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.

Adverse event reporting in Czech long-term care facilities.

Science.gov (United States)

Hěib, Zdenřk; Vychytil, Pavel; Marx, David

2013-04-01

To describe adverse event reporting processes in long-term care facilities in the Czech Republic. Prospective cohort study involving a written questionnaire followed by in-person structured interviews with selected respondents. Long-term care facilities located in the Czech Republic. Staff of 111 long-term care facilities (87% of long-term care facilities in the Czech Republic). None. Sixty-three percent of long-term health-care facilities in the Czech Republic have adverse event-reporting processes already established, but these were frequently very immature programs sometimes consisting only of paper recording of incidents. Compared to questionnaire responses, in-person interview responses only partially tended to confirm the results of the written survey. Twenty-one facilities (33%) had at most 1 unconfirmed response, 31 facilities (49%) had 2 or 3 unconfirmed responses and the remaining 11 facilities (17%) had 4 or more unconfirmed responses. In-person interviews suggest that use of a written questionnaire to assess the adverse event-reporting process may have limited validity. Staff of the facilities we studied expressed an understanding of the importance of adverse event reporting and prevention, but interviews also suggested a lack of knowledge necessary for establishing a good institutional reporting system in long-term care.

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

Science.gov (United States)

Palleria, Caterina; Leporini, Christian; Chimirri, Serafina; Marrazzo, Giuseppina; Sacchetta, Sabrina; Bruno, Lucrezia; Lista, Rosaria M; Staltari, Orietta; Scuteri, Antonio; Scicchitano, Francesca; Russo, Emilio

2013-12-01

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. 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. 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. 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.

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.

Factors that condition the spontaneous reporting of adverse drug reactions among nurses: an integrative review.

Science.gov (United States)

De Angelis, Alessia; Colaceci, Sofia; Giusti, Angela; Vellone, Ercole; Alvaro, Rosaria

2016-03-01

To describe and synthesise previous research on factors conditioning the spontaneous reporting of adverse drug reactions among nurses. Spontaneous reports of adverse drug reactions by health-care providers, are a main instrument for the continuous evaluation of the risk-benefit ratio of every drug. Under-reporting of adverse drug reactions by all health-care providers, in particular by nurses, is a major limitation to this system. An integrated review of the literature was conducted using MEDLINE, CINAHL, Embase, Scopus databases and Google Scholar. After evaluation for appropriateness related to inclusion/exclusion criteria, 16 studies were included in the final analysis and synthesis. Two factors emerged from the study: (1) intrinsic factors related to nurses' knowledge and attitudes; (2) extrinsic factors related to nurses' interaction with health-care organisations and to the relationship between nurses and physicians. Nurses' attitudes that hinder reporting include ignorance, insecurity, fear and lethargy. Nurses are not fully aware of their role in adverse drug reaction reporting. Nurses must acquire greater knowledge to implement specific skills into their daily clinical practice. To improve nurses' reporting of adverse drug reactions, it is necessary to develop management approaches that modify both intrinsic and extrinsic factors. © 2015 John Wiley & Sons Ltd.

Consequenses of childhood adversity on health concerns in adulthood

African Journals Online (AJOL)

Consequenses of childhood adversity on health concerns in adulthood. ... childhood adversity have similar levels of depression, acute and chronic health. ... to explain the pathways linking childhood adversity to physical health in adulthood.

Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two “challenging” case reports

Science.gov (United States)

Palleria, Caterina; Leporini, Christian; Chimirri, Serafina; Marrazzo, Giuseppina; Sacchetta, Sabrina; Bruno, Lucrezia; Lista, Rosaria M.; Staltari, Orietta; Scuteri, Antonio; Scicchitano, Francesca; Russo, Emilio

2013-01-01

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. PMID:24347986

Serious adverse events with infliximab: analysis of spontaneously reported adverse events.

Science.gov (United States)

Hansen, Richard A; Gartlehner, Gerald; Powell, Gregory E; Sandler, Robert S

2007-06-01

Serious adverse events such as bowel obstruction, heart failure, infection, lymphoma, and neuropathy have been reported with infliximab. The aims of this study were to explore adverse event signals with infliximab by using a long period of post-marketing experience, stratifying by indication. The relative reporting of infliximab adverse events to the U.S. Food and Drug Administration (FDA) was assessed with the public release version of the adverse event reporting system (AERS) database from 1968 to third quarter 2005. On the basis of a systematic review of adverse events, Medical Dictionary for Regulatory Activities (MedDRA) terms were mapped to predefined categories of adverse events, including death, heart failure, hepatitis, infection, infusion reaction, lymphoma, myelosuppression, neuropathy, and obstruction. Disproportionality analysis was used to calculate the empiric Bayes geometric mean (EBGM) and corresponding 90% confidence intervals (EB05, EB95) for adverse event categories. Infliximab was identified as the suspect medication in 18,220 reports in the FDA AERS database. We identified a signal for lymphoma (EB05 = 6.9), neuropathy (EB05 = 3.8), infection (EB05 = 2.9), and bowel obstruction (EB05 = 2.8). The signal for granulomatous infections was stronger than the signal for non-granulomatous infections (EB05 = 12.6 and 2.4, respectively). The signals for bowel obstruction and infusion reaction were specific to patients with IBD; this suggests potential confounding by indication, especially for bowel obstruction. In light of this additional evidence of risk of lymphoma, neuropathy, and granulomatous infections, clinicians should stress this risk in the shared decision-making process.

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

Science.gov (United States)

2011-09-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Requirements and Registration for ``Reporting Device Adverse Events Challenge'' Authority: 15 U.S.C. 3719. AGENCY: Office of the National..., specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse...

Spontaneous adverse drug reaction reporting in rural districts of Mozambique.

Science.gov (United States)

Sevene, Esperança; Mariano, Alda; Mehta, Ushma; Machai, Maria; Dodoo, Alexander; Vilardell, David; Patel, Sam; Barnes, Karen; Carné, Xavier

2008-01-01

The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and their performance under any circumstance is difficult to predict given the known shortage of human, financial and technical resources. Nevertheless, the importance of such systems in all countries is not in doubt, and research to identify problems, with the aim of offering pragmatic solutions, is urgently needed. To examine the impact of training and monitoring of healthcare workers, making supervisory visits and the availability of telecommunication and transport facilities on the implementation of a pharmacovigilance system in Mozambique. This was a descriptive study enumerating the lessons learnt and challenges faced in implementing a spontaneous reporting system in two rural districts of Mozambique - Namaacha and Matutuíne - where remote location, poor telecommunication services and a low level of education of health professionals are ongoing challenges. A 'yellow card' system for spontaneous reporting of adverse drug reactions (ADRs) was instituted following training of health workers in the selected districts. Thirty-five health professionals (3 medical doctors, 2 technicians, 24 nurses, 4 basic healthcare agents and 2 pharmacy agents) in these districts were trained to diagnose, treat and report ADRs to all medicines using a standardized yellow card system. There were routine site visits to identify and clarify any problems in filling in and sending the forms. One focal person was identified in each district to facilitate communication between the health professionals and the National Pharmacovigilance Unit (NPU). The report form was assessed for quality and causality. The availability of telecommunications and transport was assessed. Fourteen months after

Looking for capacities rather than vulnerabilities: The moderating effect of health assets on the associations between adverse social position and health.

Science.gov (United States)

Roy, Mathieu; Levasseur, Mélanie; Doré, Isabelle; St-Hilaire, France; Michallet, Bernard; Couturier, Yves; Maltais, Danielle; Lindström, Bengt; Généreux, Mélissa

2018-05-01

To increase capacities and control over health, it is necessary to foster assets (i.e. factors enhancing abilities of individuals or communities). Acting as a buffer, assets build foundations for overcoming adverse conditions and improving health. However, little is known about the distribution of assets and their associations with social position and health. In this study, we documented the distribution of health assets and examined whether these assets moderate associations between adverse social position and self-reported health. A representative population-based cross-sectional survey of adults in the Eastern Townships, Quebec, Canada (n = 8737) was conducted in 2014. Measures included assets (i.e. resilience, sense of community belonging, positive mental health, social participation), self-reported health (i.e. perceived health, psychological distress), and indicators of social position. Distribution of assets was studied in relation to gender and social position. Logistic regressions examined whether each asset moderated associations between adverse social position and self-reported health. Different distributions of assets were observed with different social positions. Women were more likely to participate in social activities while men were more resilient. Resilience and social participation were moderators of associations between adverse social position (i.e. living alone, lower household income) and self-reported health. Having assets contributes to better health by increasing capacities. Interventions that foster assets and complement current public health services are needed, especially for people in unfavorable situations. Health and social services decision-makers and practitioners could use these findings to increase capacities and resources rather than focusing primarily on preventing diseases and reducing risk factors. Copyright © 2018 Elsevier Inc. All rights reserved.

Scanning and vicarious learning from adverse events in health care

Directory of Open Access Journals (Sweden)

2001-01-01

Full Text Available Studies have shown that serious adverse clinical events occur in approximately 3%-10% of acute care hospital admissions, and one third of these adverse events result in permanent disability or death. These findings have led to calls for national medical error reporting systems and for greater organizational learning by hospitals. But do hospitals and hospital personnel pay enough attention to such risk information that they might learn from each other's failures or adverse events? This paper gives an overview of the importance of scanning and vicarious learning from adverse events. In it I propose that health care organizations' attention and information focus, organizational affinity, and absorptive capacity may each influence scanning and vicarious learning outcomes. Implications for future research are discussed.

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

OpenAIRE

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

2007-01-01

A cross-sectional analysis was carried out to describe adverse reactions to antiretroviral therapy (ART) reported by HIV-infected patients initiating treatment at two public health AIDS referral centers in Belo Horizonte, Brazil, 2001-2003 and to verify their association with selected variables. Adverse reactions were obtained through interview at the first follow-up visit (first month) after the antiretroviral prescription. Socio-demographic and behavioral variables related to ART were obtai...

Relational aggression and adverse psychosocial and physical health symptoms among urban adolescents.

Science.gov (United States)

Williams, Jessica Roberts; Fredland, Nina; Han, Hae-Ra; Campbell, Jacquelyn C; Kub, Joan E

2009-01-01

The purpose of this study was to examine relational aggression and its relationship with adverse psychosocial and physical health symptoms among urban, African American youth. Quantitative, cross-sectional survey design. The sample consisted of 185 predominantly African American (95.1%) seventh-grade students (mean age: 13.0; female: 58%) attending 4 urban middle schools. The Children's Social Behavior Scale and Social Experience Questionnaire were used to measure relational aggression and relational victimization. The Pediatric Symptom Checklist was used to assess psychosocial difficulties, including internalizing behaviors, externalizing behaviors, and attention problems. Physical health symptoms were measured with questions about colds/flu, headaches, and stomach aches. 2-way multivariate analysis of variance revealed significant differences in externalizing behavior, with perpetrators reporting higher levels than nonperpetrators. Victims reported more internalizing behavior than nonvictims; however, this was only significant for males. For females, significant negative effects on health outcomes were found, resulting from the interaction of perpetration and victimization. Findings suggest that relational aggression is a common occurrence among urban, minority adolescents and may result in adverse health outcomes. These results provide several avenues for future research and implications for healthcare practice. Intervention strategies are needed to prevent relational aggression and continual or subsequent adverse health symptoms.

Adverse health effects of non-medical cannabis use.

Science.gov (United States)

Hall, Wayne; Degenhardt, Louisa

2009-10-17

For over two decades, cannabis, commonly known as marijuana, has been the most widely used illicit drug by young people in high-income countries, and has recently become popular on a global scale. Epidemiological research during the past 10 years suggests that regular use of cannabis during adolescence and into adulthood can have adverse effects. Epidemiological, clinical, and laboratory studies have established an association between cannabis use and adverse outcomes. We focus on adverse health effects of greatest potential public health interest-that is, those that are most likely to occur and to affect a large number of cannabis users. The most probable adverse effects include a dependence syndrome, increased risk of motor vehicle crashes, impaired respiratory function, cardiovascular disease, and adverse effects of regular use on adolescent psychosocial development and mental health.

Adverse childhood experiences and mental health in young adults: a longitudinal survey

Directory of Open Access Journals (Sweden)

Aseltine Robert H

2007-03-01

Full Text Available Abstract Background Adverse childhood experiences (ACEs have been consistently linked to psychiatric difficulties in children and adults. However, the long-term effects of ACEs on mental health during the early adult years have been understudied. In addition, many studies are methodologically limited by use of non-representative samples, and few studies have investigated gender and racial differences. The current study relates self-reported lifetime exposure to a range of ACEs in a community sample of high school seniors to three mental health outcomes–depressive symptoms, drug abuse, and antisocial behavior–two years later during the transition to adulthood. Methods The study has a two-wave, prospective design. A systematic probability sample of high school seniors (N = 1093 was taken from communities of diverse socioeconomic status. They were interviewed in person in 1998 and over the telephone two years later. Gender and racial differences in ACE prevalence were tested with chi-square tests. Each mental health outcome was regressed on one ACE, controlling for gender, race/ethnicity, and SES to obtain partially standardized regression coefficients. Results Most ACEs were strongly associated with all three outcomes. The cumulative effect of ACEs was significant and of similar magnitude for all three outcomes. Except for sex abuse/assault, significant gender differences in the effects of single ACEs on depression and drug use were not observed. However, boys who experienced ACEs were more likely to engage in antisocial behavior early in young adulthood than girls who experienced similar ACEs. Where racial/ethnic differences existed, the adverse mental health impact of ACEs on Whites was consistently greater than on Blacks and Hispanics. Conclusion Our sample of young adults from urban, socio-economically disadvantaged communities reported high rates of adverse childhood experiences. The public health impact of childhood adversity is evident

Adverse event reporting in cancer clinical trial publications.

Science.gov (United States)

Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

2014-01-10

Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

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

Directory of Open Access Journals (Sweden)

Cristiane A. Menezes de Pádua

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

Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

Science.gov (United States)

Hohl, Corinne M; Small, Serena S; Peddie, David; Badke, Katherin; Bailey, Chantelle; Balka, Ellen

2018-02-27

Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care. ©Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka. Originally published in JMIR

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...

The association between cumulative adversity and mental health: considering dose and primary focus of adversity.

Science.gov (United States)

Keinan, Giora; Shrira, Amit; Shmotkin, Dov

2012-09-01

The study addressed the dose-response model in the association of cumulative adversity with mental health. Data of 1,725 participants aged 50+ were drawn from the Israeli component of the Survey of Health, Ageing, and Retirement in Europe. Measures included an inventory of potentially traumatic events, distress (lifetime depression, depressive symptoms), and well-being (quality of life, optimism/hope). The maximal effect of cumulative trauma emerged in the contrast between 0-2 and 3+ events, where the higher number of events related to higher distress but also to higher well-being. While self-oriented adversity revealed no, or negative, association with well-being, other-oriented adversity revealed a positive association. The study suggests an experiential dose of cumulative adversity leading to a co-activation of distress and well-being. The source of this co-activation seems to be other-oriented adversity.

Asking women about mental health and social adversity in pregnancy: results of an Australian population-based survey.

Science.gov (United States)

Yelland, Jane; Brown, Stephanie J

2014-03-01

Social adversity undermines health in pregnancy. The objective of this study was to examine the extent to which pregnant women were asked about their mental health and life circumstances in pregnancy checkups. Population-based postal survey of recent mothers in two Australian states. Around half of the 4,366 participants reported being asked about depression (45.9%) and whether they were anxious or worried about things happening in their life (49.6%); fewer reported being asked about relationship issues (29.6%), financial problems (16.6%), or family violence (14.1%). One in five women (18%) reported significant social adversity. These women were more likely to recall being asked about their mental health and broader social health issues. Far higher levels of inquiry were reported by women in the public maternity system with midwives more likely than doctors to ask about mental health, family violence, and other social hardships. Routine pregnancy visits afford a window of opportunity for identifying and supporting women experiencing mental health problems and social adversity. Changing practice to take advantage of this opportunity will require concerted and coordinated efforts by practitioners and policy makers to build systems to support public health approaches to antenatal care. © 2014, Copyright the Authors Journal compilation © 2014, Wiley Periodicals, Inc.

Pharmacy Student Facilitation of Reporting of Adverse Drug Reactions in a Hospital.

Science.gov (United States)

Wentzell, Jason; Nguyen, Tiffany; Bui, Stephanie; MacDonald, Erika

2017-01-01

Health Canada relies on health professionals to voluntarily report adverse reactions to the Canada Vigilance Program. Current rates of reporting adverse drug reactions (ADRs) are inadequate to detect important safety issues. To assess the impact of pharmacy student facilitation of ADR reporting by pharmacists at a tertiary care teaching hospital in Canada. The intervention of interest, implemented at one campus of the hospital, was facilitation of ADR reporting by pharmacy students. The students received training on how to submit ADR reports and presented information sessions on the topic to hospital pharmacists; the pharmacists were then encouraged to report ADRs to a designated student for formal reporting. Frequency of reporting by pharmacists at the intervention campus was compared with reporting at a control campus of the same hospital. Data were collected prospectively over a 6-month pilot period, starting in April 2015. During the pilot period, 27 ADR reports were submitted at the intervention campus, and 3 reports at the control campus. All student participants strongly agreed that they would recommend that responsibility for submitting ADR reports to the Canada Vigilance Program remain with pharmacy students during future rotations. Availability of a pharmacy student to facilitate reporting of ADRs may increase the frequency of ADR reporting and could alleviate pharmacist workload; this activity is also a potentially valuable learning experience for students.

The household food insecurity gradient and potential reductions in adverse population mental health outcomes in Canadian adults.

Science.gov (United States)

Jessiman-Perreault, Geneviève; McIntyre, Lynn

2017-12-01

Household food insecurity is related to poor mental health. This study examines whether the level of household food insecurity is associated with a gradient in the risk of reporting six adverse mental health outcomes. This study further quantifies the mental health impact if severe food insecurity, the extreme of the risk continuum, were eliminated in Canada. Using a pooled sample of the Canadian Community Health Survey (N = 302,683), we examined the relationship between level of food insecurity, in adults 18-64 years, and reporting six adverse mental health outcomes. We conducted a probit analysis adjusted for multi-variable models, to calculate the reduction in the odds of reporting mental health outcomes that might accrue from the elimination of severe food insecurity. Controlling for various demographic and socioeconomic covariates, a food insecurity gradient was found in six mental health outcomes. We calculated that a decrease between 8.1% and 16.0% in the reporting of these mental health outcomes would accrue if those who are currently severely food insecure became food secure, after controlling for covariates. Household food insecurity has a pervasive graded negative effect on a variety of mental health outcomes, in which significantly higher levels of food insecurity are associated with a higher risk of adverse mental health outcomes. Reduction of food insecurity, particularly at the severe level, is a public health concern and a modifiable structural determinant of health worthy of macro-level policy intervention.

Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003-2012.

Science.gov (United States)

Wong, Carmen K; Marshall, Nathaniel S; Grunstein, Ronald R; Ho, Samuel S; Fois, Romano A; Hibbs, David E; Hanrahan, Jane R; Saini, Bandana

2017-02-15

Stimulated reporting occurs when patients and healthcare professionals are influenced or "stimulated" by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006-2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored. Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012. Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster. Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies. © 2017 American Academy of Sleep Medicine

Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems.

Science.gov (United States)

Pham, Julius Cuong; Williams, Tamara L; Sparnon, Erin M; Cillie, Tam K; Scharen, Hilda F; Marella, William M

2016-05-01

In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of events reported in each database were related

Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems

Science.gov (United States)

Pham, Julius Cuong; Williams, Tamara L; Sparnon, Erin M; Cillie, Tam K; Scharen, Hilda F; Marella, William M

2016-01-01

BACKGROUND: In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. METHODS: We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. RESULTS: A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. CONCLUSIONS: Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of

An overview of adverse health effects caused by mycotoxins and bioassays for their detection

NARCIS (Netherlands)

Wijnands LM; Leusden van FM; MGB

2000-01-01

Exposure to moulds and their (toxic) metabolites (mycotoxins) is a menace to human and animal health. A risk analysis can shed light on the actual risk of adverse health effects. In a previously published RIVM report (nr. 257852 002) on hazard identification the genera, Aspergillus, Penicillium,

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. (c) 2016 APA, all rights reserved).

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.

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,

Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012

Science.gov (United States)

Wong, Carmen K.; Marshall, Nathaniel S.; Grunstein, Ronald R.; Ho, Samuel S.; Fois, Romano A.; Hibbs, David E.; Hanrahan, Jane R.; Saini, Bandana

2017-01-01

Study Objectives: Stimulated reporting occurs when patients and healthcare professionals are influenced or “stimulated” by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006–2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored. Methods: Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012. Results: Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster. Conclusions: Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies. Citation: Wong CK, Marshall NS, Grunstein RR, Ho SS, Fois RA, Hibbs DE, Hanrahan JR, Saini B

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…

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants.

Science.gov (United States)

Cornell, Erika; Kwa, Michael; Paller, Amy S; Xu, Shuai

2018-03-01

Despite their ubiquitous use and several recent health controversies involving cosmetics and personal care products for children, the Food and Drug Administration has little oversight of these products and relies on consumer-submitted adverse event reports. We assessed the recently released Center for Food Safety and Applied Nutrition's Adverse Event Reporting System database for adverse event reports submitted to the Food and Drug Administration for baby personal care products and to determine whether useful insights can be derived. We extracted the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System data file from 2004 to 2016 and examined the subset classified according to the Food and Drug Administration-designated product class as a baby product. Events were manually categorized into product type and symptom type to assess for trends. Only 166 total adverse events were reported to the Food and Drug Administration for baby products from 2004 to 2016. The majority of reports indicated rash or other skin reaction; 46% of reported events led to a health care visit. Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health. © 2018 Wiley Periodicals, Inc.

Do Carpets Impair Indoor Air Quality and Cause Adverse Health Outcomes: A Review.

Science.gov (United States)

Becher, Rune; Øvrevik, Johan; Schwarze, Per E; Nilsen, Steinar; Hongslo, Jan K; Bakke, Jan Vilhelm

2018-01-23

Several earlier studies have shown the presence of more dust and allergens in carpets compared with non-carpeted floors. At the same time, adverse effects of carpeted floors on perceived indoor air quality as well as worsening of symptoms in individuals with asthma and allergies were reported. Avoiding extensive carpet use in offices, schools, kindergartens and bedrooms has therefore been recommended by several health authorities. More recently, carpet producers have argued that former assessments were obsolete and that modern rugs are unproblematic, even for those with asthma and allergies. To investigate whether the recommendation to be cautious with the use of carpets is still valid, or whether there are new data supporting that carpet flooring do not present a problem for indoor air quality and health, we have reviewed the literature on this matter. We have not found updated peer reviewed evidence that carpeted floor is unproblematic for the indoor environment. On the contrary, also more recent data support that carpets may act as a repository for pollutants which may become resuspended upon activity in the carpeted area. Also, the use of carpets is still linked to perception of reduced indoor air quality as well as adverse health effects as previously reported. To our knowledge, there are no publications that report on deposition of pollutants and adverse health outcomes associated with modern rugs. However, due to the three-dimensional structure of carpets, any carpet will to some extent act like a sink. Thus, continued caution should still be exercised when considering the use of wall-to-wall carpeted floors in schools, kindergartens and offices, as well as in children's bedrooms unless special needs indicate that carpets are preferable.

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

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. Female students (N = 795) participated between October 2009 and May 2010. Participants completed self-report measures of early family adversity, self-focused (self-esteem, personal growth initiative) and other-focused (perceived social support, gratitude) resiliency, stress, subjective health, and health behaviors. Using structural equation modeling, self-focused resiliency associated with less stress, better subjective health, more sleep, less smoking, and less weekend alcohol consumption. Other-focused resiliency associated with more exercise, greater stress, and more weekend alcohol consumption. Early family adversity was indirectly related to all health outcomes, except smoking, via self-focused and other-focused resiliency. Self-focused and other-focused resiliency represent plausible mechanisms through which early family adversity relates to stress and health in college women. This highlights areas for future research in disease prevention and management.

Childhood Adversity, Religion, and Change in Adult Mental Health.

Science.gov (United States)

Jung, Jong Hyun

2018-02-01

Research indicates that childhood adversity is associated with poor mental health in adulthood. The purpose of this study is to examine whether the deleterious long-term effects of childhood adversity on adult mental health are reduced for individuals who are involved in religious practices. Using longitudinal data from a representative sample of American adults ( N = 1,635), I find that religious salience and spirituality buffer the noxious effects of childhood abuse on change in positive affect over time. By contrast, these stress-buffering properties of religion fail to emerge when negative affect serves as the outcome measure. These results underscore the importance of religion as a countervailing mechanism that blunts the negative impact of childhood abuse on adult mental health over time. I discuss the theoretical implications of these findings for views about religion, childhood adversity, and mental health.

Adverse selection in a voluntary Rural Mutual Health Care health insurance scheme in China.

Science.gov (United States)

Wang, Hong; Zhang, Licheng; Yip, Winnie; Hsiao, William

2006-09-01

This study examines adverse selection in a subsidized voluntary health insurance scheme, the Rural Mutual Health Care (RMHC) scheme, in a poor rural area of China. The study was made possible by a unique longitudinal data set: the total sample includes 3492 rural residents from 1020 households. Logistic regression was employed for the data analysis. The results show that although this subsidized scheme achieved a considerable high enrollment rate of 71% of rural residents, adverse selection still exists. In general, individuals with worse health status are more likely to enroll in RMHC than individuals with better health status. Although the household is set as the enrollment unit for the RMHC for the purpose of reducing adverse selection, nearly 1/3 of enrolled households are actually only partially enrolled. Furthermore, we found that adverse selection mainly occurs in partially enrolled households. The non-enrolled individuals in partially enrolled households have the best health status, while the enrolled individuals in partially enrolled households have the worst health status. Pre-RMHC, medical expenditure for enrolled individuals in partially enrolled households was 206.6 yuan per capita per year, which is 1.7 times as much as the pre-RMHC medical expenditure for non-enrolled individuals in partially enrolled households. The study also reveals that the pre-enrolled medical expenditure per capita per year of enrolled individuals was 9.6% higher than the pre-enrolled medical expenditure of all residents, including both enrolled and non-enrolled individuals. In conclusion, although the subsidized RMHC scheme reached a very high enrollment rate and the household is set as the enrollment unit for the purpose of reducing adverse selection, adverse selection still exists, especially within partially enrolled households. Voluntary RMHC will not be financially sustainable if the adverse selection is not fully taken into account.

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 manu...

Adverse drug reaction reporting among health care workers at ...

African Journals Online (AJOL)

populations3,5. This may consequently lead to increased ... about the purpose of reporting, fear of extra workload, failure to ... over in excess of 140,000 patients and attends to over ..... tems in Uganda's public health sector will go a long way.

Do Carpets Impair Indoor Air Quality and Cause Adverse Health Outcomes: A Review

Directory of Open Access Journals (Sweden)

Rune Becher

2018-01-01

Full Text Available Several earlier studies have shown the presence of more dust and allergens in carpets compared with non-carpeted floors. At the same time, adverse effects of carpeted floors on perceived indoor air quality as well as worsening of symptoms in individuals with asthma and allergies were reported. Avoiding extensive carpet use in offices, schools, kindergartens and bedrooms has therefore been recommended by several health authorities. More recently, carpet producers have argued that former assessments were obsolete and that modern rugs are unproblematic, even for those with asthma and allergies. To investigate whether the recommendation to be cautious with the use of carpets is still valid, or whether there are new data supporting that carpet flooring do not present a problem for indoor air quality and health, we have reviewed the literature on this matter. We have not found updated peer reviewed evidence that carpeted floor is unproblematic for the indoor environment. On the contrary, also more recent data support that carpets may act as a repository for pollutants which may become resuspended upon activity in the carpeted area. Also, the use of carpets is still linked to perception of reduced indoor air quality as well as adverse health effects as previously reported. To our knowledge, there are no publications that report on deposition of pollutants and adverse health outcomes associated with modern rugs. However, due to the three-dimensional structure of carpets, any carpet will to some extent act like a sink. Thus, continued caution should still be exercised when considering the use of wall-to-wall carpeted floors in schools, kindergartens and offices, as well as in children’s bedrooms unless special needs indicate that carpets are preferable.

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

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

2015-03-01

Dwelling and neighbourhood characteristics associated with the prevalence of self-reported heat-induced adverse health effects are not well known. We interviewed 3485 people in the most disadvantaged neighbourhoods of the nine largest cities in Québec, Canada. The prevalence of heat-induced adverse health effects was 46%, out of which one fourth led to medical consultation. Multivariate analyses showed that dissatisfaction with the summer dwelling temperature, which refers to home heat exposure, and perception that the neighbourhood is polluted due to traffic, were determinant, even after adjusting for current health status. These risk indicators can be used to identify subgroups at high risk and as priority-setting criteria for urban renewal programs for the hotter climate to come. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Alcohol and cannabis: Comparing their adverse health effects and regulatory regimes.

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Hall, Wayne

2017-04-01

The claim that the adverse health effects of cannabis are much less serious than those of alcohol has been central to the case for cannabis legalisation. Regulators in US states that have legalised cannabis have adopted regulatory models based on alcohol. This paper critically examines the claim about adverse health effects and the wisdom of regulating cannabis like alcohol. First, it compares what we know about the adverse health effects of alcohol and cannabis. Second, it discusses the uncertainties about the long term health effects of sustained daily cannabis use. Third, it speculates about how the adverse health effects of cannabis may change after legalisation. Fourth, it questions the assumption that alcohol provides the best regulatory model for a legal cannabis market. Fifth, it outlines the major challenges in regulating cannabis under the liberal alcohol-like regulatory regimes now being introduced. Copyright © 2016 Elsevier B.V. All rights reserved.

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

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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.

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

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.

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

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Philipp Bruland

2016-11-01

Full Text Available Abstract 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. Methods Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. Results The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Conclusions Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

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

Science.gov (United States)

Bruland, Philipp; McGilchrist, Mark; Zapletal, Eric; Acosta, Dionisio; Proeve, Johann; Askin, Scott; Ganslandt, Thomas; Doods, Justin; Dugas, Martin

2016-11-22

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. Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

Cognition- and Dementia-Related Adverse Effects With Sacubitril-Valsartan: Analysis of the FDA Adverse Event Report System Database.

Science.gov (United States)

Perlman, Amichai; Hirsh Raccah, Bruria; Matok, Ilan; Muszkat, Mordechai

2018-05-07

Because neprilysin is involved in the degradation of amyloid-beta, there is concern that the angiotensin-neprilysin inhibitor sacubitril-valsartan could increase the risk for dementia. We analyzed adverse event cases submitted to the Food and Drug Administration Adverse Event Report System from July 2015 to March 2017. Cognition- and dementia-related adverse event cases were defined with the use of broad and narrow structured medical queries. During the period evaluated, 9,004 adverse event reports (out of a total of 2,249,479) involved the use of sacubitril-valsartan. Based on the broad definition, sacubitril-valsartan was associated with cognition- and dementia-related adverse events in 459 reports (5.1%), but this was lower than the proportion of these reports among other medications (6.6%, reporting odds ratio [ROR] 0.72, 95% confidence interval [CI] 0.65-0.79). Restricting the comparison to cases with age >60 years and with the use of a comparator group with heart failure resulted in no association between sacubitril-valsartan and dementia-related adverse events, with the use of both the broad and the narrow definitions (ROR 0.87, 95% CI 0.76-1.02, and ROR 1.06, 95% CI 0.4-3.16, respectively). Sacubitril-valsartan is not associated with a disproportionately high rate of short-term dementia-related adverse effect reports. Long-term studies assessing cognitive outcomes are required to better establish the medication's cognition effects. Copyright © 2018 Elsevier Inc. All rights reserved.

Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015.

Science.gov (United States)

Myers, Tanya R; McNeil, Michael M; Ng, Carmen S; Li, Rongxia; Lewis, Paige W; Cano, Maria V

2017-03-27

Limited data are available describing the post-licensure safety of meningococcal vaccines, including Menveo®. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in all age groups. VAERS is a national spontaneous vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. We searched the VAERS database for US reports of adverse events in persons who received Menveo from 1 January 2010 through 31 December 2015. We clinically reviewed reports and available medical records for serious AEs, selected pre-specified outcomes, and vaccination during pregnancy. We used empirical Bayesian data mining to identify AEs that were disproportionately reported after receipt of Menveo. During the study period, VAERS received 2614 US reports after receipt of Menveo. Of these, 67 were classified as serious, including 1 report of death. Adolescents (aged 11-18years) accounted for 74% of reports. Most of the reported AEs were non-serious and described AEs consistent with data from pre-licensure studies. Anaphylaxis and syncope were the two most common events in the serious reports. We did not identify any new safety concerns after review of AEs that exceeded the data mining threshold, although we did observe disproportionate reporting for terms that were not associated with an adverse event (e.g., "incorrect drug dosage form administered", "wrong technique in drug usage process"). Although reports were limited, we did not find any evidence for concern regarding the use of Menveo during pregnancy. In our review of VAERS reports, findings of AEs were consistent with the data from pre-licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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

2014-06-27

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

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...... 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.......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...

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...... 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...... 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...

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.

Suspected adverse reactions to veterinary drugs reported in South Africa (January 1998 - February 2001 : special report

Directory of Open Access Journals (Sweden)

R. Gehring

2001-07-01

Full Text Available The Veterinary Pharmacovigilance Centre received 59 reports of suspected adverse drug reactions during the period January 1998 - February 2001. The number of reports received increased after the establishment of a formal procedure for recording and responding to reports. The number of reports received per species was: dogs 19, cats 15, cattle 7, sheep/ goats 6, chickens 4, pigs 3, horses 2 and giraffe 1. Many different types of adverse reactions were reported, including lack of efficacy, hypersensitivity, inappropriate use of products by non-veterinarians, known adverse effects and adverse effects encountered with extra-label use of products.

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

OpenAIRE

Vilhelmsson, Andreas; Svensson, Tommy; Meeuwisse, Anna; Carlsten, Anders

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...

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

Science.gov (United States)

Blettner, M; Schlehofer, B; Breckenkamp, J; Kowall, B; Schmiedel, S; Reis, U; Potthoff, P; Schüz, J; Berg-Beckhoff, G

2009-02-01

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. The researchers conducted a population-based, multi-phase, cross-sectional study within the context of a large panel survey regularly carried out by a private research institute in Germany. In the initial phase, reported on in this paper, 30,047 persons from a total of 51,444 who took part in the nationwide survey also answered questions on how mobile phone base stations affected their health. A list of 38 health complaints was used. A multiple linear regression model was used to identify predictors of health complaints including proximity of residence to mobile phone base stations and risk perception. Of the 30,047 participants (response rate 58.6%), 18.7% 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. 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 of health complaints near base stations can not however be fully explained by attributions or concerns.

The reasons for Chinese nursing staff to report adverse events: a questionnaire survey.

Science.gov (United States)

Hong, Su; Li, QiuJie

2017-04-01

To investigate the impact of nurses' perception of patient safety culture and adverse event reporting, and demographic factors on adverse event reporting in Chinese hospitals. Accurate and timely adverse event reporting is integral in promoting patient safety and professional learning around the incident. In a cross-sectional survey, a sample of 919 nurses completed a structured questionnaire composed of two validated instruments measuring nurses' perception of patient safety culture and adverse event reporting. Associations between the variables were examined using multiple linear regression analysis. The positive response rates of five dimensions of the Patient Safety Culture Assessment Scale varied from 47.55% to 80.62%. The accuracy rate of Adverse Event Reporting Perception Scale was 63.16%. Five hundred and thirty-one (58.03%) nurses did not report adverse event in past 12 months. Six variables were found to be associated with nurses' adverse event reporting: total work experience (P = 0.003), overall patient safety culture score (P teamwork climate (P importance or reporting (P = 0.002). The results confirmed that improvements in the patient safety culture and nurses' perception of adverse event reporting were related to an increase in voluntary adverse event reporting. The knowledge of adverse event reporting should be integrated into the patient safety curriculum. Interventions that target a specific domain are necessary to improve the safety culture. © 2017 John Wiley & Sons Ltd.

Categories of adverse health effects from indoor air pollution

International Nuclear Information System (INIS)

Weetman, D.F.; Munby, J.

1994-01-01

There is a lack of precision in the definition of health, which leads to confusion in the assessment of adverse effects arising from indoor air pollution. Adverse health effects range from annoyance to life-threatening conditions. Survey responses suggest that males and females differ in their perception of a healthy person, but both sexes envisage a male in terms of positive fitness, strength, energy and the possession of an athletic body, rather than how long one was likely to live. Psychological fitness was relatively unimportant in describing the health of others, but was rates as very important with respect to one's own health. Mortality statistics tend to obscure the proportion of the population who suffer chronic illness that is not life threatening. Although health is largely determined by genetic constitution, lifestyle and environmental factors, the morale of an individual is also important. A new classification of the adverse effects on health of indoor air pollution is proposed: this includes 'comfort' responses, such as sick building syndrome (category 1); acute chemical effects, the nature of which depends upon the specific intoxicant (category 2B), and perceived chronic grave risk, including cancer causation (category 3). The magnitude of risk in this latter category is imprecise, because its measurement involves the technique of quantitative risk assessment. (author) 1 fig., 2 tabs., 158 refs

Cumulative burden of lifetime adversities: Trauma and mental health in low-SES African Americans and Latino/as.

Science.gov (United States)

Myers, Hector F; Wyatt, Gail E; Ullman, Jodie B; Loeb, Tamra B; Chin, Dorothy; Prause, Nicole; Zhang, Muyu; Williams, John K; Slavich, George M; Liu, Honghu

2015-05-01

This study examined the utility of a lifetime cumulative adversities and trauma model in predicting the severity of mental health symptoms of depression, anxiety, and posttraumatic stress disorder. We also tested whether ethnicity and gender moderate the effects of this stress exposure construct on mental health using multigroup structural equation modeling. A sample of 500 low-socioeconomic status African American and Latino men and women with histories of adversities and trauma were recruited and assessed with a standard battery of self-report measures of stress and mental health. Multiple-group structural equation models indicated good overall model fit. As hypothesized, experiences of discrimination, childhood family adversities, childhood sexual abuse, other childhood trauma, and chronic stresses all loaded on the latent cumulative burden of adversities and trauma construct (CBAT). The CBAT stress exposure index in turn predicted the mental health status latent variable. Although there were several significant univariate ethnic and gender differences, and ethnic and gender differences were observed on several paths, there were no significant ethnic differences in the final model fit of the data. These findings highlight the deleterious consequences of cumulative stress and trauma for mental health and underscore a need to assess these constructs in selecting appropriate clinical interventions for reducing mental health disparities and improving human health. (c) 2015 APA, all rights reserved).

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.

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. PMID:28077473

Impact of High-Reliability Education on Adverse Event Reporting by Registered Nurses.

Science.gov (United States)

McFarland, Diane M; Doucette, Jeffrey N

Adverse event reporting is one strategy to identify risks and improve patient safety, but, historically, adverse events are underreported by registered nurses (RNs) because of fear of retribution and blame. A program was provided on high reliability to examine whether education would impact RNs' willingness to report adverse events. Although the findings were not statistically significant, they demonstrated a positive impact on adverse event reporting and support the need to create a culture of high reliability.

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

Classification of individual well-being scores for the determination of adverse health and productivity outcomes in employee populations.

Science.gov (United States)

Shi, Yuyan; Sears, Lindsay E; Coberley, Carter R; Pope, James E

2013-04-01

Adverse health and productivity outcomes have imposed a considerable economic burden on employers. To facilitate optimal worksite intervention designs tailored to differing employee risk levels, the authors established cutoff points for an Individual Well-Being Score (IWBS) based on a global measure of well-being. Cross-sectional associations between IWBS and adverse health and productivity outcomes, including high health care cost, emergency room visits, short-term disability days, absenteeism, presenteeism, low job performance ratings, and low intentions to stay with the employer, were studied in a sample of 11,702 employees from a large employer. Receiver operating characteristics curves were evaluated to detect a single optimal cutoff value of IWBS for predicting 2 or more adverse outcomes. More granular segmentation was achieved by computing relative risks of each adverse outcome from logistic regressions accounting for sociodemographic characteristics. Results showed strong and significant nonlinear associations between IWBS and health and productivity outcomes. An IWBS of 75 was found to be the optimal single cutoff point to discriminate 2 or more adverse outcomes. Logistic regression models found abrupt reductions of relative risk also clustered at IWBS cutoffs of 53, 66, and 88, in addition to 75, which segmented employees into high, high-medium, medium, low-medium, and low risk groups. To determine validity and generalizability, cutoff values were applied in a smaller employee population (N=1853) and confirmed significant differences between risk groups across health and productivity outcomes. The reported segmentation of IWBS into discrete cohorts based on risk of adverse health and productivity outcomes should facilitate well-being comparisons and worksite interventions.

Patient-Reported Disease Activity and Adverse Pregnancy Outcomes in Systemic Lupus Erythematosus and Rheumatoid Arthritis.

Science.gov (United States)

Harris, Nathaniel; Eudy, Amanda; Clowse, Megan

2018-06-15

While increased rheumatic disease activity during pregnancy has been associated with adverse pregnancy outcomes, this activity is typically assessed by the physician. Little is known, however, about the association between patient-reported measures of disease activity and pregnancy outcomes. Univariate and multivariable regression models were used to assess the relationship between patient and physician-reported measures of disease activity and adverse pregnancy outcomes in 225 patients with lupus or rheumatoid arthritis (RA) enrolled in a prospective registry at a single academic center from 2008-2016. In women with RA, patient-reported disease activity is associated with preterm birth (OR 5.9 (1.5-23.9)), and gestational age (beta -1.5 weeks (-2.6, -0.4 weeks)). The physician assessment of disease activity also predicted preterm (OR 2.1 (1.2-3.5)), small for gestational age births (OR 1.8 (1.03-3.1), and gestational age in weeks (beta -0.6 weeks (-0.9, -0.02 weeks)). On the other hand, SLE patient-reported disease activity measures, including the HAQ, pain or global health measures, are not associated with adverse pregnancy outcomes. However, physician measures of SLE disease activity are associated with preterm birth (OR 2.9 (1.-6.3)), cesarean delivery (OR 2.3 (1.0-5.3)), and preeclampsia (OR 2.8 (1.3-6.3)). The results do not appear to be driven by lupus nephritis or antiphospholipid syndrome. For women with RA, patient-reported measures of disease activity may be useful adjuncts to physician-reported measures in identifying pregnancies at greater risk. In contrast, in SLE, no patient-reported measures were associated with adverse outcomes while physician measures of disease activity helped predict several adverse pregnancy outcomes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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

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

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

MedWatch, the FDA Safety Information and Adverse Event Reporting Program

Science.gov (United States)

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

Adverse Selection and Inertia in Health Insurance Markets: When Nudging Hurts.

Science.gov (United States)

Handel, Benjamin R

2013-12-01

This paper investigates consumer inertia in health insurance markets, where adverse selection is a potential concern. We leverage a major change to insurance provision that occurred at a large firm to identify substantial inertia, and develop and estimate a choice model that also quantifies risk preferences and ex ante health risk. We use these estimates to study the impact of policies that nudge consumers toward better decisions by reducing inertia. When aggregated, these improved individual-level choices substantially exacerbate adverse selection in our setting, leading to an overall reduction in welfare that doubles the existing welfare loss from adverse selection.

Symptoms of Common Mental Disorders and Adverse Health Behaviours in Male Professional Soccer Players

Directory of Open Access Journals (Sweden)

Gouttebarge Vincent

2015-12-01

Full Text Available To present time, scientific knowledge about symptoms of common mental disorders and adverse health behaviours among professional soccer players is lacking. Consequently, the aim of the study was to determine the prevalence of symptoms of common mental disorders (distress, anxiety/depression, sleep disturbance and adverse health behaviours (adverse alcohol behaviour, smoking, adverse nutrition behaviour among professional soccer players, and to explore their associations with potential stressors (severe injury, surgery, life events and career dissatisfaction. Cross-sectional analyses were conducted on baseline questionnaires from an ongoing prospective cohort study among male professional players. Using validated questionnaires to assess symptoms of common mental disorders and adverse health behaviours as well as stressors, an electronic questionnaire was set up and distributed by players’ unions in 11 countries from three continents. Prevalence of symptoms of common mental disorders and adverse health behaviours among professional soccer players ranged from 4% for smoking and 9% for adverse alcohol behaviour to 38% for anxiety/depression and 58% for adverse nutrition behaviour. Significant associations were found for a higher number of severe injuries with distress, anxiety/depression, sleeping disturbance and adverse alcohol behaviour, an increased number of life events with distress, sleeping disturbance, adverse alcohol behaviour and smoking, as well as an elevated level of career dissatisfaction with distress, anxiety/depression and adverse nutrition behaviour. Statistically significant correlations (p<0.01 were found for severe injuries and career dissatisfaction with most symptoms of common mental disorders. High prevalence of symptoms of common mental disorders and adverse health behaviours was found among professional players, confirming a previous pilot-study in a similar study population.

Surveillance guidelines for smallpox vaccine (vaccinia) adverse reactions.

Science.gov (United States)

Casey, Christine; Vellozzi, Claudia; Mootrey, Gina T; Chapman, Louisa E; McCauley, Mary; Roper, Martha H; Damon, Inger; Swerdlow, David L

2006-02-03

CDC and the U.S. Food and Drug Administration rely on state and local health departments, health-care providers, and the public to report the occurrence of adverse events after vaccination to the Vaccine Adverse Event Reporting System. With such data, trends can be accurately monitored, unusual occurrences of adverse events can be detected, and the safety of vaccination intervention activities can be evaluated. On January 24, 2003, the U.S. Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a biologic terrorism event. As part of the DHHS Smallpox Preparedness and Response Program, CDC in consultation with experts, established surveillance case definitions for adverse events after smallpox vaccination. Adverse reactions after smallpox vaccination identified during the 1960s surveillance activities were classified on the basis of clinical description and included eczema vaccinatum; fetal vaccinia; generalized vaccinia; accidental autoinoculation, nonocular; ocular vaccinia; progressive vaccinia; erythema multiforme major; postvaccinial encephalitis or encephalomyelitis; and pyogenic infection of the vaccination site. This report provides uniform criteria used for the surveillance case definition and classification for these previously recognized adverse reactions used during the DHHS Smallpox Preparedness and Response Program. Inadvertent inoculation was changed to more precisely describe this event as inadvertent autoinoculation and contact transmission, nonocular and ocular vaccinia. Pyogenic infection also was renamed superinfection of the vaccination site or regional lymph nodes. Finally, case definitions were developed for a new cardiac adverse reaction (myo/pericarditis) and for a cardiac adverse event (dilated cardiomyopathy) and are included in this report. The smallpox vaccine surveillance case

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...... 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...... to investigate the dependence between type of reporter and reported ADRs (classified by ATC or SOC). FINDINGS: We analysed 6319 ADR reports corresponding to 15 531 ADRs. Consumers reported 11% of the ADRs. Consumers' share of 'serious' ADRs was comparable to that of physicians (approximately 45%) but lower than...

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.

Adverse event reports following yellow fever vaccination, 2007-13.

Science.gov (United States)

Lindsey, Nicole P; Rabe, Ingrid B; Miller, Elaine R; Fischer, Marc; Staples, J Erin

2016-05-01

Yellow fever (YF) vaccines have been available since the 1930s and are generally considered safe and effective. However, rare reports of serious adverse events (SAE) following vaccination have prompted the Advisory Committee for Immunization Practices to periodically expand the list of conditions considered contraindications and precautions to vaccination. We describe adverse events following YF vaccination reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2007 through 2013 and calculate age- and sex-specific reporting rates of all SAE, anaphylaxis, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). There were 938 adverse events following YF vaccination reported to VAERS from 2007 through 2013. Of these, 84 (9%) were classified as SAEs for a rate of 3.8 per 100 000 doses distributed. Reporting rates of SAEs increased with increasing age with a rate of 6.5 per 100 000 in persons aged 60-69 years and 10.3 for ≥70 years. The reporting rate for anaphylaxis was 1.3 per 100 000 doses distributed and was highest in persons ≤18 years (2.7 per 100 000). Reporting rates of YEL-AND and YEL-AVD were 0.8 and 0.3 per 100 000 doses distributed, respectively; both rates increased with increasing age. These findings reinforce the generally acceptable safety profile of YF vaccine, but highlight the importance of continued physician and traveller education regarding the risks and benefits of YF vaccination, particularly for older travellers. Published by Oxford University Press on behalf of the International Society of Travel Medicine, 2016. This work is written by US Government employees and is in the public domain in the United States.

Adverse Health Effects and Unhealthy Behaviors among Medical Students Using Facebook

OpenAIRE

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 relationshi...

Bad news: The influence of news coverage and Google searches on Gardasil adverse event reporting.

Science.gov (United States)

Faasse, Kate; Porsius, Jarry T; Faasse, Jonathan; Martin, Leslie R

2017-12-14

Human papilloma virus vaccines are a safe and effective tool for reducing HPV infections that can cause cervical cancer. However, uptake of these vaccines has been suboptimal, with many people holding negative beliefs and misconceptions. Such beliefs have been linked with the experience of unpleasant side effects following medical treatment, and media coverage may heighten such concerns. The present study sought to assess the influence of news coverage (number of news articles per month) on adverse event reporting in response to Gardasil vaccination in New Zealand over a 7.5-year period, and whether the influence of news coverage was mediated by internet search activity (Google search volumes). Multiple linear regression analyses and simple mediation analyses were used, controlling for year and number of vaccinations delivered. News coverage in the previous month, and Google search volumes in the same month, were significant predictors of adverse event reporting, after accounting for vaccination rates and year. Concurrent Google search volumes partially mediated the effect of prior news coverage. The results suggest that some of the adverse events reported were not related to the vaccination itself, but to news coverage and internet search volumes, which may have contributed to public concerns about potentially unpleasant or harmful outcomes. These findings have implications for the importance of psychological and social factors in adverse event reporting, and the role of the news media in disseminating health information. Copyright © 2017 Elsevier Ltd. All rights reserved.

A systematic review of possible serious adverse health effects of nicotine replacement therapy.

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Lee, Peter N; Fariss, Marc W

2017-04-01

We conducted a systematic literature review to identify and critically evaluate studies of serious adverse health effects (SAHEs) in humans using nicotine replacement therapy (NRT) products. Serious adverse health effects refer to adverse events, leading to substantial disruption of the ability to conduct normal life functions. Strength of evidence evaluations and conclusions were also determined for the identified SAHEs. We evaluated 34 epidemiological studies and clinical trials, relating NRT use to cancer, reproduction/development, CVD, stroke and/or other SAHEs in patients, and four meta-analyses on effects in healthy populations. The overall evidence suffers from many limitations, the most significant being the short-term exposure (≤12 weeks) and follow-up to NRT product use in most of the studies, the common failure to account for changes in smoking behaviour following NRT use, and the sparse information on SAHEs by type of NRT product used. The only SAHE from NRT exposure we identified was an increase in respiratory congenital abnormalities reported in one study. Limited evidence indicated a lack of effect between NRT exposure and SAHEs for CVD and various reproduction/developmental endpoints. For cancer, stroke and other SAHEs, the evidence was inadequate to demonstrate any association with NRT use. Our conclusions agree with recent statements from authoritative bodies.

Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation

International Nuclear Information System (INIS)

Chen Yuhchyau; Trotti, Andy; Coleman, C. Norman; Machtay, Mitchell; Mirimanoff, Rene O.; Hay, John; O'Brien, Peter C.; El-Gueddari, Brahim; Salvajoli, Joao V.; Jeremic, Branislav

2006-01-01

Purpose: Recent research has enhanced our understanding of radiation injury at the molecular-cellular and tissue levels; significant strides have occurred in standardization of adverse event reporting in clinical trials. In response, the International Atomic Energy Agency, through its Division of Human Health and its section for Applied Radiation Biology and Radiotherapy, organized a consultation meeting in Atlanta (October 2, 2004) to discuss developments in radiobiology, normal tissue reactions, and adverse event reporting. Methods and Materials: Representatives from cooperative groups of African Radiation Oncology Group, Curriculo Radioterapeutica Ibero Latino Americana, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada Clinical Trials Group, Radiation Therapy Oncology Group, and Trans-Tasman Radiation Oncology Group held the meeting discussion. Results: Representatives of major radiotherapy groups/organizations and prominent leaders in radiotherapy discussed current understanding of normal tissue radiobiologic effects, the design and implementation of future clinical and translational projects for normal tissue injury, and the standardization of adverse-event reporting worldwide. Conclusions: The consensus was to adopt NCI comprehensive adverse event reporting terminology and grading system (CTCAE v3.0) as the new standard for all cooperative group trials. Future plans included the implementation of coordinated research projects focusing on normal tissue biomarkers and data collection methods

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

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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.

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

Science.gov (United States)

Sakaeda, Toshiyuki; Kadoyama, Kaori; Okuno, Yasushi

2011-01-01

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. 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. 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. 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.

Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database.

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Kim, Seonji; Park, Kyounghoon; Kim, Mi-Sook; Yang, Bo Ram; Choi, Hyun Jin; Park, Byung-Joo

2017-10-01

Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database. We defined signals in this study by the reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) indices. The KAERS database included 860,224 AE reports, among which 866 reports contained fluoxetine. We compared the labels of fluoxetine among the United States, UK, Germany, France, China, and Korea. Some of the signals, including emotional lability, myositis, spinal stenosis, paradoxical drug reaction, drug dependence, extrapyramidal disorder, adrenal insufficiency, and intracranial hemorrhage, were not labeled in the six countries. In conclusion, we identified new signals that were not known at the time of market approval. However, certain factors should be required for signal evaluation, such as clinical significance, preventability, and causality of the detected signals. Copyright © 2017 Elsevier B.V. All rights reserved.

Proarrhythmic potential of dronedarone: emerging evidence from spontaneous adverse event reporting.

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Kao, David P; Hiatt, William R; Krantz, Mori J

2012-08-01

To characterize the frequency and type of cardiac events, including torsade de pointes, associated with dronedarone and its structural analog, amiodarone, outside of the clinical trial setting. Retrospective analysis. Spontaneous reports in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database generated between July 1, 2009, and June 30, 2011. All reports of adverse events during the study period were reviewed to identify cardiac events associated with any approved drug in the United States. The type and number of cardiac events associated with dronedarone and amiodarone were determined. Active ingredients were identified using the Drugs@FDA database, and the Medical Dictionary for Regulatory Activities (MedDRA) was used to aggregate related adverse events. To avoid redundant reporting, all statistics were generated in reference to unique case identifiers. Dronedarone was associated with more adverse cardiovascular event reports than amiodarone (810 vs 493 reports) during the study period. Dronedarone was also associated with the most reports of torsade de pointes of any approved drug in the United States (37 reports), followed by amiodarone (29 reports). Reports of ventricular arrhythmias and cardiac arrest (138 vs 113 reports) as well as heart failure (179 vs 126 reports) were more common with dronedarone than amiodarone. Dronedarone was associated with reports of ventricular arrhythmia, cardiac arrest, and torsade de pointes in clinical practice. Whether this observation accounts for the increased risk of fatal arrhythmia observed in a recent prospective trial requires further investigation. © 2012 Pharmacotherapy Publications, Inc. All rights reserved.

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

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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.

Women's health: periodontitis and its relation to hormonal changes, adverse pregnancy outcomes and osteoporosis.

Science.gov (United States)

Krejci, Charlene B; Bissada, Nabil F

2012-01-01

To examine the literature with respect to periodontitis and issues specific to women's health, namely, hormonal changes, adverse pregnancy outcomes and osteoporosis. The literature was evaluated to review reported associations between periodontitis and genderspecific issues, namely, hormonal changes, adverse pregnancy outcomes and osteoporosis. Collectively, the literature provided a large body of evidence that supports various associations between periodontitis and hormonal changes, adverse pregnancy outcomes and osteoporosis; however, certain shortcomings were noted with respect to biases involving definitions, sample sizes and confounding variables. Specific cause and effect relationships could not be delineated at this time and neither could definitive treatment interventions. Future research must include randomised controlled trials with consistent definitions, adequate controls and sufficiently large sample sizes in order to clarify specific associations, identify cause and effect relationships, define treatment options and determine treatment interventions which will lessen the untoward effects on the at-risk populations.

Adverse selection and moral hazard in health insurance

OpenAIRE

Bien, Franck; Alary, David

2006-01-01

In this paper, we want to characterize the optimal health insurance contract with adverse selection and moral hazard. We assume that policyholders differ by the permanent health status loss and choose an unobservable preventive effort in order to reduce the probability of illness which is ex-ante identical. The difference in illness'after-effect modifies policyholders' preventive actions. By the way, they differ in probabilities of illness leading to a situation close to Rothschild and Stigli...

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…

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.

An Enduring Health Risk of Childhood Adversity: Earlier, More Severe, and Longer Lasting Work Disability in Adult Life.

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Laditka, Sarah B; Laditka, James N

2018-02-08

Childhood adversity has been linked with adult health problems. We hypothesized that childhood adversity would also be associated with work limitations due to physical or nervous health problems, known as work disability. With data from the Panel Study of Income Dynamics (PSID) (1968-2013; n=6,045; 82,374 transitions; 129,107 person-years) and the 2014 PSID Childhood Retrospective Circumstances Study, we estimated work disability transition probabilities with multinomial logistic Markov models. Four or more adversities defined a high level. Microsimulations quantified adult work disability patterns for African American and non-Hispanic white women and men, accounting for age, education, race, sex, diabetes, heart disease, obesity, and sedentary behavior. Childhood adversity was significantly associated with work disability. Of African American women with high adversity, 10.2% had moderate work disability at age 30 versus 4.1% with no reported adversities; comparable results for severe work disability were 5.6% versus 1.9% (both pwork disability remained significant after adjusting for diabetes, heart disease, obesity, and sedentary behavior (pwork disability throughout adult life. © The Author(s) 2018. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[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.

Adverse Health Effects and Unhealthy Behaviors among Medical Students Using Facebook

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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.

Adverse Childhood Experiences and the Mental Health of Veterans.

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McGuinness, Teena M; Waldrop, Jessica R

2015-06-01

Many U.S. Veterans have experienced the burdens of mental illness and suicide. The current article focuses on Veterans who served from 2001-2015. Although combat exposure and suicidal ideation are linked, approximately one half of all suicides among Active Duty service members (who have served since 2001) occurred among those who never deployed. Researchers who sought additional risks for suicide found that Veterans have greater odds of adversities in childhood than the general population. Adverse childhood experiences are stressful and traumatic experiences, including abuse and neglect, as well as witnessing household dysfunction, or growing up with individuals with mental illness or substance abuse. Further, childhood physical abuse has been shown to be a significant predictor for posttraumatic stress disorder and suicide. Adverse childhood experiences confer additional risk for the mental health of service members. Psychiatric nursing implications include the importance of assessing early childhood adversity during psychosocial assessments. Providing trauma-informed strategies for treatment is an essential element of psychiatric nursing care. Copyright 2015, SLACK Incorporated.

Social work and adverse childhood experiences research: implications for practice and health policy.

Science.gov (United States)

Larkin, Heather; Felitti, Vincent J; Anda, Robert F

2014-01-01

Medical research on "adverse childhood experiences" (ACEs) reveals a compelling relationship between the extent of childhood adversity, adult health risk behaviors, and principal causes of death in the United States. This article provides a selective review of the ACE Study and related social science research to describe how effective social work practice that prevents ACEs and mobilizes resilience and recovery from childhood adversity could support the achievement of national health policy goals. This article applies a biopsychosocial perspective, with an emphasis on mind-body coping processes to demonstrate that social work responses to adverse childhood experiences may contribute to improvement in overall health. Consistent with this framework, the article sets forth prevention and intervention response strategies with individuals, families, communities, and the larger society. Economic research on human capital development is reviewed that suggests significant cost savings may result from effective implementation of these strategies.

Clinical survey on adverse reaction of contrast media, final report

International Nuclear Information System (INIS)

Katayama, Hitoshi; Ishida, Osamu; Osawa, Tadashi

1988-01-01

This report is a final analysis of adverse reactions to iodinated contrast media examined in 33,440 patients from 11 hospitals during the period from October 1983 through June 1986. Adverse reactions, such as nausea, exanthema and vomiting, to contrast media occurred in 2,523 patients (7.5 %), with the higher number occuring in patients aged 40 - 60, irrespective of sex. There were no significant alternations in vital signs. Patients positive for pretesting and having a history of allergy had higher incidences of adverse reactions (48 % and 52 %, respectively). A history of allergy is the most potential predictor for adverse reactions to contrast media. There was no definitive correlation between prior medication of contrast media and the occurrence of their adverse reactions. The relationship between the occurrence of adverse reactions and both kinds and dosage of contrast media was unknown. (Namekawa, K.)

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

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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.

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

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Protić D

2016-02-01

Full Text Available Dragana Protić,1 Nada Vujasinović-Stupar,2 Zoran Bukumirić,3 Slavica Pavlov-Dolijanović,4 Snežana Baltić,5 Slavica Mutavdžin,6 Ljiljana Markovic-Denić,7 Marija Zdravković,8 Zoran Todorović1 1Department of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 2Department 2, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 3Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 4Department 5, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 5Department 5, Institute of Rheumatology, Belgrade, Serbia; 6Institute of Physiology “Rihard Burjan”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 7Institute of Epidemiology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 8Department of Cardiology, Medical Center “Bežanijska kosa”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia Background: Adverse drug reactions (ADRs have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system. Methods: Semi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261 completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history. Results: Group 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found

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

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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.

Adverse effects of aromatherapy: a systematic review of case reports and case series.

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Posadzki, Paul; Alotaibi, Amani; Ernst, Edzard

2012-01-01

This systematic review was aimed at critically evaluating the evidence regarding the adverse effects associated with aromatherapy. Five electronic databases were searched to identify all relevant case reports and case series. Forty two primary reports met our inclusion criteria. In total, 71 patients experienced adverse effects of aromatherapy. Adverse effects ranged from mild to severe and included one fatality. The most common adverse effect was dermatitis. Lavender, peppermint, tea tree oil and ylang-ylang were the most common essential oils responsible for adverse effects. Aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.

Differential roles of childhood adversities and stressful war experiences in the development of mental health symptoms in post-war adolescents in northern Uganda.

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Okello, James; De Schryver, Maarten; Musisi, Seggane; Broekaert, Eric; Derluyn, Ilse

2014-09-09

Previous studies have shown a relationship between stressful war experiences and mental health symptoms in children and adolescents. To date, no comprehensive studies on the role of childhood adversities have been conducted with war-exposed adolescents living in post-war, low-resource settings in Sub-Saharan Africa. A cross-sectional study of 551 school-going adolescents aged 13-21 years old was undertaken four years post-war in northern Uganda. Participants completed self-administered questionnaires assessing demographics, stressful war experiences, childhood adversities, posttraumatic stress disorder (PTSD), depression, and anxiety symptoms. Our analyses revealed a main effect of gender on all mental health outcomes except avoidance symptoms, with girls reporting higher scores than boys. Stressful war experiences were associated with all mental health symptoms, after adjusting for potential confounders. Childhood adversity was independently associated with depression symptoms but not PTSD, anxiety, and PTSD cluster symptoms. However, in situations of high childhood adversity, our analyses showed that stressful war experiences were less associated with vulnerability to avoidance symptoms than in situations of low childhood adversity. Both stressful war experiences and childhood adversities are risk factors for mental health symptoms among war-affected adolescents. Adolescents with histories of high childhood adversities may be less likely to develop avoidance symptoms in situations of high stressful war experiences. Further exploration of the differential roles of childhood adversities and stressful war experiences is needed.

Analysis of adverse events of renal impairment related to platinum-based compounds using the Japanese Adverse Drug Event Report database.

Science.gov (United States)

Naganuma, Misa; Motooka, Yumi; Sasaoka, Sayaka; Hatahira, Haruna; Hasegawa, Shiori; Fukuda, Akiho; Nakao, Satoshi; Shimada, Kazuyo; Hirade, Koseki; Mori, Takayuki; Yoshimura, Tomoaki; Kato, Takeshi; Nakamura, Mitsuhiro

2018-01-01

Platinum compounds cause several adverse events, such as nephrotoxicity, gastrointestinal toxicity, myelosuppression, ototoxicity, and neurotoxicity. We evaluated the incidence of renal impairment as adverse events are related to the administration of platinum compounds using the Japanese Adverse Drug Event Report database. We analyzed adverse events associated with the use of platinum compounds reported from April 2004 to November 2016. The reporting odds ratio at 95% confidence interval was used to detect the signal for each renal impairment incidence. We evaluated the time-to-onset profile of renal impairment and assessed the hazard type using Weibull shape parameter and used the applied association rule mining technique to discover undetected relationships such as possible risk factor. In total, 430,587 reports in the Japanese Adverse Drug Event Report database were analyzed. The reporting odds ratios (95% confidence interval) for renal impairment resulting from the use of cisplatin, oxaliplatin, carboplatin, and nedaplatin were 2.7 (2.5-3.0), 0.6 (0.5-0.7), 0.8 (0.7-1.0), and 1.3 (0.8-2.1), respectively. The lower limit of the reporting odds ratio (95% confidence interval) for cisplatin was >1. The median (lower-upper quartile) onset time of renal impairment following the use of platinum-based compounds was 6.0-8.0 days. The Weibull shape parameter β and 95% confidence interval upper limit of oxaliplatin were impairment during cisplatin use in real-world setting. The present findings demonstrate that the incidence of renal impairment following cisplatin use should be closely monitored when patients are hypertensive or diabetic, or when they are co-administered furosemide, loxoprofen, or pemetrexed. In addition, healthcare professionals should closely assess a patient's background prior to treatment.

The concept of adverse drug reaction reporting: awareness among ...

African Journals Online (AJOL)

Arun Kumar Agnihotri

concept of pharmacovigilance and adverse drug reaction reporting, a section on ... ADR go undocumented worldwide8,9. ... international drug monitoring collaborating centre, ... practitioners to report all suspected ADR, the few .... more with some of the guidelines such as nurses, .... patients: a meta-analysis of prospective.

Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

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Pohlman, Katherine A; Carroll, Linda; Tsuyuki, Ross T; Hartling, Lisa; Vohra, Sunita

2017-12-01

Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance

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

Adverse health events associated with domestic violence during pregnancy among Brazilian women.

Science.gov (United States)

Audi, Celene Aparecida Ferrari; Segall-Corrêa, Ana M; Santiago, Silvia M; Pérez-Escamilla, Rafael

2012-08-01

domestic violence during pregnancy remains an unsolved and neglected social problem despite the recognised adverse physical and mental health consequences. to examine the association between domestic violence (psychological violence and physical or sexual violence) and health problems self-reported by pregnant women. a cross-sectional analysis from a cohort study of 1,379 pregnant women attending prenatal care in public primary care units in Campinas, São Paulo, Brazil. Data were collected by interviewing women when they enroled for prenatal care. Domestic violence and alcohol abuse were ascertained by validated questionnaires. Referred morbidities, undesirable behaviours and sociodemographic characteristics were also recorded. Univariate analyses were used to estimate prevalence and unadjusted odd ratios. Multivariate logistic regression was used to identify the independent association between psychological violence and physical or sexual violence during pregnancy and women's health outcomes. psychological violence and physical or sexual violence were reported by 19.1% (n=263) and 6.5% (n=89) of the pregnant women, respectively. Psychological violence was significantly associated with obstetric problems [odds ratio (OR) 1.95; 95% confidence interval (CI) 1.39-2.73], premature rupture of membranes (OR 1.64, 95% CI 1.01-2.68), urinary tract infection (OR 1.71, 95% CI 1.19-2.42), headache (OR 1.75, 95% CI 1.25-2.40) and sexual risk behaviours (OR 2.28, 95% CI 1.18-4.41). Physical or sexual violence was significantly associated with: obstetric problems (OR 1.72, 95% CI 1.08-2.75), premature rupture of membranes (OR 2.11, 95% CI 1.14-3.88), urinary tract infection (OR 2.05, 95% CI 1.26-3.34), vaginal bleeding (OR 1.95, 95% CI 1.10-3.43) and lack of sexual desire (OR 3.67, 95% CI 2.23-6.09). domestic violence during pregnancy was associated with adverse clinical and psychological outcomes for women. These results suggest that a well-organised health-care system and

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

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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; Haro, Josep Maria; Hu, Chi-Yi; Karam, Elie G; Kawakami, Norito; Lee, Sing; Lépine, Jean-Pierre; Ormel, Johan; Posada-Villa, José; Sagar, Rajesh; Tsang, Adley; Ustün, T Bedirhan; Vassilev, Svetlozar; Viana, Maria Carmen; Williams, David R

2010-11-01

Although significant associations of childhood adversities with adult mental disorders are widely documented, most studies focus on single childhood adversities predicting single disorders. To examine joint associations of 12 childhood adversities with first onset of 20 DSM-IV disorders in World Mental Health (WMH) Surveys in 21 countries. Nationally or regionally representative surveys of 51 945 adults assessed childhood adversities and lifetime DSM-IV disorders with the WHO Composite International Diagnostic Interview (CIDI). Childhood adversities were highly prevalent and interrelated. Childhood adversities associated with maladaptive family functioning (e.g. parental mental illness, child abuse, neglect) were the strongest predictors of disorders. Co-occurring childhood adversities associated with maladaptive family functioning had significant subadditive predictive associations and little specificity across disorders. Childhood adversities account for 29.8% of all disorders across countries. Childhood adversities have strong associations with all classes of disorders at all life-course stages in all groups of WMH countries. Long-term associations imply the existence of as-yet undetermined mediators.

Dietary supplement adverse events: report of a one-year poison center surveillance project.

Science.gov (United States)

Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

2008-06-01

The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

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

, 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...... a positive attitude to reporting adverse events to a database if the system granted legal and administrative immunity to reporters. The majority preferred a reporting system located at a research institute. CONCLUSION: GPs have a very positive attitude towards discussing and reporting adverse events......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...

Childhood adversity, mental health, and violent crime.

Science.gov (United States)

Brewer-Smyth, Kathleen; Cornelius, Monica E; Pickelsimer, E Elisabeth

2015-01-01

Little is understood about childhood traumatic brain injury (TBI) and lifetime violent crime perpetration. The purpose was to evaluate TBI before the age of 15 years and other childhood environmental factors, mental health, and lifetime history of committing a violent crime. A cross-sectional study of 636 male and female offenders from a southeastern state prison population was conducted using Chi-squared tests, t tests, and logistic regression to determine factors associated with ever committing a violent crime. Committing a violent crime was associated with male gender, younger age, greater childhood sexual abuse (CSA), greater childhood emotional abuse, no TBI by the age of 15 years, and greater neighborhood adversity during childhood. Although TBI has been related to violent and nonviolent crime, this study showed that absence of TBI by the age of 15 years was associated with lifetime violent crime when adjusting for CSA, childhood emotional abuse, and neighborhood adversity during childhood. This builds upon neurobehavioral development literature suggesting that CSA and the stress of violence exposure without direct physical victimization may play a more critical role in lifetime violent criminal behavior than childhood TBI. Violence risk reduction must occur during childhood focusing on decreasing adversity, especially violence exposure as a witness as well as a direct victim.

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.

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.

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

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

Report of adverse events related to treatments to Institute de Veille sanitaire

International Nuclear Information System (INIS)

Maingon, P.; Simmon-Tellier, S.

2007-01-01

The 'code de sante publique' imposes to all health professionals an obligation to declare serious and undesirable events following cares applied during treatment investigations or prevention actions. An experimentation has been installed under the responsibility of the Institut de Veille sanitaire further to the 9 August 2004 bill. It aims to define how to declare undesirable adverse events to test its feasibility, its efficiency and to identify the necessary conditions to widespread its modalities. The field of these experimentations concerns all health professionals, working in public hospital or in private practice. The definition of undesirable adverse events should be clarified. Different ways to declare these events will be discussed with S.F.R.O. (Societe francaise de radiotherapie oncologique) to improve the current management of incidents and adverse events. (authors)

The reasons of the nursing staff to notify adverse events

Directory of Open Access Journals (Sweden)

Miriam Cristina Marques da Silva de Paiva

2014-10-01

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

[Adverse drug reaction reporting in emergency medicine].

Science.gov (United States)

Milojevic, Kolia; Chassagnol, Isabelle; Brion, Nathalie; Cléro, Joël; Degrèze, Nathalie; Lambert, Yves

2004-01-01

A regional survey was performed between June and September 2002, to evaluate knowledge and attitudes of emergency physicians regarding adverse drug reaction (ADR) reporting in a French district. 100 questionnaires completed by physicians working in emergency departments and/or mobile intensive care units were analysed. The frequency of ADRs encountered by emergency practitioners was estimated at > or = 0.73 per year and per physician. The ADR notification rate in emergency medicine was estimated at advertising ADR reporting procedures could help to improve the notification rate in emergency medicine.

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Science.gov (United States)

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

2017-12-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

Occupational health of miners at altitude: adverse health effects, toxic exposures, pre-placement screening, acclimatization, and worker surveillance.

Science.gov (United States)

Vearrier, David; Greenberg, Michael I

2011-08-01

Mining operations conducted at high altitudes provide health challenges for workers as well as for medical personnel. To review the literature regarding adverse health effects and toxic exposures that may be associated with mining operations conducted at altitude and to discuss pre-placement screening, acclimatization issues, and on-site surveillance strategies. We used the Ovid ( http://ovidsp.tx.ovid.com ) search engine to conduct a MEDLINE search for "coal mining" or "mining" and "altitude sickness" or "altitude" and a second MEDLINE search for "occupational diseases" and "altitude sickness" or "altitude." The search identified 97 articles of which 76 were relevant. In addition, the references of these 76 articles were manually reviewed for relevant articles. CARDIOVASCULAR EFFECTS: High altitude is associated with increased sympathetic tone that may result in elevated blood pressure, particularly in workers with pre-existing hypertension. Workers with a history of coronary artery disease experience ischemia at lower work rates at high altitude, while those with a history of congestive heart failure have decreased exercise tolerance at high altitude as compared to healthy controls and are at higher risk of suffering an exacerbation of their heart failure. PULMONARY EFFECTS: High altitude is associated with various adverse pulmonary effects, including high-altitude pulmonary edema, pulmonary hypertension, subacute mountain sickness, and chronic mountain sickness. Mining at altitude has been reported to accelerate silicosis and other pneumoconioses. Miners with pre-existing pneumoconioses may experience an exacerbation of their condition at altitude. Persons traveling to high altitude have a higher incidence of Cheyne-Stokes respiration while sleeping than do persons native to high altitude. Obesity increases the risk of pulmonary hypertension, acute mountain sickness, and sleep-disordered breathing. NEUROLOGICAL EFFECTS: The most common adverse neurological

[Vaccinovigilance: Reports of adverse reactions in the year 2016].

Science.gov (United States)

Albrecht, N; Ottiger, H

2017-08-01

In the year 2016, 107 reports of adverse reactions following the application of various authorized vaccines were received and evaluated by the IVI (Institute of Virology and Immunology). The notifications were submitted primarily by marketing authorization holders (81) or veterinarians and private persons (26). The aim of the Vigilance System is the identification of rare events to assess the individual risks of the vaccine application. During the last year, the correlation between reaction and vaccination was considered probable in 34% of the cases. As in previous years, companion animals were involved in most of the adverse effects (48% dogs, 21% cats), followed by cattle (13%). In dogs, approximately half of the reports concern the combination vaccines against distemper, hepatitis, parvovirus, parainfluenza and leptospirosis. The reported symptoms, such as itching, facial edema, acute vomiting and diarrhea, usually indicated forms of hypersensitivity. In cats, apathy was most frequently observed regardless of the vaccination.

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.

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

Science.gov (United States)

Vogel, Ineke; van de Looij-Jansen, Petra M; Mieloo, Cathelijne L; Burdorf, Alex; de Waart, Frouwkje

2014-01-01

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. 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. 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. 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.

Can premium differentiation counteract adverse selection in the Dutch supplementary health insurance? A simulation study

NARCIS (Netherlands)

K.P.M. Winssen van (Kayleigh); R.C. van Kleef (Richard); W.P.M.M. van de Ven (Wynand)

2017-01-01

textabstractMost health insurers in the Netherlands apply community-rating and open enrolment for supplementary health insurance, although it is offered at a free market. Theoretically, this should result in adverse selection. There are four indications that adverse selection indeed has started to

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.

Poor mental health among low-income women in the U.S.: The roles of adverse childhood and adult experiences.

Science.gov (United States)

Mersky, Joshua P; Janczewski, Colleen E; Nitkowski, Jenna C

2018-06-01

It is well established that exposure to a greater number of adverse childhood experiences (ACEs) increases the risk of poor physical and mental health outcomes. Given the predictive validity of ACE scores and other cumulative risk metrics, a similar measurement approach may advance the study of risk in adulthood. We examined the prevalence and interrelations of 10 adverse adult experiences, including household events such as intimate partner violence and extrafamilial events such as crime victimization. We also tested the relation between cumulative adult adversity and later mental health problems, and we examined whether adult adversity mediates the link between childhood adversity and mental health. Data were collected from 501 women in the Families and Children Thriving Study, a longitudinal investigation of low-income families that received home visiting services in Wisconsin. We conducted correlation analyses to assess interrelations among study measures along with multivariate analyses to test the effects of childhood and adult adversity on three outcomes: depression, anxiety, and posttraumatic stress disorder (PTSD). We then fit a structural equation model to test whether the effects of childhood adversity on mental health are mediated by adult adversity. Over 80% of participants endorsed at least one adverse adult experience. Adult adversities correlated with each other and with the mental health outcomes. Controlling for ACEs and model covariates, adult adversity scores were positively associated with depression, anxiety, and PTSD scores. Path analyses revealed that the ACE-mental health connection was mediated by adult adversity. Our findings indicate that mental health problems may be better understood by accounting for processes through which early adversity leads to later adversity. Pending replication, this line of research has the potential to improve the identification of populations that are at risk of poor health outcomes. Copyright © 2018

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

Science.gov (United States)

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

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. There is a widespread misperception that PED use is safe or that adverse effects are manageable. In reality, the vast majority of PED users are not athletes but rather nonathlete weightlifters, and the adverse health effects of PED use are greatly underappreciated. This scientific statement synthesizes available information on the medical consequences of PED use, identifies gaps in knowledge, and aims to focus the attention of the medical community and policymakers on PED use as an important public health problem. PED users frequently consume highly supraphysiologic doses of PEDs, combine them with other PEDs and/or other classical drugs of abuse, and display additional associated risk factors. PED use has been linked to an increased risk of death and a wide variety of cardiovascular, psychiatric, metabolic, endocrine, neurologic, infectious, hepatic, renal, and musculoskeletal disorders. Because randomized trials cannot ethically duplicate the large doses of PEDs and the many factors associated with PED use, we need observational studies to collect valid outcome data on the health risks associated with PEDs. In addition, we need studies regarding the prevalence of PED use, the mechanisms by which PEDs exert their adverse health effects, and the interactive effects of PEDs with sports injuries and other high-risk behaviors. We also need randomized trials to assess therapeutic interventions for treating the adverse effects of PEDs, such as the anabolic-androgen steroid withdrawal syndrome. Finally, we need to raise public awareness of the serious health consequences of PEDs. PMID:24423981

Adverse Health Effects of Betel Quid and the Risk of Oral and Pharyngeal Cancers

Directory of Open Access Journals (Sweden)

Ping-Ho Chen

2017-01-01

Full Text Available Global reports estimate 600 million betel quid (BQ chewers. BQ chewing has been demonstrated not only to be a risk factor for cancers of the oral cavity and pharynx and oral potentially malignant disorders (OPMD but also to cause other cancers and adverse health effects. Herein, we summarized the international comparison data to aid in the understanding of the close relationship between the prevalence of BQ chewing, the occurrence of oral and pharyngeal cancers, and adverse health effects. Potential biomarkers of BQ carcinogens, such as areca nut, alkaloids, and 3-methylnitrosaminopropionitrile (MNPN, are closely associated with human health toxicology. Molecular mechanisms or pathways involving autophagy, hypoxia, COX-2, NF-κB activity, and stemness are known to be induced by BQ ingredients and are very closely related to the carcinogenesis of cancers of oral and pharynx. BQ abuse-related monoamine oxidase (MAO gene was associated with the occurrence and progress of oral and pharyngeal cancers. In summary, our review article provides important insights into the potential roles of environmental BQ (specific alkaloid biomarkers and nitrosamine products MNPN and genetic factors (MAO and offers a basis for studies aiming to reduce or eliminate BQ-related OPMD and oral/pharyngeal cancer incidences in the future.

Adverse Health Effects of Betel Quid and the Risk of Oral and Pharyngeal Cancers

Science.gov (United States)

Mahmood, Qaisar; Chiang, Tai-An

2017-01-01

Global reports estimate 600 million betel quid (BQ) chewers. BQ chewing has been demonstrated not only to be a risk factor for cancers of the oral cavity and pharynx and oral potentially malignant disorders (OPMD) but also to cause other cancers and adverse health effects. Herein, we summarized the international comparison data to aid in the understanding of the close relationship between the prevalence of BQ chewing, the occurrence of oral and pharyngeal cancers, and adverse health effects. Potential biomarkers of BQ carcinogens, such as areca nut, alkaloids, and 3-methylnitrosaminopropionitrile (MNPN), are closely associated with human health toxicology. Molecular mechanisms or pathways involving autophagy, hypoxia, COX-2, NF-κB activity, and stemness are known to be induced by BQ ingredients and are very closely related to the carcinogenesis of cancers of oral and pharynx. BQ abuse-related monoamine oxidase (MAO) gene was associated with the occurrence and progress of oral and pharyngeal cancers. In summary, our review article provides important insights into the potential roles of environmental BQ (specific alkaloid biomarkers and nitrosamine products MNPN) and genetic factors (MAO) and offers a basis for studies aiming to reduce or eliminate BQ-related OPMD and oral/pharyngeal cancer incidences in the future. PMID:29376073

Vaccine Adverse Events

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... for Biologics Evaluation & Research Vaccine Adverse Events Vaccine Adverse Events Share Tweet Linkedin Pin it More sharing ... in the primary immunization series in infants Report Adverse Event Report a Vaccine Adverse Event Contact FDA ( ...

Association of adverse oral health outcomes with socioeconomic inequalities and dental needs in Brazilian adolescents.

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Figueiredo, Daniela de Rossi; Bastos, João Luiz; Peres, Karen Glazer

2017-06-05

This study aimed to explore the relations between adverse oral outcomes and socioeconomic, demographic, and self-rated oral health variables and to describe their distribution. Principal component analysis was conducted on data from adolescents in the Brazilian National Oral Health Survey (N = 5,445). Higher loadings were found for crowding (0.6), maxillary and mandibular irregularities (0.5), and count of communitary periodontal index (CPI) sextants with bleeding and dental calculus (0.5). The mean rates for periodontal and occlusal disorders were at least two times higher in adolescents from lower income families and those reporting the need for dental prostheses, as well as those dissatisfied with their dental and overall oral health. Increased mean rates of occlusal disorders were associated with schooling delay and history of toothache in the previous six months. The mean scores suggested accumulation of at least one of the negative oral health indicators in the lower income strata, among adolescents with schooling delay, and in those reporting dental needs. The results suggest priorities for planning and monitoring as a function of oral health requirements.

Association of adverse oral health outcomes with socioeconomic inequalities and dental needs in Brazilian adolescents

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Daniela de Rossi Figueiredo

Full Text Available Abstract: This study aimed to explore the relations between adverse oral outcomes and socioeconomic, demographic, and self-rated oral health variables and to describe their distribution. Principal component analysis was conducted on data from adolescents in the Brazilian National Oral Health Survey (N = 5,445. Higher loadings were found for crowding (0.6, maxillary and mandibular irregularities (0.5, and count of communitary periodontal index (CPI sextants with bleeding and dental calculus (0.5. The mean rates for periodontal and occlusal disorders were at least two times higher in adolescents from lower income families and those reporting the need for dental prostheses, as well as those dissatisfied with their dental and overall oral health. Increased mean rates of occlusal disorders were associated with schooling delay and history of toothache in the previous six months. The mean scores suggested accumulation of at least one of the negative oral health indicators in the lower income strata, among adolescents with schooling delay, and in those reporting dental needs. The results suggest priorities for planning and monitoring as a function of oral health requirements.

Stress and resource pathways connecting early socioeconomic adversity to young adults' physical health risk.

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Wickrama, Kandauda K A S; Lee, Tae Kyoung; O'Neal, Catherine Walker; Kwon, Josephine A

2015-05-01

Although research has established the impact of early stress, including stressful life contexts, and early resources, such as educational attainment, on various adolescent health outcomes, previous research has not adequately investigated "integrative models" incorporating both stress and resource mediational pathways to explain how early socioeconomic adversity impacts physical health outcomes, particularly in early life stages. Data on early childhood/adolescent stress and socioeconomic resources as well as biomarkers indicating physical health status in young adulthood were collected from 11,798 respondents (54 % female) over a 13-year period from youth participating in the National Study of Adolescent Health (Add Health). Physical health risk in young adulthood was measured using a composite index of nine regulatory biomarkers of cardiovascular and metabolic systems. Heterogeneity in stress and socioeconomic resource pathways was assessed using latent class analysis to identify clusters, or classes, of stress and socioeconomic resource trajectories. The influence of early socioeconomic adversity on young adults' physical health risk, as measured by biomarkers, was estimated, and the role of stress and socioeconomic resource trajectory classes as linking mechanisms was assessed. There was evidence for the influence of early socioeconomic adversity on young adults' physical health risk directly and indirectly through stress and socioeconomic resource trajectory classes over the early life course. These findings suggest that health models should be broadened to incorporate both stress and resource experiences simultaneously. Furthermore, these findings have prevention and intervention implications, including the importance of early socioeconomic adversity and key intervention points for "turning" the trajectories of at-risk youth.

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

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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.

Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study.

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Kåre Mølbak

Full Text Available Since 2013 the number of suspected adverse reactions to the quadrivalent human papillomavirus (HPV vaccine reported to the Danish Medicines Agency (DMA has increased. Due to the resulting public concerns about vaccine safety, the coverage of HPV vaccinations in the childhood vaccination programme has declined. The aim of the present study was to determine health care-seeking prior to the first HPV vaccination among females who suspected adverse reactions to HPV vaccine.In this registry-based case-control study, we included as cases vaccinated females with reports to the DMA of suspected severe adverse reactions. We selected controls without reports of adverse reactions from the Danish vaccination registry and matched by year of vaccination, age of vaccination, and municipality, and obtained from the Danish National Patient Registry and The National Health Insurance Service Register the history of health care usage two years prior to the first vaccine. We analysed the data by logistic regression while adjusting for the matching variables.The study included 316 cases who received first HPV vaccine between 2006 and 2014. Age range of cases was 11 to 52 years, with a peak at 12 years, corresponding to the recommended age at vaccination, and another peak at 19 to 28 years, corresponding to a catch-up programme targeting young women. Compared with 163,910 controls, cases had increased care-seeking in the two years before receiving the first HPV vaccine. A multivariable model showed higher use of telephone/email consultations (OR 1.9; 95% CI 1.2-3.2, physiotherapy (OR 2.1; 95% CI 1.6-2.8 and psychologist/psychiatrist (OR 1.9; 95% CI 1.3-2.7. Cases were more likely to have a diagnosis in the ICD-10 chapters of diseases of the digestive system (OR 1.6; 95% CI 1.0-2.4, of the musculoskeletal system (OR 1.6; 95% CI 1.1-2.2, symptoms or signs not classified elsewhere (OR 1.8; 95% CI 1.3-2.5 as well as injuries (OR 1.5; 95% CI 1.2-1.9.Before receiving the

Adverse Effects of Prolonged Sitting Behavior on the General Health of Office Workers.

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Daneshmandi, Hadi; Choobineh, Alireza; Ghaem, Haleh; Karimi, Mehran

2017-07-01

Excessive sitting behavior is a risk factor for many adverse health outcomes. This study aimed to survey the prevalence of sitting behavior and its adverse effects among Iranian office workers. This cross-sectional study included 447 Iranian office workers. A two-part questionnaire was used as the data collection tool. The first part surveyed the demographic characteristics and general health of the respondents, while the second part contained the Nordic Musculoskeletal Questionnaire (NMQ) to assess symptoms. Statistical analyses were performed using the Statistical Package for the Social Sciences software using Mann-Whitney U and Chi-square tests and multiple logistic regression analysis. The respondents spent an average of 6.29 hours of an 8-hour working shift in a sitting position. The results showed that 48.8% of the participants did not feel comfortable with their workstations and 73.6% felt exhausted during the workday. Additionally, 6.3% suffered from hypertension, and 11.2% of them reported hyperlipidemia. The results of the NMQ showed that neck (53.5%), lower back (53.2%) and shoulder (51.6%) symptoms were the most prevalent problem among office workers. Based upon a multiple logistic regression, only sex had a significant association with prolonged sitting behavior (odds ratio = 3.084). Our results indicated that long sitting times were associated with exhaustion during the working day, decreased job satisfaction, hypertension, and musculoskeletal disorder symptoms in the shoulders, lower back, thighs, and knees of office workers. Sitting behavior had adverse effects on office workers. Active workstations are therefore recommended to improve working conditions.

Disability and Exposure to High Levels of Adverse Childhood Experiences: Effect on Health and Risk Behavior.

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Austin, Anna; Herrick, Harry; Proescholdbell, Scott; Simmons, Jacqueline

2016-01-01

Health disparities among persons with disabilities have been previously documented. However, there is little research specific to adverse childhood experiences (ACEs) in this population and how ACE exposure affects health outcomes in adulthood. Data from the 2012 North Carolina Behavioral Risk Factor Surveillance System (BRFSS) survey were analyzed to compare the prevalence of ACEs between adults with and without disabilities and high ACE exposure (3-8 ACEs). Adjusted risk ratios of health risks and perceived poor health by disability status were calculated using predicted marginals. A higher percentage of persons with disabilities (36.5%) than those without disabilities (19.6%) reported high ACE exposure. Among those with high ACE exposure, persons with disabilities were more likely to report several ACE categories, particularly childhood sexual abuse. In adjusted analyses, persons with disabilities had an increased risk of smoking (relative risk [RR] = 1.29; 95% CI, 1.10-1.51), poor physical health (RR = 4.34; 95% CI, 3.08-6.11), poor mental health (RR = 4.69; 95% CI, 3.19-6.87), and doctor-diagnosed depression (RR = 2.16; 95% CI, 1.82-2.56) compared to persons without disabilities. The definition of disability derived from the BRFSS survey does not allow for those with disabilities to be categorized according to physical disabilities versus mental or emotional disabilities. In addition, we were unable to determine the timing of ACE exposure in relation to disability onset. A better understanding of the life course associations between ACEs and disability and the impact of exposure to multiple types of childhood adversity on disability and health is needed to inform research and services specific to this vulnerable population. ©2016 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.

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

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

2017-01-01

Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children...... and 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......, hallucinations. As some of the reported ADEs are life threatening and not listed as ADRs in the SPCs, off-label use of quetiapine in children and adolescents gives rise to safety concerns....

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

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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

Childhood adversity and insomnia in adolescence.

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Wang, Yan; Raffeld, Miriam R; Slopen, Natalie; Hale, Lauren; Dunn, Erin C

2016-05-01

The study aims to evaluate the association between exposure to childhood adversity and insomnia, with an emphasis on the role of adversity type, timing, and accumulation (i.e., the number of specific types of adversities the child reported being exposed to). Our analytic sample comprised 9582 adolescents from the National Comorbidity Survey Replication Adolescent Supplement (NCS-A), a nationally representative population-based sample. We examined the association between 18 different types of retrospectively reported adversities (capturing interpersonal violence, accidents and injuries, social network or witnessing events, and other adverse events) and risk of self-reported past-year insomnia. We also examined whether the age at first exposure to adversity was associated with the risk of insomnia, and whether exposure to a greater number of different types of adversities (ie, accumulation) conferred an elevated risk of insomnia. In addition, we performed a sensitivity analysis excluding adolescents with a past-year diagnosis of major depression, dysthymia, post-traumatic stress disorder (PTSD), or generalized anxiety disorder. Almost one-third of adolescents reported insomnia, with a higher prevalence among girls and those from racial/ethnic minority groups. Adolescents exposed to at least one childhood adversity of any type (59.41%) were more likely than their nonexposed peers to experience insomnia (across adversities, prevalence ratios (PRs) ranged from 1.31 to 1.89). Risk of insomnia differed based on the age at first exposure to adversity as well as the type of adversity. Adolescents exposed to a greater number of different types of adversities had a higher risk of insomnia compared to those experiencing fewer adversities. These results were similar, by and large, to those obtained after excluding adolescents with at least one of the four past-year psychiatric disorders. Exposure to adversity confers an elevated risk of insomnia. This association varied by type

Childhood Adversity and Pain Sensitization.

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You, Dokyoung Sophia; Meagher, Mary W

Childhood adversity is a vulnerability factor for chronic pain. However, the underlying pain mechanisms influenced by childhood adversity remain unknown. The aim of the current study was to evaluate the impact of childhood adversity on dynamic pain sensitivity in young adults. After screening for childhood adverse events and health status, healthy individuals reporting low (below median; n = 75) or high levels of adversity (the top 5%; n = 51) were invited for pain testing. Both groups underwent heat pain threshold and temporal summation of second pain (TSSP) testing after reporting depressive symptoms. TSSP refers to a progressive increase in pain intensity with repetition of identical noxious stimuli and is attributed to central sensitization. Changes in pain ratings over time (slope) were computed for TSSP sensitization and decay of subsequent aftersensations. The high-adversity group showed greater TSSP sensitization (meanslope, 0.75; SDpositive slope, 1.78), and a trend toward a slower decay (meanslope, -11.9; SD, 3.4), whereas the low-adversity group showed minimal sensitization (meanslope, 0.07; SDnear-zero slope, 1.77), F(1,123) = 5.84, p = .017 and faster decay (meanslope, -13.1; SD, 3.4), F(1,123) = 3.79, p = .054. This group difference remained significant even after adjusting for adult depressive symptoms (p = .033). No group difference was found in heat pain threshold (p = .85). Lastly, the high-adversity group showed blunted cardiac and skin conductance responses. These findings suggest that enhancement of central sensitization may provide a mechanism underlying the pain hypersensitivity and chronicity linked to childhood adversity.

Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional.

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Herdeiro, María T; Polonia, Jorge; Gestal-Otero, Juan J; Figueiras, Adolfo

2004-11-01

The spontaneous reporting of adverse drug reactions (ADRs) through the yellow card and made concrete by the knowledge and attitudes of doctors, has been rousing a great deal of bibliographical interest in recent years. However, there does not seem to be any actual revision in the theme on which the theoretical models that explain the process of decision in reporting are proposed. In this work an explanatory model of the factors that condition reporting is proposed and a revision of the literature on the subject has also been carried out. The proposed model is centralized in the medical professional and it considers the habit of reporting as the result of the doctor's formation and his interaction with the environment. The combination of knowledge-attitudes-practices and the theory of the satisfaction of needs seemed very adequate for ADR systematization. The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors.

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

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Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

2017-09-01

Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected Pbrand and generics for all three drugs of interest (Breslow-Day Pbrands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

Gender differences in the physical and psychological manifestation of childhood trauma and/or adversity in people with psychosis

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Shaun eSweeney

2015-11-01

Full Text Available The link between childhood trauma and/or adversity and risk of psychosis is well known. Our aim was to determine the prevalence of childhood trauma and/or adversity in people who have psychotic disorders and to investigate the association between childhood trauma and/or adversity and a range of social and health measures. Participants (n=391, 42% male were specifically asked about any experience of childhood trauma and/or adversity. Respondents provided information about education, employment, physical health and health service utilisation. Univariate analyses revealed that childhood trauma and/or adversity was associated with poorer levels of self-reported physical health and social problems. This includes the experience of chronic pain, headaches, arthritis, asthma and victimisation/stigma in men. Participants with a childhood trauma and/or adversity history indicated higher rates of lifetime suicide attempts with women reporting more lifetime depressive symptoms. Multivariate analyses revealed differing profiles in relation to physical and psychological health variable between males and females. Males with the experience of childhood trauma and/or adversity were significantly more likely to report cardiovascular/stroke issues, migraines and anhedonia. Females with the experience of childhood trauma and/or adversity were more likely to report a lifetime history of elevated mood and to be married or in a defacto relationship. There has been very little research into the assessment and treatment of the effects of childhood trauma and/or adversity in adults with psychosis. Childhood trauma and/or adversity may contribute to higher rates of self-reported poor health in men and is associated with increased depression in women. Our findings suggest that interventions to address the effects of past trauma are urgently needed.

Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2001 - February 2002 : report

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V. Naidoo

2002-07-01

Full Text Available An overview of reports of suspected adverse drug reactions received by the Veterinary Pharmacovigilance and Medicines Information Centre during the period March 2001 to February 2002 is given. A total of 77 reports were received. The majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most products implicated in the reports were Stock Remedies. The products were predominantly administered either by veterinarians or trained paraveterinary professionals. Although the majority of reports were received from veterinary pharmaceutical companies, the proportion of reports received directly from veterinarians increased compared with previous years.

Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

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Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

2013-01-01

Aim: The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). Methodology: A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Results: Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. Conclusion: The GPs and CPs were aware about the importance and benefits

Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

Science.gov (United States)

Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

2013-10-01

The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. The GPs and CPs were aware about the importance and benefits of consumer reporting. Such reporting

Predictive modeling of structured electronic health records for adverse drug event detection.

Science.gov (United States)

Zhao, Jing; Henriksson, Aron; Asker, Lars; Boström, Henrik

2015-01-01

The digitization of healthcare data, resulting from the increasingly widespread adoption of electronic health records, has greatly facilitated its analysis by computational methods and thereby enabled large-scale secondary use thereof. This can be exploited to support public health activities such as pharmacovigilance, wherein the safety of drugs is monitored to inform regulatory decisions about sustained use. To that end, electronic health records have emerged as a potentially valuable data source, providing access to longitudinal observations of patient treatment and drug use. A nascent line of research concerns predictive modeling of healthcare data for the automatic detection of adverse drug events, which presents its own set of challenges: it is not yet clear how to represent the heterogeneous data types in a manner conducive to learning high-performing machine learning models. Datasets from an electronic health record database are used for learning predictive models with the purpose of detecting adverse drug events. The use and representation of two data types, as well as their combination, are studied: clinical codes, describing prescribed drugs and assigned diagnoses, and measurements. Feature selection is conducted on the various types of data to reduce dimensionality and sparsity, while allowing for an in-depth feature analysis of the usefulness of each data type and representation. Within each data type, combining multiple representations yields better predictive performance compared to using any single representation. The use of clinical codes for adverse drug event detection significantly outperforms the use of measurements; however, there is no significant difference over datasets between using only clinical codes and their combination with measurements. For certain adverse drug events, the combination does, however, outperform using only clinical codes. Feature selection leads to increased predictive performance for both data types, in isolation and

Adverse childhood experiences and health-related quality of life in adulthood: revelations from a community needs assessment.

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Salinas-Miranda, Abraham A; Salemi, Jason L; King, Lindsey M; Baldwin, Julie A; Berry, Estrellita Lo; Austin, Deborah A; Scarborough, Kenneth; Spooner, Kiara K; Zoorob, Roger J; Salihu, Hamisu M

2015-08-11

Adverse childhood experiences (ACE) have been previously linked to quality of life, health conditions, and life expectancy in adulthood. Less is known about the potential mechanisms which mediate these associations. This study examined how ACE influences adult health-related quality of life (HRQoL) in a low-income community in Florida. A community-based participatory needs assessment was conducted from November 2013 to March 2014 with 201 residents of Tampa, Florida, USA. HRQoL was measured by an excessive number of unhealthy days experienced during the previous 30-day window. Mediation analyses for dichotomous outcomes were conducted with logistic regression. Bootstrapped confidence intervals were generated for both total and specific indirect effects. Most participants reported 'good to excellent health' (76%) and about a fourth reported 'fair to poor health' (24%). The mean of total unhealthy days was 9 days per month (SD ± 10.5). Controlling for demographic and neighborhood covariates, excessive unhealthy days was associated with ACE (AOR = 1.23; 95% CI: 1.06, 1.43), perceived stress (AOR = 1.07; 95% CI: 1.03, 1.10), and sleep disturbance (AOR = 8.86; 3.61, 21.77). Mediated effects were significant for stress (β = 0.08) and sleep disturbances (β = 0.11) as they related to the relationship between ACE and excessive unhealthy days. ACE is linked to adult HRQoL. Stress and sleep disturbances may represent later consequences of childhood adversity that modulate adult quality of life.

Adverse childhood experiences: towards a clear conceptual meaning.

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Kalmakis, Karen A; Chandler, Genevieve E

2014-07-01

To report an analysis of the concept of adverse childhood experiences. Adverse childhood experiences have been associated with negative physical and psychological health outcomes, but this phenomenon lacks the clear, consistent meaning necessary for use in nursing research, theory development and practice. Concept clarification. The literature search was not limited a priori by date and included publications with abstracts in English from PubMed, CINAHL, PsychINFO and Social Abstracts. The search retrieved 128 articles published from 1970-2013. The search term 'adverse childhood experiences' was used, with similar terms permitted. A snowball approach was used to expand the search to relevant literature. The articles were read and analysed following Norris's five steps for concept clarification to refine, elucidate and operationally define the concept and the context in which it occurred. Adverse childhood experiences were defined operationally as childhood events, varying in severity and often chronic, occurring in a child's family or social environment that cause harm or distress, thereby disrupting the child's physical or psychological health and development. This concept clarification should raise awareness and understanding of the diverse nature and shared characteristics of adverse childhood experiences that are believed to influence the health of individuals as they age. This clarified concept will help expand research on health consequences of adverse childhood experiences and interventions to improve health. We recommend promoting a model of primary care that pays attention to the social and familial influences on the health of individuals worldwide. © 2013 John Wiley & Sons Ltd.

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

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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 surfing Facebook until midnight, and postponing, forgetting, or skipping meals (P well as social isolation from the family and community.

Early Adversity, Elevated Stress Physiology, Accelerated Sexual Maturation, and Poor Health in Females

Science.gov (United States)

Belsky, Jay; Ruttle, Paula L.; Boyce, W. Thomas; Armstrong, Jeffrey M.; Essex, Marilyn J.

2015-01-01

Evolutionary-minded developmentalists studying predictive-adaptive-response processes linking childhood adversity with accelerated female reproductive development and health scientists investigating the developmental origins of health and disease (DOoHaD) may be tapping the same process, whereby longer-term health costs are traded off for…

[Adverse effects of seasonal flu vaccine and new influenza A (H1N1) vaccine in health care workers].

Science.gov (United States)

Torruella, Joan Inglés; Soto, Rosa Gil; Valls, Rosa Carreras; Lozano, Judit Valverde; Carreras, Dolors Benito; Cunillera, Arnau Besora

2013-01-01

To assess and compare adverse effects of Seasonal Influenza Vaccine (SIV) and new Influenza A(H1N1) Vaccine (AIV) in health care workers. Multicenter cross-sectional study in health care workers from acute care hospitals, primary health care centers, social centers, mental health centers and a geriatric hospital participating in the 2009 vaccination campaign. Self-administered questionnaires were sent to all workers vaccinated with SIV and/or AIV. 527 valid questionnaires were collected out of 1123 sent to SIV vaccinated workers (46.9%), and 241 out of 461 sent to AIV vaccinated workers (52.%%). Participant workers include 527 vaccinated only with SIV, 117 first vaccinated with SIV and later with AIV (SIV+AIV), and 125 vaccinated only with AIV. Overall, 18.4% (95%CI 15.1-21.7) of workers vaccinated only with SIV reported adverse effects, as compared to 45.3% (95I 36.3-54.3) reporting adverse effects to AIV in the SIV+AIV group and 46.4% (95%CI 37.7-55.1) of workers vaccinated only with AIV. In all participants the most common adverseeffect was a local reaction. Women wre more reactive to both SIV and AIV than men. In all age groups SIV vaccination alone caused fewer reactions that either AIV only or the combination of SIV+AIV, with the exception of workers below 29 years of age. AIV was associated with more reactions than SIV, with no differences observed in relation to administration sequence. There were differences by sex and age, but reactions always occurred more commonly with AIV. Copyright belongs to the Societat Catalana de Seguretat i Medicina del Treball.

Are adverse effects incorporated in economic models? An initial review of current practice.

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Craig, D; McDaid, C; Fonseca, T; Stock, C; Duffy, S; Woolacott, N

2009-12-01

To identify methodological research on the incorporation of adverse effects in economic models and to review current practice. Major electronic databases (Cochrane Methodology Register, Health Economic Evaluations Database, NHS Economic Evaluation Database, EconLit, EMBASE, Health Management Information Consortium, IDEAS, MEDLINE and Science Citation Index) were searched from inception to September 2007. Health technology assessment (HTA) reports commissioned by the National Institute for Health Research (NIHR) HTA programme and published between 2004 and 2007 were also reviewed. The reviews of methodological research on the inclusion of adverse effects in decision models and of current practice were carried out according to standard methods. Data were summarised in a narrative synthesis. Of the 719 potentially relevant references in the methodological research review, five met the inclusion criteria; however, they contained little information of direct relevance to the incorporation of adverse effects in models. Of the 194 HTA monographs published from 2004 to 2007, 80 were reviewed, covering a range of research and therapeutic areas. In total, 85% of the reports included adverse effects in the clinical effectiveness review and 54% of the decision models included adverse effects in the model; 49% included adverse effects in the clinical review and model. The link between adverse effects in the clinical review and model was generally weak; only 3/80 (manipulation. Of the models including adverse effects, 67% used a clinical adverse effects parameter, 79% used a cost of adverse effects parameter, 86% used one of these and 60% used both. Most models (83%) used utilities, but only two (2.5%) used solely utilities to incorporate adverse effects and were explicit that the utility captured relevant adverse effects; 53% of those models that included utilities derived them from patients on treatment and could therefore be interpreted as capturing adverse effects. In total

Tuberculin skin testing: Spectrum of adverse reactions.

Science.gov (United States)

Praveen, Ramar; Bahuguna, Amit; Dhadwal, Bhumesh Singh

2015-01-01

Tuberculin skin testing (TST) is one of the primary diagnostic modalities recommended by the World Health Organization (WHO) and the National Institute for Health and Care Excellence (NICE) study conducted in the United Kingdom (UK) for diagnosing tuberculosis (TB). Even after acceptance as a diagnostic modality and stern standardization, TST has its own flaws that include a spectrum of adverse reactions. We report a series of cases with a spectrum of adverse reactions occurring with a higher frequency than present in the available evidence. The study has some demerits such as being a retrospective one with interobserver variation and lack of histopathological confirmation. The observation is presented to accentuate the fact that adverse reactions are not a rarity and that further studies are required to establish the cause and exact incidence of the same.

Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007-15: Report from the Medical Products Agency.

Science.gov (United States)

Svedlund, Erika; Larsson, Maria; Hägerkvist, Robert

2017-06-01

In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. To evaluate the characteristics and frequency of adverse events recorded by the Swedish Medical Products Agency, where herbal medicinal products and natural remedies were suspected as causative agents. Adverse drug reactions reported to the Swedish Medical Product Agency during 2007-15 related to approved herbal medicinal products or natural remedies were included and analysed in the retrospective study. Reports had been assessed for causality when they were lodged and only reports that had been assessed as at least possible were included in the study. In total, 116 reports (concerning 259 adverse reactions) related to herbal medicinal products or natural remedies were found in the Swedish national pharmacovigilance database. The active ingredients most frequently suspected during the study period were black cohosh rhizome (15 reports), purple coneflower herb (14 reports) and a combination of extracts of pollen (13 reports). Adverse reactions related to skin and subcutaneous tissue were the most commonly reported reactions. No previously unknown safety problems have been discovered in the present study. This finding could be explained by a thorough pre-approval assessment of medicinal products and the fact that most herbal preparations in medicinal products have been in clinical use for many years (for traditional herbal medicinal products, the requirements are ≥30 years), i.e. adverse reactions are acknowledged and assessed before approval.

Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association.

Science.gov (United States)

Vilhelmsson, Andreas; Svensson, Tommy; Meeuwisse, Anna; Carlsten, Anders

2012-12-23

The new European pharmacovigilance legislation has been suggested as marking the beginning of a new chapter in drug safety, making patients an important part of pharmacovigilance. In Sweden since 2008 it has been possible for consumers to report adverse drug reactions (ADRs) to the Medical Products Agency (MPA), and these reports are now understood as an increasingly valuable contribution in the monitoring of safety aspects in medicines. Already in 2002 it was possible to report experiences with medicines to the non-profit and independent organization Consumer Association for Medicines and Health (KILEN) through a web-based report form with an opportunity to describe ADR experiences in free text comments. The aim of this study was to qualitatively analyze the free text comments appended to consumer reports on antidepressant medication. All reports of suspected adverse reactions regarding antidepressant medications submitted from January 2002 to April 2009 to KILEN's Internet-based reporting system in Sweden were analyzed according to reported narrative experience(s). Content analysis was used to interpret the content of 181 reports with free text comments. Three main categories emerged from the analyzed data material: (1) Experiences of drug treatment with subcategories (a) Severe psychiatric adverse reactions, and (b) Discontinuation symptoms; (2) Lack of communication and (3) Trust and distrust. A majority of the reports to KILEN were from patients experiencing symptoms of mental disturbances (sometimes severe) affecting them in many different ways, especially during discontinuation. Several report included narratives of patients not receiving information of potential ADRs from their doctor, but also that there were no follow-ups of the treatment. Trust was highlighted as especially important and some patients reported losing confidence in their doctor when they were not believed about the suspected ADRs they experienced, making them attempt to discontinue their

Mesotherapy-induced panniculitis treated with dapsone: case report and review of reported adverse effects of mesotherapy.

Science.gov (United States)

Tan, Jennifer; Rao, Babar

2006-01-01

Mesotherapy is a procedure involving the injection of substances into the dermis and subcutaneous tissue. Used in Europe for decades in the treatment of various medical conditions and cosmetic fat dissolution, the technique only recently became widely available in the United States. Mesotherapy has been surrounded by controversy pertaining to efficacy and has been associated with localized complications, including allergic reactions, necrosis, and infections. Panniculitis is a rare adverse reaction to mesotherapy that may result from injection pressure, local trauma, or the type of injected substances. Treatment options for complications are limited. We report a case of mesotherapy-induced panniculitis successfully treated with dapsone. This case illustrates one of the potential adverse effects of mesotherapy and suggests that dapsone may be effective in the treatment of panniculitis resulting from such injections. Reported adverse effects associated with mesotherapy are also reviewed.

The curvilinear relationship of early-life adversity and successful aging: the mediating role of mental health.

Science.gov (United States)

Höltge, Jan; Mc Gee, Shauna L; Thoma, Myriam V

2018-02-15

The steeling effect suggests that early-life adversity can have a beneficial impact later in life. However, little is known about its underlying mechanisms and long-term outcomes . The study aimed to examine the role of early-life adversity (ELA) on successful aging, and whether this relationship can be explained by mental and physical health. Socio-demographics, early-life adversity (ELA), individual quality of life (iQoL), and mental and physical health of 270 individuals (M age = 66.82 years, 71.5% female) were assessed. Polynomial regressions and mediation analyses were conducted. Significant inverse U-shaped associations were found between ELA and iQoL (β = -.59, p = .005) and between ELA and mental health (β = -.64, p = .002), but not between ELA and physical health. Furthermore, mental health significantly mediated the relationship between ELA and iQoL (b = -.84, BCa CI [-1.66, -.27]). Highest level of individual quality of life (i.e. successful aging) was related to a moderate amount of ELA. Additionally, mental health significantly mediated this relationship. These findings suggest that some amount of ELA could be beneficial for successful aging. Resource-focused interventions are needed to improve health and promote successful aging for an underdetected, at-risk subgroup with low early-life adversity.

Childhood adversity and behavioral health outcomes for youth: An investigation using state administrative data.

Science.gov (United States)

Lucenko, Barbara A; Sharkova, Irina V; Huber, Alice; Jemelka, Ron; Mancuso, David

2015-09-01

This study aimed to measure the relative contribution of adverse experiences to adolescent behavioral health problems using administrative data. Specifically, we sought to understand the predictive value of adverse experiences on the presence of mental health and substance abuse problems for youth receiving publicly funded social and health services. Medicaid claims and other service records were analyzed for 125,123 youth age 12-17 and their biological parents. Measures from administrative records reflected presence of parental domestic violence, mental illness, substance abuse, criminal justice involvement, child abuse and/or neglect, homelessness, and death of a biological parent. Mental health and substance abuse status of adolescents were analyzed as functions of adverse experiences and other youth characteristics using logistic regression. In multivariate analyses, all predictors except parental domestic violence were statistically significant for substance abuse; parental death, parental mental illness, child abuse or neglect and homelessness were statistically significant for mental illness. Odds ratios for child abuse/neglect were particularly high in both models. The ability to identify risks during childhood using administrative data suggests the potential to target prevention and early intervention efforts for children with specific family risk factors who are at increased risk for developing behavioral health problems during adolescence. This study illustrates the utility of administrative data in understanding adverse experiences on children and the advantages and disadvantages of this approach. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

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......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...

All Unhappy Childhoods Are Unhappy in Their Own Way—Differential Impact of Dimensions of Adverse Childhood Experiences on Adult Mental Health and Health Behavior

Directory of Open Access Journals (Sweden)

Anna L. Westermair

2018-05-01

Full Text Available Adverse childhood experiences have consistently been linked with poor mental and somatic health in adulthood. However, due to methodological restraints of the main lines of research using cumulative or selective models, little is known about the differential impact of different dimensions of adverse childhood experiences. Therefore, we gathered data from 396 psychiatric in-patients on the Adverse Childhood Experiences (ACE questionnaire, extracted dimensions using factor analysis and compared this dimensional model of adverse childhood experiences to cumulative and selective models. Household Dysfunction (violence against the mother, parental divorce, substance abuse or incarceration of a household member was associated with poor health behaviors (smoking, alcohol dependency and obesity as proxy marker for an imbalance between energy intake and physical activity and with poorer socio-economic achievement (lower education and income in adulthood. The previously reported associations of maltreatment and sexual abuse with these outcome criteria could not be corroborated. Both Maltreatment (emotional and physical neglect and abuse and Sexual Abuse predicted BPD, PTSD and suicidal behavior. However, the two ACE dimensions showed sufficiently divergent validity to warrant separate consideration in future studies: Maltreatment was associated with affective and anxiety disorders such as social phobia, panic disorder and major depressive disorder, whereas Sexual Abuse was associated with dysregulation of bodily sensations such as pain intensity and hunger/satiation. Also, we found both quantitative and qualitative evidence for the superiority of the dimensional approach to exploring the consequences of adverse childhood experiences in comparison to the cumulative and selective approaches.

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

Science.gov (United States)

Vilhelmsson, Andreas; Svensson, Tommy; Meeuwisse, Anna; Carlsten, Anders

2011-10-25

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 and independent organization Consumer Association for Medicines and Health, KILEN has launched the possibility for consumers to report their perceptions and experiences from their use of medicines in order to strengthen consumer rights within the health care sector. This study aimed to analyze these consumer reports. All reports submitted from January 2002 to April 2009 to an open web site in Sweden where anyone could report their experience with the use of pharmaceuticals were analyzed with focus on common psychiatric side effects related to antidepressant usage. More than one ADR for a specific drug could be reported. In total 665 reports were made during the period. 442 reports concerned antidepressant medications and the individual antidepressant reports represented 2392 ADRs and 878 (37%) of these were psychiatric ADRs. 75% of the individual reports concerned serotonin-reuptake inhibitor (SSRI) and the rest serotonin-norepinephrine reuptake inhibitor (SNRI). Women reported more antidepressant psychiatric ADRs (71%) compared to men (24%). More potentially serious psychiatric ADRs were frequently reported to KILEN and withdrawal symptoms during discontinuation were also reported as a common issue. The present study indicates that consumer reports may contribute with important information regarding more serious psychiatric ADRs following antidepressant treatment. Consumer reporting may be considered a complement to traditional ADR reporting.

Health insurance, cost expectations, and adverse job turnover.

Science.gov (United States)

Ellis, Randall P; Albert Ma, Ching-To

2011-01-01

Because less healthy employees value health insurance more than the healthy ones, when health insurance is newly offered job turnover rates for healthier employees decline less than turnover rates for the less healthy. We call this adverse job turnover, and it implies that a firm's expected health costs will increase when health insurance is first offered. Health insurance premiums may fail to adjust sufficiently fast because state regulations restrict annual premium changes, or insurers are reluctant to change premiums rapidly. Even with premiums set at the long run expected costs, some firms may be charged premiums higher than their current expected costs and choose not to offer insurance. High administrative costs at small firms exacerbate this dynamic selection problem. Using 1998-1999 MEDSTAT MarketScan and 1997 Employer Health Insurance Survey data, we find that expected employee health expenditures at firms that offer insurance have lower within-firm and higher between-firm variance than at firms that do not. Turnover rates are systematically higher in industries in which firms are less likely to offer insurance. Simulations of the offer decision capturing between-firm health-cost heterogeneity and expected turnover rates match the observed pattern across firm sizes well. 2010 John Wiley & Sons, Ltd.

The pharmacist and adverse drug reaction reporting.

Science.gov (United States)

Pearson, K

1982-08-01

During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.

Adverse reactions to radiopharmaceuticals and their reporting

International Nuclear Information System (INIS)

Keeling, D.

1988-01-01

Adverse reactions to radiopharmaceuticals are uncommon and the great majority that do occur are relatively trivial and require little or no treatment. Reporting schemes for such reactions are in operation in a number of countries but they vary in their effectiveness and the best collect only a minority of cases; only 10-15% of total reactions in the United Kingdom, for instance. Radiopharmaceutical reaction reports in the UK for the period 1982-1987 are summarised in a table and then discussed. Reliable incidence figures for such reactions are difficult to obtain. The UK figure is estimated here to be near 1 per 2000. The great majority of reactions reported are of an idiopathic hypersensitivity nature and are related to the chemical form of the material; radiation has very rarely caused recognisable problems since the discontinuance of colloid gold for lymphatic clearance studies. The value of such reaction reports is their role as a forewarning to doctors

Act to keep patients safe: device-related adverse event reporting.

Science.gov (United States)

Schoem, Scott R; Shah, Udayan K

2010-05-01

Primum non nocere- "Above all do no harm." Since the first year of medical school, we have all heard and spoken this dictum countless times. Translating this dictum into action may present challenges in our daily practice. Every day, clinicians must distinguish between scientific evidence, clinical experience, and marketing claims by industry vendors of improved efficacy and safety regarding medical devices. Adverse event reporting and device failure notification are generally laid out well in hospital practice settings. Reporting beyond the local level takes on a new dimension for most surgeons. Perceived stigma from peers and corporations, lack of confidentiality, and cynicism regarding protective actions for patients should not limit one from "raising the alarm" when concerns arise about device safety or performance. This commentary aims to explain the process for reporting device-related adverse events. Copyright 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

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

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Vinther, Line Dausel; Jensen, Christian Møller; Hjelmager, Ditte Meulengracht; Lyhne, Nicoline; Nøhr, Christian

2017-01-01

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

Sharing adverse drug event data using business intelligence technology.

Science.gov (United States)

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

2009-03-01

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

77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

Science.gov (United States)

2012-02-24

... organizational unit responsible for adverse event reporting compliance when these conditions exist and when the...'s current thinking on postmarketing adverse event reporting for medical products and dietary...

Development of an adverse events reporting form for Korean folk medicine.

Science.gov (United States)

Park, Jeong Hwan; Choi, Sun-Mi; Moon, Sujeong; Kim, Sungha; Kim, Boyoung; Kim, Min-Kyeoung; Lee, Sanghun

2017-05-01

We developed an adverse events (AEs) reporting form for Korean folk medicine. The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Knowledge, Attitude and Practice of Adverse Drug Reaction ...

African Journals Online (AJOL)

Erah

. Keywords: Adverse drug reactions; Knowledge, attitude and practice; Health care workers; Yellow card reporting scheme. Received: 24 August 2010. Revised accepted: 22 April 2011. *Corresponding author: E-mail: jofadare@gmail.com ...

Adverse event reporting patterns of newly approved drugs in the USA in 2006: an analysis of FDA Adverse Event Reporting System data.

Science.gov (United States)

Chhabra, Pankdeep; Chen, Xing; Weiss, Sheila R

2013-11-01

The Weber effect states that adverse event (AE) reporting tends to increase in the first 2 years after a new drug is placed onto the market, peaks at the end of the second year, and then declines. However, since the Weber effect was originally described, there has been improvement in the communication of safety information and new policies regarding the reporting of AEs by healthcare professionals and consumers, prompting reassessment of the existence of the Weber effect in the current AE reporting scenario. To determine the AE reporting patterns for new molecular entity (NME) drugs and biologics approved in 2006 and to examine these patterns for the existence of the Weber effect. Publicly available FDA Adverse Event Reporting System data were used to assess the AE reporting patterns for a 5-year period from the drug’s approval date. The total number of annual reports from all sources, based on the report date, was plotted against time (in years). In the period from 2006 to 2011, a total of 91,187 AE reports were submitted for 19 NMEs approved in 2006. The highest number of AE reports were submitted for varenicline tartrate (N = 47,158) and the lowest number for anidulafungin (N = 161). Anidulafungin was reported to have the highest proportion of death reports (36 %) and varenicline tartrate the lowest proportion (1.7 %). The classic Weber pattern was not observed for any of the 19 NMEs approved in 2006. While there was no one predominant pattern of AE report volume, we grouped the drugs into four general categories; the majority of drugs had either a continued increase in reports (Category A 31.6 %) or an N-pattern with reporting reaching an initial peak in year 2 or 3, declining and then beginning to climb again (Category B 42.1 %). There have been numerous changes in AE reporting, particularly a huge increase in overall annual report volume, since the Weber effect was first reported. Our results suggest that a Weber-type reporting pattern should not be assumed

A multilevel analysis to explain self-reported adverse health effects and adaptation to urban heat: a cross-sectional survey in the deprived areas of 9 Canadian cities

Directory of Open Access Journals (Sweden)

Diane Bélanger

2016-02-01

Full Text Available Abstract Background This study identifies the characteristics and perceptions related to the individual, the dwelling and the neighbourhood of residence associated with the prevalence of self-reported adverse health impacts and an adaptation index when it is very hot and humid in summer in the most disadvantaged sectors of the nine most populous cities of Québec, Canada, in 2011. Methods The study uses a cross-sectional design and a stratified representative sample; 3485 people (individual-level were interviewed in their residence. They lived in 1647 buildings (building-level in 87 most materially and socially disadvantaged census dissemination areas (DA-level. Multilevel analysis was used to perform 3-level models nested one in the other to examine individual impacts as well as the adaptation index. Results For the prevalence of impacts, which is 46 %, the logistic model includes 13 individual-level indicators (including air conditioning and the adaptation index and 1 building-level indicator. For the adaptation index, with values ranging from -3 to +3, the linear model has 10 individual-level indicators, 1 building-level indicator and 2 DA-level indicators. Of all these indicators, 9 were associated to the prevalence of impacts only and 8 to the adaptation index only. Conclusion This 3-level analysis shows the differential importance of the characteristics of residents, buildings and their surroundings on self-reported adverse health impacts and on adaptation (other than air conditioning under hot and humid summer conditions. It also identifies indicators specific to impacts or adaptation. People with negative health impacts from heat rely more on adaptation strategies while low physical activity and good dwelling/building insulation lead to lower adaptation. Better neighbourhood walkability favors adaptations other than air conditioning. Thus, adaptation to heat in these neighbourhoods seems reactive rather than preventive. These first multi

A multilevel analysis to explain self-reported adverse health effects and adaptation to urban heat: a cross-sectional survey in the deprived areas of 9 Canadian cities.

Science.gov (United States)

Bélanger, Diane; Abdous, Belkacem; Valois, Pierre; Gosselin, Pierre; Sidi, Elhadji A Laouan

2016-02-12

This study identifies the characteristics and perceptions related to the individual, the dwelling and the neighbourhood of residence associated with the prevalence of self-reported adverse health impacts and an adaptation index when it is very hot and humid in summer in the most disadvantaged sectors of the nine most populous cities of Québec, Canada, in 2011. The study uses a cross-sectional design and a stratified representative sample; 3485 people (individual-level) were interviewed in their residence. They lived in 1647 buildings (building-level) in 87 most materially and socially disadvantaged census dissemination areas (DA-level). Multilevel analysis was used to perform 3-level models nested one in the other to examine individual impacts as well as the adaptation index. For the prevalence of impacts, which is 46 %, the logistic model includes 13 individual-level indicators (including air conditioning and the adaptation index) and 1 building-level indicator. For the adaptation index, with values ranging from -3 to +3, the linear model has 10 individual-level indicators, 1 building-level indicator and 2 DA-level indicators. Of all these indicators, 9 were associated to the prevalence of impacts only and 8 to the adaptation index only. This 3-level analysis shows the differential importance of the characteristics of residents, buildings and their surroundings on self-reported adverse health impacts and on adaptation (other than air conditioning) under hot and humid summer conditions. It also identifies indicators specific to impacts or adaptation. People with negative health impacts from heat rely more on adaptation strategies while low physical activity and good dwelling/building insulation lead to lower adaptation. Better neighbourhood walkability favors adaptations other than air conditioning. Thus, adaptation to heat in these neighbourhoods seems reactive rather than preventive. These first multi-level insights pave the way for the development of a

Adverse health effects associated with Islamic fasting -A literature review

Directory of Open Access Journals (Sweden)

Nania Mohamed Pakkir Maideen

2017-09-01

Full Text Available Introduction: Millions of Muslims across the world observe Islamic fasting during the holy month of Ramadan, as well as the other specific dates in the lunar calendar year. While fasting during this month, Muslims refrain from eating or drinking from dawn to dusk. Islamic fasting is similar to alternate day fasting (ADF since it incorporates an average of 12 hours of fasting and 12 hours of feasting periods. This present review study is aimed to find out the common adverse health effects associated with Islamic fasting and the preventive measures to be followed to avoid them. Methods: The literature was reviewed through searching in databases such as PubMed, Google Scholar, and reference lists to identify the related articles. Results: Many health benefits have been attributed to Islamic fasting, including the reduced risk of cardiovascular diseases, diabetes, cancer, hypertension, and asthma. On the other hand, some studies have mentioned a few health problems associated with Islamic fasting, such as headaches, heartburn, constipation, dehydration, decreased sleep quality, and anemia, which may occur in some fasting individuals during Ramadan. Conclusion: Islamic fasting could be beneficial for health if it is performed correctly. During Ramadan, fasting individuals are advised to adhere to a balanced diet that contains sufficient portions of fruits and vegetables, whole grains, pulses, meat, fish, milk, and dairy products. Moreover, fasting individuals must drink adequate fluids, such as water, fresh fruit juices, and soups, in order to prevent the possible adverse health effects associated with Islamic fasting.

Identification of a Syndrome Class of Neuropsychiatric Adverse Reactions to Mefloquine from Latent Class Modeling of FDA Adverse Event Reporting System Data.

Science.gov (United States)

Nevin, Remington L; Leoutsakos, Jeannie-Marie

2017-03-01

Although mefloquine use is known to be associated with a risk of severe neuropsychiatric adverse reactions that are often preceded by prodromal symptoms, specific combinations of neurologic or psychiatric reactions associated with mefloquine use are not well described in the literature. This study sought to identify a distinct neuropsychiatric syndrome class associated with mefloquine use in reports of adverse events. Latent class modeling of US Food and Drug Administration Adverse Event Reporting System (FAERS) data was performed using indicators defined by the Medical Dictionary for Regulatory Activities neurologic and psychiatric high-level group terms, in a study dataset of FAERS reports (n = 5332) of reactions to common antimalarial drugs. A distinct neuropsychiatric syndrome class was identified that was strongly and significantly associated with reports of mefloquine use (odds ratio = 3.92, 95% confidence interval 2.91-5.28), defined by a very high probability of symptoms of deliria (82.7%) including confusion and disorientation, and a moderate probability of other severe psychiatric and neurologic symptoms including dementia and amnesia (18.6%) and seizures (18.1%). The syndrome class was also associated with symptoms that are considered prodromal including anxiety, depression, sleep disturbance, and abnormal dreams, and neurological symptoms such as dizziness, vertigo, and paresthesias. This study confirms in FAERS reports the existence of a severe mefloquine neuropsychiatric syndrome class associated with common symptoms that may be considered prodromal. Clinical identification of the characteristic symptoms of this syndrome class may aid in improving case finding in pharmacovigilance studies of more serious adverse reactions to the drug.

[Adverse health events and health hazards reflections of epidemiologists and environmentalists].

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Vitale, Ksenija; Smoljanović, Mladen

2010-12-01

In this article we present management of water resources in Croatia as a model of integral approach in public health interventions. The links between provision of clean water, sanitation and good health are so strong that today management and water protection are deeply integrated in primary health care. This article is a follow up on topics presented on 2nd Croatian congress on preventive medicine and health promotion which gave us "state of art" in Croatian public health. We strongly believe that every system has its own advantages and downsides, and only by knowing the system well and continuous improvement we can protect ourselves in time of health, social or economic crisis. The model of water protection showed that to prevent and overcome the variety of water-related health risks, implementation of various activities that include general environmental protection, development of water management system, permanent water quality monitoring and control, and improvement of standards and legislative is needed. On the other hand if there is no holistic approach, to the public health problems, all the efforts in just one field will not result in health indicators improvement. Constant monitoring and uniform analysis of data could help to identify possible risks of adverse effects of various environmental factors and possible burden of disease as a consequence. That information could be a point of arguing with local governments and communities for public health interventions. It is important that epidemiological and environmental data do not remain in the domain of academic discussion or statistics, and never reach primary health care which could use them in direct health care providing. Information exchange in real time is important for the real time public health intervention. Primary health care is the front line in communication with patients and diagnostics of disease as well as prevention, and they need to have access to all relevant data.

Childhood adversities and clinical symptomatology in first-episode psychosis.

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Lindgren, Maija; Mäntylä, Teemu; Rikandi, Eva; Torniainen-Holm, Minna; Morales-Muñoz, Isabel; Kieseppä, Tuula; Mantere, Outi; Suvisaari, Jaana

2017-12-01

In addition to severe traumatic experiences, milder, more common childhood adversities reflecting psychosocial burden may also be common in people with psychotic disorders and have an effect on symptomatology and functioning. We explored eleven negative childhood experiences and their influence on clinical symptoms among young adults with first-episode psychosis (FEP, n = 75) and matched population controls (n = 51). Individuals with FEP reported more adversities than controls. Specifically serious conflicts within the family, bullying at school, maternal mental health problems, and one's own and parents' serious illness during childhood were experienced by the patients more often than by controls. In the FEP group, the severity of adversity was associated with increased anxiety, manic, and obsessive-compulsive symptoms, but not with the severity of positive psychotic symptoms. Adversity produced a more pronounced effect on symptoms in male patients than in female patients. To conclude, in line with earlier studies of more chronic psychosis, a majority of the participants with FEP reported exposure to childhood adversities, with the FEP group reporting more adversities than controls. High levels of mood and anxiety symptoms in patients with FEP may be related to cumulative exposure to childhood adversities. This should be taken into account in the treatment for FEP. Copyright © 2017 Elsevier B.V. All rights reserved.

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

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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…

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

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......Med 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...

The Association Between Adverse Child Health, Psychological, Educational and Social Outcomes, and Nondependent Parental Substance: A Rapid Evidence Assessment.

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McGovern, Ruth; Gilvarry, Eilish; Addison, Michelle; Alderson, Hayley; Geijer-Simpson, Emma; Lingam, Raghu; Smart, Debbie; Kaner, Eileen

2018-01-01

Between 5% and 30% of children in high-income countries live with a substance misusing parent, the majority of which is below dependent levels. However, little is understood about the impact of nondependent parental substance misuse upon children. We searched the international literature using rigorous systematic methods to identify studies examining parental substance misuse and adverse outcomes in children. The inclusion criteria were cross-sectional, longitudinal, case-control, and cohort studies; of children aged 0-18 years whose parents are high-risk substance misusers; reporting on their health, psychological, substance use, educational, and social outcomes. We identified 36 papers (from 33 unique studies), most of which were assessed as being of medium to high methodological quality ( N= 28). Parental nondependent substance misuse was found to be associated with adversity in children, with strong evidence of an association with externalizing difficulties ( N = 7 papers, all finding an association) and substance use ( N = 23 papers, all finding an association) in adolescents and some evidence of adverse health outcomes in early childhood ( N = 6/8 papers finding an association). There is less evidence of an association between parental substance misuse and adverse educational and social outcomes. The body of evidence was largest for parental alcohol misuse, with research examining the impact of parental illicit drug use being limited. Methodological limitations restrict our ability to make causal inference. Nonetheless, the prevalence of adverse outcomes in children whose parents are nondependent substance misusers highlights the need for practitioners to intervene with this population before a parent has developed substance dependency.

Information about adverse drug reactions reported in children

DEFF Research Database (Denmark)

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

2010-01-01

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...... included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category...... of reporter. ADR occurrence was calculated as incidence rate and prevalence. RESULTS: We included 33 studies monitoring ADRs in general paediatric populations. The highest numbers of ADRs were reported in national ADR databases where data were collected over a longer period than in studies monitoring...

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

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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.

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

Expert panel evaluation of health information technology effects on adverse events.

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Abramson, Erika L; Kern, Lisa M; Brenner, Samantha; Hufstader, Meghan; Patel, Vaishali; Kaushal, Rainu

2014-08-01

Adverse events (AEs) among hospitalized patients occur frequently and result in significant sequelae. Federal policy is incentivizing health information technology (HIT) use, although research demonstrating safety benefits from HIT is mixed. Our objective was to evaluate the potential effects of HIT on reducing 21 different inpatient AEs. Identifying AEs most likely to be reduced by HIT can inform the design of future studies evaluating its effectiveness. We conducted a modified Delphi panel of national experts in HIT and safety. We conducted a focused literature review to inform the experts. Using a novel framework, experts rated each AE as 'definitely reduced by health IT,' 'possibly reduced by health IT' and 'not likely to be reduced by health IT'. From our panel discussion, experts identified six AEs as 'definitely reduced by health IT': (1) adverse drug events (ADEs) associated with digoxin; (2) ADE associated with IV heparin; (3) ADE associated with hypoglycaemic agents; (4) ADE associated with low molecular weight heparin and factor Xa inhibitor; (5) contrast nephropathy associated with catheter angiography; and (6) ADE hospital-acquired antibiotic-associated Clostridium difficile. Understanding the effects of HIT on patient outcomes will be essential to ensuring that the significant federal investment results in anticipated improvements. This study serves as an important early step in helping with the design of future work evaluating level of HIT infrastructure and rates of inpatient AEs. © 2014 John Wiley & Sons, Ltd.

The Relationship between Adverse Childhood Events, Resiliency and Health among Children with Autism

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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.…

Racial disparities in reported prenatal care advice from health care providers.

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Kogan, M D; Kotelchuck, M; Alexander, G R; Johnson, W E

1994-01-01

OBJECTIVES. The relationship between certain maternal behaviors and adverse pregnancy outcomes has been well documented. One method to alter these behaviors is through the advice of women's health care providers. Advice from providers may be particularly important in minority populations, who have higher rates of infant mortality and prematurity. This study examines racial disparities according to women's self-report of advice received from health care providers during pregnancy in four areas: tobacco use, alcohol consumption, drug use, and breast-feeding. METHODS. Health care providers' advice to 8310 White non-Hispanic and Black women was obtained from the National Maternal and Infant Health Survey. RESULTS. After controlling for sociodemographic, utilization, and medical factors, Black women were more likely to report not receiving advice from their prenatal care providers about smoking cessation and alcohol use. The difference between Blacks and Whites also approached significance for breast-feeding. No overall difference was noted in advice regarding cessation of drug use, although there was a significant interaction between race and marital status. CONCLUSIONS. These data suggest that Black women may be at greater risk for not receiving information that could reduce their chances of having an adverse pregnancy outcome. PMID:8279618

Is there evidence that recent consolidation in the health insurance industry has adversely affected premiums?

Science.gov (United States)

Kopit, William G

2004-01-01

James Robinson suggests that recent consolidation in the insurance market has been a cause of higher health insurance prices (premiums). Although the recent consolidation among health insurers and rising premiums are indisputable, it is unlikely that consolidation has had any adverse effect on premiums nationwide, and Robinson provides no data that suggest otherwise. Specifically, he does not present data showing an increase in concentration in any relevant market during the past few years, let alone any resulting increase in premiums. Health insurance consolidation in certain local markets could adversely affect premiums, but it seems clear that it is not a major national antitrust issue.

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

Science.gov (United States)

2011-01-07

... appropriate FDA organizational unit responsible for adverse event reporting compliance when these conditions... regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking... appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions...

Adverse health consequences of the Vietnam War.

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Levy, Barry S; Sidel, Victor W

2015-01-01

The 40th anniversary of the end of the Vietnam War is a useful time to review the adverse health consequences of that war and to identify and address serious problems related to armed conflict, such as the protection of noncombatant civilians. More than 58,000 U.S. servicemembers died during the war and more than 150,000 were wounded. Many suffered from posttraumatic stress disorders and other mental disorders and from the long-term consequences of physical injuries. However, morbidity and mortality, although difficult to determine precisely, was substantially higher among the Vietnamese people, with at least two million of them dying during the course of the war. In addition, more than one million Vietnamese were forced to migrate during the war and its aftermath, including many "boat people" who died at sea during attempts to flee. Wars continue to kill and injure large numbers of noncombatant civilians and continue to damage the health-supporting infrastructure of society, expose civilians to toxic chemicals, forcibly displace many people, and divert resources away from services to benefit noncombatant civilians. Health professionals can play important roles in promoting the protection of noncombatant civilians during war and helping to prevent war and create a culture of peace.

Reporting of adverse drug reactions: predictors of under-reporting in Malaysia.

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Aziz, Zoriah; Siang, Tan Ching; Badarudin, Nurul Suhaida

2007-02-01

Malaysia like many other countries worldwide uses spontaneous reporting systems as a mean of collecting data on suspected adverse drug reaction (ADR). However, compared to other countries, which use the system, the reporting rate in Malaysia is very low. Why some physicians do not report ADRs is not well understood. To identify factors, which would predict physicians' failure to send ADR reports. Face-to-face interview using a structured questionnaire involving physicians working at the University of Malaya Medical Centre, Malaysia. About a third of the physicians in the Centre participated. Sixty-five of the 415 approached refused to participate. A high proportion of the respondents (81.4%) indicated that they had suspected an ADR but did not report it, while about 40% of the respondents were not aware of the existence of the national reporting system in Malaysia. Logistic regression modelling identified the variable 'ADR considered to be too trivial or too well known to report' as the strongest predictor of not reporting, followed by physicians' category and uncertainty that the reaction had been definitely caused by a drug. Important predictor variables, which limit physicians from reporting ADR in Malaysia, were related to uncertainty of types of reaction to report, lack of awareness about the existence, function and purpose of national ADR reporting. The findings could be useful for planning strategies to improve the reporting rate.

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

for content analysis4 and thematic analysis5. Medical experts and simulation faculty will design scenarios for in situ simulation training based on the analysis. Short-term observations using time logs will be performed along with interviews with key informants at the departments. Video data will be collected...... 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...

Self-reported adverse tattoo reactions: a New York City Central Park study.

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Brady, Bobbi G; Gold, Heidi; Leger, Elizabeth A; Leger, Marie C

2015-08-01

Although permanent tattoos are becoming increasingly commonplace, there is a paucity of epidemiological data on adverse tattoo reactions. Several European studies have indicated that tattoo reactions may be relatively common, although the extent of this phenomenon in the United States is largely unknown. To provide insights into the prevalence and nature of adverse tattoo reactions. We administered a survey about adverse tattoo reactions to 300 randomly selected tattooed people in Central Park, New York City. Of 300 participants, 31 (10.3%) reported experiencing an adverse tattoo reaction, 13 (4.3%) reported acute reactions, and 18 (6.0%) suffered from a chronic reaction involving a specific colour lasting for >4 months. Forty-four per cent of colour-specific reactions were to red ink, which was only slightly higher than the frequency of red ink in the sampled population (36%). Twenty-five per cent of chronic reactions were to black ink, which was less than expected based on the number of respondents with black tattoos (90.3%). Study participants with chronic, colour-specific reactions had more tattoo colours than those without reactions. This study shows that tattoo reactions are relatively common, and that further investigation into the underlying causes is merited. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Disclosing large scale adverse events in the US Veterans Health Administration: lessons from media responses.

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Maguire, E M; Bokhour, B G; Asch, S M; Wagner, T H; Gifford, A L; Gallagher, T H; Durfee, J M; Martinello, R A; Elwy, A R

2016-06-01

We examined print, broadcast and social media reports about health care systems' disclosures of large scale adverse events to develop future effective messaging. Directed content analysis. We systematically searched four communication databases, YouTube and Really Simple Syndication (RSS) feeds relating to six disclosures of lapses in infection control practices in the Department of Veterans Affairs occurring between 2009 and 2012. We assessed these with a coding frame derived from effective crisis and risk communication models. We identified 148 unique media reports. Some components of effective communication (discussion of cause, reassurance, self-efficacy) were more present than others (apology, lessons learned). Media about 'promoting secrecy' and 'slow response' appeared in reports when time from event discovery to patient notification was over 75 days. Elected officials' quotes (n = 115) were often negative (83%). Hospital officials' comments (n = 165) were predominantly neutral (92%), and focused on information sharing. Health care systems should work to ensure that they develop clear messages focused on what is not well covered by the media, including authentic apologies, remedial actions taken, and shorten the timeframe between event identification and disclosure to patients. Published by Elsevier Ltd.

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

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

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

Directory of Open Access Journals (Sweden)

Jeppe Bennekou Schroll

2016-08-01

Full Text Available 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

Development of an online morbidity, mortality, and near-miss reporting system to identify patterns of adverse events in surgical patients.

Science.gov (United States)

Bilimoria, Karl Y; Kmiecik, Thomas E; DaRosa, Debra A; Halverson, Amy; Eskandari, Mark K; Bell, Richard H; Soper, Nathaniel J; Wayne, Jeffrey D

2009-04-01

To design a Web-based system to track adverse and near-miss events, to establish an automated method to identify patterns of events, and to assess the adverse event reporting behavior of physicians. A Web-based system was designed to collect physician-reported adverse events including weekly Morbidity and Mortality (M&M) entries and anonymous adverse/near-miss events. An automated system was set up to help identify event patterns. Adverse event frequency was compared with hospital databases to assess reporting completeness. A metropolitan tertiary care center. Identification of adverse event patterns and completeness of reporting. From September 2005 to August 2007, 15,524 surgical patients were reported including 957 (6.2%) adverse events and 34 (0.2%) anonymous reports. The automated pattern recognition system helped identify 4 event patterns from M&M reports and 3 patterns from anonymous/near-miss reporting. After multidisciplinary meetings and expert reviews, the patterns were addressed with educational initiatives, correction of systems issues, and/or intensive quality monitoring. Only 25% of complications and 42% of inpatient deaths were reported. A total of 75.2% of adverse events resulting in permanent disability or death were attributed to the nature of the disease. Interventions to improve reporting were largely unsuccessful. We have developed a user-friendly Web-based system to track complications and identify patterns of adverse events. Underreporting of adverse events and attributing the complication to the nature of the disease represent a problem in reporting culture among surgeons at our institution. Similar systems should be used by surgery departments, particularly those affiliated with teaching hospitals, to identify quality improvement opportunities.

Electric fans for reducing adverse health impacts in heatwaves.

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Gupta, Saurabh; Carmichael, Catriona; Simpson, Christina; Clarke, Mike J; Allen, Claire; Gao, Yang; Chan, Emily Y Y; Murray, Virginia

2012-07-11

Heatwaves are hot weather events, which breach regional or national thresholds, that last for several days. They are likely to occur with increasing frequency in some parts of the world. The potential consequences were illustrated in Europe in August 2003 when there were an estimated 30,000 excess deaths due to a heatwave. Electric fans might be used with the intention of reducing the adverse health effects of a heatwave. Fans do not cool the ambient air but can be used to draw in cooler air from outside when placed at an open window. The aim of the fans would be to increase heat loss by increasing the efficiency of all normal methods of heat loss, but particularly by evaporation and convection methods. However, it should be noted that increased sweating can lead to dehydration and electrolyte imbalances if these fluids and electrolytes are not replaced quickly enough. Research has also identified important gaps in knowledge about the use of fans, which might lead to their inappropriate use. To determine whether the use of electric fans contributes to, or impedes, heat loss at high ambient temperatures during a heatwave, and to contribute to the evidence base for the public health impacts of heatwaves. We sought unpublished and published studies that had been published in any language. The review team were able to assess studies reported in English, Chinese, Dutch, French and German; and reports in other languages would have been translated into English as necessary. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, the Indian biomedical literature (IndMED and MedIND) and databases of Chinese literature (Chinese Journal Net and Digital Periodical of WanFang Data). The most recent electronic searches were done in April 2012. We also checked the reference lists of relevant articles and the websites of relevant national and international organisations, and consulted with researchers and policy makers with experience in

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

Disclosure of adverse events: a data linkage study reporting patient experiences among Australian adults aged ≥ 45 years.

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Walton, Merrilyn; Harrison, Reema; Smith-Merry, Jennifer; Kelly, Patrick; Manias, Elizabeth; Jorm, Christine; Iedema, Rick

2018-04-26

Objective Since Australia initiated national open disclosure standards in 2002, open disclosure policies have been adopted in all Australian states and territories. Yet, research evidence regarding their adoption is limited. The aim of the present study was to determine the frequency with which patients who report an adverse event had information disclosed to them about the incident, including whether they participated in a formal open disclosure process, their experiences of the process and the extent to which these align with the current New South Wales (NSW) policy. Methods A cross-sectional survey about patient experiences of disclosure associated with an adverse event was administered to a random sample of 20000 participants in the 45 and Up Study who were hospitalised in NSW, Australia, between January and June 2014. Results Of the 18993 eligible potential participants, completed surveys were obtained from 7661 (40% response rate), with 474 (7%) patients reporting an adverse event. Of those who reported an adverse event, a significant majority reported an informal or bedside disclosure (91%; 430/474). Only 79 patients (17%) participated in a formal open disclosure meeting. Most informal disclosures were provided by nurses, with only 25% provided by medical practitioners. Conclusions Experiences of open disclosure may be enhanced by informing patients of their right to full disclosure in advance of or upon admission to hospital, and recognition of and support for informal or bedside disclosure for appropriate types of incidents. A review of the open disclosure guidelines in relation to the types of adverse events that require formal open disclosure and those more suitable to informal bedside disclosure is indicated. Guidelines for bedside disclosure should be drafted to assist medical practitioners and other health professionals facilitate and improve their communications about adverse events. Alignment of formal disclosure with policy requirements may also be

Adverse Events in the Netherlands Vaccination Programme : Reports in 2010 and Review 1994-2010

NARCIS (Netherlands)

Vermeer-de Bondt PE; Moorer-Lanser N; PHaff TAJ; Oostvogels B; Wesselo C; van der Maas NAT; LCI; cib

2012-01-01

In 2010, 800,000 children received one or more vaccines on 1.3 million dates, with more than 7 million vaccine components. There is always some chance of adverse reactions but these are usually not severe, though sometimes frightening. This year, RIVM received 1380 reports of adverse events

Population attributable fractions of psychopathology and suicidal behaviour associated with childhood adversities in Northern Ireland.

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McLafferty, Margaret; O'Neill, Siobhan; Murphy, Sam; Armour, Cherie; Bunting, Brendan

2018-03-01

Childhood adversities are strong predictors of psychopathology and suicidality. However, specific adversities are associated with different outcomes, with cross-national variations reported. The current study examined rates of adversities reported in Northern Ireland (NI), and associations between adverse childhood experiences and psychopathology and suicidal behaviour were explored. Data was obtained from the Northern Ireland Study of Health and Stress (NISHS), conducted as part of the World Mental Health (WMH) survey initiative (2004-2008); response rate 68.4% (n = 1,986). The on-line survey used, the WHO Composite International Diagnostic Interview (CIDI) to examine psychopathology and associated risk factors in the NI population. Prevalence rates of retrospectively reported childhood adversities were calculated, with gender and age variations explored. Females were more likely to experience sexual abuse. Individuals who grew up during the worst years of the civil conflict in NI experienced elevated levels of childhood adversities. Participants who endured childhood adversities were more likely to have mental health problems but variations in risk factors were found for different disorders. Parental mental illness was associated with all disorders however, with ORs ranging from 2.20 for mood disorders to 4.07 for anxiety disorders. Population attributable fractions (PAF) estimated the reduction in psychopathology and suicidal behaviour in the population if exposure to adverse childhood events had not occurred. The highest PAF values were revealed for parental mental illness and sexual abuse. The findings indicate that a substantial proportion of psychopathology and suicide risk in NI are attributable to childhood adversities, providing support for early intervention and prevention initiatives. Copyright © 2017 Elsevier Ltd. All rights reserved.

The moderating impact of childhood adversity profiles and conflict on psychological health and suicidal behaviour in the Northern Ireland population.

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McLafferty, Margaret; O'Neill, Siobhan; Murphy, Sam; Armour, Cherie; Ferry, Finola; Bunting, Brendan

2018-04-01

Childhood adversities are key etiological factors in the onset and persistence of psychopathology. In Northern Ireland the Troubles also impacted on the population's psychological health. This study used data from the Northern Ireland Study of Health and Stress a collaborative epidemiological study which used the WMH-CIDI to assess mental health disorders in a nationally representative sample (Part 2, n = 1986). The aims of the study were to assess co-occurrences of childhood adversities and investigate the impact of adversity profiles and conflict experience on psychopathology and suicidal behaviour. Latent Class Analysis uncovered 3 discrete childhood adversity profiles, a low, medium, and high risk class. Individuals from higher risk adversity profiles displayed significantly increased odds of having psychological problems, with conflict exposure also impacting on psychopathology. However, the study revealed that the impact of conflict exposure on suicidal behaviour was moderated by latent class membership and that some adversity may actually be protective. The findings highlight the need to consider that, while adversity can have a negative impact on psychopathology, a lack of adversity early in life may hinder some people from developing adequate coping strategies. Further research is required to identify adversity patterns and other interacting factors that are protective. Copyright © 2018 Elsevier B.V. All rights reserved.

Human exposure to non-ionizing radiation and potential adverse health effects

International Nuclear Information System (INIS)

Vulevic, B.; Maric, B.; Zivkovic, D.

1999-01-01

The problem of protection from the non-ionizing radiation has presented an actual subject in the last twenty years both worldwide and in our country. Great attention has been paid to this problem throughout the world and there is not almost a field of human activities that disregards the effect of non-ionizing radiation to the human health.The object of this work is to point concisely, on the basis of numerous domestic and foreign referential data, to the potential adverse health effects caused by uncontrolled exposure to non-ionizing radiation. (author)

Changing experience of adverse medical events in the National Health Service: Comparison of two population surveys in 2001 and 2013.

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Gray, Alastair M; Fenn, Paul; Rickman, Neil; Vencappa, Dev

2017-12-01

Care quality is important to patients and providers, but is hard to measure. This study aimed to examine changes in the frequency and severity of one quality measure - adverse events associated with medical care - in Great Britain over a 12-year period when available resources initially expanded and were subsequently constrained. Data on perceived adverse events, collected from two representative population surveys in 2001 and 2013, were analysed and compared. The samples consisted of 8202 adults aged 15 and over in 2001 and 19,746 adults aged 15 and over in 2013. The main outcome measures were self-reported illness, injury or impairment caused in the opinion of the respondent by medical treatment or care. Respondents were also asked about the perceived severity of harm in terms of health and work, and any actions taken in response. The proportion of all respondents reporting that over the last three years they had suffered some illness, injury or impairment that in their opinion was caused by their medical treatment or care was 2.5% (497/19746) in 2013, compared with 4.8% (391/8202) in 2001, a reduction of 33% after adjusting for age, gender, income and social class differences between the two surveys. Perceived impact on health and work of these events was similar in both surveys, as was the proportion of injured respondents who pursued a legal claim for financial compensation, at 11% (53/497) in 2013 and 10.5% (41/391) in 2001. We also report multivariate analyses of perceived harm rates and severity, and propensity to seek, and accept, compensation. Our results suggest that the NHS became significantly safer over this period when measured by patient perceived harm from medical care. Our survey method could provide a valuable contribution to the monitoring of trends in health-care related adverse events and the impact of patient safety initiatives. Copyright © 2017. Published by Elsevier Ltd.

Bridging data models and terminologies to support adverse drug event reporting using EHR data.

Science.gov (United States)

Declerck, G; Hussain, S; Daniel, C; Yuksel, M; Laleci, G B; Twagirumukiza, M; Jaulent, M-C

2015-01-01

This article is part of the Focus Theme of METHODs of Information in Medicine on "Managing Interoperability and Complexity in Health Systems". SALUS project aims at building an interoperability platform and a dedicated toolkit to enable secondary use of electronic health records (EHR) data for post marketing drug surveillance. An important component of this toolkit is a drug-related adverse events (AE) reporting system designed to facilitate and accelerate the reporting process using automatic prepopulation mechanisms. To demonstrate SALUS approach for establishing syntactic and semantic interoperability for AE reporting. Standard (e.g. HL7 CDA-CCD) and proprietary EHR data models are mapped to the E2B(R2) data model via SALUS Common Information Model. Terminology mapping and terminology reasoning services are designed to ensure the automatic conversion of source EHR terminologies (e.g. ICD-9-CM, ICD-10, LOINC or SNOMED-CT) to the target terminology MedDRA which is expected in AE reporting forms. A validated set of terminology mappings is used to ensure the reliability of the reasoning mechanisms. The percentage of data elements of a standard E2B report that can be completed automatically has been estimated for two pilot sites. In the best scenario (i.e. the available fields in the EHR have actually been filled), only 36% (pilot site 1) and 38% (pilot site 2) of E2B data elements remain to be filled manually. In addition, most of these data elements shall not be filled in each report. SALUS platform's interoperability solutions enable partial automation of the AE reporting process, which could contribute to improve current spontaneous reporting practices and reduce under-reporting, which is currently one major obstacle in the process of acquisition of pharmacovigilance data.

Severity of mental illness as a result of multiple childhood adversities: US National Epidemiologic Survey.

Science.gov (United States)

Curran, Emma; Adamson, Gary; Stringer, Maurice; Rosato, Michael; Leavey, Gerard

2016-05-01

To examine patterns of childhood adversity, their long-term consequences and the combined effect of different childhood adversity patterns as predictors of subsequent psychopathology. Secondary analysis of data from the US National Epidemiologic Survey on alcohol and related conditions. Using latent class analysis to identify childhood adversity profiles; and using multinomial logistic regression to validate and further explore these profiles with a range of associated demographic and household characteristics. Finally, confirmatory factor analysis substantiated initial latent class analysis findings by investigating a range of mental health diagnoses. Latent class analysis generated a three-class model of childhood adversity in which 60 % of participants were allocated to a low adversity class; 14 % to a global adversities class (reporting exposures for all the derived latent classes); and 26 % to a domestic emotional and physical abuse class (exposed to a range of childhood adversities). Confirmatory Factor analysis defined an internalising-externalising spectrum to represent lifetime reporting patterns of mental health disorders. Using logistic regression, both adversity groups showed specific gender and race/ethnicity differences, related family discord and increased psychopathology. We identified underlying patterns in the exposure to childhood adversity and associated mental health. These findings are informative in their description of the configuration of adversities, rather than focusing solely on the cumulative aspect of experience. Amelioration of longer-term negative consequences requires early identification of psychopathology risk factors that can inform protective and preventive interventions. This study highlights the utility of screening for childhood adversities when individuals present with symptoms of psychiatric disorders.

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

Science.gov (United States)

2010-05-25

...] Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for...

Adversity, Adaptive Calibration, and Health: The Case of Disadvantaged Families.

Science.gov (United States)

de Baca, Tomás Cabeza; Wahl, Richard A; Barnett, Melissa A; Figueredo, Aurelio José; Ellis, Bruce J

2016-06-01

Epidemiologists and medical researchers often employ an allostatic load model that focuses on environmental and lifestyle factors, together with biological vulnerabilities, to explain the deterioration of human physiological systems and chronic degenerative disease. Although this perspective has informed medicine and public health, it is agnostic toward the functional significance of pathophysiology and health deterioration. Drawing on Life History (LH) theory, the current paper reviews the literature on disadvantaged families to serve as a conceptual model of stress-health relationships in which the allocation of reproductive effort is instantiated in the LH strategies of individuals and reflects the bioenergetic and material resource tradeoffs . We propose that researchers interested in health disparities reframe chronic degenerative diseases as outcomes resulting from strategic calibration of physiological systems to best adapt, survive, and reproduce in response to demands of specific developmental contexts. These effects of adversity on later-age degenerative disease are mediated, in part, by socioemotional and cognitive mechanisms expressed in different life history strategies.

Adversity, Adaptive Calibration, and Health: The Case of Disadvantaged Families

Science.gov (United States)

de Baca, Tomás Cabeza; Wahl, Richard A.; Barnett, Melissa A.; Figueredo, Aurelio José; Ellis, Bruce J.

2016-01-01

Epidemiologists and medical researchers often employ an allostatic load model that focuses on environmental and lifestyle factors, together with biological vulnerabilities, to explain the deterioration of human physiological systems and chronic degenerative disease. Although this perspective has informed medicine and public health, it is agnostic toward the functional significance of pathophysiology and health deterioration. Drawing on Life History (LH) theory, the current paper reviews the literature on disadvantaged families to serve as a conceptual model of stress-health relationships in which the allocation of reproductive effort is instantiated in the LH strategies of individuals and reflects the bioenergetic and material resource tradeoffs. We propose that researchers interested in health disparities reframe chronic degenerative diseases as outcomes resulting from strategic calibration of physiological systems to best adapt, survive, and reproduce in response to demands of specific developmental contexts. These effects of adversity on later-age degenerative disease are mediated, in part, by socioemotional and cognitive mechanisms expressed in different life history strategies. PMID:27175327

The interpersonal adverse effects reported by 1008 users of antidepressants; and the incremental impact of polypharmacy.

Science.gov (United States)

Read, John; Gee, Aimee; Diggle, Jacob; Butler, Helen

2017-10-01

Antidepressant drugs are being prescribed at ever increasing rates internationally, despite marginal benefit compared to placebo and a range of adverse effects. Most studies of adverse effects focus on biological phenomena. This article presents the results of an online survey of 1008 self-selected anti-depressant users in Britain, which asked about five adverse effects in the interpersonal domain. The most commonly reported among participants who took only antidepressants were: Sex Life - 43.7%, Work or Study - 27.0% and Social Life - 23.5%. These rates of interpersonal adverse effects were even higher for the 52% of participants who were also taking one or more other psychiatric drugs. Only about a half (48%) felt they had been given enough information about side effects by the prescriber. Those initially prescribed medication by a psychiatrist were more likely to be on several types of drugs and reported more adverse effects than those whose prescriber was a General Practitioner (GP). Researchers and prescribers are encouraged to pay greater attention to interpersonal adverse effects. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

Testing and testing positive: childhood adversities and later life HIV status among Kenyan women and their partners.

Science.gov (United States)

Goodman, Michael L; Raimer-Goodman, Lauren; Chen, Catherine X; Grouls, Astrid; Gitari, Stanley; Keiser, Philip H

2017-12-01

Adverse childhood experiences are a critical feature of lifelong health. No research assesses whether childhood adversities predict HIV-testing behaviors, and little research analyzes childhood adversities and later life HIV status in sub-Saharan Africa. We use regression models with cross-sectional data from a representative sample (n = 1974) to analyze whether adverse childhood experiences, separately or as cumulative exposures, predict reports of later life HIV testing and testing HIV+ among semi-rural Kenyan women and their partners. No significant correlation was observed between thirteen cumulative childhood adversities and reporting prior HIV testing for respondent or partner. Separately, childhood sexual abuse and emotional neglect predicted lower odds of reporting having previously been tested for HIV. Witnessing household violence during one's childhood predicted significantly higher odds of reporting HIV+. Sexual abuse predicted higher odds of reporting a partner tested HIV+. Preventing sexual abuse and household violence may improve HIV testing and test outcomes among Kenyan women. More research is required to understand pathways between adverse childhood experiences and partner selection within Kenya and sub-Saharan Africa, and data presented here suggest understanding pathways may help improve HIV outcomes. © The Author 2016. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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

Science.gov (United States)

Ali, Ayad K; Hartzema, Abraham G

2012-01-01

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. 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). 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. Omalizumab is associated with higher than expected reporting of arterial thrombotic events in asthmatic patients. This hypothesis needs further testing in robust epidemiological studies.

Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System.

Science.gov (United States)

Sanagawa, Akimasa; Hotta, Yuji; Kataoka, Tomoya; Maeda, Yasuhiro; Kondo, Masahiro; Kawade, Yoshihiro; Ogawa, Yoshihiro; Nishikawa, Ryohei; Tohkin, Masahiro; Kimura, Kazunori

2018-04-16

We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio (ROR) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular-targeted drugs). We focused on molecular-targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab-containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

Science.gov (United States)

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-12-01

Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

OAE: The Ontology of Adverse Events.

Science.gov (United States)

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

2014-01-01

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

Hospital staff should use more than one method to detect adverse events and potential adverse events: incident reporting, pharmacist surveillance and local real‐time record review may all have a place

Science.gov (United States)

Olsen, Sisse; Neale, Graham; Schwab, Kat; Psaila, Beth; Patel, Tejal; Chapman, E Jane; Vincent, Charles

2007-01-01

Background Over the past five years, in most hospitals in England and Wales, incident reporting has become well established but it remains unclear how well reports match clinical adverse events. International epidemiological studies of adverse events are based on retrospective, multi‐hospital case record review. In this paper the authors describe the use of incident reporting, pharmacist surveillance and local real‐time record review for the recognition of clinical risks associated with hospital inpatient care. Methodology Data on adverse events were collected prospectively on 288 patients discharged from adult acute medical and surgical units in an NHS district general hospital using incident reports, active surveillance of prescription charts by pharmacists and record review at time of discharge. Results Record review detected 26 adverse events (AEs) and 40 potential adverse events (PAEs) occurring during the index admission. In contrast, in the same patient group, incident reporting detected 11 PAEs and no AEs. Pharmacy surveillance found 10 medication errors all of which were PAEs. There was little overlap in the nature of events detected by the three methods. Conclusion The findings suggest that incident reporting does not provide an adequate assessment of clinical adverse events and that this method needs to be supplemented with other more systematic forms of data collection. Structured record review, carried out by clinicians, provides an important component of an integrated approach to identifying risk in the context of developing a safety and quality improvement programme. PMID:17301203

Association of Adverse Childhood Experiences with Life Course Health and Development.

Science.gov (United States)

Austin, Anna

2018-01-01

Several studies demonstrate an association between adverse childhood experiences (ACEs) and poor outcomes over the life course. Data from the 2012 North Carolina Behavioral Risk Factor Surveillance System show that ACEs are common among North Carolina residents, ACEs co-occur, and cumulative ACE exposure is associated with poor health outcomes. ©2018 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.

Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system.

Science.gov (United States)

Fukuda, Akiho; Tahara, Kohei; Hane, Yuuki; Matsui, Toshinobu; Sasaoka, Sayaka; Hatahira, Haruna; Motooka, Yumi; Hasegawa, Shiori; Naganuma, Misa; Abe, Junko; Nakao, Satoshi; Takeuchi, Hirofumi; Nakamura, Mitsuhiro

2017-01-01

Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS) databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS). This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ) database. We also calculated the reporting odds ratios (RORs) of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX). The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI) from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89-13.68), 6.43 (5.81-7.13), and 14.73 (11.42-18.99), respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI) for palmar-plantar erythrodysesthesia (PPE) associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74-9.07), 64.77 (56.84-73.80), and 28.76 (15.77-52.45), respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated

Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system.

Directory of Open Access Journals (Sweden)

Akiho Fukuda

Full Text Available Doxorubicin (DOX is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS. This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA and the standardized MedDRA Queries (SMQ database. We also calculated the reporting odds ratios (RORs of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX. The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89-13.68, 6.43 (5.81-7.13, and 14.73 (11.42-18.99, respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI for palmar-plantar erythrodysesthesia (PPE associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74-9.07, 64.77 (56.84-73.80, and 28.76 (15.77-52.45, respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated

Setting the stage for chronic health problems: cumulative childhood adversity among homeless adults with mental illness in Vancouver, British Columbia.

Science.gov (United States)

Patterson, Michelle L; Moniruzzaman, Akm; Somers, Julian M

2014-04-12

It is well documented that childhood abuse, neglect and household dysfunction are disproportionately present in the backgrounds of homeless adults, and that these experiences adversely impact child development and a wide range of adult outcomes. However, few studies have examined the cumulative impact of adverse childhood experiences on homeless adults with mental illness. This study examines adverse events in childhood as predictors of duration of homelessness, psychiatric and substance use disorders, and physical health in a sample of homeless adults with mental illness. This study was conducted using baseline data from a randomized controlled trial in Vancouver, British Columbia for participants who completed the Adverse Childhood Experiences (ACE) scale at 18 months follow-up (n=364). Primary outcomes included current mental disorders; substance use including type, frequency and severity; physical health; duration of homelessness; and vocational functioning. In multivariable regression models, ACE total score independently predicted a range of mental health, physical health, and substance use problems, and marginally predicted duration of homelessness. Adverse childhood experiences are overrepresented among homeless adults with complex comorbidities and chronic homelessness. Our findings are consistent with a growing body of literature indicating that childhood traumas are potent risk factors for a number of adult health and psychiatric problems, particularly substance use problems. Results are discussed in the context of cumulative adversity and self-trauma theory. This trial has been registered with the International Standard Randomized Control Trial Number Register and assigned ISRCTN42520374.

Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

Science.gov (United States)

Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

2018-03-01

Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

Medical assessment of adverse health outcomes in long-term survivors of childhood cancer

NARCIS (Netherlands)

Geenen, Maud M.; Cardous-Ubbink, Mathilde C.; Kremer, Leontien C. M.; van den Bos, Cor; van der Pal, Helena J. H.; Heinen, Richard C.; Jaspers, Monique W. M.; Koning, Caro C. E.; Oldenburger, Foppe; Langeveld, Nelia E.; Hart, Augustinus A. M.; Bakker, Piet J. M.; Caron, Huib N.; van Leeuwen, Flora E.

2007-01-01

CONTEXT: Improved survival of children with cancer has been accompanied by multiple treatment-related complications. However, most studies in survivors of childhood cancer focused on only 1 late effect. OBJECTIVE: To assess the total burden of adverse health outcomes (clinical or subclinical

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.

Adverse health effects associated with Islamic fasting -A literature review

OpenAIRE

Nania Mohamed Pakkir Maideen; Aََََbdurazak Jumale; Rajkapoor Balasubramaniam

2017-01-01

Introduction: Millions of Muslims across the world observe Islamic fasting during the holy month of Ramadan, as well as the other specific dates in the lunar calendar year. While fasting during this month, Muslims refrain from eating or drinking from dawn to dusk. Islamic fasting is similar to alternate day fasting (ADF) since it incorporates an average of 12 hours of fasting and 12 hours of feasting periods. This present review study is aimed to find out the common adverse health effects ass...

Adverse effects of iodine thyroid blocking: A systematic review

International Nuclear Information System (INIS)

Spallek, L.; Krille, L.; Reiners, C.; Schneider, R.; Yamashita, S.; Zeeb, H.

2008-01-01

131 I, when released in a radiological or nuclear accident as happened recently in Fukushima (Japan)), may cause thyroid cancer as a long-term consequence. Iodine thyroid blocking (ITB) is known to reduce the risk of developing thyroid cancer. Potential adverse effects of ITB have not been systematically investigated so far. This article summarises the results of a review on adverse effects of ITB based on a systematic literature search in scientific medical databases. A meta-analysis was not performed as identified studies displayed major heterogeneity. The search resulted in 14 articles relevant to the topic, reporting mostly on surveys, ecological and intervention studies. Only one study from Poland focused on effects (both desired and adverse) of an ITB intervention following the Chernobyl accident. All other studies reported on iodine administration in a different context. Overall, the studies did not reveal severe adverse reactions to potassium iodide in the general public. Since ITB is a protective measure only applied in very specific circumstances, scientifically sound studies of adverse effects are scarce and consequently the evidence base is weak. The assessment of adverse effects of ITB relies on indirect evidence from related areas. This study may contribute to ongoing developments in pharmaco-epidemiology aiming to better quantify adverse effects of medications and health care interventions including ITB. All rights reserved. (authors)

A comprehensive review of regulatory test methods for endocrine adverse health effects.

Science.gov (United States)

Manibusan, M K; Touart, L W

2017-07-01

Development of new endocrine disruption-relevant test methods has been the subject of intensive research efforts for the past several decades, prompted in part by mandates in the 1996 Food Quality Protection Act (FQPA). While scientific understanding and test methods have advanced, questions remain on whether current scientific methods are capable of adequately addressing the complexities of the endocrine system for regulatory health and ecological risk assessments. The specific objective of this article is to perform a comprehensive, detailed evaluation of the adequacy of current test methods to inform regulatory risk assessments of whether a substance has the potential to perturb endocrine-related pathways resulting in human adverse effects. To that end,  approximately 42 existing test guidelines (TGs) were considered in the evaluation of coverage for endocrine-related adverse effects. In addition to evaluations of whether test methods are adequate to capture endocrine-related effects, considerations of further enhancements to current test methods, along with the need to develop novel test methods to address existing test method gaps are described. From this specific evaluation, up to 35 test methods are capable of informing whether a chemical substance perturbs known endocrine related biological pathways. Based on these findings, it can be concluded that current validated test methods are adequate to discern substances that may perturb the endocrine system, resulting in an adverse health effect. Together, these test methods predominantly form the core data requirements of a typical food-use pesticide registration submission. It is recognized, however, that the current state of science is rapidly advancing and there is a need to update current test methods to include added enhancements to ensure continued coverage and public health and environmental protection.

Managing Adverse and Reportable Information Regarding General and Flag Officers

Science.gov (United States)

2012-01-01

require a complete reading. xvii Acknowledgments The authors appreciate the sponsor support provided by William Carr , Lernes Hebert, Cheryl Black, and...E7. 22 Managing Adverse and Reportable Information nel also review the promotion board statistics regarding race, gender , acquisition personnel... discrimination brought by service members are called “equal opportunity (EO)” complaints, or some- times “military equal opportunity (MEO)” complaints.1 In

[Current movements of four serious adverse events induced by medicinal drugs based on spontaneous reports in Japan].

Science.gov (United States)

Sudo, Chie; Azuma, Yu-ichiro; Maekawa, Keiko; Kaniwa, Nahoko; Sai, Kimie; Saito, Yoshiro

2011-01-01

Spontaneous reports on suspected serious adverse events caused by medicines from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated by the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety features. Although causal relationship between the medicine and the adverse event is not evaluated, and one incidence may be redundantly reported, this information would be useful to roughly grasp the current movements of drug-related serious adverse events, We searched open-source data of the spontaneous reports publicized by Pharmaceutical and Medical Devices Agency for 4 serious adverse events (interstitial lung disease, rhabdomyolysis, anaphylaxis, and Stevens-Johnson syndrome/toxic epidermal necrolysis) from 2004 to 2010 fiscal year (for 2010, from April 1 st to January 31th). Major drug-classes suspected to the adverse events were antineoplastics for interstitial lung disease, hyperlipidemia agents and psychotropics for rhabdomyolysis, antibiotics/chemotherapeutics, antineoplastics and intracorporeal diagnostic agents for anaphylaxis (anaphylactic shock, anaphylactic reactions, anaphylactoid shock and anaphylactoid reactions), and antibiotics/chemotherapeutics, antipyretics and analgesics, anti-inflammatory agents/common cold drugs, and antiepileptics for Stevens-Johnson syndrome/toxic epidermal necrolysis. These results would help understanding of current situations of the 4 drug-related serious adverse events in Japan.

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...

Association of Adverse Childhood Experiences with Co-occurring Health Conditions in Early Childhood.

Science.gov (United States)

Bright, Melissa A; Thompson, Lindsay A

2018-01-01

To understand how adverse childhood experiences (ACEs) are associated with co-occurring physical, mental and developmental problems during early childhood. A subsample of 19,957 children aged 2-5 years were selected from the 2011-2012 National Survey for Child Health. Outcomes included 18 health conditions organized in singular condition domains (physical, mental, and developmental), and combinations of condition domains (e.g., physical plus mental, mental plus developmental, etc.). Predictors included 8 ACEs (divorce of a parent, death of a parent, exposure to domestic violence, living with someone with a drug or alcohol abuse problem, household member with a mental illness, parent incarceration, neighborhood violence, discrimination). Multivariable logistic regression was performed controlling for demographic characteristics, having a personal doctor, health insurance coverage, and seeing a health care professional in the previous year. Experiencing 3 or more ACEs before the age of 5 years was associated with increased likelihood of nearly every co-occurring condition combination across 3 domains of health. Most notably, experiencing 3 or more ACEs was also associated with a 2-fold increase in likelihood of having ≥1 physical condition and ≥1 developmental condition, a 9-fold increase in likelihood of having ≥1 mental and ≥1 developmental condition, and a 7-fold increase in likelihood of having ≥1 physical, ≥1 mental, and ≥1 developmental condition. This study demonstrates that we can identify the health effects of adversity quite early in development and that management should include communication between both health care and early childhood education providers.

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

Science.gov (United States)

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

2014-06-04

To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Clinical study reports obtained from the EMA in 2011. Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives

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

...] Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary...

A Hospital Nursing Adverse Events Reporting System Project: An Approach Based on the Systems Development Life Cycle.

Science.gov (United States)

Cao, Yingjuan; Ball, Marion

2017-01-01

Based on the System Development Life Cycle, a hospital based nursing adverse event reporting system was developed and implemented which integrated with the current Hospital Information System (HIS). Besides the potitive outcomes in terms of timeliness and efficiency, this approach has brought an enormous change in how the nurses report, analyze and respond to the adverse events.

Childhood adversity increases the risk of onward transmission from perinatal HIV-infected adolescents and youth in South Africa.

Science.gov (United States)

Kidman, Rachel; Nachman, Sharon; Dietrich, Janan; Liberty, Afaaf; Violari, Avy

2018-05-01

Repeated exposure to childhood adversity (abuse, neglect and other traumas experienced before age 18) can have lifelong impacts on health. For HIV-infected adolescents and youth, such impacts may include onward transmission of HIV. To evaluate this possibility, the current study measured the burden of childhood adversity and its influence on risky health behaviors among perinatally-infected adolescents and youth. We surveyed 250 perinatally-infected adolescents and youth (13-24 years) receiving care in Soweto, South Africa. Both male and female participants reported on childhood adversity (using the ACE-IQ), sexual behavior, and psychosocial state. Viral load was also abstracted from their charts. We used logistic regressions to test the association between cumulative adversity and behavioral outcomes. Half the sample reported eight or more adversities. Overall, 72% experienced emotional abuse, 59% experienced physical abuse, 34% experienced sexual abuse, 82% witnessed domestic violence, and 91% saw someone being attacked in their community. A clear gradient emerged between cumulative adversities and behavioral risk. Having experienced one additional childhood adversity raised the odds of risky sexual behavior by almost 30% (OR 1.27, 95% CI 1.09-1.48). Viral suppression was poor overall (31% had viral loads >400 copies/ml), but was not related to adversity. Adversity showed a robust relationship to depression and substance abuse. Childhood adversity is common, influences the current health of HIV-positive adolescents and youth, and puts their sexual partners at risk for HIV infection. Greater primary prevention of childhood adversity and increased access to support services (e.g., mental health) could reduce risk taking among HIV-positive adolescents and youth. Copyright © 2018 Elsevier Ltd. All rights reserved.

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 (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.

[Management of adverse drug effects].

Science.gov (United States)

Schlienger, R G

2000-09-01

Adverse drug reactions (ADRs) are still considered one of the main problems of drug therapy. ADRs are associated with considerable morbidity, mortality, decreased compliance and therapeutic success as well as high direct and indirect medical costs. Several considerations have to come into play when managing a potential ADR. It is critical to establish an accurate clinical diagnosis of the adverse event. Combining information about drug exposure together with considering other possible causes of the reaction is crucial to establish a causal relationship between the reaction and the suspected drug. Identification of the underlying pathogenesis of an ADR together with the severity of the reaction will have profound implications on continuation of drug therapy after an ADR. Since spontaneous reports about ADRs are a key stone of a functioning post-marketing surveillance system and therefore play a key role in improving drug safety, health care professionals are highly encouraged to report ADRs to a local or national organization. However, because the majority of ADRs is dose-dependent and therefore preventable, individualization of pharmacotherapy may have a major impact on reducing such events.

A cross-sectional study of self-reported general health, lifestyle factors, and disease: the Hordaland Health Study

Directory of Open Access Journals (Sweden)

Randi Jepsen

2014-10-01

Full Text Available Background. Information on self-reported health is important for health professionals, and the aim of this study was to examine associations between lifestyle factors and self-reported health and the mediating effect of disease in a Norwegian population.Methods and Materials. The data collection was conducted as part of the Hordaland Health Study (HUSK 1997–99, which was a cross-sectional epidemiological study. All individuals in Hordaland county born in 1953–1957 were invited to participate (aged 40–44 years. Complete information for the present study was obtained from 12,883 individuals (44% response rate. Height and weight were measured at a physical examination. Information on lifestyle factors, self-reported health, disease (heart attack, apoplexy, angina pectoris, and diabetes, and socio-demographic variables was obtained from a self-administered questionnaire. Self-reported health was measured with a one-item question. Odds ratios for fair or poor self-reported health were calculated using multiple logistic regression analyses adjusted for disease and socio-demographic variables.Results. Respondents reporting adverse lifestyle behaviours (obesity (odds ratio (OR 1.7, p < 0.001, smoking (OR 1.2, p < 0.001, or excessive intake of alcohol (OR 3.3, p < 0.001 showed an increased risk of poor self-reported health. Furthermore, a moderate intake of wine (OR 0.6, p < 0.001 or strenuous physical activity (OR 0.5, p < 0.001 decreased the risk of poor health. Disease did not mediate the effect.Conclusion. A one-item question measuring self-reported health may be a suitable measure for health professionals to identify levels of subjective health and reveal a need to target lifestyle factors in relatively young individuals with or without disease.

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.

The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

Science.gov (United States)

Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

2018-04-20

A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

A database in ACCESS for assessing vaccine serious adverse events

Directory of Open Access Journals (Sweden)

Thomas RE

2015-04-01

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

Childhood adversity and adult personality.

Science.gov (United States)

Rosenman, Stephen; Rodgers, Bryan

2006-05-01

To explore how recalled childhood adversity affects trait measures of personality in three age cohorts of an Australian adult population and to examine the effects of particular adversities on adult personality traits. A total of 7485 randomly selected subjects in the age bands of 20-24, 40-44 and 60-64 years were interviewed at the outset of a longitudinal community study of psychological health in the Canberra region of Australia. In the initial interview, subjects answered 17 questions about domestic adversity and three questions on positive aspects of upbringing to age 16 years. Personality traits were measured by Eysenck Personality Questionnaire, Behavioural Activation and Inhibition Scales, Positive and Negative Affect Scales and a measure of dissocial behaviours. Higher levels of childhood adversity substantially increase the risk of high neuroticism (OR = 2.6) and negative affect (OR = 2.6), less for behavioural inhibition (OR = 1.7) and for dissocial behaviour (OR = 1.7). No significant effect is seen for extraversion, psychoticism or behavioural activation. Age and gender had little effect on the pattern of risk. Maternal depression has significant and substantial independent effects on measures of neuroticism and negative affect as well as most other measures of personality. Childhood domestic adversity has substantial associations with clinically important aspects of personality: neuroticism and negative affect. Only small effects are seen on behavioural inhibition and dissocial behaviour, and no significant effect on extraversion and behavioural activation. These unexpected findings contradict clinical belief. Maternal psychological ill-health is pre-eminent among adversities predicting later disadvantageous traits, even for those traits that had only the slightest association with childhood adversity. Consequences of childhood adversity prevail throughout the lifespan in men and women equally. The study underlines the importance of childhood domestic

A Review of Adverse Effects of Road Traffic Noise on Human Health

Science.gov (United States)

Singh, Devi; Kumari, Neeraj; Sharma, Pooja

Noise pollution due to road traffic is a potential threat to human health. Since it is a global hazard, the rapid urbanization and exponential traffic growth have aggravated the problem. Population residing along the busy traffic lanes is continuously exposed to the sound levels which are above the permissible limits. This constant exposure to noise pollution is a cause of concern as it leads to several adverse impacts on human health. Traffic noise causes irritation and annoyance, sleep disturbances, cardiovascular disease, risk of stroke, diabetes, hypertension and loss of hearing. It results in decreased work performance. The present review highlights the serious health hazards of road traffic noise (RTN) which needs to be curbed. Preventive measures of noise pollution can help in combating noise-induced health hazards and increased work performance.

Serious reportable events within the inpatient mental health care: Impact on physicians and nurses.

Science.gov (United States)

Martens, J; Van Gerven, E; Lannoy, K; Panella, M; Euwema, M; Sermeus, W; De Hert, M; Vanhaecht, K

2016-07-01

To investigate the prevalence of physicians and nurses involved in an adverse event within mental health. A quantitative, cross-sectional study was performed. Six Flemish psychiatric hospitals (Belgium) participated in this exploratory cross-sectional study. All psychiatrists and nurses working in these hospitals were invited to complete an online questionnaire in March 2013. 28 psychiatrists and 252 nurses completed the survey. 205 (73%) of the 280 respondents were personally involved at least once in an adverse event within their entire career. Respondents reported that the adverse event with the greatest impact was related to suicide in almost 64% of the cases. About one in eight respondents considered quitting their job because of it. Almost 18% declared that due to the impact of the event, they believed that the quality of the administered care was affected for longer than one month. Respondents stated that they received much support of colleagues (95%), the chief nurse (86%) and the partner (71%). Colleagues seemed to be most supportive in the recovery process. Physicians and nurses working in inpatient mental health care may be at high risk to being confronted with an adverse event at some point in their career. The influence on health professionals involved in an adverse event on their work is particularly important in the first 4-24h. Professionals at those moments had higher likelihood to be involved in another adverse event. Institutions should seriously consider giving support almost at that time. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Household air pollution from cooking and risk of adverse health and birth outcomes in Bangladesh: a nationwide population-based study.

Science.gov (United States)

Khan, Md Nuruzzaman; B Nurs, Cherri Zhang; Mofizul Islam, M; Islam, Md Rafiqul; Rahman, Md Mizanur

2017-06-13

Household air pollution (HAP) from cooking with solid fuels has become a leading cause of death and disability in many developing countries including Bangladesh. We assess the association between HAP and risk of selected adverse birth and maternal health outcomes. Data for this study were extracted from Bangladesh Demographic and Health Survey conducted during 2007-2014. Selected adverse birth outcomes were acute respiratory infection (ARI) among children, stillbirth, low birth weight (LBW), under-five mortality, neonatal mortality and infant mortality. Maternal pregnancy complications and cesarean delivery were considered as the adverse maternal health outcomes. Place of cooking, use of solid fuel within the house boundary and in living room were the exposure variables. To examine the association between exposure and outcome variables, we used a series of multiple logistic regression models accounted for complex survey design. Around 90% of the respondents used solid fuel within the house boundary, 11% of them used solid fuel within the living room. Results of multiple regression indicated that cooking inside the house increased the risk of neonatal mortality (aOR,1.25; 95% CI, 1.02-1.52), infant mortality (aOR, 1.18; 95% CI, 1.00-1.40), ARI (aOR, 1.18; 95% CI, 1.08-1.33), LBW (aOR, 1.25; 95% CI, 1.10-1.43), and cesarean delivery (aOR,1.18; 95% CI, 1.01-1.29). Use of solid fuel, irrespective of cooking places, increased the risk of pregnancy complications (aOR, 1.36; 95% CI, 1.19-1.55). Compared to participants who reported cooking outside the house, the risk of ARI, LBW were significantly high among those who performed cooking within the house, irrespective of type of cooking fuel. Indoor cooking and use of solid fuel in household increase the risk of ARI, LBW, cesarean delivery, and pregnancy complication. These relationships need further investigation using more direct measures of smoke exposure and clinical measures of health outcomes. The use of clean fuels

Prospective associations of psychosocial adversity in childhood with risk factors for cardiovascular disease in adulthood: the MRC National Survey of Health and Development.

Science.gov (United States)

Anderson, Emma L; Caleyachetty, Rishi; Stafford, Mai; Kuh, Diana; Hardy, Rebecca; Lawlor, Debbie A; Fraser, Abigail; Howe, Laura D

2017-09-07

Studies assessing associations of childhood psychosocial adversity (e.g. sexual abuse, physical neglect, parental death), as opposed to socioeconomic adversity, with cardiovascular disease (CVD) risk factors in adulthood are scarce. We aimed to assess associations of various forms of psychosocial adversity and cumulative adversity in childhood, with multiple CVD risk factors in mid-life. Participants were from the MRC National Survey of Health and Development. Childhood psychosocial risk factors were reported prospectively by parents from 1950-1957, and retrospectively by participants at mean age 43 years in 1989. CVD risk factors were assessed at mean age 60-64 years in 2006-2011. Associations of a summary score of total psychosocial adversity and CVD risk in adulthood were assessed. There was no consistent evidence that cumulative psychosocial adversity, nor any specific form of psychosocial adversity in childhood, was associated with CVD risk factors in late adulthood. There was some evidence that parental death in the first 15 years was associated with higher SBP (Beta: 0.23, 95% confidence interval: 0.06 to 0.40, P=0.01) and DBP (Beta: 0.15, 95% confidence interval: -0.01 to 0.32, P=0.07). We found no evidence that exposure to greater psychosocial adversity, or specific forms of psychosocial adversity during childhood is associated with adult CVD risk factors. Further large population studies are needed to clarify whether parental death is associated with higher systolic and diastolic blood pressure.

Australian regulatory framework and reporting entities are hindering the lessons to be learned from adverse radiation events

International Nuclear Information System (INIS)

Denham, G.

2016-01-01

When adverse radiation events occur in the medical radiation science profession in Australia they are reported to the relevant state or territory authority. The details and cause of the incident are forwarded to the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) to be included in the Australian Radiation Incident Register. The aim of any error reporting system is to learn from previous errors and to prevent them occurring again. The information obtained from past errors is one of the most invaluable tools to prevent future adverse events. This article examines the current regulatory framework, reporting systems and radiation protection authorities in Australia and their effectiveness at improving patient safety. Several obstacles must be overcome if the systems and organisations responsible for radiation safety are to meet the expectations of both the community and the medical radiation science profession. - Highlights: • Adverse radiation events in Australia are reported to state and territory authorities. • Adverse radiation events are included in the Australian Radiation Incident Register State and territory radiation authorities have failed to implement changes agreed upon in 1999. • The Australian Radiation Incident Register requires reforms if it is to operate as an effective learning system.

Adverse Drug Event Monitoring at the Food and Drug Administration: Your Report Can Make a Difference

OpenAIRE

Ahmad, Syed Rizwanuddin

2003-01-01

The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treati...

Evidence Report: Risk of Adverse Health Effects Due to Host-Microorganism Interactions

Science.gov (United States)

Ott, C. Mark; Oubre, Cherie; Wallace, Sarah; Mehta, Satish; Pierson, Duane

2016-01-01

While preventive measures limit the presence of many medically significant microorganisms during spaceflight missions, microbial infection of crewmembers cannot be completely prevented. Spaceflight experiments over the past 50 years have demonstrated a unique microbial response to spaceflight culture, although the mechanisms behind those responses and their operational relevance were unclear. In 2007, the operational importance of these microbial responses was emphasized as the results of an experiment aboard STS-115 demonstrated that the enteric pathogen Salmonella enterica serovar Typhimurium (S. Typhimurium) increased in virulence in a murine model of infection. The experiment was reproduced in 2008 aboard STS-123 confirming this finding. In response to these findings, the Institute of Medicine of the National Academies recommended that NASA investigate this risk and its potential impact on the health of the crew during spaceflight. NASA assigned this risk to the Human Research Program. To better understand this risk, evidence has been collected and reported from both spaceflight analog systems and actual spaceflight including Mir, Space Shuttle, and ISS missions. Although the performance of virulence studies during spaceflight are challenging and often impractical, additional information has been and continues to be collected to better understand the risk to crew health. Still, the uncertainty concerning the extent and severity of these alterations in host-microorganism interactions is very large and requires more investigation as the focus of human spaceflight shifts to longer-duration exploration class missions.

[Causes of underreporting of occupational injuries and adverse events in Chile].

Science.gov (United States)

Luengo, Carolina; Paravic, Tatiana; Valenzuela, Sandra

2016-02-01

Objective To describe the causes of underreporting of occupational injuries and adverse events as identified in the international literature and by key informants in the area of health and risk prevention in Chile. Methods The study uses a qualitative descriptive approach. This includes a systematized literature review that follows the SALSA method (Search, Appraisal, Synthesis and Analysis) and is in line with the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). In addition, interviews were conducted with informants in the area of health and risk prevention in Chile. Results The leading causes of underreporting of occupational injuries as described in the literature and by key informants were economic factors and ignorance. With regard to adverse events, the principal causes indicated were fear of sanctions, limited support provided by the authorities, lack of knowledge, and excessive workload. Conclusions It is important to continue working to strengthen the reporting of occupational injuries and adverse events and to implement measures aimed at minimizing factors that appear to be the leading causes of underreporting. In the case of occupational injuries, this means making sure that economic factors are not an impediment but rather an incentive to reporting. With respect to adverse events, steps should be taken to eliminate the fear of sanctions and to develop recommendations, focusing more on systemic improvements than on individuals, to promote joint learning. In both cases it will be necessary to combat ignorance through continuous, systematic training and support.

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

Science.gov (United States)

Pietrobon, Ricardo; Lima, Raquel; Shah, Anand; Jacobs, Danny O; Harker, Matthew; McCready, Mariana; Martins, Henrique; Richardson, William

2007-05-01

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. 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. 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. 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. 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.

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

NARCIS (Netherlands)

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

2013-01-01

Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to

Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

Directory of Open Access Journals (Sweden)

Marília Berlofa Visacri

2014-04-01

Full Text Available The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

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.

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. Copyright © 2012 John Wiley & Sons, Ltd.

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

Adverse Selection in Community Based Health Insurance among Informal Workers in Bangladesh: An EQ-5D Assessment

Directory of Open Access Journals (Sweden)

Sayem Ahmed

2018-01-01

Full Text Available Community-based Health Insurance (CBHI schemes are recommended for providing financial risk protection to low-income informal workers in Bangladesh. We assessed the problem of adverse selection in a pilot CBHI scheme in this context. In total, 1292 (646 insured and 646 uninsured respondents were surveyed using the Bengali version of the EuroQuol-5 dimensions (EQ-5D questionnaire for assessing their health status. The EQ-5D scores were estimated using available regional tariffs. Multiple logistic regression was applied for predicting the association between health status and CBHI scheme enrolment. A higher number of insured reported problems in mobility (7.3%; p = 0.002; self-care (7.1%; p = 0.000 and pain and discomfort (7.7%; p = 0.005 than uninsured. The average EQ-5D score was significantly lower among the insured (0.704 compared to the uninsured (0.749. The regression analysis showed that those who had a problem in mobility (m 1.25–2.17; self-care (OR = 2.29; 95% CI: 1.62–3.25 and pain and discomfort (OR = 1.43; 95% CI: 1.13–1.81 were more likely to join the scheme. Individuals with higher EQ-5D scores (OR = 0.46; 95% CI: 0.31–0.69 were less likely to enroll in the scheme. Given that adverse selection was evident in the pilot CBHI scheme, there should be consideration of this problem when planning scale-up of these kind of schemes.

Symptoms of Common Mental Disorders and Adverse Health Behaviours in Male Professional Soccer Players

NARCIS (Netherlands)

Gouttebarge, Vincent; Aoki, Haruhito; Kerkhoffs, Gino

2015-01-01

To present time, scientific knowledge about symptoms of common mental disorders and adverse health behaviours among professional soccer players is lacking. Consequently, the aim of the study was to determine the prevalence of symptoms of common mental disorders (distress, anxiety/depression, sleep

Understanding the nature of errors in nursing: using a model to analyse critical incident reports of errors which had resulted in an adverse or potentially adverse event.

Science.gov (United States)

Meurier, C E

2000-07-01

Human errors are common in clinical practice, but they are under-reported. As a result, very little is known of the types, antecedents and consequences of errors in nursing practice. This limits the potential to learn from errors and to make improvement in the quality and safety of nursing care. The aim of this study was to use an Organizational Accident Model to analyse critical incidents of errors in nursing. Twenty registered nurses were invited to produce a critical incident report of an error (which had led to an adverse event or potentially could have led to an adverse event) they had made in their professional practice and to write down their responses to the error using a structured format. Using Reason's Organizational Accident Model, supplemental information was then collected from five of the participants by means of an individual in-depth interview to explore further issues relating to the incidents they had reported. The detailed analysis of one of the incidents is discussed in this paper, demonstrating the effectiveness of this approach in providing insight into the chain of events which may lead to an adverse event. The case study approach using critical incidents of clinical errors was shown to provide relevant information regarding the interaction of organizational factors, local circumstances and active failures (errors) in producing an adverse or potentially adverse event. It is suggested that more use should be made of this approach to understand how errors are made in practice and to take appropriate preventative measures.

Individual case safety reports--how to determine the onset date of an adverse reaction: a survey.

Science.gov (United States)

Klepper, Michael J; Edwards, Brian

2011-04-01

The building blocks of a pharmacovigilance system depend primarily on good quality individual case safety reports (ICSRs), which are stand-alone summaries describing one or more suspected adverse reactions that occur while a subject is taking either an investigational or marketed medicinal product and may require expedited reporting to regulatory authorities. For regulatory reporting purposes, the information of an ICSR is usually captured on forms such as MedWatch 3500/3500A, CIOMS I, Vaccine Adverse Event Report System (VAERS) or Adverse Events Following Immunization (AEFI). ICSRs that are sent electronically must meet the standards for electronic transmission specified in the International Conference on Harmonisation (ICH) E2B (R2) guideline. In filling out these regulatory forms, there are some areas of ambiguity. One of these is what the 'date of event' (MedWatch) or 'reaction onset date' (CIOMS) is interpreted to be. The aim of the survey was to determine the uniformity of responses for the onset date of an adverse reaction. A pilot and three surveys of pharmacovigilance professionals were undertaken between February and July 2009 to determine the range of responses for the onset of an adverse reaction. A narrative of a subject admitted to hospital with a diagnosis of pneumonia was presented and the respondent was asked to pick the date of onset of the adverse reaction. The total number of respondents was 129. The results of the surveys indicated there was considerable variation in responses. These differences were based on different perspectives regarding the suspected adverse reaction. Some viewed the 'reaction' to be the first onset of signs and symptoms (even if non-specific), others considered the onset of the reaction to be the date of the diagnosis, while others considered the date to be when the reaction became serious. By means of a survey, we have illustrated an example of the variability of determining the onset date of a suspected adverse reaction

Adverse Effects of Nutraceuticals and Dietary Supplements.

Science.gov (United States)

Ronis, Martin J J; Pedersen, Kim B; Watt, James

2018-01-06

Over 70% of Americans take some form of dietary supplement every day, and the supplement industry is currently big business, with a gross of over $28 billion. However, unlike either foods or drugs, supplements do not need to be registered or approved by the US Food and Drug Administration (FDA) prior to production or sales. Under the Dietary Supplement Health and Education Act of 1994, the FDA is restricted to adverse report monitoring postmarketing. Despite widespread consumption, there is limited evidence of health benefits related to nutraceutical or supplement use in well-nourished adults. In contrast, a small number of these products have the potential to produce significant toxicity. In addition, patients often do not disclose supplement use to their physicians. Therefore, the risk of adverse drug-supplement interactions is significant. An overview of the major supplement and nutraceutical classes is presented here, together with known toxic effects and the potential for drug interactions.

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.

The Relationship between Gender, Cumulative Adversities and ...

African Journals Online (AJOL)

The Relationship between Gender, Cumulative Adversities and Mental Health of Employees in ... CAs were measured in three forms (family adversities (CAFam), personal adversities ... Age of employees ranged between 18-65 years.

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...

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....

Anticipating demand for emergency health services due to medication-related adverse events after rapid mass prophylaxis campaigns.

Science.gov (United States)

Hupert, Nathaniel; Wattson, Daniel; Cuomo, Jason; Benson, Samuel

2007-03-01

Mass prophylaxis against infectious disease outbreaks carries the risk of medication-related adverse events (MRAEs). The authors sought to define the relationship between the rapidity of mass prophylaxis dispensing and the subsequent demand for emergency health services due to predictable MRAEs. The authors created a spreadsheet-based computer model that calculates scenario-specific predicted daily MRAE rates from user inputs by applying a probability distribution to the reported timing of MRAEs. A hypothetical two- to ten-day prophylaxis campaign for one million people using recent data from both smallpox vaccination and anthrax chemoprophylaxis campaigns was modeled. The length of a mass prophylaxis campaign plays an important role in determining the subsequent intensity in emergency services utilization due to real or suspected adverse events. A two-day smallpox vaccination scenario would produce an estimated 32,000 medical encounters and 1,960 hospitalizations, peaking at 5,246 health care encounters six days after the start of the campaign; in contrast, a ten-day campaign would lead to 41% lower peak surge, with a maximum of 3,106 encounters on the busiest day, ten days after initiation of the campaign. MRAEs with longer lead times, such as those associated with anthrax chemoprophylaxis, exhibit less variability based on campaign length (e.g., 124 out of an estimated 1,400 hospitalizations on day 20 after a two-day campaign versus 103 on day 24 after a ten-day campaign). The duration of a mass prophylaxis campaign may have a substantial impact on the timing and peak number of clinically significant MRAEs, with very short campaigns overwhelming existing emergency department (ED) capacity to treat real or suspected medication-related injuries. While better reporting of both incidence and timing of MRAEs in future prophylaxis campaigns should improve the application of this model to community-based emergency preparedness planning, these results highlight the need

Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS

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Sakaeda Toshiyuki

2011-10-01

Full Text Available Abstract Background Previously, adverse event reports (AERs submitted to the US Food and Drug Administration (FDA database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide. Methods After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Results Based on 1,644,220 AERs from 2004 to 2009, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals. Conclusions The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.

The validity of a patient-reported adverse drug event questionnaire using different recall periods

NARCIS (Netherlands)

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

2014-01-01

PURPOSE: To assess the validity of a patient-reported adverse drug events (ADEs) questionnaire with a 3-month or 4-week recall period. METHODS: Patients receiving at least one oral glucose-lowering drug were asked to report potential ADEs they experienced related to any drug in a daily diary for a

Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database.

Science.gov (United States)

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

2017-05-01

To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries. There were 807582 spontaneous AEs reports in the KIDS-KD. Among those, the number of antibiotics related AEs was 192510; 3382 reports were associated with imipenem. The most common imipenem-associated AE was the drug eruption; 353 times. We calculated the signal by comparing with all other antibiotics and drugs; 58 and 53 signals satisfied the three methods. We compared the drug labelling information of nine countries, including the USA, the UK, Japan, Italy, Switzerland, Germany, France, Canada, and South Korea, and discovered that the following signals were currently not included in drug labels: hypokalemia, cardiac arrest, cardiac failure, Parkinson's syndrome, myocardial infarction, and prostate enlargement. Hypokalemia was an additional signal compared with all other antibiotics, and the other signals were not different compared with all other antibiotics and all other drugs. We detected new signals that were not listed on the drug labels of nine countries. However, further pharmacoepidemiologic research is needed to evaluate the causality of these signals. © Copyright: Yonsei University College of Medicine 2017

Nurses' reporting of suspect adverse drug reactions: a mixed-methods study

Directory of Open Access Journals (Sweden)

Alessia De Angelis

2015-12-01

Full Text Available OBJECTIVE: To assess nurses' knowledge, attitudes and practices (KAP towards spontaneous adverse drug reactions (ADRs reporting. METHODS: The mixed-method study was conducted following a quanti-qualitative sequential approach: a survey (using a KAP questionnaire followed by a focus group was performed. RESULTS: In the quantitative findings, responders (570 hospital nurses declared that they were unaware of the pharmacovigilance system (58.1%, n = 331; where to find the reporting form (63.5%, n = 362; how fill it in (71.6%, n = 408; to whom and how to send it (65.8%, n = 375. Only 11.1% (n = 63 reported ADRs. The qualitative phase supported the quantitative findings and provided new information about other factors that condition ADR reporting: misinterpretation of the meaning of "reporting", unawareness of nurses' autonomy in ADR reporting and fear of consequences after ADR reporting. CONCLUSION: Nurses are not fully aware of their role in ADR reporting. We recommend educational interventions and management changes.

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

OpenAIRE

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

2014-01-01

Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical codi...

Self-Reported Extremely Adverse Life Events and Longitudinal Changes in Five-Factor Model Personality Traits in an Urban Sample

Science.gov (United States)

Löckenhoff, Corinna E.; Terracciano, Antonio; Patriciu, Nicholas S.; Eaton, William W.; Costa, Paul T.

2009-01-01

This study examined longitudinal personality change in response to extremely adverse life events in a sample (N = 458) drawn from the East Baltimore Epidemiologic Catchment Area study. Five-factor model personality traits were assessed twice over an average interval of 8 years. Twenty-five percent of the participants reported an extremely horrifying or frightening event within 2 years before the second personality assessment. Relative to the rest of the sample, they showed increases in neuroticism, decreases in the compliance facet of agreeableness, and decreases in openness to values. Baseline personality was unrelated to future events, but among participants who reported extreme events, lower extraversion and/or conscientiousness at baseline as well as longitudinal increases in neuroticism predicted lower mental health at follow-up. PMID:19230009

Adverse Event extraction from Structured Product Labels using the Event-based Text-mining of Health Electronic Records (ETHER)system.

Science.gov (United States)

Pandey, Abhishek; Kreimeyer, Kory; Foster, Matthew; Botsis, Taxiarchis; Dang, Oanh; Ly, Thomas; Wang, Wei; Forshee, Richard

2018-01-01

Structured Product Labels follow an XML-based document markup standard approved by the Health Level Seven organization and adopted by the US Food and Drug Administration as a mechanism for exchanging medical products information. Their current organization makes their secondary use rather challenging. We used the Side Effect Resource database and DailyMed to generate a comparison dataset of 1159 Structured Product Labels. We processed the Adverse Reaction section of these Structured Product Labels with the Event-based Text-mining of Health Electronic Records system and evaluated its ability to extract and encode Adverse Event terms to Medical Dictionary for Regulatory Activities Preferred Terms. A small sample of 100 labels was then selected for further analysis. Of the 100 labels, Event-based Text-mining of Health Electronic Records achieved a precision and recall of 81 percent and 92 percent, respectively. This study demonstrated Event-based Text-mining of Health Electronic Record's ability to extract and encode Adverse Event terms from Structured Product Labels which may potentially support multiple pharmacoepidemiological tasks.

Drug Adverse Event Detection in Health Plan Data Using the Gamma Poisson Shrinker and Comparison to the Tree-based Scan Statistic

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David Smith

2013-03-01

Full Text Available Background: Drug adverse event (AE signal detection using the Gamma Poisson Shrinker (GPS is commonly applied in spontaneous reporting. AE signal detection using large observational health plan databases can expand medication safety surveillance. Methods: Using data from nine health plans, we conducted a pilot study to evaluate the implementation and findings of the GPS approach for two antifungal drugs, terbinafine and itraconazole, and two diabetes drugs, pioglitazone and rosiglitazone. We evaluated 1676 diagnosis codes grouped into 183 different clinical concepts and four levels of granularity. Several signaling thresholds were assessed. GPS results were compared to findings from a companion study using the identical analytic dataset but an alternative statistical method—the tree-based scan statistic (TreeScan. Results: We identified 71 statistical signals across two signaling thresholds and two methods, including closely-related signals of overlapping diagnosis definitions. Initial review found that most signals represented known adverse drug reactions or confounding. About 31% of signals met the highest signaling threshold. Conclusions: The GPS method was successfully applied to observational health plan data in a distributed data environment as a drug safety data mining method. There was substantial concordance between the GPS and TreeScan approaches. Key method implementation decisions relate to defining exposures and outcomes and informed choice of signaling thresholds.

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

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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 (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

Standardized reporting of adverse events after microvascular decompression of cranial nerves; a population-based single-institution consecutive series

DEFF Research Database (Denmark)

Bartek, Jiri; Gulati, Sasha; Unsgård, Geirmund

2016-01-01

and 1 June 2013. Adverse events occurring within 30 days were classified according to the Landriel Ibanez classification for neurosurgical complications: grade I represents any non-life threatening complication treated without invasive procedures; grade II is complications requiring invasive management......OBJECTIVE: To investigate frequencies of adverse events occurring within 30 days after microvascular decompression (MVD) surgery using a standardized report form of adverse events. METHODS: We conducted a retrospective review of 98 adult patients (≥16 years) treated with MVD between 1 January 1994......; grade III is life-threatening adverse events requiring treatment in an intensive care unit (ICU); grade IV is death as a result of complications. We sought to compare our results with reports from the literature. RESULTS: Patients' median age was 61 years (range 26-83), and 64 (65 %) were females...

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

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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.

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

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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.

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

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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

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

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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.

Modelling the adverse effects associated with ecstasy use.

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Fisk, John E; Murphy, Philip N; Montgomery, Catharine; Hadjiefthyvoulou, Florentia

2011-04-01

Ecstasy, the street name for 3,4-meththylenedioxymethamphetamine, has been associated with a range of psychiatric symptoms and impaired psychological health in both problem and recreational users. The purpose of the present paper is to determine how these impairments are related to the history of polydrug use, and the conditions under which individuals ingest ecstasy. Associations between the variables of interest were investigated utilizing negative binomial regression. Liverpool and Preston in the North West of England. A convenience sample of 159 recreational ecstasy/polydrug users (80 males, 79 females). The sample was composed primarily of undergraduates. The dependent variable was the number of reported ecstasy-related adverse effects. Independent variables included quantitative aspects of ecstasy and other drug use, and the various beliefs and behaviours associated with ecstasy use. The number of adverse effects was associated positively with life-time exposure to ecstasy and negatively with period of abstinence from the drug. Adverse effects were more common among those who consumed ecstasy and alcohol concurrently, but were unrelated to other aspects of polydrug use. They were unaffected by whether the user took precautions when using the drug, and only weakly related to prior beliefs concerning the effects of ecstasy. Greater life-time exposure to ecstasy and consuming the drug concurrently with alcohol increase the likelihood of experiencing adverse effects, including paranoia, poor general health, irritability, confusion and moodiness. Adverse effects decrease with the period of abstinence from the drug. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.

An evaluation of selected herbal reference texts and comparison to published reports of adverse herbal events.

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Haller, Christine A; Anderson, Ilene B; Kim, Susan Y; Blanc, Paul D

2002-01-01

There has been a recent proliferation of medical reference texts intended to guide practitioners whose patients use herbal therapies. We systematically assessed six herbal reference texts to evaluate the information they contain on herbal toxicity. We selected six major herbal references published from 1996 to 2000 to evaluate the adequacy of their toxicological information in light of published adverse events. To identify herbs most relevant to toxicology, we reviewed herbal-related calls to our regional California Poison Control System, San Francisco division (CPCS-SF) in 1998 and identified the 12 herbs (defined as botanical dietary supplements) most frequently involved in these CPCS-SF referrals. We searched Medline (1966 to 2000) to identify published reports of adverse effects potentially related to these same 12 herbs. We scored each herbal reference text on the basis of information inclusiveness for the target 12 herbs, with a maximal overall score of 3. The herbs, identified on the basis of CPCS-SF call frequency were: St John's wort, ma huang, echinacea, guarana, ginkgo, ginseng, valerian, tea tree oil, goldenseal, arnica, yohimbe and kava kava. The overall herbal reference scores ranged from 2.2 to 0.4 (median 1.1). The Natural Medicines Comprehensive Database received the highest overall score and was the most complete and useful reference source. All of the references, however, lacked sufficient information on management of herbal medicine overdose, and several had incorrect overdose management guidelines that could negatively impact patient care. Current herbal reference texts do not contain sufficient information for the assessment and management of adverse health effects of botanical therapies.

Cytogenetic risks and possible adverse health effects by narcotic substances dependent.

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Movafagh, Abolfazl; Haeri, Ali; Kolahi, Ali Asghar; Hassani-Moghadam, Hossein

2012-09-01

Illicit drug abuse has crossed social, economic, and geographical borders, and remains one of the major health problems that modern society is facing worldwide. The role of multiple drug abuse as a basic for chromosome damage has been overlooked and it is important to determine its possible adverse health effects. This study aimed to compare the frequency of chromosomal damages between drug addicts and free drug controls. Cytogenetic study was obtained from 146 illicit drug-users and 200 free drug controls. Subjects were grouped into three categories depending on main drug of dependence. Cytogenetic studies on cultured lymphocytes showed an increase the frequency of chromosomal damages among addicts including opiate (5.89%), heroin (7.65%), and crystal (4.9%) when compared with drug free controls (1.45%). The frequency of chromosomal abnormalities was breaks, gaps, marker, and acentric, respectively. Our findings are also important as they are among the first to suggest here, illicit drug addiction continue to be significant public health problems in Iran.

Perceived adverse health effects of heat and their determinants in deprived neighbourhoods: a cross-sectional survey of nine cities in Canada.

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

2014-10-24

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.

Study of the health effects of bicycling in an urban atmosphere. Final report

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Waldman, M.; Weiss, S.; Articola, W.

1977-10-14

This report analyzes data on the health effects of bicycling in an urban environment through intensive study of ten healthy male subjects bicycling or driving in systematically varied conditions in the streets of Washington, D.C. Evaluation criteria for available technology and instrumentation are included and a methodology is developed for route selection. Specific air pollutants (carbon monoxide, ozone, sulfates, nitrates, and particulates) are measured concurrently with exposure and subsequent changes in health status identified through pulmonary function testing, cardiovascular testing, and blood and symptoms analysis. The report concludes that no major adverse short-term health effects were noted for ten healthy male subjects while bicycling or driving in levels of pollution and thermal stress encountered during the study period. Recommendations for further research are also presented.

Do Childhood Adversities Predict Suicidality? Findings from the General Population of the Metropolitan Area of Sao Paulo, Brazil.

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Bruno Mendonça Coêlho

Full Text Available Childhood adversities have been associated with a number of medical and psychiatric outcomes. However, the reported effects that specific childhood adversities have on suicidality vary across studies.This was a cross-sectional, stratified, multistage area probability investigation of a general population in Brazil, designated the São Paulo Megacity Mental Health Survey. The World Mental Health Composite International Diagnostic Interview was applied in 5037 individuals ≥ 18 years of age, in order to assess 12 different adversities occurring during childhood and/or adolescence, as well as to look for associations between those adversities and subsequent suicidality in different age strata.Over half of the respondents reported at least one childhood adversity. Only physical abuse was consistently associated with suicide attempts in all subsequent life stages (OR = 2.1. Among adults 20-29 years of age, the likelihood of a suicide attempt was correlated with parental divorce, whereas suicidal ideation was associated with prior sexual abuse. Among adults over 30 years of age, physical illness and economic adversity emerged as relevant childhood adversities associated with suicide attempts, whereas sexual abuse, family violence, and economic adversity were associated with suicidal ideation.Childhood adversities, especially physical abuse, are likely associated with unfavorable consequences in subsequent years. For suicidality across a lifespan, the role of different childhood adversities must be examined independently.

[Trends in drug-induced liver injury based on reports of adverse reactions to PMDA in Japan].

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Sudo, Chie; Maekawa, Keiko; Segawa, Katsunori; Hanatani, Tadaaki; Sai, Kimie; Saito, Yoshiro

2012-01-01

Reports on drug-related adverse reactions from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated under the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety measures. Although association between the medicine and the adverse event has not been clearly evaluated, and an incidence may be redundantly reported, this information would be useful to roughly grasp the current status of drug-related adverse reactions. In the present study, we analyzed the incidence of drug-induced liver injury by screening the open-source data publicized by the homepage of Pharmaceutical and Medical Devices Agency from 2005 to 2011 fiscal years. Major drug-classes suspected to cause general drug-induced liver injury were antineoplastics, anti-inflammatory agents/common cold drugs, chemotherapeutics including antituberculous drugs, antidiabetics, antiulcers and antiepileptics. In addition, reported cases for fulminant hepatitis were also summarized. We found that antituberculous isoniazid and antineoplastic tegafur-uracil were the top two suspected drugs. These results might deepen understanding of current situations for the drug-induced liver injury in Japan.

Adverse Drug Events and Medication Errors in African Hospitals: A Systematic Review.

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Mekonnen, Alemayehu B; Alhawassi, Tariq M; McLachlan, Andrew J; Brien, Jo-Anne E

2018-03-01

Medication errors and adverse drug events are universal problems contributing to patient harm but the magnitude of these problems in Africa remains unclear. The objective of this study was to systematically investigate the literature on the extent of medication errors and adverse drug events, and the factors contributing to medication errors in African hospitals. We searched PubMed, MEDLINE, EMBASE, Web of Science and Global Health databases from inception to 31 August, 2017 and hand searched the reference lists of included studies. Original research studies of any design published in English that investigated adverse drug events and/or medication errors in any patient population in the hospital setting in Africa were included. Descriptive statistics including median and interquartile range were presented. Fifty-one studies were included; of these, 33 focused on medication errors, 15 on adverse drug events, and three studies focused on medication errors and adverse drug events. These studies were conducted in nine (of the 54) African countries. In any patient population, the median (interquartile range) percentage of patients reported to have experienced any suspected adverse drug event at hospital admission was 8.4% (4.5-20.1%), while adverse drug events causing admission were reported in 2.8% (0.7-6.4%) of patients but it was reported that a median of 43.5% (20.0-47.0%) of the adverse drug events were deemed preventable. Similarly, the median mortality rate attributed to adverse drug events was reported to be 0.1% (interquartile range 0.0-0.3%). The most commonly reported types of medication errors were prescribing errors, occurring in a median of 57.4% (interquartile range 22.8-72.8%) of all prescriptions and a median of 15.5% (interquartile range 7.5-50.6%) of the prescriptions evaluated had dosing problems. Major contributing factors for medication errors reported in these studies were individual practitioner factors (e.g. fatigue and inadequate knowledge

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

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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.

Family Adversity and Resilience Measures in Pediatric Acute Care Settings.

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O'Malley, Donna M; Randell, Kimberly A; Dowd, M Denise

2016-01-01

Adverse childhood experiences (ACEs) impact health across the life course. The purpose of this study was to identify caregiver ACEs, current adversity, and resilience in families seeking care in pediatric acute care settings. Study aims included identifying demographic characteristics, current adversities, and resilience measures associated with caregiver ACEs ≥4. A cross-sectional survey study design was used and a convenience sample (n = 470) recruited at emergency and urgent care settings of a large Midwest pediatric hospital system. Measures were self-reported. The original 10-item ACEs questionnaire measured caregiver past adversity. Current adversity was measured using the 10-item IHELP. The six-item Brief Resiliency Scale measured resilience, and WHO-5 Well-Being Index was used to measure depressive affect. Compared to participants with ACEs score of 0-3 participants with ACEs ≥4 were more likely to have multiple current adversities, increased risk of depression, and lower resilience. Caregivers using pediatric acute care settings carry a high burden of ACEs and current adversities. Caregiver ACEs are associated with current child experiences of adversity. Caregivers socioeconomic status and education level may not be an accurate indicator of a family's risks or needs. Pediatric acute care settings offer opportunities to access, intervene, and prevent childhood adversity. © 2016 Wiley Periodicals, Inc.

A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm.

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McDonald, Cameron J; Kalisch Ellett, Lisa M; Barratt, John D; Caughey, Gillian E

2014-12-01

Concerns with the safety profiles of the newer anticoagulants have been raised because of differences in treatment populations between pre-marketing studies (randomized controlled trials) and clinical practice. Little is known about the potential safety issues and the reporting in spontaneous adverse event databases associated with rivaroxaban. To analyse spontaneous adverse event reports associated with the oral anticoagulant rivaroxaban from Australia, Canada and the USA; and to examine concomitant medicine use that may increase the risk of adverse events. Spontaneous adverse event report databases from Australia, Canada and the USA were examined for all reports of adverse events associated with rivaroxaban and concomitant medicines from 1 August 2005 to 31 March 2013. Disproportionality analysis (the proportional reporting ratio [PRR] and reporting odds ratio [ROR]) was conducted for quantitative detection of signals, using the US database. There were 244 spontaneous adverse event reports associated with rivaroxaban from Australia, 536 from Canada and 1,638 from the USA. Reporting of haemorrhage (any type) was common, ranging from 30.7% for Australia to 37.5% for Canada. Gastrointestinal haemorrhage was the most commonly reported haemorrhage, accounting for 13.9% of Australian, 16.4% of Canadian and 11.1% of US adverse event reports. Positive signals were confirmed in the US data (haemorrhage [any type] PRR 11.93, χ (2) 4,414.78 and ROR 13.41, 95% confidence interval [CI] 12.13-14.81; gastrointestinal haemorrhage PRR 12.52, χ (2) 2,018.48 and ROR 13.15, 95% CI 11.36-15.21). Reporting of concomitant use of medicines with the potential to increase bleeding risk ranged from 63.7% in Australia to 89.2% in Canada. A large proportion of adverse event reports for rivaroxaban were associated with use of concomitant medicines, which may have increased the risk of adverse events-in particular, haemorrhage. Increased awareness of a patient's comorbidity and associated

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

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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

Attitudes and Usage of the Food and Drug Administration Adverse Event Reporting System Among Gastroenterology Nurse Practitioners and Physician Assistants.

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Salk, Allison; Ehrenpreis, Eli D

2016-01-01

The Food and Drug Administration Adverse Event Reporting System (FAERS) is used for postmarketing pharmacovigilance. Our study sought to assess attitudes and usage of the FAERS among gastroenterology nurse practitioners (NPs) and physician assistants (PAs). A survey was administered at the August 2012 Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant course, held in Chicago, IL. Of the 128 respondents, 123 (96%) reported a specialty in gastroenterology or hepatology and were included in analysis. Eighty-nine participants were NPs and 32 PAs, whereas 2 did not report their profession. Although 119 (98%) agreed or strongly agreed with the statement that accurately reporting adverse drug reactions is an important process to optimize patient safety, the majority of participants (54% NPs and 81% PAs) were unfamiliar with the FAERS. In addition, only 20% of NPs and 9% of PAs reported learning about the FAERS in NP or PA schooling. Our study shows enthusiasm among gastroenterology NPs and PAs for the reporting of adverse drug reactions, coupled with a lack of familiarity with the FAERS. This presents an opportunity for enhanced education about reporting of adverse drug reactions for gastroenterology NPs and PAs.

45 CFR 61.9 - Reporting civil judgments related to the delivery of a health care item or service.

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2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting civil judgments related to the delivery of a health care item or service. 61.9 Section 61.9 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION HEALTHCARE INTEGRITY AND PROTECTION DATA BANK FOR FINAL ADVERSE INFORMATION...

Development of a Pediatric Adverse Events Terminology.

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

2017-01-01

In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute's Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute's Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization. Copyright © 2017 by the American Academy of Pediatrics.

Cinnamon: A systematic review of adverse events.

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Hajimonfarednejad, Mahdie; Ostovar, Mohadeseh; Raee, Mohammad Javad; Hashempur, Mohammad Hashem; Mayer, Johannes Gottfried; Heydari, Mojtaba

2018-04-05

Cinnamon, from the genus Cinnamomum and Lauraceae family, has been used as a popular spice for thousands of years around the world. Many studies have shown therapeutic effects of cinnamon including its antimicrobial, antiviral, antifungal, antioxidant, antitumor, antihypertensive, antilipemic, antidiabetic, gastroprotective, and immunomodulatory effects. Due to popular use of cinnamon and several human reports on adverse events associated with short or long term use of cinnamon, we aimed to systematically review its human reports of adverse event. Databases including Medline, Scopus, Science Direct, Embase, PubMed Central and Google scholar were searched using the key words "cinnamon" or "cinnamomum" for clinical trials, case reports and case series. Also spontaneous reports about adverse effects of cinnamon were collected from five national and international spontaneous reporting schemes. Thirty eight clinical trials were found, five of them reported adverse events. Twenty case reports and seven case series, as well as, spontaneous reports including 160 adverse events were also included. The most frequent adverse events were gastrointestinal disorders and allergic reactions which were self-limiting in the majority of cases. The available data suggests that despite the safety of cinnamon use as a spice and/or flavoring agent, its use may be associated with significant adverse effects in medicinal uses with larger doses or longer duration of use and should be clinically monitored. Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

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Bigi, Caterina; Tuccori, Marco; Bocci, Guido

2017-02-17

To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

Economic burden related to chemotherapy-related adverse events in patients with metastatic breast cancer in an integrated health care system

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Rashid N

2016-10-01

Full Text Available Nazia Rashid,1 Han A Koh,2 Hilda C Baca,3 Kathy J Lin,1 Susan E Malecha,4 Anthony Masaquel5 1Drug Information Services, Kaiser Permanente, Downey, 2Southern California Permanente Medical Group, Kaiser Permanente, Bellflower, 3Pharmacy Analytical Services, Kaiser Permanente, Downey, 4US Medical Affairs, Genetech Inc., San Francisco, 5Health Economics and Outcomes, Genentech Inc., San Francisco, CA, USA Background: Breast cancer is treated with many different modalities, including chemotherapy that can be given as a single agent or in combination. Patients often experience adverse events from chemotherapy during the cycles of treatment which can lead to economic burden.Objective: The objective of this study was to evaluate costs related to chemotherapy-related adverse events in patients with metastatic breast cancer (mBC in an integrated health care delivery system.Methods: Patients with mBC newly initiated on chemotherapy were identified and the first infusion was defined as the index date. Patients were ≥18 years old at time of index date, had at least 6 months of health plan membership and drug eligibility prior to their index date. The chemotherapy adverse events were identified after the index date and during first line of chemotherapy. Episodes of care (EOC were created using healthcare visits. Chart review was conducted to establish whether the adverse events were related to chemotherapy. Costs were calculated for each visit, including medications related to the adverse events, and aggregated to calculate the total EOC cost.Results: A total of 1,682 patients with mBC were identified after applying study criteria; 54% of these patients had one or more adverse events related to chemotherapy. After applying the EOC method, there were a total of 5,475 episodes (4,185 single episodes [76.4%] and 1,290 multiple episodes [23.6%] related to chemotherapy-related adverse events. Within single episodes, hematological (1,387 EOC, 33

Patient safety incident reports related to traditional Japanese Kampo medicines: medication errors and adverse drug events in a university hospital for a ten-year period.

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Shimada, Yutaka; Fujimoto, Makoto; Nogami, Tatsuya; Watari, Hidetoshi; Kitahara, Hideyuki; Misawa, Hiroki; Kimbara, Yoshiyuki

2017-12-21

Kampo medicine is traditional Japanese medicine, which originated in ancient traditional Chinese medicine, but was introduced and developed uniquely in Japan. Today, Kampo medicines are integrated into the Japanese national health care system. Incident reporting systems are currently being widely used to collect information about patient safety incidents that occur in hospitals. However, no investigations have been conducted regarding patient safety incident reports related to Kampo medicines. The aim of this study was to survey and analyse incident reports related to Kampo medicines in a Japanese university hospital to improve future patient safety. We selected incident reports related to Kampo medicines filed in Toyama University Hospital from May 2007 to April 2017, and investigated them in terms of medication errors and adverse drug events. Out of 21,324 total incident reports filed in the 10-year survey period, we discovered 108 Kampo medicine-related incident reports. However, five cases were redundantly reported; thus, the number of actual incidents was 103. Of those, 99 incidents were classified as medication errors (77 administration errors, 15 dispensing errors, and 7 prescribing errors), and four were adverse drug events, namely Kampo medicine-induced interstitial pneumonia. The Kampo medicine (crude drug) that was thought to induce interstitial pneumonia in all four cases was Scutellariae Radix, which is consistent with past reports. According to the incident severity classification system recommended by the National University Hospital Council of Japan, of the 99 medication errors, 10 incidents were classified as level 0 (an error occurred, but the patient was not affected) and 89 incidents were level 1 (an error occurred that affected the patient, but did not cause harm). Of the four adverse drug events, two incidents were classified as level 2 (patient was transiently harmed, but required no treatment), and two incidents were level 3b (patient was

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

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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.

The associations between self-reported sleep duration and adolescent health outcomes: what is the role of time spent on Internet use?

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Do, Young Kyung; Shin, Eunhae; Bautista, Mary Ann; Foo, Kelvin

2013-02-01

This study aimed to examine the associations of self-reported sleep duration with adolescent health outcomes, taking into account time spent on Internet use. We used data from the 2008-2009 Korea Youth Behavioral Risk Factor Survey, a cross-sectional online survey of middle and high school students aged 13-18years in South Korea (N=136,589) to examine the associations of self-reported sleep duration with four mental and physical health measures, e.g. self-report of depressive symptoms, suicidal ideation, weight status, and self-rated health. The binary logit and generalized ordered logit models controlled for time spent on Internet use for non-study purposes and other factors. Shorter self-reported sleep duration was associated with a higher likelihood of reporting depressive symptoms, suicidal ideation, and overweight or obese status, and a lower likelihood of reporting better self-rated health, even after accounting for time spent on Internet use. Excessive Internet use was found to be an independent risk factor for these outcomes. Among in-school adolescents in South Korea, shorter sleep duration and excessive Internet use are independently and additively associated with multiple indicators of adverse health status. Excessive Internet use may have not only direct adverse health consequences, but also have indirect negative effects through sleep deprivation. Copyright © 2012 Elsevier B.V. All rights reserved.

Using patients' experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above.

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Walton, Merrilyn; Jorm, Christine; Smith-Merry, Jennifer; Harrison, Reema; Manias, Elizabeth; Iedema, Rick; Kelly, Patrick

2014-10-13

Evidence of patients' experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia. The 45 and Up Study is a cohort of 265,000 adults aged 45 years and above in NSW. Patients who were hospitalised between 1 January and 30 June 2014 will be identified from this cohort using data linkage and a random sample of 20,000 invited to participate. A cross-sectional survey (including qualitative and quantitative components) will capture patients' experiences in hospital and specifically of adverse events. Approximately 25% of respondents are likely to report experiencing an adverse event. Quantitative components will capture the nature and type of events as well as common features of patients' experiences. Qualitative data provide contextual knowledge of their condition and care and the impact of the event on individuals. Respondents who do not report an adverse event will report their experience in hospital and be the control group. Statistical and thematic analysis will be used to present a patient perspective of their experiences in hospital; the characteristics of patients experiencing an adverse event; experiences of information sharing after an event (open disclosure) and the other avenues of redress pursued. Interviews with key policymakers and a document analysis will be used to create a map of the current practice. Dissemination via a one-day workshop, peer-reviewed publications and conference presentations will enable effective clinical responses and service provision and policy responses to adverse events to be developed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

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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

Characterization of scientific studies usually cited as evidence of adverse effects of GM food/feed.

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Sánchez, Miguel A; Parrott, Wayne A

2017-10-01

GM crops are the most studied crops in history. Approximately 5% of the safety studies on them show adverse effects that are a cause for concern and tend to be featured in media reports. Although these reports are based on just a handful of GM events, they are used to cast doubt on all GM crops. Furthermore, they tend to come from just a few laboratories and are published in less important journals. Importantly, a close examination of these reports invariably shows methodological flaws that invalidate any conclusions of adverse effects. Twenty years after commercial cultivation of GM crops began, a bona fide report of an adverse health effect due to a commercialized modification in a crop has yet to be reported. © 2017 The Authors. Plant Biotechnology Journal published by Society for Experimental Biology and The Association of Applied Biologists and John Wiley & Sons Ltd.

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

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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

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

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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.

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

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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

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

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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

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

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Edokpolo, Benjamin; Yu, Qiming Jimmy; Connell, Des

2015-01-01

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 (HQ 50/50 and HQ 95/5 ), 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 HQ 50/50 and HQ 95/5 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 HQ 50/50 and HQ 95/5 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.

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

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Bero Lisa

2010-11-01

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

Sexual Trauma and Adverse Health and Occupational Outcomes Among Men Serving in the U.S. Military.

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Millegan, Jeffrey; Wang, Lawrence; LeardMann, Cynthia A; Miletich, Derek; Street, Amy E

2016-04-01

Although absolute counts of U.S. service men who experience sexual trauma are comparable to service women, little is known about the impact of sexual trauma on men. The association of recent sexual trauma (last 3 years) with health and occupational outcomes was investigated using longitudinal data (2004-2013) from the Millennium Cohort Study. Of 37,711 service men, 391 (1.0%) reported recent sexual harassment and 76 (0.2%) sexual assault. In multivariable models, sexual harassment or assault, respectively, was associated with poorer mental health: AOR = 1.60, 95% CI [1.22, 2.12], AOR = 4.39, 95% CI [2.40, 8.05]; posttraumatic stress disorder: AOR = 2.50, 95% CI [1.87, 3.33], AOR = 6.63, 95% CI [3.65, 12.06]; depression: AOR = 2.37, 95% CI [1.69, 3.33], AOR = 5.60, 95% CI [2.83, 11.09]; and multiple physical symptoms: AOR = 2.22, 95% CI [1.69, 2.92]; AOR = 3.57, 95% CI [1.98, 6.42], after adjustment for relevant covariates. Sexual harassment was also associated with poorer physical health: AOR = 1.68, 95% CI [1.27, 2.22]. Men who reported sexual trauma were more likely to have left military service: AOR = 1.60, 95% CI [1.14, 2.24], and be disabled/unemployed postservice: AOR = 1.76, 95% CI [1.02, 3.02]. Results suggest that sexual trauma was significantly associated with adverse health and functionality extending to postmilitary life. Findings support the need for developing better prevention strategies and services to reduce the burden of sexual trauma on service men. Copyright © 2016 International Society for Traumatic Stress Studies.

Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

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Hoffman, Keith B; Demakas, Andrea R; Dimbil, Mo; Tatonetti, Nicholas P; Erdman, Colin B

2014-11-01

The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.

Suicidality in male prisoners: influence of childhood adversity mediated by dimensions of personality.

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Godet-Mardirossian, Hélène; Jehel, Louis; Falissard, Bruno

2011-07-01

This study aims to study the influence of childhood adversity on suicidal behavior in male prisoners. Including a random sample of 899 male prisoners (French National Mental Health Prison Survey, 2003), this paper studied suicidal ideations and suicide attempts using MINI criteria, and personality using Temperament and Character Inventory. Risk factors of suicidality were examined, and structural equations studied the influence of childhood trauma on suicidality, mediated by personality dimensions. The prisoners reported high levels of childhood adversity. More than a third reported recent suicidal ideations. Childhood adversity and dimensions of personality were associated with suicidality. Structural equations showed that childhood adversity was positively associated with suicidality, mediated by poor dimensions of character (affective stability, self-cooperativeness, and self-transcendence). In conclusion, these results confirm the importance of screening and treatment of childhood trauma among male prisoners. They suggest the importance to study dimensions of personality and tailor treatment to specific needs. © 2011 American Academy of Forensic Sciences.

Childhood Adversity, Self-Esteem, and Diurnal Cortisol Profiles across the Lifespan

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Zilioli, Samuele; Slatcher, Richard B.; Chi, Peilian; Li, Xiaoming; Zhao, Junfeng; Zhao, Guoxiang

2016-01-01

Childhood adversity is associated with poor health outcomes in adulthood; the hypothalamic-pituitary-adrenal (HPA) axis has been proposed as a crucial biological intermediary of these long-term effects. Here we tested whether childhood adversity was associated with diurnal cortisol parameters, and whether this link was partially explained by self-esteem. In both adults and children, childhood adversity was associated with lower levels of cortisol at awakening and this association was partially driven by low self-esteem. Further, we found a significant indirect pathway through which greater adversity during childhood was linked to a flatter cortisol slope via self-esteem. Lastly, those youth who had a caregiver with high self-esteem experienced a steeper decline in cortisol throughout the day compared to those youth whose caregiver reported low self-esteem. We conclude that self-esteem is a plausible psychological mechanism through which childhood adversity may get embedded in the activity of the HPA axis across the lifespan. PMID:27481911

Building an Evidence-Based Mental Health Program for Children with History of Early Adversity

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Kroupina, Maria; Vermeulen, Marlous; Moberg, Stephanie

2015-01-01

Adoption is a major intervention in a child's life, however internationally adopted (IA) children remain at risk for long-term neurodevelopmental and mental health issues due to the fact that most of them have a history of early adversity prior to their adoption. In the last 20 years, extensive research with this population has increased the…

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

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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

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

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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.

Pediatric Emergency Department and Primary Care Provider Attitudes on Assessing Childhood Adversity.

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Schilling, Samantha; Murray, Ashlee; Mollen, Cynthia J; Wedin, Tara; Fein, Joel A; Scribano, Philip V

2017-07-03

The purpose of this study was to understand pediatric emergency department (ED) and primary care (PC) health care provider attitudes and beliefs regarding the intersection between childhood adversities and health care. We conducted in-depth, semistructured interviews in 2 settings (ED and PC) within an urban health care system. Purposive sampling was used to balance the sample among 3 health care provider roles. Interview questions were based on a modified health beliefs model exploring the "readiness to act" among providers. Interviews were recorded, transcribed, and coded. Interviews continued until theme saturation was reached. Saturation was achieved after 26 ED and 19 PC interviews. Emergency department/primary care providers were similar in their perception of patient susceptibility to childhood adversity. Childhood mental health problems were the most frequently referenced adverse outcome, followed by poor childhood physical health. Adult health outcomes because of childhood adversity were rarely mentioned. Many providers felt that knowing about childhood adversity in the medical setting was important because it relates to provision of tangible resources. There were mixed opinions about whether or not pediatric health care providers should be identifying childhood adversities at all. Although providers exhibited knowledge about childhood adversity, the perceived effect on health was only immediate and tangible. The effect of childhood adversity on lifelong health and the responsibility and potential accountability health systems have in addressing these important health determinants was not recognized by many respondents in our study. Addressing these provider perspectives will be a critical component of successful transformation toward more accountable health care delivery systems.

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

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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.

Adverse effects of caffeinated energy drinks among youth and young adults in Canada: a Web-based survey.

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Hammond, David; Reid, Jessica L; Zukowski, Sara

2018-01-09

Energy drink consumption has increased dramatically among young Canadians, with anecdotal evidence of adverse health effects. There is a lack of population-based studies to examine the prevalence of adverse events from energy drinks, particularly among young people. The current study sought to assess adverse events from energy drinks among a population-based sample of youth and young adults in Canada. An online survey was conducted in 2015 with a national sample of youth (aged 12-17 yr) and young adults (aged 18-24 yr) recruited from a consumer panel. Respondents reported prior consumption of energy drinks as well as adverse outcomes, concurrent activities associated with the outcomes and whether medical attention was sought or considered. Adverse events from coffee were also assessed for comparison. Weighted analyses are reported. Of the 2055 respondents, 1516 (73.8%) reported having ever consumed an energy drink, and 1741 (84.7%) reported having ever consumed coffee (unweighted). Overall, 55.4% of respondents who had ever consumed an energy drink reported that they had experienced at least 1 adverse event, including fast heartbeat (24.7%), difficulty sleeping (24.1%), headache (18.3%), nausea/vomiting/diarrhea (5.1%), chest pain (3.6%) and seizures (0.2%); 3.1% had sought or had considered seeking medical help for an adverse event. The prevalence of reported adverse events was significantly greater among energy drink consumers than among coffee consumers (36.0%) (odds ratio [OR] 2.67 [95% confidence interval (CI) 2.01-2.56]), as was the proportion who reported seeking or considering seeking medical help for adverse events (3.1% v. 1.4%) (OR 2.18 [95% CI 1.39-3.41]). More than half of youth and young adults who had consumed energy drinks reported adverse outcomes, some serious enough to warrant seeking medical help. The adverse outcomes were consistent with the physiologic effects of caffeine but were significantly more prevalent than with other sources of

Tool to assess causality of direct and indirect adverse events associated with therapeutic interventions.

Science.gov (United States)

Zorzela, Liliane; Mior, Silvano; Boon, Heather; Gross, Anita; Yager, Jeromy; Carter, Rose; Vohra, Sunita

2018-03-01

To develop and test a tool to assess the causality of direct and indirect adverse events associated with therapeutic interventions. The intervention was one or more drugs and/or natural health products, a device, or practice (professional delivering the intervention). Through the assessment of causality of adverse events, we can learn about factors contributing to the harm and consider what modification may prevent its reoccurrence. Existing scales (WHO-UMC, Naranjo and Horn) were adapted to develop a tool (algorithm and table) to evaluate cases of serious harmful events reported through a national surveillance study. We also incorporated a novel approach that assesses indirect harm (caused by the delay in diagnosis/treatment) and the health provider delivering the intervention (practice). The tool was tested, revised and then implemented to assess all reported cases of serious events resulting from use of complementary therapies. The use of complementary therapies was the trigger to report the event. Each case was evaluated by two assessors, out of a panel of five, representing different health care professionals. The tool was used in assessment of eight serious adverse events. Each event was independently evaluated by two assessors. The algorithm facilitated assessment of a serious direct or indirect harm. Assessors agreed in the final score on seven of eight cases (weighted kappa coefficient of 0.75). A tool to support the assessment of causality of adverse events was developed and tested. We propose a novel method to assess direct and indirect harms related to product(s), device(s), practice or a combination of the previous. Further research will probably help evaluate this approach across different settings and interventions.

Early socioeconomic adversity and young adult physical illness: the role of body mass index and depressive symptoms.

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Wickrama, K A S; Kwon, Josephine A; Oshri, Assaf; Lee, Tae Kyoung

2014-10-01

The present study investigated the psychophysiological inter- and intra-individual processes that mediate the linkage between childhood and/or adolescent socioeconomic adversities and adult health outcomes. Specifically, the proposed model examined the roles of youth depressive symptoms and body mass index (BMI) trajectories as mediators that explain the link between early adversity and young adults' general health and physical illnesses after controlling for gender, race or ethnicity, and earlier general health reports. Using a nationally representative sample of 12,424 from National Longitudinal Study of Adolescent Health (Add Health), this study used growth curve modeling to consider both the severity (initial level) and the change over time (deterioration or elevation) as psychophysiological mediators, thereby acknowledging multiple facets of depressive symptoms and BMI trajectories as psychophysiological mediators of early adversity to adult health. Results provide evidence for (1) the influence of early childhood and early adolescent cumulative socioeconomic adversity on both the initial levels and changes over time of depressive symptoms and BMI and (2) the independent influences depressive symptoms and BMI trajectories on the general health and the physical illnesses of young adults. These findings contribute valuable knowledge to existing research by elucidating how early adversity exerts an enduring long-term influence on physical health problems in young adulthood; furthermore, this information suggests that effective intervention and prevention programs should incorporate multiple facets (severity and change over time) of multiple mechanisms (psychological and physiological). Published by Elsevier Inc.

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

OpenAIRE

Castleden, C M; Pickles, H

1988-01-01

1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age grou...

Adulthood Personality Correlates of Childhood Adversity

Directory of Open Access Journals (Sweden)

Charles S. Carver

2014-11-01

Full Text Available Objective: Childhood adversity has been linked to internalizing and externalizing disorders and personality disorders in adulthood. This study extends that research by examining several personality measures as correlates of childhood adversity. Method: In a college sample self-reports were collected of childhood adversity, several scales relating to personality, and current depression symptoms as a control variable. The personality-related scales were reduced to four latent variables, which we termed Anger/Aggression, Extrinsic focus, Agreeableness, and Engagement. Results: Controlling for concurrent depressive symptoms and gender, higher levels of reported childhood adversity related to lower Agreeableness and to higher Anger/Aggression and Extrinsic focus. Conclusions: Findings suggest that early adversity is linked to personality variables relevant to the building of social connection.

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......, and cardio-metabolic risk markers). Firstly, findings indicated that waist-worn accelerometers could be used to obtain a proxy measure of sleep duration meaning that monitoring of physical activity and sleep could be done by a single accelerometer worn on the waist for 24-hours a day. Secondly, most...

Psychotic-spectrum symptoms, cumulative adversity exposure and substance use among high-risk girls.

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Lansing, Amy E; Plante, Wendy Y; Fennema-Notestine, Christine; Golshan, Shahrokh; Beck, Audrey N

2018-02-01

Psychotic-spectrum symptoms are linked to trauma, substance/alcohol use (SAU), criminality/violence and poor functional outcomes, supporting the need for early detection in vulnerable populations. To better understand high-risk girls' mental health, we assessed: (1) psychotic-spectrum symptoms; (2) cumulative trauma, adversity and loss exposures (C-TALE) and adversity-indicators (symptoms, maladaptive coping, stressor-reactivity); and SAU risk-factors; and (3) relationships among psychotic-spectrum symptoms, adversity-indicators and SAU risk-factors. We administered the Structured Clinical Interviews for Psychotic Spectrum, and Trauma and Loss Spectrum to 158 adolescent delinquent girls. Girls' psychotic-spectrum profiles were similar to previously reported adult psychotic patients and characterized by typical symptoms (hallucinations/delusions, reported largely SAU-independent), interpersonal sensitivity, schizoid traits and paranoia (over-interpretation, anger over-reactivity, hypervigilance). Auditory/visual hallucinations (55.7%), delusions (92.4%), ideas of reference (96.8%) and adversity (90.0% ≥10/24 C-TALE-types) were common. Mean loss (4) and trauma (8) onset-age occurred before SAU-onset (12). Significant positive correlations were found among psychotic-spectrum symptoms, stressor-reactivity, C-TALE, adversity-indicators; and number of SAU-types; and a negative correlation occurred between psychotic-spectrum symptoms and earlier alcohol use onset. After controlling for number of SAU-types, stressor-reactivity and adversity-related numbing individually had the largest associations with total psychotic-spectrum symptoms (b = 2.6-4.3). Girls averaged more than 4 maladaptive coping strategies (e.g., 24.8% attempted suicide) in response to adversity, amplifying potential health-disparities. No racial/ethnic differences emerged on psychotic-spectrum symptoms. This symptom constellation during adolescence likely interferes with social and academic

2013 Advanced Environmental Health/Advanced Food Technology Standing Review Panel Final Report

Science.gov (United States)

Steinberg, Susan

2014-01-01

The 2013 Advanced Environmental Health/Advanced Food Technology (AEH/AFT) Standing Review Panel (from here on referred to as the SRP) participated in a WebEx/teleconference with members of the Space Human Factors and Habitability (SHFH) Element, representatives from the Human Research Program (HRP), and NASA Headquarters on November 22, 2013 (list of participants is in Section IX of this report). The SRP reviewed the updated research plans for the Risk of Adverse Health Effects Due to Alterations in Host-Microorganism Interactions (Host Microbe Risk) and the Risk of Performance Decrement and Crew Illness Due to an Inadequate Food System (Food Risk). The SRP also received a status update on the Risk of Adverse Health Effects of Exposure to Dust and Volatiles during Exploration of Celestial Bodies (Dust Risk). Overall, the SRP was impressed with the strong research plans presented by the scientists and staff associated with the SHFH Element. The SRP also thought that the updated research plans were thorough, well organized, and presented in a comprehensive manner. The SRP agrees with the changes made to the Host Microbe Risk and Food Risk portfolios and thinks that the targets for Gap closure are appropriate.

Adverse Effects of Antidepressants Reported by 1,431 people from 38 Countries: Emotional Blunting, Suicidality, and Withdrawal Effects.

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Read, John; Williams, James

2018-06-04

Studies of the adverse effects of antidepressants tend to focus on biological symptoms. The prevalence of suicidality and withdrawal effects are currently a source of controversy. To directly ascertain the experiences of an international sample of antidepressant users. An online survey asked adult antidepressant users whether they had experienced 20 adverse effects 'as a result of taking the antidepressant', and if so, to what degree of severity. 1,431 people from 38 countries responded. 61% of the respondents reported at least ten of the 20 effects, most commonly: 'Feeling emotionally numb' (reported by 71%), 'Feeling foggy or detached' (70%); 'Feeling not like myself' (66%), 'Sexual difficulties' (66%), 'Drowsiness' (63%), and 'Reduction in positive feelings' (60%). 'Suicidality' as a result of the drugs was reported by 50%. Withdrawal effects were reported by 59%, and 'Addiction' by 40%. Rates of adverse effects were higher for those prescribed multiple antidepressants and those who also took antipsychotics. Younger age and longer use of ADs were positively related to total adverse effects. One third did not recall being told about any side effects by the prescriber. Less than 5% were told about suicidality, emotional numbing, withdrawal effects or addiction. Asking people directly reveals far higher rates of adverse responses to antidepressants than previously understood, especially in the emotional, psychological and interpersonal domains. Given recent findings that antidepressants are only marginally more effective than placebo, the findings of the current study imply a cost-benefit analysis that cannot justify the extremely high prescription rates for these drugs. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Influence of Japanese Regulatory Action on Denosumab-Related Hypocalcemia Using Japanese Adverse Drug Event Report Database.

Science.gov (United States)

Takeyama, Mayu; Sai, Kimie; Imatoh, Takuya; Segawa, Katsunori; Hirasawa, Noriyasu; Saito, Yoshiro

2017-01-01

The anti-receptor activator of nuclear factor kappa-B ligand (RANKL) antibody, Denosumab (DEN), was approved in April 2012 in Japan, but a Dear Healthcare Professional Letter of Rapid Safety Communication was released in September, 2012 by the regulatory authority because of the severe hypocalcemia risks. Currently, the effectiveness of this regulatory action has not been evaluated and, therefore, this study aimed to assess its impact on DEN-induced hypocalcemia using the Japanese Adverse Drug Event Report database (JADER). The case reports from April 2012 to September 2014 were collected from the JADER, which included 151642 adverse events for the primary suspected drugs. The reporting odds ratio (ROR) of hypocalcemia as a signal of the target adverse event was analyzed for DEN and zoledronic acid (ZOL, a reference drug). Changes in RORs were compared between the pre- (Pre, April 2012 to September 2012) and post- (Post 1, October 2012 to September 2013 and Post 2, October 2013 to September 2014) periods of the regulatory action. A decrease in the hypocalcemia ROR was observed for DEN in the post-periods, especially Post 2. Multivariate logistic regression analysis showed a significant decrease in hypocalcemia signal in Post 1 (p=0.0306 vs. Pre) and Post 2 (p=0.0054 vs. Pre). ZOL caused no significant changes in ROR of hypocalcemia, and none of the drugs caused ROR changes in jaw osteonecrosis (a reference adverse event). This study suggests that the regulatory action against hypocalcemia in DEN effectively decreased hypocalcemia signal. Further studies using medical information databases are needed to confirm this result.

A Multivariate Analysis of Adverse Childhood Experiences and Health Behaviors and Outcomes among College Students

Science.gov (United States)

Windle, Michael; Haardörfer, Regine; Getachew, Beth; Shah, Jean; Payne, Jackie; Pillai, Dina; Berg, Carla J.

2018-01-01

Objective: This study investigated associations between adverse childhood experiences (ACE) prior to age 18 years and multiple health behaviors (eg, cigarette and other substance use) and outcomes (eg, obesity, depression) for a large college sample. Participants: 2,969 college students from seven universities in the state of Georgia were included…

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

Science.gov (United States)

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

2017-01-01

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

Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting

Science.gov (United States)

Green, Christopher F; Mottram, David R; Rowe, Philip H; Pirmohamed, Munir

2001-01-01

Aims To investigate the attitudes of UK hospital pharmacists towards, and their understanding, of adverse drug reaction (ADR) reporting. Methods A postal questionnaire survey of 600 randomly selected hospital pharmacists was conducted. Results The response rate was 53.7% (n = 322). A total of 217 Yellow Cards had been submitted to the CSM/MCA by 78 (25.6%) of those responding. Half of those responding felt that ADR reporting should be compulsory and over three-quarters felt it was a professional obligation. However, almost half were unclear as to what should be reported, while the time available in clinical practice and time taken to complete forms were deemed to be major deterrents to reporting. Pharmacists were not dissuaded from reporting by the need to consult a medical colleague or by the absence of a fee. Education and training had a significant influence on pharmacists' participation in the Yellow Card Scheme. Conclusions Pharmacists have a reasonable knowledge and are supportive of the Yellow Card spontaneous ADR reporting scheme. However, education and training will be important in maintaining and increasing ADR reports from pharmacists. PMID:11167664

Utilization of healthcare services and renewal of health insurance membership : evidence of adverse selection in Ghana

NARCIS (Netherlands)

Duku, Stephen Kwasi Opoku; Asenso-Boadi, Francis; Nketiah-Amponsah, Edward; Arhinful, Daniel Kojo

2016-01-01

Background: Utilization of healthcare in Ghana’s novel National Health Insurance Scheme (NHIS) has been increasing since inception with associated high claims bill which threatens the scheme’s financial sustainability. This paper investigates the presence of adverse selection by assessing the effect

Admissions and Readmissions Related to Adverse Events, 2007-2014

Science.gov (United States)

2015-12-01

DRG is a classification system primarily used for billing purposes. It uses the principle and secondary diagnoses to assign clinical conditions to...This study assessed adverse events as they relate to readmissions in the Military Health System (MHS). Among 142,579 admissions with an adverse event...The following study retrospectively assessed admissions and readmissions for adverse events in the Military Health System (MHS) by quantifying

Adverse Outcome Pathway (AOP) Network Development for Fatty Liver

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Adverse outcome pathways (AOPs) are descriptive biological sequences that start from a molecular initiating event (MIE) and end with an adverse health outcome. AOPs provide biological context for high throughput chemical testing and further prioritize environmental health risk re...

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.

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

Science.gov (United States)

Pittler, M H; Schmidt, K; Ernst, E

2005-05-01

Herbal weight-loss supplements are marketed with claims of effectiveness. Our earlier systematic review identified data from double-blind, randomized controlled trials for a number of herbal supplements. The aim of this systematic review was to assess all clinical evidence of adverse events of herbal food supplements for body weight reduction for which effectiveness data from rigorous clinical trials exist. We assessed Ephedra sinica, Garcinia cambogia, Paullinia cupana, guar gum, Plantago psyllium, Ilex paraguariensis and Pausinystalia yohimbe. Literature searches were conducted on Medline, Embase, Amed and The Cochrane Library. Data were also requested from the spontaneous reporting scheme of the World Health Organization. We hand-searched relevant medical journals and our own files. There were no restrictions regarding the language of publication. The results show that adverse events including hepatic injury and death have been reported with the use of some herbal food supplements. For herbal ephedra and ephedrine-containing food supplements an increased risk of psychiatric, autonomic or gastrointestinal adverse events and heart palpitations has been reported. In conclusion, adverse events are reported for a number of herbal food supplements, which are used for reducing body weight. Although the quality of the data does not justify definitive attribution of causality in most cases, the reported risks are sufficient to shift the risk-benefit balance against the use of most of the reviewed herbal weight-loss supplements. Exceptions are Garcinia cambogia and yerba mate, which merit further investigation.

Is violent radicalisation associated with poverty, migration, poor self-reported health and common mental disorders?

Directory of Open Access Journals (Sweden)

Kamaldeep Bhui

Full Text Available BACKGROUND: Doctors, lawyers and criminal justice agencies need methods to assess vulnerability to violent radicalization. In synergy, public health interventions aim to prevent the emergence of risk behaviours as well as prevent and treat new illness events. This paper describes a new method of assessing vulnerability to violent radicalization, and then investigates the role of previously reported causes, including poor self-reported health, anxiety and depression, adverse life events, poverty, and migration and socio-political factors. The aim is to identify foci for preventive intervention. METHODS: A cross-sectional survey of a representative population sample of men and women aged 18-45, of Muslim heritage and recruited by quota sampling by age, gender, working status, in two English cities. The main outcomes include self-reported health, symptoms of anxiety and depression (common mental disorders, and vulnerability to violent radicalization assessed by sympathies for violent protest and terrorist acts. RESULTS: 2.4% of people showed some sympathy for violent protest and terrorist acts. Sympathy was more likely to be articulated by the under 20s, those in full time education rather than employment, those born in the UK, those speaking English at home, and high earners (>£75,000 a year. People with poor self-reported health were less likely to show sympathies for violent protest and terrorism. Anxiety and depressive symptoms, adverse life events and socio-political attitudes showed no associations. CONCLUSIONS: Sympathies for violent protest and terrorism were uncommon among men and women, aged 18-45, of Muslim heritage living in two English cities. Youth, wealth, and being in education rather than employment were risk factors.

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...... agents for 23 % and sex hormones for 13 %. Conclusion Only few paediatric ADR consumer reports were found in EudraVigilance. Many of these ADRs were serious, and fatal cases were reported, however also nonserious reports were present. The findings indicate that consumer reports may be of value....... Methods We analysed ADRs reported to the European ADR database, EudraVigilance (EV) for individuals from birth to 17 years. Data were characterized with respect to age and sex of the child, type of ADR (system organ class and preferred term), seriousness and suspected medicines (anatomical therapeutic...