significantly affected physical and psychological health. Chronic pain is a multifaceted health condition that requires a multidisciplinary treatment approach.

  17. Are Food Insecurity’s Health Impacts Underestimated in the U.S. Population? Marginal Food Security Also Predicts Adverse Health Outcomes in Young U.S. Children and Mothers123

    Science.gov (United States)

    Cook, John T.; Black, Maureen; Chilton, Mariana; Cutts, Diana; Ettinger de Cuba, Stephanie; Heeren, Timothy C.; Rose-Jacobs, Ruth; Sandel, Megan; Casey, Patrick H.; Coleman, Sharon; Weiss, Ingrid; Frank, Deborah A.

    2013-01-01

    This review addresses epidemiological, public health, and social policy implications of categorizing young children and their adult female caregivers in the United States as food secure when they live in households with “marginal food security,” as indicated by the U.S. Household Food Security Survey Module. Existing literature shows that households in the US with marginal food security are more like food-insecure households than food-secure households. Similarities include socio-demographic characteristics, psychosocial profiles, and patterns of disease and health risk. Building on existing knowledge, we present new research on associations of marginal food security with health and developmental risks in young children (food security is positively associated with adverse health outcomes compared with food security, but the strength of the associations is weaker than that for food insecurity as usually defined in the US. Nonoverlapping CIs, when comparing odds of marginally food-secure children’s fair/poor health and developmental risk and caregivers’ depressive symptoms and fair/poor health with those in food-secure and -insecure families, indicate associations of marginal food security significantly and distinctly intermediate between those of food security and food insecurity. Evidence from reviewed research and the new research presented indicates that households with marginal food security should not be classified as food secure, as is the current practice, but should be reported in a separate discrete category. These findings highlight the potential underestimation of the prevalence of adverse health outcomes associated with exposure to lack of enough food for an active, healthy life in the US and indicate an even greater need for preventive action and policies to limit and reduce exposure among children and mothers. PMID:23319123

  18. 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.

  19. The state of health of children living in adverse environmental conditions

    Directory of Open Access Journals (Sweden)

    lmagul Bolatovna Kuzgibekova

    2016-12-01

    Full Text Available The state of health of 4,078 children and the morbidity pattern among the child population in the Karkaraly district of the Karaganda region was studied as part of the screening to assess the impact of the ecological situation. The control group included 2,272 children, living in the Osakarov district of the Karaganda region (as the most ecologically favourable district. Screening cards were developed for the examination, which included questionnaire data, complaints, medical history, and physical examination data. The screening involved cardiologists, gastroenterologists, neurologists, and other doctors. A number of necessary verifying laboratory and instrumental studies was carried out. Child morbidity in the Karakaly district exceeded that in the Osakarov district by several times in almost all cases. The diseases were found for the first time in more than 60 per cent of children. The prevailing classes among the studied diseases were pathologies of blood and hematopoietic organs, mental and behavioural disorders, respiratory and digestive diseases, congenital anomalies, deformations, and other pathologies. This is related to the negative impact of man-induced factors.

  20. Adverse health effects and histological changes in white sturgeon (Acipenser transmontanus) exposed to dietary selenomethionine.

    Science.gov (United States)

    Zee, Jenna; Patterson, Sarah; Gagnon, Danielle; Hecker, Markus

    2016-07-01

    It has been shown that selenium (Se) released to the aquatic environment can have devastating effects on local wildlife. White sturgeon (Acipenser transmontanus) have a life history particularly susceptible to contaminants, and their protection is of interest as they are culturally and economically important, and many populations are classified as endangered. During the present 72-d dietary study, multiple signs of decreased health and Se lethality were observed. Juvenile white sturgeon were given diets containing 1.4 μg, 5.6 μg, 22.4 μg, or 104.4 μg selenomethionine/g food (dry mass). Selenium accumulated in muscle and liver tissue in a dose-dependent manner. Edema causing exophthalmos developed within 15 d and 23 d, and lethal effects occurred in 54% and 22% of fish in the high- and medium-dose groups, respectively. Growth and hepatosomatic index were significantly lower in the high-dose group, which also had a high incidence of food avoidance. Histology of the liver revealed a dose-dependent increase in melanomacrophage aggregates and decrease of energy stores, which indicated toxicity. These results indicate that white sturgeon are susceptible to the effects of Se accumulation over relatively short time periods. This stresses the need for continued sturgeon research and studies looking into the environmental fate and regulation of released Se. Environ Toxicol Chem 2016;35:1741-1750. © 2015 SETAC.

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

    Directory of Open Access Journals (Sweden)

    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.

  2. Adverse health effects in workers exposed to trace/toxic metals at workplace.

    Science.gov (United States)

    Mehra, Rita; Juneja, Meenu

    2003-04-01

    Widespread use of metals in industrial activities has enhanced the occupational exposure to toxic metals as well as the health risks of metal hazards to humans. Elemental analysis in human tissues is the most common application of biological monitoring for screening, diagnosis and assessment of such exposures and risk. Among various biopsy materials, blood, hair, nail, teeth and body fluids may be used as bioindicators for this purpose. The present paper deals with the determination of Pb, Cr, Ni, Mn, Fe, Cu and Zn elemental concentration in workers exposed to these metals at workplace by atomic absorption spectrophotometry, with adequate quality control measures using hair as biopsy material. The study group includes the male workers such as welders, foundry man, fitter, hammer man, machine man, cupola man etc., besides office workers of locomotive workshop in Ajmer and surrounding areas exposed to different metals. Age and sex matched controls of persons working in the same area of work in offices etc. and not exposed to metal pollution were selected for valid comparison. It is proposed to validate the use of hair as a biological marker for assessing metal body burden of workers. In our study significant correlations have been found between skin disease and Cr, Mn, Fe, Cu; chest pain and Pb; hypertension and Cu, Mn; mental stress and Mn, Ni, Cu, Zn; liver problem and Ni; indigestion and Cr; Ni, diabetes and Cr, Mn, Ni; tuberculosis and Zn; breathing trouble and Cr, Mn, Fe, Ni, Zn. The advantages of choosing hair as a biopsy material are also given.

  3. Report of thirty one admissions due to adverse drug reactions inBo-Ali Sina hospital, Sari, Iran

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Rafati

    2009-01-01

    Full Text Available , (Received 16 May, 2009 ; Accepted 8 July, 2009AbstractBackground and purpose: Adverse drug reactions (ADRs are one of the leading causes of morbidity and mortality, worldwide. Mortality rate due to ADRs are ahead of pulmonary disease, AIDS, pneumonia and automobile accidents. This study evaluated the admission rates in a University teaching hospital related to ADRs.Materials and methods: During this retrospective study between 2001 and 2007, all patients admitted due to adverse drug reaction in Sari Bo-Ali Sina Hospital were evaluated.Results: In these years, 31 patients out of 71,680 were admitted, due to ADRs. Most common ADRs were skin reaction (74% and fever (22%. Phenobarbital and penicillin were the most common drugs causing ADRs.Conclusion: Only 0.04% of hospital admissions were drug related, while reported admission due to ADRs in other countries were 2.4 to 6.2%. It appears that less drug-depended hospital admissions in Iran rational drug administration, but are due to lack of enough detection, records and reporting procedures.J Mazand Univ Med Sci 2009; 19(71: 67-70 (Persian.

  4. An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study

    Directory of Open Access Journals (Sweden)

    Akram Ahmad

    2013-01-01

    Full Text Available Background: Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010. Objectives: This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists′ participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates. Materials and Methods: A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.. The study was conducted, over a period of 3 months from May 2012 to July 2012. Results: Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients. Conclusion : The Indian pharmacists have poor knowledge, attitude, and practice (KAP towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists

  5. Does switching from oral to subcutaneous administration of methotrexate influence on patient reported gastro-intestinal adverse effects?

    DEFF Research Database (Denmark)

    Kromann, Charles B; Lage-Hansen, Philip R; Koefoed, Mette

    2015-01-01

    INTRODUCTION: When treating patients with methotrexate (MTX) the most frequently reported adverse effects (AE) are gastrointestinal (GI) with nausea being reported by 10-20%. If intolerable AE of oral MTX persist, switching from oral to subcutaneous (SC) or intramuscular (IM) administration...... is common. However, this approach is largely empirical and the evidence is inconsistent. To our knowledge, this will be the first study to estimate the change in GI AE of switching from oral to SC MTX. METHODS: A retrospective postal survey was sent to patients who had changed from oral MTX to SC MTX. GI AE...... was rated by visual analogue scale (VAS) regarding frequency and intensity of nausea, frequency of vomiting and frequency of discomfort. All participants gave informed consent. No further ethical clearance was necessary according to national law. RESULTS: Of the sample 39/57 (68.4%) responded. Significant...

  6. Severe cutaneous adverse drug reaction to leflunomide: a report of two cases.

    Science.gov (United States)

    Jian, Xingdong; Guo, Guangran; Ruan, Yanjun; Lin, Dawei; Li, Xingfu

    2008-01-01

    The purpose of this study was to report severe cutaneous reactions in two patients related with leflunomide. A 13-year-old girl was treated with leflunomide for systemic lupus erythematosus. Three months later a progressive generalized blistering formation occurred and epidermolysis appeared on her skin. Methylprednisolone pulse therapy and intravenous immunoglobulin were used to control the severe cutaneous reactions. The patient recovered within 18 days. Another case is a 63-year-old woman who was treated with leflunomide for primary Sjögren's syndrome. Four months later widespread prunosus skin rash appeared on her skin. Methylprednisolone pulse therapy was also used to control the severe cutaneous reactions. The patient was recovered 11 days later. Our report suggests that an association between leflunomide intake and severe cutaneous reactions in rheumatic disease patients should be considered.

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

    Science.gov (United States)

    dos Santos, Rafael Guimarāes

    2013-01-01

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

  8. Association between childhood adversities and long-term suicidality among South Africans from the results of the South African Stress and Health study: a cross-sectional study

    OpenAIRE

    Bruwer, Belinda; Govender, Ravi; Bishop, Melanie; Williams, David R.; Stein, Dan J.; Seedat, Soraya

    2014-01-01

    Objective Suicide and suicidal behaviours are significant public health problems and a leading cause of death worldwide and in South Africa. We examined the association between childhood adversities and suicidal behaviour over the life course. Methods A national probability sample of 4351 South African adult participants (aged 18 years and older) in the South African Stress and Health (SASH) study was interviewed as part of the World Mental Health Surveys initiative. Respondents provided soci...

  9. Association between childhood adversities and long-term suicidality among South Africans from the results of the South African Stress and Health study: a cross-sectional study

    OpenAIRE

    Bruwer, Belinda; Govender, Ravi; Bishop, Melanie; Williams, David R.; Stein, Dan J.; Seedat, Soraya

    2014-01-01

    Objective: Suicide and suicidal behaviours are significant public health problems and a leading cause of death worldwide and in South Africa. We examined the association between childhood adversities and suicidal behaviour over the life course. Methods: A national probability sample of 4351 South African adult participants (aged 18 years and older) in the South African Stress and Health (SASH) study was interviewed as part of the World Mental Health Surveys initiative. Respondents provided so...

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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...

  15. A cooperative reduction model for regional air pollution control in China that considers adverse health effects and pollutant reduction costs.

    Science.gov (United States)

    Xie, Yujing; Zhao, Laijun; Xue, Jian; Hu, Qingmi; Xu, Xiang; Wang, Hongbo

    2016-12-15

    How to effectively control severe regional air pollution has become a focus of global concern recently. The non-cooperative reduction model (NCRM) is still the main air pollution control pattern in China, but it is both ineffective and costly, because each province must independently fight air pollution. Thus, we proposed a cooperative reduction model (CRM), with the goal of maximizing the reduction in adverse health effects (AHEs) at the lowest cost by encouraging neighboring areas to jointly control air pollution. CRM has two parts: a model of optimal pollutant removal rates using two optimization objectives (maximizing the reduction in AHEs and minimizing pollutant reduction cost) while meeting the regional pollution control targets set by the central government, and a model that allocates the cooperation benefits (i.e., health improvement and cost reduction) among the participants according to their contributions using the Shapley value method. We applied CRM to the case of sulfur dioxide (SO2) reduction in Yangtze River Delta region. Based on data from 2003 to 2013, and using mortality due to respiratory and cardiovascular diseases as the health endpoints, CRM saves 437 more lives than NCRM, amounting to 12.1% of the reduction under NCRM. CRM also reduced costs by US $65.8×10(6) compared with NCRM, which is 5.2% of the total cost of NCRM. Thus, CRM performs significantly better than NCRM. Each province obtains significant benefits from cooperation, which can motivate them to actively cooperate in the long term. A sensitivity analysis was performed to quantify the effects of parameter values on the cooperation benefits. Results shown that the CRM is not sensitive to the changes in each province's pollutant carrying capacity and the minimum pollutant removal capacity, but sensitive to the maximum pollutant reduction capacity. Moreover, higher cooperation benefits will be generated when a province's maximum pollutant reduction capacity increases.

  16. 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.

  17. 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

  18. [Modern microbiological methods in diagnosis of adverse reactions after BCG vaccination. Case reports].

    Science.gov (United States)

    Zwolska, Zofia; Augustynowicz-Kopeć, Ewa; Zabost, Anna; Ziółkowski, Jerzy; Buchwald, Joachim; Płończak, Marian; Walas, Wojciech; Ziebiński, Marek

    2004-01-01

    The attenuated bacilli Calmette-Guerin (BCG) vaccine is administered worldwide to prevent tuberculosis and is considered to have an excellent safety profile. In Poland, since 1955 BCG mass vaccinations have been compulsory. More than 95% newborns and 80% of older children of the population have been vaccinated. Complications of vaccination are uncommon. Although BCG has been used safely for many years, it can cause disease in humans, especially those with cellular immunodeficiencies. The risks associated with BCG vaccination include local complications, extraregional localized disease, and disseminated BCG disease. Identification of M. bovis BCG in laboratory is a very difficult process. Routine identification of mycobacterial isolates in clinical laboratories involves culture of Mycobacterium tuberculosis complex which includes M. tuberculosis, M. bovis, M. africanum and M. microti and the vaccine strain M.bovis BCG. Most laboratories cannot quickly differentiate between BCG and other members of M. tuberculosis complex and some cases of BCG complications in children may be considered and treated as tuberculosis. Because of difficulties in proper identification of BCG strains isolated from the patients, the prevalence of BCG infections is not know exactly